Change Request Tracker

Package Number Publication Date(s)
P1 2010-03-05
P2 2010-10-06; 2010-10-22
P3 2011-01-07
P4 2011-04-08
P5 2011-06-10
P6 2011-07-22
P7 2011-12-09
P8 2011-12-09
P9 2012-03-23
P10 2012-06-29
P11 2012-08-03
P12 2012-12-21
P13 2013-04-12
P14 2013-06-28
P15 2013-10-04
P16 2013-12-20
P17 2014-03-28
P18 2014-06-27
P19 2014-09-26; 2014-10-06
P20 2014-12-19
P21 2015-03-27
P22 2015-06-26
P23 2015-09-25
P24 2015-12-18
P25 2016-03-25
P26 2016-06-24
P27 2016-09-30
P28 2016-12-16
P29 2017-03-31
P30 2017-06-30
P31 2017-09-29
P32 2017-12-22
P33 2018-03-30
P34 2018-06-29
P35 2018-09-28
P36 2018-12-21
P37 2019-03-29
P38 2019-06-28
P39 2019-09-27
P40 2019-12-20
P41 2020-03-27
P41a 2020-05-08
P42 2020-06-26
P43 2020-09-25
P44 2020-12-18
P45 2021-03-26
P46 2021-06-25
P47 2021-09-24
P48 2021-12-17
P49
P50
Date of Request Submitter
Status Submitter Name Submitter E-mail Submitter Phone
Submission Code Affiliation
Closed 1/21/2009 18854 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345
Closed 1/23/2009 18905 Mauron, Hoffmann-La charlotte.mauron 41-61-688 9316

Charlotte Roche @roche.com
Closed 1/23/2009 18906 Quinn, Theresa NCI quinnt@mail.nih.g 757-238-3582

ov
Closed 1/29/2009 19014 Muhlbradt, Erin NCI-EVS muhlbradtee@mai 703 891 6415
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov
l.nih.gov

Closed 2/4/2009 19140 Mattson, Monica Celgene mmattson@celge Not given

Corporation ne.com
Closed 2/12/2009 19374 Stoner, Gail Johnson & gstoner@its.jnj.com610-889-4652

Johnson
Closed 2/13/2009 19396 Austin, Randall GlaxoSmithKlin randall.r.austin@g 919.483.1379
e sk.com
Closed 2/17/2009 19:24 19449 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345
Closed 2/17/2009 20:00 19458 Muhlbradt, Erin Lockheed muhlbradtee@mai 703 891-6415
Martin l.nih.gov

Closed 2/17/2009 21:35 19464 Tolk, Chris CDISC ctolk@cdsic.org 203-220-9345
Closed 2/20/2009 8:27 19507 Quinn, Theresa NCI quinnt@mail.nih.g 757-238-3582

ov
Martin l.nih.gov
Martin l.nih.gov

Closed 2/27/2009 10:26 19653 Gromen, Not Provided andreas.gromen@bayerhealthcare.com

+49 30 468 17071
Andreas
Closed 2/27/2009 18:50 19678 Matejunas, Shire amatejunas@shir 484-595-8324

Armand e.com
Closed 2/27/2009 19:28 19682 Tolk, Chris CDISC ctolkl@cdisc.org 203-220-9345
Closed 2/27/2009 19:32 19684 Tollk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 3/2/2009 10:43 19704 Lenzen, Mary Octagon mlenzen@octago 401-364-7402
Research nresearch.com
Solutions
Closed 3/4/2009 12:39 19750 Muhlbradt, Erin Lockheed erin.e.muhlbradt 703 891 6415
Martin @lmco.com
Martin @lmco.com
Martin @lmco.com
Closed 3/12/2009 8:54 19884 Nulton-Bodiford, CDASH liz.m.nulton- Not given
Liz bodiford@gsk.co
m
Martin @lmco.com
Closed 3/18/2009 17:59 20003 Mary Lenzen Octagon mlenzen@octago 401-364-7402

Solutions

Solutions

Solutions
Closed 3/24/2009 16:23 20131 Cheng, Yuan ImClone yuan.cheng@imcl 646-638-5043

System one.com
Closed 4/6/2009 9:12 20469 Gromen, Bayer Schering andreas.gromen@bayerschering.
+49 30 468 [incorrect e-mail
Andreas AG 170071
Closed 4/7/2009 16:12 20530 Austin, Randall GlaxoSmithKlin randall.r.austin@g 919.483.1379

e sk.com
Closed 4/14/2009 13:24 20704 Facile, Rhonda CDISC rfacile@cdisc.org 5122639529
Closed 4/14/2009 13:36 20706 Facile, Rhonda CDISC rfacile@cdisc.org 5122639530
Martin l.nih.gov

Solutions
Solutions
Solutions

Solutions

Solutions

Solutions

Solutions

Solutions

Solutions

Solutions

Solutions
Solutions
Solutions

Solutions

Solutions

Solutions

Solutions
Closed 4/23/2009 14:54 20908 Randall Austin GlaxoSmithKlin randall.r.austin@gsk.com

919.483.1379
e
closed 4/27/2009 1:17 20930 Mauron, Hoffmann-La charlotte.mauron 41-61-6889316

Charlotte Roche @roche.com
closed 4/28/2009 9:13 20964 Quinn, theresa NCI/EVS tquinn@charterint 757 238-3582
ernet.com
closed 4/28/2009 9:17 20965 Quinn, Theresa NCI/EVS tquinn@charterint 758 238-3582
ernet.com
closed 4/28/2009 9:19 20966 quinn, theresa NCI/EVS tquinn@charterint 759 238-3582
ernet.com
closed 4/28/2009 9:21 20967 quinn, theresa NI/EVS tquinn@charteinte 760 238-3582
rnet.con
closed 4/28/2009 9:24 20968 quinnt, theresa NCI/EVS tquinn@charterint 761 238-3582
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
ernet.com
closed 5/19/2009 3:34 21352 Pemble, Nik J&J npemble@its.jnj.com
closed 5/19/2009 3:45 21353 Pemble, Nik J&J npemble@its.jnj.com

closed 5/20/2009 13:56 21398 ONeill, Debra Merck debra_oneill@merck.com
267-305-8124
closed 5/21/2009 10:38 21416 Vaughn, Carol sanofi-aventis Carol.Vaughn@sanofi-aventis.com

908-304-6298
Closed 6/3/2009 8:19 21561 Wientges, Jens IBM wientges@de.ibm 49 160 5826897
.com
Deutschland .com
GmbH
Closed 6/16/2009 12:14 21778 Dong, Fugui Pharmanet fdong@pharmanet.com

609-951-6941
Closed 6/16/2009 12:14 21778 Dong, Fugui Pharmanet fdong@pharmanet.com

609-951-6941
Closed 6/19/2009 12:06 21869 Dong, Fugui Pharmanet fdong@pharmane 609-951-6941

t.com

t.com

t.com
.com
Closed 7/10/2009 10:38 22280 Vaughn, Carol Sanofi-Aventis Carol.Vaughn@sanofi-aventis.com
908-304-6298
Closed 7/13/2009 2:06 22292 Gromen Bayer Schering andreas.gromen +49 30 468 17071
Pharma @bayerhealthcare
.com
Closed 7/15/2009 6:01 22324 Haglund, Tore AstraZeneca tore.haglund@ast Not given
razeneca.com
Closed 7/16/2009 10:21 22356 Lenzen, Mary Octagon mlenzen@octagonresearch.com

484-881-2295
Research
Solutions
484-881-2295
Research
Solutions

484-881-2295
Research
Solutions

484-881-2295
Research
Solutions

484-881-2295
Research
Solutions

484-881-2295
Research
Solutions
Closed 7/23/2009 12:15 22464 SRIVASTAVA, Booz-Allen- srivastava_ranjan 301-838-3813
RANJANA Hamilton a@bah.com
Closed 7/23/2009 14:50 22485 Randall Austin GlaxoSmithKlin randall.r.austin@gsk.com

919.483.1379
e
Closed 7/30/2009 10:21 22628 Pallas, MIchelle Genentech michelcp@gene.c 650-225-2676

om
Closed 7/30/2009 10:26 22629 Pallas, Michelle Genentech michelcp@gene.c 650-225-2676
om
Deutschland .com
GmbH
Closed 8/6/2009 19:12 22775 Omundsen, CDISC eomundsen@fibro 415-978-1351

Erica Corporate gen.com
Member
Closed 8/21/2009 19:59 22970 Ramage, David Daiichi Sankyo dramage@dsi.co 732-590-4943
m
Closed 10/12/2009 16:37 23782 Ort, Jack ResearchPoint jort@researchpoin
t.com
Closed 11/16/2009 10:26 24313 Van-Keer, sanofie-aventis marie-rose.van- 33-01-55-71-28-41

Marie-rose keer@sanofi-
aventis.com
Closed 12/8/2009 13:02 24744 quinn, theresa NCI EVS quinnt@mail.nih.g

ov
Closed 12/9/2009 12:51 24798 ONeill, Debra Merck debra_oneill@mer 267-305-8124

ck.com

ck.com

ck.com
Closed 12/23/2009 14:59 25174 Muhlbradt, Erin LMCO erin.e.muhlbradt@lmco.com
Open 12/23/2009 15:57 25190 Harrington, ERT bharrington@ert.c 215-282-5565

Brian (eResearch om
Technology)
closed 5/19/2009 3:41 Comment Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345
on item
18856
New Term or
Request Type CDISC Codelist Codelist/Existing Term or Justification
Code Number
Modify Existing Term SDTM-LBTEST Codelist C67154 To be consistent with other
"Ratio" terms.
Modify Existing Term SDTM-LBTEST C 35266 - Anisocytois Use the cell name rather than the
diagnosis.
Modify Existing Term SDTM- HYPO HYPO is not specific enough.

LBTESTCD
Modify Existing Term SDTM- For LBTEST and The definition is not specific
VSTESTCD LBTESTCD - May-Hegglin enough. Need to add the
Anomaly additional text.
Modify Existing Term SDTM-LBTEST ALT Add synonym
Modify Existing Term SDTM-UNIT C42570, C68858 in codelist This is a topic we had discussed
C71620 ealier and decided to wait until this
change process was
implemented. The terms C42570
and C68858 have the same
CDISC PT of m3. From the
definitions provided, they seem to
represent different concepts.
Modify Existing Term SDTM-LBTEST, Pokilocytosis Modification

SDTM-
LBTESTCD
Modify Existing Term SDTM-TPHASE C49686 Phase IIa Trial Misspelling in definition.
Modify Existing Term SDTM-TPHASE C49688 Phase IIb Trial Misspelling in definition.
Modify Existing Term SDTM-SOC C49399 CONGENITAL, Misspelling in definition

FAMILIAL AND GENETIC
DISORDERS
Modify Existing Term SDTM-DICTNAM C49476 LOINC Double 'the' in definition.
Modify Existing Term SDTM-LBTEST C74610 Dohle Bodies Misspelling in definition.
Modify Existing Term SDTM- NOTCHED T-WAVES Misspelling in definition

EGTESTCD
Modify Existing Term SDTM-EGTEST BIFASICULAR BLOCK Misspelling in definition
Modify Existing Term SDTM-EGTEST ATRIAL FLUTTER Grammar in definition.
Modify Existing Term SDTM-UNIT C44277 Degree Fahrenheit Double (NCI) in def.
(F)
Modify Existing Term SDTM- DIVORCED Misspelling in definition

MARISTAT
Modify Existing Term SDTM-UNIT C42546 Newton Stylistic inconsistency in definition.
Modify Existing Term SDTM-LBTEST C74688 The term should be Barbiturates

instead of Barbiturate because we
are measuring the drug class. This
is consistant with other drug
classes.
Modify Existing Term SDTM-LBTEST C64470 To be consistent with other
definitions change A count of the
basophils per unit of a biological
specimen to A measurement of of
the basophils per unit of a
biological specimen.
Modify Existing Term SDTM- C64471 Change text from measure to

LBTESTCD measurement to be consistent and
use ther word measurement for all
terms
Modify Existing Term SDTM- AST Add synonym of SGOT
LBTESTCD
Modify Existing Term SDTM- C64487 Change the text from measure to
LBTESTCD measurement. New text: A relative
measurement (ratio or
percentage) of the blasts to
leukocytes in a biological
specimen. All should have the
word measurement to be
consistent.
Modify Existing Term SDTM-LBTEST C74753 The CDSIC submission value
should be without the word ratio.
New text:BUN/Creatinine. There
are only a couple of values that
have the word ratio. THis will
make all of the ratio terms
consistent.
Modify Existing Term SDTM-LBTEST C61032 Add Total Cholesterol as a

synonym.
Create New Term SDTM-AESEV Two new terms: LIFE- Need more granularity in the
THREATENING and FATAL differentiation of severity of AEs
Create New Term SDTM- SUBJECT REFUSED Many of our study designs have
NCOMPLT STUDY TREATMENT an extended period of post-
treatment follow up (3-6 months)
that includes both efficacy and
safety assessments. If a subject
discontinues study drug
prematurely, most protocols
require that they still complete the
full follow-up period. For this
reason, we collect and report on
disposition for the treatment phase
of the study separately from the
follow up phase. We have
situations where the subject
refuses further study drug, but is
willing to stay in the study and
complete the follow up period.
Oncology colleagues have
indicated that this is not
uncommon and they wish to
include this reason on the CRF for
use in summary tables. None of
the existing REAS terms seems
appropriate. We specifically do
not want to use "Withdrawal
by subject" because that is
widely interpreted as meaning the
subject refuses participation/data
collection of any kind.
Modify Existing Term SDTM-STENRF C66728 - add term Codelist is not extensible but does
BEFORE/DURING not cover all scenarios
Modify Existing Term SDTM-LBTEST C64549 Correct text to match other terms.
Modify Existing Term SDTM-LBTEST C64550 Consistwncy with other definitions.
Modify Existing Term SDTM-LBTEST C64604 Consistency in definitions.
Modify Existing Term SDTM-LBTEST C74782 Add synonym.
Modify Existing Term SDTM- C74676 All of the other vitamins are
LBTESTCD referred to by VIT. Change to be
consistent.
Modify Existing Term SDTM- C64847 Error in definition.
LBTESTCD
Modify Existing Term SDTM- C64851 Add synonym for HCG
LBTESTCD
Modify Existing Term SDTM- C74739 Add synonym Glutamic Acid.
LBTESTCD
Modify Existing Term SDTM-FRM C42956, C42945, C42899, The values in column E should
C42995, C42926, C42951 equal the values in column F in
this codelist.
Modify Existing Term SDTM- C64818 Consistency with other definitions

LBTESTCD
Modify Existing Term SDTM- C64919 Consistent definition.
LBTESTCD
Modify Existing Term SDTM-LBTEST C64820 Consistency of definition

Modify Existing Term SDTM- C74654 Definition consistency
LBTESTCD
Modify Existing Term SDTM- C64821 Consistent definition

LBTESTCD
Other None Life Threatening Life Threatening is listed as a
CDISC PT; however, it is not
actually a part of any codelist. 4 is
the PT for the SDTM-TOXGR. I
suggest either changing the
designation of Life Threatening to
a SY or adding it to a codelist.
Modify Existing Term SDTM- C17095 Reunion The definition is incorrect,

COUNTRY gramatically.
Modify Existing Term SDTM- C16334 Bermuda Bermuda requires a definition.

COUNTRY
Modify Existing Term SDTM-LBTEST Ery. Mean Corpuscluar HB Change Ery. Mean Corpuscluar
Concentration C64798 HB Concentration to Ery. Mean
Corpuscluar HGB Concentration
to add the B in HB for consistency
in the abbreviation of hemaglobin.
Modify Existing Term SDTM-LBTEST Modify definition text for Consistency in text.
Microcytes
Modify Existing Term SDTM- Monocytes/C64823 Consistent definition.

LBTESTCD
Modify Existing Term SDTM-LBTEST Monocytes/Leukocytes Change to make definition

/C64824 consistent with other terms.
Modify Existing Term SDTM- Myeloblasts/Leukocytes / Text change for consistency.

LBTESTCD C74646
Modify Existing Term SDTM-LBTEST Myelocytes/Leukocytes Consistent text in definition.

/C64826
Modify Existing Term SDTM-LBTEST Neutrophils Consistent definition.
Modify Existing Term SDTM-LBTEST Neutrophils Band Form / Consistent text

C64830
Modify Existing Term SDTM-LBTEST Neutrophils Band Consistent Text

Form/Leukocytes / C64831
Modify Existing Term SDTM-LBTEST Neutrophils/Leukocytes / Text consistency

C64827
Modify Existing Term SDTM-LBTEST Pelger Huet Anomaly / Better understanding

C74617
Modify Existing Term SDTM-LBTEST Phosphate /C64857 Add synonym
Modify Existing Term SDTM- C48227 A clarification is needed if this is

NCOMPLT the CDISC indented definition or if
this will be changed, because the
exact same term has been used in
my organization with a different
definition.
Modify Existing Term SDTM-AESEV Severe term / C41340 Shire's physicians rationale and
support of their position: We
believe the CDISC definition itself
is 'too severe' and the definition
overlaps a lot with Serious AE.
From our perspective, there needs
to be a more clear distinction.
Modify Existing Term SDTM-LBTEST Platelets / C51951 Consistent definition
Modify Existing Term SDTM- Poikilocytes/Erythrocytes / Correct error, remove )

LBTESTCD C74649
Modify Existing Term SDTM- RBC /C51946 Add synonym and modify
LBTESTCD definition for consistency.
Modify Existing Term SDTM- RBCNUC / C74705 Add synonym for RBCNUC
LBTESTCD
Modify Existing Term SDTM- Nucleated Add synonym for Nucleated
LBTESTCD Erythrocytes/Erythrocytes / Erythrocytes/Erythrocytes
C74647
Modify Existing Term SDTM-LBTEST Reticulocytes / C51947 Consistent text definition
Modify Existing Term SDTM-LBTEST Reticulocytes/ Consistent documentation of

Erythrocytes /C64828 definition
Modify Existing Term SDTM-LBTEST Thyroxine, Free /C74786 Correct spelling error
Modify Existing Term SDTM- Dacryocytes /C64801 Change definition to be consistent

LBTESTCD with other terms and add
synonym.
Modify Existing Term SDTM-LBTEST Urate /C64814 Add synonym
Modify Existing Term SDTM- WBC /C51948 Add synonym: White Blood Cells
LBTESTCD
Modify Existing Term SDTM-LBTEST Prolymphocytes/Leukocytes Change definition for consistency
/C64829
Modify Existing Term SDTM- Lymphocytes /C51949 Consistent definition

LBTESTCD
Other SDTM- Not completed Change definition of NCOMPLT
NCOMPLT codlist (C66727) to "If the
subject completed the study or
segment of the study (e.g.
Treatment if data is collected at
that granularity) then the term will
be "COMPLETED". If
the subject does not complete the
study or segment of the study then
this is the reason that a subject
discontinued." Current
definition of "The reason that
a subject was discontinued from a
clinical trial." does not
encompass the fact that the
subject could complete a portion
of the trial. Current defintion is not
consistent with CDISC SDTMIG
(Study Data Tabulation
Implementation Guide).
Modify Existing Term SDTM- C74792, C75386 C74792, C75386 are potential
LBTESTCD Somatotropin and Growth synonyms. Technically,
Hormone Measurement Somatotrophin and Growth
Hormone are analogous; both are
names for the 191kDa hormone
that is produced by somatotroph
cells in the anterior pituitary gland
(other synonyms also include
HGH, Human Growth Hormone).
The term somatotropin (without
the h) is an analogous term that
indicates the recombinant form of
Somatotrophin, or a structurally
and functionally identical hormone
that is produced by bacterial
expression systems for clinical
use.
Modify Existing Term SDTM- C74634 Bite C74634 Bite Cells/Erythrocytes

LBTESTCD Cells/Erythrocytes appears twice in LBTEST and
LBTESTCD codelist.
Modify Existing Term SDTM-LBTEST C74761, C74894, C74753 All other terms of this type do not
contain the word ratio. For
consistency CDISC may want to
consider removing the word ratio
from the PT.
Modify Existing Term SDTM-FRM C42966, C42993, C42887, These abbreviations will be how
C42994 these terms are recorded on the
CRF by site personnel. Addition of
these synonyms will align CDASH
IG appendix A with SDTM fully.
Modify Existing Term SDTM-LBTEST CDISC PT Folic Acid See request 19454
Modify Existing Term SDTM-ETHNIC C66790 Change name of codelist from

"Patient Ethnic Group"
to "Ethnic Group".
1)codelist is not limited to
patients. 2) Not consistent with
other codelist names -
"Race" is called
"Race" and not
"Subject Race".
Modify Existing Term SDTM-TPHASE C49687 Typo in term "Phase

IIIaTrial" needs to be
corrected to "Phase IIIa
Trial". Space is missing.
Modify Existing Term All All Change "CDISC Code
List" drop down list in this
form to 1) remove
"SDTM" from each
codelist name since these
codelists are not just applicable for
SDTM so it's very confusing and
misleading 2) please sort codelist
alphabetically - order in dropdown
list seems to be random and it's
difficult to find a codelist without
searching through the whole list.
Create New Term SDTM-LBTEST Indican Urine Indican Test, also known as
Obermeyer test, is one type of
Urine Metabolism Tests. This test
serves as an indication of protein
Metabolism status in digest duct
and it is used in clinical trial.
Modify Existing Term SDTM-LBTEST C74616 Clarify defintion, because it is
unclear
Modify Existing Term SDTM- C67154 Correct typos, remove duplicates

LBTESTCD
Create New Term SDTM-UNIT PACK YEARS Pack year is a commonly term
used to describe the amount a
person has smoked over time.
One pack year is defined as 20
manufactured cigarettes (1 pack)
smoked per day for one year.
Create New Term SDTM-UNIT QD The CDASH project team requests

that QD be added the terminology
codelists to mean every day. The
closest term is "Q24 hr", however,
QD is commonly used by
clinicians in medical charts and on
case report forms.
Modify Existing Term SDTM-LBTEST C74768 Misspelling in definition - Change

'course' to 'coarse'
Modify Existing Term SDTM-ETHNIC C66790 - Patient Ethnic Name of this codelist should be
Group changed to Subject Ethnic Group
as per page 272 of the
SDTMIGv3.1.2 - row 1 in the
table.
Create New Term SDTM-DOMAIN Domain - C66734 Add new term for CE - Clinical
Events to Domain codelist as per
page 274 of SDTMIGv3.1.2.
Create New Term SDTM-DOMAIN Domain - C66734 Add new term FA (Findings About)
to the Domain codelist as per
Modify Existing Term SDTM-DOMAIN Correct term C49566 for BM Correct BM to "Bone
code in Domain (C66734 ) Measurements" in the
codelist Domain codelist as per page 277
of SDTMIGv3.1.2. Current
description is "Bone
Mineral Density (BMD)
Data"
Other SDTM- Delete term AEDICT Delete term AEDICT ( C49700) in

TSPARMCD ( C49700) in TSPARMCD TSPARMCD (C66738) codelist as
(C66738) codelist per page 279 of SDTMIGv3.1.2.
Other None Delete term Adverse Event Delete term Adverse Event
Dictionary (C49700) Dictionary (C49700) in TSPARM
(C67152) codelist as per page 279
of SDTMIGv3.1.2.
Other SDTM- DRUGDICT (C49701) in Delete term DRUGDICT (C49701)

TSPARMCD TSPARMCD (C66738) in TSPARMCD (C66738) codelist
codelist as per page 280 of
SDTMIGv3.1.2.
Other SDTM-TSPARM Delete term Drug Dictionary Delete term Drug Dictionary
(C49701) in (C49701) in TSPARM(C67152)
TSPARM(C67152) codelist codelist as per page 280 of
SDTMIGv3.1.2.
Other SDTM- MHDICT (CC49702) in Delete term MHDICT (CC49702)

TSPARMCD TSPARMCD (C66738) in TSPARMCD (C66738) codelist
as per page 281 of
SDTMIGv3.1.2.
Other SDTM-TSPARM Medical Dictionary Delete term Medical
(C49702) in Dictionary(C49702) in
TSPARM(C67152) TSPARM(C67152) codelist as per
Create New Term SDTM- TSPARMCD (C66738) Add new term OBJPRIM as per
TSPARMCD page 281 of SDTMIGv3.1.2.
Create New Term SDTM-TSPARM TSPARM (C67152) Add new term "Trial Primary
Objective" to TSPARM (C67152)
Create New Term SDTM-TSPARM new term OBJSEC to the Add new term OBJSEC to the
TSPARM C67152) codelist TSPARM C67152) codelist as per
Create New Term SDTM- new term OBJSEC to the Add new term OBJSEC to the
TSPARMCD TSPARMCD (C66738) TSPARMCD (C66738) codelist as
per page 281 of SDTMIGv3.1.2.
Create New Term SDTM-TSPARM new term "Trial Add new term "Trial
Secondary Objective" Secondary Objective" to the
to the TSPARM C67152) TSPARM C67152) codelist as per
Create New Term SDTM- TSPARMCD (C66738) Add new term SPONSOR to the
TSPARMCD codelist TSPARMCD (C66738) codelist as
per page 281 of SDTMIGv3.1.2.
Create New Term SDTM-TSPARM new term "Sponsoring Add new term "Sponsoring
Organization" to the Organization" to the
TSPARM (C67152) TSPARM (C67152) codelist as per
Create New Term SDTM- none Expand ECG Results list
EGSTRESC
Other SDTM-POSITION C62174 Clarify semi-fowlers versus semi-

supine, as they are used as
synonyms and semi-fowlers not
used commonly as a term in trial
protocols.
Modify Existing Term Not provided C49641 Change spelling of foetus to fetus
x2
Modify Existing Term Not provided C28233 Misspelled term
Modify Existing Term Not provided C33507 Misspell
Modify Existing Term Not provided C34786 Definition misspell
Modify Existing Term Not provided C38235 misspell
Modify Existing Term Not provided C72554 capitalize proper name
Modify Existing Term Not provided C42558 proper name needs to be

capitalized - Henry and Weber in
definition
Modify Existing Term Not provided C44277 capitalize proper name 4
Modify Existing Term Not provided C49641 change British spelling
Modify Existing Term Not provided C68915 change tesla to Tesla
Modify Existing Term Not provided C70511,C70512,C70513, change becquerel to Becquerel

c71168
Modify Existing Term Not provided C71061 change characterised to
characterized
Modify Existing Term Not provided C71089 change occuring to occurring
Modify Existing Term Not provided C71325 change stoping to stopping
Modify Existing Term Not provided C74700 change erthrocytes to erythrocytes
Modify Existing Term SDTM- FGRANCS - change to Consistency with other test codes
LBTESTCD CSFGRAN related to urinary casts
Modify Existing Term SDTM- LACTICAC Consistency with literature

LBTESTCD
Create New Term SDTM-LBTEST Protein 24 Hr For the urine Protein 24 hour test,
we are running into the issue
where the units of measure are
not going through our conversion
table because the urine Protein 24
Hr units (ie. mg/day) are different
than the random urine Protein
units (ie. mg/dL). The 24 Hour
attribute can be captured in an
additional field within the LB
domain but this is not pulled into
our conversion table. Can you
please add Protein 24 Hr with the
test code PROT24H.
Create New Term SDTM-ACN DOSE DELAYED The codelist is not estensible and
we believe that there exists no
equivalent CDISC term for the
action taken of delaying a dose.
We do not think delaying a dose is
equivalent to interrupting the
dose. We think interrupting the
dose means to temporarily stop
the dose, while delaying the dose
means to alter the dosing
schedule.
Modify Existing Term SDTM-UNIT C70526 There is an error in the CDISC

Synonym of C70526
Modify Existing Term SDTM-UNIT Code C70527 of Codelist There is an error in the CDISC
C71620 Synonym of C70527
Create New Term SDTM-LBTEST Fragment D-dimer The corresponding lbtest, lbtestcd
are not in the SDTM control
terminology
Create New Term SDTM-LBTEST Fragment D-dimer The corresponding lbtest, lbtestcd
are not in the SDTM control
terminology
Modify Existing Term SDTM-UNIT for the all terms in the unit Common terminology
code list add synonym with
mcg for u
Create New Term SDTM-VSTEST Knee to Heel Length Knee to Heel Length is used quite
often for the infant studies
Create New Term SDTM-LBTEST Partial pressure of carbon Partial pressure of carbon dioxide
dioxide
Create New Term SDTM-LBTEST Oxygen, partial pressure Oxygen, partial pressure
Other SDTM- C66786 / COUNTRY Issues to map existing company

COUNTRY country list against SDTM
COUNTRY codelist. SDTM-
COUNTRY codelist does not
contain all ISO3166-1 alpha-3
country codes. However it is
defined as not being extensible
Create New Term SDTM-TOXGR We capture LBTOXGR values of 0
to equate to Normal. We do not
wish to set this value to missing
because missing is used when the
values or normal ranges are
missing.
Create New Term SDTM-UNIT U/L Only international unit terms are
available in the CDISC UNIT
terms list: Unit IU/L, Unit IU/mL,
Unit IU/kg, Unit IU/mg, Unit IU/g.
The symbol IU is reserved for
WHO International biological
reference preparations
(http://www.who.int/biologicals/refe
rence_preparations/en/). This
applies only for the parameters as
listed in the PDF document from
WHO. In order to represent
original and standard enzyme
activities (because none of the
common enzym reference
preparation ist listed in this
document) in a correct unit the
addition of the following terms
would be needed: Unit U/L, Unit
U/mL, Unit U/kg, Unit U/mg, Unit
U/g. In this context the definition of
"IU" should be re-
visited, since the example
mentiones enzymes which seems
misleading.
Create New Term SDTM-VSTEST SAD - Sagittal Abdominal Standard measure of visceral
Diameter obesity (size of one's belly).
Create New Term SDTM- EXISTRT An example is an oncology trial

TSPARMCD where surgery is added on to a
chemotherapy regimen for one
Arm. In this case, surgery was the
ADDON (ADDON = Y) and
EXISTRT was the chemotherapy
regimen.
Create New Term SDTM-TSPARM Existing Treatment Existing Treatment (TSPARM) for
(TSPARM) for EXISTRT EXISTRT (TSPARMCD). An
(TSPARMCD) example is an oncology trial where
surgery is added on to a
chemotherapy regimen for one
Arm. In this case, surgery was the
ADDON (ADDON = Y) and
EXISTRT was the chemotherapy
regimen. TSPARMCD EXISTRT
was also requested on July 16,
2009.
None SDTM- New TSPARMCD = TRT for New Term for both TSPARMCD
TSPARMCD "Name of (TRT) and TSPARM (Name of
Treatment" Treatment) requested. In the
SDTMIG v3.1.2 implementation
guide on page 282.
None SDTM-TSPARM Add TSPARM (Name of New Term for both TSPARMCD
Treatment) (TRT) and TSPARM (Name of
Treatment) requested. In the
SDTMIG v3.1.2 implementation
guide on page 282.
None SDTM- New Term TSPARMCD = New Term for both TSPARMCD
TSPARMCD OBJ (OBJ) and TSPARM
(OBJECTIVE) requested to be
added. Have situation of a
protocol that only lists objectives
and does not indicate whether
they are Primary or Secondary so
need a TSPARM/TSPARMCD to
cover this.
None SDTM-TSPARM New Term TSPARM = New Term for both TSPARMCD
OBJECTIVE (OBJ) and TSPARM
(OBJECTIVE) requested to be
added. Have situation of a
protocol that only lists objectives
and does not indicate whether
they are Primary or Secondary so
need a TSPARM/TSPARMCD to
cover this.
Modify Existing Term SDTM-TOXGR New Term: Grade 0 Grade 0 Adverse Event:No
Adverse Event; C66784, Adverse Event(Synonym). In
C66784, C66784, C66784, addition to the five grades for
C66784 describibg adverse events, this
term also exists in NCI Common
Terminology Criteria for Adverse
Events v4.0.Please refer to the
owl file at
http://evs.nci.nih.gov/ftp1/CTCAE.
New term definitions exist for
grade terms which were provided
by the EVS group at NCI, in
CTCAE v4.0.
Modify Existing Term SDTM-STENRF STENRF The current codelist description is

"The name of a code list that
contains terms that reference
timepoints within and without a
defined time period." I
propose changing it to "The
relative relationship of a timepoint
to a reference timepoint."
The current wording is somewhat
awkward and confusing.
Create New Term SDTM-ACN MULTIPLE Action taken with treatment can be
for multiple treatments (sometimes
there is more than one study
drug). Then we would QNAM =
AEACNR1-n where n is the
number of study drugs, QLABEL
is Reported Action Taken with
<Drug>.
Create New Term SDTM-ACN INFUSION For oncology trials, an action
taken is often to decrease the
infusion rate. This is not the same
as reducing the dose, as often the
total dose received will be the
same, it is the administration
interval that is lengthened by
decreasing infusion rate.
Modify Existing Term None LBTESTCD, C65047 In the codelist LBTESTCD

(C65047) there are a number of
codes for cell counts of all kinds of
specific cell types (The NCI
Preferred Term usually is
"XXX Count"). The
CDISC definition however uses
three different wordings: 1)
"A measurement of the XXX
per unit of a biological
specimen." (e.g. MONO) 2)
"A measurement of the XXX
in a biological specimen."
(e.g. BLAST) 3) "A count of
the XXX per unit of a biological
specimen." (e.g. CD3). I
would prefer to have consistently
wording 1).
Create New Term SDTM- New Term needed for Total potentially missing code
LBTESTCD Bilirubin
Modify Existing Term SDTM-EVAL C78735 There are duplicates for Code,
Codelist Code and Codelist name
in EVAL
Create New Term SDTM-FREQ Every a.m. / Every p.m. The terms Q.A.M. (every day
before noon) and Q.P.M. (every
day after noon) are missing from
the FREQ codelist (C71113)
Create New Term SDTM-OUT Add Not The reason why we want to add
Recovered/Stabilized 'Stabilization' is to comply with
regulatory requirements. An AE
has to be followed until resolution
or stabilization. With the current
codelist we only know whether the
AE is recovered or not recovered.
Stabilization could apply to any
diagnosis of chronic diseases of
conditions (present before or
starting during the course of the
study) that are not curable/not
expected to recover.
Modify Existing Term SDTM-LOC C32996 The definition for transverse liver
fissure is in the liver fissure
concept. Which concept does
CDSIC want, so we can move the
correct data into the correct
concept?
Create New Term SDTM-LBTEST Cortisol, Free This concept is currently not
captured in the Lab Terminology.
Create New Term SDTM- CORTISLF Addition of Test code to go with

LBTESTCD the request to add the new term
Cortisol, Free
Modify Existing Term SDTM-LBTEST Cortisol Add a synonym for clarification of
term
Modify Existing Term SDTM-UNIT mL Add cm3 as a synonym of mL

C28254
Create New Term EGSTRESC Other Would you please add OTHER as
an allowable value for the
EGSTRESC variable within the
ECG Result Codelist contained
within the SDTM Terminology
spreadsheet? By doing this, it will
enable an easier record linking
capability between the EG and
SUPPQUAL datasets.
Modify Existing Term SDTM- HYPO HYPO is not specific enough.
LBTESTCD
Summary Detailed Description
Remove "Ratio" from

Albumin/Creatinine Ratio.
Change Anisocytosis to
Anisocytes
Change HYPO to
HYPOCROM
For LBTEST and LBTESTCD The new definition should read: A measurement of the
- May-Hegglin Anomaly May-Hegglin Amonaly (which is characterized by large,
misshapen platelets and the presence of Dohle bodies in
leukocytes) in a blood specimen.
Add SGPT as a synonym.
2 different concepts with I cut-and-paste some additional very useful information

same PT (m3) provided at the time by Connie (sorry for putting you in the
spot!: I did a little digging and these two concepts are in
fact two distinct concepts with two different definitions.
Remap Pokilocytosis to CN 35267 is mapped to the lab result and should be

Pokilocyte Measurement mapped to Poikilocyte Measurement, which needs to be
created. The CDISC PTs and definitions are correct.
The word 'Refered' spelled Old Def: A clinical research protocol generally refered to as
wrong - Should be 'referred' a pilot or feasibility trial that aims to prove the concept of
the new intervention in question. New Def: A clinical
research protocol generally referred to as a pilot or
feasibility trial that aims to prove the concept of the new
intervention in question.
Misspelling in definition of Old Def: A clinical research protocol generally refered to as

Phase IIb Trial - Refered a well-controlled and pivotal trial that aims to prove the
change to Referred mechanism of action of the new intervention in question. A
pivotal study will generally be well-controlled, randomized,
of adequate si
Characteristic is misspelled in New Def: A class of disorders that encompasses conditions
def resulting from a congenital, familial hereditary trait or
genetic abnormality as is manifested by a characteristic set
of symptoms and signs.
Take one 'the' in definition of New Def: Published by The Regenstrief Institute, the
LOINC Logical Observation Identifiers Names and Codes covers
clinical and clinical laboratory terminology.
Change bodie to body in New Def: A measurement of the Dohle body (blue-gray,
definition basophilic, leukocyte inclusions located in the peripheral
cytoplasm of neutrophils) in a biological specimen.
Change 'occuring' to New: Any depression occurring in a positive t wave.

'occurring' in definition
Change 'occuring' to Change 'occuring' to 'occurring' in definition
'occurring' in def
Add word 'is' between New: An electrocardiographic finding of an organized
'generally' and 'at' in def. rhythmic contraction of the atria which is generally at a rate
of 200-300 beats per minute. (NCI)
Remove (NCI) from end of New: The Fahrenheit temperature scale is named after the
CDISC definition. German physicist Gabriel Fahrenheit (1686-1736), who
proposed it in 1724. In this scale, the freezing point of
water is 32 degrees Fahrenheit and the boiling point is 212
degrees, placing the boilin
Marriage is spelled wrong in Marriage is spelled wrong in def.
the definition
Change meter/sec(2) to New: A unit of force which, when applied in a vacuum to a
meter/sec2 in definition. body having a mass of one kilogram, causes an
acceleration of one meter/sec2. It is equal to 10E5 dynes.
Make the term Barbituates The term should be Barbiturates instead of Barbiturate
because we are measuring the drug class. This is
consistant with other drug classes.
Change definition to A To be consistent with other definitions change A count of

measurement of of the the basophils per unit of a biological specimen to A
basophils per unit of a measurement of of the basophils per unit of a biological
biological specimen. specimen.
Change for measure to Change text from measure to measurement in the following
measurement text. New text should read: A relative measurement (ratio
or percentage) of the basophils to leukocytes in a biological
specimen.
Add synonym of SGOT Add synonym of SGOT
Change measure to Change the text from measure to measurement. New text:
measurement. A relative measurement (ratio or percentage) of the blasts
to leukocytes in a biological specimen.
Remove the word Ratio from The CDSIC submission value should be without the word
CDISC submission value ratio. New text:BUN/Creatinine. There are only a couple of
values that have the word ratio. THis will make all of the
ratio terms consistent.
Add Total Cholesterol as a Add Total Cholesterol as a synonym.

synonym.
AESEV new terms Request the addition of two new terms "LIFE-
THREATENING and FATAL" to the AESEV codelist. In
addition to providing more detail for the differentiation of
severity of an AE that is not categorized by a standard
terminology, it would also provide a more log
Add "SUBJECT REFUSED Please see text in Justification section.

STUDY TREATMENT" to
SDTM-NCOMPLT codelist
Add BEFORE/DURING term Codelist STENRF currently has terms AFTER, BEFORE,
to STENRF codelist DURING, DURING/AFTER, UNKNOWN. If a con med CRF
reports that ONGOING?=No, but does not include a stop
time, we know that CMENRF is not "AFTER", but we don't
know if it was BEFORE or DURING. (If it started DURING
then we know it ended DURING, but if it started BEFORE
we have no clue as to when it ended.) A new term
BEFORE/DURING needs to be added to parallel the
wishiwashiality of the existing term DURING/AFTER.
Otherwise the sponsor cannot represent the specificity of
information that is available. This addition will enable the
codelist to be "closed" and still cover all cases.
Recommend the following description, to be consistent with
other existing descriptions in the codelist: "Before a certain
point or period in time or within a certain period of time."
Modify definition to A Modify definition to A measurement of the elliptically

measurement of the shaped erythrocytes in a biological specimen. Add
elliptically shaped synonym Ovalocytes.
erythrocytes in a biological
specimen. Add synonym
Ovalocytes.
Modify definition Modify definition to A measurement of the eosinophils per

unit fo a biological specimen.
Modify definition. Modify definition to A relative measurement (ratio or
percentage) of the eosinophils to leukocytes in a biological
specimen.
Add synonym. Add synonym Oestradiol.
Change term to VITB9 Modify the existing term of FOLICAC to VITB9.
Change from transpeptidase The definition should read: A measurement of the gamma
to tranferase glutamyl transferase in a biological specimen.
Add synonym for HCG Add synonym Pregnancy Test
Add synonym Glutamic Acid. Add synonym Glutamic Acid for Glutamate.
Please make the Submission On rows 407 to 412 of published spreadsheet, the CDISC
Value equal to PT on row submission value in column E does not match the CDISC
407-412 of published preferred term in column F. This is one of those codelists in
spreadsheet which the term in column E should equal the term in
Column F. It looks like a copy and paste error.
Modfiy definition for New text should read: A measurement of the atypical
Lymphocytes Atypical lymphocytes per unit in a biological specimen.
Change measure to Definition new text for Lymphocytes Atypical/Leukocytes: A
measurement relative measurement (ratio or percentage) of the
lymphocytes to leukocytes in a biological specimen.
Change measure to Correct text for LYMLE is: A relative measure (ratio or
measurement for LYMLE percentage) of the atypical lymphocytes to leukocytes in a
Change definition Change definition of Reactive Lymphocytes/Lymphocytes
to: A relative measurement (ratio or percentage) of the
reactive lymphocytes (lymphocytes which have become
large due to an antigen reaction) to all lymphocytes in a
Modify definition for New text should read: A measurement of the macrocytes
Macrocytes per unit of a biological specimen.
Life Threatening is not a part See Justification
of any codelist
Minor change to definition for Old Def: An Southern Africa, occupying an island in the
Reunion, the country. Indian Ocean, east of Madagascar. New Def: A country in
Southern Africa, occupying an island in the Indian Ocean,
east of Madagascar.
No definition on CT Place definition for Bermuda on Controlled Terminology
spreadsheet for Bermuda spreadsheet: A group of islands in the North Atlantic
Ocean, east of South Carolina.
Change Ery. Mean Change Ery. Mean Corpuscluar HB Concentration to Ery.
Corpuscluar HB Mean Corpuscluar HGB Concentration to add the B in HB
Concentration to Ery. Mean for consistency in the abbreviation of hemaglobin.
Corpuscluar HGB
Concentration
New text should read: A New text should read: A measurement of the microcytes
measurement of the per unit of a biological specimen.
microcytes per unit of a
New text should read: A New text should read: A measurement of the monocytes
measurement of the per unit of a biological specimen.
monocytes per unit of a
New text should be: A New text should be: A relative measurement (ratio or
relative measurement (ratio percentage) of the monocytes to leukocytes in a biological
or percentage) of the specimen.
monocytes to leukocytes in a
relative measurement (ratio percentage) of the myeloblasts to leukocytes in a biological
myeloblasts to leukocytes in
a biological specimen.
relative measurement (ratio percentage) of the myelocytes to leukocytes in a biological
myelocytes to leukocytes in a
New text: A measurement of New text: A measurement of the neutrophils per unit of a
the neutrophils per unit of a biological specimen.
New text: A measurement of New text: A measurement of the banded neutrophils per
the banded neutrophils per unit of a biological specimen.
unit of a biological specimen.
New test: A relative New test: A relative measurement (ratio or percentage) of

measurement (ratio or the banded neutrophils to leukocytes in a biological
percentage) of the banded specimen.
neutrophils to leukocytes in a
New test: A relative New test: A relative measurement (ratio or percentage) of
measurement (ratio or the neutrophils to leukocytes in a biological specimen.
percentage) of the
neutrophils to leukocytes in a
New text: A measurement of New text: A measurement of the Pelger Huet Anomaly
the Pelger Huet Anomaly (neutrophils and eosinophils nuclei appear rod like,
(neutrophils and eosinophils spherical or dumbbell shaped) in a biological specimen.
nuclei appear rodlike,
spherical or dumbbell
shapped) in a biological
specimen.
Add synonym: Phosphorus Add synonym: Phosphorus
Lost to follow-up defintion The CDISC defintion for the "Lost to follow-up" says: "The
change request loss or lack of continuation of follow-up after a study has
officially closed. See Follow-up. (NCI)" In my organization
this term was used rather with a definition as follows: "The
lost to follow-up means that there was no further contact,
independent of the study epoch where the subject got lost."
Modify definiton of severe in Shire’s current definition of “severe” - : The AE is

AESEV codelist incapacitating and the subject is unable to work or
complete usual activity. CDISC’s current definition of
“severe” - : A type of adverse event that requires intensive
therapeutic intervention.The event interrupts usual activities
of daily living, or significantly affects clinical status. The
event possesses a significant risk of harm to the research
participant and hospitalization may be required Shire’s
physicians preferred definition of “severe” - : The event
interrupts usual activities of daily living, or significantly
affects clinical status, and/or a type of AE that requires
intensive therapeutic intervention.
New definition: A
measurement of the platelets
in a biological specimen.
Correct error, remove ) in

definition
Add Red Blood Cells as
synonym and change
definition as below.
Add synonym: Nucleated
Red Blood Cells
Synonym is: Nucleated Red
Blood Cells/Erythrocytes
New text: A measurement of

the reticulocytes per unit of a
New text: A relative
percentage) of reticulocytes
to erythrocytes in a biological
specimen.
New term: Thyroxine, Free
New synonym: Tear Shaped

Erythrocytes. New definition:
A measurement of
dacryocytes per unit of a
New synonym: Uric Acid
Add synonym: White Blood

Cells
New text: A relative
percentage) of
prolymphocytes to leukocytes
New text: A measurement of

the lymphocytes per unit of a
Change definition of Change definition of NCOMPLT codlist (C66727) to "If the
NCOMPLT codlist (C66727) subject completed the study or segment of the study (e.g.
Treatment if data is collected at that granularity) then the
term will be "COMPLETED". If the subject does not
complete the study or segment of the study then this is the
reason that a subject discontinued." Current definition of
"The reason that a subject was discontinued from a clinical
trial."
C74792, C75386 are The use of the term 'growth hormone' as a general class of
potential synonyms in hormones may be used to denote any hormone that
LBTEST and LBTESTCD stimulates cell growth in the popular lexicon. I am unsure
codelists whether CDISC is using the term Growth Hormone
Measurement as a broad category to denote the
measurement of any 'growth' hormones or whether it really
does mean Somatotrophin. In the SDTM both of these
terms are synonyms of each other which makes me think
that perhaps CDISC does really mean Growth Hormone =
Somatotrophin. CDISC needs to determine whether these
two should remain separate on the codelist or if not, to pick
one PT and create the other term as a synonym. Also
CDISC needs to resolve the issue of whether they mean
Somatotrophin or Somatotropin (without the h).
C74634 Bite C74634 Bite Cells/Erythrocytes appears twice in LBTEST

Cells/Erythrocytes appears and LBTESTCD codelist. Remove one.
twice in LBTEST and
LBTESTCD codelist
Consistency issues in CDISC The CDISC PT for C74761: Albumin/Creatinine Ratio,
PT C74894: Albumin/Globulin Ratio, C74753: BUN/Creatinine
Ratio all contain the word 'Ratio'. All other terms of this type
do not contain the word Ratio in the PT. For consistency,
CDISC may want to consider removing the term Ratio from
the PT.
Add synonyms to align Please add the terms as CDISC synonyms: C42966
CDASH IG appendix A with Ointment - oint; C42993 Suppository - supp; C42887
SDTM fully Aerosol - aer; C42994 Suspension - susp.
Change CDISC PT Folic Acid Im conjunction with decision regarding change request
to Vitamin B9 19454, please change CDISC PT from Folic Acid to
Vitamin B9. Keep Folic Acid as a synonym.
Change name of codelist Change name of codelist from "Patient Ethnic Group" to
from "Patient Ethnic Group" "Ethnic Group"
to "Ethnic Group"
Typo in term "Phase IIIaTrial" Typo in term "Phase IIIaTrial" needs to be corrected to
needs to be corrected to "Phase IIIa Trial". Space is missing.
"Phase IIIa Trial". Space is
missing.
Change "CDISC Code List" Change "CDISC Code List" drop down list in this form to 1)
drop down list remove "SDTM" from each codelist name since these
codelists are not just applicable for SDTM so it's very
confusing and misleading 2) please sort codelist
alphabetically - order in dropdown list seems to be random
and it's difficult to find a codelist without searching through
the whole list.
indican test In normal urine, the amount of indican excreted is small. It

is increased with high protein diets or inefficient protein
digestion. If not digested properly, or if the wrong type of
proteins are ingested, bowel putrefaction can occur.
Problems with protein digestion can be caused by
overgrowth of anaerobic bacteria, intestinal obstruction,
stomach cancer, low stomach acid, parasitic infections,
malabsorptive syndromes (sprue, etc.), fungal infections,
lack of digestive enzymes, or liver problems. Please see
following website for more information:
http://biocenterlab.org/tests/urine/indican.shtml
Pappenheimer Bodies and CDISC definition of Pappenheimer Bodies is unclear.
Siderocytes Pappenheimer Bodies are found in siderocytes. However,
the CDISC defintion says: A measurement of the
Pappenheimer Bodies (violet or blue staining, ferritin
granules usually found along the periphery of the red blood
cells) in a biological specimen. Does this mean that the
number of Pappenheimer Bodies per siderocyte is counted
or is it possible to use this for the count of siderocytes or
aren't Pappenheimer Bodies counted?
3 lab test entries may have 1) C74630 C65047 Laboratory Test Code BLASTLM
issues (typo, duplicates) BLASTLM Leukemic Blasts; Lymphocytes; Lymphoblasts;
Immunoblastic - Should the second synonym be
'Lymphocyte Blasts'rather than 'Lymphocytes'? 2) Within
the 2009-02-17 posted spreadsheet, there are duplicate
rows for the term BTECERBC: LBTEST: rows 1367 and
1538 (definitions are slightly different but the terms are the
same) LBTESTCD: rows 945 and 1116 (ditto) 3) There
appear to be 2 codes for the same test, where the TESTCD
is simply worded differently: C74767 C65047 Laboratory
Test Code FGRANCS FGRANCS Fine Granular Casts A
measurement of the fine granular casts present in a urine
specimen. C74769 C65047 Laboratory Test Code
CSGRANF CSGRANF Granular Fine Casts A
measurement of the fine granular casts present in a urine
specimen.
Pack Years = Pack year is a The CDASH Medical History team proposes that "Pack
term used to describe the Years" be added to the terminology code lists. Pack Years
amount a person has is a commonly term used to describe the amount a person
smoked over time. One pack has smoked over time. One pack year is defined as 20
year is defined as 20 manufactured cigarettes (1 pack) smoked per day for one
manufactured cigarettes (1 year.
pack) smoked per day for
one year.
Add QD to the terminology The CDASH project team requests that QD be added the
code lists terminology codelists to mean every day. The closest term
is "Q24 hr", however, QD is commonly used by clinicians in
medical charts and on case report forms.
Mispelling in definition of Old Def: A measurement of the granular (course and fine)
C74768 casts present in a urine specimen. New Def: A
measurement of the granular (coarse and fine) casts
present in a urine specimen.
Change name of codelist to Name of this codelist should be changed to Subject Ethnic
Subject Ethnic Group Group as per page 272 of the SDTMIGv3.1.2 - row 1 in the
table.
Add Clinical Events to Add new term for CE - Clinical Events to Domain codelist
Domain codelist. as per page 274 of SDTMIGv3.1.2.
Add new term FA (Findings Add new term FA (Findings About) to the Domain codelist
About) to the Domain codelist as per page 274 of SDTMIGv3.1.2.
Correct term C49566 for BM Correct BM to "Bone Measurements" in the Domain

code in Domain (C66734 ) codelist as per page 277 of SDTMIGv3.1.2. Current
codelist description is "Bone Mineral Density (BMD) Data"
Delete term AEDICT Delete term AEDICT ( C49700) in TSPARMCD (C66738)

( C49700) in TSPARMCD codelist as per page 279 of SDTMIGv3.1.2.
(C66738) codelist
Delete term Adverse Event Delete term Adverse Event Dictionary (C49700) in
Dictionary (C49700) in TSPARM (C67152) codelist as per page 279 of
TSPARM (C67152) codelist SDTMIGv3.1.2.
Delete term DRUGDICT Delete term DRUGDICT (C49701) in TSPARMCD

(C49701) in TSPARMCD (C66738) codelist as per page 280 of SDTMIGv3.1.2.
(C66738) codelist
Delete term Drug Dictionary Delete term Drug Dictionary (C49701) in

(C49701) in TSPARM(C67152) codelist as per page 280 of
TSPARM(C67152) codelist SDTMIGv3.1.2.
Delete term MHDICT Delete term MHDICT (CC49702) in TSPARMCD (C66738)

(CC49702) in TSPARMCD codelist as per page 281 of SDTMIGv3.1.2.
(C66738) codelist
Delete term Medical Delete term Medical Dictionary(C49702) in

Dictionary(C49702) in TSPARM(C67152) codelist as per page 281 of
TSPARM(C67152) SDTMIGv3.1.2.
Add new term OBJPRIM Add new term OBJPRIM as per page 281 of
SDTMIGv3.1.2.
Add new term "Trial Primary Add new term "Trial Primary Objective" to TSPARM
Objective" to TSPARM (C67152) as per page 281 of SDTMIGv3.1.2.
(C67152)
Add new term OBJSEC to Add new term OBJSEC to the TSPARM C67152) codelist
the TSPARM C67152) as per page 281 of SDTMIGv3.1.2.
codelist
Add new term OBJSEC to Add new term OBJSEC to the TSPARMCD (C66738)
the TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.
codelist
Add new term "Trial Add new term "Trial Secondary Objective" to
Secondary Objective" to the the TSPARM C67152) codelist as per page 281 of
TSPARM C67152) SDTMIGv3.1.2.
Add new term SPONSOR to Add new term SPONSOR to the TSPARMCD (C66738)
the TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.
codelist
Add new term "Sponsoring Add new term "Sponsoring Organization" to the TSPARM
Organization" to the (C67152) codelist as per page 281 of SDTMIGv3.1.2.
TSPARM (C67152) codelist
Expand ECG Results list Request from Brian Harrington: These findings fall under
the “Result” code list. Please see the below from our
Director of International Cardiology: An authoritative
reference would be Chou’s Electrocardiography In Clinical
Practice, 5th Ed., by Surawica and Knilans (Saunders,
2001). Definitions: AV MOBITZ I - AV conduction block
characterized by gradual lengthening of the PR interval
leading to a P wave which is not conducted, and a
shortening of the PR after the nonconducted P wave; AV
MOBITZ II - AV conduction block characterized by abrupt
AV block without a change in the PR interval before or after
the nonconducted P wave; ARTIFICIAL PACEMAKER -
ECG pattern recorded in a subject who has either a
permanent or temporary electronic pacemaker (or
Implantable Cardiac Defibrillator with pacing capabilities);
PROLONGED QTC - Prolonged QT interval (corrected for
heart rate) which is associated with increased risk of
sudden death. In addition, we are requesting the removal
of the current finding (U WAVES) and replace it with the
new finding (U WAVES ABNORMAL). This is due to all U
waves not being abnormal.
Body position of semi-fowlers In the clinical trial context, blood pressure is most
versus semi-supine needs commonly measured in the supine and semi-supine
clarification position. These are the common terms used, used by the
study sites. Feedback received is that terms such as semi-
fowlers are not very usable (not really accepted for use).
Furthermore, there is an issue of different interpretations of
what this is.
foetus should be fetus foetus should be fetus
Misspelled term singlemasked should be single-masked
Ileum definition ilium should be ileum
British spelling repolarisation should be repolarization
misspell corporus should be corpus
capitalize proper name capitalize Siemens in definition
capitalize proper name -3 capitalize Siemens in definition
capitalize proper name-2 capitalize Siemens in definition
proper name needs capitalize Weber in definition

capitalization
capitalize proper name - 4 capitalize Kelvin in definition
change British spelling change foetus to fetus
Pascals change pascals to Pascals
change tesla to Tesla change tesla to Tesla
change becquerel to change becquerel to Becquerel

Becquerel
change characterised to change characterised to characterized
characterized
change occuring to occurring change occuring to occurring
change stoping to stopping change stoping to stopping
change erthrocytes to change erthrocytes to erythrocytes

erythrocytes
LBTEST All lab test codes related to urinary casts are prefixed with
CS with the exception of fine granular casts which has a
test code of FGRANCS. For consistency reasons, please
change this test code to CSFGRAN
LACTICAC to LA For Lactate Dehydrogenase we use LDH (the common
abbreviation) as the test code. Can we consider changing
LACTICAC to LA to keep a consistent approach?
Add the lab test name For the urine Protein 24 hour test, we are running into the
Protein 24 Hr with the test issue where the units of measure are not going through our
code PROT24H conversion table because the urine Protein 24 Hr units (ie.
mg/day) are different than the random urine Protein units
(ie. mg/dL). The 24 Hour attribute can be captured in an
additional field within the LB domain but this is not pulled
into our conversion table. Can you please add Protein 24
Hr with the test code PROT24H.
Add DOSE DELAYED as a See justification for request

term to --ACN codelist
Error in CDISC Synonym The CDISC Synonym for C70526 (GBq/ug) says
"Gigabecquerel per microgram; MBq/ug, Megabecquerel
per microgram". This is wrong. It should be "...; MBq/ng,
Megabecquerel per nanogram"
Error in CDISC Synonym of The CDISC Synonym for C70527 (GBq/mg) says
C70527 "Gigabecquerel per Milligram; MBq/mg, Megabecquerel per
Milligram". This is wrong. It should be "...; MBq/ug,
Megabecquerel per Microgram"
D-dimer, one of the fibrin The fragments of the disintegrating fibrin in the clot are
degradation products, called fibrin degradation products (FDP). One of the FDPs
consists of variously sized produced is D-dimer, which consists of variously sized
pieces of crosslinked fibrin. It pieces of crosslinked fibrin. D-dimer is normally
is produced only after a clot undetectable in the blood and is produced only after a clot
has formed and is in the has formed and is in the process of being broken down.
process of being broken Measurement of D-dimer can tell your doctor that
down. something has increased above normal the body's clotting
mechanisms.
D-dimer, one of the fibrin The fragments of the disintegrating fibrin in the clot are
degradation products, called fibrin degradation products (FDP). One of the FDPs
consists of variously sized produced is D-dimer, which consists of variously sized
pieces of crosslinked fibrin. It pieces of crosslinked fibrin. D-dimer is normally
is produced only after a clot undetectable in the blood and is produced only after a clot
has formed and is in the has formed and is in the process of being broken down.
process of being broken Measurement of D-dimer can tell your doctor that
down. something has increased above normal the body's clotting
mechanisms.
for the all terms in the unit Numbers that I found 48152, 67306, 67327, 67394, 67396,
code list add synonym with 67397, 70523, 70526, 70530, 70581, 71205, 71210,
mcg for u 71211. I may have missed a few so please search the file
to ensure we have all terms
Knee to Heel Length is used Knee to Heel Length is used quite often for the infant
quite often for the infant studies
studies
Partial pressure of carbon Partial pressure of carbon dioxide
dioxide
Oxygen, partial pressure Oxygen, partial pressure
SDTM-COUNTRY codelist As far as I understand the current published CDISC

does not contain all COUNTRY codelist uses (such as HL7) the ISO3166-1
ISO3166-1 alpha-3 country alpha-3 country codelist. Additionally it is defined to be not
codes. extensible. However the published CDISC COUNTRY
codelist does (for whatever reason) not contain all
elements of the ISO3166-1 alpha-3. E.g. the following
elements of ISO3166-1 alpha-3 are missing: IMN = Isle of
Man; BML = Saint Barthelemy; MAF = Saint Martin. And
two elements do have a different three letter code: Jersey =
JEY in ISO3166 and JRE in CDISC; Serbia = SRB in
ISO3166 and SCG in CDISC. All in all ISO3166 has never
been stable and will not be stable over time. So I think it
does not make sense to define a "non extensible" codelist.
Why not simply refer to the current version of ISO3166?
They have a process in place how to accomodate the
inevitable changes in the list of countries on earth.
We capture LBTOXGR We capture LBTOXGR values of 0 to equate to Normal.
values of 0 to equate to We do not wish to set this value to missing because
Normal. We do not wish to missing is used when the values or normal ranges are
set this value to missing missing.
because missing is used
when the values or normal
ranges are missing.
U/L and other units needed Only for the LB paramters where the WHO International
beside IU/L Biological Reference Preparations existed as listed in the
WHO document the "IU" can be used:
http://www.who.int/bloodproducts/catalogue/bpromay06.pdf
. In this list no common enzymes are listed e.g. ALP, ALT,
AMYLASE, AST. Using for these paramters e.g. IU/L would
not be corrected because there is no WHO reference
preparation published. However, since catal (the SI unit) is
not commonly used as standard representation it would be
very good to be able to present enzym activities with a
correct unit.
SAD - Sagittal Abdominal SAD - Sagittal Abdominal Diameter is a standard measure

Diameter is a standard of visceral obesity (size of one's belly).
measure of visceral obesity
(size of one's belly).
New TSPARMCD for EXISTRT = Existing Treatment; An example is an oncology
EXISTRT (Existing trial where surgery is added on to a chemotherapy regimen
Treatment) for one Arm. In this case, surgery was the ADDON
(ADDON = Y) and EXISTRT was the chemotherapy
regimen.
Existing Treatment Existing Treatment (TSPARM) for EXISTRT
(TSPARM) for EXISTRT (TSPARMCD). An example is an oncology trial where
(TSPARMCD) surgery is added on to a chemotherapy regimen for one
Arm. In this case, surgery was the ADDON (ADDON = Y)
and EXISTRT was the chemotherapy regimen.
TSPARMCD EXISTRT was also requested on July 16,
2009.
New TSPARMCD = TRT for New Term for both TSPARMCD (TRT) and TSPARM
"Name of Treatment" (Name of Treatment) requested. In the SDTMIG v3.1.2
implementation guide on page 282.
Add TSPARM (Name of New Term for both TSPARMCD (TRT) and TSPARM
Treatment) (Name of Treatment) requested. In the SDTMIG v3.1.2
implementation guide on page 282.
New Term TSPARMCD = New Term for both TSPARMCD (OBJ) and TSPARM
OBJ (OBJECTIVE) requested to be added. Have situation of a
protocol that only lists objectives and does not indicate
whether they are Primary or Secondary so need a
TSPARM/TSPARMCD to cover this.
New Term TSPARM = New Term for both TSPARMCD (OBJ) and TSPARM
OBJECTIVE (OBJECTIVE) requested to be added. Have situation of a
protocol that only lists objectives and does not indicate
whether they are Primary or Secondary so need a
TSPARM/TSPARMCD to cover this.
New term request and The definition of the following terms in NCI Common
request for change in Terminology Criteria for Adverse Events v4.0 are as
definition. Comment Posted follows: Codelist Code C66784 CTCAE Code E1005
by submitter 2009-07-28 CTCAE Definition An adverse event that is
13:15 Change 'CTCAE' to asymptomatic; or involves mild or minor symptoms; or is of
'CTCAE v4.0' marginal clinical relevance; or consists of clinical or
diagnostic observations alone; or for which intervention is
not indicated; or for which only non-prescription
intervention is indicated. Codelist Code C66784 CTCAE
Code E1006 CTCAE Definition An adverse event for
which only minimal, local, or noninvasive intervention (e.g.
packing, cautery) is indicated; or that limits instrumental
activities of daily living (ADLs, e.g., shopping, laundry,
transportation, or ability to conduct finances). Codelist
Code C66784CTCAE Code E1007 CTCAE Definition
An adverse event that is medically significant but not life-
threatening; or for which inpatient care or prolongation of
hospitalization are indicated; or that is an important me ical
event that does not result in hospitalization, but may
jeopardize the patient or may require intervention either to
prevent hospitalization, to prevent the AE from becoming
life-threatening or causing death; or that is disabling; or that
results in persistent or significant disability, incapacity, or
limitation of self care activities of daily living (ADLs, getting
in and out of bed, dressing, eating, getting around inside,
bathing, or using the toilet). Codelist Code C66784 CTCAE
Code E1008 CTCAE Definition An adverse event that
has life-threatening consequences; for which urgent
intervention is indicated; that puts the patient is at risk of
death at the time of the event if immediate intervention is
not undertaken; or that causes blindness or deafness
(need to decide if unilateral or bilat ral). Codelist Code
C66784 CTCAE Code E1009 CTCAE Definition Death
Modify description of The current codelist description is "The name of a code list
STENRF codelist that contains terms that reference timepoints within and
without a defined time period." I propose changing it to
"The relative relationship of a timepoint to a reference
timepoint."
MULTIPLE value proposed to Action taken with treatment can be for multiple treatments
deal iwth actions taken with (sometimes there is more than one study drug). Then we
multiple study drugs would QNAM = AEACNR1-n where n is the number of
study drugs, QLABEL is Reported Action Taken with
<Drug>.
Additional action taken with For oncology trials, an action taken is often to decrease the
study drug to reflect infusion infusion rate. This is not the same as reducing the dose,
rate as often the total dose received will be the same, it is the
administration interval that is lengthened by decreasing
infusion rate.
Inconsistent CDISC definition In the codelist LBTESTCD (C65047) there are a number of
for cell counts codes for cell counts of all kinds of specific cell types (The
NCI Preferred Term usually is "XXX Count"). The CDISC
definition however uses three different wordings: 1) "A
measurement of the XXX per unit of a biological
specimen." (e.g. MONO) 2) "A measurement of the XXX in
a biological specimen." (e.g. BLAST) 3) "A count of the
XXX per unit of a biological specimen." (e.g. CD3). I would
prefer to have consistently wording 1).
New Term needed for Total In the LBTESTCD codelist, there are codes for Bilirubin,
Bilirubin Direct Bilirubin and Indirect Bilirubin. However I do not see
a code for Total Bilirubin.
Duplicates for Code, Codelist There are duplicates for Code, Codelist Code and Codelist
Code and Codelist name in name in EVAL. C42708 C78735 Evaluator CHILD
EVAL CHILD A son or a daughter. C42708 C78735 Evaluator
PARENT PARENT A mother or a father.
Q.A.M. and Q.P.M. missing The terms Q.A.M. (every day before noon) and Q.P.M.
from FREQ codelist (every day after noon) are missing from the FREQ codelist
(C71113)
The reason why we want to The reason why we want to add 'Stabilization' is to comply
add 'Stabilization' is to with regulatory requirements. An AE has to be followed
comply with regulatory until resolution or stabilization. With the current codelist we
requirements. An AE has to only know whether the AE is recovered or not recovered.
be followed until resolution Stabilization could apply to any diagnosis of chronic
or stabilization. diseases of conditions (present before or starting during the
course of the study) that are not curable/not expected to
recover.
def in wrong place the definition for transverse liver fissure is in the liver
fissure concept. Which concept does CDSIC want, so we
can move the correct data into the correct concept?
Addition of term 'Cortisol, Listed are links to information regarding the test: Cortisol,
Free' to LBTEST Free; ARUP:
http://www.aruplab.com/guides/ug/tests/0098391.jsp;
Mayo: http://www.mayomedicallaboratories.com/test-
catalog/Overview/91644; QUEST:
http://www.questdiagnostics.com/hcp/testmenu/jsp/showTe
stMenu.jsp?fn=21469P.html&labCode=SJC;
Addition of 'CORTISLF' to Addition of test code 'CORTISLF' to go with the request to

LBTESTCD add the new term 'Cortisol, Free'
Add synonym to the LBTEST Addition of the synonym 'Total Cortisol' to the existing
term 'Cortisol' LBTEST term 'Cortisol' for further clarification.
Add cm3 as a synonym of mL Add cm3 as a synonym of mL C28254

C28254
Addition of OTHER as an Would you please add OTHER as an allowable value for
allowable value for the the EGSTRESC variable within the ECG Result Codelist
EGSTRESC variable contained within the SDTM Terminology spreadsheet? By
doing this, it will enable an easier record linking capability
between the EG and SUPPQUAL datasets.
Change HYPO to CDISC rules for representing HYPO are to use HPO.
HYPOCROM Please therefore consider change the new code to
HPOCHROM instead of HYPOCROM
Change
NCI Decision CDISC Decision Final Outcome
Type
remove "ratio" from CDISC definition Agree II Q1 2009
The original mapping is inaccurate. Do not need anisocytosis II Q1 2009

C35266 is the finding of Anisocytosis. We
will re-map this concept to the term
C74797 Anisocyte Measurement - We
would move the CDISC definition to this
term. If you want Anisocytosis as well, let
us know.
Fine Agree II Q3 2009
Change definition to: A measurement of Agree II Q2 2009

the May-Hegglin anomaly in a blood
sample. This anomaly is characterized by
large, misshapen platelets and the
presence of Dohle bodies in leukocytes.
Corresponds to C64433 Alanine Agree II Q2 2009
Aminotransferase. This synonym is
correct and NCI already has it as an NCI
SY.
We agree, the change of CDISC PT from Agree, lets use Standard Cubic Meter II Pending
m3 to scm for C68858, Standard Cubic as the term and SCM (in all caps) as
Meter, is good. 'scm' is an NCI synonym the synonym.
for this term already. scm and m3 are
sufficiently different enough that they have
separate NCI codes.
We would like to re-map this term to the The term currently show as II Q1 2009
concept C79602 Poikilyocyte Poikilyocyte so I am assuming that it
Measurement, which has been created. will just be remapping on your side with
We will transfer the existing CDISC PT, a new code. I am in agreement
SY, Def, etc. to this new concept if you
agree.
Agree. Agree II Q1 2009

Agree. Agree. II Q1 2009
NCI suggests changing to 'meter per Agree II Q1 2009

second squared'.
Agree Agree II Q1 2009

Send to CDISC to determine course of Do not agree. The AESEV codelist III Denied
action. TOXGR code list has the grade 1-5 comes from ICH E2A. It has the three
values whereas AESEV has only 3 (MILD, code choices of MILD, MODERATE,
MODERATE, SEVERE). SEVERE and is used with the variable
AESEV. The terminology team has
determined that the AESEV codelist is
not extensible. The TOXGR codelist
has the choices requested and is used
with the variable AETOXGR. Use the
TOXGR codelist and AETOXGR
variable instead of AESEV.
Send to CDISC to determine course of The CDISC team does not agree to III Denied
action. implement this request to add an
addtional term to the NCOMPLT. You
could put "SUBJECT REFUSED
STUDY TREATMENT " in DSTERM
and map it to "NON-COMPLIANCE
WITH STUDY DRUG" for DSDECOD
or you can keep the term as a
Centocor specific term for DSDECOD
since the code list is extensible
This is fine if CDISC wants it. This request has been withdrawn by II Removed from
the submitter. Request List.
Agree; Transpeptidase is correct however Agree II Q2 2009

transferase is more formal.

Life Threatening is listed as a CDISC PT III Q4 2009

because it is listed in column F of the CT
spreadsheet but differs from the column E
submission value of 4, which is also a
CDISC PT. As a business rule, we
wouldn't want a value to exist as a PT that
isn't part of a codelist. CDISC to discuss.

Agree - Change definition just slightly to Agree II Q1 2009

sound more grammatically correct: A
measurement of the Pelger Huet Anomaly
(nuclei of neutrophils and eosinophils
appear rod-like, spherical or dumbbell
shaped) in a biological specimen.
Phosphorus is the element and is not Agree II Q2 2009

analogous structurally to phosphate,
which has side chains. However,
Phosphorous is analogous to phosphate.
NCI suggests Phosphorous be the
synonym instead of Phosphate.
Send to CDISC for resolution. Use this text: The loss or lack of II Q2 2009
continuation of a subject to follow-up.
Send to CDISC for review Use this text: A type of adverse event II Q2 2009
that interrupts usual activities of daily
living, or significantly affects clinical
status, or may require intensive
therapeutic intervention.
Agree Agree I Q1 2009

Send to CDISC for review Use this text: The status of the II Q2 2009
subject's completion of the study or a
segment of the study, or the reason the
subject discontinued the study or
segment of the study.
Send to CDISC for review Agreed with Lab Terminology Team II Q2 2009
2009-03-13 to change Somatotropin to
Somatotrophin. Remove the duplicate
term Growth Hormone. Growth
Hormone would be the synonym. Use
the name SOMATRO. Do not add
Somatotropin as a new term.
Send to CDISC for review Agree II Q1 2009
Send to CDISC for review Chris says: There is already a request II Q1 2009
in to removed ratio for the two: C74761
ID 11854 and C74753 ID 19124. I will
check with Phil on the other one. Phil
says: I am fine removing the "ratio"
phrase for Allbumin/Creatinine.
1) NCI is open to suggestions for a better 1 needs further discussion. Will take to II Pending
way to differentiate source of codelist. We the Term/Gov/Imp team. No changes
feel this is necessary since currently we currently. Since SDTM is an unbrella
have four different groups submitting doc for SEND and human clinical trial
codelists, some of which overlap and we will leave as is temporarily. 2 agree
some of which are hybrids of existing to sorting alphabetically
SDTM lists. Although SDTM is currently
the only codelist mentioned on the change
control website, we anticipate the other
CDISC subgroups will want to make use
of this change control process. We're
open to alternative proposals to address
this issue. 2) NCI agrees with
alphabetizing codelist on the Request
Form if this is helpful for CDISC. As of
now, it is in the order that the codelists
appear on the published spreadsheet.
Send to CDSC for review. Lab terminology team decided to add III Q4 2009
this term to package 4. Add Indican to
General Chemist list. PT Indican,
INDICAN. Def: A measurement of the
Indican in a urine specimen.
Send to CDISC for review. FYI New Def: A measurement of the cells II Q3 2009
Pappenheimer bodies are found in many containing Pappenheimer Bodies
mature and immature red blood cells as (violet or blue staining, ferritin granules
well as sickle cells not just in siderocyte usually found along the periphery of
cells, so we suggest not specifying the red blood cells) in a biological
siderocyte counts as part of the definition specimen.
as it is too single-cell specific. Not all cells
that contain Pappenheimer bodies can be
considered siderocytes.
1) Agree, CDISC synonyms are incorrect - 1) New SYs: Leukemic Blasts, II Q3 2009
NCI suggests keeping SY 'Leukemic Leukemic Lymphoblasts,
Blasts', altering 'Lymphoblasts' to Immunoblastic Lymphocytes; 2)
'Leukemic Lymphoblasts', and removing Previously agreed to; 3) Remove
the others. 2) Concerns change request C74767 from CT spreadsheet
already submitted 19788 - we have
agreed to take off the duplicate term 'Bite
Cells/Erythrocytes' on the LBTEST and
LBTESTCD codelist 3) These terms are
synonymous. We suggest CDISC
removes C74769 from list.
Send to CDISC for review: NCI term 'Pack Agree to add with NCI definition III Q3 2009
Year' C73993 with Definition: A
quantification of lifetime tobacco exposure
defined as (number of cigarettes smoked
per day x number of years smoked)/20.
One pack-year is smoking 20 cigarettes a
day for one year.
SEND also has interest in the use of QD. Agree to add QD with 'Daily' as a III Q3 2009
In NCIt it maps to C25473 'Daily' with synonym.
definition: Occurring or done each day.
Send to CDISC for review. Agree I Q2 2009
Send to CDISC for review. Agree II Q3 2009

Send to CDISC for review. On list for development with Package III Q4 2009
4. Will be published at end of year with
P4
Send to CDISC for review. On list for development with Package III Q4 2009
4. Will be published at end of year with
P4
Send to CDISC for review. Agree II Q3 2009
Send to CDISC for review. Will be added with Pkg 4 development III Q4 2009
Send to CDISC for review. Will not be added. OBJSEC goes into III Denied
TSPARMCD. See request 20856. Will
not implement this request.
NCI agrees with including AV Mobitz I, AV I am in agreement with all term except III Q3 2009
Mobitz II. NCI asks for a better term than "QTC Prolongation > 500 msec". We
'Artificial Pacemaker'; we suggest 'Paced had huge debates over 500 vs 550. If
Rhythm'. NCI suggests 'QTC Prolongation we can get mutiple MDs in the US, EU
>500 msec' for final term. NCI has and Japan to agree on 500 then I have
determined that all U waves are abnormal no problem with that number. Could we
so 'U Waves Abnormal' would be a just use "QTC Prolongation"?
redundant term therefore we suggest to
keep U Waves as it is.
Send to CDISC for review. A group of terminology/SDS team II Denied

experts have decided not to add semi-
supine. The term is imprecise and we
have found a couple of different
definitions. The nurses and MD are
used to seeing 'semi-fowler' in orders.
Agree. Send to CDISC for review Agree I Q2 2009
Agree. Send to CDISC for review Agree however this is a CDISC I Denied. This is
Glossary Definition and should not be a CDISC-
altered by SDTM. Glossary
Definition.
Agree. Send to CDISC for review Agree however this is a FDA Definition I Denied. This is
and should not be altered by SDTM. an FDA
Definition.
Agree. Send to CDISC for review Agree however this is a FDA Definition I Denied. This is
and should not be altered by SDTM. an FDA
Definition.
Send to CDISC for review There are 2 entries for fine granular I Q3 2009
casts- C74767 and C74769. Delete
C74767 - this one is not correct
Send to CDISC for review We have tried to move away from 2 II Denied
letter codes to avoid confusion with 2
letter codes used for abbrebiations. Will
leave LACTICAC as the code.
Send to CDISC for review Our decision is not to add any timing III Denied
qualifiers to the urine protein test. If we
add a code for 24 hour, then we open
the door to add 12 hour, and many
others. We will not make this change.
Send to CDISC for review A group of terminology/SDS team III Denied

experts have decided not to add "Dose
Delayed" to the action code list
because this distinction is not
necessary in the AE database. It would
be difficult to know when to use one
versus the other. The information about
dose delays would probably be best
captured with exposure information.
Transcription error. Correct in NCIt but not Agree to fix the typo I Q2 2009
on CT terminology spreadsheet.
Agree to change SYs. Agree to change SYs. I Q3 2009
Send to CDISC for review. Will consider with the next lab term III Q4 2009
release. Will be added with Lab P4 at
end of Year.
Send to CDISC for review. Suggest to add Will add to lab P4. Add D-Dimer III Q4 2009
'D-Dimer' as a lbtest term with definition ' (DDIMER) as a LBTEST (LBTESTCD)
A measurement of the fibrin degradation term. Close out request.
fragments, or d-dimers, in a biological
specimen.'
Agree Add a synonym for all terms with II Q3 2009
microgram (ug) that includes mcg in
place of ug.Yes, I found the same ones
- do we want to change ukat/L to
mcgkat/L? Is this commonly found?
EM-Yes, See public review change
request file for final list of all terms to
be changed.
Send to CDISC for review Will not add to vital signs. This would III Q1 2010
be in a specialized domain.
Send to CDISC for review: New Term in Will add to Lab P4. Partial pressure of III Q4 2009
NCIt Partial Pressure of Carbon Dioxide carbon dioxide (PaCO2). This
Measurement Def: Measures the pressure measures how much carbon dioxide is
of carbon dioxide dissolved in the blood dissolved in the blood and how well
and how well oxygen is able to move from carbon dioxide is able to move out of
the airspace of the lungs into the blood. the body. -fdong. Close out request
Send to CDISC for review: Partial Will add in ab P4. Partial pressure of III Q4 2009
Pressure of Oxygen Measurement oxygen (PaO2). This measures the
C71251 Def: Measures the pressure of pressure of oxygen dissolved in the
oxygen dissolved in the blood and how blood and how well oxygen is able to
well oxygen is able to move from the move from the airspace of the lungs
airspace of the lungs into the blood. into the blood. -fdong. Close out
Request
Part I - Isle of Man - NCI Thesaurus Add to CDISC Country Codelist III Q3 2009
Code: C44480; Definition: An island in
the Irish Sea, between Great Britain
and Ireland. Two other islands are not
currently in the Thesaurus. Saint
Barthelemy and the northern part of
Saint Martin is part of France and the
southern part of Saint Martin is part of
the Dutch Antilles. Requester needs to
be more specific which portion of the
island of St. Martin they are requesting.
Part II - SCG (Serbia - Current in CDISC)
is transitionally reserved by ISO until
end of 2009 when it switches to SRB.
Therefore CDISC should probably make
this update by the end of the year but
sooner if possible. JRE is a
transcription error on the SDTM CT
spreadsheet. JEY is in the Thesaurus
as a CDISC PT. This needs to be
updated on the CT spreadsheet.
We have the term Absent Adverse Event Add Grade 0 to CATCAE v4 LBTOXGR III Q4 2009
(C75533) in the thesaurus with Definition: codelist
Grade 0 is universally defined as absence
of Adverse Events or within normal limits
or values. This would be what the value of
0 would map to in this case.
C67456 Unit per Liter - An arbitrary unit of Add to Units codelist III Q4 2009
substance concentration equal to the
concentration at which one liter of mixture
contains one unit of a substance. C77607
Unit per Milliliter - An arbitrary unit of
substance content expressed in unit(s) per
milliliter. C67465 Unit per Kilogram - An
arbitrary unit of substance content
expressed in units of biological activity per
unit of mass equal to one kilogram. Unit
per kilogram is also used as a dose
calculation unit expressed in arbitrary
units per one kilogram of body mass.
C73780 Unit per Milligram - An arbitrary
unit of substance content expressed in
unit(s) per milligram. C77606 Unit per
Gram - An arbitrary unit of substance
content expressed in unit(s) per gram.
This is a viable measurement. NCI Agree to add to Q1 2010 package. III Q4 2009
suggests to add. It will be a new NCI term.
Will this term be added as part of a Will be added with P4 General III Q4 2009
terminology package at some point? If so, Terminology. Close out Request
suggest to let Mary know that and close
out the request. If not, we can add these
terms. They will be new NCI terms.
terms. They will be new NCI terms.
terms. This will be new NCI term.
terms. This will be new NCI term.
terms. C49155 Objective - A goal or aim
to be accomplished or attained.
Will this term be added as part of a Will be added with P4 General III Denied
terminology package at some point? If so, Terminology. Close out Request. 2009-
suggest to let Mary know that and close 09-01: This term will not be added. The
out the request. If not, we can add these term Trial Primary Objective should be
terms. C49155 Objective - A goal or aim used to allow for all the data to be in
to be accomplished or attained. one place.
See request 22280; Request to add new Terms should match CTCAE. Agree to III Q4 2009
term has been previously submitted. change and add Grade 0 to CDISC v4
CDISC has chosen to have its own CTCAE LBTOXGR codelist. The v3
definitions outwith CTCAE. Chris/CDISC CTCAE LBTOXGR codelist will remain
can agree or disagree to implement this. intact for now. See Erin document for
final defs.
Send to CDISC for review. Agree to add to Q1 2010 package. II Q4 2009
Send to CDISC for review. FYI C17648 The SDTM concept of MULTIPLE is a III Denied
Multiple - Having, relating to, or consisting concept within the rules, not really a
of more than one individual, element, part, concept within the terms as such. It is
or other component; manifold. inappropriate to add the word
"MULTIPLE" to a codelist simply to
expediate a SDTM rule. There is no
such thing as a Severity called
MULTIPLE. Therefore MULTIPLE will
not be added.
Send to CDISC for review. FYI C15388 The information about decreasing the III Denied
Infusion Procedure - A method of putting infusion rate belongs on the exposure
fluids, including drugs, into the (EX) domain. If there is an associated
bloodstream. Also called intravenous AE then the action taken would be
infusion. "DOSE NOT CHANGED'. This has
been confirmed with the SDS oncology
team.
NCI agrees that consistency should be CDISC agrees to NCI suggestions. I Q3 2009
followed - 1) C74606 CD19; C74607 CD3;
C74608 CD4; C74609 – Change ‘count’ to
‘measurement’ and ‘per unit of’ to ‘in’ in all
definitions. 2) C51948 WBC – Change
count to measurement in definition. 3)
There are 19 cell count terms whose
definition contains 'per unit of a biological
specimen (C64801, C74699, C64818,
C64830, C64470, C64549, C64550,
C51949, C64821, C64822, C74631,
C64823, C74632, C74662, C63321,
C51951, C74621, C51947, C51946) and
19 cell count terms whose definition
contains 'in a biological specimen.'
(C74700, C74703, C74701, C74604,
C74658, C74659, C74613, C74661,
C74615, C74705, C79602, C74618,
C74620, C74622, C74629, C74706,
C74625, C74707, C74708). Since the
ratio cell count terms (those terms in
which the ratio of two cell types is being
measured (such as
'Monoblasts/Leukocytes') in CDISC CT all
end with 'in a biological specimen', NCI
suggests changing the definitions of the
first set of terms.
Total Bilirubin (the term that is being CDISC is deciding not to add. This III Q4 2009
requested) would map to the existing code maps to to Bilirubin Measurement
for Bilirubin (that is already in the CT
spreadsheet). Perhaps we would need to
change the PT to clarify and this might be
a good idea to do for all cases in which we
have a grouping of similar terms. However
Total Bilirubin can also be put in as a SY.
Change code for Parent to C42709. This Change code. I Q3 2009

is a transcription error but is correct in
EVS.
We have both terms in the Thesaurus; CDISC decision is not to add this new III Denied
C64595 Every Morning (SY QAM) and code. This is not how many times per
C64596 Every Evening (SY QPM). day, but when. This is a dose regimen
Suggest CDISC definition to be 'Every and could go into the planned dose
morning, before noon' and 'Every evening, regimen. We have previously agreed
after noon' OR 'Occurring or done every not to add "at lunch", "at bedtime", etc
morning/evening sometime before/after and this request is similar.
noon.'
NCIt contains the Term 'Stability' CDISC has decided not to add this III Denied
(C54072) with Defintion: The quality of code. The current codes come from
being free from change or variation or not E2B and as far as we know they have
taking part readily in chemical change. not changed. If you have a reference
Decision to add or create new terms is up that the E2B codes have changed,
to CDISC. please provide that reference.
This may have been either an incorrect CDISC decides to keep the C-code as III Q1 2010
mapping or an incorrect definition. Does is and change the definition to: A
CDISC want the term C32996 'Liver groove on the surface of the liver.
Fissure' or C33806 'Transverse Fissure'?
Send to CDISC Lab team for review. This request will be included in the next III Q1 2010
lab terminology package FY2010.
Send to CDISC for review. Decision: mL is already in the list will II Q1 2010
add cm3 as a synonym for code
C28254.
Need more SDS Team discussion III Pending
Agree; Send to CDISC for review Agree II Q3 2009
New Term or
Date of Request
Status Submitter Name Codelist/Existing Term or
Submission Code
Code Number
Closed 1/11/2010 14:00 25639 Allen, Laura Anti-Single Stranded DNA
Closed 1/11/2010 14:03 25640 Allen, Laura ASSDNA
Closed 1/11/2010 14:05 25641 Allen, Laura Influenza A Virus PCR
Closed 1/11/2010 14:07 25642 Allen, Laura INFAPCR

Closed 1/13/2010 16:24 25750 Omundsen, Erica Bone Specific Alkaline
Phosphatase
Closed 1/20/2010 12:06 25942 Facile, Rhonda Anatomical Location/Blood

Pressure/ ANKLE
Closed 1/20/2010 13:19 25943 Allen, Laura Type I Myeloblasts
Closed 1/20/2010 14:58 25948 Allen, Laura Add SDTM - LBTESTCD of

BLSTMY1
Closed 1/20/2010 15:09 25950 Allen, Laura Type II Myeloblasts

Closed 1/20/2010 15:16 25952 Allen, Laura BLSTMY2
Closed 1/20/2010 15:20 25953 Allen, Laura Type III Myeloblasts
Closed 1/20/2010 15:24 25954 Allen, Laura BLSTMY3
Closed 1/20/2010 15:28 25955 Allen, Laura Myeloid/Erythroid Ratio
Closed 1/20/2010 15:31 25956 Allen, Laura MERATIO

Closed 1/21/2010 12:02 25999 Allen, Laura Chlamydia Pneumoniae IgM
Antibody
Closed 1/21/2010 13:01 26005 Allen, Laura CPIGMAB
Closed 1/21/2010 13:05 26006 Allen, Laura Legionella Pneumophila IgG

Antibody
Closed 1/21/2010 13:08 26007 Allen, Laura LPIGGAB
Closed 1/21/2010 13:12 26009 Allen, Laura Legionella Pneumophila IgM

Antibody
Closed 1/21/2010 13:25 26013 Allen, Laura LPIGMAB
Closed 1/21/2010 13:28 26014 Allen, Laura Legionella Pneumophila IgG

and IgM Ab
Closed 1/21/2010 13:35 26016 Allen, Laura LPIGGMAB
Closed 1/21/2010 15:05 26018 ONeill, Debra Antimyeloperoxidase

Antibody
Closed 1/21/2010 15:08 26019 ONeill, Debra Addition of test code
'ANTIMPAB' to go with new
term request
'Antimyeloperoxidase
Antibody'
Closed 1/26/2010 12:03 26119 ONeill, Debra Acetylcholine
Closed 2/1/2010 14:36 26291 Lenzen, Mary SKINCLAS (C76351)

Closed 2/4/2010 4:28 26342 Wilden, Holger C66790, there should only be
one codelist name for this
codelist
Closed 2/5/2010 11:54 26382 Campain-Teulon ECG RESULT

Elis
Closed 2/17/2010 18:59 26544 Omundsen, Erica Bone Specific Alkaline

Phosphatase
Closed 2/22/2010 16:00 26620 ONeill, Debra D-Dimer
Closed 2/22/2010 16:02 26621 ONeill, Debra DDIMER

Closed 2/26/2010 3:16 26742 Not Provided Acetoacetate or Acetoacetic
acid
Closed 3/12/2010 10:10 27067 Erin Muhlbradt Remove the word 'SPECIES'
from all genus-level CDISC
PTs
Closed 3/12/2010 10:11 27068 Erin Muhlbradt Change NCI C-code of

CDISC PT GRAM-POSITIVE
BACILLUS from C86423 to
C62589
Closed 3/12/2010 10:12 27070 Erin Muhlbradt Remove Mycobacterium
fortuitum subsp. fortuitum as
a synonym of Mycobacterium
fortuitum C86538
Closed 3/15/2010 11:17 27125 Pemble, Nik EPISQTCE and Squamous

Transitional Epithelial Cells
Closed 3/16/2010 19:39 27186 Allen, Laura Hepatitis G RNA

Closed 3/16/2010 19:45 27188 Allen, Laura HGVRNA
Closed 3/16/2010 19:49 27189 Allen, Laura Influenza A Virus H1N1 PCR
Closed 3/16/2010 19:52 27190 Allen, Laura INFAH1N1
Closed 3/17/2010 11:20 27221 Mary Lenzen 2 terms for

TSPARMCD/TSPARM that
seem to be exactly the same -
CURTRT (Current Treatment)
and EXISTRT (Existing
Treatment). Please delete
CURTRT
Closed 3/17/2010 13:31 27229 Allen, Laura Mycobacterium Tuberculosis
QFT
Closed 3/17/2010 13:34 27230 Allen, Laura MTUBEQFT
Closed 3/19/2010 13:34 27336 Allen, Laura Chlamydia Pneumoniae IgA

and IgG Ab
Closed 3/19/2010 13:39 27337 Allen, Laura CPIGAGAB
Closed 4/19/2010 28246 Linda Pedersen Vascular Epithelial Growth

Factor please correct to the
most common test name
Vascular Endothelial Growth
Factor
Closed 4/26/2010 28340 Tobias Hermes "FASTING BLOOD
GLUCOSE (SST)"
Closed 4/26/2010 28341 Tobias Hermes "Crystals: Amorphous

phosphates", "Crystals:
Amorphous urates" and
"Crystals: Amorphous debris"
Closed 4/26/2010 28342 Tobias Hermes "Erythrocytes; Red Blood

Cells in Urine" and
"Leukocytes; White Blood
Cells in Urine"
Closed 4/26/2010 28343 Tobias Hermes "Bilirubin in Urine" and "Blood

in Urine"
Closed 5/24/2010 17:32 28658
C74724, c74725, c74726,

c74727 HAVPCR, HBVPCR,
HCVPCR, HIVPCR - remove
Chris Tolk PCR, this is a method
Closed 5/26/2010 11:45 28691 C54431 add synonym of
Chris Tolk microalbumin to albumin
Closed 5/27/2010 13:10 28705
C49610 C66734
Domain Abbreviation
SC Subject Characteristics
The subject characteristics
domain is for data not
collected in other domains
that is subject-related.
Examples: subject initials,
Dirk Van other race details, eye color,
Krunckelsven childbeari
Closed 6/4/2010 19:17 28792
Anna Pron-Zwick Nasopharyngeal

Closed 6/12/2010 19:39 28862
Estrelita Janse
van Rensburg Hepatits C virus antibodies
Closed 6/12/2010 19:41 28863
Sophia Paterakis OCCASIONAL

Closed 6/18/2010 11:46 28927
Dianne TABLET, OVER

Weatherall ENCAPSULATED
Closed 6/21/2010 19:27 28937
Add new term DOSE
Dianne ADJUSTED or allow the
Weatherall codelist to be extensible
Closed 6/25/2010 13:13 28983
AMA Antimitochondrial
Claire West Antibodies
Closed 6/25/2010 13:14 28984
BNPPRO ProB-type
Claire West Natriuretic Peptide
Closed 6/25/2010 13:16 28985
Claire West CTOT Complement Total

Closed 6/25/2010 13:17 28986
CTXI Type I Collagen C-
Claire West Telopeptides
Closed 6/25/2010 13:18 28987
HTPHAB Heterophile
Claire West Antibodies
Closed 6/25/2010 13:20 28988
VCAM1 Vascular Cell
Claire West Adhesion Molecule 1
Closed 6/25/2010 13:21 28989
Claire West PO2 Partial Pressure Oxygen

Closed 6/25/2010 13:22 28990
Claire West VITD Vitamin D

Closed 6/25/2010 13:24 28991
Claire West IGG Immunoglobulin G

Closed 6/25/2010 13:25 28992
FDP Fibrin Degradation

Claire West Products
Closed 7/8/2010 18:55 29070
LBTESTCD=PT
LBTEST=Prothrombin Time.
The team should reconsider
the definition. Currently it
indicates that it can be
expressed in units of time or
percentage activity. We can
only have one unit type per
Nik Pemble test code.
Closed 7/9/2010 14:06 29077
C85659 Liter per Gram per
Minute; remove synonym
Erin Muhlbradt uL/ug/s
Closed 7/9/2010 14:31 29078
Erin Muhlbradt C85663 L/kg/day
Closed 7/16/2010 13:02 29140
Remove C85713 mL/g/s from

Erin Muhlbradt PKUNIT codelist
Closed 8/2/2010 17:37 29241
Modify explanation of NCIt PT

column on
SDTM/CDASH/ADaM
Erin Muhlbradt spreadsheets in ReadMe tab
Closed 9/8/2010 12:16 29614
SC codelist (Subject
Manuel Horas Characteristics)
Closed 9/20/2010 11:36 29697 Tore Haglund Code C77666 = EMESIS
should be VOMIT
Closed 9/20/2010 14:19 29698 Manuel Horas /h
Closed 9/21/2010 12:13 29708 Claire West Code: 1 ; Label: Proportion of

1
Closed 9/21/2010 12:13 29709 Claire West Code: %TL CK; Label:
Percentage of total creatine
kinase
Closed 9/21/2010 12:14 29710 Claire West Code: CELLS/HPF; Label:
Cells per high power field
Closed 9/21/2010 12:15 29711 Claire West Code: CELLS/F; Label: Cells
per field
Closed 9/21/2010 12:16 29712 Claire West Code: TITER/TITRE; Label:

Titer/Titre
Closed 9/21/2010 12:17 29713 Claire West Code: %O; Label: Promille
(per 1000 RBC)
Closed 9/22/2010 12:55 29726 Claire West Code: EIA; Label: Enzyme
Immunoassay Value
Closed 9/22/2010 12:56 29727 Claire West Code: EU/dL; Label: Ehrlich
units per decilitre
Closed 9/22/2010 13:25 29728 Claire West Is there a principle about

coding non-unit words. These
include the following:
ACTUATION
Closed 9/22/2010 13:26 29729 Claire West Code: um3; Label: Cubic
micrometre
Closed 9/22/2010 13:27 29730 Claire West Code: fl; Label: Femtolitre
Closed 9/22/2010 13:34 29731 Claire West I have 3 codes that make use
of the term Femtomole...
Closed 9/22/2010 13:36 29732 Claire West g% - Grams percent; mg% -

Miligrams percent
Closed 9/22/2010 13:38 29733 Claire West Code: mg/mg creat; Label:
Milligrams per gram of
Creatinine
Closed 9/22/2010 13:39 29734 Claire West Can you please review and
comment on the following
synonym suggestions:
Closed 9/22/2010 13:40 29735 Claire West Can you please confirm the
use of k vs thousand.
Closed 9/22/2010 13:42 29736 Claire West We use GI/L (giga/Litre) and
TI/L (Tera/Litre) a lot. Should
these codes remain GI/L and
TI/L or be expanded to Giga/L
and Tera/L?
Closed 9/22/2010 13:43 29737 Claire West In the UNIT terminology for
the unit ug/m3, the definition
refers to synonyms. Can
these please be added to the
Synonym column? i.e. ng/L
and pg/mL
Closed 9/22/2010 13:44 29738 Claire West Case is a constant question

e.g. FEU (Fibrinogen
equivalent units) I assume
this should be uppercase
based on CFU (Colony
Forming Units)?
Closed 9/22/2010 13:52 29739 Claire West Can I use MESF as an

industry abbreviation for
molecules of equivalent
soluble fluorochromes? e.g.
MESF/cell (or CELL)?
Closed 9/22/2010 13:53 29740 Claire West I have a unit of Median
Fluorescence. Should I use
MFI or spell the unit in its
entirety in lowercase?
Closed 9/22/2010 13:54 29741 Claire West I have a code of CTC/7.5mL.
Closed 9/22/2010 13:54 29742 Claire West Would circulating endothelial

cells be expressed as CEC
since this appears to be an
industry std abbreviation
Closed 9/22/2010 15:10 29743 Van Krunckelsven Actually a mixture between

Dirk new term request and modify
term request...
Closed 9/29/2010 16:32 29805 Hector Robertson Not Sure
Closed 10/1/2010 12:03 29816 Matthew Peck Treatment Adjusted
Closed 10/1/2010 12:58 29817 Nik Pemble The lab test name associated
with VEGF I think is not
correct. It currently reads
VASCULAR EPITHELIAL
GROWTH FACTOR and I
think it should read
VASCULAR ENDOTHELIAL
GROWTH FACTOR
Closed 10/13/2010 16:34 29895 Audrey Walker C42576 C71620 Unit kg/m3
Closed 10/13/2010 17:05 29898 Audrey Walker C64572 C71620 Unit

g/m3
Closed 10/13/2010 17:06 29899 Audrey Walker C67255 C77528 UNIT

thous/uL
Closed 10/13/2010 17:07 29900 Audrey Walker C67308 C77528 UNIT

mill/uL million per microliter
Closed 10/14/2010 12:10 29904 Audrey Walker C67327 C71620 Unit
ug/m3
Closed 10/14/2010 18:26 29912 Monica Mattson Current codelist value

WITHDRAWAL BY
SUBJECT. Suggest enhance
to WITHDRAWAL OF
INFORMED CONSENT BY
SUBJECT to avoid possible
confusion if subject withdraws
, for example, from one phase
of the study (treatment phase)
but allows data collection for
follow-
Closed 10/22/2010 12:48 29960 Carol Vaughn Change terms to sentence

case
Closed 10/27/2010 17:06 30005 Chris Tolk Change C20587 from Age
Group to Age Span to match
the text in C67152 and Age
Span code list.
Closed 11/2/2010 12:13 30055 Albert Chau Platelet should be changed to

Platelets
Closed 11/5/2010 14:06 30081 claire west 10^3/uL

Closed 11/8/2010 13:18 30096 Gail Stoner EPISQCE
Closed 11/8/2010 14:00 30098 Erin Muhlbradt CDASH Terminology -

C78424 codelist code
Closed 11/10/2010 14:11 30117 Monica Mattson In SDTM-PKPARM: Request
addition of AUC Infinity Obs
Norm by Dose to allow for
dose-normalization of AUC
extrapolated to infinity.
Closed 11/19/2010 13:52 30166 Chris Tolk C25298 C66741 Vital Signs

Test Code SYSBP Systolic
Blood Should read 'Systolic
Blood Pressure'
Closed 11/24/2010 18:25 30217 Erin Muhlbradt Changes to ADaM

Terminology spreadsheet
Closed 11/24/2010 18:28 30218 Erin Muhlbradt Changes to existing CDASH
CT Spreadsheet format
Closed 12/6/2010 20:03 30274 Anna Pron-Zwick Cardiovascular System;

Endocrine System; Exocrine
System; Immune System;
Hematopoietic and Lymphatic
System; Musculoskeletal
System; Nervous System;
Respiratory System;
Integumentary System;
Reproductive System
Closed 12/10/2010 13:27 30302 campain-teulon CEREBRAL CORTICAL;

CEREBRAL SUBCORTICAL;
BRAINSTEM
Closed 12/10/2010 13:29 30303 Randall Austin modify CDISC definition

where TSPARM=Planned
number of subjects and
TSPARMCD=PLANSUB
Closed 12/21/2010 13:21 30358 John QHS - Every Night; MANE - In

Swithenbank the Morning; NOCTE - At
night
Closed 12/21/2010 13:22 30359 John Kappa Free Light Chain;
Swithenbank Lambda Free Light Chain;
Free Kappa/Free Lambda
Ratio; M-Protein; Quantitative
immunoglobulins and IgG,
IgM, IgA, IgD
Closed 12/21/2010 13:26 30360 John 21 days with 7 day break

Swithenbank
Closed 12/21/2010 13:27 30361 John LBTEST = Immunoglobulin D;

Swithenbank LBTESTCD = IGD
Justification Summary
This concept is not in the addition of new term

dictionary.
Addition of new test code for Anti-Single

Stranded DNA
This concept is not in the Addition of new term

dictionary.
This concept is not int he Addition of new test code for Influenza A
dictionary. Virus PCR
I do not see a code and Bone Specific Alkaline Phosphatase
decode for Bone Specific
Alkaline Phosphatase.
The code list is anatomical Add ANKLE as a location for taking

location. So the blood pressure.
measurement would be
blood pressure and the
anatomical location would be
ankle.
The lab term 'Type I Add a new SDTM - LBTEST of Type I

Myeloblasts' is not in the Myeloblasts
CDISC lab tests dictionary.
The SDTM - LBTESTCD of Add a SDTM - LBTESTCD of BLSTMY1

BLSTMY1 is not in the for the test 'Type I Myeloblasts'
The lab term (LBTEST) of Add a new SDTM - LBTEST of Type II

Type II Myeloblasts is not in Myeloblasts
the CDISC lab tests
dictionary.
The LBTESTCD of Add a new SDTM - LBTESTCD of
BLSTMY2 is not in the BLSTMY2 for Type II Myeloblasts
Justification for Change Add a new SDTM - LBTEST of Type III

Request: The lab term Myeloblasts
(LBTEST) of Type III
Myeloblasts is not in the
The lab test code Add a new SDTM - LBTESTCD of

(LBTESTCD) of BLSTMY3 is BLSTMY3 for Type III Myeloblasts
not in the CDISC lab tests
dictionary.
The lab term (LBTEST) of Add a new SDTM - LBTEST of

Myeloid/Erythroid Ratio is Myeloid/Erythroid Ratio
not in the CDISC lab test
dictionary.

(LBTESTCD) of MERATIO is MERATIO for Myeloid/Erythroid Ratio
not in the CDISC lab test
dictionary.
The lab term (LBTEST) of Add a new SDTM-LBTEST of
Chlamydia Pneumoniae IgM Chlamydia Pneumoniae IgM Antibody
Antibodyis not in teh CDISC
dictionary.
The lab test code Add a new SDTM-LBTESTCD of

(LBTESTCD) of CPIGMAB is CPIGMAB for Chlamydia Pneumoniae
not int eh CDSIC dictionary. IgM Antibody
The lab term (LBTEST) of Add a new SDTM-LBTEST of Legionella

Legionella Pneumophila IgG Pneumophila IgG Antibody
Antibody is not in the CDISC
dictionary.

(LBTESTCD) of LPIGGAB is LPIGGAB for Legionella Pneumophila
not in the CDSIC dictionary. IgG Antibody
The lab term (LBTEST) of Add a new SDTM-LBTEST of Legionella

Legionella Pneumophila IgM Pneumophila IgM Antibody
Antibody is not in the CDISC
dictionary.
(LBTESTCD) of LPIGMAB is LPIGMAB for Legionella Pneumophila
not in the CDSIC dictionary. IgM Antibody
Justification for Change Add a new SDTM-LBTEST of Legionella

Request: The lab term Pneumophila IgG and IgM Ab
(LBTEST) is not in the
CDISC dictionary.
The lab test code of Add a new SDTM - LBTESTCD of

LPIGGMAB is not in the LPIGGMAB for Legionella Pneumophila
CDISC dictionary. IgG and IgM Ab
The lab term Addition of term 'Antimyeloperoxidase

'Antimyeloperoxidase Antibody' to LBTEST
Antibody' is not currently
available in SDTM-LBTEST.
Addition of test code Addition of 'ANTIMPAB' to LBTESTCD
'ANTIMPAB' to go with the
request to add the new term
'Antimyeloperoxidase
Antibody'
Addition of a synonym(s) for

the term Acetylcholine for
clarification
Below is a reference for the Fitzpatrick Classification Scale does not

Fitzpatrick Classification match with CDISC controlled
SCale. Based on that, I terminology
expected the SKINCLAS
(C76351) CDISC
Submission Value to be I, II
etc and not TYPE1, TYPE2
etc.
http://dermatology.about.co
m/od/cosmeticprocedure/a/fit
zpatrick.htm: Fitzpatrick
Classification Scale: Skin
Type Skin Color
Characteristics: I White; very
fair; red or blond hair; blue
eyes; freckles Always burns,
never tans; II White; fair; red
or blond hair; blue, hazel, or
green eyes Usually burns,
tans with difficulty; III Cream
white; fair with any eye or
hair color; very common
Sometimes mild burn,
gradually tans; IV Brown;
typical Mediterranean
caucasian skin Rarely burns,
tans with ease; V Dark
Brown; mid-eastern skin
types very rarely burns, tans
very easily; VI Black Never
burns, tans very easily
In the SDTM Terminology
2009-10-06 there are two
codelist names for this
codelist, "Ethnic Group" and
"Patient Ethnic Group".
New codes were requested Request for new ECG results codes
by ECG vendor to code
abnormalities
We are unable to locate the new term needed in SDTM-LBTEST and

corresponding term in either SDTM-LBTESTCD CDISC Code Lists
the SDTM-LBTESTCD or
SDTM-LBTEST code lists for
Bone Specific Alkaline
Phosphatase.
Concept of D-Dimer not Addition of 'D-Dimer' to LBTEST

currently available in CDISC
code addition (DDIMER) to Addition of 'DDIMER' to LBTESTCD

go with request to add new
term (D-Dimer)
Acetoacetate or Acetoacetic Acetoacetate or Acetoacetic acid is not
acid is not a part of LBTEST a part of LBTEST and LBTESTCD
and LBTESTCD
CDISC Change
Detailed Description NCI Decision
Decision Type
addition of new term This request III

will be
considered
in the next
lab
terminology
package P5.
Addition of new test code for Anti-Single This request III

Stranded DNA will be
considered
in the next
lab
terminology
package P5.
Addition of new term. PCR is method This request III

in this will be
suggested PT. considered
May want to in the next
make the term lab
more specific for terminology
the Influenza A package P5.
Virus DNA or
RNA or
something like
that.
Addition of new test code for Influenza A PCR is method This request III
Virus PCR. in this will be
suggested PT. considered
May want to in the next
make the term lab
more specific for terminology
the Influenza A package P5.
Virus DNA or
RNA or
something like
that.
New code is needed for new term Bone Alk Phos comes This request III
Specific Alkaline Phosphatase from Liver and will be
Bone; the bone considered
Alk Phos is a in the next
different isoform lab
to the bone Alk terminology
Phos. Lab test package P5.
kits may be
specific for
either isoform.
See summary. Send to CDISC This request III

for Review will be
considered
in the next
terminology
package
FY2010.
Add a new SDTM - LBTEST of Type I Send to CDISC This request III
Myeloblasts for Review will be
considered
in the next
lab
terminology
package P5.
Add a SDTM - LBTESTCD of BLSTMY1 for Send to CDISC This request III
the test 'Type I Myeloblasts' for Review will be
considered
in the next
lab
terminology
package P5.
Add a new SDTM - LBTEST of Type II Send to CDISC This request III
considered
in the next
lab
terminology
package P5.
Add a new SDTM - LBTESTCD of Send to CDISC This request III
BLSTMY2 for Type II Myeloblasts for Review will be
considered
in the next
lab
terminology
package P5.
Add a new SDTM - LBTEST of Type III Send to CDISC This request III
considered
in the next
lab
terminology
package P5.

BLSTMY3 for Type III Myeloblasts for Review will be
considered
in the next
lab
terminology
package P5.
Add a new SDTM - LBTEST of Send to CDISC This request III

Myeloid/Erythroid Ratio for Review will be
considered
in the next
lab
terminology
package P5.

MERATIO for Myeloid/Erythroid Ratio for Review will be
considered
in the next
lab
terminology
package P5.
Add a new SDTM-LBTEST of Chlamydia Send to CDISC This request III
Pneumoniae IgM Antibody. Reference: for Review will be
http://www.aruplab.com/ considered
in the next
lab
terminology
package P5.
Add a new SDTM-LBTESTCD of CPIGMAB Send to CDISC This request III

for Chlamydia Pneumoniae IgM Antibody. for Review will be
considered
in the next
lab
terminology
package P5.
Add a new SDTM-LBTEST of Legionella Send to CDISC This request III

Pneumophila IgG Antibody. for Review will be
considered
in the next
lab
terminology
package P5.

LPIGGAB for Legionella Pneumophila IgG for Review will be
Antibody considered
in the next
lab
terminology
package P5.

Pneumophila IgM Antibody. Reference: for Review will be
http://www.questdiagnostics.com/hcp/qtim/t considered
estMenuSearch.do in the next
lab
terminology
package P5.
LPIGMAB for Legionella Pneumophila IgM for Review will be
Antibody considered
in the next
lab
terminology
package P5.

Pneumophila IgG and IgM Ab. Reference: for Review will be
http://www.questdiagnostics.com/hcp/qtim/t considered
estMenuSearch.do in the next
lab
terminology
package P5.

LPIGGMAB for Legionella Pneumophila IgG for Review will be
and IgM Ab considered
in the next
lab
terminology
package P5.
The term 'Antimyeloperoxidase Antibody' is Send to CDISC This request III

not currently available in SDTM-LBTEST. for Review will be
"Antineutrophil cytoplasmic antibodies considered
(ANCA) are autoantibodies directed against in the next
lysosomal enzymes of human neutrophils lab
and monocytes. Myeloperoxidase (MPO) is terminology
the autoantigen most commonly responsible package P5.
for ANCA reactivity that demonstrates the
perinuclear pattern (P-ANCA)." Speciality
Laboratories "Antineutrophil Cytoplasmic
Autoantibodies" - see attached file. This test
is available for testing from: ARUP
Laboratories
(http://www.aruplab.com/guides/ug/tests/20
02068.jsp); Mayo Medical Laboratory
(http://www.mayomedicallaboratories.com/te
st-catalog/Overview/80389); Quest
Diagnostics
(http://www.questdiagnostics.com/hcp/testm
enu/jsp/showTestMenu.jsp?
fn=70159X.html&labCode=SJC); Speciality
Laboratories
(http://www.specialtylabs.com/tests/details.a
sp?id=1866)
Addition of test code 'ANTIMPAB' to go with Send to CDISC This request III
the request to add the new term for Review will be
'Antimyeloperoxidase Antibody' considered
in the next
lab
terminology
package P5.
Send to CDISC This request II

for Review will be
considered
in the next
lab
terminology
package P5.
Below is a reference for the Fitzpatrick Send to CDISC Will be II

Classification SCale. Based on that, I for review. included in
expected the SKINCLAS (C76351) CDISC P5 General
Submission Value to be I, II etc and not Terminology
TYPE1, TYPE2 etc.
http://dermatology.about.com/od/cosmeticpr
ocedure/a/fitzpatrick.htm: Fitzpatrick
Classification Scale: Skin Type Skin Color
Characteristics: I White; very fair; red or
blond hair; blue eyes; freckles Always
burns, never tans; II White; fair; red or blond
hair; blue, hazel, or green eyes Usually
burns, tans with difficulty; III Cream white;
fair with any eye or hair color; very common
Sometimes mild burn, gradually tans; IV
Brown; typical Mediterranean caucasian
skin Rarely burns, tans with ease; V Dark
Brown; mid-eastern skin types very rarely
burns, tans very easily
Relates to Changes I
Request 20829. made on P4
This was agreed March
to be changed SDTM CT
to Subject terminology
Ethnic Group publication
but was not
done on the
spreadsheet for
some reason.
This change will
be made with p4
publication.
EARLY R WAVE PROGRESSION; RSR’ Send to CDISC Will be III

OR QR PATTERN IN V1 SUGGESTS for review. included in
RIGHT VENTRICULAR DELAY; P5 General
ELECTRONIC VENTRICULAR Terminology
PACEMAKER; ELECTRONIC ATRIAL
PACEMAKER; 2ND DEGREE A-V BLOCK
(MOBITZ I); 2ND DEGREE A-V BLOCK
(MOBITZ II); QTcB or QTcF Borderline
Prolonged
This is a request to have a new term added Send to CDISC Will be III
to the SDTM-LBTEST and SDTM- for review. included in
LBTESTCD CDISC Code Lists for the lab P5 Lab
test "Bone Specific Alkaline Phosphatase". Terminology
Please add the test 'D-Dimer' to the SDTM- Went in as part Changes III
LBTEST CDISC code list. This test is used of P4. Let made on P4
to measure the cross-linked fibrin Debbie know it March
degradation product, D-dimer, in a biological is in SDTM with SDTM CT
specimen. References: ARUP: c-code C82621 terminology
http://www.aruplab.com/guides/ug/tests/003 publication
0057.jsp; Quest:
http://www.questdiagnostics.com/hcp/testm
enu/jsp/showTestMenu.jsp?
fn=32466P.html&labCode=SJC;
Addition of the test code 'DDIMER' to go Went in as part Changes III

with the request to add the new term 'D- of P4. Let made on P4
Dimer'. Debbie know it March
is in SDTM with SDTM CT
c-code C82621 terminology
publication
Acetoacetate or Acetoacetic acid is not a Up until this Will be III
part of LBTEST and LBTESTCD point, CDISC included in
has not been Package 5
consistent about lab
which form (-ate terminology
or -ic acid) that
general is used
as a PT. Either
is fine. Probably
just check to
see which form
labs use more
often.
Placing the word SPECIES in the CDISC Agree. I have I

PTs of these terms in the NCI Thesaurus labeled this a
directly contradicts the CDISC definition. type 1 request
This contradiction, besides being because this
terminologically incorrect, causes problems needs to be
when exporting our databases. We strongly fixed in our
recommend removing the word 'SPECIES' database ASAP.
from the Genus level terms in the
MICROORG codelist.
This is the correct mapping in our database. Agree Agree II
This is not really a synonym but more of a Agree Agree II

parent-child relationship
EPISQTCE - This test code and related test Send to CDISC This request II
name Squamous Transitional Epithelial for review will be
Cells is an incorrect use of terminology; considered
transitional epithelial cells are typically cells in the next
originating from the bladder whereas cells lab
from the external urethra are typically terminology
coined squamous epithelial cells. These package P5.
cells have different appearances based
upon their origin. As an FYI Renal tubular
cells originate in the kidney and is the third
general group of epithelial cells found in
urine
Add a new SDTM - LBTEST of Hepatitis G Send to CDISC This request III
RNA. The lab term (LBTEST) Hepatitis G for review will be
RNA is not in the CDISC dictionary. Add a considered
new SDTM - LBTEST of Hepatitis G RNA in the next
Reference: Specialty Laboratories lab
terminology
package P5.
Add a new SDTM - LBTESTCD of HGVRNA Send to CDISC This request III
for Hepatitis G RNA. The lab test code for review will be
(LBTESTCD) of HGVRNAis not in the considered
CDISC dictionary. Add a new SDTM - in the next
LBTESTCD of HGVRNA for Hepatitis G lab
RNA. terminology
package P5.
Add a new SDTM - LBTEST of Influenza A Send to CDISC This request III
Virus H1N1 PCR. The lab term (LBTEST) of for review will be
Influenza A Virus H1N1 PCR is not in the considered
CDISC dictionary. Add a new SDTM - in the next
LBTEST of Influenza A Virus H1N1 PCR. lab
Reference: Quest Diagnostics terminology
package P5.

INFAH1N1 for Influenza A Virus H1N1 PCR. for review will be
The lab test code (LBTESTCD) of considered
INFAH1N1 is not in the CDISC dictionary. in the next
Add a new SDTM - LBTESTCD of lab
INFAH1N1 for Influenza A Virus H1N1 PCR. terminology
package P5.
I submitted the request to add EXISTRT Send to CDISC Agree. II

(Existing Treatment) based on work done by to discuss Terminology
the CDISC Trail Design Team. Do not why definition group
or who requested CURTRT but do not need clarification of determines
both since they are redundant. these two terms. to remove
the term
Existing
Treatment
(EXISTRT)
from the list
and change
the
definition of
CURTRT to
'The literal
identifier of
the therapy
or
medication
that is
currently
being given
per
protocol.'
This term is not in the CDISC Dictionary. Send to CDISC This request III
Definition: Identification of Mycobacterium for review will be
tuberculosis in a biological specimen using considered
the quantiFERON-TB Gold In Tube (QFT). in the next
QuantiFERON-TB Gold In Tube is a Cell lab
Culture/Enzyme-Linked Immunosorbent terminology
assay specific for Mycobacterium package P5.
tuberculosis, not nontuberculosis
mycobacterium or the BCG vaccine.
This term is not in the CDISC Dictionary. Send to CDISC This request III
Definition: Identification of Mycobacterium for review will be
tuberculosis in a biological specimen using considered
the quantiFERON-TB Gold In Tube (QFT). in the next
QuantiFERON-TB Gold In Tube is a Cell lab
Culture/Enzyme-Linked Immunosorbent terminology
assay specific for Mycobacterium package P5.
tuberculosis, not nontuberculosis
mycobacterium or the BCG vaccine.
The lab term (LBTEST) of Chlamydia Send to CDISC This request III
Pneumoniae IgA and IgG Ab is not in the for review will be
CDISC dictionary. considered
in the next
lab
terminology
package P5.
The lab code (LBTESTCD) of CPIGAGAB is Send to CDISC This request III
not in the CDISC dictionary. for review will be
considered
in the next
lab
terminology
package P5.
When doing some research to add this Send to CDISC This request III
LBTEST to our own system we discovered for Review will be
that the most common name is Vascular considered
Endothelial Growth Factor in the next
lab
terminology
package P5.
Suggesting "FBG" Send to CDISC This request III
for review. will be
Include with P5 considered
lab stuff in the next
lab
terminology
package P5.
Suggesting "CYAMPHOS", "CYAMURAT" Send to CDISC This request III

and "CYAMDEBR" for review. will be
lab
terminology
package P5.
Suggesting "URBC" and "UWBC" Send to CDISC This request III

for review. will be
lab
terminology
package P5.
Suggesting "UBILI" and "UBLOOD" Send to CDISC This request III

for review. will be
lab
terminology
package P5.
C74724, c74725, c74726, c74727 Agree; Also will Agree III

HAVPCR, HBVPCR, HCVPCR, HIVPCR - need to change
remove PCR, this is a method existing CDISC
definitions and
the c-codes.
New Definition
type: A
measurement of
the HXV viral
load in a
biological
specimen.
C54431 add synonym of microalbumin to Agree Agree II

albumin
The description, example part seems to not Send to CDISC Updated II
accord with SDTM 3.1.2 where the race for review. text to read
other is now captured on SUPPDM C49610
(personally I preffered SC for this as per C66734
SDTM IG 3.1.1, but it seems to have Domain
changed). Abbreviation
SC
Subject
Characteristi
cs "The
subject
characteristi
cs domain is
for data not
collected in
other
domains
that is
subject-
related.
Please consider either adding Nasopharynx Send to CDISC Swab would III
or Nasopharyngeal as a specimen type. for review; be the
Nasopharyngeal swabs are frequently used CDISC has collection
when testing for various viruses, e.g. published method, (in
Adenovirus, Rhinovirus, Influenza, etc. 'Nasopharynx' suppqual).
C12423 as part 'Nasopharyn
of the x' C12423 is
Anatomical the location
Location and the
codelist. Should specimen is
it be in two possibly
places or is this "mucus". No
an change
implementation
issue?
The list that I saw contained the following Send to CDISC Will remove II
name: Hepatitis C virus surface antibodies. for review "surface"
The term "surface" should be removed since from
it is used with Hepatitis B virus. Hepatitis A
&C
This FREQ term is actually in the SDTM IG Send to CDISC Agree to III
3.1.2. We include this frequency in our for review add
CRFs (for SU cigarette smoking). Non of the
existing terms for FREQ actually cover this.
We have a trial where tablets were over- Send to CDISCBased on III
encapsulated in order to blind the treatment for review expert
taken. I could not match this to any existing terminology
terms, and would therefore like to request a resources
new term for this. we willnot
add. If FDA
were to refer
to one
product as
an "OVER
ENCAPSUL
ATED
TABLET"
and to
another
similar
appearing
product as a
"CAPSULE",
then those
two products
could never
be assessed
for
bioequivalen
ce because
federal
regulations
require
pharmaceuti
cal
equivalence.
the United
States
Pharmacope
ia does not
have the
I have a legacy study where the action Send to CDISC III
taken = "Dose adjusted". This does not map for review
to the SDTM terminology, and the codelist is
not extensible.
Is this the same as Mitochondrial antibody? Yes, these are Agree to III
If so, can this be added as a synonym? synonymous. add
Applies to LBTESTCD and LBTEST synonym
Is this the same as N-terminal pro-Brain Yes, these are Agree to III
Natriuretic Peptide? synonymous. add
synonym.
P6
Is this the same as Total Haemolytic Total hemolytic Agree to III
Complement (CH50)? complement add 2
(CH50) is the synonyms
best functional CH50 and
assay of the Total
complete Hemolytic
complement Complement
sequence.
CH50 is often
decreased in
SLE,
glomerulonephri
tis and other
immune
complex
diseases. A
normal CH50
level indicates
that all the
components, C1
through C9, are
present.
However,
individual
complement
factors may be
depleted 50 to
80% without
affecting CH50
activity.
Depletion of
alternative
factors is not
detected. For
this reason, it
may be
necessary to
Is this the same as Type I collagen X-linked I think the X- Agree to III
C-telopeptide? linked is actually add
referring to a synonym
cross-linking of
the Type I
Collagen C-
telopeptides.
Is this the same as Heterophile Antibody Yes. This test is Will not add III
Mono screen? screening for new test.
the presence of Should be
Heterophile mapped to
Antibodies, HTPHAB
which is
indicative of
Mononucleosis.
GSK should
map to the
CDISC PT.
Is this the same as Soluble VCAM1? There are two III
different forms
of VCAM1.
Membrane-
bound and
soluble. More
info: 'Serum
levels of soluble
vascular cell
adhesion
molecule 1
(sVCAM-1) shed
from its
membrane-
bound form are
elevated in
hypertension.
(http://content.k
arger.com/Prod
ukteDB/produkt
e.asp?
Doi=112941).'
We also have Partial Pressure of Arterial Send to CDISC Yes, III

Oxygen - is this a new code or PO2 with for review location
'Arterial' as location? Atrial
How do we differentiate from 1,25- These are Will need to III
Dihydroxy-Vitamin D? We have 2 Vitamin D different add a term,
tests: Calcidiol (inactive form) which is 25- compounds and synonym
Hydroxy-Vitamin D; Calcitriol (active form) so would and clarify
which is1,25-Dihydroxy-Vitamin D probably require definition
different lab
tests.
Can I question Gamma Globulin as a She is correct. Remove II

synonym: As per Wiki: The most significant This must have synonym;
gamma globulins are immunoglobulins been an Gamma
("Igs"), more commonly known as oversight on our Globulin
antibodies, although some Igs are not part because
gamma globulins, and some gamma Immunoglobulin
globulins are not Igs. G and Gamma
Globulin are
coded
separately in
NCIt.
Can you please add Fibrinogen Degradation These are not Agree with II
Products as a Synonym as I believe this is synonymous. NCI
true based on research I've done. Thrombin comment,
http://peir.path.uab.edu/coag/article_77.sht converts soluble will not add
ml fibrinogen into
insoluble fibrin.
They are coded
separately in
Thesaurus since
they are two
separate
proteins.
I suggest the team modifies the definition of Send to CDISC Will consider III
PT to indicate that it is expressed in units of for review with P6
time and that they develop a new testcd,
test name and definition (eg: PTACT or
PTAT, Prothrombin Time Activity, and a
suitable definition inidcating units expressed
as a percentage of activity.
On term C85659 L/g/min, remove the Agree Agree II

synonym uL/ug/s from published CDISC
terminology. Add uL/ug/min as a CDISC SY.
Change c-code to C73755 Agree Agree II
Term mL/g/s is a synonym of term C85664 Agree Agree III

L/kg/s in the PKUNIT codelist. Please keep
L/kg/s as the CDISC PT. Synonyms are fine
for C85664 and do not need to be altered.
This identifies the NCI preferred name for a Agree Agree II

term as identified in NCIt. **NOTE - This
column designates the human readable,
fully specified preferred term corresponding
to the NCI c-code, and is especially helpful
for searching NCIt to get the entire concept
with links to all instances of the term.
In the last version of controlled terminology Send to CDISC Add ot III
there is the codelist SCCD, but in my for review package 6.
opinion we need also de codelist SC in Until we add
order to have the meaning of the SCCD terms for
terms. i.e. in the CODE column this new SCTEST
codelist SC, have to have the same values please use
than SCCD codelist terms. Example: in the the
codelist SCCD there is the value SALTYP synonym.
(C74556) but there is no way to link with
the appropriate value of this code. The
solution I propose is the same you have
already implemented in VSTEST and
VSTESCD, LBTEST and LBTESTCD,
EGTEST and EGTESTCD, DATEST and
DATESTCD, TSPARM and TSPARMCD. If
you decide implement this codelist in a
future versionof controlled terminology,
maybe you have to take into account that
"SC" is included as a term for the codelist
DOMAIN.
Emesis is "the act of vomiting", cannot be a Send to CDISC Agree with II

specimen type. This should be VOMIT. for review; NCI - No
Emesis is Change
considered both
a SY of 'Vomit'
and 'Vomitus'
from multiple
sources, the
greek origin use
of the word is as
a noun, it is
used in clinical
practice as a
noun, and it is
currently
published and in
I think the use of this unit is very common Send
use bytothe
CDISC Discuss with III
for LAMZ PK parameter for review
CDISC P 6 terms.
community and
Predominently used for WBC differentials, is not to
Send technically
reticulocytes and Hematocrit. For WBC diffs, for reviewto use
incorrect P 6 terms.
the data is converted to % by x100. For the word as a
retics and hct, the SI is 1 (as per Quest specimen. NCI
central labs) feels that
CDISC does not
I have a couple of codes such as these need to
Send to change
where the vendor defines the percentage the PT of this
for review P 6 terms.
based on the reference test. I really need terms unless
confirmation whether these are valid units, necessary.
or whether the cod should just be % and
leave the LBTESTCD/LBTEST to define the
reference.
I have a number of units that begin with the Send to CDISC Discuss with III
words casts and cells e.g. CELLS/HPF and for review P 6 terms.
CASTS/UL. Can you tell me whether the
word should be upper or lowercase and
whether it should be singular or plural. i.e.
cell/HPF, CELL/HPF, cells/HPF or
CELLS/HPF or should the word be dropped
entirely and just have a unit of /HPF or
/LPF?
The unit for High Power Field is HPF. Send to CDISC Discuss with III
Would field be expressed as F or FIELD? F for review P 6 terms.
is the unit for Fahrenheit so I wasnt sure.
Will Titer be spelt TITER or TITRE? Is it an Send to CDISC Discuss with III
uppercase or lowercase code? for review P 6 terms.
This has been used for a reticulocyte test Send to CDISC Discuss with III
where this was the original unit and was for review P 6 terms.
converted to '1' x 0.001
Is this the same as ELISA unit? Send to CDISC Discuss with III
Send to CDISC Discuss with III


Ia this valid or should it be converted to a Send to CDISC Discuss with III

litre equivalent? for review P 6 terms.
Used for mean corpuscle volume and mean Send to CDISC Discuss with III
platelet volume for review P 6 terms.
Fmol values used for MCV, MCH etc Send to CDISC Discuss with III
g% - Is this a synonym for g/dL? mg% - is Send to CDISC Discuss with III
this a synonym for mg/dL? for review P 6 terms.
Used for protein/creatinine ratio Send to CDISC Discuss with III

If they are not synonyms can you please Send to CDISC Discuss with III
add them as new terms. for review P 6 terms.







BILI, WBC, and other terms can exist for Send to CDISC CDISC has III
different types of samples: urin, haem, for review made the
chem, etc. Would it make sense to create decision that
one item for each of these so that there is the
no confusion? I know that at the SDTM level specimen
there is a CATEGORY available, so that this will not be
can be split out, but upon constructing incorported
ADaMs in the BDS structure I run into into the
issues here... varialbe
name. The
specimen
goes into
the LBSPEC
field
Not Sure Send to CDISC Sent email III
for review; to requestor
Follow up to ask for
required. more
information
Some studies may not have all the details of Send to CDISC Further III
how a dose was adjusted (up or down), just for review discussion
that it was adjusted. Also older studies that needed
are completed but are being mapped to
SDTM, will not have a one to one match if
Dose Increased / Decreased was not
collected, and Dose Adjusted was.
If changed, please also update the definition This is being Agree III
taken care of in
the terminology
release for Q3
and P5. This
request can be
closed.
Please change the preferred term kg/m3 to Send to CDISC Still in II

g/L as this is the standard unit for Labs. for review. discussion
Preferred term should be g/L.
Please change the CDISC preferred term of Send to CDISC Still in II
g/m3 to mg/L as this is standard throughout for review. discussion
the industry. Change g/m3 to mg/L
Please change the CDISC preferred term Send to CDISC Still in II

thous/uL to 10^3/uL as this is standard for review. - This discussion
throughout the industry. Change thous/uL to will be resolved
10^3/uL. once we check
with FDA
Please consider changing the SEND CDISC Send to CDISC Still in III
preferred term for mill/uL to 10^6/uL as this for review. - This discussion
is the industry standard. Add 10^6/uL to the will be resolved
SDTM UNIT codelist. once we check
with FDA
Please change the CDISC preferred unit Send to CDISC Still in II
ug/m3 to ng/L as this is the industry for review. discussion
standard. We would also like this change for
consistency with all the following preferred
CDISC terms; There are currently:
15 existing terms that end with '/L', including
kg/L, ug/L, mol/L, mmol/L, nmol/L, pmol/L,
and IU/L.
22 terms that end with '/mL' rather than cm3
5 terms that end with '/uL' rather than mm3
(interestingly, 'uL' alone doesn't even seem
to be in the list).
3 terms that end in '/dL'
Current codelist value WITHDRAWAL BY Send to CDISC II

SUBJECT. Suggest enhance to for review.
WITHDRAWAL OF INFORMED CONSENT
BY SUBJECT to avoid possible confusion if
subject withdraws , for example, from one
phase of the study (treatment phase) but
allows data collection for follow-up phase.
"If the external reference for the controlled Send to CDISC II

terminology is not in upper case then the for review
data should conform to the case prescribed
in the external reference (e.g., MedDRA and
LOINC)." - MedDRA SOC terms are in
sentence case.
--- Agree. Change III

PT in TSPARM
codelist from
Age Group to
Age Span and
add Age Group
as a synonym.
To be consistent with the use of plurals in Send to CDISC Agree to II

other types of cells. for review change to
Platelets
This is one of numerous codes which are Send to CDISC Still in III
represented in this way using the '10 to the for review discussion
power of' format. Others include 10^2/uL,
10^3/mm3 up to 10^12/L. I'm looking for
guidance on how to represent these data. Is
10^3/uL best expressed as Thou/uL, or k/uL
or is 10^3/uL valid? This type of unit is
typically used in relation to cells e.g. WBC
differentials.
This is more of a question than a Send to CDISC Discuss with III
suggestion. The CDISC definition of most for review. We P7
tests is "A measurement of ... in a biological may need to
specimen," but some tests a described in review all defs
terms of a particular specimen such as to make them
"urine." We have a study where sputum less specimen
cytology is being captured. An example of specific.
one of the tests is squamous epithelial cell
count. The CDISC definition for EPISQCE
indicates is "A measurement of the
squamous epithelial cells present in a urine
specimen." Do we need to request a new
test code or is this test code appropriate for
use in other biological specimens? Thanks.
Change C78424 to C78745 in column B to Send to CDISC Agree I

reflect correct codelist code subset. for review
This would also require the addition of a Send to CDISC Add to III
new code (eg, AUCIFOD) to the for review Package 6
PKPARMCD codelist. This request was
originated by a pharmacokineticist in my
organization who saw that all other AUC
parameters had values normalized to Dose
except this one.
C25298 C66741 Vital Signs Test Code To clarify, the CDISC II

SYSBP Systolic Blood Should read term in the agrees to
'Systolic Blood Pressure' synonym this change.
column needs to
be changed.
Agree.
In order to further the requirements of the Send to CDISC Agree I

ODM/XML team for generating XML format for review
of CT, it is necessary to ensure that all
terminology spreadsheets look the same.
Therefore, I propose to make the following
changes to the ADaM CT spreadhsheet. 1)
Remove column F - this is a hold over from
previous iterations of the spreadsheet. 2)
Change the title of column E from CDISC
ADaM Submission Value to CDISC
Submission Value - to be inline with SDTM
spreadsheet.
In order to further the requirements of the Send to CDISC Agree I
ODM/XML team for getting CT into XML for review
formation, it is necessary to ensure that all
terminology spreadsheets look the same.
Therefore, I propose to make the following
changes to the CDASH spreadsheet. 1)
Change the column title of column E from
CDISC CDASH Preferred Term to CDISC
Submission Value. 2) Change the column
title of column F from CDISC CDASH
Preferred Term to CDISC Synonym(s) - This
is in keeping with the SDTM terminology
spreadsheet format.
Please consider adding the above 10 terms Send to CDISC Will consider III
to CDISC's SDTM Controlled Terminology for Review for Package
Anatomical Locations Codelist in order to be 7
consistent with NCI Terminology. As a
precedent, the Anatomical Locations
codelist already contains the following
terms: Gastrointestinal System and Urinary
System. Thank you. APZ/06-Dec-2010
needed to locate stroke Send to CDISC Will consider III

for Review for Package
7, Brain
Stem is in
Package 6
The existing definition for both "Planned Agree; send to Will consider II
number of subjects" and "PLANSUB" is CDISC for for Package
"The number of subjects entered in a clinical review. 7
trial." This is not correct. The field for
"Planned number"/PLANSUB is supposed
to hold "The number of subjects planned to
be enrolled in a clinical trial." This typically is
based on Sample Size calculations. The
actual number entered is a different
concept.Change the CDISC definition for
these 2 entries to "The number of subjects
planned to be enrolled in a clinical trial."
To make the codelist more complete and Send to CDISC Will consider III
negate the need for self addition of terms to for Review for Package
the extensible list 7
Please provide LBTEST and LBTESTCD Send to CDISC Will consider III
values for the above parameters or update for Review for Package
the associated information used in 7
identifying the controlled terminology as
either these are missing or are not easily
identifiable
PLease provide a Frequency code for the Send to CDISC Will consider III
above medication frequecny to be used for for Review for Package
oral contraceptives or confirm in notes how 7
this should be mapped
Please add above to controlled terminology Send to CDISC Will consider III
list for Review for Package
7
Final Outcome
Published in P5 2010
Q1 2010
Q1 2010
Q1 2010
Q1 2010
Q3 2010
Q3 2010
Q3 2010
Q3 2010
Q3 2010
Q3 2010
No Change
Q3 2010
Q3 2010
No Change
Closed out due to age.
Q3 2010

Q3 2010
Q3 2010
No Change
Q3 2010
No Change
Q3 2010
Q3 2010
No Change
Q4 2010
Q4 2010
Q4 2010
CDASH-Published in P3;
ADaM-Published in P3
No Change


No Change
Out of Scope
Published
Published
Published
Published
Published
Published
Published
Out of Scope
Codelist no longer exists
Q2 2011
Published
Published
Q2 2011
Q2 2011
ADaM-Published in P3
Q1 2011
Published
Published
Published
Published
Published
Do not control. List is

extensible
Published
Request Submitter Request
Status Date of Submission Submitter Name Submitter E-mail
Code Affiliation Type
Open 1/7/2011 14:44 30408 Erin Muhlbradt LMCO erin.e.muhlbradt Modify

@lmco.com Existing Term
Open 1/7/2011 14:44 30408 Erin Muhlbradt LMCO erin.e.muhlbradt@lmco.com

Modify
Existing Term
Open 1/7/2011 15:41 30409 john john.swithenbank Create New

Swithenbank @covance.com Term
Open 1/7/2011 15:41 30409 john john.swithenbank@covance.com

Create New
Swithenbank Term
Open 1/14/2011 17:15 30447 john john.swithenbank Modify

Swithenbank @covance.com Existing Term
Open 1/14/2011 17:15 30447 john john.swithenbank@covance.com

Modify
Swithenbank Existing Term
Open 1/21/2011 18:31 30482 Audrey Walker Charles River Audrey.Walker@ Create New
crl.com Term
Open 1/21/2011 18:31 30482 Audrey Walker Charles River Audrey.Walker@crl.com

Create New
Laboratories Term
Laboratories crl.com Term

Create New
Laboratories Term
Create New
Laboratories Term
Closed 2/4/2011 14:11 30557 Richard Shaw Parexel richard.shaw@pa Create New
rexel.com Term
Closed 2/4/2011 14:11 30557 Richard Shaw PAREXEL richard.shaw@parexel.com

Create New
International Term
Closed 2/4/2011 14:12 30558 Erin Muhlbradt LMCO erin.e.muhlbradt@lmco.com

Modify
Existing Term
Closed 2/4/2011 14:12 30558 Erin Muhlbradt LMCO erin.e.muhlbradt Modify

Open 2/4/2011 14:14 30559 Brian V. ERT bharrington@ert. Create New
Harrington (eResearch com Term
Technology)
Open 2/4/2011 14:14 30559 Brian V. ERT bharrington@ert.com
Create New
Harrington (eResearch Term
Technology)
Open 3/4/2011 13:10 30740 John john.swithenbank@covance.com

Modify
Swithenbank Existing Term

Modify
Existing Term
Open 3/4/2011 13:12 30742 Anna Pron- AstraZeneca anna.pron-zwick@astrazeneca.com
Create New
Zwick Pharmaceutic Term
als
Open 3/4/2011 13:13 30743 John john.swithenbank@covance.com

Create New
Swithenbank Term
Open 3/4/2011 13:14 30744 Anna Pron- AstraZeneca anna.pron-zwick@astrazeneca.com

Modify
Zwick Pharmaceutic Existing Term
als
Open 3/4/2011 13:15 30745 Claire West GSK claire.m.west@gsk.com
Other
Open 3/4/2011 13:16 30746 Claire West GSK claire.m.west@gsk.com
Create New
Term
Open 3/4/2011 13:20 30747 Monica Mattson Celgene mmattson@celgene.com

Create New
Corporation Term

Other
Open 3/31/2011 17:02 30860 Nik Pemble J&J npemble@its.jnj.com

Modify
Existing Term
Closed 3/31/2011 17:04 30861 Chris Tolk CDISC ctolk@cdisc.org Modify

Existing Term
Create New
Term
Closed 3/31/2011 17:07 30863 Dennis Noe MPI Dennis.Noe@mpi.com

Create New
Terms &
Modify
Existing
Terms
Open 3/31/2011 17:08 30864 Guy Genereux Sunovion guy.genereux@sunovion.com
Modify
Pharmaceutic Existing Term
als Inc.

Modify
als Inc.

Modify
als Inc.
Open 3/31/2011 17:13 30868 David Borbas Jazz David.Borbas@jazzpharma.com

Create New
Pharmaceutic Term
als
Closed 3/31/2011 17:16 30869 Chris Tolk CDISC ctolk@cdisc.org Modify

Existing Term
Open 4/1/2011 15:18 30895 David Borbas Jazz David.Borbas@jazzpharma.com
Create New
Pharmaceutic Term
als

Modify
Existing Term

Modify
Existing Term

Modify
Existing Term

Modify
Existing Term

Modify
Existing Term

Modify
Existing Term

Modify
Existing Term
Open 4/6/2011 14:12 30939 John john.swithenbank Create New

Open 4/6/2011 14:13 30940 John john.swithenbank Create New

Open 4/18/2011 13:53 31000 FuguiÂ Dong Pharmanet fdong@pharman Create New
et.com Term
Open 4/18/2011 13:54 31001 Fugui Dong Pharmanet fdong@pharman Create New
et.com Term
et.com Term
Closed 4/18/2011 13:57 31003 Erin Muhlbradt LMCO erin.e.muhlbradt Other
@lmco.com
Open 4/22/2011 17:00 31050 Tore Haglund AstraZeneca tore.haglund@as Create New
trazeneca.com Term
Open 4/29/2011 17:53 31102 Debbie O'Neill Merck debra_oneill@me Create New
rck.com Term
rck.com Term
rck.com Term
rck.com Term
Open 5/20/2011 13:47 31281 Allen Glover Covance allen.glover@cov Create New
ance.com Term
rck.com Term
Open 5/20/2011 13:49 31283 Nicholas Pemble Johnson and npemble@its.jnj. Create New
Johnson com Term
Open 5/20/2011 13:51 31284 Richard Shaw PAREXEL richard.shaw@pa Create New
INTERNATIO rexel.com Term
NAL
NAL
NAL
Open 5/20/2011 13:54 31287 Steve Kopko CDISC skopko@cdisc.or Create New
g Term

Open 5/20/2011 13:56 31289 Steve Kopko CDISC skopko@cdisc.or Create New
g Term
Open 5/20/2011 14:01 31290 erin.e.muhlbradt LMCO erin.e.muhlbradt Modify

@lmco.com @lmco.com Existing Term
Open 5/20/2011 14:02 31291 Steve Kopko CDISC skopko@cdisc.or Other
g
Open 5/20/2011 14:04 31292 Laura Allen Merck & laura_allen@mer Create New
Co. ck.com Term
rck.com Term
rck.com Term
Open 5/20/2011 14:08 31295 David Borbas Jazz David.Borbas@ja Modify

Pharmaceutic zzpharma.com Existing Term
als


Open 5/27/2011 12:17 31312 Michael Ward Eli Lilly and mjward@lilly.com Modify
Company Existing Term
Open 5/27/2011 12:20 31315 Bess LeRoy bleroy@c- Create New

path.org Term
Open 5/27/2011 12:22 31316 Bess LeRoy bleroy@c- Create New
path.org Term
Open 6/10/2011 17:17 31374 David Borbas Jazz David.Borbas@ja Create New
Pharmaceutic zzpharma.com Term
als
Open 6/10/2011 17:18 31375 Dan O'Connell Amgen doconnel@amge Create New
n.com Term
Open 6/17/2011 17:55 31400 Rhonda Facile CDISC-NCI- rfacile@cdisc.org Modify

EVS Existing Term
Closed 6/24/2011 20:15 31412 Guy Genereux Sunovion guy.genereux@s Other

Pharmaceutic unovion.com
als Inc.
Closed 6/24/2011 20:16 31413 Guy Genereux Sunovion guy.genereux@s Other
als Inc.
Open 6/24/2011 20:17 31414 Guy Genereux Sunovion guy.genereux@s Other

als Inc.
Open 6/24/2011 20:18 31415 Guy Genereux Sunovion guy.genereux@s Other
als Inc.
Co. ck.com Term
Open 6/24/2011 20:22 31417 melanie.fuellbeck Modify

@bayer.com Existing Term
Open 6/24/2011 20:23 31418 melanie.fuellbeck Modify

@bayer.com Existing Term
Closed 6/29/2011 19:19 31428 Guy Genereux Sunovion guy.genereux@s Modify

Pharmaceutic unovion.com Existing Term
als Inc.
Closed 6/29/2011 19:20 31429 Guy Genereux Sunovion Sunovion Modify

Pharmaceutic Pharmaceuticals Existing Term
als Inc. Inc.
Open 6/29/2011 19:21 31430 Guy Genereux Sunovion guy.genereux@s Modify

als Inc.

als Inc.

als Inc.
als Inc.

als Inc.

als Inc.







Closed 6/30/2011 13:50 31443 Erin Muhlbradt LMCo erin.e.muhlbradt Modify

Closed 6/30/2011 13:52 31445 erin.e.muhlbradt LMCO erin.e.muhlbradt Modify













Closed 7/1/2011 11:56 31461 erin.e.muhlbradt LMCO erin.e.muhlbradt Modify















et.com Term
et.com Term
Open 7/8/2011 12:30 31492 Henry Farkas Parexel henry.farkas@pa Modify

rexel.com Existing Term
Open 7/8/2011 12:32 31493 Jonathan Roche jonathan.chainey Create New
Chainey @roche.com Term

Co. ck.com Term
Co. ck.com Term
Co. ck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
Open 7/15/2011 14:56 31514 Randall Austin GlaxoSmithKli randall.r.austin@ Create New
ne gsk.com Term
Open 7/22/2011 12:16 31518 Shannon Labout CDISC slabout@cdisc.or Create New
g Codelist
rck.com Codelist
rck.com Term
Open 7/22/2011 12:20 31521 Melanie Bayer melanie.fuellbeck Other
Fuellbeck @bayer.com
rck.com Term
rck.com Term
rck.com Term
rck.com Term
Open 7/29/2011 15:54 31542 Debbie O'Neill Merck debra_oneill@me Other

rck.com
rck.com Term
rck.com Term
rck.com Term
Open 7/29/2011 16:18 31546 Erin Muhlbradt Merck debra_oneill@me Create New
rck.com Term
Open 8/5/2011 17:45 31554 Jegan Pillaiyar TAKE jeganp@takesolu Other

Solutions tions.com
Open 8/5/2011 17:47 31555 Erin Muhlbradt LMCO muhlbradtee@m Modify

ail.nih.gov Existing Term
rck.com Term
rck.com Term

rck.com

rck.com

rck.com

rck.com
rck.com

rck.com

rck.com

rck.com

rck.com

rck.com
rck.com Codelist
rck.com Term
rck.com Term
rck.com Term
Open 8/5/2011 19:17 31572 Debbie O'Neill LMCO debra_oneill@me Other

rck.com
ne gsk.com Term
ne gsk.com Term
ne gsk.com Term
ne gsk.com Term
Open 8/8/2011 16:31 31577 Brittain, Sarah MDSL sbrittain@mdslint Create New
International .com Term
Open 8/10/2011 15:45 31582 Eileen Celgene egardenhire@cel Create New
Gardenhire gene.com Term
Open 8/10/2011 15:48 31583 Ilona Panis Biomedical ipanis@biomeds Create New
Systems ys.com Codelist
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
Open 8/12/2011 14:23 31596 Chris Tolk CDISC ctolk@cdisc.org Create New
Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
Open 8/25/2011 14:39 31608 Phil Pochon Covance phil.pochon@cov Create New
Labs ance.com Term
rck.com Term
Open 8/31/2011 19:49 31615 Theresa Quinn quinnt@mail.nih. Modify

gov Existing Term
Open 9/13/2011 15:26 31630 Oneill, Debra Merck debra_oneill@me Create New
rck.com Term
rck.com Term
Open 9/13/2011 17:21 31633 Oneill, Debra Merck debra_oneill@me Modify
rck.com Existing Term
rck.com Term
rck.com Term
Open 9/13/2011 17:36 31636 ALLEN, LAURA Merck LAURA_ALLEN Create New
@MERCK.COM Term
Open 9/13/2011 17:44 31637 Allen, Laura Merck laura_allen@mer Create New
ck.com Term
Open 9/14/2011 20:06 31645 Walker, Gary Quintiles gary.walker@qui Create New
ntiles.com Term
Open 9/14/2011 20:08 31646 Walker, Gary Quintiles gary.walker@qui Create New
ntiles.com Term
Open 9/26/2011 11:19 31669 McLaughlin, Biogen Idec Sarah.McLaughli Modify

Sarah n@biogenidec.co Existing Term
m
Open 10/3/2011 11:35 31673 Austin, Randall GSK randall.r.austin@ Create New
gsk.com Term
Closed 10/3/2011 11:39 31674 Gardenhire, Celgene egardenhire@cel Create New

Eileen gene.com Term
Open 10/3/2011 11:44 31675 Gardenhire, Celgene egardenhire@cel Create New

Open 10/3/2011 11:46 31676 Gardenhire, Celgene egardenhire@cel Modify

Eileen gene.com Existing Term

Eileed gene.com Term


Open 10/7/2011 18:05 31687 Hernandez, Merck joyce_hernandez Create New

Joyce @merck.com Codelist
Open 10/7/2011 18:08 31688 Oneill, Debra MERCK debra_oneill@me Create New
rck.com Term
rck.com Term
rck.com Term
Open 10/21/2011 13:27 31702 Frederik Malfait Hoffmann-La frederik.malfait@ Modify

Roche roche.com Existing Term
Open 10/21/2011 13:28 31703 Frederik Malfait Hoffmann-La frederik.malfait@ Create New
Roche roche.com Term
Open 10/21/2011 13:29 31704 Anna Pron- AstraZeneca anna.pron- Modify

Zwick zwick@astrazene Existing Term
ca.com
Open 1/4/2012 13:37 31765 Troy Smyrnios MPI Research troy.smyrnios@m Create New
piresearch.com Term
Open 1/4/2012 13:38 31766 Troy Smyrnios MPI Research troy.smyrnios@m Modify
piresearch.com Existing Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
rck.com Term
Open 1/9/2012 14:02 31786 Carol Vaughn Sanofi Carol.Vaughn@s Modify
anofi.com Existing Term


Open 1/9/2012 19:27 31789 frank senk astrazeneca frank.senk@astra Create New
zeneca.com Term
Open 1/9/2012 19:29 31790 Sandra Sandra_Abensoh Create New
Abensohn n@vrtx.com Term
Open 1/9/2012 19:32 31791 frank senk astrazeneca frank.senk@astra Create New
zeneca.com Term
rck.com Term
rck.com Term
Open 1/10/2012 16:46 31794 Monica Mattson Celgene mmattson@celge Create New
Corporation ne.com Term
Open 1/10/2012 16:49 31795 Janet Siani Shire jsiani@shire.com Modify

Existing Term
Open 1/10/2012 16:50 31796 Janet Siani Shire jsiani@shire.com Other
Open 1/10/2012 16:51 31797 Janet Siani Shire jsiani@shire.com Create New
Term
Closed 1/10/2012 16:53 31798 Janet Siani Shire jsiani@shire.com Create New
Term
Term
Term
Term
Term
Term
Term
Term
Codelist
Term
Term
Term
Term
Term
Term
Term
Term
Term
Open 1/13/2012 14:39 31818 Jennifer Instem jennifer.feldmann Create New

Feldmann @instem.com Codelist
Term
Term
Term
Term
Term
Term
Term
Term
Term
Codelist
Term
Term
Closed 1/13/2012 14:59 31831 Janet Siani Shire jsiani@shire.com Create New
Term
Term
Term
Term
Term
Term
Term
Term
Term
Term
Codelist
Codelist
Codelist
Term
Term
Open 1/13/2012 15:29 31846 john.swithenban john.swithenbank Create New

k @covance.com Term
Open 1/13/2012 15:30 31847 john.swithenban john.swithenbank Create New

k @covance.com Term
Open 1/13/2012 15:31 31848 Barrie Nelson CDISC SDS barrien@amgen. Create New
Oncology com Term
Team
rck.com Term
Open 1/13/2012 15:41 31850 Debbie O'Neill Merck debra_oneill@me Modify

rck.com Existing Term
Open 1/13/2012 15:42 31851 Bess LeRoy C-PATH bleroy@c- Create New
path.org Term
path.org Term
path.org Term
path.org Term
Open 1/13/2012 15:45 31855 Chris Tolk CDISC ctolk@cdisc.org Create New
Term
Closed 1/13/2012 15:46 31856 Erin Muhlbradt NCI-EVS muhlbradtee@m Modify
Open 1/13/2012 15:47 31857 Erin Muhlbradt NCI-EVS muhlbradtee@m Modify

New Term or Codelist/Existing Term Change
CDISC Codelist Detailed Description
or Code Number Type
SDTM-FREQ Add synonym to C25473 QD to be Add synonym of 'Once Daily' to concept QD in II

compliant with CDASH v1.1 SDTM-FREQ codelist. QD/Quaque Die
literally means Once a day or Once daily. This
change will then ensure that terminology is
aligned with CDASH 1.1.
SDTM-FREQ Add synonym to C25473 QD to be Add synonym of 'Once Daily' to concept QD in II
compliant with CDASH v1.1 SDTM-FREQ codelist. QD/Quaque Die
literally means Once a day or Once daily. This
change will then ensure that terminology is
aligned with CDASH 1.1.
SDTM-LBTEST Please add a code for Tuberculosis. Option missing from codelist III
Suggested option LBTEST =
Tuberculosis ; LBTESTCD = TB
SDTM-LBTEST Please add a code for Tuberculosis. Option missing from codelist III
Suggested option LBTEST =
Tuberculosis ; LBTESTCD = TB
SDTM-LBTEST typographical error There seems to be a typographical error in I

the codelist for the following Laboratory test
and associated synonym and NCI term.
Should Luekocyte Cell Clumps not be
Leukocyte Cell Clumps for this test and the
associated information in LBTEST and
LBTESTCD.
SDTM-LBTEST typographical error There seems to be a typographical error in I

the codelist for the following Laboratory test
and associated synonym and NCI term.
Should Luekocyte Cell Clumps not be
Leukocyte Cell Clumps for this test and the
associated information in LBTEST and
LBTESTCD.
SDTM-LBTEST Amorphous phosphate in the Lab Package 6 Amorphous Cyrstal III

contains both phospate and urate we
measure them both separately, therefore they
both need terms
SDTM-LBTEST Amorphous phosphate in the Lab Package 6 Amorphous Cyrstal III
both need terms
SDTM-LBTEST Amorphous Urate in the Lab Package 6 Amorphous Cyrstal III
both need terms
SDTM-LBTEST Amorphous Urate in the Lab Package 6 Amorphous Cyrstal III
both need terms
SDTM-LBTEST BLOOD (in Urine) There does not seem to be a CDISC III
measurement for Blood (in the urine).
SDTM-LBTEST BLOOD (in Urine) There does not seem to be a CDISC III
measurement for Blood (in the urine).
SDTM-LBTEST ADENOPL - Adeno Plasma qPCR; Virology assays encountered in clinical study III
ADENOUR - Adeno Urine qPCR; data mapped to SDTM LB domain
BKVPL - BKV Plasam qPCR;
BKVUR - BKV Urine qPCR; CMVPL
- CMV Plasma qPCR; EBVPLÂ -
EBC Plama qPCR
SDTM-LBTEST ADENOPL - Adeno Plasma qPCR; Virology assays encountered in clinical study III
ADENOUR - Adeno Urine qPCR; data mapped to SDTM LB domain
BKVPL - BKV Plasam qPCR;
BKVUR - BKV Urine qPCR; CMVPL
- CMV Plasma qPCR; EBVPL -
EBC Plama qPCR
SDTM-LBTEST C74723 - Turbidity Remove the synonym 'Clarity' from the II

concept 'Turbidity'. Clarity has been
determined to be non-synonymous and will be
put in as a separate term with P6 terminology.
SDTM-LBTEST C74723 - Turbidity Remove the synonym 'Clarity' from the II

concept 'Turbidity'. Clarity has been
determined to be non-synonymous and will be
put in as a separate term with P6 terminology.
SDTM- Codelist name = ECG Result; Thank you for the opportunity to review the III
EGSTRESC Additions to existing codelist controlled terminology Package 6. We
reviewed the terminology and noticed there
are some potential ECG finding that are
missing in the ECG Result SDTM
Terminology. I listed all of these potential
findings below. We would like to see if it is
possible to include these findings within the
SDTM to ensure our customers remain
CDISC compliant. We welcome any
questions you may have on the list of
potential findings below: Normal Sinus
Rhythm; Other Rhythm; Unable to Assess;
Atrial Bigeminy; Frequent Atrial Premature
Complexes (>2); Frequent Atrial Premature
Complexes (>3); Frequent Ventricular
Premature Complexes (>2); Other
Conduction; Prolonged QTc; Other ST
Segment; Digitalis Effect; Other T Waves;
Abnormal U Waves; Absent [U Wave]; Other
U Waves; Indeterminate; Other Axis; Antero
Lateral MI V3-V6; Antero Septal MI V1-V4;
Extensive Anterior MI 1, L, V1-V6; High
Lateral MI 1, AVL; Myocardial Ischemia; New
Anterior MI V3, V4; New Antero Lateral MI
V3-V6; New Antero Septal MI V1-V4; New
Extensive Anterior MI 1, L, V1-V6; New High
Lateral MI 1, AVL; New Inferior MI (2), 3, F;
New Lateral MI 1, L, V5, V6; New Septal MI
V1, V2, (V3); New or Acute MI; Old Anterior
MI V3, V4; Old Antero Lateral MI V3-V6; Old
Antero Septal MI V1-V4; Old Extensive
Anterior MI 1, L, V1-V6; Old High Lateral MI
1, AVL; Old Inferior MI (2), 3, F; Old Lateral
MI 1, L, V5, V6; Old MI; Old Septal MI V1, V2,
(V3); Other Myocardial Infarction; Left Atrial
Abnormality; Left Ventricular Hypertrophy
SDTM- Codelist name = ECG Result; Thank you for the opportunity to review the III
EGSTRESC Additions to existing codelist controlled terminology Package 6. We
reviewed the terminology and noticed there
are some potential ECG finding that are
missing in the ECG Result SDTM
Terminology. I listed all of these potential
findings below. We would like to see if it is
possible to include these findings within the
SDTM to ensure our customers remain
CDISC compliant. We welcome any
questions you may have on the list of
potential findings below: Normal Sinus
Rhythm; Other Rhythm; Unable to Assess;
Atrial Bigeminy; Frequent Atrial Premature
Complexes (>2); Frequent Atrial Premature
Complexes (>3); Frequent Ventricular
Premature Complexes (>2); Other
Conduction; Prolonged QTc; Other ST
Segment; Digitalis Effect; Other T Waves;
Abnormal U Waves; Absent [U Wave]; Other
U Waves; Indeterminate; Other Axis; Antero
Lateral MI V3-V6; Antero Septal MI V1-V4;
Extensive Anterior MI 1, L, V1-V6; High
Lateral MI 1, AVL; Myocardial Ischemia; New
Anterior MI V3, V4; New Antero Lateral MI
V3-V6; New Antero Septal MI V1-V4; New
Extensive Anterior MI 1, L, V1-V6; New High
Lateral MI 1, AVL; New Inferior MI (2), 3, F;
New Lateral MI 1, L, V5, V6; New Septal MI
V1, V2, (V3); New or Acute MI; Old Anterior
MI V3, V4; Old Antero Lateral MI V3-V6; Old
Antero Septal MI V1-V4; Old Extensive
Anterior MI 1, L, V1-V6; Old High Lateral MI
1, AVL; Old Inferior MI (2), 3, F; Old Lateral
MI 1, L, V5, V6; Old MI; Old Septal MI V1, V2,
(V3); Other Myocardial Infarction; Left Atrial
Abnormality; Left Ventricular Hypertrophy
SDTM- Minor edit if possible to change the Minor edit if possible to change the II
VSTESTCD associated CDISC SYNONYM text associated CDISC SYNONYM text to Systolic
to Systolic Blood Pressure to match Blood Pressure to match the CDISC
the CDISC SYNONYM text for SYNONYM text for VSTEST and to also bring
VSTEST and to also bring consistency with the presentation as per
consistency with the presentation Diastolic BP
as per Diastolic BP
SDTM-LBTEST Change the c-code of Glucose was one of the first labtests that was III
Glucose.C41376 will need to be re- added to CDISC CT. At that time, it was
coded. coded to the concept C41376 Plasma
Glucose Measurement in NCIT. I am not
convinced that the specimen in which it is
being measured should be included within the
concept itself and this tends to go against the
CDISC data model. I suggest to assign the
concept Glucose Measurement to a new c-
code as we wouldn't want someone using
C41376 if they are measuring glucose in
another specimen such as urine, whole blood,
etc.
SDTM- Please consider adding the The three above requests can be measured III
LBTESTCD following to the SDTM LBTEST and in both Plasma and Serum. Usual unit of
LBTESTCD Codelists: Iohexol measurement reported for all three types of
Glomerular Filtration Rate; Cystatin GFR measurements is mL/min/1.73 m2.
C Glomerular Filtration Rate; 51Cr- These are more specific as to the substance
EDTA Glomerular Filtration Rate being cleared when measuring GFR. Included
are some links for additional information:
http://www.diazyme.com/products/reagents/D
Z133C-3.php;
http://jasn.asnjournals.org/content/7/1/118.ab
stract;
http://ndt.oxfordjournals.org/content/13/5/117
6.abstract. Thank you for your consideration.
SDTM-LBTEST Please provide a LBTEST and Please provide a LBTEST and LBTESTCD for III
LBTESTCD for Anti-Factor Xa Anti-Factor Xa activity as this parameter is
activity as this parameter is missing missing from the pick list yet units for its
from the pick list yet units for its reporting are present in the UNIT
reporting are present in the UNIT terminology. Please consider LBTEST =Anti-
terminology. Please consider Factor Xa activity LBTESTCD = ANTIFXA
LBTEST =Anti-Factor Xa activity
LBTESTCD = ANTIFXA
SDTM- Tyrosine Crystals / CYTYRO / Please consider amending definition from "A III
LBTESTCD C74683 / Update to definition measurement of the triple phosphate crystals
required present in a biological specimen." to "A
measurement of tyrosine crystals present in a
biological specimen." Thank you. 09-Feb-
2011/APZ
SDTM-UNIT Inconsistency between PKUNIT and In UNIT, mg/mL and g/L are synonyms of III
UNIT codelist in relation to kg/m3 (C71620). In PKUNIT, mg/mL is a valid
submission values vs synonyms submission value and kg/m3 is a synonym of
it. LAB data fits better within the PKUNIT
codelist in relation to the level of unit. For
example, you would always express
Hemoglobin concentration in g/L, never in
kg/m3. Has any consideration been given to
creating a LBUNIT codelist for laboratory data
in order to make the submission value more in
keeping with the data itself?
SDTM-UNIT Use of words to express 10^2, I know I've asked a similar question back in III
10^3, 10^5, 10^6 etc. Nov 2010 but wanted to add to it. Existing unit
terms seem to make use of 'thousand', billion'
or'million' rather than using a '10 to the power
of'(10^) convention which is used extensively
in laboratory data. This makes for very long
unit codes, especially; 10^4 = ten thousand;
10^5 = hundred thousand; 10^9 = thousand
million = US Billion; 10^12 = million million =
UK Billion; As you can see, Billion is not the
same in UK and US terminology. This makes
using the word very risky in relation to lab
data as both 10^9 and 10^12 are used
routinely. Therefore I would like to request
use of 10^ or 10* terminology be added to the
terminology list.
SDTM-LOC 1) BONE MARROW; and (2) SOFT Request addition of these two new terms that III
TISSUE are not currently available in the Anatomical
Location codelist.
Other CDASH terminology spreadsheet - CDASH terminology spreadsheet - SUNCF I
SUNCF codelist code for C25471 codelist code for C25471 and C25627. Copy-
and C25627. Copy-paste error. paste error. Change codelist code to C83004
Change codelist code to C83004 in in column B of spreadsheet.
column B of spreadsheet.
SDTM-LBTEST AMYLASE - I am having an issue I am not sure whether the published II
with Amylase. In my trial, we are terminology can be changed, but if it can,
collecting both pancreatic amylase then this is definately a candidate for
and total amylase. Currently, change.Right now, to make the difference in
Amylase in the terminology is my company dictionary, I am going to have to
representing pancreatic amylase create AMYLASET to represent total amylase
(per defn). For consistency, the and differential it from the CDISC AMYLASE
current code should be updated to (pancreatic amylase).....and this is really
AMYLASEP and then AMYLASE going against the CDISC terminology
should be used to represent total principles.
amylase.
SDTM-TSPARM C49692 - Modify definition to The II

planned number of subjects entered
in a clinical trial
SDTM-EGEST Add term ECG Abnormality to the This discussion came from a SHARE meeting III
EGTEST/CD codelist. Suggest at FDA. All of the existing ECG tests on the
ECG Abnormality for EGTEST and EGTEST codelist have numeric result values.
EGABNORM for EGTESTCD. However, there are no EGTEST that have
results that can be reported as character
values and/or that correspond to the
published EGSTRESC codelist. Suggest to
add a test' ECG Abnormality' to the EGTEST
codelist which can be used as the test value
for all of the corresponding EGSTRESC
codelist values. See page 128 of the SDTM
IG for further clarification of the issue.
SDTM-PKPARM Modify existing terms and add new All modifications and additions are in file from II/III
terms to PKPARM/CD codelist. Dennis Noe.
SDTM-LBTEST Mycobacterium tuberculosis IFN These --TEST values are longer than 40 II
Gamma Response; Soluble chars, which violates SDTM principles.
Vascular Cell Adhesion Molecule 1; Should be shortened to <= 40 chars.
These --TEST values are longer
than 40 chars, which violates SDTM
principles.
SDTM- AGESPAN submission value Consistency of related terms will enable better II
TSPARMCD (code=C20587) should be edit checking for CT items.
AGEGROUP to match related
TSPARM value of "Age Group".
CDISC Synonym should be "Age
Group".
SDTM-LBTEST Vitamin B9 submission value Related to this request: the CDISC Synonym II
(code=C74676) should have the values for LBTESTCDs = VITB9 (C74676),
words in the CDISC Synonym value VITB1 (C74896), VITB2 (C74898), VITB3
reversed in order. Should read (C74899) should also have their word order
"Vitamin B9; Folic Acid" to be reversed. The Vitamim should be mentioned
consistent with CDISC Synonym first, then a semicolon, then to chemical
values for other vitamins. name. This would make these values
consistent with the CDISC Synonym values in
the corresponding LBTEST rows.
SDTM-VSTEST Oxygen Saturation Percentage -- We are using this as part of our Vital Signs III
VSTESTCD O2SAT Panel for some studies. This is also called
SaO2 or Pulse Oxygen Saturation. I checked
the 2011 Terminology list and did not find this.
Sorry if this is a duplicate request
SDTM-TSPARM C49697 - Change definition for C49697 - Change definition for LENGTH to III
LENGTH to Planned length of Planned length of observation for a single
observation for a single subject. subject.
SDTM- Add HOLTER MONITOR to this We are currently using Holter Monitor data is II
EGMETHOD codelist some Phase 1 studies. We would like to
identify / differentiate the sources of data
where we use standard 12 Lead ECGs along
with Holter monitors for the same subjects in
the dataset
SDTM-FREQ C64496 BID Add BD as a synonym to BID to be compliant II

with CDASH
SDTM-PKUNIT C71205 ug/day; C71211 ug/min; C71205-add mcg/day as a synonym; C71211- II

C67406 umol/day; C48152 ug add mcg/min as a synonym; C67406-add
mcmol/day as a synonym; C48152-addition of
mcg to SY list. - For compliance with CDASH
and SDTM-UNIT codelist
SDTM-AGEU C25529 HOURS Add SYs of Hour; hr - For compliance with II

CDASH and SDTM-UNIT codelist
SDTM-UNIT C25529 HOURS SY of hr needs to be added - For compliance II

with CDASH and SDTM-AGEU codelist
CDASH- C64496; C64527; C64530; C64525; Lowercase the word 'per' in the codelist name I
EXDOSFRQ C64498; C64499; C17998 - column for concepts on rows 72-78.
Codelist Name
CDASH- C25473 - Codelist Name Incorrect Codelist Name for concept C25473 I
EXDOSFRQ
CDASH- C78745 - Codelist Name SY Lowercase the word 'per' in the codelist name I
EXDOSFRQ synonym.
SDTM-LBTEST Please review and add where III

applicable codes for the following
Lab parameters values where
possible (suggestions made below):
LBTEST=Herpes Simplex Virus 1
IgG LBTESTCD=HSV1IgG;
LBTEST=Herpes Simplex Virus 1
IgM LBTESTCD=HSV1IgM;
LBTEST=Herpes Simplex Vir
SDTM-FREQ Please provide a frequency code for No current frequency available in the III
5 times daily controlled terminology
SDTM- TSAT Transferrin saturation: Transferrin saturation,
LBTESTCD abbreviated as TSAT and measured as a
percentage, is a medical laboratory value. It is
the ratio of serum iron and total iron-binding
capacity, multiplied by 100.
III
SDTM- CHR Reticulocyte hemoglobin content: A Test for
LBTESTCD Diagnosing Iron Deficiency. Reticulocyte
hemoglobin content (CHr)
measures the amount of hemoglobin in
reticulocytes. III
SDTM- CA_PHOS Serum calcium and phosphorus product
LBTESTCD III
SDTM-LOC Change concept code C33737 Incorrect Mapping
(TARSUS BONE) to C12796 I
SDTM-FREQ QN = Nightly (Occurring or done III
each night).
SDTM-FREQ 1XWK Requesting addition of 1XWK to capture the III
concept of once per week. Using this to
capture the number of times a subject
exercises in a week.
concept of 5 times per week. Using this to
None SEND-SPEC - JOINT, STIFLE is a Should be added to the CDISC - SEND only III
complex joint in the hind limbs of Control Terminology list. Domains that could
quadruped mammals such as the utilize the term. are OM, MA, and MI. It is a
sheep, horse or dog. It is the joint that was collected in one of our
equivalent joint to the human knee. company's study and wil be submitted to the
It is often the largest synovial joint FDA.
in the body.
SDTM-LOC Please add the following terms to The specificity of location is needed for III
the Anatomical Location codelist. ophthalmic medication administration and
Our preference is for addition as vaccination studies.
submission value terms but if not,
can they be added as synonyms.
The terms are: BOTH EYES; LEFT
EYE; RIGHT EYE; LEFT ARM;
RIGHT ARM; BUTTOCK; LEFT
BUTTO
SDTM- AMBIENT Can we please either have ambient added as III

SPECCOND a synonym of Room Temperature or retire the
concept of Room Temperature and just have
Ambient or have Ambient as an additional
term to Room Temperature....Ambient
meaning the specimen is that the temperature
of it's surroundings.
SDTM-UNIT Additional term for unit codelist: New terms required to map units encountered III
FRACTION; cm H20; mL/cm H20 on a clinical study to SDTM units controlled
terminology.
SDTM- New terms for VSTESTCD VSTEST Additional terms required to map vital signs III
VSTESTCD codelists: FIO2 - Fraction of encountered on a clinical study to
Inspired Oxygen; PA02/FIO2 - apppropriate SDTM terminology controlled
Partial Pressure of Arterial terms.
Oxygen/Fraction of Inspired
Oxygen; SA02 - Arterial Oxygen
Saturation; SPO2 - Peripheral
Oxygen Saturation; SPO2/FIO2 -
Peripheral Oxygen
SDTM-LBTEST Additional LBTESTCD LBTEST Additional terms required to map lab test data III
terms; HASA - Human Anti-Sheep collected during a clinical study to
Antibody Bridging (Total); apppropriate SDTM terminology controlled
HASAIGG - Human Anti-Sheep terms.
Antibody IgG; PROTC - Protein C;
TNFA - Tumour Necrosis Factor
alfa; TNFAFC - Tumour Necrosis
Factor alfa (FC)
SDTM- VSTESTCD VSTEST Definition - This request is for the addition of VS TESTCD III
VSTESTCD TRSKNFÂ Â Triceps skinfold & VSTEST as part of the CDISC/NINDS
thicknessÂ Â Â Â Â Â Â Â NINDS Parkinson's Disease standards. The NINDS
Definition: Triceps skinfold Working Group created these new VS tests
thickness - centimeters; as part of their Common Data Elements for
SSSKNFÂ Â Subscapular skinfold Parkinson's Disease. The NINDS CDE's form
thicknessÂ NINDS Definition: the basis for the CDISC data standards on
Subscapular skinfold thickness - this Disease Area project. These 3 fields are
centimeters; HDCIRCÂ Â Head C additonal body measuements on the Risk
Factor Questionnaire on Height & Weight.
This was a questionnaire developed by an
epidemiology working group sponsored by the
Collaborative Centers for Parkinson-s
Disease Epidemiology Research. It has been
validated and is now available in eleven
languages.
SDTM-LBTEST C81982 Typo in Definition. Change definition to: A

measurement of the cancer antigen 19-9 in a
biological specimen. I
SDTM-FREQ Additional Dose Frequency value = This request is for the addition of a new Dose
XX times per month; Defined as the Frequency value as part of the CDISC/NINDS
"number of times per Parkinson's Disease standards. The NINDS
month" the medication was Working Group created this value as part of
taken. The investigator enters the their Common Data Elements for Parkinson's
number on the CRF Disease to capture Non-PD Medications .
The NINDS CDE's form the basis for the
CDISC data standards on this Disease Area
project.
III
SDTM-TSPARM C50400 Change existing Def to make it useable II
across SDTM and SEND. Existing: Those
units of time that are routinely used to
express the age of a person. (NCI) CHANGE
TO: Those units of time that are routinely
used to express the age of a subject.
SDTM-FREQ Request the additional This request is for the addition of a new Dose III
FREQUENCY values based on the Frequency value as part of the CDISC/NINDS
NINDS definition = Average or Parkinson's Disease standards. The NINDS
typical frequency during the year of Working Group created this value as part of
greatest use.Â List number of uses their Common Data Elements for Parkinson's
per day (_/d), week (_/w), month Disease to capture Substance Usage from
(_/m), or year (_/y), as applicable. their Non-Prescribed Drug History CRF . The
XX times per day; XX times per NINDS CDE's form the basis for the CDISC
data standards on this Disease Area project.
SDTM-LBTEST LBTEST:Â Interleukin 2 Receptor; Add a new SDTM LBTEST term of Interleukin III
LBTESTCD: INTLK2R 2 Receptor. Add a new SDTM LBTESTCD of
INTLK2R.
SDTM-FRM Add term 'CAPLET' to FRM Caplet is a dosage form used in our drug III
Codelist studies.
SDTM-UNIT Add unit 'L/h' to Unit codelist Please add the unit L/h to the Unit codelist. III
Currently available in the PK Unit codelist but
also need this term in the Unit codelist.
SDTM-SOC Change the SOC to MedDRA This request matches the recently posted II
sentence case. Example - CDER document "CDER Common Data
"CARDIAC Standards Issues Document" UCM254113.
DISORDERS" should be Here the advice for MedDRA Terminology is
"Cardiac disorders" "When using MedDRA for adverse events and
medical history terms, sponsors should
exactly follow the spelling and case of the
MedDRA terms." see page 5. Currently the
terms are published in complete upper case
and this conflicts with this advice and
communication we have received from a
reviewing division at FDA.
SDTM-VSRESU Please add meter to the Vital signs III

controlled terminology as we are
recieving some heights captured as
meters
SDTM-LBTEST Please supply a new lab test for lab III
parameter Platelet Crit
SDTM-STENRF Please change 'U' to 'UNKNOWN' Please change 'U' to 'UNKNOWN' (C17998) II
(C17998). so that it is consistent with corresponding
values in 'Action Taken with Study Treatment'
'Outcome of Event', 'Ethnic Group', 'Route of
Administration', 'Frequency', and
'Microbiology Susceptibility Testing Result
Category.
SDTM-SEX Please change 'U' to 'UNKNOWN' Please change 'U' to 'UNKNOWN' (C17998) II
(C17998) in SDTM-SEX so that it is consistent with corresponding
Category.
SDTM-NY Please change 'U' to 'UNKNOWN' Please change 'U' to 'UNKNOWN' (C17998) II
(C17998) in SDTM-NY so that it is consistent with corresponding
Category.
SDTM-FREQ PER YEAR There is no frequency that would indicate per III
year.
SDTM-UNIT PACK For packs of cigarettes smoked. The term III
"PACK" is used in the SU example on page
93 of the SDTM implementation guide
(version 3.1.2) but does not appear in the
UNIT code list.
SDTM-TTYPE Add the TTYPE values = FOOD We are using these values in a current study III
EFFECT and TOLERABILITY and are getting validation errors. This codelist
is currently extensible and so we suggest that
these values be added.
SDTM-FREQ Every 6 Weeks, Immediately, 5 I would like to request that the following terms III
Times Per Week, and 6 Times Per are added to the Frequency domain. I am
Week unsure as to what the abbreviations should
be, but I would like to suggest the codes of:
Every 6 Weeks, Immediately, 5 Times Per
Week, and 6 Times Per Week. Thanks.
SDTM-DATEST C78721/C78731 Current definition Incorrect definition for DATEST. The quantity III
states "The quantity of a of the product dispensed and returned is
product that has been covered in (C78721/78732 DATESTCD) the
dispensed".Â DATEST is DISPAMT and RETAMT.
actually "The descriptive
name of the measurement or
finding, (e.g., dispensed,
returned)".Â Â The
Submission Value should be simply
be DISPENSED and RE
SDTM-LOC Duplicate Submission Values of if the two rows are different and necessary, I
"BASAL GANGLIA" in change Submission Value on one
LOC codelist
SDTM-LOC Duplicate Submission Values of if the two rows are different and necessary, I
"MEDULLA change Submission Value on one
OBLANGATA" in LOC
codelist
SDTM-DOMAIN Duplicate Submission Values of if the two rows are different and necessary, II
"ST" in DOMAIN change Submission Value on one
codelist
SDTM-UNIT Duplicate Submission Values of if the two rows are different and necessary, II
"m3" in UNIT codelist change Submission Value on one
SDTM-LBTEST LBTEST: Atherogenic Index; Add a new SDTM LBTEST and LBTESTCD III
ALBTESTCD: ATHEROIN / term
LBTEST: Histoplasma Antibody;
ALBTESTCD: HISTOAB / LBTEST:
Rheumatoid Factor IgM Antibody;
LBTESTCD: RFIGMAB / LBTEST:
Tourniquet Test; LBTESTCD:
TORNIQT / LBTEST: Ethanol
Gelation; LBTESTCD: ETHANGEL /
LBT
SDTM-DOMAIN The domain with the two letter II

abbreviation ST is used twice. It is
used for the Stress (Excercise) Test
Data domain (C49614) and for the
Subject Stages domain (C95099).
SDTM-UNIT The submission value m3 is used II

for two different codes (C42570 and
C68858).
SDTM-VSTEST Change the Synonym to For consistency with all other "TEST" II
"Knee to Heel Length" terminologies where the Submission Value is
for VSTEST='Knee to Heel Length', at least the first Synonym value. (see related
or at least add "Knee to Heel request for change to synonym for
Length" as the first synonym. VSTESTCD='KNEEHEEL'
SDTM- Change the Synonym to For consistency with all other "TESTCD" II
VSTESTCD "Knee to Heel Length" terminologies where the (first) Synonym is the
for VSTESTCD='KNEEHEEL', or at same as the Submission Value for the related
least add "Knee to Heel "TEST" term. (see related request for change
Length" as the first synonym. to synonym for VSTEST='Knee to Heel
Length'
SDTM-LBTEST Change the order of Synonyms For consistency with all other "TEST" II
such that terminologies where the Submission Value is
"Norepinephrine" is first at least the first Synonym value. (see related
for LBTEST='Norepinephrine' request for change to synonym for
LBTESTCD='NOREPI'
SDTM- Change the order of Synonyms For consistency with all other "TESTCD" II
LBTESTCD such that terminologies where the (first) Synonym is the
"Norepinephrine" is first same as the Submission Value for the related
for LBTESTCD='NOREPIN'. "TEST" term. (see related request for change
to synonym for LBTEST='Norepinephrine'
SDTM-LBTEST Change the Synonym to For consistency with all other "TEST" II
"Extractable Nuclear Antigen terminologies where the Submission Value is
Antibody" for at least the first Synonym value. (see related
LBTEST='Extractable Nuclear request for change to synonym for
Antigen Antibody', or at least add LBTESTCD='ENAAB'
"Extractable Nuclear Antigen
Antibody" as the first
synonym.
SDTM- Change the Synonym to For consistency with all other "TESTCD" II
LBTESTCD "Extractable Nuclear Antigen terminologies where the (first) Synonym is the
Antibody" for same as the Submission Value for the related
LBTESTCD='ENAAB', or at least "TEST" term. (see related request for change
add "Extractable Nuclear to synonym for LBTEST='Extractable Nuclear
Antigen Antibody" as the first Antigen Antibody'
synonym.
SDTM-LBTEST Change the order of Synonyms For consistency with all other "TEST" II
such that "Vitamin B9 " terminologies where the Submission Value is
is first for LBTEST='Vitamin B9'. at least the first Synonym value. (see related
request for change to synonym for
LBTESTCD='VITB9'
SDTM- Change the order of Synonyms For consistency with all other "TESTCD" II
LBTESTCD such that "Vitamin B9" is terminologies where the (first) Synonym is the
first for LBTESTCD='VITB9'. same as the Submission Value for the related
"TEST" term. (see related request for change
to synonym for LBTEST='Vitamin B9'
None CDASH-CMDOSFRM; C78418 Synonym Change from Dose Form to II

Concomitant Medication Dose Form
None CDASH-CMDOSU; C78417 Synonym Change from Dose Units to II

Concomitant Medication Dose Units
None CDASH-CMDOSU; C48579 NCI PT Change from International Unit of I

Biological Activity to International Unit
None CDASH-CMDOSFRQ; C78419 Synonym Change from Dosing Frequency per II

Interval to Concomitant Medication Dosing
Frequency per Interval
None CDASH-CMROUTE; C78420 Synonym Change from Route of II
Administration to Concomitant Medication
Route of Administration
None CDASH-CMDOSU; C48155 Definition Change from A metric unit of mass I
equal to one one thousandth of a kilogram.
(NCI) to A metric unit of mass equal to one
one thousandth of a kilogram. (NCI)
None CDASH-EGORRESU; C49673 Definition Change from The number of I

heartbeats measured per minute time.(NCI) to
The number of heartbeats measured per
minute time. (NCI)
None SEND-SSTYP; Update NCI PTs on C79364 Change From FDA RPS I
published spreadsheet Pharmacology: Primary Pharmacodynamics
to Pharmacology: Primary
Pharmacodynamics; C79365 Change From
FDA RPS Pharmacology: Secondary
Pharmacodynamics to Pharmacology:
Secondary Pharmacodynamics; C79367
Change From FDA RPS Pharmacology:
Pharmacodynamic Drug Interactions to
Pharmacology: Pharmacodynamic Drug
Interactions; C79368 Change From FDA RPS
Analytical Methods And Validation Reports to
Analytical Methods and Validation Reports;
C79369 Change From FDA RPS
Pharmacokinetics: Absorption to
Pharmacokinetics: Absorption; C79370
Change From FDA RPS Pharmacokinetics:
Distribution to Pharmacokinetics: Distribution;
Pharmacokinetics: Metabolism to
Pharmacokinetics: Metabolism; C79372
Change From FDA RPS Pharmacokinetics:
Excretion to Pharmacokinetics: Excretion;
Pharmacokinetics: Drug Interactions to
Pharmacokinetics: Drug Interactions; C79375
Change From FDA RPS Toxicology: Single
Dose Toxicity [Species And Route] to
Toxicology: Single Dose Toxicity [Species and
Route]; C79376 Change From FDA RPS
Toxicology: Repeat Dose Toxicity [Species,
Route, Duration] to Toxicology: Repeat Dose
Toxicity [Species, Route, Duration]; C79378
Change From FDA RPS Genotoxicity: In Vitro
to Genotoxicity: in vitro; C79379 Change
From FDA RPS Genotoxicity: In Vivo to
Genotoxicity: in vivo; C79380 Change From
None SEND-SPECIMEN; Add synonyms C12499 Add Internal Ear; C12510 Add I
to following terms (C12499; Mesencephalon; C12777 Add Radius Bone;
C12510; C12777; C12809) to be in C12809 Add Ulna Bone
line with other CDISC standards
and published spreadsheets.
None SEND-SPECIMEN; SDTM-LOC; Remove ' from end of word 'Sternum' within I
Update definition for C12381 the published definition.
None SEND-SPECIMEN; Duplicate on Duplicate codes within one codelist. One I

codelist - C12429 - contains LIMB as a submission value and one
LIMB/EXTREMITIES contains EXTREMITIES as a submission
value. SEND must determine which
submission value it would like to have. The
other row will be removed and that
submission value will be listed as a synonym.
SDTM-LOC C12452; C12784 Remove (NCI) from end of published I

definition.
SDTM- C86465 Duplicate in SY column; Remove I
MICROORG ENTEROBACTER INTERMEDIUM as an SY
on the published spreadsheet.
SDTM-DICTNAM C66788 Remove 'Name of Dictionary' from synonym II
of codelist concept.
SDTM-TCNTRL C66785 Remove 'Type of Control' from synonym of II

codelist concept.
SDTM-UNIT C70526 Comma in SY list; change to semi-colon I
SDTM- C64374 Change CDISC submission value from JRE to III

COUNTRY JEY. ISO update.
SDTM- C64377 Change CDISC submission value from SCG III

COUNTRY to SRB. ISO update.
SDTM- C16695 Remove HKG as a synonym. HKG is the II

COUNTRY submission value and we don't put the three
letter ISO codes in as synonyms.
SDTM-UNIT C29846; C49668 Definition changes: C29846 - Add space I
between period and (NCI); C49668 - Add
period at end of sentence.
SDTM-LOC C12231 Remove (NCI) from end of definition I
SDTM- MULTIPLE codes in this codelist Add (NCI) to end of definition I

COUNTRY
SDTM-ROUTE Multiple codes within this codelist Add space between period and (FDA) at end I
of definition.
SDTM-UNIT C25529; C25613; C28251; C29844; Add space between period and (NCI) at end I
C42554; C49670 of definition.
SDTM-UNIT C49673; C49674; C67069 Add (NCI) to end of definition I
None Update NCI PT on spreadsheet to Update NCI PT on spreadsheet to match I

match what is in the NCIt database what is in the NCIt database
SDTM-ACN C48660 Add 'Not Applicable' as a SY II
SDTM-AGEU SDTM-AGEU/SDTM-UNIT - Add 'hr' as a SY in SDTM-AGEU codelist. Add II

C25529 Hour and hr as SYs in the SDTM-UNIT
codelist. This will bring in-line SDTM and
CDASH.
SDTM-LOC Addition of synonyms due to use of C12290 - Add Bone, Mandibular, Inferior II
terms in other codelists. Maxillary Bone, Jaw; C12292 - Add Auricle;
C12311 - Add Uterine Cervix; C12347 - Add
Eye Socket, Ocular Orbit, Orbital Cavity;
C12381 - Add Cecal, Cecum; C12399 - Add
Hypophysis Cerebri, Hypophysis; C12401 -
Add Eyeball; C12405 - Add Womb; C12408 -
Add External Genitalia; C12412 - Add
Testicle; C12428 - Add Windpipe; C12439 -
Add Nervous System, Brain; C12470 - Add
Integument; C12499 - Add Cochlea,
Labyrinth; C12510 - Add Midbrain; C12664 -
Add Abdomen; C12683 - Add Bronchi;
C12713 - Add Palpebra; C12717 - Add Bone,
Femoral; C12719 - Add Ganglia, Neural
Ganglion; C12727 - Add Cardiac; C12731 -
Add Bone, Humeral; C12743 - Add Crystalline
Lens, Lens Of Eye, Ocular Lens; C12763 -
Add Accessory Sinuses, Nasal Cavity, Nasal
Sinuses; C12767 - Add Pelvic Cavity; C12777
- Add Radius; C12783 - Add Shoulder Blade;
C12787 - Add Seminal Sacs; C12789 - Add
Bone, Cranial, Cranium; C12793 - Add
Sterna; C12796 - Add Bone, Tarsal, Tarsus;
C13044 - Add Articulation; C13071 - Add
Facial; C32286 - Add Vena Cephalica;
C32622 - Add Feet; C32677 - Add Gum;
C32742 - Add Coxofemoral Joint; C32898 -
Add Tibiofemoral Joint; C33287 - Add Pelvis;
C33343 - Add Hepatic Portal Vein; C33718 -
Add Synovia; C12441 - Add Brain Stem;
C12444 - Add Hippocampus; C12453 - Add
Substantia Nigra; C12458 - Add
Hypothalamus; C12694 - Add Choroid
Plexus; C12905 - Add Thoracic Cavity;
C28401 - Add Olfactory Bulb
SDTM-PKUNIT Addition of synonyms to PKUNIT C64566 - Add g/mL|gram/mL|kg/L|mg/uL; II
codelist due to use of terms in other C71205 - Add mcg/day; C67394 - Add mcg/h;
codelists. C67396 - Add mcg/kg|ng/g; C71211 - Add
mcg/min; C67406 - Add mcmol/day; C64387 -
Add mcmol/mL|nmol/uL|umol/mL; C42576 -
Add mg/mL; C48153 - Add Microliter|mm3;
C73755 - Add Milliliter per Gram per Day;
C69073 - Add mL/sec; C85723 - Add mmol/s;
C67306 - Add ng/mL|mcg/L; C64572 - Add
mcg/mL|mg/L|ng/uL|ug/mL; C67405 - Add
Micro-International Unit per milliliter; C73760 -
Add Milliliter per Kilogram per Minute
SDTM- C12692; C13188; C13325; C77666 Addition of synonyms due to use of terms in II
SPECTYPE other codelists. C12692 - Add CSF; C13188 -
Add Aqua Amnii; C13325 - Add Sera; C77666
- Add Emesis
SDTM-TOXGR C41337; C48275 Addition of synonyms due to use of terms in II
other codelists. C41337 - Add LIFE
THREATENING; C48275 - Add FATAL
SDTM-UNIT Addition of synonyms in UNIT Addition of synonyms due to use of terms in II
codelist due to use of terms in other other codelists. C42554 - Add ohm; C42576 -
codelists. Add kg/m3 and mg/mL; C48520 - Add Pack
Dosing Unit; C64387 - Add mcmol/mL,
mmol/L, nmol/uL; C64566 - Add gram/mL,
kg/L, mg/uL; C64572 - Add mcg/mL and
ng/uL; C64783 - Add g%; C67015 - Add mg
%; C67069 - Add Every week; C67306 - Add
ng/mL and ug/L; C67396 - Add ng/g and
ug/kg; C67405 - Add mIU/L and mcIU/mL
SDTM-OUT C48275 Addition of synonyms due to use of terms in II

other codelists. Add FATAL as a synonym.
SDTM- C49619 Remove TE as a synonym. TE is the II

COUNTRY Submission value.
SDTM-FREQ C64496 Add BD as a synonym. This is in keeping with II

CDASH spreadsheet.
SDTM-FREQ C67069 Add Per Week and Every week as synonyms. II

This concept is in multiple codelists and every
codelist will have the same synonyms.
SDTM-FREQ C71127 Remove period from end of SY I
SDTM-AGEU C66781 Change definition of Codelist Term to: Those II

units of time that are routinely used to
express the age of a subject.
SEND-SPEC C33822 Remove SY of Vena Cephalica. Incorrectly I
added to term.
SDTM- URR Urea Reduction Ratio, a dimensionless III

LBTESTCD number used to quantify dialysis treatment
adequacy.
SDTM- KTV Kt/V, a number used to quantify hemodialysis III
LBTESTCD and peritoneal dialysis treatment adequacy.
SDTM- I would like to suggest updating the The country code for Serbia as specified in II
COUNTRY country code for Serbia from SCG the current version of the controlled
to SRB. (C64377) terminology (SCG) does not correspond with
the code specified in ISO 3166-1 alpha 3
(SRB).
SDTM-ROUTE INTRAVENOUS PUSH A study team at Roche asked my team III
(Roche Data Standards Office) to add the
term 'INTRAVENOUS PUSH' as a sponsor-
defined extension of the ROUTE codelist.
Upon some research the current NCI
definitions of the terms INTRAVENOUS
PUSH and INTRAVENOUS BOLUS appear to
contradict the FDA definition provided in the
latest CDISC CT:
NCI Thesaurus: IV Bolus: A volume of drug
intended to be administered into a vein in 30
minutes or less. IV Push: A method of drug
delivery in which a drug is administered
quickly into a vein. IV Bolus: Administration
within or into a vein or veins all at once.(FDA)
Assuming the terms are distinct, please can
or someone on the CDISC CT team clarify the
correct definition of each term? In particular
which way round the terms should be used, or
in other words which once describes the
quickest administration of a drug
intravenously?
SDTM-LBTEST Change C96615 to C60832 Change NCI c-code of C96615. Term has I
been merged into C60832.
SDTM-LBTEST LBTEST: Conductivity; LBTESTCD: Add a new SDTM LBTEST term of III
CONDUCT Conductivity; Add a new SDTM LBTESTCD of
CONDUCT
SDTM-LBTEST LBTEST: Reticulocytes Corrected; Add a new SDTM LBTEST term of III
LBTESTCD: RETICCOR Reticulocytes Corrected; Add a new SDTM
LBTESTCD of RETICCOR
SDTM-LBTEST LBTEST: Reticulocytes Add a new SDTM LBTEST term of III
Corrected/Erythrocytes; Reticulocytes Corrected/Erythrocytes; Add a
LBTESTCD: RECORRBC new SDTM LBTESTCD of RECORRBC
SDTM-VSTEST Forced Expiratory Volume in 1 Need for terminology in clinical trials III
Second (test code: FEV1)
SDTM-VSTEST Predicted Forced Expiratory Need for terminology in clinical trials III
Volume 1 Sec (test code: FEV1PR)
SDTM-VSTEST Percent Predicted FEV1 (test code: Need for terminology in clinical trials III
FEV1PPR)
SDTM-VSTEST Peak Expiratory Flow (test code: Need for terminology in clinical trials III
PEF)
SDTM-VSTEST Predicted Peak Expiratory Flow Need for terminology in clinical trials III
(test code: PEFPR)
SDTM-VSTEST Percent Predicted Peak Expiratory Need for terminology in clinical trials III
Flow (PEFPPR)
SDTM-VSTEST Forced Vital Capacity (test code: Need for terminology in clinical trials III
FVC)
SDTM-VSTEST Forced Expiratory Flow 25-75% Need for terminology in clinical trials III
(test code: FEF25_75)
SDTM-VSTEST Intraocular Pressure (test code: Need for terminology in clinical trials III
IOP)
SDTM-LOC DIAPHRAGM, DUODENUM, The existing list contains "male genitalia" and III
GENITALIA, ILIAC CREST, "female genitalia". A more general "genitalia"
OROPHARYNX, PELVIC REGION, would be a helpful addition. Pleura: The
PLEURA, RETROPERITONEUM, existing list contains "pleural cavity" but we
SCALP don't have a term for the actual membrane.
Pleura: the serous membrane investing the
lungs (visceral p.) and lining the walls of the
thoracic cavity (parietal p.); the two layers
enclose a potential space, the pleural cavity.
Miller-Keane Encyclopedia and Dictionary of
Medicine, Nursing, and Allied Health, Seventh
Edition. 2003 by Saunders, an imprint of
Elsevier, Inc. All rights reserved. So Pleura
refers to the membrane itself.
NEW Need a codelist to support the The RELSUB variable describes the III
proposed newÂ --RELSUB variable relationship (biological or other) of a person is
in SDTM not a study subject to another person who is a
study subject.
NEW Creation of new Test Category For analysis of clinical trials we are requesting III
codelist the creation of a Test Category codelist
containing the following terms: CHEMISTRY,
COAGULATION, CYTOGENETICS,
ENDOCRINOLOGY, HEMATOLOGY,
HISTOLOGY, IMMUNOHEMATOLOGY,
IMMUNOLOGY, MICROBIOLOGY,
PATHOLOGY, SEROLOGY, TOXICOLOGY,
URINALYSIS
SDTM-UNIT L/sec Please add the term L/sec with the synonym III
Liter per Second to the Unit codelist.
SDTM-EGLEAD EGLEAD (CUI: C90013) Within the ECG domain the EGLOC variable III
should be used in order to store the
information about the lead location used for
measurement. As example the following leads
are listed: V1, V6, aVR, I, II, III. As controlled
terminology codelist, the LOC codelist is
assigned to EGLOC, but this "Anatomical
location" codelist, does not contain the above
mentioned exampled for the lead location.
However, the EGLEAD codelist has all these
entries and to my understanding, this codelist
needs to be assigned to the EGLOC variable.
At the moment, the EGLEAD codelist is not
mentioned in the SDTM IG and also not
referenced in your dropdown list above. Could
you please clarify how the lead assignment
within ECG should be handled? Best
Regards, Melanie
SDTM- SYNOVIAL FLUID Please add the term 'SYNOVIAL FLUID' to III
SPECTYPE the Specimen Type codelist. The definition is:
The slippery fluid that lubricates joints and
provides nutrients to the cartilage. Also known
as the synovia. (Source:
http://www.medterms.com/script/main/art.asp
?articlekey=5686)
SDTM- PLEURAL FLUID Please add the term 'PLEURAL FLUID' to the III
SPECTYPE Specimen Type codelist. The definition is:
The thin film of serous fluid between the
visceral and parietal pleurae. (Source:
http://medical-
dictionary.thefreedictionary.com/pleural+fluid)
SDTM- PROSTATIC FLUID Please add the term 'PROSTATIC FLUID' to III
SPECTYPE the Specimen Type codelist. The definition is:
the secretion of the prostate gland, which
contributes to formation of the semen.
(Source: http://medical-
dictionary.thefreedictionary.com/prostatic+flui
d)
SDTM- BIOPSY Please add the term 'BIOPSY' to the III

SPECTYPE Specimen Type codelist. The definition of
biopsy specimen is: Tissue removed from
the body and examined under a microscope
to determine whether disease is present.
(Source: http://www.cancer.gov/dictionary?
CdrID=45619)
SDTM- TISSUE BIOPSY Please add the term 'TISSUE BIOPSY' as a III
SPECTYPE synonym to the newly requested term
'BIOPSY'.
SDTM- TUMOR BIOPSY Please add the term 'TUMOR BIOPSY' to the III
SPECTYPE Specimen type codelist. This is to distinguish
between a biopsy specimen that is tissue or
when it is the tumor. "In a biopsy, the doctor
removes a sample of tissue from the
abnormal area or may remove the whole
tumor." (Source:
http://www.medterms.com/script/main/art.asp
?articlekey=2466)
SDTM- BRAIN TUMOR BIOPSY Please add the term 'BRAIN TUMOR III
SPECTYPE BIOPSY' to the Specimen Type codelist. The
term Brain is needed to clarify the location of
the tumor biopsy. This is in alignment with
other Specimen Type terms (i.e. Lung
Surfactant) that include the location of the
specimen type in the term.
SDTM- FINE-NEEDLE ASPIRATION Please add the term 'FINE-NEEDLE III

SPECTYPE BIOPSY ASPIRATION BIOPSY' to the Specimen Type
codelist. Reference:
http://www.ncbi.nlm.nih.gov/pubmed/1626929
3
SDTM- BUCCAL SWAB Please add the term 'BUCCAL SWAB' to the III
SPECTYPE Specimen Type codelist. Buccal swab is used
to collect cheek cells from the inside of the
mouth for DNA testing. Source:
http://www.lssu.edu/campuslife/documents/bu
ccal_swab_qa_032306.pdf
SDTM-DOMAIN C66734 Is there any standards to have dataset label? III

If so, from where we have to get the label.
Since we are confused after referring to some
of the pages(No. 13, 17, 18, 19, 274 and the
TITLE above the metadata of individual
domain,the text right next to [domain].xpt at
the beginning of each domain table in the IG.
E.g., dm.xpt, Demographics, cm.xpt,
Concomitant Medications, eg.xpt, ECG) of
SDTM IG 3.1.2 and too referring CDISC
Controlled Terminology(codelist
name-"Domain Abbreviation") where we
found some minor differences with the above
referred pages to have domain's label. So it
will be consistent to use the CDISC
Synonym(s) of the codelist name-"Domain
Abbreviation" for datasets label, if CT makes
it mandatory or can have a new Term for
dataset label.
SEND-STSPRM C69208; C90462 Change c-codes for Study Start Date and I
Study End Date. Need to create Nonclinical
specific concepts for SEND as these had
been incorrectly coded to Clinical-specific
concepts.
SDTM-LBTEST HLA-B27 Antigen Please add the Lab test HLA-B27 to the III
Laboratory Test Name codelist. References:
Quest Diagnostics
http://www.questdiagnostics.com/hcp/testmen
u/jsp/showTestMenu.jsp?
fn=48215P.html&labCode=SJC. ARUP
Laboratories:
http://www.aruplab.com/guides/ug/tests/0095
840.jsp
SDTM- HLAB27AG Please add the term HLAB27 to the III
LBTESTCD Laboratory Test Code codelist and associate
it with the newly requested term 'HLA-B27
Antigen' in the Laboratory Test Name
codelist.
NEW Forced Expiratory Volume in 1 Please move the previously requested term III
Second (test code: FEV1) 'Forced Expiratory Volume in 1 Second (test
code: FEV1)' from the Vital Signs codelist to
the newly requested 'Non Laboratory Test
Name' and 'Non Laboratory Test Code'
codelists. This type of data (Spirometry)
would be mapped to the VS domain with the
variables VSORRES, VSSTRESC and
VSSTRSSN.
NEW Predicted Forced Expiratory Please move the previously requested term III
Volume 1 Sec (test code: FEV1PR) 'Predicted Forced Expiratory Volume 1 Sec
(test code: FEV1PR)' from the Vital Signs
codelist to the newly requested 'Non
Laboratory Test Name' and 'Non Laboratory
Test Code' codelists. This type of data
(Spirometry) would be mapped to the VS
domain with the variables VSORRES,
VSSTRESC and VSSTRSSN.
NEW Percent Predicted FEV1 (test code: Please move the previously requested term III
FEV1PPR) 'Percent Predicted FEV1 (test code:
FEV1PPR)' from the Vital Signs codelist to
VSSTRSSN.
NEW Peak Expiratory Flow (test code: Please move the previously requested term III
PEF) 'Peak Expiratory Flow (test code: PEF)' from
the Vital Signs codelist to the newly requested
'Non Laboratory Test Name' and 'Non
Laboratory Test Code' codelists. This type of
data (Spirometry) would be mapped to the VS
NEW Predicted Peak Expiratory Flow Please move the previously requested term III
(test code: PEFPR) 'Percent Predicted FEV1 (test code:
FEV1PPR)' from the Vital Signs codelist to
VSSTRSSN.
NEW Forced Vital Capacity (test code: Please move the previously requested term III
FVC) 'Predicted Peak Expiratory Flow (test code:
PEFPR)' from the Vital Signs codelist to the
newly requested 'Non Laboratory Test Name'
and 'Non Laboratory Test Code' codelists.
This type of data (Spirometry) would be
mapped to the VS domain with the variables
VSORRES, VSSTRESC and VSSTRSSN.
NEW Forced Vital Capacity (test code: Please move the previously requested term III
FVC) 'Forced Vital Capacity (test code: FVC)' from
data (Spirometry) would be mapped to the VS
NEW Percent Predicted Peak Expiratory Please move the previously requested term III
Flow (PEFPPR) 'Percent Predicted Peak Expiratory Flow
(PEFPPR)' from the Vital Signs codelist to the
newly requested 'Non Laboratory Test Name'
and 'Non Laboratory Test Code' codelists.
This type of data (Spirometry) would be
mapped to the VS domain with the variables
VSORRES, VSSTRESC and VSSTRSSN.
NEW Forced Expiratory Flow 25-75% Please move the previously requested term III
(test code: FEF25_75) 'Forced Expiratory Flow 25-75% (test code:
FEF25_75)' from the Vital Signs codelist to
VSSTRSSN.
NEW Intraocular Pressure (test code: Please move the previously requested term III
IOP) 'Intraocular Pressure (test code: IOP)' from
data (Ophthalmology) would be mapped to
the OP domain with the variables OPORRES,
OPSTRESC and OPSTRSSN.
NEW SDTM-Non Laboratory Test Name The Non Laboratory Test Name codelist III
and SDTM-Non Laboratory Test would be used to capture diagnostic tests and
Code procedures that do not use a laboratory
specimen (ie. Audiometric tests, Spirometry
Tests, Ophthalmology tests, etc.). These
types of tests don't fit in the Laboratory Test
Name or Vital Signs codelist. Proposed
definition: A test or procedure not using a
laboratory specimen that is performed to
diagnose disease, disordered function, or
disability.
NEW FEV1/FVC (test code: FEV1FVC) Please add the term 'FEV1/FVC' to the newly III
requested codelist 'Non Laboratory Test
Name' and the term 'FEV1FVC' to the newly
requested codelist 'Non Laboratory Test
Code'. This type of data (Spirometry) would
be mapped to the VS domain with the
VSSTRSSN.
NEW FEV1 Reversibility (test code: Please add the term 'FEV1 Reversibility' to III
FEV1REVR) the newly requested codelist 'Non Laboratory
Test Name' and the term 'FEV1REVR' to the
newly requested codelist 'Non Laboratory
Test Code'. This type of data (Spirometry)
VSSTRSSN.
SDTM- FORMALIN-FIXED, PARAFFIN- Please add the term 'FORMALIN-FIXED, III

SPECTYPE EMBEDDED TISSUE PARAFFIN-EMBEDDED TISSUE' to the
Specimen Types codelist. References:
http://www.asuragen.com/Services/services/s
ample_prep/FFPE.aspx -AND-
http://www.bioserve.com/human-
biorepository/sample-types.cfm -AND-
http://www.abstracts2view.com/sabcs07/view
p.php?nu=p1112
SDTM- FFPE Tissue Please add the term 'FFPE Tissue' as a III
SPECTYPE synonym to the newly requested term
'FORMALIN-FIXED, PARAFFIN-EMBEDDED
TISSUE'
SDTM- New VSTEST terms Aortic Pulse Wave Velocity(APWV); III
VSTESTCD Augmentation Pressure(AUGPLHT); Central
Aug Pressure at HR75(AUGPR); Central
Aug/Pulse Height(AUGPR75); Central
Diastolic Blood Pressure(CAPHHR75);
Central Systolic Blood Pressure(CDIABP);
Forearm Circumference(CSYSBP); Heart
Rate Adjusted AIx(FARMCIR); Hip
Circumference(HIPCIR); Lean Body
Mass(LBM); Pulse Pressure(PULP); Waist
Circumference(WSTCIR)
SDTM-SCCD Add the following Subject Add the following Subject Characteristic III
Characteristic Code: CHDPOT Code: CHDPOT (Child bearing potential)
(Child bearing potential)
SDTM- Add the following EGTEST: QT Add the following EGTEST: QT Interval, III
EGTESTCD Interval, Corrected and Corrected and corresponding EGTESTCD:
corresponding EGTESTCD: QTC QTC
SDTM- New terms for EGSTRESC ATRIAL FIBRILLATION WITH RAPID III
EGSTRESC VENTRICULAR RESPONSE (RATE > 100
BPM); ATRIAL PREMATURE
DEPOLARIZATION; DYNAMIC
HORIZONTAL/DOWN-SLOPING; DYNAMIC
HORIZONTAL/DOWN-SLOPING
DEPRESSION; FREQUENT VENTRICULAR
PREMATURE DEPOLARIZATION (VPD) >=
3; IDIOVENTRICULAR RHYTHM - HEART
RATE < 100 BEATS/MIN; JUNCTIONAL
ESCAPE COMPLEXES; JUVENILE TWAVE
PATTERN, EARLY REPOLARIZATION;
LATE R WAVE TRANSITION; LEFT ATRIAL
ABNORMALITY; LEFT AXIS DEVIATION
(QRS AXIS MORE NEGATIVE THAN -30
DEGREES); MULTIFOCAL ATRIAL
TACHYCARDIA (WANDERING ATRIAL
PACEMAKER W/RATE >100 BEATS/MIN);
NON-SPECIFIC INTRAVENTRICULAR
CONDUCTION DELAY (QRS >= 120 MSEC);
OCCASIONAL VENTRICULAR
PREMATURE DEPOLARIZATION (VPD) <3;
PATHOLOGICAL Q WAVES; PERSISTENT
ST ELEVATION; PROLONGED QTC
INTERVAL 450-500 MSEC; QTCF >= 450
MSEC; RIGHT AXIS DEVIATION (QRS AXIS
MORE POSITIVE THAN +110 DEGREES);
SINUS BRADYCARDIA (HEART RATE <30
BEATS/MIN); SINUS BRADYCARDIA
(HEART RATE 30-39 BEATS/MIN); SINUS
BRADYCARDIA (HEART RATE 40-50
BEATS/MIN); ST-T WAVE ABNORMALITIES
WITH THE EXCEPTION OF NON-SPECIFIC
CHANGES; SUPRAVENTRICULAR
TACHYCARDIA (>100/MIN); T WAVE
ALTERNANS; TRANSIENT ST ELEVATION;
TRIFASCICULAR BLOCK; UNUSUAL P
SDTM-VSTEST WAIST CIRCUMFERENCE, with WAIST CIRCUMFERENCE, with WAISTCIR III
WAISTCIR as VSTESTCD as VSTESTCD
SDTM-UNIT Create New Term: mL/min/1.73m^2 This is needed as unit for creatinine clearance III
or mL/min/square surface area and GFR (glomerular filtration rate).
None Create New Codelist: Peakflow We would like to implement Peak Flow Data III
Data Set into a CDISC compliant format. I already
discussed this with Chris Tolk and shall sent
him our output fields we currently use.
SDTM-UNIT Create New Term: D (submission Please add the the term 'D' to the Unit III
term) and Diopter (synonym) codelist with the synonym Diopter. Diopter is
a unit of measurement of the refractive power
of lenses equal to the reciprocal of the focal
length measured in meters. Source:
http://medical-
dictionary.thefreedictionary.com/diopter
SDTM-LOC Create New Term: Please add the term COSTOCHONDRAL III
COSTOCHONDRAL JOINT 1 JOINT 1 to the Anatomical Location codelist.
Definition: the cartilaginous joints between the
sternal end of ribs and the lateral ends of
costal
cartilages.Reference:http://www.medilexicon.c
om/medicaldictionary.php
SDTM-LOC Term Suggestion for CDISC Please add the term COSTOCHONDRAL III
Terminology: COSTOCHONDRAL JOINT 7 to the Anatomical Location
JOINT 7 codelist.Definition: the cartilaginous joints
between the sternal end of ribs and the lateral
ends of costal cartilages. Definition
Reference:
http://www.medilexicon.com/medicaldictionary
.php Term Reference:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC
1754445/pdf/v062p00127.pdf
SDTM-LOC Term Suggestion for CDISC Please add the term ILIAC CREST to the Anatomical
III Location codelist
Terminology: ILIAC CREST
SDTM-LOC Term Suggestion for CDISC Definition: the posterior extremity of the iliac III
Terminology: ILIAC SPINE, crest, the uppermost point of attachment of
POSTERIOR SUPERIOR the sacrotuberous and posterior sacroiliac
ligaments; a readily apparent dimple occurs in
the skin overlying the posterior superior iliac
spine that is clinically useful as an indication
of the level of the S2 vertebra, the level of the
inferior limit of the subarachnoid space.
(http://www.medilexicon.com/medicaldictionar
y.php)
Reference:
1754445/pdf/v062p00127.pdf
SDTM-LOC Term Suggestion for CDISC Please add the term ACHILLES TENDON, III
Terminology: ACHILLES TENDON, PROXIMAL INSERTION to the Anatomical
PROXIMAL INSERTION Location codelist. Reference:
1754445/pdf/v062p00127.pdf
SDTM-LOC Term Suggestion for CDISC Please add the term SPINOUS PROCESS, III
Terminology: SPINOUS PROCESS, L5 to the Anatomical Location dictionary.
L5 References:
1754445/pdf/v062p00127.pdf -and-
.php?t=72343
SDTM-LBTEST Add Iohexol Clearance, Add DTPA Note this is entered for Ron Perrone: Add III
Clearance, Add EDTA Clearance, Iohexol Clearance, Add DTPA Clearance,
Add GRF from Beta-trace Protein Add EDTA Clearance, Add GRF from Beta-
Adjusted for BSA, Add GRF from trace Protein Adjusted for BSA, Add GRF
Beta-2 Microglobulin Adjusted for from Beta-2 Microglobulin Adjusted for BSA
BSA
SDTM-LOC Term Suggestion for CDISC Please add the term ILIAC SPINE, III
Terminology: ILIAC SPINE, ANTERIOR SUPERIOR to the Anatomical
ANTERIOR SUPERIOR Location codelist.Definition: the anterior
extremity of the iliac crest, which provides
attachment for the inguinal ligament and the
sartorius muscle.
.php). Reference:
1754445/pdf/v062p00127.pdf
SDTM- Term Suggestion for CDISC Please add the term 'SKIN PUNCH' to the III
SPECTYPE Terminology: SKIN PUNCH Specimen Type codelist. Reference:
2153859/pdf/canfamphys00231-0125.pdf
SDTM- Term Suggestion for CDISC Please add the term 'Skin Punch Biopsy' as a III
SPECTYPE Terminology: Skin Punch Biopsy synonym for the recently requested term
'SKIN PUNCH' to the Specimen Type
codelist.
SDTM- Term Suggestion for CDISC Please add the term 'HAIR FOLLICLE' to the III
SPECTYPE Terminology: HAIR FOLLICLE Specimen Type codelist. Definition: a tubelike
invagination of the epidermis from which the
hair shaft develops and into which the
sebaceous glands open; the follicle is lined by
a cellular inner and outer root sheath of
epidermal origin and is invested with a fibrous
sheath derived from the dermis.
.php?t=34408 Reference: For Drug Testing
http://www.craigmedical.com/Hair_Drug_Test.
htm
SDTM-UNIT Please add the following units to Follicle Stimulating Hormone is measured III
the Unit codelist: mU/L, mU/L using the unit mU/mL; Thyroid Stimulating
Hormone is measured using the unit mU/L
SDTM- LBTESTCD LBTEST Synonym APOC2 Apolipoprotein C2 III
LBTESTCD Notes Apolipoprotein CII;
APOJ Apolipoprotein J Clusterin
Overexpressed in Cancer and Alzheimer's
Biomarker;
HOMA-IR Homostat Model Assess. of Insulin
Rest. homeostatic model assessment of
insulin resistance;
A1AGLP Alpha-1-Acid Glycoprotein;
A1MGLB Alpha-1-Microglobulin Protein HC;
A1MCREAT Alpha1-Microglobulin
Creatinine Ratio;
AAP Alanine Aminopeptidase;
APCREST Activated Protein C Resistance
Factor V Leiden Screen ;
ANTDNASB AntiDnase B
Screening Test for Streptococcus Group A
(Throat Infection);
ANTHROM3 Antithrombin III AT3 ;
ANTM3ACT Antithrombin III Activity;
APPTLAS Lupus Anticoagulant Sensitive
APTT APPT-LA;
BETACRTN Beta Carotene b-Carotene,
Beta Carotin;
APOC2 Apolipoprotein C2
Apolipoprotein CII;
APOJ Apolipoprotein J Clusterin
Overexpressed in Cancer and Alzheimer's
Biomarker;
HOMA-IR Homostat Model Assess. of Insulin
Rest. homeostatic model assessment of
insulin resistance;
A1AGLP Alpha-1-Acid Glycoprotein;
A1MGLB Alpha-1-Microglobulin Protein HC;
A1MCREAT Alpha1-Microglobulin
Creatinine Ratio;
AAP Alanine Aminopeptidase;
SDTM-LOC Term Suggestion for CDISC Please add the term 'CENTRAL NERVOUS III
Terminology: CENTRAL NERVOUS SYSTEM' to the Anatomical Location
SYSTEM codelist.Definition: the brain and the spinal
cord.
y.php?t=89268)
None Enter Term or Codelist Request The definitions require modification so that II
Information the (FDA) attribution is removed at the end.
SDTM-UNIT CDISC Addition of 3 terms to CDISC Addition of 3 terms to codelist dB / III

codelist dB / SY: Decibel per month SY: Decibel per month (submission term) Per
(submission term) Per Month Month (synonym) NIGHTS PER WEEK
(synonym) NIGHTS PER WEEK
SDTM- CDISC Addition of 2 terms to CDISC Addition of 2 terms to codelist III

NCOMPLT codelist WITHDRAWAL BY WITHDRAWAL BY PARENT/GUARDIAN
PARENT/GUARDIAN SUBJECT SUBJECT REFUSED
REFUSED
SDTM- CDISC Change existing Definition Can the definition be updated to include tests II
NCOMPLT of codelist NCOMPLT Can the as a completion marker in the study. The
definition be updated to include current definition 'The status of the subject's
tests as a completion marker in the completion of the study or a segment of the
study. study, or the reason the subject discontinued
the study or segment of the study.' includes
segment of the study which would pertain to a
phase rather than an individual aspect (ie.
test) in the study.
SDTM-LOC New Terms for existing lists EAR, New Terms for existing lists EAR, RIGHT III
RIGHT EAR, LEFT EAR, LEFT TEMPOROMANDIBULAR JOINT
TEMPOROMANDIBULAR JOINT SY:TMJ METACARPOPHALANGEAL JOINT
SY:TMJ 1 (submission term) / MCP1 (synonym)
METACARPOPHALANGEAL METACARPOPHALANGEAL JOINT 2
JOINT 1 (submission term) / MCP1 (submission term) /MCP2 (synonynm)
(synonym) "METACARPOPHALANGEAL JOINT 3
METACARPOPHALANGEAL (submission term) M
JOINT 2 (submission term) /MCP2
(synonynm)
"METACARPOPHALANGEAL
JOINT 3 (submission term) M
None Add terms to new Laterality codelist Add terms to new Laterality codelist RIGHT III
RIGHT SIDE LEFT SIDE SIDE LEFT SIDE
SDTM-LBTEST additional terms to exisiting codelist additional terms to exisiting codelist LBTEST: III
LBTEST: Clusterin LBTEST: Clusterin LBTEST: Chlamydia Trachomatis
Chlamydia Trachomatis IgA IgA Antibody
Antibody
SDTM- additional terms to existing list- additional terms to existing list-LBTESTCD: III
LBTESTCD LBTESTCD: CLUSTERN CLUSTERN LBTESTCD: CTIGAAB
LBTESTCD: CTIGAAB
NEW new term to new list - III
patientdeathreport Reason for suggestion
patientdeathreport
plus any other additional information: Need a
test code for reported reason of death. This
should be aligned to the e2b reporting
element B.1.9.2.b "In case of death: Reported
cause(s) of death"
NEW a new term to new list - III
patientdetermineautopsy patientdetermineautopsy Reason for
suggestion plus any other additional
information: Need a test code for reported
reason of death from an autopsy. This should
be aligned to the e2b reporting element
B.1.9.4b "In case of death: Autopsy-
determined cause(s) of death"
SDTM- Change Serbia to SRB II
COUNTRY
Change term to be consistent with ISO-3166
None OPEN TREATMENT; BLIND OPEN TREATMENT A period in a clinical III
TREATMENT study during which subjects receive open
label therapeutic treatment. {needed for
study design where open label treatment
needs to distinguished from blinded
treatment}; BLIND TREATMENT A period in
a clinical study during which subjects receive
blinded therapeutic treatment. {needed for
study design where open label treatment
needs to distinguished from blinded
treatment}
SDTM- ACUTE RIGHT VENTRICULAR MI; ACUTE RIGHT VENTRICULAR MI; ACUTE III
EGSTRESC ACUTE SEPTAL MI; ADVANCED/ SEPTAL MI; ADVANCED/ HIGH GRADE AV
HIGH GRADE AV BLOCK; ATRIAL BLOCK; ATRIAL BIGEMINY; ATRIAL
BIGEMINY; ATRIAL COUPLETS; COUPLETS; ATRIAL TRIGEMINY;
ATRIAL TRIGEMINY; BORDERLINE LEFT ATRIAL
BORDERLINE LEFT ATRIAL ENLARGEMENT; DECREASE IN AXIS;
ENLARGEMENT; DECREASE IN DEXTROCARDIA; EARLY R WAVE
AXIS; DEXTROCARDIA; EARLY R TRANSITION; EARLY REPOLARIZATION;
WAVE TRANSITION; EARLY FUSION COMPL
REPOLARIZATION; FUSION
COMPL
SDTM-EGTEST Axis; Comparison to Baseline; Axis; Comparison to Baseline; Conduction; III

Conduction; Electrocardiogram Test Electrocardiogram Test Results;
Results; Interpretation; Morphology; Interpretation; Morphology; Myocardial
Myocardial Infarction; Pacemaker; Infarction; Pacemaker; Repolarization;
Repolarization; Rhythm/Arrhythmia; Rhythm/Arrhythmia; ST Segment; T Wave; U
ST Segment; T Wave; U Wave; Wave;
SDTM-LBTEST Luekocyte Cell Clumps this test is misspelled in CDISC controlled II

terminology as 'Luekocyte Cell Clumps',
correct spelling to "Leukocyte Cell Clumps
SDTM-FREQ Q12M; QAM; QHS; Every year; In the morning; Before bedtime; III
SDTM-NRIND ABNORMAL ALERT for Abnormal ABNORMAL ALERT for Abnormal Alert for III
Alert for Non/Quantitative Results;; Non/Quantitative Results;; ABNORMAL
ABNORMAL PANIC for Abnormal PANIC for Abnormal Panic for
Panic for Non/Quantitative Results;; Non/Quantitative Results;; HIGH ALERT for
HIGH ALERT for High Alert for High Alert for Quantitative Results;; HIGH
Quantitative Results;; HIGH PANIC PANIC for High Panic for Quantitative
for High Panic for Quantitative Results;; LOW ALERT; LOW PANIC
Results;; LOW ALERT; LOW PANI
SDTM-RACE OTHER; Reason for suggestion plus any other III

additional information: per SDTM IG one is
allowed to store OTHER as RACE in DM and
further specify race in SUPPDB
SDTM-ROUTE IMPLANT; INJECTION; III
INTRAJEJUNAL; INTRANASAL;
INTRAORAL; INTRATRACHEAL;
OSTOMY; PALATAL; RADIATION; Other routes that medications can be
received. No current term covers these.
None 10^12/L for Tera per Liter; 10^9/L III
for Giga per Liter; CIGARETTES for
Cigarettes; CIGARS for Cigars;
DRINKS for Drinks; PIPES for Units needed for Hematology results; units for
Pipes; substance use (SU)
None Genetic Sample III
List of material extracted from biological
specimens such as Deoxyribonucleic acid or
Ribonucleic acid which are made up of long
nucelotides to be used for molecular analysis.
SDTM- LESION III
SPECTYPE Reason for suggestion plus any other
additional information: Please add the term
"LESION" to the Specimen Type codelist.
Lesion is being used in our clinical trials. The
definitions for this term are: A pathologic
change in the tissues; OR One of the
individual points or patches of a multifocal
disease.
y.php?t=48927)
SDTM-LBTEST Motility (with the Test Code III
MOTILITY) Please add the term Motility to the Laboratory
Test Name codelist and the term MOTILITY to
the Laboratory Test Code codelist. This test is
used in Semen Analysis and is used to
measure the sperm capable of forward,
progressive movement in a biological
specimen.
SDTM-LBTEST Sperm Concentration (with the test III
code CONCSPM); Sperm Count
(with test code COUNTSPM)
Please add the term Sperm Concentration to

the Laboratory Test Name codelist and the
term CONCSPM to the Laboratory Test Code
codelist. This test is used in Semen Analysis
and is used to measure the amount of sperm
in a specified volume of a semen sample.
This is different than the existing term
Spermatozoa which would be used in the
count of sperm in a urine sample, which
would have a numeric result of sperm per field
while Sperm Concentration has the unit of
million per milliliter. Please add the term
Sperm Count to the Laboratory Test Name
codelist and the term COUNTSPM to the
Laboratory Test Code codelist. This test is
used in Semen Analysis and is a calculation
of the sperm concentration multiplied by the
semen sample size. This is different than the
existing term Spermatozoa which would be
used in the count of sperm in a urine sample,
which would have a numeric result of sperm
per field while Sperm Count has the unit of
million per ejaculate or million per specimen.
SDTM- For the country Serbia, change the
COUNTRY code SCG (transitional reserved) to
SRB (current ISO code).
II
SDTM- Add terms for BES (Bonaire, Sint
COUNTRY Eustasius and Saba), for CUW
(Curacao), for SSD(South Sudan),
and for SXM (Sint Maarten (Dutch)).
III
SDTM-LBTEST C74763 - CASTS; C74673 -
Please review definitions for Casts and
CRYSTALS
Crystals and consider modifying to e.g. "A
statement that indicates casts were looked for
in a biological specimen." and "A statement
that indicates crystals were looked for in a
biological specimen." II
NEW SEND-Neoplasm - Undifferentiated Please add the following terms to the III
(Embryonal) Sarcoma; Benign NEOPLASM list: Undifferentiated (Embryonal)
Cardiac Schwannoma Sarcoma (C27096); Benign Cardiac
Schwannoma (C5358)In addition, please add
respective synonyms of: SARCOMA,
UNDIFFERENTIATED, MALIGNANT,
SCHWANNOMA, ENDOCARDIAL, BENIGN
NEW SEND-NEOPLASM - C3146 Please add a synonym for C3416 of II

(Keratoacanthoma) "KERATOACANTHOMA, BENIGN".
NEW SEND-NEOPLASM - C3764 Please add a synonym for C3764 of POLYP, II
(Adenomatous Polyp) GLANDULAR, BENIGN.
NEW SEND-NEOPLASM - C6803 Please add a synonym for C6803 of SEX- II

(Benign Ovarian Sex Cord-Stromal CORD/STROMAL TUMOR, BENIGN.
Tumor)
SDTM-LOC PARA-AORTIC LYMPH NODE Please add the term PARA-AORTIC LYMPH III
NODE to the Anatomical Location codelist.
Para-aortic lymph node are Lymph nodes
located next to the major blood vessel that
carries oxygenated blood throughout the
body.
SDTM-LOC PERIHILAR LYMPH NODE Please add the term PERIHILAR LYMPH III
NODE to the Anatomical Location codelist.
Perihilar lymph nodes are lymph nodes that
are in the vicinity of an organ where nerves
and vessels enter and leave.
SDTM-LOC PERIPANCREATIC LYMPH NODE Please add the term PERIPANCREATIC III
LYMPH NODE to the Anatomical Location
codelist. Reference:
SDTM- LIVER BIOPSY Please add the term LIVER BIOPSY to the III
SPECTYPE Specimen Type codelist. This is a term used
in our clinical trials to designate the type of
specimen being tested.
SDTM-FREQ Days one, three, five, seven every Please add the term DAYS 1, 3, 5, 7/CYCLE III
cycle with the synonym Days one, three, five, seven
every cycle to the Frequency codelist. This
term is used in our clinical trials to capture the
frequency of treatment within one cycle of a
treatment period.
SDTM-FREQ CYCLE4X; Synonym: Four times a Please add the term CYCLE4X with the III
cycle synonym Four times a cycle to the Frequency
codelist. This term is used in our clinical trials
to capture the frequency of treatment within
one cycle of a treatment period.
SDTM-FREQ Q8S; Synonym: once every eight Please add the term Q8S with the synonym III
weeks once every eight weeks to the Frequency
to capture the frequency of treatment.
SDTM-FREQ Q6S; Synonym: once every six Please add the term Q6S with the synonym III
weeks once every six weeks to the Frequency
SDTM-FREQ Q5S; Synonym: once every five Please add the term Q5S with the synonym III
weeks once every five weeks to the Frequency
SDTM-FREQ WK1 ON WK1 OFF; Synonym: One Please add the term WK1 ON WK1 OFF with III
week on One week off the synonym One week on One week off to
the Frequency codelist. This term is used in
our clinical trials to capture the frequency of
treatment with the treatment cycle lasting one
week and then a week off before starting
treatment again.
week on Two weeks off the synonym One week on Two weeks off to
week and then two weeks off before starting
treatment again.
week on Three weeks off the synonym One week on Three weeks off to
week and then three weeks off before starting
treatment again.
SDTM-FREQ WK2 ON WK1 OFF; Synonym: Two Please add the term WK2 ON WK1 OFF with III
weeks on One week off the synonym Two weeks on One week off to
treatment with the treatment cycle lasting two
weeks and then one week off before starting
treatment again.
SDTM-FREQ WK2 ON WK2 OFF; Synonym: Two Please add the term WK2 ON WK2 OFF with III
weeks on Two weeks off the synonym Two weeks on Two weeks off to
treatment with the treatment cycle lasting two
weeks and then two weeks off before starting
treatment again.
SDTM-FREQ WK3 ON WK1 OFF; Synonym: Please add the term WK3 ON WK1 OFF with III
Three weeks on One week off the synonym Three weeks on One week off to
treatment with the treatment cycle lasting
three weeks and then one week off before
starting treatment again.
SDTM-LBTEST Please shorten the value of LBTEST values may not exceed 40 II
"Mycobacterium tuberculosis characters
IFN Gamma Response" to 40
characters or less.
SDTM-LBTEST Please shorten the value of LBTEST values may not exceed 40 II
"Soluble Vascular Cell characters
Adhesion Molecule 1" to 40
characters or less.
SDTM- The country code for Due to recent ISO changes. Please see the II
COUNTRY "Serbia" should be following link:
"SRB" not http://www.iso.org/iso/pressrelease.htm?
"SCG". refid=Ref1031
SDTM- HIPCIRC Hip Circumference; These values collected in AstraZeneca study. III
VSTESTCD WSTCIRC Waist Circumference
SDTM-LBTEST New Additions to LAB terminology See Attached spreadsheet III
SDTM-UNIT cm/s The unit codelist has m/sec. Perhaps you III
could add cm/sec?
SDTM-LOC CNS - Submission Value; Central Please add the term CNS to the Anatomical III
Nervous System - Synonym Location codelist with the synonym Central
Nervous System. This term is used in our
oncology trials.CNS encompasses the brain
and the spinal cord. (Reference:
.php?t=89268)
SDTM-LOC OTHER Please add the term OTHER to the III

Anatomical Location codelist. This term is
used to capture the location that is different
from the others previously specified in the
codelist.
SDTM- Request new term EBVVLD, Request new term EBVVLD, corresponding to III
LBTESTCD corresponding to new suggested new suggested LBTEST "Epstein-Barr Virus
LBTEST "Epstein-Barr Virus Viral Load".
Viral Load".
SDTM- TRGTCE: add synonyms 1) From Wikipedia: Codocytes, also known as II
LBTESTCD Codocytes and 2) Mexican hat cells target cells or Mexican hat cells are red blood
cells that have the appearance of a shooting
target with a bullseye. The cells have a dark
center (a central, hemoglobinized area)
surrounded by a white ring (an area of relative
palor), followed by dark outer (peripheral)
second ring containing a band of hemoglobin.
SDTM- LBTESTCD = TRAP: Please Synthetic peptides corresponding to the N- II
LBTESTCD change the value to TRTAP.Â We terminal tethered ligand sequence, commonly
will request a new term added with known as thrombin receptor-activating
TRAP as the suggested code.Â peptide (TRAP) mimics almost all the
(Synthetic peptides corresponding activities of the thrombin. See
to the N-terminal tethered ligand http://www.kerafast.com/p-193-trap-thrombin-
sequence, commonly known as receptor-activating-peptide.aspx
thrombin receptor-activating peptide
(TR
SDTM- VSTESTCD: WAISTCIR / VSTEST Measurement of the abdomen between the III
VSTESTCD Waist Circumference rib cage and the hips commonly used to
assess abdominal obesity
SDTM- VSTESTCD: TBW / VSTEST: Total Measurement of Total Body Water III
VSTESTCD Body Water
SDTM- EGTESTCD: QTCFMEDN / The median duration (time) of the correct III
EGTESTCD EGTEST: Summary (Median) QTcF QTC interval, obtained from a set of
measurements of the QT interval and
corrected using the Fridiricia's correction
Formula.
SDTM- EGTESTCD: EGINTPR / EGTEST: ECG interpretation provided by Overreader. III
EGTESTCD Detailed overread Interpretation
SDTM- EGTESTCD: HRMEDN / EGTEST: The median number of cycles of contraction III
EGTESTCD Summary (Median) Heart Rate and subsequent relaxation of the heart,
usually expressed as beats per minute,
obtained from a set of measurements of the
heart rate.
SDTM- EGTESTCD: PRMEDN / EGTEST: The medianduration (time) of the PR interval, III
EGTESTCD Summary (Median) PR Duration obtained from a set of measurements of the
PR interval. The PR interval is defined as the
time from the beginning of the P wave
(representing the onset of atrial
depolarization) to the beginning of the R wave
(representing the onset of ventricular
depolarization). In some cases, a Q wave will
precede the R wave, in which case the PR
interval is measured from the beginning of the
P wave to the beginning of the Q wave.
SDTM- EGTESTCD: QRSMEDN / The median duration (time) of the QRS III
EGTESTCD EGTEST: Summary (Median) QRS interval, obtained from a set of measurements
Duration of the QRS interval. The QRS interval is
defined as the time from the beginning of the
QRS complex to the end of the QRS complex,
representing the time it takes for the
ventricles to depolarize.
SDTM- EGTESTCD: QTMEDN / EGTEST: The median duration (time) of the QT interval, III
EGTESTCD Summary (Median) QT Duration obtained from a set of measurements of the
QT interval. The QT interval is defined as the
time from the beginning of the QRS complex
to the end of the T wave, representing the
time it takes for the ventricles to depolarize
and subsequently repolarize. In some cases,
the Q wave will be absent, in which case the
QT interval is measured from the beginning of
the R wave to the end of the T wave.
SDTM- EGTESTCD: RRMEDN / EGTEST: The median duration (time) of the RR interval, III
EGTESTCD Summary (Median) RR Duration obtained from a set of measurements of the
RR interval. The RR interval is defined as the
time between successive peaks of the R
wave and can be used to measure the
ventricular rate.
NEW DACAT / Values: RESCUE Category for Drug Accountability / Rescue III
MEDICATION / STUDY Medication: Non-surgical medical treatment in
MEDICATION life-threatening situations // Study Medication:
An active drug that is being studied in a
clinical trial.
SDTM-LOC Loc: SUBLINGUAL Under the Tongue III
SDTM-FREQ Freq: HS / Synonyms: At betime., Every night III

QHS
SDTM- LBTESTCD: H2 / LBTEST: Measurement of Hydrogen in a biological III
LBTESTCD Hydrogen specimen.
SDTM-LBTEST p50 / LBTEST: p50 This test calculates the partial pressure of III
oxygen when haemoglobin is half saturated
(SO2=50%) in a blood sample. The result is
corrected to standard conditions of pH=7.400,
CO} = 40 mmHg, and a temperature of 37.
SDTM- CD34POS / LBTEST: CD34 This is the number of cells in a blood sample III
LBTESTCD which contain the CD34 protein
SDTM- Add Synonym for newly requested This test calculates the partial pressure of III
LBTESTCD LBTESTCD p50: Oxygen oxygen when haemoglobin is half saturated
Dissociation (SO2=50%) in a blood sample. The result is
corrected to standard conditions of pH=7.400,
CO} = 40 mmHg, and a temperature of 37.
SDTM- LEUKALP / LBTEST: Leukocytes Measures amount of Alkaline Phosphataste III

LBTESTCD Alkaline Phosphatase found within white blood cells
SDTM- FACTXIV / LBTEST: Factor XIV / Also known as autoprothrombin IIA and blood III
LBTESTCD Synonyms: Autoprothrombin IIA, coagulation factor XIV, is a protein, the
Blood Coagulation, Prot C activated form of which plays an important
role in regulating blood clotting, inflammation,
cell death and maintaining the permeability of
blood vessel walls in humans and other
animals.
SDTM- LBTESTCD: DAMPHET / LBTEST: Measurement of d-amphetamine in a III
LBTESTCD d-amphetamine / Synonym: biological sample.
Dextroamphetamine
SDTM-RELTYPE We'd like this RELTYPE codelist to III
be available for the SEND RELREC
variable RELTYPE, instead of the
RELTYPE variable having two
possible entries listed in the
SENDIG domain table.
SDTM- LBTESTCD: DRGABUSE / To collect routine drug screens where specific III
LBTESTCD LBTEST: Drugs of Abuse drug results are not listed
SDTM- LBTESTCD: ADP / LBTEST: A coenzyme composed of adenosine and two III
LBTESTCD Adenosine diphosphate molecules of phosphoric acid that is important
in intermediate cellular metabolism.
SDTM- LBTESTCD: ADPAUC / LBTEST: Area under the curve for Adenosine III
LBTESTCD Adenosine diphosphate AUC diphosphate
SDTM- LBTESTCD: ADPMA / LBTEST: Maximum aggregation for Adenosine III
LBTESTCD Adenosine diphosphate Max Agg diphosphate
SDTM- LBTESTCD: ADPV / LBTEST: Velocity for Adenosine diphosphate III
LBTESTCD Adenosine diphosphate Velocity
SDTM- LBTESTCD: COLLAGEN / A group of naturally occurring proteins found III
LBTESTCD LBTEST: Collagen in animals, especially in the flesh and
connective tissues of mammals. It is the
main component of connective tissue
SDTM- LBTESTCD: TRAPMA / LBTEST: Note: Request assumes that the LBTESTCD III
LBTESTCD Thrombin receptor-activated value, TRAP, will be assigned to Thrombin
peptide MA receptor-activated peptide. Currently, this is
assigned to another term. Maximum
aggregation for Thrombin receptor-activated
peptide.
SDTM- LBRESTCD: TRAPV / LBTEST: Note: Request assumes that the LBTESTCD, III
LBTESTCD Thrombin receptor-activated TRAP, is assigned to Thrombin receptor-
peptide Vel activated peptide. Currently, this is assigned
to another term. Velocity for Thrombin
receptor-activated peptide.
SDTM-FRM CAPSULE, OPEN Open capsule III
NEW LBCAT Category for Laboratory Tests III
NEW For Codelist LBCAT, ALCOHOL Screen for presence of alcohol in a biological III
SCREEN sample.
NEW For new codelist LBCAT, Set of laboratory tests that measure III
CHEMISTRY chemicals in the blood
NEW For new codelist, LBCAT 6 new COAGULATION: Set of laboratory tests used III
terms: COAGULATION, DRUGS to assess the function of the coagulation
OF ABUSE SCREEN, system; DRUGS OF ABUSE SCREEN: Set of
HEMATOLOGY, PLATELET laboratory tests used to measure the amount
AGGREGATION, PREGNANCY, of illicit drugs in a biological sample;
URINALYSIS HEMATOLOGY: Set of laboratory tests used
to measure the components of the blood;
PLATELET AGGREGATION: Set of
laboratory tests used to assess the functon of
platelets.; PREGNANCY: Laboratory tests
used to measure the presence of pregnancy
hormones.; URINALYSIS: Set of laboratory
tests used to measure the components in a
urine sample
NEW Codelist AEREL; Values NOT AEREL (Relationship to Adverse Event); NOT III
RELATED, RELATED RELATED: Investigator indicates the
Adverse Event was not related to the drug
under study.; RELATED: Investigator
indicates the Adverse Event was related to
the drug under study.
SDTM- LBTESTCD: APLAB / LBTEST: Detect several specific phospholipid-binding III

LBTESTCD Anti-phospholipid antibodiesÂ proteins that the body produces against itself
in an autoimmune response to phospholipids.
SDTM- LBTESTCD: FVL / LBTEST: Factor This test is used to diagnose suspected factor III
LBTESTCD V Leiden V Leiden disorder (an inherited blood-clotting
condition.
SDTM- LBTESTCD: PG20210A / LBTEST: Gene Mutation. A common genetic risk factor III
LBTESTCD Prothrombin G20210A for thrombosis (clots) including deep venous
thrombosis (DVT).
SDTM- LBTESTCD: CLUECE / LBTEST: LBTESTCD: CLUECE / LBTEST: Clue Cells III
LBTESTCD Clue Cells
SDTM- LBTESTCD: METHAMPHÂ / A measurement of any methamphetamine III
LBTESTCD LBTEST: Methampetamine drug present in a biological specimen
SDTM- RANDOMIZED Subject is randomized. III
NCOMPLT
SDTM- DRUG INTERRUPTION Interruption of study medication dosing not III
NCOMPLT related to an Adverse Event.
SDTM- DRUG RESUMPTION Resumption of study drug medication dosing III
NCOMPLT following an interruption that was not related
to an Adverse Event.
NEW New Codelist PCSPCCND. / New codelist: PCSPCCND: Condition of the III
Associated values: CLOTTED; Pharmacology Specimen.; CLOTTED: A
HEMOLYZED; INSUFFICIENT specimen that has become coagulated.;
VOLUME; LIPEMIC HEMOLYZED: A specimen that has
undergone the destruction of red blood cells
followed by the release of the hemoglobin.;
INSUFFICIENT VOLUME: Inadequate volume
of specimen in order to conduct the test.;
LIPEMIC: A specimen that consists of or
contains excessive amounts of fat and fatty
substances.
NEW New Codelist SUCAT; Associated CODELIST SUCAT: Category for Substance III
values: ALCOHOL; CAFFEINE; Use. ALCOHOL: Alcohol Use; CAFFEINE:
TOBACCO Caffeine Use; TOBACCO: Tobacco Use
NEW New Codelists SCTEST / SCTESTCD / SCTEST: Set of subject III

SCTESTCD / Associated values: characteristics // SCTESTCD EYECOLOR:
SCTESTCD: EYECOLOR / Color of a subject's eyes / SCTESTCD
SCTEST: Eye Color / SCTESTCD: INITIALS: Subject's Initials / SCTESTCD
INITIALS / SCTEST: Initials / CBPOT: Subject is of Childbearing Potential
SCTESTCD: CBPOT / SCTEST:
Subject is of Childbearing Potential
SDTM- LBTESTCD: ARA / LBTEST: polyunsaturated omega-6 fatty acid that is III
LBTESTCD Arachidonic Acid present in the phospholipids
SDTM- SCTESTCD: PREGSTAT / Subject's Pregnancy Status - associated with III
LBTESTCD SCTEST: Pregnancy Status - newly requested codelists for
associated with newly requested SCTESTCD/SCTEST
codelist SCTESTCD / SCTEST
SDTM- Please create a new LBTEST and III
LBTESTCD LBTESTCD for the parameeters
listed below: PTT-LA (Partial
Thromboplastin Time - Lupus
Anticoagulant) Lupus Anicoagulant;
Immature Reticulocyte Fraction IRF;
Generic Drug Screen
SDTM- Please provide a new LBTEST and III

LBTESTCD LBTESTCD for the parameter listed
below: Von Willebrand factor
Antigen
SDTM- Multiple updaes requested based I have sent a list of terms in spreadsheet III
RSSTRESC on feedback recieved during the format to Chris Tolk via email
public review of the onclogy domain
package
SDTM- Please add the synonym of 'Urine The test Specific Gravity is also known as a II
LBTESTCD Density' to the Submission Term urine density test. Please add 'urine density'
'Specific Gravity' as a synonym to the test Specific Gravity.
SDTM-LBTEST Please add the synonym of The test Ammonium Biurate Crystals is also II
'Ammonium Urate Crystals' to the known as Ammonium Urate Crystals. Please
Submission Term 'Ammonium add 'Ammonium Urate Crystals' as a synonym
Biurate Crystals'. to the test Ammonium Biurate Crystals.
SDTM-FREQ less than once/yr Add as part of PKD development III
SDTM-FREQ 1-5 times/yr Add as part of PKD development III
SDTM-FREQ daily/constant Add as part of PKD development III
SDTM-FREQ None Add as part of PKD development III
SDTM-UNIT Add term UNITS. This is the unit of Add term UNITS. This is the unit of measure II
measure for whole blood. for whole blood.
SDTM-TTYPE C49667; No spaces in between Existing: A studythat assessesthemedical I
some words in definition. risks to a subject. Safety is usually assessed
by examining a wide range of clinical
parameters, includingadverse events, vital
signs, physical exam, laboratory tests.
Change: A study that assesses the medical
risks to a subject. Safety is usually assessed
by examining a wide range of clinical
parameters, including adverse events, vital
signs, physical exam, laboratory tests.
SEND-DESIGN C82637; C82638; C82639 SDTM and SEND have slightly different II
definitions for these three terms and currently
we have two different CDISC definitions in the
database. I can't make separate concepts
however because the definitions are too
similar in meaning for us to logically split them
up. CDISC must make a decision on which
definition stays and which needs to be
deleted.
Final Outcome
SDTM, SEND-Published with P7

SDTM-Published in P6
SDTM, SEND-Published in P11
SDTM, SEND-Published in P7-P8

CDASH-Published in P7-P8;
CDASH-Published in P6
SEND-Published in P6
SDTM-Published in P7-P8
Date of Request Submitter Submitter Submitter E-
Status Request Type
Submission Code Name Affiliation mail
Closed 1/13/2012 15:50 31858 Coulange Sanofi anthony.coulan Create New

Anthony ge@sanofi.com Term
Closed 1/13/2012 15:51 31859 Debbie Merck debra_oneill@ Modify

merck.com Existing Term

Closed 1/13/2012 15:52 31861 Debbie Merck debra_oneill@ Create New

merck.com Term

merck.com Term


O'Neill merck.com Existing Term
Closed 1/20/2012 17:09 31870 Valerie Boehringe valerie.sjovall@ Other

Sjovall r- boehringer-
Ingelheim ingelheim.com
Closed 1/27/2012 14:24 31877 frank senk astrazene frank.senk@ast Modify

ca razeneca.com Existing Term
Closed 1/27/2012 14:25 31878 frank senk astrazene frank.senk@ast Modify

ca razeneca.com Existing Term
Open 1/27/2012 14:26 31879 Claire West GSK claire.m.west@ Other
gsk.com
Closed 1/27/2012 14:27 31880 Steve Kopko CDISC skopko@cdisc. Create New
org Codelist
Closed 1/27/2012 14:28 31881 Sarah Biogen Sarah.McLaugh Create New

McLaughlin Idec lin@biogenidec. Term
co
Closed 1/27/2012 14:29 31882 Sarah Biogen Sarah.McLaugh Create New
McLaughlin Idec lin@biogenidec. Term
com
Open 2/3/2012 16:30 31886 Phil Pochon Covance Phil.Pochon@c Create New
ovance.com Term
Open 2/3/2012 16:31 31887 Phil Pichotta Biodel ppichotta@biod Create New
Inc. el.com Term
Open 2/3/2012 16:32 31888 Guy Sunovion guy.genereux@ Modify

Genereux Pharmace sunovion.com Existing Term
uticals
Inc.
Open 2/3/2012 16:33 31889 Debbie Merck debra_oneill@ Create New

merck.com Term
Closed 2/10/2012 15:37 31895 Claire West GSK claire.m.west@ Modify

gsk.com Existing Term
Closed 2/10/2012 15:38 31896 Claire West GSK claire.m.west@ Modify
Open 2/10/2012 15:39 31897 Claire West GSK claire.m.west@ Modify

Closed 2/10/2012 15:40 31898 Tisanna Eli Lilly tisanna@lilly.co Create New
Shelton & m Term
Co.
Open 2/10/2012 15:41 31899 Anna Pron- AstraZene anna.pron- Create New
Zwick ca zwick@astraze Term
neca.com
Closed 2/10/2012 15:42 31900 Chris Tolk CDISC ctolk@cdisc.org Create New
Term
Closed 2/10/2012 15:43 31901 Rhonda CDISC rfacile@cdisc.or Create New

Facile g Term
O'Neill merck.com Term
Open 2/17/2012 13:33 31911 Theresa quinnt@mail.nih Modify

Quinn .gov Existing Term
Closed 2/17/2012 13:33 31912 Mary Jo Merck mj.brucker@me Create New

Brucker & rck.com Term
Co.

O'Neill merck.com Existing Term
Closed 2/23/2012 13:54 31918 Mary Jo Merck mj.brucker@me Create New

Brucker & rck.com Term
Co.
Open 2/23/2012 13:59 31919 Joyce Merck joyce_hernande Create New

Hernandez z@merck.com Term
Open 2/23/2012 14:01 31920 john.swithenban Create New

k@covance.co Term
m
Open 3/8/2012 17:43 31956 Barbara bbartocci@ucsd Other
Bartocci .edu
Closed 3/8/2012 17:44 31957 Phil Pochon phil.pochon@co Create New

vance.com Term
path.org Term
path.org Term
path.org Term
Closed 3/8/2012 17:50 31961 Mary Jo Merck mj.brucker@me Modify
Brucker & rck.com Existing Term
Co.

Closed 3/8/2012 17:52 31963 Barrie Nelson Amgen barrien@amgen Create New
Inc .com Term
Closed 3/8/2012 17:53 31964 Erin LMCO erin.e.muhlbradt Modify

Muhlbradt @lmco.com Existing Term
Open 3/8/2012 17:54 31965 Erin LMCO erin.e.muhlbradt Modify


Open 3/8/2012 18:01 31968 Troy MPI troy.smyrnios@ Modify

Smyrnios Research mpiresearch.co Existing Term
m
Open 3/8/2012 18:02 31969 Troy MPI troy.smyrnios@ Modify
Smyrnios Research mpiresearch.co Existing Term
m
Open 3/8/2012 18:03 31970 Rohit Dhanjal Sanofi rohit.dhanjal@s Create New
anofi.com Term
Open 3/8/2012 18:05 31972 VERONIQUE veronique Modify
BOURCIER .bourcier Existing Term
@bayer.c
om
Open 3/8/2012 18:06 31973 Guy Sunovion guy.genereux@ Modify

Genereux Pharmace sunovion.com Existing Term
uticals
Inc.
Closed 3/8/2012 18:45 31974 Randall GSK randall.r.austin Create New
Austin @gsk.com Codelist
Open 3/13/2012 31987 Carol Vaughn Sanofi carol.vaughn@sanofi.com

Create New
Term
Open 3/13/2012 31988 Erin LMCO erin.e.muhlbradt@lmco.com

Modify
Muhlbradt Existing Term
Open 3/14/2012 31989 john.swithenbank@covance.com
Modify
Existing Term
Closed 3/16/2012 31990 Coulange Sanofi anthony.coulange@sanofi.com

Create New
Anthony Term
Open 3/16/2012 31991 Anna Pron- AstraZene anna.pron-zwick@astrazeneca.com
Modify
Zwick ca Existing Term
Pharmace
uticals
Closed 3/16/2012 31994 Anna Pron- AstraZene anna.pron-zwick@astrazeneca.com
Create New
Zwick ca Term
Pharmace
uticals

Create New
Zwick ca Term
Pharmace
uticals
Open 3/20/2012 32007 Aron awisneski@synteract.com

Modify
Wisneski Existing Term
Closed 3/20/2012 32008 Erin LMCO erin.e.muhlbradt@lmco.com

Modify

Create New
Zwick ca Term
Open 3/22/2012 32010 Jeannie Le Orphan jlemouhaer@orphan-europe.com

Create New
Mouhaer Europe Term
Closed 3/22/2012 32011 Jeannie Le Orphan jlemouhaer@orphan-europe.com

Create New
Mouhaer Europe Term

Create New
Mouhaer Europe Term

Create New
Mouhaer Europe Term

Create New
Zwick ca Term
Create New
Zwick ca Term
Open 3/22/2012 32016 Anna Pron- AstraZene anna.pron-zwick@astrazeneca.com

Modify

Create New
Zwick ca Term

Create New
Zwick ca Term
Closed 3/23/2012 32019 Jeannie Le Orphan jlemouhaer@orphan-europe.com

Create New
Mouhaer Europe Term

Create New
Mouhaer Europe Term

Create New
Zwick ca Term

Create New
Zwick ca Term

Create New
Zwick ca Term
Create New
Zwick ca Term

Create New
Zwick ca Term
Closed 3/26/2012 32039 Sally Cassells Define.X Sally.Cassells@gmail.com

Create New
ML team Codelist
Closed 3/26/2012 32040 Derek Covidien derek.morgan@covidien.com

Create New
Morgan Term
Closed 3/26/2012 32041 Derek Covidien derek.morgan@covidien.com
Create New
Morgan Term
Closed 3/27/2012 32042 Johannes HMR jstanta@hmrlondon.com
Modify
Stanta Existing Term
Open 3/27/2012 32042 Johannes HMR jstanta@hmrlon Modify

Stanta don.com Existing Term
Open 3/27/2012 32043 David Ju ERT dju@ert.com Create New

Services, Term
Inc.
Closed 3/27/2012 32044 David Ju ERT dju@ert.com Create New
Services, Term
Inc.

Services, Term
Inc.

Services, Term
Inc.

Services, Term
Inc.
Open 3/28/2012 32048 Rhonda rfacile@cdisc.orgCreate New

Facile Term

Modify
Closed 4/2/2012 32050 Veronique Bayer veronique.bourcier@bayer.com
Modify
Bourcier Existing Term

Modify
Modify
Closed 4/9/2012 32069 Debbie Merck debra_oneill@merck.com

Create New
O'Neill Term

Modify
Open 4/16/2012 32081 Mike Hamidi Octagon mhamidi@octagonresearch.com

Create New
Research Term
Solutions,
Inc.

Other
Research
Solutions,
Inc.

Create New
Research Codelist
Solutions,
Inc.
Closed 4/16/2012 32084 Nik Pemble (J&J) npemble@its.jnj.com

Create New
Term

Modify
Open 4/24/2012 32092 Kapila Patel Novartis kapila.patel@novartis.com]

Create New
Pharmace Term
uticals
Corporati
on
Closed 4/24/2012 32093 Kapila Patel Novartis kapila.patel@novartis.com]
Create New
Pharmace Term
uticals
Corporati
on
Create New
Pharmace Term
uticals
Corporati
on

Create New
Pharmace Term
uticals
Corporati
on

Create New
Pharmace Term
uticals
Corporati
on

Create New
Pharmace Term
uticals
Corporati
on
Closed 4/24/2012 32098 Kapila Patel Novartis kapila.patel@no Create New

Pharmace vartis.com] Term
uticals
Corporati
on

Create New
Pharmace Term
uticals
Corporati
on

uticals
Corporati
on
uticals
Corporati
on

uticals
Corporati
on

uticals
Corporati
on

uticals
Corporati
on

uticals
Corporati
on

uticals
Corporati
on

uticals
Corporati
on
uticals
Corporati
on

uticals
Corporati
on

uticals
Corporati
on

Create New
Pharmace Term
uticals
Corporati
on

Modify

Modify
Open 4/25/2012 32114 Anna Pron- AstraZene Anna.Pron-Zwick@astrazeneca.com

Create New
Zwick ca Term
Pharmace
uticals
Open 4/25/2012 32115 Monica Celgene mmattson@celgene.com
Create New
Mattson Corporati Term
on
Closed 4/25/2012 32116 Peggy Zorn INDS, Inc. peggy.zorn@inds-inc.com

Modify
Existing Term

Create New
on
Create New
on
Open 4/27/2012 32121 Sandra Ott Baxter sandra_ott@baxter.com]
Create New
Innovation Codelist
s GmbH

Create New
Zwick ca Term
Pharmace
uticals
Closed 4/30/2012 32128 Scott Roche scottab@gene.com

Create New
Bahlavooni Term
Closed 5/1/2012 32129 Chris Tolk CDISC ctolk@cdisc.org Create New

Codelist
Open 5/2/2012 32130 Chris Tolk CDISC ctolk@cdisc.org Other
Closed 5/2/2012 32131 Tore Haglund AstraZene tore.haglund@astrazeneca.com

Other
ca
Closed 5/2/2012 32132 Tore Haglund AstraZene tore.haglund@astrazeneca.com

Other
ca
Closed 5/3/2012 32133 Anna Pron- AstraZene Anna.Pron-Zwick@astrazeneca.com

Create New
Zwick ca Term
Pharmace
uticals
Open 5/3/2012 32134 Carrie Neeley Covance carrie.neeley@covance.com

Create New
Laboratori Term
es, Inc.
Create New
Laboratori Term
es, Inc.
Modify
Laboratori Existing Term
es, Inc.

Modify

Modify
Open 5/4/2012 32139 Nik Pemble Janssen npemble@its.jnj.com
Create New
Term

Create New
Zwick ca Term
Pharmace
uticals
Closed 5/7/2012 32159 kapila.patel@novartis.com

Kapila 862.778.2233 Create New
Patel Term
Open 5/7/2012 32159 kapila.patel@novartis.com

Patel Term

Patel Term

Patel Term
Patel Term

Patel Term

Patel Term

Patel Term

Patel Term

Patel Term

Patel Term
Closed 5/7/2012 32160 kapila.patel@novartis.com

Patel Term
Open 5/8/2012 32161 lorraine.spencer@takeda.com

Lorraine P 224-544-2999 Modify
Spencer Existing Term
Closed 5/9/2012 32162 claire.m.west@gsk.com
Claire Create New
West Term

Claire Create New
West Term
Closed 5/9/2012 32164 debra_oneill@merck.com

Debbie 267-305-8124 Modify
O'Neill Existing Term
Closed 5/9/2012 32165 debra_oneill@merck.com

Debbie 267-305-8124 Create New
O'Neill Term
Open 5/9/2012 32166 debra_oneill@merck.com

Debbie 267-305-8124 Modify
Claire Create New
West Term
Open 5/9/2012 32168 claire.m.west@gsk.com

Claire Create New
West Term
Closed 5/11/2012 32170 josephine_anne.gough@roche.com

Josephine 41 - 61 – 688 Create New
Anne 76 05 Term
Gough

O'Neill Term
Open 5/14/2012 32180 michael_morozewicz@yahoo.com

Michael 856-417-3294 Create New
Morozewi Term
cz
Morozewi Term
cz

Morozewi Term
cz

Morozewi Term
cz

Morozewi Term
cz
Closed 5/16/2012 32185 arianne.motter@nih.gov

Arianne Modify
Motter Existing Term

O'Neill Term
Open 5/21/2012 32187 Laura DiTullio TAKE laura.ditullio@takesolutions.com

Modify
Solutions Existing Term
Closed 5/22/2012 32188 Terry Quinn LMCO quinnt@mail.nih.gov

Modify
Existing Term

Modify
Existing Term

Modify
Existing Term
Closed 5/23/2012 32194 David Daiichi dramage@dsi.com

Modify
Ramage Sankyo Existing Term
Open 5/23/2012 32195 David Turner Shire terminology4Shire@shire.com
Modify
Existing Term
Open 5/23/2012 32196 Michael Independ michael_morozewicz@yahoo.com

Create New
Morozewicz ent Term
Closed 5/28/2012 32197 David Turner Shire terminology4shire@shire.com

Create New
Term
Open 5/28/2012 32198 David Turner Shire terminology4shire@shire.com

Create New
Term

Modify
Existing Term

Modify
Existing Term

Modify
Existing Term
Modify
Existing Term

Modify
Existing Term

Modify
Existing Term
Open 5/29/2012 32205 Peggy Zorn INDS peggy.zorn@inds-inc.com

Other

Modify
Closed 6/4/2012 32209 Chris Tolk CDISC ctolk@cdisc.org Modify

Existing Term
Open 6/4/2012 32210 Cathy Bezek Astellas cathy.bezek@astellas.com
Create New
Pharma Term
Create New
Pharma Term
Open 6/5/2012 32212 Lorraine Takeda lorraine.spencer@takeda.com
Other
Spencer Pharmace
uticals

Create New
O'Neill Term

Other
Spencer Pharmace
uticals
Closed 6/5/2012 32215 Mary Jo Merck mj.brucker@merck.com
Create New
Brucker Term
Open 6/5/2012 32216 Josephine Hoffmann josephine_anne.gough@roche.com

Create New
Gough La-Roche Term
Closed 6/5/2012 32217 Josephine Hoffmann josephine_anne.gough@roche.com

Create New
Gough La-Roche Term

Create New
Gough La-Roche Term

Create New
Gough La-Roche Term
Open 6/8/2012 32220 Steve Kopko CDISC skopko@cdisc.org
Create New
Term

Create New
Spencer Pharmace Term
uticals
Closed 6/8/2012 32228 john.swithenbank@covance.com

Modify
Existing Term
Open 6/12/2012 32229 Debbie Merck debra_oneill@merck.com

Create New
O'Neill Term

Create New
O'Neill Term
Create New
O'Neill Term

Create New
O'Neill Term
Closed 6/12/2012 32233 Carol Charles carol.detrisac@crl.com

Modify
Detrisac River Existing Term
Closed 6/14/2012 32234 Randall GlaxoSmit randall.r.austin@gsk.com

Modify
Austin hKline Existing Term

Modify

Modify
Closed 6/14/2012 32237 David Turner Shire terminology4Shire@shire.com
Other
Closed 6/14/2012 32238 Chris Tolk ctolk@cdisc.org Create New

Term
Open 6/14/2012 32239 Chris Tolk ctolk@cdisc.org Create New
Term
Closed 6/14/2012 32240 Joyce Merck & joyce_hernandez@merck.com

Create New
Hernandez Co. Inc Term

Modify
Closed 6/19/2012 32245 Valerie boehringe valerie.sjovall@boehringer-ingelheim.com
Create New
Sjovall r- Term
ingelheim
Open 6/22/2012 32246 David Daiichi dramage@dsi.com

Modify
Ramage Sankyo Existing Term

Create New
Gough La-Roche Term

Create New
Gough La-Roche Term
Open 7/6/2012 32254 David Tillery Purdue david.tillery@pharma.com
Other
Pharma
Closed 7/17/2012 32269 Monica Celgene mmattson@celgene.com

Create New
on
Closed 7/17/2012 32270 Randall GlaxoSmit randall.r.austin@gsk.com
Modify
Austin hKline Existing Term

Create New
Zwick ca Term
Pharmace
uticals

Create New
Zwick ca Term
Pharmace
uticals
Closed 7/18/2012 32273 Scott Genentec scottab@gene.com
Create New
Bahlavooni h, a Term
member
of the
Roche
group
Open 7/18/2012 32274 Nik Pemble Janssen npemble@its.jnj.com

Create New
Term

Modify
Pharmace
uticals
Modify

Modify
Open 7/23/2012 32278 Van Merck dirk.van.krunckelsven@merckgroup.com
Modify
Krunckelsven Serono Existing Term
Dirk
Closed 7/26/2012 32279 Cathy Bezek Astellas cathy.bezek@astellas.com

Create New
Pharma Term
Closed 7/26/2012 32280 Cathy Bezek Astellas cathy.bezek@astellas.com
Create New
Pharma Term

Modify
Closed 7/27/2012 32283 Adrienne Amgen aboyance@amgen.com
Create New
Boyance Codelist
Create New
Pharma Term
Closed 8/1/2012 32285 claire west GSK claire.m.west@gsk.com

Modify
Existing Term
Closed 8/2/2012 32286 Alla Yelina GRPD alla.yelina@abbott.com

Create New
Term

Create New
Term

Modify

Modify

Modify

Modify
Modify
Modify

Create New
Term

Modify
Create New
Term

Create New
Term
Closed 8/10/2012 16:03 32298 Arianne NCI/EVS arianne.motter Modify

Motter @nih.gov Existing Term
Open 8/10/2012 16:07 32299 Arianne NCI/EVS arianne.motter Modify



Closed 8/10/2012 16:12 32305 Erin LMCO erin.e.muhlbradt Create New

Muhlbradt @lmco.com Term

Closed 8/16/2012 12:56 32308 Guy Sunovion guy.genereux@ Other
Genereux Pharmace sunovion.com
uticals
Inc.
Closed 8/31/2012 13:11 32315 Kapila Patel Novartis kapila.patel@no Create New
Pharmace vartis.com Term
uticals
Corporati
on
uticals
Corporati
on
Open 8/31/2012 13:18 32317 Kapila Patel Novartis kapila.patel@no Create New
uticals
Corporati
on
Closed 8/31/2012 13:19 32318 Veronqiue Bayer veronique.bourc Modify
Bourcier Vital ier@bayer.com Existing Term
GmbH
Open 8/31/2012 13:20 32319 David Daiichi dramage@dsi.c Create New

Ramage Sankyo om Term

Closed 8/31/2012 13:23 32321 Steve Kopko CDISC skopko@cdisc. Create New
org Term
Closed 8/31/2012 13:24 32322 Valerie Boehringe valerie.sjovall@ Create New
Sjovall r boehringer- Term
Open 8/31/2012 13:24 32323 Dagmar Merck dagmar.kottigrot Create New

Kottigroth h@merckgroup. Term
com

com

com

Open 9/7/2012 16:30 32328 David Turner Shire terminology4Shi Create New
re@shire.com Term




O'Neill merck.com Codelist

O'Neill merck.com Codelist
Closed 9/7/2012 16:41 32335 Valerie Boehringe valerie.sjovall@ Create New

Sjovall r boehringer- Term
Open 9/7/2012 16:44 32336 David Turner Shire terminology4Shi Create New
re@shire.com Term
uticals
Corporati
on
Closed 9/7/2012 16:46 32338 Scott Genentec scottab@gene.c Create New
Bahlavooni h om Term
Closed 9/7/2012 16:47 32339 Janet Siani Shire jsiani@shire.co Modify

m Existing Term
Closed 9/14/2012 13:31 32341 Colleen Bonjo Merck colleen_bonjo@ Create New
merck.com Term





Open 9/14/2012 13:44 32350 claire west gsk claire.m.west@ Other

gsk.com
Closed 9/27/2012 18:33 32359 Colleen Bonjo Merck cocolleen_bonjo Create New
@merck.com Term





Closed 9/27/2012 19:06 32368 Jennifer Instem jennifer.feldman Other
Feldmann n@instem.com








Closed 9/27/2012 19:24 32381 Erin LMCO erin.e.emuhlbra Modify
Muhlbradt dt@lmco.com Existing Term

Open 9/27/2012 19:26 32383 Mary Jo Merck mj.brucker@me Modify

Co.
Open 9/27/2012 19:27 32384 Mary Jo Merck mj.brucker@me Modify
Co.
Open 10/5/2012 18:59 32387 Scott Genentec scottab@gene.c Create New

Bahlavooni h/Roche om Term
Closed 10/5/2012 19:00 32388 Dennis Noe Millenniu dennis.noe@m Create New
m pi.com Term
Pharmace
uticals Inc
Closed 10/5/2012 19:01 32389 Veronqiue Bayer veronique.bourc Other
Bourcier Vital ier@bayer.com
GmbH
Closed 10/12/2012 19:25 32391 Chris Tolk ctolk@cdisc.org Create New

Term
Open 10/12/2012 19:32 32392 Chris Tolk ctolk@cdisc.org Create New
Term

Closed 10/12/2012 19:37 32394 Alla Yelina Abbott alla.yelina@abb Create New
Laboratori ott.com Term
es
Closed 10/12/2012 19:42 32396 David Turner terminology4shi Create New

re@shire.com Term

Closed 10/19/2012 17:38 32399 Randall GSK randall.r.austin Modify

Austin @gsk.com Existing Term
Closed 10/19/2012 17:41 32400 Randall GSK randall.r.austin Modify

Austin @gsk.com Existing Term
Closed 10/19/2012 17:42 32401 Scott Genentec scottab@gene.c Modify

Bahlavooni h/Roche om Existing Term
Closed 10/27/2012 19:13 32406 Veronique veronique.bourc Modify

Bourcier ier@bayer.com Existing Term
Open 10/27/2012 19:15 32407 Ben Young Spaulding youngb@spauld Modify

Clinical ingclinical.com Existing Term
Research
Open 11/9/2012 17:42 32413 troy.smyr Modify

nios@mpi Existing Term
research.
com
Closed 11/9/2012 17:44 32414 Anna Pron- AstraZene anna.pron- Other

Zwick ca zwick@astraze
Pharmace neca.com
uticals
Closed 11/9/2012 17:45 32415 valerie.sjovall@ Create New

boehringer- Term
ingelheim.com
Closed 11/9/2012 17:46 32416 Peter Certara / peter.schaefer Create New

Schaefer Pharsight @certara.com Term

Closed 11/9/2012 17:50 32418 Ben Young Spaulding youngb@spauld Modify

Clinical ingclinical.com Existing Term
Research
Open 11/9/2012 17:52 32419 Colleen Bonjo Merck colleen_bonjo@ Create New
merck.com Term
Open 11/9/2012 17:53 32420 Colleen Bonjo Merck colleen_bonjo@ None

merck.com
Closed 11/16/2012 15:41 32424 Charles Audrey.Walker Create New
River @crl.com Term
Laboratori
es
Open 11/16/2012 15:42 32425 Charles Audrey.Walker Create New

River @crl.com Term
Laboratori
es
Open 11/16/2012 15:43 32426 Lorraine Takeda Lorraine.Spenc Create New

Spencer er@Takeda.co Term
m
Closed 11/16/2012 15:45 32427 ROUCH Sanofi maxime.rouch Create New

@sanofi.com Term
Open 11/16/2012 15:47 32428 Lorraine Takeda Lorraine.Spenc Create New

Spencer er@Takeda.co Term
m
Open 11/26/2012 13:31 32434 Debbie Merck debra_oneill@ Other

O'Neill merck.com
Closed 11/30/2012 13:42 32439 Michael Grunenth michael.schmitz Modify

Schmitz al GmbH @grunenthal.co Existing Term
m
Closed 11/30/2012 13:43 32440 Scott Genentec scottab@gene.c Create New

Bahlavooni h/Roche om Term
Open 11/30/2012 13:44 32441 Arianne NCI-EVS arianne.motter Modify

Closed 11/30/2012 13:46 32442 Arianne NCI-EVS arianne.motter Modify

Closed 11/30/2012 13:53 32443 Monica Celgene mmattson@celg Create New

Mattson Corporati ene.com Term
on
Closed 11/30/2012 13:59 32444 Erin NCI-EVS muhlbradtee@ Modify
Muhlbradt mail.nih.gov Existing Term
Closed 12/5/2012 32448 Mary Jo Merck mj.brucker@merck.com

Other
Brucker

Create New
O'Neill Term
Open 12/6/2012 32450 veronique.bourcier@bayer.com

None
Closed 12/6/2012 32451 veronique.bourcier@bayer.com

None
Closed 12/14/2012 32462 Audrey Charles audrey.walker@crl.com

Create New
Walker River Term
Laboratori
es
Create New
Walker River Term
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es
Create New
Walker River Term
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es
Create New
Walker River Term
Laboratori
es
Create New
Walker River Term
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es
Create New
Walker River Term
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es
Create New
Walker River Term
Laboratori
es
Closed 12/21/2012 32471 Nik Pemble Janssen npemble@its.jnj.com
Modify
Existing Term
Closed 12/21/2012 32472 Nik Pemble Janssen npemble@its.jnj.com

Modify
Existing Term
Closed 12/21/2012 32473 David Turner Shire terminology4Shi Create New

re@shire.com Term
Closed 12/21/2012 32474 Elizabeth Genentec nicol.elizabeth Create New

Nicol h/Roche @gene.com Term
Closed 12/28/2012 32476 Erin MSC muhlbradtee@ Modify

Open 12/28/2012 32477 Erin MSC muhlbradtee@ Modify
New Term or Codelist/Existing Term
CDISC Codelist
or Code Number
SDTM-LBTEST Apolipoprotein B/Apolipoprotein A1
SDTM-UNIT 10^3 Organisms
SDTM-UNIT 10^ 3 CFU/g
SDTM-UNIT APPLICATION
SDTM-UNIT CAPFUL
SDTM-FRM LOTION. AUGMENTED
SDTM- Update synonym for LBY from

COUNTRY Libya Arab Jamahiriya to Libya
None For your consideration please find

attached an Excel document
containing requests for expansion
of multiple STDM codelists from
Boehringer Ingelheim.
SDTM-UNIT c71620 change "%
(v/v)" to "%(v/v)" -
remove space to be consistent with
other terms
SDTM-UNIT change "10^ 3 CFU/g"
to "10^3 CFU/g" -
remove space
SDTM- Clarification required for Antibody
LBTESTCD type codes
None RD - Reproduction Details domain

(NEW); RDTESTCD &
RDTEST
SDTM-VSTEST Add 'Waist Circumference' and

'Abdominal Fold Thickness'
SDTM- Add 'WSTCIRC' for 'Waist

VSTESTCD Circumference' and 'ABDFOLD' for
'Abdominal Fold Thickness'
SDTM- List of 43 Microorganism terms sent
MICROORG to Chris Tolk
SDTM-ROUTE SUBCUTANEOUS PUMP
INFUSION
None SDTM-NEOPLASM; Change

Synonym(s) on either SDTM-
NEOPLASM (codelist=C88025)
term of "GRANULOSA CELL
TUMOR, MALIGNANT"
(C4205) or "GRANULOSA
CELL TUMOR,
UNDETERMINED" (C3070) or
both.
SDTM-VSTEST Oxygen Saturation with code

OXYSAT
SDTM-UNIT SCM and M3

SDTM-UNIT ug/kg
SDTM-UNIT C73755 - mL/g/day
SDTM-LBTEST Please add a test code and term for

albumin expressed as a percentage
of total protein.Â
SDTM- SYNOVIAL FLUID
SPECTYPE
SDTM-DOMAIN Add about 15 new domain codes

for procedure, morphology, and
physiology by body system
SDTM-DOMAIN DI; DO; DU; DX; DE; DT; DR
SDTM-LOC OROPHARYNX; RECTOSIGMOID
SEND-SPEC C77678 Implantation Site from

SEND Biospecimens Codelist -
Update definition to include Devices
as per request from ACC and
Cardiovascular Therapeutic Area
standards work.
SDTM-DOMAIN Domain Code = PR, Domain Name

= Pregnacy Results, Domain
Description = Pregnancy results of
female subjects.
SDTM-LOC THYROID GLAND, LEFT LOBE;
THYROID GLAND, RIGHT LOBE;
HEPATIC
SDTM-DOMAIN Requesting to reserve two new

domain codes for Repro Tox
studies: FF = Fetal Findings
(Individual fetal examinations and
measurements) and PA = Pairing
Events (The pairing event records
during cohabitation for the fertility
component of a study).
SDTM-DOMAIN PS domain code for

Pharmacogenomics Reference
Sequence: VF Virology Findings;
VR Virology Reference Sequence;
VP Virology Phenotype
NEW SDTM-PKPARM: Please consider

adding Metabolic Ratio as an urgent
addition to the codelist as we
cannot see this referenced but
report this frequently
SDTM-OUT Adverse Event Outcomes
SDTM- Submiting requested terms for

LBTESTCD package 11 lab test vocabulary
SDTM-UNIT logCFU
SDTM- Direct Nucleic Acid Amplification

LBTESTCD
SDTM- ELISPOT
LBTESTCD
SEND- Expand the definition of the
DSDECOD "ACCIDENTAL"
DSDECOD from "An
indication that the subject's death
was due to a mishap" to
"An indication that the
subject's death or sacrifice was due
to a mishap or technical /
operational error."
SDTM- Please add the term BIOPSY to the

METHOD Method Codelist.
SDTM-DOMAIN RS Response (RS Definition: The

RS domain represents the response
evaluation determined from the data
in TR (Tumor Results).
None SDTM- PORTOT: Change c-code

for MULTIPLE from C78728 to
C17648
None SEND-Neoplasm: Remove 4
synonyms from the published list.
They are incorrect.
SDTM-LBTEST Discuss the term (C25748) Iron
Binding Capacity versus the CDISC
term (C74718) Total Iron Binding
Capacity. Are these inherently
different?
None SDTM-LAT: Change c-code for
UNILATERAL from C68598 to
C28012
SDTM-PKUNIT mg/mL
SDTM-PKUNIT h*mg/mL
SDTM-ACN INVESTIGATIONAL PRODUCT

WITHDRAWN
SEND-CLCAT Change c-code for CLINICAL
SIGNS from C3367 to C100104
SDTM- Both TSPARM values have more
TSPARM than 40 characters in SDTM
Terminology. The TSPARM variable
is however limited to 40 characters.
SDTM- Change codelist short name for

TOXGRV4 codelist code=C87162 (TOXGR) to
something else. Or for codelist
code=C66784 (TOXGR).
SDTM-SCCD CDISC has a codelist for
SCTESTCD called SCCD. We need
a corresponding codelist for
SCTEST (the decode of
SCTESTCD). This should have
been done when SCCD was
created but apparently was
overlooked.
SDTM-OUT STABILIZED
SEND- Remove Mastocystosis from

NEOPLASM synonym column of C9295.
SDTM- Please amend the TSPARM value
TSPARM for TSPARMCD=FCNTRY from
Planned Country of Investigational
Site(s) to Planned Country of
Investigational Site as this currently
exceeds the accepted 40 character
ruling specified in the IG
SDTM- AVITE for Alpha Tocopherol-

LBTESTCD Vitamin E
SDTM-LOC Please consider making GASTRIC
(C13307) a synonym to term
STOMACH (C12391). Thank you.
SDTM-LOC PERITONEAL CAVITY
SDTM-LOC Pericardial Cavity
SDTM- LBTESTCD of CD19, CD3, CD4,

LBTESTCD CD8 -- all have a CDISC Definition
that begins with the words "A count
of...", but the LBTEST values have
CDISC Definitions that start with the
words "A measurement of...".
SDTM-EPOCH C49236: TREATMENT
SDTM- Vitreous humor

SPECTYPE
SDTM-LBTEST ratio vitamin E/ (Total cholesterol +

Triglycerides)
SDTM-LBTEST ratio vitamin E/ Cholesterol
SDTM-UNIT mg/g
SDTM-VSTEST Tanner score
SDTM-LOC Abdominal Wall

SDTM-LOC Clitoris
SDTM-LOC Fat tissue as synonym to existing

term Adipose tissue
SDTM-LOC Lacrimal glands
SDTM-LOC Add synonym "Lymphatic gland" to

existing SDTM LOC term LYMPH
NODE (C12745)
SDTM-LBTEST leukocyte cystine (or WBC cystine)
SDTM-UNIT nmoles half-cystine per mg protein
SDTM-LOC Mammary gland
SDTM-LOC Mesentery
SDTM-LOC Cranial Nerves

SDTM-LOC Pineal gland
SDTM-LOC Preputial gland, Salivary glands,

Sebaceous glands, Sweat glands
NEW We are requesting a code list to

further the standardize dataset
Class metadata used for ADaM,
SDTM and SEND submissions.
Terms that should be included are:
Special Purpose, Findings, Events,
Interventions, Analysis. THe code
list should not be extensible.
SDTM- MDMA
LBTESTCD
SDTM-LBTEST MDMA
SDTM-LBTEST N-acetyl-beta-D-glucosaminidase
SDTM-LBTEST NAG
SDTM- EXTENSIVE ANTERIOR

EGSTRESC MYOCARDIAL INFARCTION
SDTM- OVERALL EVALUATION
EGTESTCD NORMAL; OVERALL
EVALUATION ABNORMAL;
OVERALL EVALUATION UNABLE
TO EVALUATE
SDTM- FREQUENT ATRIAL PREMATURE

EGTESTCD COMPLEXES (>3)
SDTM- FREQUENT VENTRICULAR

EGTESTCD PREMATURE COMPLEXES (>2)
SDTM- U WAVES ABNORMAL

EGTESTCD
SDTM-DOMAIN SAE - Serious Adverse Event
SDTM-PKUNIT C85628 - Incorrect synonym
SDTM-TOXGR TOXGR is defined twice: once =

under codelist_code C66784 and
once under codelist_code C87162.
One with code 0 to take into
account the absence scenario. If
two lists are kept, would it be
possible to have two different
names?
None C12366; C12434; C12472; C29848;

C3263; C42559; C42569; C45997;
C48152; C49668; C49671; C53262;
C62145; C74606; C74607; C74608;
C74609; C85582
SEND- Synonym update from NCI
NEOPLASM
SDTM-UNIT mL/s
SDTM-LOC C12435; C13050; C12437; C12436;

C12471
SDTM- Additional CT for collection of

TSPARM Exploratory Objectives and Other
Objectives that are not considered
Primary/Secondary.
None Additional domain and CodeList for

Echocardiogram procedures.
None Domain Descriptions
SDTM- BONE MARROW ASPIRATE;

SPECTYPE BONE MARROW BIOPSY; NASAL
LAVAGE FLUID; TUMOR TISSUE;
ASCITIC FLUID; SKIN
SEND- Update definition of SITE,
SPECIMEN IMPLANTATION to serve both the
SEND and the SDTM community.
This update is being requested as
part of the CV therapeutic area
standard.
SDTM-VSTEST BODY FAT
SDTM-STENRF BEFORE/DURING
SDTM-SCCD IS THE SUBJECT OF CHILD
BEARING STATUS
SDTM-SCCD COLLECTION OF INITIALS

ALLOWED
SDTM-SCCD SUBJECTS INITIALS
SDTM-SCCD SOURCE OF SUBJECT

REFERRAL
SDTM-SCCD REC. REG. MAINT. ORAL

CORTICOSTEROIDS
SDTM-SCCD CLIN. SIGN. EXACERB. REQ.

SYST. CORTI.
SDTM-SCCD END DATE OF THE MOST REC

ASTHMA EXACERB
SDTM-SCCD DOES THE PATIENT HAVE A
HISTORY OF ATOPY
SDTM-SCCD LONG ACTING B2 AGONISTS
SDTM-SCCD ORAL CORTICOSTEROID

MEDICATION
SDTM-SCCD REGULAR INHALED

CORTICOSTEROID MED?
SDTM-SCCD DATE OF DIAGNOSIS OF

ASTHMA
SDTM-SCCD HIGHEST LEVEL OF EDUCATION
SDTM-SCCD LEVEL OF EXERCISE

PARTICIPATION
SDTM-SCCD NUMBER OF BIOLOGICAL
BROTHERS
SDTM-SCCD DIAMETER OF PSORIATIC

TARGET LESION
SDTM-SCCD CLASSIFICATION OF
FUNCTIONAL STATUS
SDTM-SCCD MUMBER OF BIOLOGICAL

SISTERS
SEND- Change C3809 to C6963; Remove

NEOPLASM synonyms NEUROENDOCRINE
TUMOR NOS;
NEUROENDOCRINE TUMOR
SDTM- C74606; C74635; C74607; C74636;

LBTEST/CD C74608; C74637; C74638; C74609;
C74639
SDTM-LBTEST Lysergic acid diethylamide
SDTM- TRANSITION TO COMMERCIALLY

NCOMPLT AVAILABLE STUDY DRUG
SEND-SSTYP CDISC submission value for

BIOAVAILBILITY misspelled,
should be BIOAVAILABILITY
SDTM- SUMPROD
TRTESTCD
SDTM-TRTEST Sum of Products of Perp Diameters
NEW the addition of several

Questionnaire Terminology Test
Codes (QSTESTCD), Test Names
(QSTEST), Categories (QSCAT)
and Subcategories (QSSCAT)
SDTM-LBTEST Coombs Test with synonyms

Antiglobulin Test and AGT / Also
need Indirect Coombs Test with
synonyms Indirect Antiglobulin Test
and IAT
SDTM-ROUTE Please create new terms for the
following routes: INTRACAMERAL;
SUBTENON.These are currently in
the NCI-T, but not part of CDISC
CT.
None Add new code list for severity with

the terms, mild, moderate, severe.
The AESEV because the terms are
coded to: Mild Adverse Event, etc.
SDTM-DOMAIN Remove domain code ST = Stress

test. Stress test data goes into the
new CV domain.
SDTM-RACE Code list should be set to Not
Extensible.
SDTM-ETHNIC Code list should be set to Not

Extensible.
SDTM-ROUTE Oromucosal
SDTM-UNIT E3/uL = 10E3 Cells/uL

SDTM-UNIT E6/uL= 10E6 Cells/uL
SDTM-UNIT EU/dL = EU
SDTM-UNIT Coding error; change C66968 to

C25473. These will be merged in
NCIt.
SDTM-FREQ C25473
SDTM-LBTEST Please create a new test code for

Immunoblasts with a synonym
Lymphocytes, Immunoblastic.
Please also remove the synonyms
Luekemic Lymphoblasts and
Immunoblastic Lymphocytes from
BLASTLM (C74630)
SDTM-LBTEST Dilute Russell's Viper Venom Time,

Ratio
SDTM-EGTEST TECHNICAL CONDITION
SDTM-EGTEST RHYTHM
SDTM-EGTEST ECTOPY
SDTM-EGTEST CONDUCTION
SDTM-EGTEST MORPHOLOGY
SDTM-EGTEST ST SEGMENT
SDTM-EGTEST T WAVES
SDTM-EGTEST U WAVES
SDTM-EGTEST MYOCARDIAL INFARCTION
SDTM-EGTEST OVERALL BASELINE

COMPARISON
SDTM-EGTEST MAJOR ALERT
SDTM- Failure to meet randomization

NCOMPLT criteria
The definitions of the following

codes (already in production) all
use the phrase intravascular
administration: C85773-C85774,
C85797-C85798, C92403, C92405-
C92409, C92421, and C92423-
C92427.
SDTM- Aspergillus Fumigatus (M3) IgE
LBTESTCD classification; Aspergillus
Fumigatus (M3) IgE antibody;
Alternaria tenuis (M6) IgE
classification; Alternaria tenuis (M6)
IgE antibody; Bermuda Grass (G2)
IgE classification; Bermuda Grass
(G2) IgE antibody; Birch Pollen (T3)
IgE classification; Birch Pollen (T3)
IgE antibody; Cat Dander (E1) IgE
classification; Cat Dander (E1) IgE
antibody; Cockroach (I6) IgE
classification; Cockroach (I6) IgE
antibody; Dermatiphagoides farinae
(D2) house dust mite IgE
classification; Dermatiphagoides
farinae (D2) house dust mite IgE
antibody; Dog Dander (E5) IgE
classification; Dog Dander (E5) IgE
antibody; Dermatiphagoides
pteronyssinus (D1) house dust mite
IgE classification;
Dermatiphagoides pteronyssinus
(D1) house dust mite IgE antibody;
Orchard Grass (G3) IgE
classification; Orchard Grass (G3)
IgE antibody; English Plantain (W9)
IgE classification; English Plantain
(W9) IgE antibody; Timothy Grass
Pollen (G6) IgE classification;
Timothy Grass Pollen (G6) IgE
antibody; Western Ragweed (W2)
IgE classification; Western
Ragweed (W2) IgE antibody
SDTM- Vitamin K1 (also known as

LBTESTCD phylloquinone or phytomenadione
(also called phytonadione)
SDTM-LOC MUCOSA - update definition and
synonym
SDTM-LOC ORAL MUCOSA
SDTM-LOC MALE GENITALIA and FEMALE

GENITALIA - remove and replace
with generic term of GENITALIA
SDTM- PTHW - Whole Parathyroid
LBTESTCD Hormone
SDTM- BONE MARROW BIOPSY; BONE

SPECTYPE MARROW ASPIRATE
SDTM-LOC Occipital Lymph Node; Preauricular

Lymph Node; Submandibular
Lymph Node; Epitrochlear Lymph
Node; Paratracheal Lymph Node;
Pulmonary Hilar Lymph Node;
Retrocrural Lymph Node; Portal
Lymph Node; Hepatic Lymph Node;
Splenic Hilar Lymph Node;
Paraaortic Lymph Node; Mesenteric
Lymph Node; Femoral Lymph
Node; Popliteal Lymph Node;
Retroperitoneal Lymph Node;
Extranodal; Iliac Fossa; Ischiorectal
Fossa; Perianal Region;
Enteroenteric; Rectovaginal;
Rectovesicular; Enterovesicular;
Cheek; Gingiva; Floor of the mouth;
Central Nervous System; Salivary
Gland; Testis; Waldeyer's Tonsillar;
Ring; Mucosa of the lip; Skin of the
Lip; Scalp
SDTM-UNIT List of units to be added to the Unit

codelist.
SDTM-VSTEST VSTESTCD = BSAM; VSTEST =

Body Surface Area - Mosteller
Formula
SDTM-VSTEST VSTESTCD = BSAD; VSTEST =
Body Surface Area -DuBois/DuBois
Formula
SDTM-VSTEST VSTESTCD = BSAH; VSTEST =

Body Surface Area - Haycock
Formula
SDTM-VSTEST VSTESTCD = BSAG; VSTEST =

Body Surface Area - Gehan/George
Formula
SDTM-VSTEST VSTESTCD = BSAB; VSTEST =

Body Surface Area - Boyd Formula
SDTM- C86100; C86179; C86384 -

MICROORG Spelling errors
SDTM- LC/MS
METHOD
SDTM- C16268: ELDERLY (> 65) An age

AGESPAN group comprised by people 65
years of age and older. (NCI)
SDTM- C-code change. Duplicate concepts
EGSTRESC created in NCIt. C83811 changes to
C62017. C83812 changes to
C62018.
EGSTRESC created in NCIt. C71075 will change
to C35586. C71070 will change to
C35398.
EGSTRESC created in NCIt. C71028 will change
to C50540.
CDASH- Typo in spelling of
CMROUTE INTRAPERITONEAL for C38258
C78420 Concomitant
Medication Route of Administration
INTRAPERITEONEAL
SDTM-SCCD SCTESTCD has the extensible
codelist SCCD attached to it but
there is no corresponding codelist
for SCTEST. Please provide
SDTM-ACN NO ACTION TAKEN
SDTM- VSTEST = Length, VSTESTCD =

VSTESTCD LENGTH, Definition = The
measurement or distance from the
base to the top of an object.
SDTM- LBTESTCD = CLR, LBTEST =

LBTESTCD RENAL CLEARANCE, Definition =
The measured rate of drug
clearance by the kidney.
SDTM- C71051; Junctional Rhythm
EGSTRESC
SDTM- C71074; Junctional Bradycardia

EGSTRESC
SDTM- C71090; Wide QRS Tachycardia

EGSTRESC
SDTM- C71043; Ectopic Supraventricular
EGSTRESC Rhythm
SDTM- C71026; ST Segment Abnormality

EGSTRESC
SDTM- Remove Term C71063;

EGSTRESC IDIOPATHIC RIGHT BUNDLE
BRANCH BLOCK VENTRICULAR
TACHYCARDIA
SDTM-VSTEST Please remove the VSTEST,

VSTESTCD and VSUNITS
codelists from the SEND
terminology spreadsheet. This
should be done when the codelists
for CV and RE tests/codes are
added to the SEND terminology
spreadsheet, probably in Q12013.
SDTM-UNIT Duplicate Identified: C66975

(g/kg/day) is the same as C74993
(mg/g/day).
SDTM-DOMAIN Remove DC and EE
SDTM-DOMAIN SR - Survival Status
SDTM-DOMAIN OP - Ophthalmology Findings
SDTM-LBTEST In the recently released CT file

dated 2012.03.23, there are four lab
test codes codes with slightly
different definitions than the
corresponding lab test names. The
code defintions read "...cells per
unit of a biological..." while teh
name defintions read "...cells in a
biological...".
SDTM-UNIT cGY
SDTM- In the recently released CT file

LBTESTCD dated 2012.03.23, there is one lab
test codes with slightly different
synonyms than the corresponding
lab test names.
SDTM-DOMAIN Requesting to reserve a Domain
Code, "FM", for a "Fetal
Measurements" domain being
developed by the SEND Repro
team to capture prenatal body
and/or organ weights and
measurements of fetuses in
Developmental and Reproductive
Toxicology studies.
SDTM- Request to add LYMPH NODE to

SPECTYPE C78734
SDTM-LOC ISCHAIL/SACRAL PROMINENCE;

OCCIPTAL SCALP; ACHILLES
TENDON; ENDOCERVIX;
CENTRAL NERVOUS SYSTEM;
ASCITES; BILE DUCT; PELVIS
(NON-BONE); PERICARDIAL
EFFUSION; PLEURA; PLEURAL
EFFUSION; ABDOMINAL LYMPH
NODE; THORACIC LYMPH NODE;
INTERPHALANGEAL JOINT 1;
INTERPHALANGEAL JOINT
THUMB;
METACARPOPHALANGEAL
JOINT 1;
METACARPOPHALANGEAL
JOINT 2;
METACARPOPHALANGEAL
JOINT 3;
METACARPOPHALANGEAL
JOINT 4;
METACARPOPHALANGEAL
JOINT 5;
METATARSOPHALANGEAL
JOINT 1;
METATARSOPHALANGEAL
JOINT 2;
METATARSOPHALANGEAL
JOINT 3;
METATARSOPHALANGEAL
JOINT 4;
METATARSOPHALANGEAL
JOINT 5; PROXIMAL
SDTM-RACE Add UNKNOWN
SDTM- Add PERIPHERAL BLOOD

SPECTYPE
None CYSTS; COMPLEX CYST,
HEMORRHAGIC; COMPLEX
CYST, OTHER; EXTRARENAL
CYSTS; NON-CYSTIC
PARENCHYMAL
SDTM- Please add a specimen type of

SPECTYPE "Synovial Fluid"
SDTM- The long text for TSPARM of

TSPARM Pharmacological Class of
Investigational Therapy
contravenes the length of 40 stated
in the 3.1.2 IG for this var. Please
correct the text to meet this
restriction
SDTM- BONE SCAN

METHOD
SDTM- MIBG SCINTISCAN

METHOD
SDTM- PET SCAN; PET/MRI SCAN;
METHOD PHYSICAL EXAM
SDTM- BRONCHOALVEOLAR FLUID

SPECTYPE
SEND-SPEC Large Intestine, sacculus rotundus
SDTM- 1) Shorten TSPARM "Planned

TSPARM Country of Investigational Site(s)" to
"Planned Country of Investigational
Sites"; 2) Shorten
TSPARM="Pharmacological Class
of Investigational Therapy" to
something like "Pharmacological
Class of Inv Therapy"
SDTM- Synonym: Venezuela; Synonym:

COUNTRY Saint Helena
SDTM- Synonym: Saint Martin, French;

COUNTRY Synonym: Sint Maarten, Dutch
SDTM- Please remove the terminology for
AGESPAN agespan as adolescence, child ect
could be described using differing
age ranges.
SDTM-LOC Add new term Aortic Valve
SDTM- STRESS ECHOCARDIOGRAM,

METHOD INTRAVASCULAR ULTRASOUND
SDTM-DOMAIN PGx Bio-Marker (PB) - (New)

Used to list the known individual
mutations and or to associate to a
group when multiple ones are
required to confer a specific medical
condition. ; Subject Bio-Marker
(SB) - (New) Associates a
subject to a individual bio-marker
or a set of bio-markers that are
associated ; Viral Resistance (VR)
- (Change long name and use
description) - Stores the drug
resistance viral load test results
SDTM- BENIN REPUBLIC, BOLIVIA,

COUNTRY BOSNIA-HERZEGOVINA, BRUNEI,
DEMOCRATIC REPUBLIC OF THE
CONGO, FALKLAND ISLANDS,
NORTH KOREA, SOUTH KOREA,
REPUBLIC OF MACEDONIA,
SAINT HELENA, VENEZUELA,
VIETNAM
SDTM- Addition of 6 new lab tests from
LBTESTCD Boehringer-Ingelheim
SDTM-DIR C99073 and C99074 (Laterality and

Directionality)
SDTM- 12 Lead Superimposed Median

EGMETHOD Beat
SDTM-ROUTE Intracameral and Subtenon

SDTM-UNIT kg/m3 - ug/uL are present on row
3043 of the SDTM Terminology
Excel spreadsheet but should be on
their own row. There are many
more examples of this under the
codelist name = Unit
SDTM-UNIT Add "/mL" with synonym "Per

Milliliter"
SDTM-DOMAIN Change CDISC definition of

DOMAIN=QS to remove phrase
related to "validated or non-
validated diaries"
SDTM-LBTEST Lymphoblasts/Leukocytes
SDTM-LBTEST Protein C Activity

SDTM- Please create laboratory
LBTESTCD terminology for CD11A and CD11B.
CD11A: LBTESTCD = ITGAL;
LBTEST = Integrin Alpha-L
(http://ncit.nci.nih.gov/ncitbrowser/C
onceptReport.jsp?dictionary=NCI
%20Thesaurus&version=12.05d&co
de=C17372&key=1893619943).
CD11B: LBTESTCD = ITGAM;
LBTEST = Integrin Alpha M
(Reference:
http://ncit.nci.nih.gov/ncitbrowser/C
onceptReport.jsp?dictionary=NCI
%20Thesaurus&version=12.05d&co
de=C17373)
SDTM- Please add SPECTYPE of TUMOR

SPECTYPE TISSUE
SDTM- CDISC Submission Value

LBTESTCD "APPTLAS" (C102277) and CDISC
Synonym APPT-LA require
corrections
SEND- C46101: ADENOMA, C-CELL,
NEOPLASM BENIGN
SDTM-UNIT; Same code for g/day across

SDTM-PKUNIT codelists: - g/day (CODE=C67372
in UNIT codelist C71620); - g/day
(CODE=C85494 in PKUNIT codelist
C85494)
SDTM- HRMEAN (and RR, PR, QT, etc.)
EGTESTCD exists, but for the QT corrections,
there is no such *MEAN this is
strange... The problem is worse
though (if my understanding is
correct).
SDTM-EPOCH LONG-TERM FOLLOW-UP
SDTM- NOT FULFILL INCLUSION OR

NCOMPLT EXCLUSION CRITERIA
QS-CAT C102120; C102121; C102122;

C102123
New QS-C-SSRS Since Last Visit TEST
and TESTCD
SDTM- Please clarify whether UNABLE TO
EGSTRESC EVALUATE should be added as
controlled terminology. For
example, should it be added to
Codelist SDTM-EGSTRESC, i.e.
EGSTRESC=UNABLE TO
EVALUATE? Or should UNABLE
TO EVALUATE be stored as a
Reason Not Done, i.e.
EGSTAT=NOT DONE and
EGREASND=UNABLE TO
EVALUATE? Note, this question
may apply to other domains and
codelists, and not just EGSTRESC.
SDTM- Please add 'Immunofluorescence

METHOD Assay' and 'Fluorescent Antibody
Assay' as synonyms to existing
term FLUORESCENT
IMMUNOASSAY
SDTM-LBTEST Low RNA Reticulocytes; Medium
RNA Reticulocytes; High RNA
Reticulocytes
SDTM- LOWRET; MEDRET; HIGHRET

LBTESTCD
QS-MMSE C100141 - Definition

TEST
QS-MMSE C100142 - Definition

TESTCD
QS-SOAPP-R C100160 - Synonym

TESTCD
QS-QSCAT C100778 - Update NCI PT
CDISC-CLINDE C15292 - Update NCI PT

CDISC-CLINDE C80078 - Update Definition
SEND-SPEC Dried blood spot
CDISC-CLINDE C101241 - Update NCI PT
SDTM-UNIT ng/mL- Nanograms per milliliter;

pg/mL- Picograms per milliliter
SEND- A code needs to be added for

DSDECOD subjects that are euthanized
unscheduled but not moribund. The
majority of the group of subjects
may be moribund, but the decision
may be made to euthanize the
entire group, but some subjects
may not be moribund. Need
DSDECOD to cover these subjects.
SDTM-PKUNIT C85628 h*ng/mL/mg/kg;

Codelist:Â C85494 PK Parameter
Units of Measure
SDTM-PKUNIT Codelist: C85494 PK Parameter
Units of Measure
SDTM-UNIT C74993 is retired. Remove this term

from the codelist and add the
synonyms 'mg/g/day' and 'Milligram
per Gram per Day' to the existing
published term C66975.
SDTM-PKUNIT Change c-code of C85600 in the

PKUNIT codelist to C67372.
SDTM-UNIT; C73753 is being merged into
SDTM-PKUNIT C67410.
SDTM-FREQ Submission Value:Q6M; Synonym:
Every 6 months.; Definition: Every
six months.
SDTM-UNIT Submission Value: CAPLET;
Submission Value: DRIP
SDTM-LOC ILIAC CREST - This was supposed

to go in with P10. Include with P12
publication. Does not need to go
out for public review since it's
already been done.
SDTM-UNIT C66968 needs to change to

C25473.
SDTM-LOC Delete duplicate LOC value of
PERICARDIUM (code=C13005)
SDTM-LOC Attach is the file to review

codes/term for â€˜SDTM-LOCâ€™
codelist. Thanks
SDTM- CONTAMINATED
SPECCND
SDTM- Attach is the file to review

TSPARM codes/term for â€˜SDTM-
TSPARMâ€™ codelist.
SDTM-LOC code=C13005
codelist_code=C74456 Anatomical
Location PERICARDIUM =>
remove duplicate
SDTM-LOC Need ARM-RIGHT, ARM-LEFT,

THIGH-RIGHT and THIGH-LEFT
since we cannot use --LAT
(Laterality) in Events or
Interventions domains
SDTM- PERIPHERAL BLOOD
SPECTYPE MONONUCLEAR CELL
(Submission Value); PBMC
(Synonym)
New Pain Intensity, Pain Relief, General
Clinical Global Impressions need
new QS code lists. Additions to
code lists for METHOD and Trial
Summary Parameter also proposed
thru CDISC SRC.
SDTM-UNIT; For your consideration please find
SDTM- attached an Excel document
SPECTYPE; containing Â a request for
SDTM-RACE; expansion of the STDM codelist
SDTM-POS; from Boehringer Ingelheim. Please
SDTM- let me know if you have any
NCOMPLT; questions.
SDTM-
METHOD;
SDTM-LOC;
SDTM-FREQ;
SDTM
SDTM-UNIT per HPF equivalent
SDTM-LBTEST FOXp3 positive cells,

GranzymeB+/CD8+, CD68 positive
cells, CD20 positive cells, S100
protein positive cells (all counts or
percentages)
SDTM-LBTEST MUC-1 (number of MUC1 positive
cells in a tumor biopsy sample - ie
"solid" form of MUC-1)
and soluble MUC-1
SDTM- ORAL, TYMPANIC, RECTAL,
METHOD AXILLARY
SDTM- Submission Value =

NCOMPLT INTERVENTION; Synonym(s) =
Medical Intervention, Therapeutic
Intervention; Definition = Any action
that is designed to alter the course
of a disease or improve health.
SDTM-LOC C91405 - Change CDISC

Submission Value. Remove the
word 'Tissue' from the Submission
Value
SDTM-LOC C91404 - Change CDISC
Submission Value. Remove the
word 'Tissue' from the Submission
Value
SDTM-LOC C12371 - Cardiac Muscle Tissue
SDTM- DENGUE VIRUS, HEPATITIS B

MICROORG VIRUS, RESPIRATORY
SYNCYTIAL VIRUS, VARICELLA-
ZOSTER VIRUS
New Drug Susceptibility Tests
New Skin Tests
SDTM- For your consideration please find

LBTESTCD attached an Excel document
containing Â a request for
expansion of the STDM Lab test
code list from Boehringer Ingelheim.
SDTM- RCAMINTD; RCAMTAUD

PKPARM
SDTM- Attached is the file to review

SPECTYPE codes/term for 'SDTM-SPECTYPE'
and SDTM-SPECCOND codelist.
SDTM- Please add QUANTITATIVE
METHOD REVERSE TRANSCRIPTASE
POLYMERASE CHAIN
REACTION.Â
QS-C-SSRS Please update the CDISC Definition

Baseline associated with the TESTCD
TESTCD CSS0118A to Columbia-Suicidality
Severity Rating Scale Baseline -
Description of aborted attempt.
SDTM-UNIT cy/cm
Original request cy/cm. Updated by
CB 2013-11-04: Submission value
cycle/cm with a synonym as Cycle
per Centimeter
QS-UPDRS C100147 - Typo in NCI Preferred

TEST term
QS-QSCAT C100775 - Need a space between

words in definition.
QS-ADAS-Cog C100263 - Update NCI Preferred
CDISC Version Term is it matches what is in the
TESTCD Database.
QS-HAMD 17 C100408 - Remove comma after
TEST; QS- the word 'Cardiovascular' in the
HAMD 17 definition.
TESTCD
QS-QSCAT C100778 - Add an apostrophe into
the NCI Preferred Term
QS-QSCAT Codelist - C100129; Questionnaire
Category; Term - C100769; MDS-
UPDRS
QS-QSCAT Codelist - C100129; Questionnaire
Category; Terms - C102120,
C102121,C102122, C102123
SDTM-FRM C66726 Remove synonym from

codelist concept 'Pharmaceutical
Dosage Form/FRM'
SDTM- CLARITY(C96594) VS
LBTESTCD TURB(C74723)
SDTM- SITE TERMINATED BY SPONSOR

NCOMPLT
SEND- C12510
SPECIMEN
SEND- C12499
SPECIMEN
SEND- C12777
SPECIMEN
SEND- C12809
SPECIMEN
SEND-CLCAT C100104
C33318
SEND- C12298
SPECIMEN
SDTM- PRESENT, ABSENT

RSSTRESC
SEND-DDTEST DDTESTCD and DDTEST are both
listed as extensible. However, in
SEND, those fields each have one
and only one possible entry:
DEATHD and Death Diagnosis
respectively. Therefore those term
lists should be nonextensible.
MULTIPLE Update the NCI PT column to

reflect what is in NCIt database.
MULTIPLE Type I definition updates to 27
terms across multiple codelists.
SDTM-LOC; C12366 BONE
SDTM-
SPECTYPE
SDTM-LOC; C12434 BLOOD
SDTM-
SPECTYPE
SDTM-LOC; C12458 HYPOTHALAMUS
SEND-
SPECIMEN
SDTM-UNIT; C49668 cm
SDTM-
VSTRESU
SDTM-UNIT; C49671 kg/m2
SDTM-
VSTRESU
SDTM- C53262 DOMESTIC PARTNER
MARISTAT;
SDTM-EVAL
SDTM-ACN C66767 ACN
MULTIPLE Updates to multiple c-codes to

reflect NCIt database.
MULTIPLE Type I synonym updates to 13
terms across multiple codelists.
SDTM-FRM C66726 - remove synonym from
codelist term. Remove Dose Form
from synonym column.
SDTM- C85571 - Change submission value

PKPARM in PKPARM codelist only.
SDTM-DOMAIN FX Domain definition updates:

SDTM-DOMAIN Repro Domain definition updates for
IC, SJ, TP and TT.
SDTM- Create a codelist for urine dipstick

LBSTRESC results. For example, 0, +1, +2, +3,
+4 or NEGATIVE, TRACE, +1, +2,
+3, +4
SDTM- ERINT (and associated

PKPARM normalization terms): the excretion
rate over the interval from T1 to T2.
SDTM- TSPARM/TSPARMCD: Mismatch
TSPARM SDTM IG3.1.3 versus SDTM
Terminology 2012-08-03
SDTM-PKUNIT Add 2 terms: h and L.
SDTM-PKUNIT See code C67306. In the UNIT

code list ug/L is the submission
value. In the PKUNIT codelist
mg/mL is the submission value.
SDTM- FUNCTIONAL MRI (with synonym
METHOD fMRI); PHARMACOLOGICAL MRI
(with synonym phMRI)
SDTM-PKUNIT New terms for PKUNIT

SDTM- C79459 - Add a synonym
LBTEST;
SDTM-
LBTESTCD
SDTM- PK Parameters; Submission Value
PKPARM = Renal CL Norm WT / RCLW;
Synonym(s) = Renal CL Norm
WT;Definition = The renal clearance
divided by body weight.
QS-C-SSRS C100993 - CSS0113A
Baseline
TESTCD
SDTM- The name of the CCINVCTYP
CCINVCTYP codelist is 9 characters long, which
violates the convention of having
the codelist name correspond to the
8-character SDTM variable name.
Please correct the name to follow
the convention followed by ALL of
the other codelist nam
SDTM- The name of the REASTRTNA

REASTRTNA codelist is 9 characters long, which
violates the convention of having
the codelist name correspond to the
8-character SDTM variable name.
Please correct the name to follow
the convention followed by ALL of
the other codelist nam
SDTM- Should the value of

RSSTRESC "NonCR/NonPD" be in
uppercase or the value stated in
RECIST v1.1?
MULTIPLE Could you please ensure that the

definition for same codes in SDTM
Terminology?
SDTM-LOC It appears that NCI Code C13005 is
listed twice in the SDTM
terminology.
SDTM- ELASTOGRAPHY
METHOD
SDTM-LBTEST Amyloid Precursor Beta; AMYLPB
SEND- PHEOCHROMOCYTOMA,
NEOPLASM COMPLEX, MALIGNANT
SDTM- Laboratory Test Standard Character

LBSTRESC Result Codelist
SDTM-LBTEST For your consideration please find

attached a zip file containing an
Excel document containing a
request for expansion of the STDM
Lab test code list from Boehringer
Ingelheim.
SDTM-PKUNIT The following unit terms are

missing: - for time variables: h, min,
day; - for amount variables: mol,
mmol, umol, nmol (equivalent to the
existing mass units)
SDTM-LBTEST Triglyceride Lipoprotein Subfraction

with Test Code TRIGLPSF
SDTM-SCCD It appears that NCI Code C28407

has a CDISC Submission Value of
NATORIGIN that has a length of
nine(9) which exceeds the
allowable limit for the variable
SCTESTCD to which it is assigned.
SDTM- NOT DONE (synonym ND and NOT
RSSTRESC EVALUATED); irCR (synonym
IMMUNE-RELATED COMPLETE
RESPONSE); irPR (synonym
IMMUNE-RELATED PARTIAL
RESPONSE); irSD (synonym
IMMUNE-RELATED STABLE
DISEASE); irPD (synonym
IMMUNE-RELATED
PROGRESSIVE DISEASE)
None New Tumor Response (TESTCD =

NEWTUMOR)
SEND- ANESTHETIZED PERFUSION;
MHTERM CAPTIVE BOLT; Carbon Dioxide
and Exsanguination
SDTM-LBTEST Corpuscular Hemoglobin Content;

Hemoglobin Concentration
Distribution Width; Corpuscular
Hemoglobin Concentration Mean
SDTM-LBTEST Please add the test "Hepatitis

E Virus IgG Antibody". We
suggest the corresponding
LBTESTCD value
"HEIGGAB" and the
definition "A measurement of
IgG antibody to the hepatitis E virus
in a biological specimen."
SDTM-LBTEST 'Yeast Budding' = 'YEASTBUD';

'Interpretation-38-PNL' = 'EBINTP';
'HIV Ab Confirmation' =
'HIVABCON'; 'Reticulocyte Count
FC' = 'RETICFC'
SDTM-LBTEST Please add the test name
"Glucose-Dependent
Insulinotropic Peptide" to the
LBTEST list. We suggest the
corresponding LBTESTCD value of
"GDIP". A synonym is
"Gastric Inhibitory
Polypeptide" or
"GIP".
SDTM- PLATELET RICH PLASMA
SPECTYPE
None inconsistency for keyword

unplanned
QS-HAMD 21 C102107; C102109

TEST
SDTM-LOC Please add CORPUS CALLOSUM

to the anatomical location codelist.
QS-QSCAT C100761 - Update the BPRS-A

reference.
SDTM-EQ5D3L SDTM-EQ5D3L TEST/CD; MMSE

TEST/CD; TEST/CD: NPI TEST/CD; SF36
MMSE V1.0 Standard TEST/CD
TEST/CD: NPI
TEST/CD;
SF36 V1.0
Standard
TEST/CD
SDTM-LOC INTERNAL MAMMARY LYMPH

NODE
SDTM-LBTEST Modify Definition C96652
SDTM-DOMAIN The FF domain code (Fetal

Findings) can be retired/released.
This domain will be replaced with
the FM domain code (Fetal
Measurements).
SDTM-LBTEST Inclusion Bodies, Cytoplasmic
(INCLBDC); Calprotectin
(CALPTCTN); ALT/AST (ALTAST)
None codelist_code=C66734 (DOMAIN),

TR and TU are now release domain
in SDTM IG 3.1.3 but not listed as
cdisc submission value. could you
add them?
SDTM-DOMAIN RS (code=C102722). The synonym

value should be Disease Response
as in SDTM IG 3.1.3 and not Tumor
Response. Tumor Response is for
TR domain.
SEND-STRAIN NIH MINIPIG
SEND-STRAIN LEWIS
SEND-STRAIN SUFFOLK
SEND-STRAIN SWISS WEBSTER

SEND-STRAIN FROG
SEND-SPEC FLUID, PLEURAL
SEND-SPEC FLUID
SDTM- C code C98862 APTTSTND and

LBTESTCD C100421 APTTSPTT seem to be
representing the same test concept.
Please consider removing one of
these from the published
terminology or make definitions
more clear
SDTM- Enzymatic Units

LBTESTCD
MULTIPLE I'm going to send through aa

attachment via email of various
terminology requests.
SDTM-AEOUT This request is to add the term
WORSENING to the Outcome of
Event codelist (AE OUT)
QS-HAMD1 C100410
SDTM- C81255
VSTEST/CD
Change
Detailed Description Final Outcome
Type
The ratio of apolipoprotein B/apolipoprotein A-1 can provide III SDTM, SEND-Published in P12
an estimate of the relative risk for coronary atherosclerotic
disease.
Please update the term '10^3 Organisms' in the Unit codelist I SDTM, SEND-Published in P10
to '10^3 organisms'. Having organisms start with a lower case
o is consistent with the other terms in the Unit codelist.
Please update the term '10^ 3 CFU/g' in the Unit codelist to I SDTM, SEND-Published in P10
'10^3 CFU/g'. Removing the space between the ^ and the 3
is consistent with the other terms in the Unit codelist
Please add the term 'APPLICATION' to the Unit codelist. III SDTM, SEND-Published in 11
Application is for use with a drug and the unit associated with
it.
Please add the unit 'CAPFUL' to the Unit Codelist. This unit is III SDTM, SEND-Published in 11
used in our clinical trials when administering a drug that is
measured out by the amount from the bottle cap.
Please update the term 'LOTION. AUGMENTED' in the I SDTM-Published in P9
Pharmaceutical Dosage Form codelist to 'LOTION,
AUGMENTED'. Having a comma rather than a period is
consistent with the other terms in the Pharmaceutical Dosage
Form codelist.
Please update the synonym for LBY from Libya Arab II SDTM, SEND-Published in P12
Jamahiriya to Libya. This update is based on the name
change on the ISO 3166-1 Newsletter VI-11 issued on 11-08-
2011.
For your consideration please find attached an Excel III SDTM, SEND-Published in P17,
document containing requests for expansion of multiple P19; Do not add (SDTM-P17,
STDM codelists from Boehringer Ingelheim: SDTM-P18): See Requests Denied
Spreadsheet
make terms consistent with other term I SDTM, SEND-Published in P10
to be consistent I SDTM,SEND-Published in P10

I'm struggling to use the SDTM terms defined for Antibodies. I
This is because I'm not sure if they are intended to be used
for all the different types of antibody result data or not. As an
example, for Epstein Barr IgG, I have 3 different types of
quantitative results: IgG Strength of Signal in units of INDEX
and ISR or unit is null; IgG Titer in a unit of TITER or unit is
null; IgG concentration in a unit of U/ML; as well as a
qualitative result usually represented as
POS/NEG/EQUIVOCAL. At GSK we have each of these
stored as a different test because we would never want to
combine the results. Should all of these results be stored in
the SDTM LBTESTCD of EBCIGMAB (Epstein-Barr Capsid
IgM Antibody)? Sometimes the units are not provided as the
results are a calculated figure and titer is not a 'real' unit. For
qual results there will be no unit. I'm not happy providing all
these different types of results to the FDA under the one
EBCIGMAB code. I'd apreciate your thoughts since this is
obviously a big issue given all the antibody tests we have.
Many thanks
This draft domain was reviewed in the SDS team and is III SDTM-Published in P14
being scheduled to go out for public review. I have provided
a list of proposed RDTESTCD & RDTEST terminology based
on legacy data provided during the domain development to
Chris Tolk. Chris asked that this request be tracked via the
New Term Request Form. Chris has this terminology
spreadsheet and will include it on the terminology review
schedule.
We recently began collecting this information for some III SDTM, SEND-Published in P12
studies on our vital sign page.
We recently began collecting this information for some III SDTM, SEND-Published in P12
studies on our vital sign page.
List of 43 Microorganism terms sent to Chris Tolk III

Our company primarily develops insulin formulations, most of III
the time the formulation is administered subcutaneously with
syringes. These are injections as they are administered over
a few seconds. We have also had some studies where the
formulation is administered subcutaneously via insulin pump.
The subject may get a bolus infusion (10 seconds to 1 min or
more depending on the type of infusion pump) and also a
basal (continuous infusion). While these are both
subcutaneous, there is a significant difference between pump
use and syringe use in safety and efficacy. The problem is
that there isn�t a good way to distinguish between the two
routes/methods. Currently, insulins administered by pump
are often given a route of SC and other times Other (with
other specify via pump) so it makes it difficult to easily find
such records. I have reviewed SDTM implementation
guideline (3.1.2) for EX and CM and don�t find any
reasonable alternatives. I also reviewed the CDISC Public
Discussion Forum to see if there were any relevant
discussions and I didn�t find any. At a previous company,
we had narcotic analgesics that were administered as SC
PCA so I don't believe the term applies only to insulin pumps.
Our company is also developing a glucagon formulation that
will be delivered by SC pump and we need to distinguish this
route from IV or even SC.
I have reviewed the ROUTE Codelist (C66729) but do not
find an appropriate term. It seems like there should be a
standardized code. We propose that a term like
SUBCUTANEOUS PUMP INFUSION be added to the
standard dictionary. This does not seem unreasonable as
there are three codes for intravenous (INTRAVENOUS,
INTRAVENOUS BOLUS, INTRAVENOUS DRIP).
Two terms in the SDTM NEOPLASM codelist (C88025) have II

the same Synonym, even though the terms have unique
Submission Values. Terms are "GRANULOSA CELL
TUMOR, MALIGNANT" (C4205) and "GRANULOSA CELL
TUMOR, UNDETERMINED" (C3070). They both have the
same Synonym of "GRANULOSA CELL NEOPLASM". Is this
intentional? It seems unusual and against principles of
uniqueness across terms.
Please add the term Oxygen Saturation to the Vital Signs III
Test Name codelist and OXYSAT to the Vital Signs Test
Code codelist. This term differs from Oxygen Saturation in
the Laboratory Test Name codelist by utilizing a pulse
oximeter to measure the amount of oxygen saturation in the
blood.
C68858 for scm and C42570 for m3. But m3 is also a II SDTM, SEND-Published in P12
synonym for scm. I realise that one is related to volume and
the other is more specific to a gas. But I wonder if this was
intended?
The synonym for C67396 - ug/kg is 'mcg/kg; Microgram per I SDTM, SEND-Published in P9
Kilogram; ng/g; ug/k'. Shouldn't this last synonym be ug/kg?
The CDISC definition for mL/g/day is 'Liters per kilogram per II

day'. � Shouldn�t this be Milliliter per Gram per Day?
What�s there now belongs to a synonym.
Please add a test code and term for albumin expressed as a III SDTM, SEND-Published in P12
percentage of total protein.
Please consider adding synovial fluid to the specimen types III

code list. It is a common specimen used in clinical
laboratories to check for gout, joint infections,
injury/hemorrhage in joint areas, etc. CDISC definition for
synovial fluid from Anatomical Locations code list is as
follows: A viscid fluid secreted by the synovial membrane,
serving as a lubricant. (NCI) Synonym: JOINT FLUID. Thank
you.
III SDTM, SEND-Published in P11
1. Device Identifiers (DI): This is a special-purpose domain III SDTM, SEND-Published in P11
designed for the submission of information that identifies a
specific device unit. The primary purpose of this domain is to
provide a consistent sponsor-defined variable (UDEVID) for
linking data across Device domains. 2. Device Properties
(DO): The Device Properties special-purpose domain is used
to report characteristics of the device that are important to
include in the submission, do not vary over the course of the
study, but are not used to identify the device. Examples
include expiration date or shelf life. 3. Device-In-Use (DU):
Device in Use is a Findings domain that contains the values
of measurements and settings that are intentionally set on a
device when it is used and may vary from subject to subject
or other target. These are characteristics that exist for the
device, and have a specific setting for a use instance. 4.
Device Exposure (DX): Device Exposure is an Interventions
domain records the details of a subject’s exposure to a
medical device under study. Examples include but are not
limited to stents and drug delivery systems. 5. Device Events
(DE): Device Events is an Events domain that contains
information about various kinds of device-related events,
such as malfunctions. A device event may or may not be
associated with a subject or a visit, and device malfunctions
may or may not be associated with adverse events. 6.
Tracking and Disposition (DT): The Device Tracking and
Disposition domain is an Events domain that represents
records of tracking events for a given device. These could
include initial shipment, deployment, return, and destruction.
7. Device-Subject Relationship (DR): The Device-Subject
Relationship domain is a special-purpose domain that links
each subject to device(s) to which they may have been
exposed. This domain provides a single, consistent location
to find the relationship between a subject and a device.
Please add the terms 'OROPHARYNX' and III SDTM-Published in P12
'RECTOSIGMOID' to the Anatomical Location codelist.
OROPHARYNX definition: The portion of the pharynx that
lies posterior to the mouth; it is continuous above with the
nasopharynx via the pharyngeal isthmus and below with the
laryngopharynx. (Source:
http://www.medilexicon.com/medicaldictionary.php).
New Definition: The anatomic site at which a material such as II

a tissue, graft, device or radioactive material is inserted with
some intended degree of permanence. This term may also
refer to the site of the uterus at which the early embryo is
attached.
This is a new domain being implemented for Animal III SDTM, SEND-Published in P11
Reproductive Toxicology studies.
The synonym and definition is switched for the terms I SDTM-Published in P9, P12
THYROID GLAND, LEFT LOBE and THYROID GLAND,
RIGHT LOBE. Update as follows: THYROID GLAND, LEFT
LOBE; Synonym - change from Right Thyroid Gland Lobe to
Left Thyroid Gland Lobe. Definition - change from The cone-
like lobe of the thyroid gland that is located in the right side of
the trachea. to The cone-like lobe of the thyroid gland that is
located in the left side of the trachea.
Requesting to reserve two new domain codes for Repro Tox III SDTM, SEND-Published in P11
studies: FF = Fetal Findings (Individual fetal examinations
and measurements) and PA = Pairing Events (The pairing
event records during cohabitation for the fertility component
of a study).
These domains might be used for SEND as well. III
Please consider adding Metabolic Ratio as an urgent addition III

to the codelist as we cannot see this referenced but report
this frequently
I would like background information and rationale for the III
outcome terms chosen by CDASH. Other than 'Fatal' and
'Unknown' the others are very ambiguous. We run
Alzheimer's clinical trials and currently, we use following
terms: Ongoing, Resolved, Resolved with Sequalae, Death,
Unresolved and Unknown. After much consideration, it was
determined that these terms best captured all of the various
scenarios that have occurred in our other studies over the
past 15 years. Is there a "rule" or timeframe that fields and
variables much match exactly those that CDISC has
established? I would greatly appreciate a response or contact
information of someone that can answer my questions.
Thank you.
logCFU III
Direct Nucleic Acid Amplification III
Needed for TB standard III
The reason for the request is to clarify that the subject's II SEND-Published in P12
accidental death may have either been directly caused by the
accident (e.g., escaped found dead, intubation accident) or a
decision was made to sacrifice the subject after the mishap
(e.g., escaped sacrifice). And to broaden "mishap" to include
operational or technical error that caused the removal of the
animal from the study.
Biopsy is the removal and examination, usually microscopic, III

of tissue from the living body, performed to establish precise
diagnosis.
RS Response (RS Definition: The RS domain represents the III SDTM, SEND-Published in P11,
response evaluation determined from the data in TR (Tumor P14
Results).
Wrong coding occurred with first publication of this term. I SDTM, SEND-Published in P10
Remove: DIGUGLIELMO'S DISEASE; DIGUGLIELMO'S II

SYNDROMA; DI GUGLIELMO'S DISEASE; DI GUGLIELMO
DISEASE
C25748: The capacity of iron-binding protein in serum III
(transferrin) to bind serum iron. CDISC C74718: A
measurement of the amount of iron needed to fully saturate
the transferrin in a serum specimen. Compare these two
terms to determine if they should stay separated or need to
be merged and a new c-code assigned to the CDISC
concept.
Wrong coding occurred with first publication of this term. I SDTM, SEND-Published in P10
Please add synonyms of "(ng/mL)/(mg/kg)" and III

"kg*ng/mL/mg". This may help mapping efforts, where the
units have not been condensed.
Please add synonyms of "(ng*hr/mL)/(mg/kg)" and III
"hr*kg*ng/mL/mg". This may help mapping efforts, where the
units have not been condensed.
DRUG WITHDRAWN is the closest synonym but it is not III
accurate for use in devices where no drug is given.
Wrong coding occurred with first publication of this term. I SEND-Published in P11
Coding updated in our DB to be more precise.
TSPARMCD=FCNTRY TSPARM=Planned Country of II
Investigational Site(s). TSPARMCD=PCLAS
TSPARM=Pharmacological Class of Investigational Therapy.
TS domain - TSPARM variable is limited to 40 characters (cf
CDISC Notes).
There are currently two codelists with the same short name, II
TOXGR, but different codelist codes and different values in
the codelists. This is a violation of basic CT key structure.
CDISC has a codelist for SCTESTCD called SCCD. We need III SDTM-Published in P12
a corresponding codelist for SCTEST (the decode of
SCTESTCD). This should have been done when SCCD was
created but apparently was overlooked. Additionally, SCCD
should be renamed to SCTESTCD if at all possible to be
consistent with other SDTM TESTCD/TEST codelists.
Certain AEs related to chronic diseases (e.g., emphysema, III

Alzheimer�s disease, AIDS, diabetes, etc.) can not be
expected to ever completely resolve. We would like a way to
represent this other than reporting these AEs as "NOT
RECOVERED/NOT RESOLVED". Such an outcome does
not seem applicable to these types of AEs. Being able to
report these AEs as "STABILIZED" would be in line with
regulatory requirements to follow AE until resolution or
stabilization.
II
Please amend the TSPARM value for TSPARMCD=FCNTRY II

from Planned Country of Investigational Site(s) to Planned
Country of Investigational Site as this currently exceeds the
accepted 40 character ruling specified in the IG
alpha-Tocopherol is an important lipid-soluble antioxidant. It III SDTM, SEND-Published in P12

is especially measured during clinical development of
treatment of hypercholesterolemia.
As per NCI definition of gastric - Relating to the stomach. II
Please consider adding term "PERITONEAL CAVITY" to the III SDTM-Published in P12
Anatomical Locations Codelist. This term would be more
specific to the area of the body that fills with fluid,
inflammatory cells, and pus when the peritoneum becomes
infected. Thank you
Please consider adding term "PERICARDIAL CAVITY" to the III SDTM-Published in P12
Anatomical Locations Codelist. This term would be more
specific to the space between the layers of the pericardium
that contains fluid that lubricates the membrane surfaces and
allows easy heart movement. Thank you.
This is not consistent with the way other LBTESTCD/LBTEST II

values are defined.
Incorrect coding. Need to assign a new code to the CDISC I SDTM-Published in P11
content that describes a treatment Epoch and not the
'treatment' itself.
Please consider adding "Vitreous humor" as a term to the III SDTM-Published in P12
Specimen Types codelist. Synonyms are "Vitreous fluid" and
"Vitreous synchysis". Definition: The clear colorless
transparent jelly that fills the posterior chamber of the eyeball.
(WordNet) Thank you. Best Regards, Anna Pron-Zwick/21-
Mar-2012
The ratio of vitamin E/ (TC + TG) can provide an evaluation III

of serum alpha-tocopherol (vitamin E) in terms of a lipid ratio
The ratio of vitamin E/ TC is now the preferred measure of III SDTM, SEND-Published in P12
vitamin E status. Its use prevents the overestimation of
vitamin E deficiency and permits comparison between groups
unit necessary for new lab test (requested) ratio vitaminE/TC III
and for ratio vitaminE/(TC+TG)
Tanner score provide a staging sexual maturity score III
Please consider adding "Abdominal Wall" to the Anatomical III SDTM-Published in P12
Locations codelist. MeSH Definition: The outer margins of the
ABDOMEN, extending from the osteocartilaginous thoracic
cage to the PELVIS. Though its major part is muscular, the
abdominal wall consists of at least seven layers: the SKIN,
subcutaneous fat, deep FASCIA; ABDOMINAL MUSCLES,
transversalis fascia, extraperitoneal fat, and the parietal
PERITONEUM. Thank you. Anna Pron-Zwick/22-Mar-2012
Please consider adding the term "Clitoris" to the Anatomical III SDTM-Published in P12
Locations codelist. CDISC Definition: The erectile tissue in
the vulva. It is composed of the corpora cavernosa and the
glans clitoris. Synonym could be Clitoral structure. Thank
you. Anna Pron-Zwick/22-Mar-2012
Please consider adding the term "Fat tissue" as a synonym to II

existing CDISC SDTM LOC term "Adipose tissue". Thank
Please consider adding the term "Lacrimal glands" to the III SDTM-Published in P12
Anatomical Locations codelist. CDISC Definition: Paired,
almond-shaped exocrine glands situated superior and
posterior to each orbit of the eye that produce and secrete
the watery serous component of tears. (NCI). Synonyms
could be Lacrimal gland structure and Tear gland. Thank
Please consider adding the term "Lymphatic gland" as a III SDTM-Published in P12
synonym to existing CDISC SDTM LOC term LYMPH NODE
(C12745). Thank you. Anna Pron-Zwick/22-Mar-2012
The most direct diagnostic method for cystinosis is III SDTM, SEND-Published in P13
measurement of leukocyte cystine
This unit is the current unit for measurement of leucocyte III

cystine (WBC cystine)
Please consider adding the term "Mammary gland" to the III SDTM-Published in P12
CDISC SDTM Anatomical Locations codelist. MeSH
Definition: "Glandular tissue in the BREAST of human that is
under the influence of hormones such as ESTROGENS;
PROGESTINS; and PROLACTIN. In WOMEN, after
PARTURITION, the mammary glands secrete milk (MILK,
HUMAN) for the nourishment of the young." Synonyms could
be Mammary glands and Lactiferous glands. Thank you.
Anna Pron-Zwick/23-Mar-2012
Please consider adding term "Mesentery" to the Anatomical III SDTM-Published in P12
Locations codelist. MeSH Definition: A layer of the
peritoneum which attaches the abdominal viscera to the
abdominal wall and conveys their blood vessels and nerves.
Synonym could be "Mesenterium". Thank you. Anna Pron-
Zwick/23-Mar-2012
Please consider adding the term "Cranial Nerves" to the III SDTM-Published in P12
Anatomical Locations codelist. MeSH Definition: Twelve pairs
of nerves that carry general afferent, visceral afferent, special
afferent, somatic efferent, and autonomic efferent fibers.
Synonyms could be Nervus cranialis and Nerve, cranial.
Thank you. Anna Pron-Zwick/23-Mar-2012.
Please consider adding the term "Pineal gland" to the III SDTM-Published in P12
Anatomical Locations codelist. MeSH Definition: A light-
sensitive neuroendocrine organ attached to the roof of the
THIRD VENTRICLE of the brain. The pineal gland secretes
MELATONIN, other biogenic amines, and neuropeptides.
Synonym could be Glandula pinealis. Thank you. Anna Pron-
Zwick/23-Mar-2012.
Please consider adding the following terms and possible III SDTM-Published in P12
synonyms to the Anatomical Locations codelist: Preputial
gland (Synonyms are Glands of Tyson and Parafrenal
glands), Salivary glands (Synonym is Glandula salivaria),
Sebaceous glands (Synonym is Glands of Zeis), Sweat
glands (Synonym is Sudoriferous gland). Thank you. Anna
Pron-Zwick/23-Mar-2012
It is worth considering whether 2 additional classes: Trial III SDTM-Published in P12

Design, and RELATIONSHIP should be included.
A test for the recent use of Ecstasy (3,4- III SDTM, SEND-Published in P12
methylenedioxymethamphetamine)
Ecstasy III SDTM, SEND-Published in P12
N-acetyl-beta-D-glucosaminidase is not defined. The II SDTM, SEND-Published in P12

abbreviation for N-acetyl-beta-D-glucosaminidase is
commonly NAG, however, CDISC uses NAG as the
abbreviation for N-Acetyl Glucosamide which causes
confusion.
The abbreviation for N-acetyl-beta-D-glucosaminidase is II

commonly NAG, however, CDISC uses NAG as the
abbreviation for N-Acetyl Glucosamide which causes
confusion.
The below two items have been added. Therefore, this III
finding should be included as well:- NEW EXTENSIVE
ANTERIOR MYOCARDIAL INFARCTION - OLD OR AGE
INDETERMINATE EXTENSIVE ANTERIOR MYOCARDIAL
INFARCTION. Definition:A necrosis of the myocardium, as a
result of an occlusion of the left anterior descending coronary
artery and interruption to the blood supply intraventricular
septum, anterior wall, and anterolateral wall.
Overall Evaluation of ECG is one of key information in ECG III SDTM, SEND-Published in P15
data. Definition: Normal - An ECG with normal interval
duration measurements and without abnormal morphologic
findings. Abnormal - An ECG with one or more abnormal
interval duration measurements and/or abnormal
morphologic findings. Unable to Evaluate - An ECG which
cannot be fully evaluated by a cardiologist due to technical
issues.
This is a finding for Abnormal ECGs, where as PREMATURE III

ATRIAL COMPLEXES can be found in Normal ECGs.
Definition: 4 or more atrial premature complexes.
This is a finding for Abnormal ECGs, where as PREMATURE III

VENTRICULAR COMPLEX can be found in Normal ECGs.
Definition: 3 or more ventricular premature complexes.
This is a new item to indicate Abnormal ECGs with Abnormal III

U WAVES. Currently there is 'U WAVES' but the meaning is
not clear as all ECGs have U waves. Definition: Presence of
abnormal U waves with are defined as u waves which
approximate or exceed the height of a normal T wave, merge
with the T wave, or are negative.
The CDASH-E2B team proposes the use of the abbreviation III

“SAE” for a new Serious Adverse Event CDASH domain for
the several reasons: SAE data are not submitted as SDTM
data sets but rather as part of the clinical study report and the
integrated summary of safety and initial case safety report
(ICSR) by drug safety and according to rules and timeframes
dictated by regulation. SAE is commonly understood to
mean Serious Adverse Event. Using a three-letter code will
make it easier to differentiate from the domains that form the
submitted clinical domains. This being the case we request
that the terminology team review this proposal.
Second synonym is incorrect. Possible copy/paste error. II
TOXGR is defined twice: once = under codelist_code II SDTM-Published in P12

C66784 and once under codelist_code C87162. One with
code 0 to take into account the absence scenario. If two lists
are kept, would it be possible to have two different names?
One code with several CDISC definitions. Agree on one. II SDTM, SEND-Published in P13
A comparison was run between SEND synonyms and NCI II SEND-Published in P12
synonyms and some changes are suggested. The file
contains 36 suggested changes to include removal of
synonyms and spelling errors.
Please add the term mL/s to the Unit Codelist with the III SDTM, SEND-Published in P12
synonym mL/sec and the definition of 'milliliter per second'.
Remove tissue-specific terms from the Anatomical location II SDTM-Published in P13

codelist as this is a mis-use of the LOC codelist. Should use
SPECTYPE codelist value of TISSUE.
In more recent clinical trial studies, collection of exploratory III
research is being conducted/collected. At present, specific
CDSIC SDTM CT does not exist to collect such information
within the SDTM Trial Summary (TS) domain. In addition, a
secondary CT list could be created as an "Other" objective
designation for any remaining information not represented in
the aforementioned.
Echocardiogram information is usually migrated into standard III

SDTM Electrocardiogram (EG) domain or, in certain cases,
placed into a custom domain. It would be beneficial to have a
designated Echocardiogram domain and associated
CodeList, indifferent of ECG/EKG data.
At present, Domain Abbreviation does exist within the CT, but III
it's not necessarily utilized for Domain Description (i.e. its
synonymy). Moreover, many sponsors have utilized
differentiating domain descriptors within their submissions. It
would be highly beneficial to maintain some form of
consistency with domain descriptions being submitted to the
agency. Note: CT to be created for all known/reserved
domains only.
Provided are 6 specimen types that I believe can be added to III SDTM-Published in P12
the SPECTYPE code list to promote consistent usage across
the industry
Proposed new definition: The anatomic site at which a II SEND-Published in P12

material such as a tissue, graft, device or radioactive material
is inserted with some intended degree of permanence. This
term may also refer to the site of the uterus at which the early
embryo is attached.
Routinely, the percent body fat is collected in our trials. III

There is nothing in the controlled terminology currently that is
equivalent to this choice. Other options would be FAT
INDEX or FAT PERCENT rather than BODY FAT.
Other choices are BEFORE, DURING, DURING/AFTER, III P14 - do not add. Do not add. Team
AFTER, etc. It seems reasonable that a choice of could not determine the context for
BEFORE/DURING is needed. how this would be used and nothing
provided by requester.
We use this to determine if the subject is of childbearing III P14 - do not add. Codelist is
status at the time of study entry and store in the SC domain. extensible and sponsors can use
Note: The SCCD codelist will become a long list over time their own CT for this purpose.
and will be difficult to control across sponsors. We suggest CDISC will not add this as a
that this codelist should not be a CDISC SDTM controlled controlled term to the CDISC
terminology, or that it is allowed to be extensible by the codelist.
sponsors.
We use this to help determine if the country allows collection III P14 - do not add. Codelist is
of subject initials and store the answer in the SC domain. extensible and sponsors can use
sponsors.
We store the subject initials in the SC domain when they are III P14 - do not add. Codelist is
allowed to be collected. Note: The SCCD codelist will extensible and sponsors can use
become a long list over time and will be difficult to control their own CT for this purpose.
across sponsors. We suggest that this codelist should not be CDISC will not add this as a
a CDISC SDTM controlled terminology, or that it is allowed to controlled term to the CDISC
be extensible by the sponsors. codelist.
We use this to help determine the source of subject referral. III P14 - do not add. Codelist is
Note: The SCCD codelist will become a long list over time extensible and sponsors can use
and will be difficult to control across sponsors. We suggest their own CT for this purpose.
that this codelist should not be a CDISC SDTM controlled CDISC will not add this as a
terminology, or that it is allowed to be extensible by the controlled term to the CDISC
sponsors. codelist.
We store whether or not the subject was receiving regular III P14 - do not add. Codelist is
maintenance oral corticosteroids at the time of study entry in extensible and sponsors can use
the SC domain. Note: The SCCD codelist will become a long their own CT for this purpose.
list over time and will be difficult to control across sponsors. CDISC will not add this as a
We suggest that this codelist should not be a CDISC SDTM controlled term to the CDISC
controlled terminology, or that it is allowed to be extensible by codelist.
the sponsors.
We store whether or not the subject displays clinically III P14 - do not add. Codelist is
significant exacerbations requiring systemic corticosteroid extensible and sponsors can use
treatment at the time of study entry in the SC domain. Note: their own CT for this purpose.
The SCCD codelist will become a long list over time and will CDISC will not add this as a
be difficult to control across sponsors. We suggest that this controlled term to the CDISC
codelist should not be a CDISC SDTM controlled codelist.
terminology, or that it is allowed to be extensible by the
sponsors.
We store the end date of the most recent asthma III P14 - do not add. Codelist is
exacerbation relative to study entry in the SC domain. Note: extensible and sponsors can use
The SCCD codelist will become a long list over time and will their own CT for this purpose.
be difficult to control across sponsors. We suggest that this CDISC will not add this as a
codelist should not be a CDISC SDTM controlled controlled term to the CDISC
sponsors.
We store whether or not the subject has a history of atopy at III P14 - do not add. Codelist is
study entry in the SC domain. Note: The SCCD codelist will extensible and sponsors can use
become a long list over time and will be difficult to control their own CT for this purpose.
across sponsors. We suggest that this codelist should not be CDISC will not add this as a
a CDISC SDTM controlled terminology, or that it is allowed to controlled term to the CDISC
be extensible by the sponsors. codelist.
We store whether or not the subject is using long acting B2 III P14 - do not add. Codelist is
agonists at the time of study entry in the SC domain. Note: extensible and sponsors can use
sponsors.
We store whether or not the subject is taking oral III P14 - do not add. Codelist is
corticosteroid medication at the time of study entry in the SC extensible and sponsors can use
domain. Note: The SCCD codelist will become a long list their own CT for this purpose.
over time and will be difficult to control across sponsors. We CDISC will not add this as a
suggest that this codelist should not be a CDISC SDTM controlled term to the CDISC
the sponsors.
We store whether or not the subject is taking regular inhaled III P14 - do not add. Codelist is
corticosteroid medications at the time of study entry in the SC extensible and sponsors can use
domain. Note: The SCCD codelist will become a long list their own CT for this purpose.
over time and will be difficult to control across sponsors. We CDISC will not add this as a
suggest that this codelist should not be a CDISC SDTM controlled term to the CDISC
the sponsors.
We collect the date of diagnosis of asthma at study entry and III P14 - do not add. Codelist is
store the response in the SC domain. Note: The SCCD extensible and sponsors can use
codelist will become a long list over time and will be difficult their own CT for this purpose.
to control across sponsors. We suggest that this codelist CDISC will not add this as a
should not be a CDISC SDTM controlled terminology, or that controlled term to the CDISC
it is allowed to be extensible by the sponsors. codelist.
We collect the highest level of education of the subject at the III P14 - do not add. Codelist is
time of study entry and store in the SC domain. Note: The extensible and sponsors can use
SCCD codelist will become a long list over time and will be their own CT for this purpose.
difficult to control across sponsors. We suggest that this CDISC will not add this as a
sponsors.
We collect the level of exercise participation of the subject at III P14 - do not add. Codelist is
the time of study entry and store in the SC domain. Note: extensible and sponsors can use
sponsors.
We collect the number of biological brothers of the subject at III P14 - do not add. Codelist is
study entry and store in the SC domain. Note: The SCCD extensible and sponsors can use
We collect the diameterl of psoriatic target lesion of the III P14 - do not add. Codelist is
subject at the time of study entry and store in the SC domain. extensible and sponsors can use
sponsors.
We collect the classification of functional status of the subject III P14 - do not add. Codelist is
at the time of study entry and store in the SC domain. Note: extensible and sponsors can use
sponsors.
We collect the number of biological brothers of the subject at III P14 - do not add. Codelist is
study entry and store in the SC domain. Note: The SCCD extensible and sponsors can use
Incorrect mapping occurred. NEURAL CREST TUMOR, II SDTM, SEND-Published in P12

UNDETERMINED was incorrectly mapped to
Neuroendocrine Neoplasm in NCIt. It should be mapped to
Neuroblastic Tumor C6963. The synonyms were associated
with C3809, hence are not valid synonyms.
Remove cell-specific information from the definition. CD III SDTM, SEND-Published in P12
proteins can be expressed on other cell types than T and B
cells. Cell type information should go into SPECTYPE.
Please add Lysergic acid diethylamide as a new term to the III
SDTM Laboratory Test Name/Code codelists. Consider
adding LSD as a synonym. This is considered a drug of
abuse. Thank you. Anna Pron-Zwick/25-Apr-2012
Request for new term to allow for studies in which study drug III
is supplied to subjects until such time as the product is
available commercially (e.g., compassionate use studies).
Proposed definition: �An indication that the study participant
will begin receiving commercially available study drug.�
CDISC submission value for BIOAVAILBILITY misspelled, I SEND-Published in P11

should be BIOAVAILABILITY
Requesting new term SUMPROD, representing Sum of the III

Products of the Perpendicular Diameters.
Requesting new term to capture tumor results represented as III
Sum of Products of Perpendicular Diameters
on behalf of the Baxter Clinical Data Management Group I’m III

sending you a request for the addition of several
Questionnaire Terminology Test Codes (QSTESTCD), Test
Names (QSTEST), Categories (QSCAT) and Subcategories
(QSSCAT). See attached spreadsheet for questionnaires.
Since we put a lot of effort in defining this Test Codes and
Names we would highly appreciate, if they could be added to
the QS Terminology. Note: For the HAEM-A-QOL and
HAEMO – QOL Questionnaires I’ve added also the question
text as provided on the questionnaire to make it easier to link
the Test Codes and Names to the original question. Please
let me know if you need anything else (e.g. annotated
questionnaires). I would be more than happy to provide you
with this.
Already have Direct Coombs Test in controlled terminology III

for LAB; however, need Coombs test and Indirect Coombs
Test as well. Thank you. Anna Pron-Zwick/30-Apr-2012
Add new code list for severity with the terms, mild, moderate, III P15 - do not add.
severe. The AESEV because the terms are coded to: Mild
Adverse Event, etc.
Remove domain code ST = Stress test. Stress test data goes III
into the new CV domain.
I sent a mail about the RACE and ETHNIC code lists to Chris III SDTM-Published in P13
Tolk. Her reply was: "I will work with the Controlled
Terminology group to change the extensibility of the 2
codelists".
I sent a mail about the RACE and ETHNIC code lists to Chris III SDTM-Published in P13
Tolk. Her reply was: "I will work with the Controlled
Terminology group to change the extensibility of the 2
codelists".
Please consider adding Oromucosal as a route of III SDTM, SEND-Published in P12
administration to CDISC Controlled Terminology. As per NCI
and SNOMEDCT Definition: Oromucosal is an oral route that
begins on the moist tissue lining the oral cavity. Thank you.
Anna Pron-Zwick/03-May-2012
The new term needs to be included in SEND. Source = NCI; III
Type = SY; NCI Code = C67244; NCI Terminology =
Thousand Cells per Microliter
The new term needs to be included in SEND. Source = NCI; III
Type = SY; NCI Code = C67251; NCI Terminology = Million
Cells per Microliter
Source = CDISC; Type = SUBV; NCI Code = C96599; NCI III
Terminology = A unit of measure equal to one milligram of
urobilinogen per deciliter.(CDISC DEFINITION)
QD and /day are the same concept. We will need to change II

the c-code in the UNIT codelist from C66968 to C25473. The
definition of the term in the unit codelist will also change from
'A frequency rate of occurrences of something within a period
of time equal to twenty-four hours. (NCI)' to 'Occurring or
done each day.' Add the synonym Daily to the unit codelist
for this term.
Addition of a new synonym Per Day. II SDTM, SEND-Published in P13
Please create a new test code for Immunoblasts with a II; III
synonym Lymphocytes, Immunoblastic. Please also remove
the synonyms Luekemic Lymphoblasts and Immunoblastic
Lymphocytes from BLASTLM (C74630)
Please consider adding "Dilute Russell's Viper Venom Time, III

Ratio" to CDISC Controlled Terminology. Rationale: CDISC
already has LBTEST Dilute Russell's Viper Venom Time;
however after performing the DRVVT, frequently the test is
then repeated using patient plasma and the ratio of
test:normal plasma is calculated. Here is a link to one
reference:
http://www.practical-haemostasis.com/Thrombophilia
%20Tests/APS/drvvt.html. Thank you. Anna Pron-Zwick/04-
May-2012
The SDTM implementation guide 3.1.2- suggests these as III SDTM, SEND-Published in P19
appropriate test code names for ECG finding. This list of
terms was created with our External Vendor ERT as
appropriate Findings. .
The SDTM implementation guide 3.1.2- suggests these as III
Currently- the codelist term only include a code for screen III SDTM-Published in P13
failure. However, many Clinical Trials have epochs that first
screen subjects- and then enters these subject into a epoch
like Diet, Stablization, or Medication stablization epochs. It is
not appropriate to denote these subjects as screen failures.
These subject have passed the screening epoch but have
failed the study randomization criteria. It would be ideal for
the terminology team to consider what code to add when
trials have both screening and pre- investigational medication
epochs- but are not randomized as well.
In draft release 11, the definitions of VZOD and VZPD also III
use the phrase intravascular administration. In the same
draft release, VZFOD and VZFPD use the phrase
extravascular administration. Is there a reason for switching
to intravenous in release 10, or should these new definitions
also use the less specific intravascular? And (since I am
already asking a question) should dosing be changed to
administration for the sake of consistency?
We have a study which is performing Allergen specific IgE III SDTM, SEND-Published in P28
testing. They are capturing the concentrations in KU/L as well
as the subsequent classification type (Class 0 = <0.35, 1 =
0.35-0.70, 2 = 0.71-3.50, 3 = 3.51-17.5, 4 = 17.6-50.0, 5 =
51-100, 6 = >100 kU/L). There are no apparent SDTM terms
for allergens yet and I wondered if you could give any
guidance on naming conventions? There seems to be 3
different 'names': the common english name e.g.English
Plantain; the latin name e.g. Plantago lanceolata; the class
type e.g. (w9). Here are the codes I require:
Existing VITK term is not sufficiently specific. III SDTM, SEND-Published in P12
Please update the definition for MUCOSA to 'The moist, inner II SDTM-Published in P13
lining of some organs and body cavities (such as the nose,
mouth, lungs, and stomach). Glands in the mucosa make
mucus (a thick, slippery fluid).' (Reference:
http://www.cancer.gov/dictionary?CdrID=257213) Also,
please make the term 'mucous membrane' a synonym.
Please add the term 'ORAL MUCOSA' to the Anatomical III SDTM-Published in P13
Location codelist. The definition is 'the mucous membrane of
the oral cavity, including the gingiva'. (Reference: Stedman's
Medical Dictionary). Also, please add the synonym of
'mucosa of mouth'.
The current terms of MALE GENITALIA and FEMALE III
GENITALIA are multi-conceptual terms that include both the
sex of the subject and the anatomical location. We are
requesting that the terms MALE GENITALIA and FEMALE
GENITALIA be replaced with the generic term of GENITALIA
since the sex is captured in a different field.
Whole PTH is different from Intact PTH: III SDTM, SEND-Published in P12
http://www.ncbi.nlm.nih.gov/pubmed/14739849. It is
measured in NG/L
We have had a number of studies recently where the III

protocol has defined the bone marrpw specimen more
specifically as being from the aspirate or biopsy specimen.
Often both are done during the study (and sometimes from
the same procedure ie a biopsy produces a bone marrow
biopsy and aspirate sample) and Clinical want to differentiate
them. I have struggled to find the appropriate term for the
specimen but my clinical rep says that biopsy and aspirate
are the terms usually used. I am open to suggestions. The
generic BONE MARROW will be used where a protocol has
not specified a particular type of specimen and allow either
collection method.
I have compiled a list of new anatomical sites that our III SDTM-Published in P12, P13
Oncology and Crohn’s disease studies have recently
requested. Ultimately we would like them added to CDISC’s
C74456.
Please add the following units used for Skin Allergen testing III
to the Unit codelist: BE/mL (Biological Units per milliliter);
HEP (Histamine Equivalent Prick); SBE/mL (Standardized
Biological Units per milliliter); SQU/mL (Standardized Quality
Units per milliliter); BAU/mL (Bioequivalent Allergy Units per
milliliter); PNU/mL (Protein Nitrogen Unit per milliliter)
I feel like these are similar to QTCF, QTCB and it is important III
to know which formula was used. You might need to have
multiple formula's at a study level, so a comment in the
define may not be enough.
Currently - Actinobacillus lignierssi Change to - Actinobacillus I SDTM-Published in P10
lignieresii; Currently - Bacteroides thetaiotamicron Change to
- Bacteroides thetaiotaomicron; Currently - Eubacterium
adactolyticum Change to - Eubacterium alactolyticum
Please add the term 'LC/MS' to the Method codelist with the III
synonym "Liquid Chromatography/Mass Spectrometry". The
definition is 'An analytical technique wherein liquid
chromatography is coupled to mass spectrometry in order to
separate, identify, and quantify substances in a sample'. This
term is to be used in clinical trials.
There is an overlap in agespan per the CDISC Definition. II

Should be corrected to include individuals over the age of 65.
C49685 includes those who are 18 - 65.
Mobitz I (C83811) and Mobitz II (C83812); C83811 changes I SDTM, SEND-Published in P11
to C62017. C83812 changes to C62018.
Lateral Wall Myocardial Infarction (C71075) is the same as I SDTM, SEND-Published in P11
Lateral Myocardial Infarction (C35586); Inferior Wall
Myocardial Infarction (C71070) is the same as Inferior
Myocardial Infarction (C35398)
ST elevation C71028 (retiring) with ST Segment Elevation I SDTM, SEND-Published in P11
C50540 (Surviving)
This request is for CDASH terminology, it is OK in the CDISC I CDASH-Published in P10

terminology
as per emails with Chris Tolk III
If an AE occurs in a subject and they stop therapy III

temporarily the ACN for that AE will be DRUG
INTERRUPTED. If they have another AE while the drug has
been interrupted what action should be selected? We do not
like having NOT APPLICABLE on the CRF because we think
the site will choose that too often for scenarios we do not
want them selecting it, so adding NO ACTION TAKEN would
be preferred. We would include this term on our CRF instead
of DOSE NOT CHANGED.
I agree that length and height are very distinct measures. III SDTM, SEND-Published in P13
Length is used for children less than 2 (measure while lying
down) or children aged 24 to 36 months who cannot stand
unassisted and height is used for children more than 2 years
old while standing. There are age percentile growth charts for
both parameters. These are instructions how to measure.
Length is measured with a suitable measuring board with a
fixed headpiece and movable footpiece which is
perpendicular to the surface of the table. One person holds
the infant�s head so the infant is looking upward and the
crown of the head is against the headpiece. The measurer
aligns the infant�s trunk and legs, extends both legs, and
brings the footpiece firmly against the feet .
LBTESTCD = CLR, LBTEST = RENAL CLEARANCE, III

Definition = The measured rate of drug clearance by the
kidney.
Change published definition from: "An electrocardiographic II SDTM, SEND-Published in P14

finding in which the pacer of the heart is located in the AV
junction, normally presenting with a narrow QRS complex
and a rate of 60-100 beats per minute. (NCI)" to "An
electrocardiographic finding in which the pacer of the heart is
located in the AV junction, presenting with a narrow QRS
complex and a rate of 40-60 beats per minute."

finding in which the pacer of the heart is located in the AV
junction, normally presenting with a narrow QRS complex at
a rate less than 60 beats per minute. (NCI)" to "An
electrocardiographic finding in which the pacer of the heart is
located in the AV junction, presenting with a narrow QRS
complex at a rate less than 40 beats per minute."

finding of a QRS complex. (NCI)" to "An electrocardiographic
finding of a QRS complex greater wider than 120 msec and a
rate greater than 100 beats per minute."
finding of a rhythm originating at a site other than the
sinoatrial node, which is also above the atrioventricular node.
(NCI)" to "An electrocardiographic finding of a rhythm
originating above the ventricles at a site other than the
sinoatrial node."

finding of the ST segment elevation or depression which is
not indicative of ischemia or infarction. (NCI)" to "An
electrocardiographic finding of ST segment elevation or
depression."
This term doesn't make sense. Suggest to remove it from the III SDTM, SEND-Published in P14
list and if necessary, add the term IDIOPATHIC RIGHT
BUNDLE BRANCH BLOCK with definition: An
electrocardiographic finding of blocked cardiac electrical
impulse conduction along the fibers of the right bundle
branch that cannot be attributed to any cause.
Please remove the VSTEST, VSTESTCD and VSUNITS III

codelists from the SEND terminology spreadsheet. This
should be done when the codelists for CV and RE
tests/codes are added to the SEND terminology spreadsheet,
probably in Q12013.
Keep C66975. Decide which PT you want to keep. The other III SDTM, SEND-Published in P12
can become a synonym
These 2 domain codes were agreed to be removed and are III SDTM, SEND-Published in P13
documented in the SDTMIG Revision history.
Used to collect the assessment of whether a subject is alive III
or dead in studies with long-term follow-up.
A domain for the findings related to the anatomy, physiology, III
and diseases of the eye.
C74606; C74607; C74608; C74609 II
Please add the term cGY with the synonym centigray to the III SDTM, SEND-Published in P12
Unit codelist. Definition: a unit of absorbed radiation dose
equal to one hundredth (10−2) of a gray, or 1 rad7d
C74758 Test Code Synonym: Ammonium Biurate II

Crystals; Ammonium Urate. test Name Synonym:
Ammonium Biurate Crystals
Has been used as a specimen type in an oncology study III
These anatomical locations have been used in a variety of III SDTM-Published in P13
studies.
In countries such as France a subject does not have to give III

their race unless required by the protocol. Therefore we need
a term for when people are not required by local regulations
to state their race.
III
In developing the Polycystic Kidney Disease Therapeutic III
Area CDISC data standards we need new terminology for the
concept of CYSTS, which are not an anatomical location.
The PKD common data elements define the capture of
morphologic results, such as length, width, depth, volume
and number of cysts relating to Kidney cysts and Liver cysts.
C. Tolk suggested I send this request for further input by the
CDISC Terminology Team. Below is the definition I found for
CYSTS. Definition: A cyst is a closed sac, having a distinct
membrane and division compared to the nearby tissue. It
may contain air, fluids, or semi-solid material. A collection of
pus is called an abscess, not a cyst. Once formed, a cyst
could go away on its own or may have to be removed
through surgery.
Please add a specimen type of "Synovial Fluid", defined as a III

transparent viscous lubricating fluid secreted by a synovial
membrane. With gout, synovial fluid may be analyzed.
The long text for TSPARM of Pharmacological Class of II SDTM-Published in P12

Investigational Therapy contravenes the length of 40 stated
in the 3.1.2 IG for this var. Please correct the text to meet
this restriction
Please add the term BONE SCAN to the Method codelist. A III
technique to create images of bones on a computer screen
or on film. A small amount of radioactive material is injected
into a blood vessel and travels through the bloodstream; it
collects in the bones and is detected by a scanner.
Reference: http://www.cancer.gov/dictionary?cdrid=46499
Please add the term MIBG SCINTISCAN to the Method III

codelist. Definition: A nuclear scan that images the adrenal
glands after a radioactive tracer is injected into the
bloodstream. This test is useful in detecting a
pheochromocytoma, particularly if it not within the adrenal
gland.
Reference:
http://www.biology-online.org/dictionary/Mibg_scintiscan
Please add the following terms to the Method codelist: PET III
SCAN, PET/MRI SCAN and PHYSICAL EXAM. Definition for
PET SCAN: A procedure in which a small amount of
radioactive glucose (sugar) is injected into a vein, and a
scanner is used to make detailed, computerized pictures of
areas inside the body where the glucose is used. Because
cancer cells often use more glucose than normal cells, the
pictures can be used to find cancer cells in the body.
Definition for PET/MRI SCAN: An imaging technique that
utilizes positron emission tomography and magnetic
resonance imaging in a single machine.
Definition for PHYSICAL EXAM: An exam of the body to
check for general signs of disease.
Please add the term BRONCHOALVEOLAR FLUID to the III

Specimen Type codelist.
Definition: a fluid containing several lytic enzymes that serves
to remove inspired particulates from the pulmonary airways.
Reference:
http://www.medilexicon.com/medicaldictionary.php?t=34100
A tissue in rabbits defined as terminal part of the ileum, which II SEND-Published in P12
is small intestine. This term should change to Small
Intestine, sacculus rotundus. Microscopically, the sacculus
rotundus has villi on the mucosal surface.
Per SDTM IG, TSPARM must not exceed 40 characters. II SDTM-Published in P12
These two term values violate the rule.
In the Country codelist for the Submission Value VEN, II SDTM, SEND-Published in P13
update the synonym 'Venezuela' to 'Venezuela, Bolivarian
Republic of' based on the ISO 3166-1 Newsletter VI-5 (2009-
03-03). In the Country codelist for the Submission Value
SHN, update the synonym 'Saint Helena' to 'Saint Helena,
Ascension and Tristan da Cunha' based on the ISO 3166-1
Newsletter VI-7 (2010-02-22).
In the Country Codelist for the Submission Value MAF, II SDTM, SEND-Published in P13
update the synonym 'Saint Martin, French' to 'Saint Martin
(French Part)' based on ISO 3166-1 Newsletter VI-1 (2007-
09-21). In the Country Codelist for the Submission Value
SXM, update the synonym 'Sint Maarten (Dutch)' to 'Sint
Maarten (Dutch Part)' based on ISO 3166-1 Newsletter VI-8
(2010-12-15).
Please remove the terminology for agespan as adolescence, II SDTM-Published in P13
child ect could be described using differing age ranges.
Add new term Aortic Valve III SDTM-Published in P13
STRESS ECHOCARDIOGRAM, INTRAVASCULAR III

ULTRASOUND
Needed for PGx and Virology IG to support recent changes III SDTM, SEND-Published in P14
in th design.
The following synonyms in the Country codelist need to be II SDTM, SEND-Published in P13
updated to match ISO3166: BEN - BENIN REPUBLIC -
BENIN; BOL - BOLIVIA - BOLIVIA, PLURINATIONAL STATE
OF; BIH - BOSNIA-HERZEGOVINA - BOSNIA AND
HERZEGOVINA; BRN - BRUNEI - BRUNEI DARUSSALAM;
COD - DEMOCRATIC REPUBLIC OF THE CONGO -
CONGO, THE DEMOCRATIC REPUBLIC OF; FLK -
FALKLAND ISLANDS - FALKLAND ISLANDS (MALVINAS);
PRK - NORTH KOREA - KOREA, DEMOCRATIC PEOPLE'S
REPUBLIC OF; KOR - SOUTH KOREA - KOREA,
REPUBLIC OF; MKD - REPUBLIC OF MACEDONIA -
MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF;
SHN - SAINT HELENA - SAINT HELENA, ASCENSION AND
TRISTAN DA CUNHA; VEN - VENEZUELA - VENEZUELA,
BOLIVARIAN REPUBLIC OF; VNM - VIETNAM - VIET NAM
Proposed Code; Long Name; Definition: HCVGEN; Hepatits III SDTM, SEND-Published in P12,
C Viral Genotype; A measurement of Hepatitis C virus P13
genotype [Identifier] in a biological specimen / A1MGCR;
Alpha-1 Microglobulin CRE Ratio; A relative measurement
(ratio or percentage) of the alpha-1-microglobulin to
creatinine in a biological specimen. / ACT; Activated Clot
Time; Coagulation activated; A measurement of activated
clotting time in blood by coagulation assay / HCMRNA ;
Hepatitis C mRNA; A measurement of the Hepatitis C mRNA
in a biological specimen. / THEO; Theophylline; A
measurement of the Theophylline present in a biological
specimen. / A1MICG; Alpha-1 Microglobulin; A measurement
of the alpha-1 microglobulin in a biological specimen.
WIthin Directionality there are 2 terms - DORSOLATERAL II

AND VENTROLATERAL that I think should be under the
Laterality codelist.
This ECG method has come up in one of our studies. In this III
study measurements will be made in the GLOBAL
SUPERIMPOSED MEDIAN BEAT MODE. Global
Superimposed Median Beat mode: All interval
measurements will be made from the Global Median Beat
across the 10 seconds. The Global Super Imposed Median
Beat mode allows measurements to be performed on the 12
individual median beats. The Cardiologist can view the
measurements in the individual median beats to assure
measurements are performed at the earliest onset of any
viable lead to the latest offset of any viable lead. This
measurement methodology ensures the QRS and PR
intervals are measured from the earliest onset in any lead to
the latest offset in any lead. Similarly, the QT interval is
measured from the earliest detection of depolarization in any
lead to the latest detection of repolarization in any lead.
Please let me know if you require further information
Used for administration in Opthalmological studies III

This issue with the spreadsheet has been in place and III
causes problems recognizing valid units when using
validation tools. Please contact me via email if this
information is not clear. Thank you. Since it is difficult for me
to determine which of the file types is the actual source file, I
am only familiar with those that I use. I would suspect
however that the situation is present in all file types. A
validation tool or program will look for consistent positional
elements. OpenCDISC provides an exact copy of the SDTM
Terminology.txt file in the config\data folder. This file appears
to be processed as a tab delimited file. The line item I copied
and pasted from the txt file in the last email was directly from
that OpenCDISC folder. I have sometimes manually cleaned
up some of these by directly editing the txt file, but this is not
always successful nor desirable as I cannot assign a unique
code value. My belief is that your organization should initiate
the clean-up with the following criteria: Multiple values for
Unit appear to be embedded within the CDISC Synonym(s)
field. Each Unit requires its own line item and unique "Code"
value. Locate with...If Codelist Name= Unit and CDISC
Synonym(s) contains a ; (semi-colon) then evaluate for clean-
up....The communication to OpenCDISC can be simply this:
A sponsor is getting a control terminology warning for the
Unit mg/mL for LBSTRESU within the LB dataset. Upon
looking, we find that this unit is present in SDTM
Terminology.txt file as well as the SDTM Terminology.xls
version (Cell F3043) but appears to be erroneously
embedded within the g/L Unit line item. This is one of many
examples. Can you please confirm this in respect to
OpenCDISC as we evaluate a clean-up.
(1) Analogous with ''uL" which is already in the UNIT III SDTM, SEND-Published in P12
Controlled Terminology; (2) Per mL is commonly used in cell
count lab results.
Diaries are a method of data collection. "Diary data" does not II SDTM, SEND-Published in P14
provide any indication of the topicality of the data. Typically
diaries collect random questions, not questionnaires. There is
a great deal of confusion among implementers about what
belongs in QS. This phrase in the definition leads people
astray, causing them to put inappropriate data in QS. FYI, the
SDS QS team is creating a QS guidance so the clear
definition of what is QS should be left to that document.
Need a term to reflect the relative measurement (ratio or III SDTM, SEND-Published in P13
percentage) of the lymphoblasts to leukocytes in a biological
specimen. Synonym could be Lymphoblast to Leukocyte
Ratio Measurement. Thank you. APZ/17-Jul-2012
Need a term to capture the measurement of the biological III SDTM, SEND-Published in P13
activity of Protein C in a biological specimen. Synonym could
be Factor XIV Activity and Protein C Activity Measurement.
Thank you. APZ/17-Jul-2012
Collected by sponsor and included in NCI-T, but not present III SDTM, SEND-Published in P13
in CDISC CT. CD11A and CD11B are the common terms,
but based on NCI-T, these should be synonyms.
Whilst I understand that tissue already existing in the III

terminology and the location of the tissue may be stored in
LBLOC, like adipose tissue, I would argue Tumor tissue is a
special case as it could be located in multiple locations on
the body
Please correct CDISC Submission Value "APPTLAS" II SDTM, SEND-Published in P12,
(C102277) to APTTLAS and CDISC Synonym APPT-LA to P13
APTT-LA as per discussion during the CDISC LAB Team
Meeting today. Thank you. APZ/18-Jul-2012
This tumor cannot be considered Benign since it is a II
precursor lesion to a malignancy. Change PT of C46101 from
ADENOMA, C-CELL, BENIGN to ADENOMA, C-CELL,
UNDETERMINED. Change definition from 'A benign
neoplasm arising from C-cells of the thyroid gland.' to 'A
neoplasm arising from C-cells of the thyroid gland in which
the malignancy status has not been established.'
All unit common to UNIT and PKUNIT codelists have the II SDTM, SEND-Published in P12
same CODE but for g/day.
The terminology provided for ECG seems to assume that the II
data delivered in SDTM is immediatyle a summary measure
(hence HRMEAN, etc.). It is however not necessarily so that
the data is delivered as such summaries, possibly the - often
- triplicate raw data points are provided which are then further
worked upon in the ADaM data. The suggestion would be to
loose the *MIN, *MAX, *MEAN indications so that the SDTM
ECG data can be true "raw" data as measured. Regardless
of agreement with the above, we feel it is necessary that we
can differentiate between Summary measures delivered in
SDTM (*MIN, *MAX, *MEAN), raw measures delivered in
SDTM (at the moment only existing for the corrected QT
intervals and not for most other measure), Calculations
provided in ADaM (ADaM terminology is at the moment not
including anything on ECG, SDTM serves as a basis there).
LONG-TERM FOLLOW-UP III SDTM-Published in P13
NOT FULFILL INCLUSION OR EXCLUSION CRITERIA III P14 - do not add. Team sees
"failure to meet inc/exc criteria" as
being equivalent to 'screen failure'
and use-case from requestor is
consistent with that interpretation.
Up-case the CDISC Submission values II QRS-Published in P12
QS-C-SSRS Baseline TEST and TESTCD codelist is III QRS-Published in P12

available, but there are three different CSSRS
questionnaires. Baseline, Since last visit are two. The Since
last visit is needed for ongoing studies, and it's not clear if the
same TESTCD/TEST values apply to the different
questionnaire types. It seems that if terminology for one
questionnaire type within a version is created, terminology for
all types within a questionnaire version would be created at
the same time. This would provide Sponsors with all
necessary terms, instead of leaving them guessing how the
terminology would be developed. Thanks for any help you
can offer!
Please clarify whether UNABLE TO EVALUATE should be III
added as controlled terminology. For example, should it be
added to Codelist SDTM-EGSTRESC, i.e.
EGSTRESC=UNABLE TO EVALUATE? Or should UNABLE
TO EVALUATE be stored as a Reason Not Done, i.e.
EGSTAT=NOT DONE and EGREASND=UNABLE TO
EVALUATE? Note, this question may apply to other domains
and codelists, and not just EGSTRESC.
Please add 'Immunofluorescence Assay' and 'Fluorescent II SDTM-Published in P13

Antibody Assay' as synonyms to existing term
FLUORESCENT IMMUNOASSAY
option missing from codelist III Do not add (SDTM-P15): Chris Tolk
sent email to requestor on 2012-11-
07 asking follow-up question.
Response never received. Request
was closed out as of P15
publication on 2013-06-25.
option missing from codelist III Do not add (SDTM-P15): Chris Tolk
sent email to requestor on 2012-11-
07 asking follow-up question.
Response never received. Request
was closed out as of P15
publication on 2013-06-25.
Remove the wording from the definition after the author list: I QRS-Published in P12
The Mini-Mental State Examination (MMSE) (Folstein MF,
Folstein SE, McHugh PR test name. 'Mini-Mental State': a
practical method for grading the cognitive state of patients for
the clinician test name. J Psychiatr Res test name.
1975;12:196-198) test name.
Remove the wording from the defintion after the author list: I QRS-Published in P12
The Mini-Mental State Examination (MMSE) (Folstein MF,
Folstein SE, McHugh PR test code. "Mini-Mental State": a
practical method for grading the cognitive state of patients for
the clinician test code. J Psychiatr Res test code.
1975;12:196-198) test code.
Opioid is misspelled in the synonym column - Screener and I QRS-Published in P12

Opiod Assessment for Patients with Pain - Revised Test
Code
Update NCI PT in column H to Unified Parkinson's Disease I QRS-Published in P12
Rating Scale Questionnaire
Update NCI PT in column H to Palliative Therapy I
Defined is misspelled. Remove the question mark and add I
'fi'. Chronic kidney disease is defined as either kidney
damage or GFR less than 60 ml/min/1.73 m2 for greater than
or equal to 3 months. Kidney damage is de?ned as
pathologic abnormalities or markers of damage, including
abnormalities in blood or urine tests or imaging studies.
option missing from codelist III Do not add (SDTM-P13):

Consensus is that Dried Blood Spot
is not a specimen but a type of
specimen preparation or method. --
SPEC should be WHOLE BLOOD,
SERUM, PLASMA and --METHOD
can be DRIED BLOOD SPOT.
Update NCI PT in column H to Lead Dislodgement I
option missing from codelist III Do not add (SDTM-P13): ng/mL is

already published as a synonym by
CDISC (C67306). pg/mL is already
published as a synonym by CDISC
(C67372).
A code needs to be added for subjects that are euthanized III SDTM, SEND-Published in P14
unscheduled but not moribund. The majority of the group of
subjects may be moribund, but the decision may be made to
euthanize the entire group, but some subjects may not be
moribund. Need DSDECOD to cover these subjects.
The CDISC Synonym 'h*ng/mL/mg' should be I SDTM, SEND-Published in P12

'h*ng/mL/mg/kg.' The '/kg' part on the end is missing.
Why are parentheses '()' not used for units of measure? II

Based on the order of operation some of the CDISC
synonyms do not properly match the PT unless () are added.
CDISC has a duplicate term on the UNIT codelist. C74993 III SDTM, SEND-Published in P12,
has been retired so cannot be used AND CDISC also has a P13
synonymous term published. Move the submission value and
synonym from C74993 over into C66975
Concept merge; NCI editors have decided 'per day' and 'per I SDTM, SEND-Published in P12
24 hours' are synonymous.
CDISC is using C73753 in both units codelists. change c- I SDTM, SEND-Published in P12
code to C67410
Please add the term Q6M to the Frequency codelist to III SDTM, SEND-Published in P13
capture the frequency of every six months.
Please add the terms CAPLET and DRIP to the Unit codelist. III SDTM, SEND-Published in P13
These terms can be both a unit as well as a dosage form (like
the current term TABLET that is in both codelists).
CDISC Submission Value: ILIAC CREST; Definition: A I SDTM-Published in P12

predominate bone structure which borders the ilium wing
stretching from the anterior superior iliac spine to the
posterior superior iliac spine.
We determined /day and /24 Hours is synonymous and will I SDTM, SEND-Published in P12
merge these terms.
Two rows exist for PERICARDIUM (code=C13005) in the I SDTM-Published in P12
LOC codelist. One row has a Synonym value and the other
does not. Please keep the row with synonym filled in.
Attach is the file to review codes/term for ‘SDTM-LOC’ III SDTM-Published in P14
codelist. Thanks. File Name: NCI CDISC Terminology
Requests_Novartis_Req3
In the event that the conditions of the lab sample prevent its III SDTM-Published in P13
analysis and the condition is not covered by either FROZEN,
HEMOLIZED, ROOM TEMPERATURE, CALCIFIED,
CLOTTED, AUTOLIZED; a general description of the
contaminated state of the sample is required.
Attach is the file to review codes/term for ‘SDTM-TSPARM’ III

codelist.
code=C13005 codelist_code=C74456 Anatomical Location I SDTM-Published in P12

PERICARDIUM => remove duplicate
Need ARM-RIGHT, ARM-LEFT, THIGH-RIGHT and THIGH- III

LEFT since we cannot use --LAT (Laterality) in Events or
Interventions domains
Please add the term 'PERIPHERAL BLOOD III

MONONUCLEAR CELL' to the Specimen Type codelist with
the synonym 'PBMC'. This specimen type is used for
laboratory testing in clinical trials.
Needed for the provisionally released PAIN TA standards for III P15 - Do not add for now. Upon
the questionnaires stated above. These draft terminology review at the meeting, it was decide
needs were reviewed and accepted by CDISC SRC for this to put this terminology request on
TA to be released as provisional status on 10-Aug-12. I will hold and address with in the
send the terminology spreadsheets separately to C. Tolk, B. evolving Questionnaire Metadata
Yost and E. Muhlbradt. topic.
For your consideration please find attached an Excel III SDTM, SEND-Published in P13,
document containing a request for expansion of the STDM P14, P15; CDASH-Published in
codelist from Boehringer Ingelheim. Please let me know if P19; SEND-Published in P19; Do
you have any questions. not add (SDTM-P18): For cells/mm,
the cells are described in the test
value, so you do not need cells in
the unit code. For EU/dL, Already a
synonym to another term (C96599)
The visual area under observation is not simply the field in III
HPF, but an eliptical area hich however is equivalent to the
field size of HPF. To keep the distinction between
observations with HPF vs HPF equivalent we would like to
capture this as a separate unit.
Would need to have LBTEST & LBTESTCDs for III
Immunohistochemistry stainings of Foxp3, combination stains
for Granzyme B+/CD8+ (T-Cells, positive for Granzyme B
and CD8) and S100 protein positive cells
Both, MUC-1 as a cell surface marker within a tumor sample III

and the soluble MUC-1 in blood are measured and
LBTEST/LBTESTCDs are required for both.
Please add the terms ORAL, TYMPANIC, RECTAL and III

AXILLARY to the Method Codelist. These are different
methods used in the collection of body temperature.
Submission Value = INTERVENTION; Synonym(s) = Medical III
Intervention, Therapeutic Intervention; Definition = Any action
that is designed to alter the course of a disease or improve
health.
Tissue' is handled in SPECTYPE. What is meant, and what II SDTM-Published in P13

this term codes to, is the muscle itself.
Tissue' is handled in SPECTYPE. What is meant, and what II SDTM-Published in P13

this term codes to, is the muscle itself.
Propose to remove from LOC and add to SPECTYPE. This is II SDTM-Published in P13
a type of tissue. However, do we have a LOC value to go
with this?
We need to capture viruses in our clinical trials. Currently the III SDTM-Published in P19
Microorganism codelist only contains bacteria. Can these
viruses be added to this codelist? If not, can a separate
codelist be created to capture viruses?
We would like to request the creation of a new codelist to III
capture the susceptibility test results for the various
antibiotics (ie. Amoxicillin, Vancomycin, etc.) This antibiotic
testing is often done in the laboratory on a particular
specimen type with numeric or character results but we
wouldn't consider these as part of the Laboratory Test
codelist. If a separate codelist will not be created, please
provide guidance on how these tests should be handled.
We capture allergen tests either by serum or skin testing. We III

added the allergen tests done one a serum specimen to the
Laboratory Test codelist. For the allergen skin tests, we
would like a new codelist to be created. Some example of
allergens tested via skin test include: Dust Mites, White Ash
Tree Pollen and other tree, grass and weed pollens.
PT: FibroSURE score/FIBROSUR; SY: FibroSURE score; III SDTM, SEND-Published in P13
FibroTest score; Definition: An assessment of liver damage
based on results of a six-parameter blood test, combining six
serum markers with the age and gender of the patient.; PT:
Sediment Screen/USEDSCR; Definition: An indication of the
presence or absence of abnormalities in a the sediment of a
urine specimen.
PK Parameters Code; Submission Value = RCAMINTD; III

Synonym(s) = Amt Rec from T1 to T2 Norm by DOSE;
Definition = The cumulative amount recovered from the
specimen type specified in PPSPEC over the interval from T1
to T2 divided by dose.; PK Parameters; Submission Value =
Amt Rec from T1 to T2 Norm by DOSE; Synonym(s) = Amt
Rec from T1 to T2 Norm by DOSE; Definition = The
cumulative amount recovered from the specimen type
specified in PPSPEC over the interval from T1 to T2 divided
by dose.; PK Parameters Code; Submission Value =
RCAMTAUD; Synonym(s) = Amt Rec Over Dosing Interval
Norm by DOSE;Definition = Amount Recovered Over Dosing
Interval Normalized by dose.; PK Parameters; Submission
Value = Amt Rec Over Dosing Interval Norm by DOSE;
Synonym(s) = Amt Rec Over Dosing Interval Norm by DOSE;
Definition = The cumulative amount recovered from the
specimen type specified in PPSPEC between doses (TAU)
divided by dose.
Attached is the file to review codes/term for 'SDTM- III SDTM-Published in P14, P15
SPECTYPE' and SDTM-SPECCOND codelist.
The 03Aug2012 updated included POLYMERASE CHAIN REACTION
III andSDTM-Published
REAL-TIME POLYMERASE
in P14 CHAIN REACTION AS
Currently it is a copy of the definition for TESTCD II QRS-Published in P12

CSS0116A.
Synonym = cycles/centimeter. This unit is used on the Teller III SDTM, SEND-Published in P19
Acuity cards for testing visual acuity.
http://eiiwebassets.s3.amazonaws.com/s/sterooptical/pdf/oth
er-manuals/TAC_II_manual.pdf
This unit is used on the Teller Acuity cards for testing visual
acuity.
http://eiiwebassets.s3.amazonaws.com/s/sterooptical/pdf/oth
er-manuals/TAC_II_manual.pdf
I was wondering if this requested term (cy/cm) was ever

discussed as I never received a response. However, I also
noticed that my requested term was incorrect based on other
similar terms entered into the UNIT codelist - it should have
been requested as: cycle/cm with a synonym as Cycle per
Centimeter.
THANKS
Change NCI Preferred Term from CDISC Questionnaire I QRS-Published in P12

UPDRS Test Code Terminology to CDISC Questionnaire
UPDRS Test Name Terminology
Put a space in between the '36Health Survey Standard' I QRS-Published in P12
within the definition.
C100263 - Update NCI Preferred Term is it matches what is I QRS-Published in P12
in the Database.
For consistency. I QRS-Published in P12
Update to the NCI PT column. I QRS-Published in P12
The wording in the () within the definition is incorrect. Please I QRS-Published in P12
change to the following: The Movement Disorder Society
version of the Unified Parkinson's Disease Rating Scale
(MDS-UPDRS) (copyright 2008 Movement Disorder Society.
All Rights Reserved).
Please change the CDISC Submission Value to the following: I QRS-Published in P12
C102120 - SF36 v1.0 ACUTE; C102121 - SF36 v2.0 ACUTE;
C102122 - SF36 v2.0 STANDARD; C102123 - SOWS
SUBJECTIVE
Remove Dose Form from the synonym column. It doesn't add II SDTM-Published in P14
anything in terms of synonymy and it is screwing up our
report writers.
Advise required please. Clarity appears to be the antonym to II
turbidity. When trying to map urine data where the 3 unique
results are CLEAR, CLOUDY & HAZY, which term do they
map to? Isn't one of these terms redundant? I assume
(based on number) that TURB came first and I have used it
for other urine mapping. So my preference, should you
decide to remove one, is to lose CLARITY. But maybe there's
a valid reason for having it and I just need to choose one and
stick to it for our purposes.
Currently STUDY TERMINATED BY SPONSOR is available III SDTM-Published in P14

but this does not cover an individual site being terminated
from the study. The study is on-going at all other sites, but
the ones that were terminated and this needs to be
categorized separately for reporting purposes.
Add (NCI) to the end of the definition I SEND-Published in P14
Remove (NCI) from end of definition I SEND-Published in P14
The SDTM and SEND definitions are different. Need to II SDTM-Published in P13
harmonize here across SEND-SPECIMAN and SDTM-LOC
codelists.
The SDTM and SEND definitions are different. Need to II SDTM-Published in P13
harmonize here across SEND-SPECIMAN and SDTM-LOC
codelists.
Update NCI PT on Spreadsheet. Change Finding to Sign or I SEND-Published in P12
Symptom
Update to CDISC Synonym column due to use of this I SEND-Published in P12
concept in another codelist. Add Pharyngeal Tonsil as a
synonym.
Update to CDISC Synonym column due to use of this I SEND-Published in P12
concept in another codelist. Add RETROPERITIONEAL
CAVITY as a synonym.
Please add the terms PRESENT and ABSENT to the Tumor III
Response Result codelist. For tumors that are evaluated for
metastatic disease, the result can be reported as absent or
present for metastatic involvement. If this is not the correct
codelist for capturing this concept, please let me know which
is a more suitable placement. Thanks!
DDTESTCD and DDTEST are both listed as extensible. II SEND-Published in P14
However, in SEND, those fields each have one and only one
possible entry: DEATHD and Death Diagnosis respectively.
Therefore those term lists should be nonextensible.
Update the NCI PT column to reflect what is in NCIt I SDTM, SEND-Published in P12
database. See file for list of changes
Addition of NCI to end of definitions; missing period; spacing I SDTM, SEND-Published in P12
issues between words in definition; etc. See file
Harmonize different defs for the same concept across LOC II SDTM-Published in P13
and SPECTYPE codelists.
Harmonize different defs for the same concept across LOC II SDTM-Published in P13
and SPECTYPE codelists.
Harmonize different defs for the same concept across LOC II SEND-Published in P14
and SEND-SPECIMEN codelists.
Harmonize different defs for the same concept across UNIT II

and VSTRESU codelists.
Harmonize different defs for the same concept across UNIT II SDTM, SEND-Published in P13
and VSTRESU codelists.
Harmonize different defs for the same concept across EVAL II SDTM-Published in P13
and MARISTAT codelists.
Existing definition isn't a definition, it looks like it is a copy of II SDTM-Published in P14

the codelist long name. Suggest to change to The reason
that changes were made to the therapy under study. (NCI)
See attached spreadsheet for full list of changes. I SDTM, SEND-Published in P12
See attached spreadsheet for full list of changes. I SDTM, CDASH, SEND-Published in
P12
Remove Dose Form from synonym column. The presence of I SDTM, SEND-Published in P12
the additional synonym screws up our report writers. Codelist
values cannot have additional synonyms other than the
codelist long name.
Long name in PKPARM codelist needs to change to AURC I SDTM, SEND-Published in P12
to Last Nonzero Rate. Copy/paste error occurred with last
publication. The PKPARMCD values are fine.
Implementation guidance for the draft FX domain were III
updated.
IC domain - Update the CDISC Definition from "The III
implantation classification domain provides a record for each
implantation identified for the scheduled cesarean section
component of a study." to " The implantation classification
domain captures individual implantation statuses for the
cesarean section component of studies."; SJ domain -
Update the CDISC Definition from " The subject stages
domain captures subject level non-treatment related blocks of
time known as stages, such as gestation, lactation and
premating." to " The subject stages domain captures the
actual subject level non-treatment related blocks of time
known as stages (e.g., premating, gestation). Stages are
independent of treatment."; TP domain - Update the CDISC
Definition from "The trial paths domain is not subject
oriented. This domain provides the complete planned non-
treatment related sequences of stages for each path in a
study." to " The trial paths domain is not subject oriented.
This domain provides the complete planned non-treatment
related sequences of stages for each path in a study. Paths
and stages are independent of treatment."; TT domain -
Update the CDISC Definition from "The trial stages domain is
not subject oriented. It captures non-treatment related
planned blocks of time known as stages, such as gestation,
lactation and premating." to " The trial stages domain is not
subject oriented. It captures the rules for the non-treatment
related planned blocks of time known as stages (e.g.,
gestation, lactation). Stages are independent of treatment.
Precedence exist for the creation of value level codelists (e.g. III
ECG Result, value sets associated w/Trial Summary
parameters, Tumor Identification Results, New York Heart
Association Class Responses, Tumor Response Result,
etc.). Standardizing urine dipstick results has been quite
challenging. The existence of a CDISC code list with
standard values is not only beneficial for the pooling and
analysis of dipstick results both across and within sponsors,
but provides sponsors with leverage when negotiating with
vendors for the receipt of clinical data in a standard
representation.
ERLST and ERMAX are currently present in the lexicon. III SDTM, SEND-Published in P13
These refer to the last excretion rate and the maximum
excretion rate, respectively. There is currently no term for
excretion rate that is neither the last nor the maximum;
ERINT could fill that role. The term would be used when
there are multiple collection periods and the excretion rate is
calculated for each period.
III SDTM-Published in P25
Mismatch in TSPARM (SDTM IG3.1.3 and SDTM

Terminology 2012-08-03): LENGTH
- SDTM IG 3.1.3 Planned Trial Length
- SDTM Terminology Trial Length
FCNTRY
- SDTM IG 3.1.3 Planned Country of Investigational
Sites
- SDTM Terminology Planned Country of Investigational
Site(s)
PCLAS
- SDTM IG 3.1.3 Pharmacological Class of Inv Therapy
- SDTM Terminology Pharmacological Class of
Investigational Therapy
Only in SDTM IG 3.1.3

--------------------------
STRATFCT Stratification Factor
Only in SDTM Terminology

----------------------------
AGESPAN Age Span

DOSE Dose per Administration
DOSFRQ Dosing Frequency
DOSU Dose Units
ROUTE Route of Administration
Both are used in the PP domain example in the SDTMIG, but III SDTM, SEND-Published in P13
are not in the CT list.
Should both of these be the same. I am seeing this as I am II
QCing the SDTMIG v3.1.3 to ensure that correct terminology
is included in all examples.
Please add the terms FUNCTIONAL MRI and III SDTM-Published in P14
PHARMACOLOGICAL MRI to the Method codelist.
Functional MRI: a technique that directly measures the blood
flow in the brain, thereby providing information on brain
activity. Pharmacological MRI: use of fMRI to map patterns of
brain activity induced by psychoactive drugs.
g*Hours/mL/mg/kg; mg*Hours/mL/mg/kg; III SDTM, SEND-Published in P13

pg*Hours/mL/mg/kg; g*Hours/mL/mg/kg/day;
mg*Hours/mL/mg/kg/day; ng*Hours/mL/mg/kg/day;
g/mL/mg/kg/day; ng/mL/mg/kg/day; pg/mL/mg/kg/day;
g/mL/mg/kg; mg/mL/mg/kg; ng/mL/mg/kg; pg/mL/mg/kg;
Hours
Add NAG as a synonym. II
PK Parameters; Submission Value = Renal CL Norm WT / III SDTM, SEND-Published in P13

RCLW; Synonym(s) = Renal CL Norm WT;Definition = The
renal clearance divided by body weight.
Please change the current definition to: C-SSRS Since Last II QRS-Published in P12
Visit - Description of actual attempt.
Unexpected lengths (too long) cause problems for our II SDTM-Published in P14
computing systems.
Unexpected lengths (too long) cause problems for our II SDTM-Published in P14
computing systems.
Section 4.1.3.2 of IG v3.1.2 states: It is recommended that II P14 - do not change. we are
controlled terminology be submitted in upper case text for all following the RECIST naming
cases other than those conventions for these terms.
described as exceptions below. Deviations to this rule should
be described in the define.xml. a. If the external reference for
the controlled terminology is not in upper case then the data
should conform to the case prescribed in the external
reference (e.g., MedDRA and LOINC). b. Units, which are
considered symbols rather than abbreviated text (e.g.,
mg/dL). The external reference (RECIST v1.1) uses Non-
CR/Non-PD. The value should either be in uppercase
(preferred) or match the external reference.
see attached file II SDTM, SEND-Published in P13
Please add the term ELASTOGRAPHY to the Method III SDTM-Published in P14
Codelist. Elastography is a non-invasive medical imaging
technique that detects tumors based on their stiffness
(elasticity) compared to normal tissue.
Please add the laboratory test Amyloid Precursor Beta with III SDTM, SEND-Published in P13
the test code AMYLPB. A test for a large transmembrane
glycoprotein expressed on the cell surface and of uncertain
function; endocytosis and cleavage can produce abnormal 40
to 43 amino acid peptides which aggregate to form A,
associated with Alzheimer's disease.
Correction of typographical error in CDISC Submission Value II

(lack of space). * Reason for suggestion plus any other
additional information: The current CDISC Submission Value
for CUI Code C92184 (PHEOCHROMOCYTOMA,
COMPLEX,MALIGNANT) lacks a space between the final
comma and MALIGNANT. Suggest correcting the submission
value to add a space.
Please consider changing the Laboratory Test Standard III SDTM-Published in P14
Character Result codelist to extensible. It is Codelist Code#
C102580. AstraZeneca does not understand why this
codelist is currently labeled as not extensible. Thank you.
Anna Pron-Zwick/05-Nov-2012
For your consideration please find attached a zip file III SDTM, SEND-Published in P14
containing an Excel document containing a request for
expansion of the STDM Lab test code list from Boehringer
Ingelheim.
The following unit terms are missing: - for time variables: h, III SDTM, SEND-Published in P13
min, day; - for amount variables: mol, mmol, umol, nmol
(equivalent to the existing mass units)
Please add the term 'Triglyceride Lipoprotein Subfraction' to III SDTM, SEND-Published in P14
the Laboratory Test Name Codelist with the associated Test
Code 'TRIGLPSF'. This term is for the results associated with
the measurement of triglyceride subfractions obtained by
ultracentrifugation of a lipoprotein sample. The lipoprotein
fractions are separated by density (ie. > 1.006) and
triglycerides can be measured from this portion of the
fraction. We are capturing the density in a separate field
rather than in the test name.
It appears that NCI Code C28407 has a CDISC Submission II SDTM-Published in P12
Value of NATORIGIN that has a length of nine(9) which
exceeds the allowable limit for the variable SCTESTCD to
which it is assigned.
Definitions as follows: NOT DONE = Indicates a task, III
process or examination that has either not been initiated or
completed. (NCI); irCR = complete disappearance of all
lesions (whether measurable or not, and no new lesions);
irPR = decrease in tumor burden ≥50%relative to
baseline; irSD = not meeting criteria for irCR or irPR, in
absence of irPD; irPD = increase in tumor burden
≥25%rel ative to nadir (minimum recorded tumor
burden)
Definition = The response of a tumor which has not been III

previously seen or characterized to the therapy.
Euthanasia Via Anesthesia And Perfusion is routine; Applies III SEND-Published in P14
to large animals only (like cows); Euthanasia Via Carbon
Dioxide and Exanguination, note: the animal is not
anesthetized. Synonym: ASPHIXIA EXSANGUINATION
LBTESTCD = CHC; LBTEST = Corpuscular Hemoglobin III

Content; LBTESTCD = HCDW; LBTEST = HGB
Concentration Distribution Width; LBTESTCD = CHCM;
LBTEST = Corpuscular HGB Concentration Mean; Note: This
is a directly measured parameter (CHCM) from the analyzer
as opposed to "Mean Corpuscular Hemoglobin
Concentration" which is a parameter calculated and reported
by the analyzer (MCHC) using other measurements.
We suggest the definition "A measurement of IgG antibody to III

the hepatitis E virus in a biological specimen." instead of "A
measurement of the hepatitis E virus IgG antibody in a
biological specimen." because to a lab expert in our
organization, the second definition seems to imply that the
antibody comes from the virus rather than is a reaction
against the virus.
Could you please update LBTESTCD codelist and III SDTM, SEND-Published in P14
associated LBTEST ?; in our PH III studies we have these
parameters. it will be fine to have them in the CDISC
terminology.
Please add the test name "Glucose-Dependent Insulinotropic III

Peptide" to the LBTEST list. We suggest the corresponding
LBTESTCD value of "GDIP". A synonym is "Gastric Inhibitory
Polypeptide" or "GIP".
Please add the term PLATELET RICH PLASMA to the III SDTM-Published in P14
Specimen Type codelist. This specimen type is used for
platelet aggregation and oncology biomarker tests. Definition:
plasma that has been separated from red blood cells by
centrifugation to produce a product with at least 250,000
platelets per microliter.
In SDTM implemention guide: - page 69 ETCD variable III

should have value UPPLAN for unplanned.; - But in the
naming convention page 285, the preferred syntaxe is UP
and UNPLANNED. => Could we set ETCD to UP and
ELEMENT to UNPLANNED as given in naming convention?
Whilst working with the controlled terminology for II QRS-Published in P13

questionnaires I realized that for two entries the length of the
text is >40. These are C102107 HAMD2-Depersonalization
and Derealization; C102109 HAMD2-Obsessional and
Compulsive Symptoms
This term exists in the NCI-T with a CDISC definition: III SDTM-Published in P14
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?
dictionary=NCI
%20Thesaurus&version=12.10e&code=C12446
Definition: Brief Psychiatric Rating Scale - Anchored (BPRS- II
A) (Woerner MB, Mannuzza S, and Kane JM. Anchoring the
BPRS: An Aid to Improved Reliability. Psychopharmacology
Bulletin 1988; 24(1):112-117).
C100135 - EQ-5D-3L TEST: remove the copyright info from II QRS-Published in P16
the def.
C100136 - EQ-5D-3L TESTCD: remove the copyright info
from the def.
C100141 - MMSE TEST:remove the copyright info from the
def.
C100142 - MMSE TESTCD:remove the copyright info from
the def.
C100143 - NPI TEST:remove the copyright info from the def.
C100144 - NPI TESTCD:remove the copyright info from the
def.
C100173 - SF36 v1.0 Standard TEST: remove the copyright
info from the def.
C100174 - SF36 v1.0 Standard TESTCD: remove the
copyright info from the def.
Many location-specific lymph nodes are captured in III SDTM-Published in P14

Controlled Terminology already. Radiation therapy is
sometimes targeted at the internal mammary lymph nodes,
so request is to add this as a new term. NOTE: In
researching this issue, it appears that PARASTERNAL
LYMPH NODE is possibly synonymous with INTERNAL
MAMMARY LYMPH NODE, so the team may elect to use
either one as the submission value (and have the other as a
CDISC synonym). Thank you.
Modify Definition of Glucose Clearance: A measurement of II SDTM, SEND-Published in P13
the volume of serum or plasma that would be cleared of
glucose by excretion of urine for a specified unit of time (e.g.
one minute).
Please add the following terms (and test codes): III SDTM, SEND-Published in P14
Inclusion Bodies, Cytoplasmic (INCLBDC) - these are
distinctive structures frequently formed in the cytoplasm in
cells infected with certain filtrable viruses. They are also
found in the nucleus but we want to differentiate those in the
cytoplasm.
Calprotectin (CALPTCTN) - assay performed to indicate the
presence of neutrophils in stool. Reported with the unit
microgram per gram.
ALT/AST (ALTAST) - the ratio of serum alanine
aminotransferase to serum aspartate aminotransferase.
Elevated ratio is used as an indicator of alcohol as the cause
of liver damage.
codelist_code=C66734 (DOMAIN), TR and TU are now III

release domain in SDTM IG 3.1.3 but not listed as cdisc
submission value. could you add them?
RS (code=C102722). The synonym value should be Disease II SDTM, SEND-Published in P14

Response as in SDTM IG 3.1.3 and not Tumor Response.
Tumor Response is for TR domain.
Please consider adding the following strain: NIH MINIPIG, III SEND-Published in P14
SYNONYME NIH MINIATURE SWINE
Please consider adding the following strain for Rats: LEWIS III SEND-Published in P14
Please consider adding the following strain for Sheep: III SEND-Published in P14
SUFFOLK
Please consider adding the following strain for Mouse: III SEND-Published in P14
SWISS WEBSTER
Please consider adding the following species: FROG III SEND-Published in P14
Please add the following spec to the specimen list: FLUID, III SEND-Published in P14
PLEURAL, which is not the same as PLEURA which is the
cavity.
Please add the following term to the list: FLUID when the III SEND-Published in P14
type of fliud is not otherwise specified as per STDM -
Specimen Type - FLUID.
C code C98862 APTTSTND and C100421 APTTSPTT seem II SDTM, SEND-Published in P14
to be representing the same test concept. Please consider
removing one of these from the published terminology or
make definitions more clear
Please create a unit to present enzymatic units. This is III SDTM, SEND, CDASH-Published in
typically represented as "U" but that has already been used. P17
Preference would be to change the existing "U" to Arbitary
Unit and use "U" for Enzymatic Unit as this is what is always
seen in literature for enzymes. Failing that, create a unit
called "Enzyme unit"
I'm going to send through aa attachment via email of various III SDTM, SEND-Published in P14
terminology requests.
In our company, an event that worsens is captured as a III P14 - Do not add. List is taken
separate event. In other words, anytime an event worsens verbatim from ICH E2B.
the original event is resolved in the clinical database (e.g. a
stop date is entered) and the event is entered with new start
date and new intensity (See example below. I believe that
this method of data collection is common across other
companies. AEENDTC
HEADACHE MILD ??? 2012-01-01
2012-01-15
HEADACHE MODERATE RECOVERED/RESOLVED
2012-01-16 2012-01-18 There is currently no option
in the AEOUT codelist that relects that an event is
worsening. Selecting AE Out = Recovered/Resolved or
Recovered/Resolved with sequelae for the mild event is
incorrect given that this event worsened. Similary,
selecting the option Not recovered/Not resolved does not
reflect that the event worsened. I understand that the AE
OUT codelist is aligned with E2B and that it may be
difficult to have this term added. However, could you
please provide guidance on how to handle these
situations?
Change QSTESTCD for consistency; Change HAMD0113 to II QRS-Published in P13

HAMD113. This will make the numbering consistent.
Change definition to make it more usable by send. Change: II
A circumferential measurement of the head at the widest
point, which is traditionally above the eyebrows.; To: A
circumferential measurement of the head at the widest point.
Date of Request Submitter Submitter Submitter E- Request CDISC
Status
Submission Code Name Affiliation mail Type Codelist
Closed 1/4/2013 15:17 32479 Nicholas Janssen npemble@it Modify SDTM-

Pemble s.jnj.com Existing LBTEST
Term
Closed 1/4/2013 15:18 32480 Nicholas Janssen npemble@it Create SDTM-

Pemble s.jnj.com New Term LBTEST
Open 1/11/2013 13:51 32487 David Shire dturner- Create MULTIPL

Turner Pharmaceutic c@shire.co New Term E
als m
Open 1/11/2013 13:53 32488 Anna Pron- AstraZeneca anna.pron- Create SDTM-
Zwick Pharmaceutic zwick@astr New Term LBTEST
als azeneca.co
m
Closed 1/18/2013 19:14 32491 Carrie Covance carrie.neele Modify SEND-

Neeley y@covance. Existing STRAIN
com Term
Open 1/18/2013 19:14 32492 Carrie Covance carrie.neele Create SDTM-

Neeley y@covance. New Term LBTEST
com
Closed 1/18/2013 19:19 32493 Phil Pochon Covance phil.pochon Create SDTM-
@covance.c New Term MICROO
om RG
Open 1/18/2013 19:26 32494 Carrie Covance carrie.neele Modify SDTM-
Neeley y@covance. Existing LBTEST/
com Term CD
Open 1/18/2013 19:28 32495 Annette E Quality Data ainker@qds Modify MULTIPL
Inker Services, Inc. ervices.com Existing E
Term
Closed 1/18/2013 19:29 32496 Cheryl BMS cheryl.sloan Create SDTM-
Sloan @bms.com New Term LBTEST
Closed 1/25/2013 14:21 32499 John Covance john.swithen Modify SDTM-

Swithenban bank@cova Existing TPHASE
k nce.com Term
Closed 1/25/2013 14:22 32500 Debbie Merck debra_oneill Create SDTM-

O'Neill @merck.co New Term UNIT
m
Closed 1/25/2013 14:25 32501 Debbie Merck debra_oneill Modify SDTM-
O'Neill @merck.co Existing LOC
m Term
Closed 1/25/2013 14:27 32502 Janet Shire jsiani@shire Modify QS-C-
.com Existing SSRS
Term Baseline
TESTCD
Closed 1/25/2013 14:28 32503 Janet Shire jsiani@shire Modify QS-
.com Existing CSSRS
Term Since
Last Visit
Closed 1/25/2013 14:29 32504 Aimee Celgene abasile@cel Create SDTM-
Basile gene.com New Term LBTEST
Closed 1/25/2013 14:33 32505 Erin MSC Inc. muhlbradtee Create SDTM-
Muhlbradt @mail.nih.g New Term ROUTE
ov
Open 1/25/2013 14:34 32506 Erin MSC Inc. muhlbradtee Create SDTM-
Muhlbradt @mail.nih.g New Term UNIT
ov
Closed 2/1/2013 14:52 32508 Erin MSC Inc. muhlbradtee Modify QS-
Muhlbradt @mail.nih.g Existing QSCAT
ov Term
Open 2/1/2013 19:22 32509 Erin MSC Inc. muhlbradtee Modify SDTM-
Muhlbradt @mail.nih.g Existing CCINVCT
ov Term YP
Closed 2/8/2013 18:03 32520 Bernice Yost CDISC byost@cdis Modify SDTM-
c.org Existing PKPARM/
Term CD
Closed 2/15/2013 13:13 32521 Joyce Merck joyce_herna Create SDTM-

Hernandez ndez@merc New Term DOMAIN
k.com
Closed 2/15/2013 13:15 32522 Joyce Merck joyce_herna Other SDTM-
Hernandez ndez@merc DOMAIN
k.com
Closed 2/15/2013 13:16 32523 Steve CDISC skopko@cdi None Other

Kopko sc.org
Closed 2/15/2013 13:17 32524 Bernice Yost CDISC byost@cdis Create SDTM-
c.org New Term UNIT
Closed 2/15/2013 13:17 32525 Spencer Takeda lorraine.spe Modify SDTM-

Pharmaceutic ncer@taked Existing METHOD
als a.com Term
c.org New Term ROUTE
Closed 2/15/2013 13:19 32527 Bernice Yost CDISC byost@cdis None SDTM-
c.org METHOD
c.org New Term LOC
c.org Existing DOMAIN
Term
O'Neill @merck.co New Term METHOD
m
Closed 2/22/2013 16:41 32537 frank senk astrazeneca frank.senk Modify SDTM-
@astrazene Existing GRSTNL
ca.com Term OC
Open 2/22/2013 16:42 32538 Audrey Charles River Audrey.Wal Modify SDTM-
Walker Labs ker@crl.co Existing LBTEST
m Term
Open 2/22/2013 16:43 32539 Audrey Charles River Audrey.Wal Create SDTM-
Walker Labs ker@crl.co New Term LBTEST
m
m
Closed 2/22/2013 16:46 32541 Audrey Charles River Audrey.Wal Create SDTM-
m
m
m
Open 2/22/2013 16:48 32544 Scott Roche/ scottab@ge Create SDTM-
Bahlavooni Genentech ne.com New Term PKPARM
CD

m
m
Closed 2/22/2013 16:52 32548 Tom Morrow Lilly morrow_tho Create SDTM-
mas_e@lilly New Term METHOD
.com
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
O'Neill @merck.co Existing POSITIO
m Term N
Closed 2/22/2013 17:31 32584 Scott Roche/ scottab@ge Create SDTM-

Bahlavooni Genentech ne.com New Term UNIT

O'Neill @merck.co New Term POSITIO
m N
O'Neill @merck.co New Term NCOMPL
m T
Open 3/1/2013 14:25 32600 Bernice Yost CDISC byost@cdis Modify SDTM-
c.org Existing PKUNIT
Term
Term
Term
Closed 3/1/2013 14:28 32603 Audrey Charles River Audrey.Wal Create SEND-
Walker Labs ker@crl.co New Term STRAIN
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
m
Walker Labs ker@crl.co New Term SPECIES
m
m
m
m
m
m
m
m
m

Bahlavooni Genentech ne.com New Term LOC


Open 3/1/2013 14:51 32633 Rajinder GlaxoSmithKli Rajinder.Ra Modify SDTM-
Randhawa ne ndhawa@gs Existing LBTESTC
k.com Term D
Open 3/1/2013 14:52 32634 Randall GSK randall.r.aus Other SDTM-

Austin tin@gsk.co UNIT
m
Open 3/1/2013 14:53 32635 Audrey Charles River Audrey.Wal Modify SDTM-
Walker Labs ker@crl.co Existing LBTEST
m Term
Closed 3/1/2013 14:54 32636 Audrey Charles River Audrey.Wal Other SEND-
Walker Labs ker@crl.co NEOPLA
m SM
m
m
m
m
m

Bahlavooni Genentech ne.com New Term UNIT
m
m
c.org Existing NCOMPL
Term T

O'Neill @merck.co New Term SPECTY
m PE

O'Neill @merck.co New Term LBTEST
m
c.org New Term UNIT
Closed 3/8/2013 19:35 32663 Randall GlaxoSmithKli randall.r.aus Modify SDTM-
Austin ne tin@gsk.co Existing LBTESTC
m Term D
Closed 3/8/2013 19:35 32664 Cliff UCB, Inc. cliff.reinhard Modify QS-
Reinhardt t@ucb.com Existing QSCAT
Term
Open 3/8/2013 19:36 32665 Cliff UCB, Inc. cliff.reinhard Create QS-
Reinhardt t@ucb.com New Term HAMA
TESTCD

m
Closed 3/15/2013 12:41 32674 Janice Hess jhess@octa Modify SDTM-

gonresearch Existing LOC
.com Term
Closed 3/15/2013 12:42 32675 Cheryl BMS cheryl.sloan Create SDTM-

Sloan @bms.com New Term LBTEST
c.org Existing UNIT
Term
Walker Labs ker@crl.co New Term SPEC
m
Closed 3/22/2013 14:01 32688 Joyce Merck joyce_herna Create SDTM-

hernandez ndez@merc New Term DOMAIN
k.com
Closed 3/22/2013 14:02 32689 Colleen Merck colleen_bon Create SDTM-
Bonjo jo@merck.c New Term LOC
om

O'Neill @merck.co Existing RSSTRE
m Term SC
O'Neill @merck.co New Term RSSTRE
m SC

Bonjo jo@merck.c New Term PROCED
om URE
Open 3/22/2013 14:06 32693 Nik Pemble Janssen npemble@it Create SDTM-
s.jnj.com New Term LBTEST
Term
Closed 3/29/2013 14:36 32705 Annette QDS, Inc. ainker@qds Modify SDTM-
Inker ervices.com Existing COUNTR
Term Y
Closed 3/29/2013 14:36 32706 Lorraine P. Takeda Lorraine.Sp Create SDTM-
Spencer encer@take New Term LBTEST
da.com
Closed 3/29/2013 14:37 32707 Monica Celgene mmattson@ Create SDTM-

Mattson Corporation celgene.co New Term NCOMPL
m T
Open 4/5/2013 11:52 32709 Debbie Merck debra_oneill Create SDTM-

m
m
m
m
m
m
Open 4/19/2013 17:40 32726 Dan Amgen doconnel@ Modify SDTM-
O'Connell amgen.com Existing LOC
Term
Closed 4/19/2013 17:41 32727 Dan Amgen doconnel@ Modify SDTM-
O'Connell amgen.com Existing POSITIO
Term N
Closed 4/19/2013 17:42 32728 Dan Amgen doconnel@ Create SDTM-

O'Connell amgen.com New Term LBTES
Closed 4/19/2013 17:43 32729 Troy troy.furnace Create SDTM-

Smyrnios @gmail.com New Term UNIT
Closed 4/26/2013 11:46 32733 Erin MSC Inc. muhlbradtee Modify SDTM-
Muhlbradt @mail.nih.g Existing VSTEST
ov Term
Open 4/26/2013 11:48 32734 Erin MSC Inc. muhlbradtee Modify SEND-
Muhlbradt @mail.nih.g Existing OMTEST
ov Term
Closed 5/3/2013 12:18 32740 Bron Kisler CDISC bkisler@cdi Create NEW
sc.org New
Codelist
Closed 5/3/2013 12:19 32741 Roberta Pfizer, Inc roberta.e.ro Modify QS-
Rosenberg senberg@pf Existing OABQ
izer.com Term
@covance.c New Term METHOD
om
O'Neill @merck.co New Term TRTEST
m
Open 5/3/2013 15:06 32744 Lou Florio lou.florio@p Modify QS-

harma.com Existing COMM
Term TEST
Closed 5/3/2013 15:34 32745 Lou Florio lou.florio@p Modify QS-

harma.com Existing COMM
Term TESTCD
Open 5/10/2013 12:56 32749 claire west gsk claire.m.wes Modify SDTM-
t@gsk.com Existing LBTESTC
Term D
Closed 5/10/2013 12:58 32750 claire west gsk claire.m.wes Create SDTM-
t@gsk.com New Term LBTESTC
D
Closed 5/16/2013 17:20 32761 Audrey Charles River Audrey.Wal Modify SEND-
Walker Labs ker@crl.co Existing NEOPLA
m Term SM
Closed 5/16/2013 17:21 32762 Audrey Charles River Audrey.Wal Modify SEND-
Walker Labs ker@crl.co Existing NEOPLA
m Term SM

m

O'Neill @merck.co New Term LOC
m
Closed 5/16/2013 17:24 32765 Erin MSC Inc muhlbradtee Modify SDTM-
Muhlbradt @mail.nih.g Existing FRM
ov Term
Muhlbradt @mail.nih.g Existing FRM
ov Term
m
Closed 5/24/2013 12:59 32773 Anna Pron- AstraZeneca anna.pron- Create SDTM-
Zwick zwick@astr New Term UNIT
azeneca.co
m
Open 5/24/2013 13:00 32774 Anna Pron- AstraZeneca anna.pron- Create SDTM-
Zwick zwick@astr New Term SPECTY
azeneca.co PE
m
Open 5/24/2013 13:01 32775 Sharon Boehringer sharon.brod Create SDTM-

Broderick Ingelheim erick@boeh New Term LBTESTC
Pharmaceutic ringer- D
als, Inc ingelheim.c
om
Broderick Ingelheim erick@boeh New Term EGTEST
Pharmaceutic ringer- CD
als, Inc ingelheim.c
om
O'Neill @merck.co New Term RSSTRE
m SC
Closed 5/24/2013 13:07 32778 Nate Theorem nate.freimar Create SDTM-
Freimark Clinical k@theorem New Term DOMAIN
Research clinical.com
Open 5/31/2013 12:47 32784 Gary Walker Quintiles gary.walker Create SDTM-
@quintiles.c New Term RACE
om
Open 5/31/2013 12:48 32785 Erin MSC Inc muhlbradtee Modify SDTM-
Muhlbradt @mail.nih.g Existing LOC
ov Term
Open 5/31/2013 12:48 32786 Bernice Yost CDISC byost@cdis Create NEW
c.org New Term
Zwick Pharmaceutic zwick@astr New Term MICROO
als azeneca.co RG
m

om
Closed 6/7/2013 16:08 32797 Rhonda CDISC rfacile@cdis Other New
Facile c.org
Closed 6/7/2013 16:08 32798 Colleen Merck colleen_bon Create New
Bonjo jo@merck.c New
om Codelist
Closed 6/7/2013 16:09 32799 Colleen Merck colleen_bon Create New
om Codelist
Closed 6/7/2013 16:10 32800 Steve CDISC skopko@cdi Create QS-DAD

Kopko sc.org New Term
Open 6/7/2013 16:11 32801 Colleen Merck colleen_bon Create QS-
Bonjo jo@merck.c New Term QSCAT
om
Open 6/7/2013 16:12 32802 Janet Siani Shire jsiani@shire Create QS-
.com New Term QSCAT
.com New Term QSCAT

O'Neill @merck.co New Term EGSTRE
m SC
Open 6/7/2013 16:14 32805 Erin MSC Inc. muhlbradtee Modify SDTM-
Muhlbradt @mail.nih.g Existing LOC
ov Term
Closed 6/14/2013 13:49 32808 Veronique Bayer Vital veronique.b Other SDTM-
Bourcier ourcier@ba AGESPA
yer.com N
Zwick Pharmaceutic zwick@astr New Term PKPARM
als azeneca.co
m
Closed 6/21/2013 12:49 32818 Lorraine Takeda Lorraine.Sp Create SDTM-

Spencer Pharmaceutic encer@Tak New Term SPECTY
als eda.com PE
Open 6/21/2013 12:50 32819 Kimberley Novartis kimberley.h Modify SDTM-
Heron Pharma AG eron@novar Existing EGTEST
tis.com Term
Closed 6/21/2013 12:51 32820 Diane Wold GSK (but diane.e.wol Create SDTM-
acting for the d@gsk.com New Term DOMAIN
CDISC SDTM
team)
Closed 6/21/2013 12:52 32821 Chris Tolk CDISC ctolk@cdisc Modify SDTM-
.org Existing DOMAIN
Term
Walker Labs ker@crl.co New Term SSTYP
m
@covance.c New Term MICROO
om RG
.com New Term QSCAT
Closed 6/28/2013 12:02 32827 Erin MSC muhlbradtee Modify SDTM-

Muhlbradt @mail.nih.g Existing TSPARM
ov Term
Muhlbradt @mail.nih.g Existing LBTEST
ov Term
Muhlbradt @mail.nih.g Existing VSTEST
ov Term
Open 6/28/2013 12:05 32830 Erin MSC muhlbradtee Modify SDTM-
Muhlbradt @mail.nih.g Existing PKPARM
ov Term

Muhlbradt @mail.nih.g Existing MICROO
ov Term RG
Closed 6/28/2013 12:08 32832 Veronique Bayer Vital veronique.b Create SDTM-
Bourcier ourcier@ba New Term TSPARM
yer.com CD
Open 6/28/2013 12:16 32835 Jenny Roche jenny.griffith Create SDTM-
Griffiths Products Ltd s@roche.co New Term LOC
m
Closed 7/5/2013 14:21 32838 Cathy Bezek astellas cathy.bezek Modify SDTM-
@astellas.c Existing LBTESTC
om Term D

Bonjo jo@merck.c New LOC
om Codelist
Open 7/12/2013 16:25 32843 Colleen Merck colleen_bon Create SDTM-

om

Muhlbradt @mail.nih.g Existing EGSTRE
ov Term SC
Closed 7/12/2013 16:26 32845 Jozef Aerts Jozef.aerts Modify SDTM-
@fh- Existing UNIT
joanneum.at Term

@fh- Existing UNIT
joanneum.at Term

@fh- Existing UNIT
joanneum.at Term
Closed 7/12/2013 16:30 32848 Monika www.bioclinica monika.pali Create SDTM-

Paliwal .com wal@bioclini New Term VSTESTC
ca.com D
Closed 7/12/2013 16:31 32849 Steve CDISC skopko@cdi Create QS-
Kopko sc.org New Term UPDRS
TEST

ov Term SC
ov Term SC
ov Term SC
Closed 7/19/2013 16:24 32854 Randall GlaxoSmithKli randall.r.aus Create SDTM-
Austin ne tin@gsk.co New Term EGSTRE
m SC
Open 7/19/2013 16:26 32855 Steve CDISC skopko@cdi Create New
Kopko sc.org New
Codelist
om
Open 7/19/2013 16:35 32857 Harsh Ekagra harsh.marw Create SDTM-
Marwaha Software aha@ekagr New Term TSPARM
asoft.com CD
Closed 7/19/2013 16:36 32858 Benjamin Merck benjamin_s Create SEND-

Sefing efing@merc New Term NEOPLA
k.com SM

k.com SM
Closed 7/19/2013 16:39 32860 Create SEND-

New Term NEOPLA
SM

k.com SM
Open 7/19/2013 16:40 32862 Benjamin Merck benjamin_s Create SEND-

k.com SM
k.com SM

k.com SM
Open 7/19/2013 16:41 32865 Benjamin Merck benjamin_s Create SEND-

k.com SM

k.com SM

k.com SM

k.com SM
Closed 7/26/2013 12:12 32874 Jordan Li NCI EVS jordan.li@ni Modify QS-
h.gov Existing CSSRS
Term Baseline
TEST/CD
Open 7/26/2013 12:13 32875 Jordan Li NCI EVS jordan.li@ni Modify MULTIPL
h.gov Existing E
Term
m
Walker Labs ker@crl.co New Term NEOPLA
m SM
m
m
m
Closed 8/2/2013 12:13 32885 Amy Roche/ klopman.am Create SDTM-

Klopman Genentech y@gene.co New Term LOC
m
Open 8/2/2013 12:13 32886 Amy Roche/ klopman.am Create SDTM-
Klopman Genentech y@gene.co New Term METHOD
m
Closed 8/2/2013 12:15 32887 Elizabeth The Takeda elizabeth.la Modify SDTM-
Langevin Oncology ngevin@mpi Existing NYHAC
Company .com Term
Closed 8/3/2013 14:05 32888 Audrey Charles River audrey.walk Modify SEND-
Walker Laboratories er@crl.com Existing DESIGN
Term
Closed 8/9/2013 13:46 32894 Lorraine Takeda Lorraine.Sp Create SDTM-
Spencer Pharmaceutic encer@Tak New Term LOC
als eda.com
Closed 8/9/2013 13:48 32895 Luc Dekie Biomedical ldekie@bio Create SDTM-
Systems medsys.co New Term EGSTRE
m SC
Walker Labs ker@crl.co New Term SSTYP
m
m
m

m

O'Neill @merck.co New Term SPECTY
m PE
Open 8/16/2013 12:23 32911 Erin MSC muhlbradtee Create SDTM-
Muhlbradt @mail.nih.g New Term SPECTY
ov PE
Closed 8/16/2013 12:24 32912 Jennifer Instem jennifer.feld Create SEND-
Feldmann mann@inst New Term SPEC
em.com
Closed 8/16/2013 12:25 32913 Jennifer Instem jennifer.feld Create SEND-

Feldmann mann@inst New Term SPEC
em.com
Closed 8/16/2013 12:25 32914 Bess LeRoy C-Path bleroy@c- Create SDTM-
path.org New Term LOC
Closed 8/23/2013 17:04 32926 Amy Genentech/ klopman.am Create SDTM-

Klopman Roche y@gene.co New Term TRTESTC
m D
Closed 8/23/2013 17:05 32927 Carrie Covance carrie.neele Create SDTM-

Neeley Laboratories y@covance. New Term ROUTE
com
Closed 8/23/2013 17:06 32928 Carrie Covance carrie.neele Modify SDTM-
Neeley Laboratories y@covance. Existing ROUTE
com Term
Closed 8/23/2013 17:07 32929 Carrie Covance carrie.neele Modify SDTM-

Neeley Laboratories y@covance. Existing FREQ
com Term
Open 8/23/2013 17:31 32930 Anna Pron- AstraZeneca anna.pron- Other None
Zwick Pharmaceutic zwick@astr
als azeneca.co
m

Muhlbradt @mail.nih.g Existing SIZE
ov Term
Closed 8/30/2013 12:22 32945 Janet Siani Shire jsiani@shire Modify SDTM-
.com Existing SPECCO
Term ND
Closed 8/30/2013 12:22 32946 Amy Genentech/ klopman.am Create SDTM-
Klopman Roche y@gene.co New Term METHOD
m
Closed 8/30/2013 12:23 32947 Kapila Patel Novartis kapila.patel Create

Pharma @novartis.c New Term
om
Closed 8/30/2013 12:24 32948 Kapila Patel Novartis kapila.patel Create SDTM-
Pharma @novartis.c New Term EGMETH
om OD
Open 8/30/2013 12:25 32949 Kapila Patel Novartis kapila.patel Create SDTM-
Pharma @novartis.c New Term UNIT
om
Pharma @novartis.c New Term LOC
om
Pharma @novartis.c New Term UNIT
om
Closed 8/30/2013 12:27 32952 Bob Stafford C-Path bstafford@c Create QS-NPI
-path.org New Term TEST
Closed 8/30/2013 16:34 32953 Joyce joyce_herna Create SDTM-
Hernandez ndez@merc New Term RSSTRE
k.com SC
Closed 9/5/2013 18:14 32956 Abhishek Forest Labs abhishek.da Other SDTM-
Dabral bral@frx.co NCOMPL
m T

Muhlbradt @mail.nih.g Existing TSPARM
ov Term
Closed 9/5/2013 20:24 32958 Kapila Patel Novartis Kapila.Patel Create SDTM-
Pharma @yahoo.co New Term EGTEST
m
Closed 9/13/2013 15:40 32972 Sabina Charles River Audrey.Wal Create SEND-
Hussain Laboratories ker@crl.co New Term MTHTRM
m
Closed 9/13/2013 15:41 32973 Gary Teva gary.cunnin Create SDTM-QS

Cunningham Pharmaceutic gham@teva New Term COWS
als pharm.com TESTCD
Closed 9/13/2013 15:45 32974 Gary Teva gary.cunnin Create SDTM-QS

Cunningham Pharmaceutic gham@teva New Term COWS
als pharm.com TESTCD
Closed 9/20/2013 12:19 32983 Bernice Yost CDISC byost@cdis Create Multiple
c.org New Term
Closed 9/20/2013 12:19 32984 Bernice Yost CDISC byost@cdis Create Multiple
c.org New Term
Open 9/20/2013 12:20 32985 Amy Palmer CDISC apalmer@c Create SDTM-
disc.org New Term EGTEST
Open 9/20/2013 12:21 32986 Rostgaard H. Lundbeck. kast@lundb Other SDTM-

Stender A/S eck.com EGSTRE
SC
Closed 9/20/2013 15:29 32987 Audrey Charles River audrey.walk Create SEND-
Walker er@crl.com New Term SPEC
Open 9/20/2013 15:29 32988 Erin MSC muhlbradtee Modify SEND-

Muhlbradt @mail.nih.g Existing SPEC
ov Term
Open 9/20/2013 15:31 32989 Erin MSC muhlbradtee Modify SEND-
Muhlbradt @mail.nih.g Existing MTHTRM
ov Term
Closed 9/27/2013 12:12 32992 Roberta Pfizer roberta.e.ro Modify QS-NPI

Rosenberg senberg@pf Existing TEST
izer.com Term
Open 9/27/2013 12:13 32993 Bernice Yost CDISC byost@cdis Modify Multiple
c.org Existing
Term
Closed 9/27/2013 12:14 32994 Audrey Charles River audrey.walk Create SDTM-
Walker er@crl.com New Term LBTESTC
D
Closed 9/27/2013 12:15 32995 Colleen Merck colleen_bon Create NEW
om Codelist
Open 9/27/2013 12:16 32996 Erin MSC muhlbradtee Modify Multiple

Muhlbradt @mail.nih.g Existing
ov Term
Open 9/27/2013 17:42 32997 Bernice Yost CDISC byost@cdis Create SDTM-
c.org New Term UNIT
c.org New Term SPECCO
ND
Closed 9/27/2013 17:43 32999 Erin MSC muhlbradtee Modify SEND-

Muhlbradt @mail.nih.g Existing NEOPLA
ov Term SM
Closed 9/27/2013 18:11 33000 Randall GlaxoSmithKli randall.r.aus Modify SDTM-
Austin ne tin@gsk.co Existing LOC
m Term
c.org Existing
Term

als, Inc. ingelheim.c
om
Closed 10/18/2013 16:20 33007 Kapila Patel Novartis Kapila.patel Create SDTM-
Pharma @novartis.c New Term LOC
om
Open 10/18/2013 16:21 33008 Bernice Yost CDISC byost@cdis Create SDTM-
c.org New Term LBTEST
Closed 10/18/2013 16:22 33009 Lakshmi Johnson and lmallela@its Modify Multiple
Mallela Johnson .jnj.com Existing
Term
Closed 10/18/2013 16:23 33010 Cliff UCB, Inc. cliff.reinhard Create QS-MDS-
Reinhardt t@ucb.com New Term UPDRS
TESTCD
Closed 10/18/2013 16:24 33011 Sharon Boehringer sharon.brod Create SDTM-

Broderick Ingelheim erick@boeh New Term UNIT
Pharmaceutic ringer-
om
Closed 10/18/2013 16:25 33012 Bess LeRoy bleroy@c- Create SDTM-

path.org New Term SCTEST
Closed 10/18/2013 16:26 33013 Steve CDISC skopko@cdi Create Multiple
Kopko sc.org New Term
Open 10/18/2013 16:27 33014 Joyce Merck Merck Modify SDTM-

Hernandez Existing DOMAIN
Term
Open 10/18/2013 16:32 33015 Joyce Merck joyce_herna Modify SDTM-

Hernandez ndez@merc Existing DOMAIN
k.com Term
Closed 10/18/2013 16:33 33016 Debra Merck debra_oneill Create SDTM-

m
Closed 10/18/2013 16:35 33017 Bernice Yost CDISC byost@cdis Create New
c.org New
Codelist
Closed 10/18/2013 16:36 33018 Lacey Eli Lilly and wallace_lac None SDTM-
Wallace Company ey_m@lilly. EGSTRE
com SC
Open 10/18/2013 16:37 33019 Lacey Eli Lilly and wallace_lac Modify SDTM-
Wallace Company ey_m@lilly. Existing EGMETH
com Term OD
Walker er@crl.com New Term LBTEST
Closed 10/18/2013 16:38 33021 Audrey Charles River audrey.walk Create SEND-
Walker er@crl.com New Term NEOPLA
SM
Closed 10/18/2013 16:39 33022 Carrie Covance Labs carrie.neele Create SDTM-
com
c.org Existing STENRF
Term
Open 10/18/2013 16:41 33024 Bernice Yost CDISC byost@cdis Modify SDTM-NY
c.org Existing
Term
c.org Existing SEX
Term
c.org Existing CVPRCIN
Term D
c.org New Term UNIT
c.org New Term UNIT
Open 10/25/2013 19:52 33030 Jennifer Instem jennifer.feld Modify SEND-

Feldmann mann@inst Existing NEOPLA
em.com Term SM
c.org Existing
Term
c.org Existing
Term
Muhlbradt @mail.nih.g Existing SSTYP
ov Term
Closed 10/25/2013 19:55 33034 Bernice Yost CDISC byost@cdis Modify

c.org Existing
Term
Closed 10/25/2013 19:56 33035 Bernice Yost CDISC byost@cdis Modify Multiple
c.org Existing
Term
c.org Existing LBTEST
Term
Closed 11/1/2013 14:18 33044 Bernice Yost CDISC byost@cdis Modify Multiple
c.org Existing
Term
Open 11/1/2013 14:18 33045 Lacey wallace_lac Other SDTM-

Wallace ey_m@lilly. PROCED
com UR
Closed 11/1/2013 14:20 33046 Carol Charles Liver Carol.Detris Modify Multiple
Detrisac ac@crl.com Existing
Term

om
Broderick Ingelheim erick@boeh New Term LBTEST
om
O'Neill @merck.co New Term MICROO
m RG

Bonjo jo@merck.c New Term UNIT
om
Closed 11/8/2013 20:45 33053 Eileen Celgene cdsi@celge Create SDTM-
Gardenhire ne.com New Term SPECTY
PE
Closed 11/8/2013 20:46 33054 Jane PharmaStat jdiefenbach Create SDTM-

Diefenbach LLC @pharmast New Term SPECTY
at.com PE
Open 11/8/2013 20:47 33055 Steve CDISC skopko@cdi Create QS-CDR
Kopko sc.org New Term TEST
Closed 11/8/2013 20:49 33056 Robert CDISC rdempsey@ Create SDTM-

Dempsey cdisc.org New Term EGMETH
OD
Closed 11/8/2013 20:50 33057 Guy Sunovion guy.genereu Modify SDTM-
Genereux x@sunovion Existing EGTEST
.com Term

m
m
m

O'Neill @merck.co New Term CVEXAM
m
Closed 11/8/2013 20:55 33062 Emily Critical Path ehartley@c- Create Multiple
Hartley Institute path.org New Term

Bonjo jo@merck.c New Term CVEXAM
om
Closed 11/22/2013 14:06 33072 Mary Jo Merck & mj.brucker Create SEND-
Brucker Co. @merck.co New Term SPEC
m
Closed 11/22/2013 14:08 33073 Mary Jo Merck & mj.brucker Create New
Brucker Co. @merck.co New
m Codelist
Closed 11/22/2013 14:09 33074 Saloni Shah Chiltern Intl. saloni.shah Modify SDTM-
@chiltern.co Existing NCOMPL
m Term T
Closed 11/22/2013 14:10 33075 Carrie Covance Labs carrie.neele Create SDTM-
com
Closed 11/22/2013 17:11 33076 Audrey Charles River audrey.walk Modify SDTM-
Walker er@crl.com Existing LBTEST
Term
Open 11/22/2013 17:12 33077 Audrey Charles River audrey.walk Create SDTM-
Closed 11/29/2013 12:43 33080 Bess LeRoy bleroy@c- Modify SDTM-

path.org Existing LOC
Term
Closed 11/29/2013 12:44 33081 Peggy Zorn peggy.zorn Modify Multiple

@inds- Existing
inc.com Term
Closed 11/29/2013 12:45 33082 Peggy Zorn peggy.zorn Create New
@inds- New
inc.com Codelist
Open 11/29/2013 12:45 33083 Gitte gttf@novon Other SDTM-

Frausing ordisk.com LBTEST
Open 11/29/2013 12:46 33084 Erin muhlbradtee Other SDTM-

Muhlbradt @mail.nih.g DOMAIN
ov

als Inc ingelheim.c
om
Open 12/13/2013 13:01 33092 Carrie Covance Labs carrie.neele Create SDTM-
com
Open 12/13/2013 13:02 33093 Debra Merck debra_oneill Create SDTM-
m
Closed 12/13/2013 13:03 33094 Janet Siani Shire jsiani@shire Create New
.com New
Codelist
Open 12/20/2013 13:52 33099 Debra Merck debra_oneill Create SDTM-
m

om
Closed 12/27/2013 16:05 33101 Jane NIAID/DAIDS jdiefenbach Create SDTM-
Diefenbach and @pharmast New Term SPECTY
PharmaStat at.com PE
LLC
Muhlbradt @mail.nih.g Existing MICROO
ov Term RG
New Term or Codelist/Existing Term or
Detailed Description
Code Number
Please add synonym for C96603 I guess there may be some lack of granularity in the term above. I
EBNAB; Synonym proposed is Epstein- guess it can be used for EBNA antibodies when the immunoglobin
Barr Nuclear Antigen Antibody is not known or stated and when the EBNA subtype is not known.
Typically now I see serology specific for EBNA1 IgG. I am going to
write a separate request for this
EBNA1IGG - Epstein-Barr Nuclear Additional granularity on EBNA supported by recent research
Antigen 1 IgG Ab OR EBN1IGAB - articles
Epstein-Barr Nuclear Antigen 1 IgG Ab http://www.wjgnet.com/2220-3249/full/v1/i1/31.htm
and assay product inserts
http://www.medac.de/medac_international/data/diagnostics/
brochures/EBV%20Flyer_Homepage.pdf
See Attached File See Attached File
Immunoblastic Please consider adding the term "Immunoblastic

Lymphocytes/Lymphocytes Lymphocytes/Lymphocytes". CDISC Controlled Terminology already
has the term "Lymphocytes, Immunoblastic" and there is also a term
to capture "Plasmacytoid Lymphocytes/Lymphocytes". We require a
term to capture the relative measurement of Immunoblastic
Lymphocytes. Thank you. Anna Pron-Zwick/09-Jan-2013
Change submission value "CB6F1- CB6F1-TgN (RasH2) was the original nomenclature and this is what
TgN (RasH2)" to "CByB6F1- is used as the controlled terminology. The reason for the change is
Tg(HRAS)2Jic" for Code C98711. because CByB6F1-Tg(HRAS)2Jic is the nomenclature that Taconic
uses and Taconic is the only supplier of rasH2 mice in the US.
Taconic changed their nomenclature at some point between 05 andf
08 but I couldn't find exactly when.
Add "Hemoglobin Distribution According to the Clinical pathologist, the definition of the test is that
Width" to SEND LBTEST. it is measuring the Haemoglobin distribution width in the red blood
Corresponding LBTESTCD would be cell, so it would be different than red blood cell distribution width.
needed. We considered mapping it to Hemoglobin, but this test is also being
conducted for this study so it would be an error to have 2 data
values reported for Hemoglobin.
New MICROORG terms 2012 Q3 and Q4 updates to Covance Microorganism dictionary
Definition correction for C74683 It appears in CDISC SEND Controlled Terminology, 2012-12-21,
CYTYRO Tyrosine Crystals that the definitions are the same for C74756 CYTRPHOS Triple
Phosphate Crystals and C74683 CYTYRO Tyrosine Crystals. The
definition for both is "A measurement of the triple phosphate crystals
present in a biological specimen." So it appears that the definition
for Tyrosine Crystals needs to be updated. This same issue affects
LBTEST as well.
Is it possible, now that there are more It 'used to be' that the synonym for LBTESTCD was also the
synonyms for each LBTESTCD, to make controlled term for LBTEST, or if there were two synonyms, the first
the first synonym for any LBTESTCD one correlated to LBTEST. Now, however, when there are more
correlate to the controlled term in than two synonyms for LBTESTCD, there is no correlation to
LBTEST? LBTEST. It's literally twice the work and time to look up, first, the
LBTESTCD, then the LBTEST.
Please see the attached list of terms for Please see the attached list of terms for addition to the LB domains.
addition to the LB domains.
Please add the option Phase 1b Trial to Please add the option Phase 1b Trial to the list as we have had a
the list as we have had a number of trials number of trials denoted as 1b recently
denoted as 1b recently
STEPS; BLOCKS Please add the terms STEPS and BLOCKS to the Unit codelist;
these terms are used in respiratory trials to capture the number of
steps or blocks that a patient has walked
PELVIC BONE Please remove the synonym 'Pelvis' from the term PELVIC BONE -
the term Pelvis is listed as a synonym and also as a submission
value.
Please modify the definitions associated he definition text is not an exact match to the text on the
with the following TESTCD - and questionnaire. Review requested by the QS Terminology team
associated TEST values:
Definitions do not match the Definitions do not match the questionnaire exactly. Review
questionnaire exactly. Review requested requested by the QS Terminology team.
by the QS Terminology team.
Total Immunoglobulins Although Total Immunoglobulins (Ig) may not always be reported by
the laboratory, it can be calculated by adding the three main classes
of Ig: IgG, IgM, and IgA and would be reported in the SDTM LB
domain as a derived lab test. Another possible term or synonym
would be Total Ig.
Intra corpus cavernosum; Intracervical; On behalf of CDASH SAE team, they are submitting these new
Intrahepatic; Subdermal; Transmammary terms to be included within the SDTM UNIT codelist to be compliant
with E2B SAE standard.
DF (Dosage Form Unit of Measure) On behalf of CDASH SAE team, they are submitting a term to be
included within the SDTM UNIT codelist to be compliant with E2B
SAE standard.
C66957 Change NCI PT from EuroQOL Three Dimension Five Level
Questionnaire to EuroQOL Five Dimension Three Level
Questionnaire
The codelist name is too long, Should be Change to CNTCINVT, to be consistent with SCTEST/CD value.
8 characters.
ERMAX and ERLST: please add the ERMAX and ERLST: please add the following to the existing
following to the existing definitions at the definition at the end of the definition. "...determined for the
end of the definition. specimen type specified in PPSPEC". Update all definitions,
"...determined for the specimen including the normalizations.
type specified in PPSPEC"
Reserve a New Domain Code for PT = Pharmacogenomics Trial Characteristics
Pharmacogenomics (PGx) caled PT This domain will store PGx Trial parameters that will store design
paramerters use in performing the tests. This could include details
on the array design.
This will be a domain that SEND could use as well.
Addition of Domain codes a. I would like tpo request that you sort your list by the Domain
Code in alphabetical sequence.
b. Some PGx domains seem to have been dropped. We also need
some new ones.
c. PG - change in the domain title - domain code stays the same
d. New Domain codes: BE, BS, ES, PG, PF, PB, SB and VR
Parkinson;s Disease v1.0 Standards Parkinson;s Disease v1.0 Standards controlled terminology updates
controlled terminology updates based on based on CDISC SRC approval of provisional PD User Guide on
CDISC SRC approval of provisional PD 20-Dec-12. I have sent and reviewed the CT spreadsheet with
User Guide on 20-Dec-12. I have sent Bernice Yost that covers the either new terms updates for the
and reviewed the CT spreadsheet with following SDTM domains: FATEST, SCTEST, DIPARM, DOTEST,
Bernice Yost that covers the either new and DUTEST. In addition new terms are requested for the following
terms updates code lists: METHOD and Relationship to Subject.
kHz: A unit of measure denoting the This term is coming in from the Device terminology group.
frequency equal to 1000 cycles per
second meaning e.g. that the cylical
waveform changes from one state to the
other (from one polarity to the other)
1000 times per second.
There are two method that reference x- There are two method that reference x-rays - C38101 (XRAY) and
rays - C38101 (XRAY) and C85830 (X- C85830 (X-RAY FLUORESCENCE SPECTROMETRY). The first
RAY FLUORESCENCE reference "XRay" and the second references "X-Ray". Please
SPECTROMETRY) change C38101 from XRAY to X-RAY for consistency. Alternately,
change C85830 from X-RAY FLUORESCENCE SPECTROMETRY
to XRAY FLUORESCENCE SPECTROMETRY.
Catheter - Route When the General Team discusses this request, we can have a
Devices Team member available to answer questions.
Catheter- Method When the General Team discusses this request, we can have a
Devices Team member available to answer questions.
Fascia (Fascia of the foot) This term is coming in from the Device terminology group.
Update definition for RS: The RS domain This request is from Barrie Nelson.
represents the response evaluation
determined from the data in the TR
domain or data from other sources (i.e.
other SDTM domains) for example, lab
test results (LB) or symptoms.
ASPIRATION Please add the term ASPIRATION to the Method codelist. We use
the term for the collection of samples for Oncology trials. NCI
definition: Removal of fluid or tissue through a needle.
ADLB has been assigned many different We will need labels as ADaM datasets increase in number. This rule
SAS labels at our company. I suggest could also apply to SDTM FA combination datasets AE (Adverse
concatenating the C667234 CDISC Events)and FA (Findings About Events or Interventions) would be
synonym values LB (Laboratory Data) FAAE (Findings About Adverse Events). This rule however breaks
and AD (Analysis Dataset) to create the 40 character limit for SAS labels and would be shortened.
ADLB (Laboratory Data Analysis
Dataset). This could work for all
combination
Please consider changing the LBTEST The present term �erythrocytes distribution width� should be
for SDTM and SEND for changed to �red cell distribution width� for the following reasons:
"Erythrocytes Distribution � The abbreviation for this parameter is RDW. Thus,
Width" to "Red cell �erythrocytes distribution width� does not conform to the
distribution width" please see abbreviation. �Red cell distribution width� conforms to the
justification from our Scientists below... abbreviation, RDW.
� �Red cell distribution width� is the terminology used in
modern human and veterinary hematology text books.
o Feldman, BF, et. al., Schalm�s Veterinary Hematology,
Lippincott Williams & Wilkins, Philadelphia, 2000, Chapter 1,
�Clinical Automated Hematology Systems�, pp. 3 � 11.
o Williams, WJ, et. al., Hematology, McGraw-Hill, New York,
1990, Chapter 2, �Examination of the Blood �, pp. 9 � 24.
� �Red cell distribution width� is the description/definition of
the measurement on modern hematology analyzers � Advia 120
and 2120, Cell Dyn 3200, etc.
� Internet search for �erythrocyte distribution width� returns
primarily �red cell distribution width�
Best regards, Glenn (Glenn S. Elliott, D.V.M., Ph.D.)
Please consider adding LBTEST, We need the mono/macro tests for the fluids such as thoracic,
LBTESTCD abdominal, pericardial.
"Monocytes/Macrocytes"
absolute and percent tests please.
Please consider adding LBTEST, Microscopic examination in Blood Cell Morphology in Whole Blood
LBTESTCD "Agglutination"
Alpha Hydroxybutyrate Alpha Hydroxybutyrate Dehydrogenase/α-HBDH

Dehydrogenase/α-HBDH
"Macrophages" absolute and Macrophages test is usually done in FLUID, BRONCHOALVEOLAR

percentage LAVAGE; FLUID, CEREBROSPINAL and FLUID, SYNOVIAL
"Amplitude" Amplitude test is within the Whole Blood using aggregometry
impedance method. Unit of Ohm if this helps.
PPTESTCD: AUCPBEO PPTESTCD: AUCPBEO

Definition: The area under the curve (AUC) from the observed
concentration value at time zero to the first measured concentration
value as a percentage of the area under the curve extrapolated to
infinity. Applies only for intravascular bolus dosing.
PPTEST: AUC %Back Extrapolation Obs PPTEST: AUC %Back Extrapolation Obs
Definition: The area under the curve (AUC) from the observed
concentration value at time zero to the first measured concentration
value as a percentage of the area under the curve extrapolated to
infinity. Applies only for intravascular bolus dosing.
Please consider adding a new LBTEST Please consider adding a new LBTEST and LBTESTCD for the
and LBTESTCD for the following following term:
term:"Mast Cell" absolute and "Mast Cell" absolute and percentage
percentage
"Volume Wash" Volume Wash is a manual or visual test done in the FLUID,
BRONCHOALVEOLAR LAVAGE in mL
Here is a list of 21 - Lilly Methods codes Here is a list of 21 - Lilly Methods codes that we would like to be
that we would like to be included into included into CDISC terms.
CDISC terms.
Please consider adding a new LBTEST Surfactant protein D, also known as SFTPD or SP-D
and LBTESTCD for the following term:
"Surfactant D"
"Bb Fragment of Factor B" Please consider adding a new LBTEST and LBTESTCD for the
following term:
"Bb Fragment of Factor B"
"Butyl Cholinesterase" Please consider adding a new LBTEST and LBTESTCD for the
following term:
"Butyl Cholinesterase"
Please consider adding a new LBTEST Please consider adding a new LBTEST and LBTESTCD for the
and LBTESTCD for the following term: following term:
Chymotrypsin "Chymotrypsin"
"C-Reactive Protein High Please consider adding a new LBTEST and LBTESTCD for the
Sensitivity" following term:
"C-Reactive Protein High Sensitivity"
"Corpuscular Hemoglobin Please consider adding a new LBTEST and LBTESTCD for the
Concentration Mean Gated" following term:
"Corpuscular Hemoglobin Concentration Mean Gated"
"Corpuscular Hemoglobin Content Please consider adding a new LBTEST and LBTESTCD for the
Gated" following term:
"Corpuscular Hemoglobin Content Gated"
"Meningeal Cell" test within FLUID, CEREBROSPINAL
"Meningeal Cell" for absolute test within FLUID, CEREBROSPINAL
and percent
"Monocytoid Cell" for test within FLUID, CEREBROSPINAL

absolute and percent
"Degenerated Cells" microscopic examination in whole blood and in buffy coats
"Pi Glutathione-S- Please consider adding a new LBTEST and LBTESTCD for the
Transferase" - GSTPI following term:
"Pi Glutathione-S-Transferase" - GSTPI
"Content of Hemoglobin- Please consider adding a new LBTEST and LBTESTCD for the
Bound Oxygen" following term:
"Content of Hemoglobin-Bound Oxygen"
"Curve Type" Platelet Rich Plasma (PRP) Aggregometry. Optical photometry
"Cytoplasmic Basophilia Blood Cell Morphology - microscopic examination

Neutrophil"
"Mean Amplitude" Please consider adding a new LBTEST and LBTESTCD for the
following term:
"Mean Amplitude"
"Mean Curve Type" Please consider adding a new LBTEST and LBTESTCD for the
following term:
"Mean Curve Type"
"Heinz Bodies" Please consider adding a new LBTEST and LBTESTCD for the
percent following term:
"Heinz Bodies" percent
"Glycosylated Please consider adding a new LBTEST and LBTESTCD for the
Hemoglobin" percent following term:
"Glycosylated Hemoglobin" percent
"Immature Cells" Please consider adding a new LBTEST and LBTESTCD for the
percent following term:
"Immature Cells" percent
"Platelet Component Please consider adding a new LBTEST and LBTESTCD for the
Distribution Width" following term:
"Platelet Component Distribution Width"
"Platelet Please consider adding a new LBTEST and LBTESTCD for the
Aggregation" Percent following term:
"Platelet Aggregation" Percent
"Platelet Activating Please consider adding a new LBTEST and LBTESTCD for the
Factor" following term:
"Platelet Activating Factor"
"Thrombocyte Please consider adding a new LBTEST and LBTESTCD for the
Count" following term:
"Thrombocyte Count"
"Vacuolated Please consider adding a new LBTEST and LBTESTCD for the
Lymphocytes" following term:
"Vacuolated Lymphocytes"
"Troponin" Please consider adding a new LBTEST and LBTESTCD for the
following term:
"Troponin"
"Total Ketone Please consider adding a new LBTEST and LBTESTCD for the
Bodies" following term:
"Total Ketone Bodies"
"Thyroid Stimulating Please consider adding a new LBTEST and LBTESTCD for the
Hormone" - TSH following term:
"Thyroid Stimulating Hormone" - TSH
"Packed Cell Please consider adding a new LBTEST and LBTESTCD for the
Volume" - PCV following term:
"Packed Cell Volume" - PCV
"Nuclear Swelling Cell Morphology- Microscopic examination
"Mean Platelet Dry Please consider adding a new LBTEST and LBTESTCD for the
Mass" following term:
"Mean Platelet Dry Mass"
"MCV Please consider adding a new LBTEST and LBTESTCD for the
Reticulocytes" following term:
"MCV Reticulocytes"
"Iron Saturation" Please consider adding a new LBTEST and LBTESTCD for the
Percent following term:
"Iron Saturation" Percent
Semi-Recumbent
Please add semi-recumbent as a synonym to the current term of
SEMI-FOWLERS
Reference: http://books.google.com/books?
id=uCgWuJ7XG_gC&pg=PA242&lpg=PA242&dq=define+SEMI-
FOWLERS+semi-
recumbent&source=bl&ots=x_Skcf2ypw&sig=Se1Txhgz2iVhOvDVB
xhWGIJf7ug&hl=en&sa=X&ei=NzgmUauGKqSO0QGHjoE4&ved=0
CFkQ6AEwBg#v=onepage&q=define%20SEMI-FOWLERS
%20semi-recumbent&f=false
Please add mmol/mol to the SDTM-UNIT Please see this document:
code list. This is the new SI Unit for http://dtb.bmj.com/site/about/HBA1C_chart_Feb_10.pdf
HBA1c
DECUBITUS Please add the term �DECUBITUS� to the Position codelist. We
use this term for studies where they want to know what position the
subject was in when the symptoms occurred. It�s not an
assessment that has to be done with the patient in a specific
condition, they need to know that the patient was lying down but not
necessarily whether it was on their back, side or stomach.
SUBJECT DISCONTINUED DUE TO Please add the term �SUBJECT DISCONTINUED DUE TO
CAREGIVER WITHDRAWAL CAREGIVER WITHDRAWAL� to the Completion/Reason for Non-
Completion codelist. We use this term for Alzheimer studies where
the patient is no longer able to participate in the study without a
caregiver�s assistance. If the caregiver no longer wants to help
the patient participate in the study then the patient would not be
able to participate. The caregiver would be someone without legal
responsibility � in other words they do not have guardianship or
make any legal decisions regarding care for the patient. They just
provide daily assistance and care for the patient. To say
WITHDRAWAL BY SUBJECT would not be correct nor would
WITHDRAWAL BY PARENT/GUARDIAN.
C85628 h*ng/mL/mg/kg please add PK Team request.

parenthesis h*ng/mL/(mg/kg)
C85629 h*ng/mL/mg/m2 please add PK Team request.

parenthesis h*ng/mL/(mg/m2)
C85748 ng/mL*kg please remove this PK Team request.

unit code, this request is from the PK
terminology team.
Please consider adding the following for dogs
STRAIN: HOUND
Please consider adding the following for ferret

STRAIN: domestic
Please consider adding the following for Monkey

STRAIN: CYNOMOLGUS CAMBODIAN

STRAIN: CYNOMOLGUS CHINA

STRAIN: CYNOMOLGUS INDIA
CYNOMOLGUS INDONESIA for Monkeys

CYNOMOLGUS MAURITIUS for Monkeys
CYNOMOLGUS PHILLIPINES for Monkeys
CYNOMOLGUS PORT DOWN UK for Monkeys
CYNOMOLGUS for Monkeys
RHESUS CHINA for Monkeys
RHESUS INDIA for Monkeys
RHESUS INDONESIA for Monkeys
RHESUS PHILIPPPINES for Monkeys
RHESUS PORT DOWN UK for Monkeys
RHESUS VIETNAM for Monkeys

NEW ZEALAND WHITE for Rabbits
UK for Marmosets
Dog Juvenile
Hamster Juvenile
Monkey Juvenile
Mouse Juvenile
Rabbit Juvenile
Rat Juvenile
NEW ZEALAND BLACK for Rabbit Juvenile
NEW ZEALAND RED for Rabbit Juvenile
NEW ZEALAND HYBRID for Rabbit Juvenile
Please add EYE, ANTERIOR CHAMBER Term exists in the NCI-T:

to the LOC code list. http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI
%20Thesaurus&version=13.01c&code=C12667
Please add OPTIC DISC to the LOC Term exists in the NCI-T:
code list. http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI
%20Thesaurus&version=13.01c&code=C12760
Please add ANTERIOR VITREOUS to This term is for an ophthalmology trial
the LOC code list.
Update the CDISC Submission Value for
LBTESTCD from APPTLAS to
APTTLAS. The associated LBTEST has
been updated but not the LBTESTCD.
Request guidance on use of As we create extensible UNIT terms and attempt to follow CDISC
"/sec" versus "/s" convention, we are confused by the inconsistent use of "/sec"
versus "/s" in the UNIT codelist. Why is there an inconsistency?
Which convention should we follow to be CDISC-like?
Please remove the word blood and Blood Urea Nitrogen - BUN - A measurement of the urea nitrogen in
replace with biological in the definition of a blood specimen."
Blood Urea Nitrogen - BUN Change to: Blood Urea Nitrogen - BUN - A measurement of the urea
nitrogen in a biological specimen."
We test Urea Nitrogen in blood and within urine.
hair follicle tumors
Please submit for discussion the direction taken for hair follicle
tumors
IN SEND CT neoplasm list are:
Carcinoma, Adnexal, malignant
Hair follicle neoplasm, benign or malignant or undetermined (that�s
3 line items)
Pilomatrixoma, benign (which has a synonym of benign hair follicle
neoplasm ..huh? what? I have 2 choices for one tumor?
Trichoepithelioma, benign
Combining Adnexal Carcinoma and Hair follicle neoplasms, SEND
looks to be lumping together types of neoplasms�with the
exception of Pilomatricoma and Trichoepithelioma. Why are there
these 2 outliers (specific terminology names)
2nd question � if keep those 2 outliers
All other brethren of hair follicle tumors have been slighted. These
brethren are (as per Veterinary Dermatopathology text)
Tricofolliculoma � a benign hair follicle tumor of dogs and cats.
Infundibular keratizing ancanthoma (aka intracutaneous cornifying
epithelioma) a benign follicular neoplasm of dogs.
Tricholemmoma, bulb type- neoplasm of the outer root sheath of
the hair follicle.
Tricholemmoma, isthmus-catagen type � Neoplasm of the isthmus
segment of the hair follicle
Trichoblastoma (basal cell tumor, benign) which should be a
synonym for Neoplasm Basal Cell Benign
Matrical carcinoma (syn malignant pilomatricoma)
3) What is difference of Neoplasm, Basal Cell Malignant and
Carcinoma, Basal Cell Malignant?
4) Trichogenic adnexal tumor � how is that differentiated from the
definition of pilomatrixoma?
Carol. J. Detrisac, DVM, PhD, DACVP

NEW ZEALAND for Rabbit Juvenile
NEW ZEALAND in STRAIN codelist for Rabbit Juvenile
MOUSE
RAT
FATHEAD for Fish
Please add Hounsfield Unit to the UNIT Present in NCI:

code list. Needed for tumor http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI
assessments %20Thesaurus&code=C94908
NOD.SCID for Mouse
LISTER HOODED for Rat
Can this please be changed to This request came from Cathy Bezek. She had missed the deadline
"Failure to meet enrollment for public comment on package 13.
criteria" since not all studies have
randomization.
LYSATE Please add the term LYSATE to the Specimen Type codelist. This
specimen type is used for the analysis of tests, such as cGMP
(cyclic guanosine 3,5-monophosphate). The definition is: the mixture
of substances formed by the lysis of cells.
Cyclic Guanosine 3,5-Monophosphate Please add the term Cyclic Guanosine 3,5-Monophosphate to the
with the test code CGMP Laboratory Test Name codelist with CGMP to the Laboratory Test
Code codelist.
Reference: http://www.piercenet.com/browse.cfm?
fldID=ABEDD3AE-44EF-4469-BD2D-784F56A20892
Submission Value = PULSE ; Synonyms This request is from the Devices Terminology Team.
= Pulse Dosing Unit; Pulses Dosing Unit;
Definition = A dosing measurement
based on the pulse unit.
LBTESTCD HIVIMONA, HIVIOAB, Codelist Name CDISC Submission Value CDISC Synonym(s)
HIVI24AG - the 4th character in the code Laboratory Test Code HIV1AB HIV-1 Antibody
value should be a 'one'? Laboratory Test Code HIV12AB HIV-1/2 Antibody
Laboratory Test Code HIV2AB HIV-2 Antibody
Laboratory Test Code HIVVLD HIV Viral Load
Laboratory Test Code HIVIMONA HIV-1 Group M and O
Nucleic Acid
Laboratory Test Code HIVIOAB HIV-1 Group O Antibody
Laboratory Test Code HIVI24AG HIV-1 p24 Antigen
Laboratory Test Code HIV2NUAC HIV-2 Nucleic Acid
In the first 2 examples above, the LBTESTCD submission value

represents HIV-1 as a numeric �1�. But in examples 5-7 one is
represented as �I�. Is this a mistake or a conscious decision? If
the latter can it please be explained? It maybe that �I� is used to
differentiate the HIV-1 from the 24. But if this is a mistake, can they
please be revised.
I have a number of other p and gp antibodies to map and I �m not
sure if I should represent them as HIV124AB or HIVI24AB.
Code C102118 submission value is: All references of the Hamilton Anxiety Rating Scale (HAM-A) use
HAMA. Request this updated to HAM-A HAM-A with the dash including in CDISC Definition. In addition,
with the dash between the M and 2nd A. other instrument in Codelist Code C100129 which include dashes in
the definition has the dash in the CDISC Submission Value (see
ADAS-COG, BPRS-A etc.)
Consider adding a HAM-A total score. In the reference materials provided to develop the Hamilton Anxiety
Rating Scale (HAM-A) QS supplement, a section for Scoring is
present (...with a total score range of 0-56, ...) yet no QSTESTCD /
QSTEST values are currently present for the terminology.
Unspecified Cells with Test Code: Please add the tests Unspecified Cells (UNSPCELL) and Bronchial
UNSPCELL; Test Name: Bronchial Epithelial Cells (EPIBRON). These cell types are being identified in
Epithelial Cells with Test Code: a sputum microscopic analysis. The cell types identified are being
EPIBRON counted and other cell types that are not specified are being
captured under the Unspecified Cells which is used for the
calculation of the percentage of each cell type.
Change 'CORONARY ARTERY, During review of CV domain for posting to public review, the SRC
ANTERIOR DESCENDING' to 'LEFT found it confusing that 'LEFT' was in CVLAT rather than CVLOC,
CORONARY ARTERY, ANTERIOR since other examples contained LEFT in CVLOC. Future used of
DESCENDING'. CVLAT will be for side of body, not side of organ, therefore side of
organ may need to be added to some LOC terms.
Please see the attached list of terms for Please see the attached list of terms for addition to the LB domains.
addition to the LB domains. File sent on 2013-03-11
Definition for pH: The negative logarithm Request from the PK Terminology Team.
(base 10) of the concentration of
hydrogen ions expressed in moles per
liter, which is used as a measure of the
acidity or alkalinity of a fluid.
Add new terms to SEND-SPEC BONE, CALVARIUM
BONE, CARPUS
BONE, GROWTH PLATE
GANGLION, CERVICOTHORACIC
JOINT, FEMOROTIBIAL
JOINT, SYNOVIAL TISSUE
LYMPH NODE, MANDIBULAR
TOOTH, PREMOLAR
JOINT, ELBOW
JOINT, SCAPULOHUMERAL
PS - PROTOCOL SUMMARY for PGx Our team needs a domain to document the PGx design being used.
PERIANAL and PERIURETHRAL PERIANAL � Per Dorland�s Medical dictionary the definition is:
Near or around the anus. Synonym = CIRCUMANAL
PERIURETHRAL � Per Dorland�s Medical dictionary the
definition is: Occurring around the urethra.
The current terms available in the LOC codelist of ANUS and
URETHRA do not describe the area around the locations (i.e. the
skin surrounding the locations) and therefore they are not sufficient.
Update Cri to CRi The industry standard for Complete Response with Incomplete
Bone Marrow Recovery is CRi rather than Cri. The Complete
Response values have both the C and R captialized.
COMPLETE REMISSION WITH Please add the term 'COMPLETE REMISSION WITH
INCOMPLETE BLOOD COUNT INCOMPLETE BLOOD COUNT RECOVERY as a synonym to the
RECOVERY existing term Cri.
Please refer to attached reference:
http://bloodjournal.hematologylibrary.org/content/114/2/257/suppl/
DC1
File of 9 new terms for Procedure Hello,

codelist According to the term request website – multiple term request made
be made by e-mail via an excel, delimited text file or similar file.
Attached, please find our request for 9 terms to be added to the
Procedure codelist.
Please note – the instructions to submit a multiple term request gets
lost at the end of the request spreadsheet. Can the statement be
moved to the top and maybe provide a template that can be used as
it is not known exactly what it needed within a multiple term request.
Please add a lab test for Alpha-1 Please add a lab test for Alpha-1 Antichymotrypsin with a proposed
Antichymotrypsin with a proposed test test code of A1ANCHTR
code of A1ANCHTR
C64387, mmol/L, The PK Terminology C64387, mmol/L, The PK Terminology team would like to request
team would like to request that the that the definition be changed to: A unit of concentration (molarity
definition be changed to: A unit of unit) equal to one millimole of solute per one liter of solution.
concentration (molarity unit) equal to one
millimole of solute per one liter of
solution.
These three synonyms are inconsistent These three synonyms are inconsistent with ALL other countries in
with ALL other countries in the synonym the synonym list.
list.
All the requests are for new items in the I was about to enter several requests to add new terms to the
SDTM LBTEST / LBTESTCD lists CDISC controlled terminology when I noticed the message in the
footer suggesting that multiple requests be sent to this address in
an Excel spreadsheet of CSV. I have attached both types; the
contents are identical. All the requests are for new items in the
SDTM LBTEST / LBTESTCD lists. If you have any questions,
please do not hesitate to contact me. Thank you in advance for
your assistance in this matter.
Add new term "SYMPTOMATIC RECIST v1.1 indicates that Symptomatic Deterioration, defined as
DETERIORATION" global deterioration of health status ... without objective evidence of
disease progression, is a reason for stopping study therapy.
DEXA SCAN Please add the term DEXA SCAN to the Method Codelist with the
synonym 'Dual Energy X-Ray Absorptiometric Scan' and definition
'An imaging test that measures bone density (the amount of bone
mineral contained in a certain volume of bone) by passing x-rays
with two different energy levels through the bone. (NCI)'
Please consider adding the following Please consider adding the following terms: Hemolytic Index
terms Icterus Index
Lipemia Index
TEG Coagulation Index
Lipemia
Hemolysis
Icterus
Eosinophils Band Form Eosinophils Band Form A measurement of the banded eosinophils
Reticulocyte Distribution Width Reticulocyte Distribution Width
Please consider adding the following Please consider adding the following LBTEST, LBTESTCD:
LBTEST, LBTESTCD: Alpha-GST Excretion Rate
Fractional Calcium Excretion
Fractional Chloride Excretion
Fractional Phosphorus Excretion
Fractional Potassium Excretion
Fractional Sodium Excretion
Pi-GST Excretion Rate
Total Oxalate Excretion
Total Urine Albumin Excretion
Total Urine Calcium Excretion
Total Urine Chloride Excretion
Total Urine Creatinine Excretion
Total Urine Glucose Excretion
Total Urine Magnesium Excretion
Total Urine N-Acetyl-B-D-Glucosaminidase Excretion
Total Urine Phosphorus Excretion
Total Urine Potassium Excretion
Total Urine Protein Excretion
Total Urine Sodium Excretion
Please consider adding the following for hamster studies
term for SPEC: Cheek Pouch
Abdominal Cavity and Abdomen At Amgen, we inject our investigational product into the Abdomen
and we would prefer to use this term over Abdominal Cavity (where
Abdomen is listed as a synonym).
Semi-Recumbent Semi-Fowlers is a CDISC standardized term. According to
resources within Amgen, this isn't as widely used/accepted as
'Semi-Recumbent'. We would like to propose adding 'Semi-
Recumbent' to the Position code list. If that is not acceptable, please
make 'Semi-Recumbent' a synonym to 'Semi-Fowlers'.
At Amgen, we have gone through our lab As there are so many, I would imagine there will be some questions.
analytes and compared them to CDISC Please let me know if there are some. If you would rather get
equivalent terms. The attached together in a meeting, I can make sure that my colleagues here will
spreadsheet lists out all terms for which be in attendance as well to answer all questions.
we feel there is no CDISC equivalent.
BISCUIT A unit of the the number of biscuits given or observed.; Food

consumption studies esp. for large animals will sometimes
administer food in the form of biscuits (not frequent, but not
uncommon), with measurements being of the number of biscuits
present and the number of biscuits consumed. These numeric
measurements can then be statistically analyzed.
Please add new terms: PKPARMCD = Description
VZ, PKPARM = Vol Z; PKPARMCD = VZ: Volume of distribution based on a single steady-state dosing
VZF PKPARM = Vol Z by F interval. Computed as the Dose divided by the product of λz
and AUC from 0 to τ.
VZF: Relative volume of distribution based on a single steady-state

dosing interval. Computed as Vz divided by the fraction of dose
absorbed.
Reference for description: Helen Moore, PhD Senior Scientific

Consultant. Email Helen.Moore@certara.com
C25208-WEIGHT/Weight Suggest to update Submission value to BODY WEIGHT with

definition update since this term is really a measurement of body
weight and nothing else.
C25208-WEIGHT/Weight in OMTEST Suggest to update Submission value to ORGAN WEIGHT with

definition update since this term is really a measurement of body
weight and nothing else.
Codelists for Education Status and While working on project in Europe as well as with NIH in the US,
Employment Status there have been several requests for CDISC to re-explore codelists
for Education and Employment Status. Although differences will
exist between US and Europe, it is worth trying to synchronize as
FDA and EMA seek to work more closely together.
C103671 OABQ0119 Based on the article "Psychometric validation of an overactive

bladder symptom and health-related quality of life questionnaire:
The OABq. Quality of Life Research 563-574 (2002), the TEST and
TESTCD for OABQ0119 should be updated from:
Current: OABQ01-Caused You Anxiety and Worry

to
OABQ01-Caused You Anxiety or Worry
New Methods from Phil Pochon Synonym list will be E-mailled to Chris Tolk
Slice Thickness (Test Code: SLTHKT;
Percent Change Sum Diameters From
Bsln (Test Code: PCHSDBL); Percent
Change Sum Diameters From Nadir
(Test Code: PCHSDNAD) Please add the following test names, test codes and definitions to
the Oncology Tumor Properties codelists:
Slice Thickness (Test Code: SLTHKT)
Definition: The most common distance between the slices in the
sequence.
Percent Change Sum Diameters From Bsln (Test Code: PCHSDBL)
Definition: The sum of all non-nodal longest diameters and lymph
node target short axes lesions at a specified time point and
subtracting the sum of all non-nodal longest diameters and lymph
node target short axes lesions from the baseline, then dividing the
difference by the sum of all non-nodal longest diameters and lymph
node target short axes lesions from the baseline.
Percent Change Sum Diameters From Nadir (Test Code:
PCHSDNAD)
Definition: The sum of all non-nodal longest diameters and lymph
node target short axes lesions at a specified time point and
subtracting by the lowest value of all time points, then dividing the
difference by the lowest value of all time points.
(Code C100764) Questionairre Category
for Current Opioid Misuse Measure
(COMM)is inconsistent with COMM Test
QS Term Rule violation. Our actual preference for QSCAT would
Codes, according to QS term rules.
be:
Suggest change COMM to COMM1.
"COMM1: Current Opioid Misuse Measure" but we realize that does
not follow your rules.
Existing term is inconsistent with all other Inconsistency
terms for this questionnaire.
Code=C105288, Submission
Value="ADL106". All other
terms use the prefix ï¿½ADL01ï¿½.
Either change this term to
"ADL0106" or change the
prefix to ï¿½ADL1ï¿½ for all other Tests
APTTSTND and APTTSPTT These 2 terms (and associated LBTEST labels) appear to be
duplicated. The definitions are:
APTTSTND: A relative measurement (ratio or percentage) of the
subject's partial thromboplastin time to a standard or control partial
thromboplastin time.
APTTSPTT: A relative measurement (ratio or percentage) of the
subject's activated partial thromboplastin time to a standard or
control partial thromboplastin time.
Can you please confirm and clarify which one to use? I need this
fairly urgently for a study being actively mapped for submission now
so your priority would be appreciated. Please note that this query
was originally submitted on this form by Randall Austin on April 17
2012. Many thanks
Measles vs Rubeola I have a couple of Antibody tests for Measles (Rubeola):
Measles (Rubeola) IgG antibody
Measles (Rubeola) IgM antibody
I'm not sure whether the code should refer to Measles or Rubeola.
Please advise on new terms.
C84537 - ADENOMA, YOLK SAC, YOLK SACS TUMORS are not classified as ADENOMAS.
BENIGN should be renamed to YOLK
SAC TUMOR, BENIGN to be
harmonized/align with C3011 YOLK SAC
TUMOR, MALIGNANT.
C2797 - ADENOMA, ACINAR CELL, Please explain the difference in the definitions.
BENIGN and C2798 ADENOMA,
ADNEXAL, BENIGN both have the exact
same definition.
Sialyl SSEA-1 Antigen - Test Name Please add the term 'Sialyl SSEA-1 Antigen' to the Laboratory Test
Name Codelist and SLXAG to the Laboratory Test Code Codelist
with SLX as a syonynm for both terms. A reference for this term can
be found at: http://www.ncbi.nlm.nih.gov/pubmed/1683194
PLEURA Please add the term PLEURA to the Anatomical Location codelist.
The definition from the NCI website is: A thin layer of tissue that
covers the lungs and lines the interior wall of the chest cavity. It
protects and cushions the lungs. This tissue secretes a small
amount of fluid that acts as a lubricant, allowing the lungs to move
smoothly in the chest cavity while breathing.
FDA is removing the following dosage FDA is removing the following dosage forms from its SPL list:
forms from its SPL list: BEAD, IMPLANT, BEAD, IMPLANT, EXTENDED RELEASE; BLOCK; CEMENT;
EXTENDED RELEASE; BLOCK; CIGARETTE; CONE; CORE, EXTENDED RELEASE; CULTURE;
CEMENT; CIGARETTE; CONE; CORE, GENERATOR; GRAFT; GUM; GUM, RESIN; LINER, DENTAL;
EXTENDED RELEASE; CULTURE; PACKING; SUTURE; UNASSIGNED; DIAPHRAGM. CDISC to
GENERATOR; GRAFT; GUM; GUM, decide what (if anything) it wants to do with this information. Options
RESIN; LINER, DENTAL; PACKING; are to keep list as is or remove these to be consistent with SPL,
SUTURE; UNASSIGNED; DIAPHRAGM. though other parts of the agency and EMA may still be using and
needing this for submission.
Remove (FDA) attribution from 56 terms The FDA definitions were created by a group within FDA (Bill Hess)
in the Dosage form codelist. that has asked not to be attributed for the definitions.
Please consider adding the following
Avian specimen: BURSA OF
FABRICIUS, CROP,
PROVENTRICULUS, SYRINX, BURSA OF FABRICIUS: An epithelial outgrowth of the cloaca in
VENTRICULUS birds similar to the thymus in mammals. It atrophies within 6 months
after birth and remains as a fibrous remnant in adult birds. It is
composed of lymphoid tissue and prior to involution, is the site of B-
lymphocyte maturation.
CROP: a saccular diverticulum of the esophagus just anterior to the

entrance to the thorax. Present in all domestic birds. OR A crop
(sometimes also called a croup or a craw, or ingluvies) is a thin-
walled expanded portion of the alimentary tract used for the storage
of food prior to digestion.
PROVENTRICULUS: A thin-walled, glandular stomach found in

birds. It precedes the gizzard
SYRINX: The lower larynx in birds. The 'songbox' of a bird, situated

at the point where the trachea divides into two branches, each of
which connects with a lung. The vibration of a membrane within the
syrinx produces sounds. The adjective from 'syrinx' is 'syringeal'
Torr Please consider promoting the unit term "Torr" to its own term rather
than remaining as a synonym of "Millimeter of Mercury". Historically,
one torr was intended to be the same as one "millimeter of
mercury". However, subsequent redefinitions of the two units made
them slightly different (by less than 0.000015%). Thank you. Anna
Pron-Zwick/17-May-2013
Lysate suggestion plus any other additional information: Please consider

adding term "Lysate" as a specimen type. NCI Definition: The
cellular debris and fluid produced by lysis of a cell. NCI Thesaurus
Code: C62004. For example, lysate of red blood cells would be
used as the sample for testing in hemoglobin electrophoresis.
Thank you. Anna Pron-Zwick/17-May-2013
LBALL Ad defined in the STDM User Guide Version 3.1.2, the LBTESTCD
of LBALL is permissible when all parameters are Not Done,
however LBALL is not currently one of the choices for LBTESTCD
EGALL As defined in the SDTM User Guide Version 3.1.2, the EGTESTCD
of EGALL is permissible when all parameters are Not Done,
however EGALL is not currently one of the choices for EGTESTCD.
sCR; HI-E; HI-N; HI-P; mCR
Please add the following responses (with synonyms) to the Tumor

Response Result Codelist: sCR (stringent Complete Response), HI-
E (Hematologic Improvement - Erythroid Response); HI-N
(Hematologic Improvement - Neutrophil Response); HI-P
(Hematologic Improvement - Platelet Response); mCR (Marrow
Complete Response)
This is Internationsl Working Group (IWG) response criteria used in
our Oncology Trials for MDS (myelodysplastic syndromes)
AX ADaM would like to reserve/define AX for non-compliant ADaM
datasets
MULTIPLE and OTHER There are two terms missing from the published list, that are cited in
the SDTM Implementation guide and CDISC SDTM Training:
MULTIPLE (when someone selects more than one value) and
OTHER (when other is selected and value is provided that does not
correspond to the provided list). As this is a non-extensible list,
these should offically be added.
C32497 SEND would like to use this term in their Specimen codelist.
However, the current CDISC definition is too human-centric so they
suggested a change. Change Definition of Elbow Joint from A type
of hinge joint located between the forearm and upper arm. (NCI) to:
A joint involving the humerus, radius and ulna bones.
Asthma Devices: Spirometer, Peak Flow Asthma Team Request

Meter, Nebulizer
File emailed separately Please consider adding the virus terms in the file (eMailed
separately) to the SDTM Microorganism code list. Thank you. Anna
Pron-Zwick/29-May-2013
SUBCUTANEOUS NCI Definition - Beneath the skin.

Currently not covered in any of the existing anatomical location
terms.
CFAST ASTHMA TA Terminology See the attached excel spreadsheet for the new ASTHMA TA
terminology.
QS-MDQT which represent the Copyrighted questionnaire from: 1968, 1989, 1990, 1991, 1999,
Menstrual Distress Questionnaire (Form 2000, 2010 Rudolf H. Moos. All Rights Reserved. Published by Mind
T - Today) Garden, Inc., www.mindgarden.com
QS-SF36 which represent the Heath SF-36v2 Health Survey 1992, 2000 Medical Outcomes Trust and
Survey Quality Metric Incorporated. All rights reserved.
SF-36 is a registered trademark of Medical Outcomes Trust.
(SF-36v2 Health Survey Acute, United States (English))
New DAD questions Need to add the following new QSTESTCD/QSTEST's that are
listed on the CRF. Revised DAD QS Terminology spreadsheet was
sent to B. Yost for review by QS Controlled Terminology Team.
DAD0141 DAD01-Sub-Total Initiation Disability Assessment for
Dementia - Sub-Total Initiation.
DAD0142 DAD01-Sub-Total Planning & Organization Disability
Assessment for Dementia - Sub-Total Planning & Organization.
DAD0143 DAD01-Sub-Total Effective Performance Disability
Assessment for Dementia - Sub-Total Effective Performance.
DAD0144 DAD01-Total Score Disability Assessment for
Dementia - Total Score.
DAD0145 DAD01-Total % Disability Assessment for Dementia -
Total %.
QS-DLQI which represents the
This can be found at:
Dermatology Life Quality Index
http://www.dermatology.org.uk/quality/dlqi/quality-dlqi-
questionnaire.html
I can provide test codes and test names for each of the questions if
youwould like.
ADHD-RS
ADHD Rating Scale-IV Home Version(ADHD-RS); Reference:
Guilford Press, Checklists, Norms, and Clinical Interpretation
George J. DuPaul, Thomas J. Power, Arthur D. Anastopoulos, and
Robert Reid
1998; CRF:
http://www.healthchoiceaz.com/docs/providers/screeningtools/child
%20adhd%20rating%20screener.pdf
SDS Sheehan Disability Scale (SDS); Reference: Sheehan DV: The
Anxiety Disease, Charles Scribner & Sons, New York, 1983; CRF
Reference: http://www.cqaimh.org/pdf/tool_lof_sds.pdf
Type 1 2nd degree AV Block; Type 2 2nd Please add Type 1 2nd degree AV Block as a synonym to the
degree AV Block existing term of AV MOBITZ I
Please add Type 2 2nd degree AV Block as a synonym to the

existing term of AV MOBITZ II
Change c-code - Duplicate concepts Change C32509 to C12608
merged in NCIT
AGESPAN is currently not in 2013-04-12 AGESPAN is currently not in 2013-04-12 version of SDTM
version of SDTM controlled terminology controlled terminology but still in TSPARMCD codelist. Will the
but still in TSPARMCD codelist. Will the AGESPAN list be put back in next version?
AGESPAN list be put back in next
version?
File emailed separately
Hello, I will email the file separately. I am submitting these requests

on behalf of an AZ colleague (Angela Dymond). For questions about
the requested PK terms, please contact Angela. EMail address for
Angela Dymond is 'Angela.Dymond@astrazeneca.com'. Thank
you. Anna Pron-Zwick/13-Jun-2013
Hello, I will email the file separately. I am submitting these requests
on behalf of an AZ colleague (Angela Dymond). For questions about
the requested PK terms, please contact Angela. EMail address for
Angela Dymond is 'Angela.Dymond@astrazeneca.com'. Thank
you. Anna Pron-Zwick/13-Jun-2013
Please add a type for capillary blood. This is the specimen type sampled for a glucometer reading of
blood sugar. It is commonly used in our diabetes studies.
Summary (mean) PR duration - correct to

PR Interval; Summary (mean) QT Rationale:
duration - correct to QT Interval; EGCAT Definitions: Interval by definition is a the period of time marked off
should also be 'duration' and not interval; by or between two events, instants, etc. or the distance between
RR should also be Interval two points, objects, etc.
Duration - is Continuance or persistence in time.
Cardiac consultants standard reference is to PR,QT interval and
QRS duration. QUESTION: with the EGTEST as it is at present,
how are can we expect correct CRF completion when the SDTM
terminology is not in line with standard Protocol detail, nor standard
medical practice?
SR and IS Domain codes I will mail two back-up documents to the address above: The
proposal for the IS and SR domains. The current draft of the
Asthma TA User Guide, which includes information about Allergen
Skin Testing.
Domain code definitions. Fix all definitions where the two letter domain code is in the
definition to add the name of the domain in additions to the two
letter code. Example the SB and TR. Check all definitions.
ADME Combined study type - Absorption, Distribution, Metabolism,
Excretion
New Bacteria terms in Covance Enterococcus thailandicus

dictionary Atopobium rimae
Peptoniphilus harei
Odoribacter splanchnicus
Alistipes shahii
Megamonas funiformis
Arthrobacter cumminsii
Corynebacterium tuberculostearicum
Clostridium bolteae
Clostridium hathewayi
Fusobacterium naviforme
Tsukamurella pulmonis
MADRS Montgomery-Asberg Depression Rating Scale (MADRS);

Montgomery SA, Asberg M: A new depression scale designed to be
sensitive to change. British Journal of Psychiatry 134:382-389,
1979.; CRF www.cnsforum.com
TSPARM and TSPARMCD codelists For consistency it would make sense to update the definitions to
have identical definitions. start with something like 'The long name/short name of the….'
LBTEST and LBTESTCD codelists have For consistency it would make sense to update the definitions to
identical definitions. start with something like 'The long name/short name of the….'
VSTEST and VSTESTCD codelists have For consistency it would make sense to update the definitions to
identical definitions. start with something like 'The long name/short name of the….'
AURC to Last Nonzero Rate (C85571) The PK team will need to review and suggest edits to differentiate
and AURC All (C85841) in the PKPARM the two definitions.
and PKPARMCD codelists have the
same definition.
C85639 and C86594 in the The team will need to review and suggest edits to differentiate the
Microorganism codelist have the same two definitions.
definitions.
STRATFCT TSPARMCD=STRATFCT is listed in appendix C3 and therefore
should also be in the TSPARMCD and TSPARM controlled
terminology.
Addition to Anatomical Location NCI
C74456
To add PORTAL HILAR NODES.
There are 'HILAR LYMPH NODES' or 'PORTAL LYMPH NODE' in
C74456.
PORTAL HILAR NODES is a different location as confirmed by one
of our scientists:
Portal nodes (external-liver general) and hilar nodes (typically
within the lungs) are different concepts. PORTAL HILAR nodes is a
specific lymph node site (within the liver near the confluence of
vessels), and this is reasonable to consider separately.
Please could this term be added to this codelist.
OCCBLD - The definition is unclear OCCBLD - The definition is "A measurement of the blood in body
products such as a stool sample, not detectable on gross
examination." It is not clear whether this test also applies to a urine
sample, where blood may be detectable on gross examination. If
this does not apply to urine, what lab test code should be used for
urine blood?
NERVE A general term is needed as specificity of exact nerve is not always

captured. Per NCI a NERVE is: A bundle of fibers that receives and
sends messages between the body and the brain. The messages
are sent by chemical and electrical changes in the cells that make
up the nerve.
MUSCLE A general term is needed as specificity of an exact muscle is not

always captured. The Definition of MUSCLE is: a body tissue
consisting of long cells that contract when stimulated and produce
motion.
U Wave Abnormality Fix double space in the CDISC submission value.
pH PH is not a unit, it is a property. As we learned in first chemistry

class, pH is dimensionless, i.e. it does not have a unit.
BEATS/MIN Remove this term or replace by "/min". The CDISC team mixes up
property (beats of the heart) with the unit. Heart beat is to be
measured as a frequency, so the unit must be e.g. "/min" or "/sec".
BAR At primary school, I learned that "bar" is a unit of pressure.

According to the unit codelist, "bar" is defined by:
"A dosing measurement based on the bar unit".
What is meant here?
a) If it is meant to be the unit of pressure, please say so.
b) if not, the definition is circular, i.e. the unit is defined by itself.
That's not a definition
c) if it is meant to be something like a "bar of chocolate", it can
never be a unit. A unit (the word speaks for itself) should be the
same everywhere in the world. Is a bar of chocolate the same
quantity in Belgium as it is in the US as it is in Tokyo? I doubt so.
Once again, the CDISC CT team is mixing up an "object" (the bar)
with a "unit".
The same applies for a good number of other CDISC units which
are not units, like box, can, bottle, ... These are objects (parent
class being "container"), not units.
Semantically, taking these as units is completely nonsense.
All above TESTCD fields are not present All above TESTCD fields are not present currently in VS domain.
currently in VS domain. File emailed File emailed separately.
separately.
Additional SDTM QSTESTS based on I have reviewed this request with B. Yost and sent the QS
the GRID portion of the UPDRS CRF Terminology team a revised UPDRS Terminology spreadsheet with
these proposed additional Tests. Below is a summary of the EMAIL
correspondence I have on research why these fields need to be
added. Further details have been provides o the QS Terminology
Team.
It is not essential that an ADL in the presence of dyskinesias is
obtained. The important score is ADL due to PD when the patient is
at his worst (OFF) and when the pt is functioning at best (ON). For
those interested in knowing the impact of dyskinesias and obtaining
an ADL in the presence of dyskinesias, and ON score at worst
dyskinesia can be scored on the bottom row. The OFF score in the
dyskinesia row should be X�d out.
I hope this helps.
Stanley Fahn, MD
H. Houston Merritt Professor of Neurology/Columbia University
Director, Movement Disorder Division
Neurological Institute
710 West 168th Street
New York, NY 10032
U.S.A.
Phone 1-212-305-5277
Fax 1-212-305-3530
sf1@columbia.edu
http://www.movement-disorders.org/
Hi, Steve,
Your question is an interesting one. The S and E ADL scale
provides the opportunity to rate �% ADL (PD) best and worst � to
capture ADLs during the on and off states. The scoring sheet also
provides opportunity to rate �%ADL score (dyskinesias)� when
the patient has advanced PD with motor fluctuations and
dyskinesias.
I don�t recall using �%ADL score (dyskinesias)� much, if at all,
C50800 Within definition, should be '180 to 250' not '180 and 250'.
C102591 Add period at end of sentence.
C71066 Add period at end of sentence.
Please add the following result terms to

the list Please add the following result terms to the list with suggested test
code mapping:
Abnormality EGTEST mapping
UNUSUAL P AXIS SPRTARRY: Supraventricular Arrhythmias
TRIFASICULAR BLOCK IVTIACD: Intraventricular and Intra-
atrial Conduction
INCREASED VOLTAGE CONSISTENT WITH LEFT
VENTRICULAR HYPERTROPHY CHYPTENL: Chamber
Hypertrophy or Enlargement
T WAVE ALTERNANS STSTWUW: ST Segment, T wave, and
U wave
Modified Rabkin Scale QS Terminology This questionnaire is in the public domain - I have sent the verifica
File emailed separately File emailed separately
STRATFCT Stratification Factor. STRATFCT "Stratification Factor" . Stratification factor is referred in

Stratification factor is referred in the the SDTM Implementation Guide but it is not included in the SDTM
SDTM Implementation Guide but it is not code list.
included in the SDTM code list.
Add: Schwannoma, malignant Sample Definition from literature: A malignant neoplasm of the
peripheral nervous system composed of Schwann cells
demonstrating invasion of adjacent tissues and potentially
metastasis. Comment: The malignant version of a Schwannoma is a
well established neoplastic finding in Veterinary and Laboratory
animal pathology literature.
Add: Neurofibrosarcoma, malignant Sample definition from literature: A malignant intraneural or

extraneural neoplasm arising from nerve tissues and neural
sheaths, composed of perineurial-like fibroblasts and Schwann
cells.A malignant intraneural or extraneural neoplasm arising from
nerve tissues and neural sheaths, composed of perineurial-like
fibroblasts and Schwann cells. Comment: The malignant version of
a Neurofibrosarcoma is a well established neoplastic finding in
Veterinary and Laboratory animal pathology literature.
Add: Polyp, Benign Sample definition from literature: A benign polypoid neoplasm of a
luminal or mucosal lining projecting into a luminal space or cavity.
Comment: The endometrial stromal polyp, vaginal polyp and
inflammatory polyp do not cover all of the instances of benign polyp
in tissues of veterinary pathology
Add Carcinoid tumor, malignant or revise Sample definition from literature: A malignant neuroendocrine
current term to remove atypical. neoplasm arising from enterochromaffin cells in the gastrointestinal
tract and (less common) in the bronchi
Comment: Malignancy covers atypia and does not need to be in the
tumor term. Aypical is not part of the diagnosis used for laboratory
animal carcinoid tumors especially in the stomach of rats. This is
the only malignant tumor on the C DISC SEND list that has atypical
in the name of a malignant tumor (where is the typical one?)
Revise Carcinoid tumor, undetermined to from literature: A benign neuroendocrine neoplasm arising from
become Carcinoid tumor, benign. enterochromaffin cells in the gastrointestinal tract and (less
common) the bronchi.
Comment: We do not use undetermined, and if the cells are well
differentiated we need to be able to diagnose it as benign.
Add: Mesenchymal tumor, malignant Sample definintion from literature: A malignant soft-tissue of the
kidney neoplasm comprising two or more non-fibroblastic
mesenchymal lines of differentiation that is infiltrative and traps
tubules and glomeruli. Comment: Mesenchymal tumor is the
established name of the unique benign or malignant tumor in rats.
Sarcoma is too generic of a diagnosis and does not represent this
specific tumor in kidney. The benign version is already in SEND we
are just needing to add the malignant version.
Add Nephroblastoma, benign Sample definition from literature: A benign embryonal neoplasm of
the kidney.
Comment: Should be able to diagnose the benign version of the
nephroblastoma which is actually higher incidence than the
malignant version.
Add Trichoepithelioma, malignant Sample definition from literature: A malignant hair follicle neoplasm
with trichoblastic differentiation.
Comment: need the malignant version of this neoplasm.
Add: Melanoma, benign Sample definition from literature: A malignant????? neoplasm

composed of melanocytes.
Comment: This benign tumor is needed for skin and eye in
veterinary pathology.
Revise the leukemias to take off the word Revise the leukemias to take off the word "Acute". Tumors are not
Acute acute and chronic. This goes for acute monocytic, acute erythroid,
and others. No change in definition because there is nothing about
acute nature in the definition. Veterinary pathology does not use
acute in neoplasm terminology.
Add: Granulosa Cell tumor, benign Sample definition from literature: A benign neoplasm of the ovary,
originating from granulosa cells.
Comment: Relatively high use of the term at Merck for
carcinogenicity studies. Fischer rat book defines both benign and
malignant versions.
Codelist Code: C100167 To keep consistency across all versions of the C-SSRS. The new
submission values also provide more information of the original
question in the questionnaire without going beyond the character
limit.
Need to change CDISC Definition for an Need to change CDISC Definition for an recurring question in 4 C-
recurring question in 4 C-SSRS SSRS questionnaires. Please see attached file for details and
questionnaires. Please see attached file change suggestions.
for details and change suggestions.
Please consider adding the following Please consider adding the following new term; BONE, CARPAL
new term; BONE, CARPAL OR BONE, OR BONE, CARPUS
CARPUS
Please consider adding the following Please consider adding the following new term
new terms CHORDORMA, BENIGN
CHOLANGOFIBROMA
LEUKEMIA, LARGE GRANULAR LYMPHOCYTIC
MELANOMA, BENIGN
NEUROEPITHELIAL CARCINOMA, MALIGNANT
NEUROMYOBLASTOMA, MALIGNANT
PINEALOMA, BENIGN
PLASMA CELL TUMOR, BENIGN
SEMINOMA, BENIGN
Please consider adding the following These tissues are often weighed for studies.
terms: bulbocavernosus, levator ani,
levator ani/bulbocavernosus
Please consider adding LBTEST, This term was missed in first review, we only added the absolute in
LBTESTCD package 15 the total cells was overlooked. Please see original
"Monocytes/Macrocytes& request 10-04-2013. MONOMACE - Monocytes/Macrocytes/Total
quot; percent tests please. Cells
Please consider adding LBTEST, This term was missed in first review, we only added the absolute in
LBTESTCD package 15 the total cells was overlooked. Please see original
"Monocytes/Macrocytes" request 10-04-2013. MONOMACE - Monocytes/Macrocytes/Total
percent tests please. Cells
OMENTUM NCI defines as "A fold of the peritoneum (the thin tissue that lines
the abdomen) that surrounds the stomach and other organs in the
abdomen."
MULTIPHASE CT SCAN Not found in codelist or among new proposed terms from 2013-06-
28. Informal definition: repeated scanning before and after contrast
injection for a CT scan.
New York Heart Association Class Our Clinical Data Standards group declined adopting this new
Responses (codelist NYHAC) codelist because the codelist name included the word "Response."
Our company deploys the NYHA classification similar to ECOG or
KPS, which codelist names do not include the word "Response".
MPI utilizes all three performance/classification systems in the same
fashion - the physician assigns the score/class. However with
NYHA, there are two data collection methods - a physician assigned
and a patient response. There are many published studies
describing the disparities between these two types of results. It was
not evident to us through the definition provided which context the
CDISC term supports so we are maintaining our Millennium codelist
"NYHA Classification Scale" (to represent objective assessment by
the investigator; see www.heart.org about Class A, B, C, D based
on objective assessment). One might argue that an Evaluator
variable could be added to distinguish the source of the person
providing the results but our team took the position that including
the word "Response" in the codelist would represent that the original
result was patient-reported. Could the CT team please clarify this
codelist?
Please can you review the definitions for

BLOCKED; PARALLEL; PARTIALLY
BLOCKED BALANCED
Please add abdomen We require an anatomical location for reported abdominal pain. Until
diagnostics are performed, the cause of the pain could be located
either in the "Abdominal Cavity" (for which abdomen is currently
listed as a synonym) or the "Abdominal Wall" (which is not now
noted as a synonym). We feel that the more broad term is
necessary to accurately represent the reported symptom.
considering that we have a code for The Study Directors have indicated that these definitions are
QTcB and QTcF prolongation, it should confusing and that all of the designs based on their definition can be
also be considered adding a code QTcB used interchangeably based on SD interpretation. If we want
and QTcF shortening besides the currect standardization the definitions should be clear on which to select by
QTc shortening code. study type.
Tumorigenicity and Oncogenicity Dear Mr. Tolk, as requested in your e-mail of July 30th. I am
entering here the request to add the codes QTcB and QTcF
shortening.
HEMISPHERE, RIGHT and Tumorigenicity = the capability of causing tumors
HEMISPHERE, LEFT Oncogenicity = the capability of inducing tumor formation
STRIATUM Please add the terms HEMISPHERE, RIGHT and HEMISPHERE,

LEFT to the anatomical location codelist. These two locations have
distinct functions which would warrant distinguishing them as two
separate locations rather than as one locatoin of HEMISPHERE and
the laterality of Right versus Left.
The left hemisphere is the cerebral hemisphere located on the left
side of the corpus callosum. The left brain controls activities on the
right side of the body, and in humans, usually controls speech and
language functions. The thought processes of logic and calculation
are generally associated with the left brain.
The right hemisphere is the cerebral hemisphere located on the
right side of the corpus callosum. The right brain controls activities
on the left side of the body and, in humans, usually controls
perception of spatial relationships and the ability to recognize
common shapes and objects. The thought processes involved in
creativity and imagination are generally associated with the right
brain.
PRECUNEUS; STRIATUM (Synonym: Please add the submission values of PRECUNEUS and STRIATUM
NEOSTRIATUM) to the Anatomical Location codelist. These terms are needed for
PET Scan analysis in a clinical trial. Also, please add the term
NEOSTRIATUM as a synonym to the submission value of
STRIATUM.
PRECUNEUS definition - A division of the medial surface of each
cerebral hemisphere between the cuneus and the paracentral
lobule; it lies above the subparietal sulcus and is bounded anteriorly
by the marginal branch of the cingulate sulcus and posteriorly by the
parietooccipital sulcus.
DRIED BLOOD SPOT Please add the term DRIED BLOOD SPOT to the Specimen Type
codelist. This is a specimen that is made from a whole blood
specimen for analysis. This is a similiar concept of a processed
specimen used for analysis as the existing term of PERIPHERAL
MONONUCLEAR BLOOD CELL.
Skin This request is made on behalf of the Asthma TA team. The
specimen type would be used for the SRSPEC variable as the
specimen type for an allergen skin test.
A controlled term for in the SEND SPEC A controlled term for in the SEND SPEC list is needed for Tympanic
list is needed for Tympanic Bulla. This Bulla. This concept is shown in the nci metathesarus as a snomed
concept is shown in the nci metathesarus preferred term. We have a client who does gross observations on
as a snomed preferred term. We have a this tissue, and we need an appropriate SPEC entry for it.
client who does gross observations on
this tissue, and we need an appropriate
SPEC entry for i
A controlled term for Ocular in the SEND A controlled term for Ocular in the SEND list is needed for Ocular
list is needed for Ocular adnexa. This adnexa. This concept is shown in the nci metathesarus as a
concept is shown in the nci metathesarus snomed synonym. We have a client who does gross and micro
as a snomed synonym. We have a client observations on this tissue, and we need an appropriate SPEC
who does gross and micro observations entry for it.
on this tissue, and we need an
appropriate SPEC entry f
Two new terms: 1. L2-L3 Intervertebral Use case: When a subject comes in for lumbar puncture for the
Space 2. L3-L4 Intervertebral Space purposes of CSF collection, the sample is collected via a spinal
needle that must be inserted between the either the L2-L3
Intervertebral Space, or the L3-L4 Intervertebral Space. We need
terminology to represent these intervertebral spaces in controlled
terminology
TRTESTCD = 'PAXIS' (TRTEST = We propose this addition to capture bi-dimensional measurements

'Perpendicular Axis') in target lymph node(s). PAXIS would be to SAXIS as LPERP is to
LDIAM for non-nodal tumor measurements. Using existing
terminology as a guide, the proposed definition is: The plane
through a body or figure that is at a right angle to a given plane.
PERIVENOUS This a term request to add to SEND for ROUTE. There is not an
appropriate term currently in the CDISC CT to map perivenous too.
A synonym would be paravenous.
Other I am requesting that "Other" be removed as a CDISC term for
ROUTE in SEND. The ROUTE is an extensible list so unpublished
terms can be added which would be more useful for submission
purposes. When "Other" is available, it is appears that it should be
used versus adding a more descriptive user defined code.
Other in SDTM-FREQ I am requesting that "Other" be removed as a CDISC term for FREQ
in SEND. The FREQ is an extensible list so unpublished terms can
be added which would be more useful for submission purposes.
When "Other" is available, it is appears that it should be used
versus adding a more descriptive user defined code.
Add Field to Capture Virus Strain Please consider adding a field for viral strains in the SDTM
Microorganism domain. Immediate intended use: to assist in the
identification of various strains of the Influenza virus. This field has
been defined in the Virology domain and could be extended to the
Microorganism domain. Thank you. Anna Pron-Zwick/21-Aug-2013
LARGE - Edit to definition The SEND Repro team would like to add the term Large to its
Result Findings codelist. CDISC has previously published this term
in the SDTM-SIZE codelist and the Repro team reviewed the
existing CDISC definition. They would like to edit the definition to
include the fact that 'Large' is still in proportion. Suggested definition
update: Of considerable or relatively great size, extent, or capacity,
but normally proportioned. (NCI)
HEMOLIZED CDISC Submission Value, HEMOLIZED, for Code C70720 appears

to be spelled incorrectly. Shouldn't this be HEMOLYZED? Note:
Synonym = Hemolysis in Specimen
Add MRI WITHOUT CONTRAST Some studies collect MRI as method when no additional detail is
needed. Some studies need to know whether a contrast agent was
used and we collected this as MRI WITH CONTRAST and MRI
WITHOUT CONTRAST until recently. We have now adopted
CDISC's CONTRAST ENHANCED MRI term. But there is still a
need to collect and tabulate MRI WITHOUT CONTRAST to
distinguish it from MRI (not otherwise specified). We ask that you
consider adding this term to SDTM-METHOD.
Foot-pound Foot-Pound (ft.lb) is a unit of work equal to the work done by a force
of one pound acting through a distance of one foot in the direction
of the force. It is one of the units out of the Quantitative Muscle
Testing Devices.
File emailed separately.
MOBILE CARDIAC TELEMETRY
The MCT system automatically collects and transmits ECG
waveforms and heart rate
wirelessly upon detection of pre-defined cardiovascular events to a
remote monitoring center,without requiring direct patient interaction.
The investigator will be notified by the remote MCT center about
reportable events, additional recordable events may be captured by
the MCT system but the investigator will not be notified.
umol/min Needed for laboratory result for glycerol using glycerol tracer and
microdialysis.
Medial femoral condyle; Lateral humeral File emailed separately. This request is to add new terms to SDTM-
epicondyle LOC.
mmol/mmol mmol/mmol unit is used for lab test USOCRR (Urine Sodium
Creatinine Ratio).Similar test in SDTM is 'NACREAT'. We have
typically always received this data in mmol/mmol. The nmol/mmol is
not the standard SI unit typically used.
Additional terms for NPI Scoring fields It was decided to add scoring items from the NPI Manual into QS
terminology. Terms sent to NciEvsCdiscHelp@mail.nih.gov. in an
attachment
Add ND- No Disease ( this is not part of Vendors send ND to us when patients are recruited for a trial but
any criteria); Add NN and IR/SDas imaging tests cannot find any evidence of disease. They also send
synonym to NonCR/NonPD NN and IR/SD so having these be included as official sysnonyms
will help us automate the standardization of the terms.
I would also like the CDISC Terminolgy team to confirm that ND or
No Disease can be either specific to oncolgy or if it has applicability
outside of oncology. There is always the pssoiblity that other
therapeutic areas might start using the RS domain.
difference between Protocol Deviation, During the 2013 DIA, there was a session of Q&A regarding the
Important Protocol Deviation and CSR (Attached) where in Question 7 (Q7, Page 9) the question is
Protocol Violation raised on the difference between Protocol Deviation, Important
Protocol Deviation and Protocol Violation.
The answer in A7, of which part is displayed below, seems to
encourage sponsors to replace the phrase �protocol violation � in
Annex IVa with �protocol deviation�.
In the CDISC/NCI Terminology, the word �Protocol Violation� is
used.
C48251 C66727 Completion/Reason for Non-Completion
PROTOCOL VIOLATION An event or decision that stands in
contrast to the guidelines set out by the protocol. (NCI)Excerpt from
the attached document.
-------------------------------------------------------------
Protocol violation and important protocol deviation are sometimes
used interchangeably to refer to a significant departure from
protocol requirements. The word violation can also have other
meanings in a regulatory context. However, in Annex IVa of the ICH
E3 guidance (Disposition of Patients), the term protocol violation
was intended to mean only a change, divergence, or departure from
the study requirements, whether by the subject or investigator, that
resulted in a subject�s withdrawal from study participation.
(Whether such subjects should be included in the study analysis is a
separate question.)
To avoid confusion over terminology, sponsors are encouraged to
replace the phrase �protocol violation� in Annex IVa with
�protocol deviation,� as shown in the example flowchart below.
Sponsors can also choose to use another descriptor, provided that
the information presented is generally consistent with the definition
of protocol violation provided above.
---------------------------------------------------------------
Because of this answer in the DIA, our Clinical team is reasoning to
change the Protocol SOP with the wording �Protocol Deviation �.
So the question is:
1. Should �Protocol Deviation� also be an allowable
submission value for this controlled terminology?
2. As per this ICH guideline should we consider replacing
INDIC/Trial Indication This concept is coded to the term 'Indication' in NCIt. Is the level of
granularity correct or do we need to create a specific term (new c-
code) for Trial Indication, as a child of Indication? The devices team
wants to use Indication in a codelist and were uncomfortable with
the idea of adding Trial Indication as a synonym.
Attached file consists information for File emailed separately

multiple term request for EGTEST
codelist.
BARBITURATE OVERDOSE Barbiturate overdose (primary method) and Exsanguination
INTRAVENOUS AND (secondary method) of termination used.
EXSANGUINATION With barbiturate overdose intravenous the barbiturate is the cause
of death. Cutting blood vessels afterwards results in partial
exsanguination as the heart is still beating, but the animal is already
dead.
Add a QSTESTCD for the total score that Add a QSTESTCD for the total score that is collected on the
is collected on the questionnaire. questionnaire. Likewise add a corresponding QSTEST value.
Add QSTESTCD = COWS101A Add QSTESTCD = COWS101A to hold the numeric pulse value
collected on the questionnaire. (The currectly-defined COWS101
QSTESTCD holds the score for the pulse.) This also requires the
addition of a corresponding term to the QS-COWS TEST codelist.
Propose "COWS1-Resting Pulse Rate beats/minute".
PK Terms for Package 15 - please see PK Terms for Package 15 - please see attached spreadsheet
attached spreadsheet
PK Terms for Package 16 - please see PK Terms for Package 16 - please see attached spreadsheet
attached spreadsheet
Abnormality Please add a new EGTEST=Abnormality and

EGTESTCD=ABNORMAL for the EG domain. These new terms are
being requested to handle the "check that all apply" boxes on a
CRF, where there are multiple configurations of how pre-specified
abnormalities on an ECG are reported. The SDSLT suggested
having a generic term to handle this.
Code C71043 from Codelist C71150 The code C71043 (ECTOPIC SUPRAVENTRICULAR RHYTHM)
from Codelist C71150 has disappeared between SDTM
Terminology 2013-04-12 and 2013-06-28. I don't know where to
find a change log on the NCI terminology page. Maybe this change
was intentional and I missed something ?
Proventriculus Proventriculus
GIZZARD SEND team suggests that work needs to be done on this term,
invconjunction with developing the term of Ventriculus (which was
pulled out of P15 for more review).
C90400; C90401 Possible suggested update to definition as discussed by SEND
team on 2013-09-20: A method of euthanasia in which barbiturate is
administered intravenously/ (with or without prior anesthesia) to
induce respiratory arrest. Following death, partial exsanguination
may occur.
'Butterflies' misspelled in Submission and Spelling error
Synonym values for NPITEST
(Code=C100662) and for the Synonym
value for NPITESTCD (NPI1E04)
Oncology_Modify_Term_Request_Packa Please see attached document
ge16 Oncology_Modify_Term_Request_Package16
Please consider the following Please consider the following LBTEST/CD: Sulfur Dioxide - SO2
LBTEST/CD: Sulfur Dioxide - SO2
Non-Measureable Assessment File emailed separately.

Response = Terminology relevant to the
test codes that describe an assessment
of non-measurable response to
treatment or therapy.
C111335; C111336; C111337; C111338; Remove single quote from codelist short name in QS file. From Lex
C111339; C111340 Jansen-having a small challenge with my programs because there
is a single quote (') in a CDISC submission value for the codelist.
From EM-Since the codelist short name has already been
shortened, it is probably unneccessary to have the 's in there
anyway.
copies/5uL; LOG10 IU/mL This is from the Virology IG.
FRESH - definition: Not previously used.; This is being requested by the Virology Terminology Team. It was
PARAFFIN-EMBEDDED - definition: in the Virology IG.
Pertaining to being preserved in paraffin.
C98800 Add ',BENIGN' to end of CDISC submission value: ADENOMA,

ZYMBAL'S GLAND
INTERPHALANGEAL JOINTs and CDISC LOC CT has the set of INTERPHALANGEAL JOINTs and
PROXIMAL INTERPHALANGEAL JOINT PROXIMAL INTERPHALANGEAL JOINTs. These are named the
same in the hand or foot, but the definitions in the CT are specific to
the hand in one case and the foot in the other. Please change the
definitions so they aren't hand/foot specific
The Submission Values and Synonyms The Submission Values and Synonyms do not follow the QS
do not follow the QS Naming Rules. I Naming Rules. I have sent a file to the above email address.
have sent a file to the above email
address.
CYLCELL A qualitative measurement of the cylindrical cells in a biological
specimen.
Multiple term request. File emailed separately for the above mentioned terms.
Hemoglobin A1C/Total Hemoglobin: A Hemoglobin A1C/Total Hemoglobin: A relative measurement (ratio

relative measurement (ratio or or percentage) of the glycosylated hemoglobin to total hemoglobin
percentage) of the glycosylated in a biological specimen.
hemoglobin to total hemoglobin in a
Vital Signs Test Code Update definition of Hip Circumference and Waist Circumference in
SDTM Terminology to provide clarity in how these measurements
should be taken.
"File emailed separately".
UPD2315B (Test value=UPD2-Postural These 2 QSTESTCD / QSTEST values are currently missing from
Tremor of Left Hand) and UPD2316A the MDS-UPDRS codelist.
(Test value=UPD2-Kinetic Tremor of
Right Hand)
mmol/mol HGB Millimole Per Mole of Hemoglobin: A unit of substance concentration
defined as the concentration of millimoles of solute per mole of
hemoglobin.
Dominant Hand New SCTESTCD and SCTEST to record dominant hand

CV Endpoints Data Standards Controlled I have created the CDISC CT spreadsheet for all necessary fields
Terminology in the project. B. Yost is in the process of forming the CV
Terminology Team and will start meetings on Tuesday's 1:)) EST to
review these terminology needs; I have sent the spreadsheet to
Bernice for these meetings;
DOMAIN codelist for SDTM. Replace SR We need to try and adhere to the guiding principles for CDISC.
domain with SK domain which is already 1. Keep the number of domains down whenever possible. This can
in the Terminilogy released in June, be done by expanding the amount of information that can be
2013. Make sure that the description for collected and stored in a domain.
the SK domain is broad enough to collect 2. The description of the domain should adequately describe what
all types of findings for skin. can be stored without inadvertantly constraining the information that
can be stored.
3. Try to keep the domain code names as stable as possible.
SL Domain Please modify Sleep domain to extend to all sleep data that is
collected in these type of studies.
Suggested defintion for SL domain"
"Subjective and objective (Polysomnography) measures of sleep

disturbance and functionality".
mg/mL/min Please add the unit mg/mL/min to the Unit codelist with the
synonym Milligram per Milliter per Minute and the definition: A dose
calculation unit expressed in milligram(s) per milliter(s) per period of
time equal to sixty seconds. This unit is used with the drug
Carboplatin in Oncology trials.
Protocol Milestone Codelist: two entries Protocol Milestone Codelist: two entries - Informed Consent
- Informed Consent Obtained and Obtained and Randomized
Randomized
sent a list to Dear CDISC/ NCI,
NciEvsCdiscHelp@mail.nih.gov other
comments are below for consideration. I am providing a spread sheet in conduction with the online
terminology request form to the above email. Here are a few
comments that can also contribute to your team discussions. Both
my fellow requestor and I are available for discussions if needed.
ECG Results: Lilly standardized how our vendors read ECGs in

1999 and we have several results that do not fit into the list provided
by CDISC. As I understand it, this list is extensible so we would like
to propose that CDISC add a few more terms to this listing.
Attached you will find our recommendations. This request includes
suggestions to add the following (and the document provides
suggested definitions):
� Junctional Escape Complexes
� Undetermined Rhythm
� Other Rhythm
� Asystole
� Aberrant Conduction
� Other Conduction
� Low Voltage in Limb Leads
� Other Morphology
� Cannot Rule Out Possible Transmural Myocardial Infarction
� Evolving Acute Right Ventricular Myocardial Infarction
� Age Undetermined Right Ventricular Myocardial Infarction
� Probable Hypercalcemia
� Probably Hypocalcemia
� PR Segment Depression
ECG Overread Method ECG Overread Method: I believe the Field Name (ECG Overread
Method) and the Explanation (The ID of the lead(s) that was used
for the interpretation of the cardiologist) are not appropriate. I
believe what you are really looking for here is the �Lead used for
interval measurement� based on the examples you have provided.
In my opinion the interval measurement is usually conducted in a
single lead or a median beat. However, the actual over read or
interpretation must consider all leads and this provides qualitative
assessments of the ECG and this cannot be accomplished by
looking at the median beat. Can the Field Name and Explanation
be changed to clarify what you expect in this field?
Please consider adding the terms Please consider adding the terms:Abdominal Fluid Other;
Abdominal Fluid Other Percent; Azurophilic Granulations; BAL
Others Percent; CSF %Others; Eosinophils Band; Eosinophils Band
(n); Heterophils; Heterophils (SI); Heterophils Percent; High
Absorption Retic Count; High Absorption Retic Count Percent; Iron
Saturation Percent (Calc); Low Absorption Retic Count; Low
Absorption Retic Count Percent; Med Absorption Retic Count; Med
Absorption Retic Count Percent; Microfilaria; Oxalate (SI Calc) /
Urine Creatinine (SI Calc) Ratio; Pericardial Fluid Other; Pericardial
Fluid Other Percent; Pleural Fluid Other; Pleural Fluid Other
Percent; Protozoa; Retic Distribution Width; Reticulocyte
Corpuscular Hemoglobin Concentration Mean; Reticulocyte
Corpuscular Hemoglobin Content; Synovial Fluid Other; Synovial
Fluid Other Percent; Urine Aspartate Aminotransferase / Urine
Creatinine Ratio; Urine Other; Urine Protozoa; Urine Uric Acid/Urine
Creatinine Ratio
benign acinar-islet cell tumor; benign acinar-islet cell tumor; ASTROCYTOMA, BENIGN;
ASTROCYTOMA, BENIGN; GRANULOSA CELL TUMOR, BENIGN; OLIGODENDROGLIOMA,
GRANULOSA CELL TUMOR, BENIGN; BENIGN; SCHWANNOMA, MALIGNANT; polyp, benign;
OLIGODENDROGLIOMA, BENIGN; EPENDYMOMA, BENIGN; chordoma, benign; Plasma cell tumor,
SCHWANNOMA, MALIGNANT; polyp, malignant
benign; EPENDYMOMA, BENIGN;
chordoma, benign; Plasma cell tumor,
malignant
Pancreatic Lipase Currently LBTEST C64807 �Triacylglycerol Lipase� is defined as

�A measurement of the pancreatic lipase in a biological
specimen�.
Our LBTEST is for pancreatic lipase is in agreement with the

definition for C64807, but the method does not pick up
triaclyglycerol.
A new term should be added called �Pancreatic lipase� with the

definition �A measurement of the pancreatic lipase in a biological
specimen�.
In addition, the term �Triacylglycerol Lipase� could remain but the
definition should change to �A measurement of the triacylglycerol
lipase in a biological specimen�.
Change the submission value to Change the submission value to UNKNOWN for C17998.
UNKNOWN for C17998 in STENRF
UNKNOWN for C17998 in NY
UNKNOWN for C17998 in SEX
UNKNOWN for C17998 for CVRPCIND
dpm, disintegrations per minute, A unit of dpm, disintegrations per minute,
radioactive decay expressed in atoms of A unit of radioactive decay expressed in atoms of radioactive
radioactive material that decay over a material that decay over a period of time equal to sixty seconds.
period of time equal to sixty seconds. (NCI)
(NCI)
pixel; The smallest resolvable pixel; The smallest resolvable rectangular area of an image, either
rectangular area of an image, either on a on a screen or stored in memory.
screen or stored in memory.
C9477 has an extra space before the inconsistent form of term
comma in the second part of the term:
ASTROCYTOMA, ANAPLASTIC ,
MALIGNANT
Please see attached spreadsheet. Please see attached spreadsheet.
CDASH should match SDTM exactly. CDASH should match SDTM exactly.
C90003 Change CDISC Codelist name and Synonym to SEND Study Type.
It is causing programmatic issues in SHARE due to the fact that the
CDISC synonym is identical across both the SEND Study Type
codelist and SDTM Study Type codelist.
C45908 The submission value of UN
should be changed to Undifferentiated. C45908 The submission value of UN should be changed to
Undifferentiated.
"Trial Phase Codelist - NA should
be NOT APPLICABLE C48660; No Yes
Trial Phase Codelist - NA should be NOT APPLICABLE C48660;
Response Codelist - NA should be NOT
No Yes Response Codelist - NA should be NOT APPLICABLE;
APPLICABLE; Tumor Response Result
Tumor Response Result Codelist - NA should be NOT
Codelist - NA should be NOT
APPLICABLE
APPLICABLE
I have attached a spreadsheet. I have attached a spreadsheet.
There are two codelists with the same There are two codelists with the same name of Study Type. The
name of Study Type. The codelists codelists names should be changed to SDTMIG Study Type and
names should be changed to SDTMIG SEND Study Type.
Study Type and SEND Study Type.
CMTRT
CMTRT is defined as, "Reported Name of Drug, Med, or Therapy".
With the new Procedure Domain would the CMTRT definition
change to just "Reported Name of Drug, or Medication" As a
Therapy might be considered a procedure?
Thanks,
Lacey
MEDIAL and LATERAL should be on Both appear to be related directional terms.
same codelist. Currently on is on the
laterality codelist and one is on the
directionality codelist.
IL28BGEN The test result indicates whether the patient has an IL28B CC, CT,
or TT genotype. The IL28B genotype test can be used to predict
response to peg-IFN and RBV in HCV genotype 1 patients.
IL28B Genotype The test result indicates whether the patient has an IL28B CC, CT,
or TT genotype. The IL28B genotype test can be used to predict
response to peg-IFN and RBV in HCV genotype 1 patients.
MICROORG File Emailed Separately Please see the attached spreadsheet to consider for Creation of
New Terms to the Microorganism codelist (SDTM-MICROORG).
The spreadsheet contains the requested submission value as well
as synonym(s), where applicable. The terms are fungal organisms
for addition to the Microorganism codelist.
cells/kg Needed to document the quanity of cells/kg in a CD34 graft.
ERYTHROCYTES We need a new lab test code or a new specimen type code for the
lab test "RBC Folate". There is a lab test for Folic acid - that is
VITB9 with synonym "Folic Acid; Vitamin B9". There are separate
tests available for folate in plasma and folate in RBCs. There is no
specimen controlled terminology for RBCs or erythrocytes so if we
used the same LBTESTCD the fact that the analyte is being
measured in RBCs would not be clear. propose adding SPECTYPE
"ERYTHROCYTES" with synonym "Erythrocytes; Red Blood Cells;
RBCs". The other alternative is creating a new LBTESTCD
specifically for RBC Folate. Folic acid can be measured in the liquid
portion of blood (plasma). Folic acid can also be measured as the
amount in the red blood cells. This test may be a better way than
the plasma test to measure the amount of folic acid stored in the
body.
BACTERIAL ISOLATE To support an MTB biorepository. The form is asking for Mtb
Isolate/Subculture, but I think it's unrealistic to think that the culture
will always be genus/species ID'd and even if it is that information
should probably be stored elsewhere.
Thinking further along these lines, if the terms was simply ISOLATE
that would probably be okay for our purposes.
CDR0109 CDR01-Behavior Component Codelist Name CDISC Submission Value CDISC Synonym(s)
and Personality; CDR0110 CDR01- CDISC Definition NCI Preferred Term
Langiage Clinical Dementia Rating - Clinical Dementia Rating Test Code CDR0109 CDR01-Behavior
Language Component and Personality Clinical Dementia Rating -
Behavior Component and Personality Clinical Dementia Rating -
Behavior Component and Personality
Clinical Dementia Rating Test Code CDR0110 CDR01-Langiage
Clinical Dementia Rating - Language Clinical Dementia Rating -
Language
The approved copyright CDR CRF has 2 additional questions on

page 2 that need to be added as new QS Terminology
Please add 'Intentional right sided leads'. Please add "Intentional right sided leads". This request comes from
This request comes from the ECG the ECG terminology team
terminology team
It appears that the new EGTEST Term code=C111131 (AVCOND)
Submission Values added in the Term code=C111132 (AXISVOLT)
10/4/2013 release are actually Term code=C111155 (CHYPTENL)
EGTESTCD values. They shouldbe Term code=C111238 (IVTIACD)
updated with the long text 'decode' Term code=C111280 (MI)
values. Term code=C111285 (PACEMAKR)
Term code=C111307 (RHYNOS)
Term code=C111312 (SNRARRY)
Term code=C111320 (SPRARRY)
Term code=C111321 (SPRTARRY)
Term code=C111363 (STSTWUW)
Term code=C111330 (VTARRY)
Term code=C111331 (VTTARRY)
Cholera Toxin B Subunit IgG Antibody A measurement of the Cholera Toxin B Subunit IgG Antibody in
(TESTCD: CTBIGGAB) serum after the administration of the recombinant cholera toxin b
subunit vaccine.
mV^2/Hz Please add the term mV^2/Hz with the synonym millivolt^2/hertz.
This unit is used in PSG sleep studies.
ELECTROENCEPHALOGRAPHY and Please add the terms ELECTROENCEPHALOGRAPHY (with the

POLYSOMNOGRAM synonym EEG) and POLYSOMNOGRAM (with the synonym PSG)
to the method codelist. Both of these methods are used in sleep
studies.
CVEXAM and CVEXAMCD additions will File emailed separately
be sent via an excel file.
These terms come from the examples File emailed separately. These terms come from the examples used
used in the Alzheimerâ€™s Disease in the Alzheimer’s Disease User Guide v2.
User Guide v2 Anatomical Location: PRECUNEUS, PONS VAROLII
Unit: GAUGE
Device-In-Use: Weighting, Interslice Spacing, Pixel Spacing X,
Pixel Spacing Y, Inversion Time, Number of Slices, Acquisition
Type, Decay Correction, Randoms Correction
Morphology [NEW]: Volume, Thickness, Boundary Shift Integral
Nervous System Physiology [NEW]: Standard Uptake Value Ratio
Device Properties [NEW]: Size, Composition, Degree of
Multiplexing, Coil Type, Detector Scintillation Crystals, Temperature
Pharmacogenomics Findings [NEW]: Allele
Multiple term request for CVEXAM and File emailed separately

CVEXAMCD codelists
Suggested new SPEC terms for Repro These are terms we came across in our analysis of protocol or
Tox (Fetal Gross Pathology): procedural organ/tissue/structure for Fetal Gross Pathology that we
could not find in the SPEC codelist.
New Codelist: "Nonclinical DART To be used in the SEND Repro Tox implementation domain, Trial
Trial Phases" (NCDPHASE) Paths (where PHASE(S) will be specified).
FAILURE TO MEET RANDOMIZATION For the studies which is not Randomized, can we have different
CRITERIA term? For example, FAILURE TO MEET
RANDOMIZATION/REGISTRATION CRITERIA
Add Percent Iron Saturation to LBTEST There's currently not a term avaiable for Percent Iron Saturation
and corresponding test code FESATP for test.
SEND. Proposed definition would be: A
relative measurement (ratio or
percentage) of total iron binding sites
occupied by iron in a biological
specimen.
Please modify the Submission term for: All thrombocytes are nucleated by definition; they are nucleated
C111283 platelets.
Please consider adding the following Please consider adding the following term:
term: RBC Fragment (Other) LBTEST: RBC Fragment (Other)
LBTEST: RBCFRAGO
Defintion: Red Blood Fragment not typical of schistocyte
Please remove "MUSCLE, Please remove "MUSCLE, DISTAL" and "MUSCLE, PROXIMAL" as
DISTAL" and "MUSCLE, distal and proximal should go in --DIR
PROXIMAL" as distal and proximal
should go in --DIR
With SEND 3.1, the CV and RE domains It is anticipated that any other terms currently on the VSTEST and
will be published. When that happens, VSTESTCD codelists will be submitted in the CV or RE domains
we would like to remove the VSUNIT, and appropriate terms have been added to those test/code name
VSTEST and VSTESTCD codelists from codelists to cover.
the SEND terminology.
We would like to add 2 SEND specific Codelist Definition: The name given to the test code/name that
VS codelists, one for VSTEST and one analyzes a vital sign in nonclinical studies.; Codelist Long Name:
for VSTESTCD that only reference the SEND Vital Signs Test Name; Codelist Short Name:
TEMPERATURE/TEMP term (as SVTEST/SVTESTCD
published with the existing SDTM
codelist).
Combinations of CD markers are not yet Below is a communication from one of my colleagues working with
included in CDISC CT immunophenotyping as endpoints in his tox-studies. He is trying to
come up with some good rules for how we should be referencing
the LBTESTs. I thought his rationale might be of interest to the CT
team once they start looking into this:
“Combinations of CD markers are not yet included in CDISC CT.
We may just await a standard or we could proactively suggest a
naming convention. In the data set provided by one source “/” has
two meanings in the test names concerning CD markers. The use to
yield relative counts (similar to already defined CDISC CT tests)
makes the use as separator for CD markers undesirable. This is
further underlined by looking at CDISC NCI code C82007
expressing the ratio between CD4 and CD8 cells as “CD4/CD8”. I
Would personally prefer “CD3+CD4+CD25+/Lymphocytes” or even
better “CD3+,CD4+,CD25+/Lymphocytes” before
CD3/4/25/Lymphocytes. It is noted that in some instances the a cell
population is defined by the absence of a marker, in which case the
wish would be to note the exclusion by”-“ instead of “+”. This would
not be possible in the absence of +/- markers.
Further, considering LBTESTCD, 8 characters will inevitably at
some occasions prove insufficient to hold all information regarding a
combination of CD markers. Thus, the effort to keep meaning to
LBTESTCD will likely fail at some point, and it might be worth to
consider other alternatives. ”
SDTMIG Domain Abbreviation Change codelist name and synonym to SDTM Domain Abbreviation.
This change was agreed upon to be implemented with P16
terminology by the general team on 2013-11-22
Myeloperoxidase Index Laboratory Test Code: MPXI
Laboratory Test Name: Myeloperoxidase Index
Defintion: The mean peroxidise activity index or staining
intensity of the neutrophil population relative to the archetype
/10^3 RBC A unit of cell concentration expressed in cells per thousand RBCs.
Tartrate-Resistant Acid Phosphatase 5b This request is to add the following for SEND CT.
LBTESTCD = TRAP5B
LBTEST = Tartrate-Resistant Acid Phosphatase 5b
Definition = A measurement of Tartrate-Resistant Acid Phosphatase
5b in a biological specimen.
Additional info: TRAP5b is the specific form of this enzyme used as
bone marker so we have to use "5b".
SKIN OF THE HEAD, SKIN OF THE Requesting the addition of SKIN OF THE HEAD, SKIN OF THE
NECK, SKIN OF THE AXILLA NECK and SKIN OF THE AXILLA for clinical trials capturing skin
lesions. The locations of HEAD, NECK and AXILLA exist but they
do not capture the fact that the lesions are on the skin for these
regions of the body.Currently the terms SKIN OF THE TRUNK and
SKIN OF THE LIP exist so requested using a similiar format.
Add to QSCAT codelist, C-SSRS Add to QSCAT codelist, C-SSRS Pediatric/Cognitively Impaired
Pediatric/Cognitively Impaired Lifetime/Recent
Lifetime/Recent
SOFT TISSUE The term SOFT TISSUE originally existed in the Anatomical
Location codelist but was moved to the Specimen Type codelist.
Requesting the term SOFT TISSUE or a similiar term (such as
TISSUE) be added back to the Anatomical Location codelist to
capture the location of a soft tissue injury, soft tissue infection or
soft tissue sarcoma.
mJoule/cm2 Synonym: Millijoule per Square Centimeter

Definition: A unit of radiant exposure used in measuring the amount
of energy incident upon an area of one square centimeter
Peritoneal Fluid; Pericardial Fluid Peritoneal Fluid; Pericardial Fluid
Change c-code: From C26431 to We coded this to the wrong concept in NCIt. The term Coronavirus
C113205. is a non-taxonomic term used to group the species within the 3
genera Gammacoronavirus, Alphacoronavirus, and
Betacoronavirus. Since CDISC wanted the family level term, it is
more correct to code this to Coronaviridae C113205. Also, not sure
why CDISC chose CORONAVIRUS as the PT when
CORONAVIRIDAE is more taxonomically correct for the family level
term. Team needs to re-look at this.
Change
Final Outcome
Type
II SDTM, SEND-Published in P14
III
III
II SEND-Published in P14
III
II
III SDTM, SEND-Published in P14, P15
III Do not add (SDTM-P16): We are very

hesitant to introduce a term here that
isn't supported by a regulatory
source.Do not add (at this time).
II QRS-Published in P13
III SDTM, CDASH, SEND-Published in

P15
III
I QRS-Published in P13
II

III SDTM-Published in P15, P16, P17
II SDTM-Published in P15
III P15 - Catheter is a Device (same as

"Needle"), it isn't a Route. The Route
would be "intratracheal",
"intraurethral", "intravenous" etc.Do
not add.
III P15 -Do not add. METHOD codelist
definition is "Method is any technique
or procedure (an action) that
determines how an observation or
clinical finding was made." So we
agree, CATHETERIZATION is a
procedure, may belong in PR domain.
But it isn't a method for determining a
finding.

III P15 -Do not add. METHOD codelist
definition is "Method is any technique
or procedure (an action) that
determines how an observation or
clinical finding was made." So we
agree, ASPIRATION is a procedure,
may belong in PR domain. But it isn't a
method for determining a finding.
II P15 -Do not add. It isn't for this team

to decide whether ADaM datasets
have controlled terminology.
Requester should F/U with ADaM
instead.
II
III
III

III
III
III P15 -Do not add. Same as VOLUME
III P15 -Do not add. Will not add this is

just a different method measuring C-
reactive protein, which is already
published.
III
III

III Already published.
III

III
II P15 - Definition of "semi-recumbent" is

too vague, whereas semi-fowlers is
very specific.Do not add as a
synonym.

III P15 -Do not add. This is a further
detail of 'Subject Withdrew' so should
map to that term instead.
II
II
II
III Do not add (SEND-P19) - Team

questions whether this is a true strain.
The term HOUND might be too vague.
Suggest to use MONGREL and put
HOUND in substrain details.
III Do not add (SEND-P17): Country of

Origin, Color, and other substrain
details removed from Strain CT and
instead put into substrain details (non-
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
controlled).
III Do not add (SEND P19): Juvenile
represented in AGE variable.





III SEND-Removed from codelist in P19.

Country of Origin, Color, and other
substrain details removed from Strain
CT and instead put into substrain
details (non-controlled).

I
III
III
III SEND-Published in P17

III Removed by Requester P17
III SEND-Do not add. Fathead is used to

describe a number of fish including:
Fathead Carp, Fathead Minnow, and 3
species in the genus Cubiceps. There
are also two deepwater fish that
colloquially go by this name. List is
extensible but the CT team will not
add.
II P15 - Do not change. "randomization

criteria" in this context are
"continuation criteria", different than
"enrollment criteria".

III
II P15 - Do not change. There is only 1

Anterior Descending Coronary Artery
in the body, which just happens to be
located on the left side of the body.
Therefore our terminology is correct as
is and we should not precoordinate the
word 'Left' into the CDISC term.

II SDTM - Published in P13
III
II

III SDTM, SEND-Published in P15;Do
not add (SDTM-P16): For
Digoxin/DIGOXIN Use FDA formulary
list and active ingredient list.
III P15 - Global deterioration of Health

Status fits nicely under the existing
Adverse Event (untoward condition
that arises or worsens during the
study). Or this could be under
Physician Decision.Do not add.
III
III SDTM, SEND-Published in P17,

P20;Do not add (SDTM-P18): See
Requests Denied Spreadsheet
II
III SDTM, SEND-Published in P15, P16;

SDTM, SEND-Published in P19;Do
not add (SDTM-P18, SDTM-P19): See
Requests Denied Spreadsheet;
Tetracycline:Do not add (P21). CDISC
Lab team does not feel they should
store drug names in
LBTEST/TESTCD. Recommend using
a standard Pharmacopeia.
Do not add (P30): For all flow
cytometry requests - The lab
terminology team is denying this
request at this time.We have now
determined a new approach to flow
cytometry terminology which involves
the following:
- The lab test name will be the Core
Cell Type.
- The lab test code will be the <C-
Code>.
- The receptor pattern should be
stored in SUPPQUAL.
We will be putting out the first batch of
flow cytometry base cell type terms for
public review with P29 in December
2016. Please review these terms and
send comments. There will be many
more terms coming in the future.

III
III P15 - Do not change. There doesn't

seem to be a compelling business
need to change HEIGHT, WEIGHT,
TEMPERATURE tests in VSTEST. If
we need to add something like 'arm
III weight', then we would address that as
needed --- either with a specific Test
or by using LOC. Team is very
reluctant to change this industry-
III SDTM-Published
standard term thatinhasP15been around
Education
forever. ToStatus: Teameverybody
be a purist, agrees that
this is ause
should finethe
idea and consistent
existing WEIGHTwithwith
what we've already
LOC=BODY. Do notdone for other
change.
SCTEST results e.g. MARISTAT.
Suggestions for the lists are needed
from the requestor before continuing
with this request.
III SDTM-Published in P15, P16

II
II
II P15 - SPL list is a specific usage of

the Dosage Form list; we don't know
how people would represent things
like 'gum' if we remove it. So we won't
trim our list at this time.
I SDTM, SEND-Published in P14

III
III
III

III
II
III
III SDTM-Published in P16;Do not add

(SDTM-P16): Strain should be a
separate field. Request to the
Microbiology Domain that they add a
field for strain
III QRS-Published in P23

III
III
III
III

III SEND, SDTM-Published in P16,
P17;Do not add (SDTM-P16): CDISC
does not have a code for Vss/F
because this parameter cannot be
accurately estimated from routine PK
data. As explained in detail below, the
accurate estimation of Vss/F requires
an estimate of the Mean Input Time
(MIT) for a drug and this is routinely
not available. Moreover, estimation of
MIT requires administration of drug by
the IV route as well as the
extravascular route, so it would be
possible to estimate Vss itself, which
is a more useful parameter than
Vss/F.Do not add (SDTM-P17): For
FB(x)/Bound fraction of drug in plasma
at time point x, None of the CDISC PK
Terms include time of measurement
as part of the terminology. Instead, if a
particular time is to be associated with
a PK Term, the time should be
specified in --TPTREF. For FU/Bound
fraction of drug in plasma at time point
x; These are measurements at points
in time, and have the potential to be
collected at many points in time (i.e.,
time points), this type of data would be
better modeled in PC, because PC is
better equipped to represent this
information. PC includes the time
point variables as well as the date/time
of sample collection. These are not as
much PK parameters as they are PK
measurements. We have declined to
include total drug or metabolite
concentrations at various times in PP,
II
III
II
III
III
II Do not add (SDTM-P16): This is a

common clinical unit of measure for
heart rate and pulse rate. It is
classified as a unit of measure by
SNOMED-CT and by NCPDP
(National Council for Prescription Drug
Program).
II Do not add (SDTM-P16): Both units of

measure and units of presentation are
in the same codelist. This term is
published in the FDA SPL list. We
understand your concern regarding
units of measure versus units of
presentation. We have included units
for presentation from ISO 11616 as
distinguished from units of measure. If
BAR for pressure is needed for clinical
trial work, please submit a request to
add that as a new term. Currently we
will leave "BAR" as a dosing unit.
III Do not add (SDTM-P16): This is DIA

BP/SYS BP/Pulse Pressure with a
location. So based on that, we will not
add
Do not add (SDTM-P23): Central
Diastolic Blood Pressure, Central
Systolic Blood Pressure, Central Pulse
Pressure; Please use the existing
tests from the Vital Signs codelist and
use Aorta from the Anatomical

III
III
III Do not add (SEND, SDTM-P23): This

is published as a synonym to
PERIPHERAL NERVE SHEATH
TUMOR, MALIGNANT (C3798).
INHAND agrees to this mapping.
III Do not add (SEND-P25) - Please use

C3798.
III
III
III

III
III
III
III Do not add (SDTM-P16): Already a
synonym to another term.
III Do not add (SDTM-P16): Use "blood"

as specimen type and "dried" as
specimen condition.
III
III Do not add (SEND P17) - These

things aren't commonly lumped. They
tend to be reported separately.
III Do not add (SDTM-P23): The

requester is using this for operational
purposes at their sites and not as a
true representation of RECIST criteria
guidelines. Currently LPERP and
LDIAM OR just plain DIAMETER
should be used for trials using
RECIST criteria. SAXIS is also being
removed from the publication with
P23.

III
II
III Do not add (SDTM-P18): Please use

the SI unit of joule.
III P21 -Do not add.

At this time we will not be adding
these terms. Please look at the holter
terms that will be going out for P21.
The codelist is extensible.
III

III Do not add (SDTM-P23):Do not add
ND- No Disease ( this is not part of
any criteria). May be submitted as a
result in trials but this is not a
true/valid response, may be used
incorrectly if added to RSSTRESC.
This issue needs to be addressed in
the IG.
II SDTM-Published in P16, P17
III P21 -Do not add.

At this time we will not be adding
these terms. Please look at the holter
terms that will be going out for P21.
The codelist is extensible.
III Do not add (SEND-P17): Map this to
new concept ANESTHETIZED
LETHAL INJECTION concepts.
III
II
II
II

Do not add (SDTM-P25) -
DECREASING, STABLE; Codelist is
extensible. Wait for criterion papers to
better define these response values
before CDISC will publish them as
standard.
II
III
II
III
III Do not add (SDTM-P18): Terms
already exists. For POSTERIOR
SUPERIOR ILIAC SPINE use
"POSTERIOR; SUPERIOR" from the
Directionality codelist. For ANTERIOR
SUPERIOR ILIAC SPINE use
"ANTERIOR; SUPERIOR" from the
Directionality codelist. For PROXIMAL
ACHILLES use "PROXIMAL" from the
Directionality codelist. For CELIAC
AXIS LYMPH NODE use CELIAC
LYMPH NODE (C65166).
III
II Do not add (SDTM-P17): The team

believes that there are many ways to
measure hip circumference. We either
need more-specific tests for specific
methods or leave this general. Hip
Circ is a simple concept and we don't
want to overly complicate the
definition. The team believes that
there are many ways to measure waist
circumference. We either need more-
specific tests for specific methods or
leave this general. Waist Circ is a
simple concept and we don't want to
overly complicate the definition.
III Do not add (SDTM-P18): Recommend

using existing CDISC unit of mmol/mol
and the test scenario could be
Hemoglobin A1C/Hemoglobin
(HBA1CHGB) . You do not need HGB
in the unit as it is already captured in
the test name.

III SDTM-Published in P18;Do not add
(SDTM-P18): PCI is a procedure, not
a method.; PVI is a procedure, not a
method.; SDTM-Published in P20, P23
II
II

not add (SDTM-P18): Other Rhythm,
Other Conduction, Other Morphology -
These are not very precise for a
controlled codelist. This list is
extensible.
P19;Do not add (SDTM-P17): See
Requests Denied Spreadsheet

not add (SDTM/SEND-P18): For
SCHWANNOMA, MALIGNANT, eam
agrees not to add because the
requested term maps to Malignant
Peripheral Nerve Sheath Tumor
C3798 which is already published in
NEOPLASM codelist.
II
II
II
II
II
I SEND-Published in P16
II SDTM-Published in P17; SEND,

II
II Do not add (SDTM-P17): These lists
support SDTM variables defined as:
--DIR, Directionality, Variable Qualifier
of --LOC, Qualifier for anatomical
location further detailing directionality.
Examples: ANTERIOR, LOWER,
PROXIMAL, UPPER.
--LAT, Laterality, Variable Qualifier of
--LOC,
Qualifier for anatomical location further
detailing laterality of the intervention
administration. Examples: LEFT,
RIGHT.

Do not add (SDTM-P16):Do not add to
LB domain. Request sent to the
Virology terminology team for
consideration.
Do not add (SDTM-P16):Do not add to
LB domain. Request sent to the
Virology terminology team for
consideration.
III

III
III
III
III
II Do not add (SDTM-P18): Requested

term seems study- or company-
specific, not commonly used. The list
is extensible so such terms are easily
accomodated.
III

III
II
III
III
III
III
III
III Do not add (SDTM-P18): Use the

specimen type of FLUID and the
peritoneal cavity or Pericardial Cavity
will be the anatomical locations
Date of Request Submitter Submitter Submitter E- Request CDISC
Status
Submission Code Name Affiliation mail Type Codelist
Closed 1/3/2014 14:16 33105 Guy Sunovion guy.genereux Modify SDTM-

Genereux @sunovion.c Existing LBTEST
om Term
Genereux @sunovion.c Existing LBTEST
om Term
Closed 1/3/2014 14:18 33107 Guy Guy Genereux guy.genereux Modify SDTM-
Genereux @sunovion.c Existing PKUNIT
om Term
Closed 1/3/2014 14:19 33108 Steve Kopko CDISC skopko@cdis Create New New
c.org Codelist

om Term

om Term
Closed 1/3/2014 14:21 33111 Lex Jansen SAS Lex.Jansen Modify QS-SOWS
@sas.com Existing Subjective
Term Test
Closed 1/10/2014 17:22 33117 Veronique Bayer veronique.bo Modify SDTM-
Bourcier urcier@bayer Existing LBTEST
.com Term
Closed 1/10/2014 17:23 33118 Audrey audrey.walke Create New SDTM-
Walker r@crl.com Term LBTEST
Closed 1/10/2014 17:23 33119 Audrey audrey.walke Create New SEND-

Walker r@crl.com Term SPEC
Closed 1/17/2014 14:04 33121 Bernice Yost CDISC byost@cdisc. Create New SDTM-
org Term METHOD
Closed 1/17/2014 14:07 33123 Erin MSC muhlbradtee Modify SDTM-UNIT
Muhlbradt @mail.nih.go Existing
v Term
Muhlbradt @mail.nih.go Existing VSSTRESU
v Term
Closed 1/17/2014 14:09 33125 Erin MSC muhlbradtee Modify SDTM-LOC
v Term
Muhlbradt @mail.nih.go Existing LBTEST
v Term
Muhlbradt @mail.nih.go Existing LBTEST
v Term
Closed 1/17/2014 14:11 33128 Erin MSC muhlbradtee Modify SDTM-FRM

v Term
Muhlbradt @mail.nih.go Existing PKUNIT
v Term
v Term
v Term
Closed 1/17/2014 14:15 33132 Erin MSC muhlbradtee Modify
v Term
Muhlbradt @mail.nih.go Existing SPEC
v Term
Closed 1/17/2014 14:16 33134 Emily Hartley Critical Path ehartley@c- Create New QS-KFSS
Institute path.org Term TEST; QS-
KFSS
TESTCD
Closed 1/17/2014 14:17 33135 Emily Hartley Critical Path ehartley@c- Modify QS-KFSS
Institute path.org Existing TEST; QS-
Term KFSS
TESTCD
Closed 1/17/2014 19:36 33136 Erin MSC muhlbradtee Modify SDTM-LOC

v Term
v Term
Muhlbradt @mail.nih.go Existing VSSTRESU
v Term
Muhlbradt @mail.nih.go Existing LBTEST;
v Term SDTM-
LBTESTCD
v Term SDTM-
LBTESTCD
Muhlbradt @mail.nih.go Existing MICROORG
v Term
Closed 1/24/2014 13:08 33147 Erin MSC muhlbradtee Modify QS-QSCAT
v Term
Closed 1/24/2014 13:09 33148 Debbie Oneill Merck debra_oneill Create New SDTM-LOC
@merck.com Term
Closed 1/24/2014 17:28 33150 Debbie Oneill Merck debra_oneill Modify SDTM-LOC
@merck.com Existing
Term
Closed 1/24/2014 17:29 33151 Debbie Oneill Merck debra_oneill Create New SDTM-
@merck.com Term FREQ
Closed 1/31/2014 19:05 33169 Debbie Oneill Merck debra_oneill Create New SDTM-UNIT
@merck.com Term
Closed 1/31/2014 19:06 33170 Colleen Bonjo Merck colleen_bonj Create New SDTM-
o@merck.co Term METHOD
m
Closed 1/31/2014 19:11 33171 Audrey Charles River Audrey.Walk Create New SDTM-
Walker Laboratories er@crl.com Term EGTEST
Closed 1/31/2014 19:12 33172 Debbie Oneill Merck debra_oneill Modify SDTM-
@merck.com Existing EGTEST
Term
Closed 1/31/2014 19:14 33173 Erin MSC muhlbradtee Modify SDTM-UNIT
v Term
Muhlbradt @mail.nih.go Existing DIABTHPY
v Term
Closed 1/31/2014 19:17 33175 Sharon Boehringer sharon.brode Create New SDTM-UNIT
Broderick Ingelheim rick@boehrin Term
Pharmaceutical ger-
s, Inc. ingelheim.co
m
Closed 1/31/2014 19:18 33176 Bess LeRoy bleroy@c- Create New SDTM-
path.org Term DOMAIN
Closed 1/31/2014 19:20 33177 Gary Teva gary.cunning Create New QS-GAD7
Cunningham Pharmaceutical ham@tevaph Term TEST/TEST
s arm.com CD; QS-
PHQ-9
TEST/TEST
CD
Closed 2/6/2014 13:23 33188 Audrey Charles River audrey.walke Create New SEND-
Walker r@crl.com Term SSTYPE
Closed 2/6/2014 13:24 33189 Erin MSC muhlbradtee Create New SEND-
Muhlbradt @mail.nih.go Term NEOPLASM
v
Closed 2/6/2014 13:25 33190 Colleen Bonjo Merck colleen_bonj Create New SDTM-LOC
o@merck.co Term
m
Closed 2/6/2014 13:26 33191 Bess LeRoy C-Path bleroy@c- Create New SDTM-DIR
path.org Term
Closed 2/6/2014 13:27 33192 Bess LeRoy C-Path bleroy@c- Create New SDTM-DIR
path.org Term
Muhlbradt @mail.nih.go Existing NEOPLASM
v Term
Closed 2/7/2014 17:57 33195 Carrie Neeley Covance Labs carrie.neeley Create New SDTM-
@covance.c Term LBTEST
om
Closed 2/7/2014 17:59 33196 Randall GSK randall.r.austi Modify SDTM-

Austin n@gsk.com Existing DOMAIN
Term
Closed 2/7/2014 18:00 33197 Randall GSK randall.r.austi Create New SDTM-
Austin n@gsk.com Term DOMAIN

v Term

v Term
Closed 2/7/2014 18:04 33200 Bess LeRoy C-Path bleroy@c- Create New SDTM-LOC
path.org Term
Closed 2/14/2014 14:02 33207 Carrie Neeley Covance Labs carrie.neeley Create New SEND-
@covance.c Term SPEC
om
@merck.com Term RSSTRESC
Closed 2/14/2014 14:04 33209 Jane PharmaStat jdiefenbach Create New SDTM-
Diefenbach LLC @pharmastat Term VSTEST
.com
@merck.com Term EGSTRESC
Closed 2/14/2014 14:06 33211 Claire West GSK claire.m.west Modify SDTM-
@gsk.com Existing EGSTRESC
Term
Closed 2/14/2014 14:07 33212 Kohji Otsuka mochinaga.k Modify SDTM-

Mochinaga oji@otsuka.jp Existing LBTEST
Term
Muhlbradt @mail.nih.go Existing COUNTRY
v Term
Closed 2/21/2014 17:16 33223 Scott Biogen Idec scott.bahlavo Create New SDTM-UNIT
Bahlavooni oni@biogeni Term
dec.com
Closed 2/21/2014 17:17 33224 Sharon Boehringer sharon.brode Create New SDTM-
Broderick Ingelheim rick@boehrin Term SCTEST
Pharmaceutical ger-
m
Broderick Ingelheim rick@boehrin Term SCTESTCD
Pharmaceutical ger-
m
Broderick Ingelheim rick@boehrin Term LBTEST
Pharmaceutical ger-
m
Closed 2/28/2014 12:52 33232 Debbie Merck debra_oneill Create New SDTM-
O'Neill @merck.com Term VSRESU
O'Neill @merck.com Term LBTEST
Closed 2/28/2014 12:54 33234 Nik Pemble Janssen npemble@its Modify SDTM-
.jnj.com Existing LBTESTCD
Term
Closed 3/7/2014 16:04 33236 Debbie Merck debra_oneill Create New SDTM-UNIT
O'Neill @merck.com Term
Closed 3/7/2014 16:06 33237 Mary Jo Merck & Co. mj.brucker@ Create New New
Brucker merck.com Codelist
Closed 3/7/2014 16:07 33238 Debbie Merck debra_oneill Modify SDTM-UNIT

O'Neill @merck.com Existing
Term
Closed 3/7/2014 16:08 33239 Debbie Merck debra_oneill Modify SDTM-UNIT
O'Neill @merck.com Existing
Term
Closed 3/7/2014 16:09 33240 Debbie Merck debra_oneill Create New SDTM-UNIT
O'Neill @merck.com Term
Closed 3/14/2014 12:10 33247 Carrie Neeley Covance carrie.neeley Create New SDTM-
Laboratories @covance.c Term LBTEST
om
Closed 3/14/2014 12:11 33248 Carrie Neeley Covance carrie.neeley Create New SDTM-UNIT
Laboratories @covance.c Term
om
c.org Codelist
c.org Codelist
Closed 3/14/2014 12:14 33251 Carrie Neeley Covance carrie.neeley Create New SDTM-
Laboratories @covance.c Term LBTESTCD
om
Closed 3/14/2014 12:15 33252 Carrie Neeley Covance carrie.neeley Create New SEND-
Laboratories @covance.c Term NEOPLASM
om
Closed 3/14/2014 12:19 33253 Carrie Neeley Covance carrie.neeley Create New SEND-
Laboratories @covance.c Term NEOPLASM
om
Closed 3/14/2014 12:20 33254 Claire West GSK claire.m.west Create New SDTM-UNIT
@gsk.com Term
Open 3/14/2014 12:21 33255 Janet Siani Shire jsiani@shire. Modify SDTM-
com Existing LBTEST
Term
Closed 3/14/2014 12:22 33256 Deborah CSL Behring deborah.ritte Create New SDTM-UNIT
Rittenhouse nhouse@csl Term
behring.com
behring.com
behring.com
Closed 3/14/2014 12:24 33259 claire west gsk claire.m.west Create New SDTM-LOC
@gsk.com Term
Closed 3/14/2014 12:25 33260 Bernice Yost CDISC byost@cdisc. Modify SDTM-UNIT
org Existing
Term
Closed 3/14/2014 12:26 33261 Bernice Yost CDISC byost@cdisc. Modify Multiple
org Existing
Term
Closed 3/14/2014 12:26 33262 Bernice Yost CDISC byost@cdisc. Modify QS-QSCAT
org Existing
Term
O'Neill @merck.com Term PROCEDU
R

Genereux Pharmaceutical @sunovion.c Existing EGTEST
s om Term
Broderick Ingelheim rick@boehrin Term METHOD
Pharmaceutical ger-
m
Closed 3/21/2014 11:39 33266 Pam Harvey CDISC pharvey@cdi Create New New
sc.org Codelist
Closed 3/21/2014 11:53 33267 Steve Kopko CDISC skopko@cdis Create New SDTM-
c.org Term METHOD
Open 3/21/2014 11:54 33268 Amy Palmer CDISC apalmer@cdi Create New New
sc.org Codelist
Closed 3/21/2014 11:55 33269 Erin EVS muhlbradtee Modify SDTM-

v Term SDTM-
LBTESTCD
O'Neill @merck.com Term LBSTRESC
Closed Friday, 28 Mar CDISC- Monika Accovion monika.kawo Create New New
2014 01:46 PM 1076 Kawohl hl@accovion. Codelist
com
Closed Friday, 28 Mar CDISC- Mary Jo Merck mj.brucker@ Modify SEND-

2014 01:49 PM 1077 Brucker merck.com Existing DSDECOD
Term
Open Friday, 28 Mar CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 01:50 PM 1078 Broderick Ingelheim rick@boehrin Term METHOD
Pharmaceutical ger-
m
Open Friday, 28 Mar CDISC- Dana Booth CDISC dbooth@cdis Create New New
2014 01:51 PM 1079 c.org Codelist
Open Friday, 28 Mar CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-UNIT
2014 01:52 PM 1080 org Term
Open Friday, 28 Mar CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-UNIT
2014 01:53 PM 1081 org Term
Open Friday, 28 Mar CDISC- Erin MSC muhlbradtee Modify CDISC-
2014 01:54 PM 1082 Muhlbradt @mail.nih.go Existing CLINDE
v Term Glossary
Closed Friday, 28 Mar CDISC- Pam Harvey CDISC pharvey@cdi Create New SDTM-
2014 02:04 PM 1083 sc.org Term SPCIES
Closed Friday, 4 Apr CDISC- Scott Biogen Idec scott.bahlavo Other SDTM-
2014 09:05 AM 1084 Bahlavooni oni@biogeni LBTEST
dec.com
Closed Friday, 4 Apr CDISC- Bess LeRoy bleroy@c- Create New Multiple
2014 09:06 AM 1085 path.org Term
Open Friday, 4 Apr CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 09:07 AM 1086 org Existing METHOD
Term
Closed Friday, 4 Apr CDISC- Dana Booth CDISC dbooth@cdis Create New New
2014 09:08 AM 1087 c.org Codelist
Closed Friday, 4 Apr CDISC- Ellina Quality Data EBabouchkin Create New New
2014 09:08 AM 1088 Babouchkina Services, Inc. a@qdservice Codelist
s.com
Closed Saturday, 12 CDISC- Audrey Charles River audrey.walke Create New Multiple
Apr 2014 07:20 1089 Walker r@crl.com Term
AM
Closed Saturday, 12 CDISC- Debbie Merck debra_oneill Create New SDTM-

Apr 2014 07:28 1090 O'Neill @merck.com Term LBTEST
AM
Open Saturday, 12 CDISC- Claire West GSK Claire.M.Wes Create New SDTM-LOC
Apr 2014 07:30 1091 t@gsk.com Term
AM
Closed Saturday, 12 CDISC- Pamela QT Studies pamela.rinald Create New Multiple
Apr 2014 07:31 1092 Rinaldi TAUG team i@boehringer Term
AM -
ingelheim.co
m
Closed Saturday, 12 CDISC- Debbie Merck debra_oneill Create New SDTM-
Apr 2014 07:32 1093 O'Neill @merck.com Term PROCEDU
AM R
Closed Saturday, 12 CDISC- Sharon Boehringer sharon.brode Create New SDTM-UNIT

Apr 2014 07:33 1094 Broderick Ingelheim rick@boehrin Term
AM Pharmaceutical ger-
m
Open Saturday, 12 CDISC- Sharon Boehringer sharon.brode Create New SDTM-UNIT
m
Closed Saturday, 12 CDISC- Sharon Boehringer sharon.brode Create New SDTM-UNIT
m
Closed Friday, 18 Apr CDISC- Gloria Jones Janssen gjones38@it Create New Multiple
2014 08:38 AM 1097 Pharmaceutical s.jnj.com Codelist
Companies of
Johnson and
Johnson
Closed Friday, 18 Apr CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 08:39 AM 1098 Broderick Ingelheim rick@boehrin Term LBTEST;
Pharmaceutical ger- SDTM-
s, Inc. ingelheim.co LBTESTCD
m
m
m
Open Friday, 18 Apr CDISC- Sharon Boehringer sharon.brode Create New SDTM-
m
m
m
m
m
m
m
m
m
m
m
m
m
m
Open Friday, 18 Apr CDISC- Erin MSC muhlbradtee Create New SDTM-UNIT
2014 08:46 AM 1115 Muhlbradt (on @mail.nih.go Term
behalf of the v
CDASH SAE
team)
Closed Friday, 18 Apr CDISC- Erin MSC muhlbradtee Create New SDTM-
2014 08:47 AM 1116 Muhlbradt @mail.nih.go Term METHOD
v
Closed Friday, 18 Apr CDISC- Carsten Ferring Consultant.C Create New Multiple
2014 08:48 AM 1117 Junge Pharmaceutical arsten.Peder Term
Pedersen s A/S sen@ferring.
com
2014 08:49 AM 1118 Broderick Ingelheim rick@boehrin Term METHOD
Pharmaceutical ger-
m
Closed Friday, 18 Apr CDISC- Erin MSC muhlbradtee Modify SDTM-

2014 08:50 AM 1119 Muhlbradt @mail.nih.go Existing METHOD
v Term
Closed Friday, 18 Apr CDISC- Erin MSC muhlbradtee Modify SDTM-

2014 08:51 AM 1120 Muhlbradt (on @mail.nih.go Existing NCOMPLT
behalf of Ron v Term
Fitzmartin,
FDA)
Open Friday, 18 Apr CDISC- Carol Vaughn Sanofi Carol.Vaugh Modify SDTM-
2014 08:52 AM 1121 n@sanofi.co Existing EGTEST
m Term
Closed Friday, 18 Apr CDISC- Daniel BioMarin ddiprimeo@b Create New SDTM-
2014 08:53 AM 1122 DiPrimeo Pharmaceutical mrn.com Term LBTEST
Inc.
Closed Friday, 25 Apr CDISC- Janet Siani Shire jsiani@shire. Create New SDTM-
2014 10:24 AM 1123 com Term EGTEST/
CD
Closed Friday, 25 Apr CDISC- Debbie Merck debra_oneill Create New SDTM-UNIT
2014 10:28 AM 1124 O'Neill @merck.com Term
Closed Friday, 25 Apr CDISC- Colleen Bonjo Merck colleen_bonj Create New Multiple
2014 10:34 AM 1125 o@merck.co Codelist
m
2014 10:37 AM 1126 Broderick Ingelheim rick@boehrin Term MITEST/CD
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Closed Friday, 25 Apr CDISC- James Johnson & jkramer2@its Create New Multiple
2014 10:46 AM 1130 Kramer Johnson / .jnj.com Term
Janssen
Research and
Development
Closed Friday, 25 Apr CDISC- Randall GSK randall.r.austi Modify SDTM-
2014 10:49 AM 1131 Austin n@gsk.com Existing TSPARM/
Term CD
Closed Friday, 25 Apr CDISC- Nicholas Janssen npemble@its Other SDTM-

2014 10:51 AM 1132 Pemble .jnj.com LBTEST/CD
Closed Friday, 2 May CDISC- Debbie Merck debra_oneill Create New SDTM-
2014 03:09 PM 1133 O'Neill @merck.com Term LBTEST/CD
Closed Friday, 2 May CDISC- Debbie Merck debra_oneill Create New SDTM-UNIT
2014 03:12 PM 1134 O'Neill @merck.com Term
Closed Friday, 2 May CDISC- Erin MSC muhlbradtee Modify SDTM-
2014 03:20 PM 1135 Muhlbradt @mail.nih.go Existing DECAT
v Term
Open Friday, 2 May CDISC- Colleen Bonjo Merck colleen_bonj Modify QSCAT:
2014 03:21 PM 1136 o@merck.co Existing QS-PBI
m Term
Closed Friday, 2 May CDISC- Theresa Novartis theresa.hend Create New SDTM-UNIT
2014 03:23 PM 1137 Hendershot ershot@nova Term
rtis.com
Closed Friday, 2 May CDISC- Theresa Novartis theresa.hend Create New SDTM-UNIT
rtis.com
Closed Friday, 2 May CDISC- Theresa Novartis theresa.hend Create New SDTM-LOC
rtis.com
Open Friday, 2 May CDISC- Theresa Novartis theresa.hend Create New SEND-
2014 03:27 PM 1140 Hendershot ershot@nova Term DSDECOD
rtis.com
Closed Friday, 2 May CDISC- Scott Biogen Idec scott.bahlavo Create New SDTM-
2014 03:32 PM 1141 Bahlavooni oni@biogeni Term SPECTYPE
dec.com
Closed Friday, 2 May CDISC- Scott Biogen Idec scott.bahlavo Create New SDTM-
2014 03:33 PM 1142 Bahlavooni oni@biogeni Term METHOD
dec.com
Closed Friday, 2 May CDISC- Erin MSC muhlbradtee Modify SEND-

2014 03:36 PM 1143 Muhlbradt @mail.nih.go Existing OMTEST/
v Term CD
Closed Friday, 2 May CDISC- Erin MSC muhlbradtee Modify SDTM-LOC

2014 03:37 PM 1144 Muhlbradt @mail.nih.go Existing
v Term
Open Friday, 2 May CDISC- Erin MSC muhlbradtee Create New SEND-
2014 03:40 PM 1145 Muhlbradt @mail.nih.go Term SPECIES
v
Closed Friday, 2 May CDISC- Erin MSC muhlbradtee Other SEND-
2014 03:42 PM 1146 Muhlbradt @mail.nih.go STRAIN
v
Closed Friday, 2 May CDISC- Erin MSC muhlbradtee Create New Multiple
2014 03:44 PM 1147 Muhlbradt @mail.nih.go Term
v
Closed Friday, 2 May CDISC- Erin MSC muhlbradtee Create New Multiple
2014 03:45 PM 1148 Muhlbradt @mail.nih.go Term
v
Closed Friday, 2 May CDISC- Audrey Charles River Audrey.Walk Create New SDTM-
2014 03:48 PM 1149 Walker er@crl.com Term LBTEST/CD
Closed Thursday, 8 CDISC- Bernice Yost CDISC byost@cdisc. Modify SEND-

May 2014 09:12 1150 org Existing NEOPLASM
PM Term
Open Thursday, 8 CDISC- Claire West GSK Claire.M.Wes Other SDTM-
May 2014 09:14 1151 t@gsk.com LBTEST/CD
PM
Closed Thursday, 8 CDISC- Erin MSC muhlbradtee Create New New

May 2014 09:18 1152 Muhlbradt (on @mail.nih.go Codelist
PM behalf of v
SEND)
Closed Thursday, 8 CDISC- Carrie Neeley Covance carrie.neeley Create New SEND-
May 2014 09:21 1153 @covance.c Term SPEC
PM om
Closed Thursday, 8 CDISC- Carrie Neeley Covance carrie.neeley Create New SEND-
May 2014 09:22 1154 @covance.c Term SPEC
PM om
Open Thursday, 8 CDISC- Amy Palmer CDISC apalmer@cdi Create New SDTM-
May 2014 09:26 1155 sc.org Term DOMAIN
PM
Closed Thursday, 8 CDISC- Amy Palmer CDISC apalmer@cdi Create New SDTM-
May 2014 09:27 1156 sc.org Term DOMAIN
PM
Open Thursday, 8 CDISC- Bess LeRoy C-path bleroy@c- Create New SDTM-
May 2014 09:28 1157 path.org Term LBTEST/CD
PM
Closed Thursday, 8 CDISC- Bess LeRoy C-path bleroy@c- Create New SDTM-
PM
Open Thursday, 8 CDISC- Bess LeRoy C-path bleroy@c- Create New SDTM-
PM
Closed Thursday, 8 CDISC- Theresa Novartis theresa.hend Create New SDTM-UNIT
May 2014 09:36 1160 Hendershot ershot@nova Term
PM rtis.com
Open Thursday, 8 CDISC- Theresa Novartis theresa.hend Create New SDTM-LOC

PM rtis.com
Open Thursday, 8 CDISC- Theresa Novartis theresa.hend Create New SDTM-UNIT
PM rtis.com
Open Thursday, 8 CDISC- Theresa Novartis theresa.hend Create New SDTM-
May 2014 09:47 1163 Hendershot ershot@nova Term EGTEST/
PM rtis.com CD
Closed Thursday, 8 CDISC- Carrie Neeley Covance carrie.neeley Create New SDTM-
May 2014 09:49 1164 @covance.c Term LBTEST/CD
PM om
Closed Thursday, 8 CDISC- Dana Booth CDISC dbooth@cdis Create New SDTM-
May 2014 09:51 1165 c.org Term MEDEVAL
PM
Open Friday, 9 May CDISC- Jordan Li MSC jordan.li@nih Modify SDTM-

2014 12:40 PM 1166 .gov Existing RSSTRESC
Term
Open Friday, 16 May CDISC- Lou Florio Purdue florio@pharm Create New SDTM-
2014 03:49 PM 1167 Pharma a.com Term METHOD
Closed Friday, 16 May CDISC- Takahiro Otsuka takeuchit@ot Create New Multiple
2014 03:59 PM 1168 Takeuchi (竹 Pharmaceutical suka.jp Term
内崇裕) Co., Ltd.
Closed Friday, 16 May CDISC- Carrie Neeley Covance carrie.neeley Create New SEND-
2014 04:01 PM 1169 @covance.c Term SPEC
om
Open Friday, 16 May CDISC- Robert CDISC rdempsey@c Modify SDTM-

2014 04:05 PM 1170 Dempsey disc.org Existing DECAT
Term
Closed Friday, 16 May CDISC- Lorraine Takeda Spencer@Ta Create New SDTM-
2014 04:06 PM 1171 Spencer Pharmaceutical keda.com Term LBTEST/CD
s
Open Friday, 16 May CDISC- Colleen Bonjo Merck colleen_bonj Modify QS-BPI
2014 04:09 PM 1172 o@merck.co Existing Short Form
m Term TEST
Closed Friday, 16 May CDISC- Audrey Charles River Audrey.Walk Create New SDTM-
2014 04:11 PM 1173 Walker er@crl.com Term LBTEST/CD
Closed Friday, 16 May CDISC- Debbie Merck debra_oneill Modify SDTM-

2014 04:14 PM 1174 O'Neill @merck.com Existing GENSMP
Term
Closed Friday, 16 May CDISC- Pam Harvey CDISC pharvey@cdi Create New SDTM-
2014 04:16 PM 1175 sc.org Term TSPARM/
CD
Closed Friday, 16 May CDISC- Debbie Merck debra_oneill Create New SDTM-
Closed Friday, 23 May CDISC- Carrie Neeley Covance carrie.neeley Create New SDTM-UNIT
2014 02:16 PM 1177 @covance.c Term
om
Closed Friday, 23 May CDISC- Audrey Charles River Audrey.Walk Create New Multiple
2014 02:18 PM 1178 Walker er@crl.com Term
Open Friday, 23 May CDISC- Amy Moore amoore@qst Create New SDTM-
2014 02:23 PM 1179 consultations Term NRIND
.com
Open Friday, 23 May CDISC- Colleen Bonjo Merck colleen_bonj Create New Multiple
2014 02:40 PM 1180 o@meerck.c Codelist
om
Closed Friday, 23 May CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-
2014 02:43 PM 1181 org Term METHOD
Closed Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-C-SSRS
2014 02:46 PM 1182 Dempsey disc.org Term Children's
Baseline
TEST/CD
Baseline/Scr
eening
TEST/CD
Since Last
Visit
TEST/CD
2014 03:42 PM 1185 Dempsey disc.org Term Screening
TEST/CD
Closed Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-FAQ
2014 03:44 PM 1186 Dempsey disc.org Term TEST/CD
Closed Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-FAQ-
2014 03:45 PM 1187 Dempsey disc.org Term NACC
Version
TEST/CD
Closed Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-MRS
Closed Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-SDS
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-AQ20
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-Disease
2014 05:01 PM 1191 Dempsey disc.org Term Steps
TEST/CD
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-EDSS
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-FAMS
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-KFSS
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-MHIS-
2014 05:07 PM 1195 Dempsey disc.org Term NACC
TEST/CD
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-PDDS
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New Multiple
2014 05:10 PM 1197 Dempsey disc.org Term
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-VFQ25-
2014 05:11 PM 1198 Dempsey disc.org Term Interviewer
Administere
d TEST/CD
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-VFQ25-
2014 05:12 PM 1199 Dempsey disc.org Term Self
Administere
d TEST/CD
Closed Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New QS-QSCAT
Closed Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New New
Open Friday, 23 May CDISC- Robert CDISC rdempsey@c Create New New
Open Friday, 23 May CDISC- Nik Pemble Janssen npemble@its Modify SDTM-UNIT
2014 05:40 PM 1222 .jnj.com Existing
Term
Open Friday, 23 May CDISC- Nik Pemble Janssen npemble@its Create New SDTM-UNIT
2014 05:42 PM 1223 .jnj.com Term
Closed Thursday, 29 CDISC- Roberta Pfizer roberta.e.ros Create New SDTM-

May 2014 07:00 1224 Rosenberg enberg@pfiz Term EVAL
PM er.com
Closed Thursday, 29 CDISC- Nik Pemble Janssen npemble@its Create New SDTM-UNIT
May 2014 07:03 1225 .jnj.com Term
PM
Open Thursday, 29 CDISC- Audrey Charles River Audrey.Walk Create New SDTM-
May 2014 07:05 1226 Walker er@crl.com Term ROUTE
PM
Open Thursday, 29 CDISC- Audrey Charles River Audrey.Walk Create New SDTM-
May 2014 07:07 1227 Walker er@crl.com Term ROUTE
PM
Closed Thursday, 29 CDISC- Audrey Charles River Audrey.Walk Create New SDTM-UNIT
May 2014 07:08 1228 Walker er@crl.com Term
PM
Open Thursday, 29 CDISC- Bernice Yost CDISC byost@cdisc. Modify SEND-
May 2014 07:11 1229 org Existing SPEC
PM Term
Closed Thursday, 29 CDISC- Colleen Bonjo Merck colleen_bonj Create New New
May 2014 07:13 1230 o@meerck.c Codelist
PM om
Open Thursday, 29 CDISC- Colleen Bonjo Merck colleen_bonj Create New New
May 2014 07:36 1231 o@meerck.c Codelist
PM om
Open Friday, 6 Jun CDISC- Colleen Bonjo Merck colleen_bonj Create New New
2014 11:25 AM 1232 o@meerck.c Codelist
om
Closed Friday, 6 Jun CDISC- Colleen Bonjo Merck colleen_bonj Create New New
om
Closed Friday, 6 Jun CDISC- Dana Booth CDISC dbooth@cdis Create New New
2014 11:30 AM 1234 c.org Codelist
Open Friday, 6 Jun CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-UNIT
2014 11:31 AM 1235 org Existing
Term
om
om
om
om
om
Closed Friday, 13 Jun CDISC- Robert CDISC rdempsey@c Modify SDTM-
2014 11:14 AM 1241 Dempsey (for disc.org Existing LBTEST/CD
Phil Pochon) Term
Closed Friday, 13 Jun CDISC- Robert CDISC rdempsey@c Create New Multiple
2014 11:22 AM 1242 Dempsey (for disc.org Term
Phil Pochon)
Closed Friday, 13 Jun CDISC- Colleen Bonjo Merck colleen_bonj Create New SDTM-
2014 11:26 AM 1243 o@merck.co Term RETEST
m
Closed Friday, 13 Jun CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-UNIT
2014 11:32 AM 1244 org Existing
Term
Closed Friday, 13 Jun CDISC- Janet Siani Shire jsiani@shire. Modify Multiple
2014 11:50 AM 1245 com Existing
Term
Closed Friday, 13 Jun CDISC- Debbie Merck debra_oneill Modify SDTM-

2014 11:52 AM 1246 O'Neill @merck.com Existing MICROORG
Term
Closed Thursday, 19 CDISC- Jordan Li NCI EVS jordan.li@nih Modify SDTM-

Jun 2014 05:05 1247 .gov Existing MICROORG
PM Term
Closed Friday, 20 Jun CDISC- Ward Janssen wputtem@its. Modify SDTM-
2014 11:06 AM 1248 Puttemans jnj.com Existing LBTEST/CD
Term
Open Friday, 20 Jun CDISC- Phil Pochon Covance Phil.Pochon Create New SDTM-
2014 11:09 AM 1249 @Covance.c Term LBTEST/CD
om
Open Friday, 20 Jun CDISC- Phil Pochon Covance Phil.Pochon Modify SDTM-
2014 11:12 AM 1250 @Covance.c Existing LBTEST/CD
om Term
Closed Friday, 20 Jun CDISC- Phil Pochon Covance Phil.Pochon Create New SDTM-
2014 11:13 AM 1251 @Covance.c Term MICROORG
om
Closed Friday, 20 Jun CDISC- Audrey Charles River audrey.walke Create New SEND-
2014 11:15 AM 1252 Walker r@crl.com Term STRAIN
Closed Friday, 20 Jun CDISC- Virginie Soete Business&Deci virginie.soete Create New QS-FIQR
2014 11:19 AM 1253 sion Life @businessd Term TEST/CD
Sciences ecision.com
Closed Friday, 20 Jun CDISC- Virginie Soete Business&Deci virginie.soete Create New QS-HADS
2014 11:20 AM 1254 sion Life @businessd Term TEST/CD
Sciences ecision.com
Open Friday, 20 Jun CDISC- Pam Harvey CDISC pharvey@cdi Create New Multiple
2014 11:22 AM 1255 (on behalf of sc.org Term
Stephanie
Caruso)
Open Friday, 20 Jun CDISC- Pam Harvey CDISC pharvey@cdi Create New Multiple
2014 11:23 AM 1256 (on behalf of sc.org Codelist
Stephanie
Caruso)
Open Friday, 27 Jun CDISC- Richard Addy Rho: Full- Richard_Add Create New SDTM-
2014 12:11 PM 1257 Service y@rhoworld. Term RACE
Contract com
Research
Organization
Closed Friday, 27 Jun CDISC- Debbie Merck debra_oneill Modify SDTM-

2014 12:15 PM 1258 O'Neill @merck.com Existing MICROORG
Term
Closed Friday, 27 Jun CDISC- Carrie Neeley Covance carrie.neeley Create New SDTM-
2014 12:16 PM 1259 @covance.c Term LBTEST/CD
om
Open Friday, 27 Jun CDISC- Rajinder GlaxoSmithKlin Rajinder.Ran Other SDTM-

2014 12:18 PM 1260 Randhawa e dhawa@gsk. CVEXAM/
com CD
Closed Friday, 27 Jun CDISC- Bess LeRoy C-path bleroy@c- Create New SDTM-
2014 12:21 PM 1261 path.org Term RETEST/CD
Closed Friday, 27 Jun CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-UNIT
2014 12:24 PM 1262 org Existing
Term
Closed Friday, 27 Jun CDISC- Audrey Charles River Audrey.Walk Create New SEND-
2014 12:25 PM 1263 Walker er@crl.com Term SPEC
Closed Friday, 27 Jun CDISC- Gitte Novo Nordisk gttf@novonor Create New SEND-
2014 12:26 PM 1264 Frausing A/S disk.com Term STSPRM/
CD
Closed Friday, 27 Jun CDISC- Dana Booth CDISC dbooth@cdis Other Multiple
2014 12:27 PM 1265 c.org
Closed Friday, 27 Jun CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 12:29 PM 1266 org Existing LBTEST/CD
Term
Closed Friday, 27 Jun CDISC- Jordan Li (on NCI EVS jordan.li@nih Modify SDTM-LOC
2014 12:31 PM 1267 behalf of .gov Existing
SEND- Term
FXLOC team)
Closed Thursday, 3 Jul CDISC- Claire West GSK claire.m.west Modify SDTM-
2014 05:24 PM 1268 @gsk.com Existing LBTEST/CD
Term
Closed Thursday, 3 Jul CDISC- Robert CDISC rdempsey@c Modify Multiple

2014 05:28 PM 1269 Dempsey disc.org Existing
Term
Closed Thursday, 3 Jul CDISC- Robert CDISC rdempsey@c Modify SDTM-
2014 05:30 PM 1270 Dempsey disc.org Existing VSRESU
Term
Closed Thursday, 3 Jul CDISC- Debbie Merck debra_oneill Create New SDTM-LOC
Closed Friday, 11 Jul CDISC- Robert CDISC rdempsey@c Modify SDTM-

2014 11:50 AM 1272 Dempsey disc.org Existing CVEXAMCD
Term
Open Friday, 11 Jul CDISC- Robert CDISC rdempsey@c Modify SDTM-
2014 11:50 AM 1273 Dempsey disc.org Existing CVEXAM
Term
Closed Friday, 11 Jul CDISC- Gitte Novo Nordisk gttf@novonor Create New SEND-
2014 11:53 AM 1274 Frausing disk.com Term STSPRM/
CD
Closed Friday, 11 Jul CDISC- Audrey Charles River Audrey.Walk Create New SEND-
2014 11:54 AM 1275 Walker er@crl.com Term NEOPLASM
Closed Friday, 11 Jul CDISC- Debbie Merck debra_oneill Create New SDTM-
2014 11:56 AM 1276 O'Neill @merck.com Term SPECTYPE
Closed Friday, 18 Jul CDISC- Robert CDISC rdempsey@c Modify SDTM-

2014 09:39 AM 1277 Dempsey disc.org Existing VSRESU
Term
Closed Friday, 18 Jul CDISC- Bernice Yost CDISC byost@cdisc. Other SDTM-
2014 09:40 AM 1278 org DSCAT
Open Friday, 18 Jul CDISC- Bernice Yost CDISC byost@cdisc. Other SDTM-
2014 09:41 AM 1279 org DATESTCD
Closed Friday, 18 Jul CDISC- Janet Siani Shire jsiani@shire. Modify Multiple
2014 09:43 AM 1280 com Existing
Term
Open Friday, 18 Jul CDISC- Janet Siani Shire jsiani@shire. Modify SDTM-
2014 09:45 AM 1281 com Existing FREQ
Term
Closed Friday, 18 Jul CDISC- Scott Biogen Idec scott.bahlavo Create New Multiple
2014 09:49 AM 1282 Bahlavooni oni@biogeni Term
dec.com
Closed Friday, 18 Jul CDISC- Scott Biogen Idec scott.bahlavo Create New SDTM-
2014 10:04 AM 1283 Bahlavooni oni@biogeni Term METHOD
dec.com
Closed Friday, 18 Jul CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 10:24 AM 1284 Broderick Ingelheim rick@boehrin Term EGLEAD
Pharmaceutical ger-
m
Closed Friday, 18 Jul CDISC- Mark Theorem mark.gummel Modify SDTM-
2014 10:32 AM 1285 Gummel Clinical @theoremcli Existing PKPARM/
Research nical.com Term CD
Closed Friday, 18 Jul CDISC- Anita Umesh Illumina aumesh@illu None Multiple
2014 10:33 AM 1286 mina.com
Closed Friday, 25 Jul CDISC- Sarah biogen idec Sarah.McLau SDTM-UNIT
2014 12:09 PM 1287 McLaughlin ghlin@bioge
nidec.com
Closed Friday, 25 Jul CDISC- Anna Pron- AstraZeneca anna.pron- Create New SDTM-UNIT
2014 12:11 PM 1288 Zwick zwick@astra Term
zeneca.com
Closed Friday, 25 Jul CDISC- Colleen Bonjo Merck colleen_bonj Create New Multiple
2014 12:14 PM 1289 o@merck.co Term
m
Closed Friday, 25 Jul CDISC- Colleen Bonjo Merck colleen_bonj Create New SDTM-
2014 12:17 PM 1290 o@merck.co Term RETEST/CD
m
Closed Friday, 25 Jul CDISC- Erin NCI EVS muhlbradtee Modify SDTM-LOC
2014 12:20 PM 1291 Muhlbradt (on @mail.nih.go Existing
behalf of v Term
SEND repro
team)
Closed Friday, 25 Jul CDISC- Erin NCI EVS muhlbradtee Modify SDTM-LOC
behalf of v Term
SEND repro
team)
Closed Friday, 25 Jul CDISC- Erin NCI EVS muhlbradtee Modify SEND-
2014 12:27 PM 1293 Muhlbradt (on @mail.nih.go Existing SPEC
behalf of v Term
SEND repro
team)
Closed Friday, 25 Jul CDISC- Erin NCI EVS muhlbradtee Modify SEND-
behalf of v Term
SEND repro
team)
Open Friday, 25 Jul CDISC- Jon Neville C-Path jneville@c- SDTM-

2014 12:58 PM 1295 path.org PKUNIT
Closed Friday, 25 Jul CDISC- Carrie Neeley Covance carrie.neeley Create New SDTM-UNIT
2014 01:23 PM 1296 @covance.c Term
om
Closed Friday, 25 Jul CDISC- Anna Pron- AstraZeneca anna.pron- Create New SDTM-UNIT
2014 02:02 PM 1297 Zwick zwick@astra Term
zeneca.com
Closed Friday, 25 Jul CDISC- Lacey Lily wallace_lace Create New SDTM-
2014 02:04 PM 1298 Wallace y_m@lilly.co Term MICROORG
m
Closed Friday, 25 Jul CDISC- Colleen Bonjo Merck colleen_bonj Create New SDTM-
2014 02:05 PM 1299 o@merck.co Term RETEST/CD
m
Open Friday, 25 Jul CDISC- Mihaela Sanofi mihaela.simi Create New Multiple
2014 02:07 PM 1300 Simion on@sanofi.c Term
om
Closed Friday, 1 Aug CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 01:29 PM 1301 org Existing CVEXAMCD
Term
2014 01:29 PM 1302 org Existing CVEXAM
Term
2014 01:30 PM 1303 org Existing PKPARM/
Term CD
2014 01:31 PM 1304 org Existing PKPARM/
Term CD
2014 01:32 PM 1305 org Existing VSTEST/CD
Term
Open Friday, 1 Aug CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 01:34 PM 1306 org Existing DUTEST/
Term CD
Open Friday, 1 Aug CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 01:35 PM 1307 org Existing TSPARM/
Term CD
2014 01:36 PM 1308 org Existing VSTEST/CD
Term
2014 01:37 PM 1309 org Existing DUTEST/
Term CD
Closed Friday, 1 Aug CDISC- Erin NCI EVS muhlbradtee Modify SEND-
behalf of v Term
SEND
REPRO
team)
Open Friday, 1 Aug CDISC- Erin NCI EVS muhlbradtee Modify SDTM-LOC
behalf of v Term
SEND
REPRO
team)
2014 01:47 PM 1312 Muhlbradt @mail.nih.go Existing NEOPLASM
v Term
Open Friday, 1 Aug CDISC- Erin NCI EVS muhlbradtee Modify SDTM-
2014 01:48 PM 1313 Muhlbradt @mail.nih.go Existing TRTEST
v Term
Closed Friday, 1 Aug CDISC- Debbie Merck debra_oneill Create New SDTM-
2014 01:51 PM 1314 O'Neill @merck.com Term METHOD
2014 01:52 PM 1315 O'Neill @merck.com Term RSSTRESC
Closed Friday, 1 Aug CDISC- Anna Pron- AstraZeneca anna.pron- Create New SDTM-
2014 01:55 PM 1317 Zwick zwick@astra Term MICROORG
zeneca.com
Closed Friday, 1 Aug CDISC- Pam Harvey CDISC pharvey@cdi Create New Multiple
2014 01:57 PM 1318 sc.org Term
Closed Friday, 1 Aug CDISC- Christopher Pfizer christopher.w Create New SDTM-
2014 01:59 PM 1319 Eley .eley@pfizer. Term EGTEST/
com CD
Closed Friday, 1 Aug CDISC- Marcelina DIcore Group, mhungria@di Create New NEW
2014 02:01 PM 1320 Hungria LLC coregroup.co Codelist
m
Closed Thursday, 7 CDISC- Debbie Merck debra_oneill Create New SDTM-
Aug 2014 03:47 1321 O'Neill @merck.com Term RSSTRESC
PM
Closed Thursday, 7 CDISC- Claire West GSK claire.m.west Create New SDTM-
Aug 2014 03:50 1322 @gsk.com Term LBTEST/CD
PM
Closed Thursday, 7 CDISC- Nik Pemble Janssen npemble@its Other SDTM-
Aug 2014 03:51 1323 .jnj.com TOXGRV3
PM
Closed Thursday, 7 CDISC- Alla Yelina AbbVie alla.yelina@a Create New SDTM-
Aug 2014 03:53 1324 bbvie.com Term VSTEST/CD
PM
Closed Friday, 8 Aug CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 03:15 PM 1325 Broderick Ingelheim rick@boehrin Term EGTEST
Pharmaceutical ger-
m
2014 03:15 PM 1326 Broderick Ingelheim rick@boehrin Term EGTESTCD
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Closed Friday, 15 Aug CDISC- Lorraine Takeda Lorraine.Spe Create New SDTM-
2014 12:17 PM 1345 Spencer Pahrmaceutical ncer@takeda Term LBTEST/CD
s .com
Closed Friday, 15 Aug CDISC- Jane NIH/NIAID/ jane.diefenba Create New SDTM-
2014 12:21 PM 1346 Diefenbach DAIDS ch@nih.gov Term LBTEST/CD
Open Friday, 15 Aug CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 12:25 PM 1347 Broderick Ingelheim rick@boehrin Term EVAL
Pharmaceutical ger-
m
Closed Friday, 15 Aug CDISC- Erin (on NCI EVS muhlbradtee Modify SEND-
2014 12:28 PM 1348 behalf of @mail.nih.go Existing SPEC
Carol v Term
Detrisac)
2014 12:31 PM 1349 Muhlbradt @mail.nih.go Existing SPEC
v Term
v Term
v Term
v Term
Closed Friday, 15 Aug CDISC- Erin NCI EVS muhlbradtee Modify SDTM-LOC
v Term
v Term
v Term
v Term
v Term
v Term
Open Friday, 22 Aug CDISC- Gary Walker Quintiles, Inc. gary.walker Create New SDTM-
2014 01:42 PM 1359 @quintiles.co Term VSTEST/CD
m
Open Friday, 22 Aug CDISC- Marcelina DIcore Group, mhungria@di Create New SDTM-
2014 03:01 PM 1360 Hungria (on LLC coregroup.co Term METHOD
behalf of the m
SDTM
Ophthalmolog
y Team)
Closed Friday, 22 Aug CDISC- Marcelina DIcore Group, mhungria@di Modify SDTM-
2014 03:02 PM 1361 Hungria (on LLC coregroup.co Existing METHOD
behalf of the m Term
SDTM
Ophthalmolog
y Team)
Closed Friday, 22 Aug CDISC- Lacey Eli Lilly and wallace_lace Create New SDTM-
2014 03:03 PM 1362 Wallace Company y_m@lilly.co Term TCNTRL
m
Closed Friday, 22 Aug CDISC- Lorraine Takeda Lorraine.Spe Other SDTM-
2014 03:05 PM 1363 Spencer Pharmaceutical ncer@takeda EGTEST/
s .com CD
Closed Friday, 22 Aug CDISC- Audrey Charles River audrey.walke Create New SEND-
2014 03:07 PM 1364 Walker r@crl.com Term SPEC
Closed Friday, 29 Aug CDISC- Bob CDISC rdempsey@c Create New SDTM-
2014 01:15 PM 1365 Dempsey disc.org Term METHOD
v Term
v Term
v Term
Closed Friday, 29 Aug CDISC- Marcelina DIcore Group, mhungria@di Create New Multiple
2014 01:45 PM 1369 Hungria / LLC coregroup.co Term
Ophthalmolog m
y Sub-team
2014 01:49 PM 1371 Broderick Ingelheim rick@boehrin Term LBTESTCD
Pharmaceutical ger-
m
2014 01:49 PM 1372 Broderick Ingelheim rick@boehrin Term LBTEST
Pharmaceutical ger-
m
Closed Friday, 29 Aug CDISC- Sharon Boehringer sharon.brode Create New SDTM-UNIT
2014 01:50 PM 1373 Broderick Ingelheim rick@boehrin Term
Pharmaceutical ger-
m
Closed Friday, 29 Aug CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-
2014 01:51 PM 1374 org Term CVSLDEXT
2014 01:52 PM 1375 org Existing CVSLDEXT
Term
Open Friday, 29 Aug CDISC- Bernice Yost CDISC byost@cdisc. Modify Multiple
Term
Open Friday, 29 Aug CDISC- Bernice Yost CDISC byost@cdisc. Create New Multiple
2014 01:55 PM 1377 org Term
Closed Friday, 29 Aug CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-UNIT
Term
Closed Friday, 29 Aug CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-UNIT
2014 01:58 PM 1379 org Term
Open Friday, 29 Aug CDISC- Bernice Yost CDISC byost@cdisc. Create New Multiple
2014 01:59 PM 1380 org Term
Closed Friday, 5 Sep CDISC- Bernice Yost CDISC byost@cdisc. Create New Multiple
2014 02:31 PM 1381 org Term
Closed Friday, 5 Sep CDISC- Bernice Yost CDISC byost@cdisc. Modify Multiple
Term
Open Friday, 5 Sep CDISC- Steve Kopko CDISC skopko@cdis Modify SDTM-
2014 02:34 PM 1383 c.org Existing CVEXAM/
Term CD
Open Friday, 5 Sep CDISC- Steve Kopko CDISC skopko@cdis Create New Other
2014 02:36 PM 1384 c.org Term
Open Friday, 5 Sep CDISC- Steve Kopko CDISC skopko@cdis Other SDTM-
2014 02:37 PM 1385 c.org CVEXAM/
CD
Closed Friday, 5 Sep CDISC- Erin NCI EVS muhlbradtee Modify SEND-
2014 02:39 PM 1386 Muhlbradt @mail.nih.go Existing STRAIN
v Term
2014 02:40 PM 1387 Muhlbradt @mail.nih.go Existing SPECIES
v Term
Open Friday, 5 Sep CDISC- Colleen Bonjo Merck colleen_bonj Other Multiple
2014 02:41 PM 1388 o@merck.co
m
Closed Friday, 5 Sep CDISC- Anna Pron- Astrazeneca anna.pron- Create New SDTM-
2014 02:42 PM 1389 Zwick zwick@astra Term LBTEST/CD
zeneca.com
Closed Thursday, 11 CDISC- Debbie Merck debra_oneill Create New SDTM-

Sep 2014 07:19 1390 O'Neill @merck.com Term MICROORG
PM
Closed Thursday, 11 CDISC- Roberta Pfizer roberta.e.ros Create New QS-QSCAT
Sep 2014 07:21 1391 Rosenberg enberg@pfiz Term
PM er.com
Closed Thursday, 11 CDISC- Lacey Eli Lilly and wallace_lace Modify SDTM-UNIT
Sep 2014 07:23 1392 Wallace Company y_m@lilly.co Existing
PM m Term
Closed Thursday, 11 CDISC- Takahiro Otsuka takeuchit@ot Create New SDTM-

Sep 2014 07:25 1393 Takeuchi (竹 Pharmaceutical suka.jp Term FREQ
PM 内崇裕) Co., Ltd.
Closed Thursday, 11 CDISC- Scott Biogen Idec scott.bahlavo Create New SDTM-
Sep 2014 07:26 1394 Bahlavooni oni@biogeni Term MOTEST/
PM dec.com CD
Closed Thursday, 11 CDISC- Sharon Boehringer sharon.brode Create New SDTM-

Sep 2014 07:28 1395 Broderick Ingelheim rick@boehrin Term EMPSTAT
PM Pharmaceutical ger-
m

Sep 2014 07:28 1396 Broderick Ingelheim rick@boehrin Term RELSUB
m
Closed Thursday, 11 CDISC- Erin NCI EVS muhlbradtee Modify SDTM-
Sep 2014 07:29 1397 Muhlbradt (on @mail.nih.go Existing LBTEST/CD
PM behalf of Lab v Term
team)
Closed Thursday, 11 CDISC- Erin NCI EVS muhlbradtee Modify SEND-

Sep 2014 07:30 1398 Muhlbradt (on @mail.nih.go Existing STSPRM
PM behalf of Lab v Term
team)
Sep 2014 07:31 1399 Broderick Ingelheim rick@boehrin Term EPOCH
m

m
m

m

m

m

m

m

m

Sep 2014 07:36 1408 Broderic Ingelheim rick@boehrin Term EPOCH
m
Sep 2014 07:36 1409 Broderic Ingelheim rick@boehrin Term EPOCH
m
behalf of v Term
SEND Repro
team)
behalf of v Term
SEND Repro
team)
Closed Friday, 12 Sep CDISC- Robert CDISC rdempsey@c Modify SDTM-
2014 12:44 PM 1412 Dempsey disc.org Existing CVPRCIND
Term
Closed Friday, 19 Sep CDISC- Debbie Merck debra_oneill Create New SDTM-
2014 03:22 PM 1413 O'Neill @merck.com Term MICROORG
Closed Friday, 19 Sep CDISC- Gordon Krall Allergan krall_gordon Create New SDTM-
2014 03:24 PM 1414 @allergan.co Term PKUNIT
m
Closed Friday, 19 Sep CDISC- Bess LeRoy C-Path bleroy@c- Create New Multiple
2014 03:24 PM 1415 path.org Term
Closed Friday, 19 Sep CDISC- Audrey Charles River audrey.walke Create New SEND-
2014 03:27 PM 1416 Walker r@crl.com Term SPEC
Closed Friday, 19 Sep CDISC- Pam Harvey CDISC pharvey@cdi Create New New
2014 03:28 PM 1417 sc.org Codelist
Closed Friday, 19 Sep CDISC- Pam Harvey CDISC pharvey@cdi Create New Multiple
2014 03:29 PM 1418 sc.org Codelist
Open Friday, 19 Sep CDISC- Sharon Boehringer sharon.brode Create New SDTM-UNIT
Pharmaceutical ger-
m
Closed Monday, 22 Sep CDISC- Dennis Noe Takeda dennis.noe@ Create New SDTM-
2014 10:08 AM 1420 Pharmaceutical takeda.com Term PKUNIT
s Intl Co
Closed Monday, 22 Sep CDISC- Dennis Noe Takeda dennis.noe@ Create New SDTM-
2014 10:13 AM 1421 Pharmaceutical takeda.com Term PKUNIT
s Intl Co
Closed Monday, 22 Sep CDISC- Dennis Noe Takeda dennis.noe@ Modify SDTM-
2014 10:15 AM 1422 Pharmaceutical takeda.com Existing PKPARM/
s Intl Co Term CD
Closed Friday, 26 Sep CDISC- Debbie Merck debra_oneill Create New SDTM-
Closed Friday, 26 Sep CDISC- Takashi Otsuka Ojima.Takas Create New SDTM-
2014 03:37 PM 1424 Ojima Pharmaceutical hi@otsuka.jp Term ROUTE
Co., Ltd.
Closed Friday, 26 Sep CDISC- Takashi Otsuka Ojima.Takas Create New SDTM-
2014 03:38 PM 1425 Ojima Pharmaceutical hi@otsuka.jp Term ROUTE
Co., Ltd.
Closed Friday, 26 Sep CDISC- Bess LeRoy C-Path bleroy@c- Create New SDTM-
2014 03:41 PM 1426 path.org Term VRTEST/CD
Open Friday, 3 Oct CDISC- Guy Sunovion guy.genereux Other Multiple

2014 12:04 PM 1427 Genereux Pharmaceutical @sunovion.c
s om
Open Friday, 3 Oct CDISC- Guy Sunovion guy.genereux Modify Multiple

2014 12:05 PM 1428 Genereux Pharmaceutical @sunovion.c Existing
s om Term
Closed Friday, 3 Oct CDISC- Bess LeRoy C-Path bleroy@c- Create New SDTM-
2014 12:07 PM 1429 path.org Term SCTEST/CD
Closed Friday, 3 Oct CDISC- Bess LeRoy C-Path bleroy@c- Create New SDTM-
2014 12:16 PM 1430 path.org Term SCTEST/CD
Closed Friday, 3 Oct CDISC- Erin NCI EVS muhlbradtee Modify SDTM-
2014 12:19 PM 1431 Muhlbradt @mail.nih.go Existing SPECTYPE
v Term
Closed Friday, 3 Oct CDISC- Mihaela Genzyme a mihaela.simi Modify SDTM-
2014 12:20 PM 1432 Simion Sanofi on@genzym Existing LBTEST/CD
Company e.com Term
Open Friday, 3 Oct CDISC- Dana Booth CDISC dbooth@cdis Modify QS-QSCAT
2014 12:22 PM 1433 c.org Existing
Term
Closed Friday, 3 Oct CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-UNIT
Term
Closed Friday, 3 Oct CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-UNIT
Term
Closed Wednesday, 8 CDISC- Jordan Li (on NCI EVS jordan.li@nih Modify SDTM-
Oct 2014 04:50 1436 behalf of the .gov Existing RSSTRESC
PM Oncology Term
Team)
Closed Thursday, 9 Oct CDISC- Dennis Noe Takeda dennis.noe@ Modify SDTM-
2014 04:22 PM 1437 Pharmaceutical takeda.com Existing PKPARM
s Term
Closed Thursday, 9 Oct CDISC- Dennis Noe "Takeda dennis.noe@ Modify SDTM-
s" Term
Closed Thursday, 9 Oct CDISC- Dennis Noe "Takeda dennis.noe@ Modify SDTM-
s" Term
Closed Thursday, 9 Oct CDISC- Dennis Noe Takeda dennis.noe@ Create New SDTM-
2014 04:25 PM 1440 Pharmaceutical takeda.com Term PKPARM
s
Closed Thursday, 9 Oct CDISC- Dennis Noe Takeda dennis.noe@ Create New SDTM-
2014 04:26 PM 1441 Pharmaceutical takeda.com Term PKPARM
s
Closed Thursday, 9 Oct CDISC- Debbie Merck debra_oneill Create New SDTM-
Closed Thursday, 9 Oct CDISC- Bess LeRoy C-path bleroy@c- Other New
2014 04:38 PM 1443 path.org
Closed Thursday, 9 Oct CDISC- Debbie Merck debra_oneill Create New SDTM-
2014 04:51 PM 1444 O'Neill @merck.com Term RSSTRESC
Closed Thursday, 9 Oct CDISC- Steve Kopko CDISC skopko@cdis Create New SDTM-
2014 04:52 PM 1445 c.org Term METHOD
Closed Thursday, 9 Oct CDISC- Scott Biogen Idec scott.bahlavo Create New SDTM-LOC
2014 04:55 PM 1446 Bahlavooni oni@biogeni Term
dec.com
Closed Friday, 10 Oct CDISC- Peggy Zorn INDS, Inc. peggy.zorn@ Create New SEND-
2014 04:31 PM 1447 inds-inc.com Term SNDIGVER
Closed Friday, 17 Oct CDISC- Dana Booth CDISC dbooth@cdis Create New Multiple
2014 11:09 AM 1448 c.org Term
Closed Friday, 17 Oct CDISC- Debbie Merck debra_oneill Create New SDTM-LOC
2014 11:11 AM 1449 O'Neill @merck.com Term
Open Friday, 17 Oct CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 11:12 AM 1450 Broderick Ingelheim rick@boehrin Term METHOD
Pharmaceutical ger-
m
2014 11:13 AM 1451 c.org Term
Open Friday, 24 Oct CDISC- Sharon Boehringer sharon.brode Create New SDTM-LOC
2014 11:59 AM 1452 Broderick Ingelheim rick@boehrin Term
Pharmaceutical ger-
m
2014 11:59 AM 1453 Broderick Ingelheim rick@boehrin Term
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Closed Friday, 24 Oct CDISC- Jordan Li NCI EVS jordan.li@nih Modify Multiple
2014 12:16 PM 1475 .gov Existing
Term
Closed Friday, 24 Oct CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 12:18 PM 1476 org Existing EGTEST/
Term CD
Closed Friday, 24 Oct CDISC- Erin NCI EVS muhlbradtee Create New SEND-
2014 12:19 PM 1477 Muhlbradt (on @mail.nih.go Term SPEC
behalf of v
SEND)
Open Friday, 24 Oct CDISC- Jordan Li (on NCI EVS jordan.li@nih Modify SDTM-
2014 12:21 PM 1478 half of the .gov Existing LBTEST/CD
HEP-C TA Term
team)
Closed Friday, 24 Oct CDISC- Sharon Boehringer sharon.brode Create New SDTM-
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Pharmaceutical ger-
m
Closed Friday, 24 Oct CDISC- Joyce Joyce joyce.hernan Create New Multiple
2014 12:45 PM 1501 Hernandez Hernandez dez_0029@y Term
Consulting ahoo.com
Closed Friday, 24 Oct CDISC- Jordan Li NCI EVS jordan.li@nih Modify Multiple
2014 12:46 PM 1502 .gov Existing
Term
Closed Friday, 24 Oct CDISC- Jordan Li (on NCI EVS jordan.li@nih Modify SDTM-
2014 12:54 PM 1503 behalf of the .gov Existing RSSTRESC
Oncology Term
Team)
Closed Friday, 24 Oct CDISC- Erin NCI EVS muhlbradtee Modify SEND-
behalf of v Term
General
team)
Closed Friday, 31 Oct CDISC- Maggie Lo Lung mlo@lungbio Create New SDTM-
2014 11:57 AM 1505 Biotechnology technology.c Term EGSTRESC
Inc. om
Closed Friday, 31 Oct CDISC- Dana Booth CDISC dbooth@cdis Modify Multiple
2014 12:01 PM 1506 c.org Existing
Term
Open Friday, 31 Oct CDISC- Nancy ADaM ADQS Nancy.Bruck Create New Multiple
2014 12:05 PM 1507 Brucken sub-team en@inventiv Term
health.com
Closed Friday, 31 Oct CDISC- Gary Walker Quintiles, Inc. gary.walker Create New SDTM-
2014 12:07 PM 1508 @quintiles.co Term TTYPE
m
Closed Friday, 31 Oct CDISC- Debbie Merck debra_oneill Create New SDTM-UNIT
Open Friday, 31 Oct CDISC- claire west GSK claire.m.west Modify SDTM-
2014 12:12 PM 1510 @gsk.com Existing METHOD
Term
Closed Friday, 31 Oct CDISC- claire west GSK claire.m.west Modify Multiple
2014 12:15 PM 1511 @gsk.com Existing
Term
Closed Friday, 31 Oct CDISC- claire west GSK claire.m.west Create New SDTM-
2014 12:16 PM 1512 @gsk.com Term METHOD
Closed Friday, 31 Oct CDISC- claire west GSK claire.m.west Create New SDTM-
2014 12:18 PM 1513 @gsk.com Term SPECTYPE
Closed Friday, 31 Oct CDISC- Debbie Merck debra_oneill Create New SDTM-
Closed Friday, 7 Nov CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-
2014 02:59 PM 1516 org Term EGTEST/
CD
Open Friday, 7 Nov CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 03:01 PM 1517 org Existing CVPRCIND
Term
Closed Friday, 7 Nov CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 03:02 PM 1518 org Existing LBTEST/CD
Term
Closed Friday, 7 Nov CDISC- claire west GSK claire.m.west Create New SDTM-LOC
2014 03:03 PM 1519 @gsk.com Term
Closed Friday, 7 Nov CDISC- claire west GSK claire.m.west Create New SDTM-LOC
2014 03:06 PM 1520 @gsk.com Term
Open Friday, 7 Nov CDISC- Sharon Boehringer sharon.brode Create New SDTM-UNIT
Pharmaceutical ger-
m
Closed Friday, 7 Nov CDISC- Gloria Jones Johnson and gjones38@it Create New Multiple
2014 03:09 PM 1522 Johnson s.jnj.com Codelist
Open Friday, 7 Nov CDISC- Jordan Li (on NCI EVS jordan.li@nih Create New SDTM-
2014 03:11 PM 1523 behalf of .gov Term LBTEST/CD
Anna M.
Pron-Zwick)
Closed Friday, 7 Nov CDISC- claire west GSK claire.m.west Create New SDTM-
2014 03:13 PM 1524 @gsk.com Term SPECTYPE
Closed Friday, 7 Nov CDISC- claire west GSK claire.m.west Create New SDTM-
2014 03:14 PM 1525 @gsk.com Term METHOD
Closed Friday, 7 Nov CDISC- Jordan Li (on NCI EVS jordan.li@nih Create New QS-QSCAT
2014 03:15 PM 1526 behalf of .gov Term
Roberta
Rosenberg)
Open Friday, 14 Nov CDISC- Debbie Merck debra_oneill Create New SDTM-
Closed Friday, 14 Nov CDISC- Debbie Merck debra_oneill Create New SDTM-
Closed Friday, 14 Nov CDISC- Emily Hartley C-Path ehartley@c- Create New QS-QSCAT
2014 12:29 PM 1529 path.org Term
Closed Thursday, 20 CDISC- Erin NCI EVS muhlbradtee Other SDTM-UNIT

Nov 2014 06:39 1530 Muhlbradt @mail.nih.go
PM v
Closed Thursday, 20 CDISC- Colleen Bonjo Merck colleen_bonj Create New SDTM-
Nov 2014 06:40 1531 o@merck.co Term RPTEST/CD
PM m
Closed Thursday, 20 CDISC- Erin NCI EVS muhlbradtee Create New Multiple
Nov 2014 06:42 1532 Muhlbradt @mail.nih.go Term
PM v
Open Thursday, 20 CDISC- Colleen Bonjo Merck colleen_bonj Create New SDTM-
Nov 2014 06:43 1533 o@merck.co Term SCTEST/CD
PM m
Open Thursday, 20 CDISC- Erin NCI EVS muhlbradtee Create New SDTM-
Nov 2014 06:45 1534 Muhlbradt @mail.nih.go Term METHOD
PM v
Open Thursday, 20 CDISC- Sharon Boehringer sharon.brode Create New SDTM-LOC
Nov 2014 06:46 1535 Broderick Ingelheim rick@boehrin Term
m
Open Thursday, 20 CDISC- Scott Biogen scott.bahlavo Create New SDTM-UNIT
Nov 2014 06:48 1536 Bahlavooni oni@biogeni Term
PM dec.com
Closed Friday, 28 Nov CDISC- Julie Ann Frontier hood@fstrf.o Create New SDTM-LOC
2014 10:46 AM 1537 Hood Science and rg Term
Technology
Research
Foundation,
Inc.
Closed Friday, 28 Nov CDISC- Erin MSC muhlbradtee Modify SDTM-

2014 10:47 AM 1538 Muhlbradt @mail.nih.go Existing METHOD
v Term
Open Friday, 28 Nov CDISC- Carrie Neeley Covance Labs carrie.neeley Create New SDTM-
2014 10:48 AM 1539 @covance.c Term LBTEST
om
Open Friday, 28 Nov CDISC- Maggie Lo Lung mlo@lungbio Create New New
2014 10:49 AM 1540 Biotechnology technology.c Term
Inc. om
Closed Friday, 28 Nov CDISC- Gloria Jones Johnson and gjones38@it Modify Multiple
2014 10:51 AM 1541 Johnson s.jnj.com Existing
Term
Closed Friday, 28 Nov CDISC- Scott Biogen scott.bahlavo Create New SDTM-LOC
2014 10:52 AM 1542 Bahlavooni oni@biogeni Term
dec.com
Closed Friday, 28 Nov CDISC- Carol CRL carol.detrisac Modify SEND-

2014 10:53 AM 1543 Detrisac @crl.com Existing SPEC
Term
Closed Friday, 28 Nov CDISC- Gitte Data gfrausing@d Create New SDTM-
2014 10:54 AM 1544 Frausing Standards atastandards Term LBTEST
Decisions Aps decisions.co
m
Closed Thursday, 4 Dec CDISC- Debbie Merck debra_oneill Modify SDTM-

2014 06:46 PM 1545 O'Neill @merck.com Existing LBTEST
Term
Closed Thursday, 4 Dec CDISC- Debbie Merck debra_oneill Create New SDTM-
Closed Thursday, 4 Dec CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 06:50 PM 1547 Broderick Ingelheim rick@boehrin Term EPOCH
Pharmaceutical ger-
m
Closed Thursday, 4 Dec CDISC- Sharon Boehringer sharon.brode Create New SDTM-
2014 06:51 PM 1548 Broderick Ingelheim rick@boehrin Term EPOCH
Pharmaceutical ger-
m
Closed Thursday, 4 Dec CDISC- Audrey Charles River Audrey.Walk Modify SEND-
2014 06:52 PM 1549 Walker er@crl.com Existing DSDECOD
Term
Closed Thursday, 4 Dec CDISC- Erin NCI EVS muhlbradtee Modify SDTM-UNIT
v Term
Closed Thursday, 4 Dec CDISC- Debbie Merck debra_oneill Create New SDTM-LOC
Open Thursday, 4 Dec CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 06:57 PM 1552 org Existing EGSTRESC
Term
Closed Thursday, 4 Dec CDISC- Bernice Yost CDISC byost@cdisc. Create New Multiple
2014 06:58 PM 1553 org Term
Closed Thursday, 4 Dec CDISC- Bernice Yost CDISC byost@cdisc. Create New New
2014 06:59 PM 1554 org Term
Closed Thursday, 11 CDISC- Jordan Li (on NCI EVS jordan.li@nih Modify SDTM-
Dec 2014 03:26 1555 behalf of the .gov Existing RSSTRESC
PM Oncology Term
Team)
Closed Friday, 12 Dec CDISC- Patricia Advanced pwozniak@a Create New Multiple
2014 01:45 PM 1556 Wozniak Clinical dvancedclinic Codelist
al.com
Closed Friday, 12 Dec CDISC- Erin NCI EVS muhlbradtee Create New SDTM-
2014 01:51 PM 1557 Muhlbradt (on @mail.nih.go Term METHOD
behalf of v
Dyslipidemia
TA team)
Closed Friday, 12 Dec CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 02:03 PM 1558 org Existing EGSTRESC
Term
Closed Friday, 12 Dec CDISC- Erin NCI EVS muhlbradtee Modify SDTM-
2014 02:19 PM 1559 Muhlbradt @mail.nih.go Existing MICROORG
v Term
Open Friday, 12 Dec CDISC- rrajkumar@ill Create New
2014 02:20 PM 1560 umina.com Term
Closed Sunday, 14 Dec CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-
2014 07:02 PM 1561 org Term PKUNIT
Closed Sunday, 14 Dec CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 07:03 PM 1562 org Existing PKUNIT
Term
Closed Friday, 19 Dec CDISC- Gloria Jones Johnson and gjones38@it Create New Multiple
Closed Friday, 19 Dec CDISC- Gloria Jones Johnson and gjones38@it Create New Multiple
Open Friday, 19 Dec CDISC- Ganesh ACI Clinical gsankaran@ Create New QS-C-SSRS
2014 01:30 PM 1565 Sankaran aciclinical.co Term Baseline/Scr
m eening
Version
TESTCD
Closed Friday, 19 Dec CDISC- Steve Kopko CDISC skopko@cdis Create New New
Closed Friday, 19 Dec CDISC- Anna Pron- AstraZeneca anna.pron- Create New SDTM-ACN
2014 01:27 PM 1567 Zwick Pharmaceutical zwick@astra Term
s zeneca.com
Closed Friday, 19 Dec CDISC- Anna Pron- AstraZeneca anna.pron- Create New SDTM-ACN
2014 01:24 PM 1568 Zwick Pharmaceutical zwick@astra Term
s zeneca.com
Closed Friday, 19 Dec CDISC- Peggy Zorn INDS, Inc. peggy.zorn@ Modify SEND-
2014 01:22 PM 1569 inds-inc.com Existing STSPRMCD
Term
Closed Friday, 19 Dec CDISC- Bernice Yost CDISC byost@cdisc. Modify SDTM-
2014 01:14 PM 1570 org Existing CCRCLSCD
Term
Closed Friday, 19 Dec CDISC- Bernice Yost CDISC byost@cdisc. Create New SDTM-
2014 01:13 PM 1571 org Term CCRCLSCD
New Term or Codelist/Existing Term or
Code Number
Change CDISC Definition for Code=C74686 CDISC Definition was changed for LBTESTCD=C74686, but
to match what it is for LBTESTCD not for corresponding LBTEST=C74686
Code=C74686
Change NCI Preferred Term for LBTEST Change NCI Preferred Term for LBTEST Code=C64488 to
Code=C64488 to have it match what it is for have it match what it is for LBTESTCD Code=C64488
LBTESTCD Code=C64488
Remove carriage return character from CRLF/ characters were removed from other PKUNIT terms
PKUNIT COde=C111264 added in 3rd quarter 2013. This is another new one.
New Morphology Findings Domain Test I will send the multiple term CDISC Multiple Term Request
Code/Test Name codelist Spreadsheet to B. Yost.with the new MOTESTs based on the
AD, PD and PKD TA data standards.
Change NCI Preferred Term for PKUNIT These were listed as changes maded in 12/20/2013 CT
Code=C67372 to 'Gram per 24 Hours' and release, but were not made.
for PKUNIT Code=C67410 to 'Milliliter per
24 Hours'. Add Synonym to PKUNIT
Code=73742 as 'Milligram per Minute'.
Update NCI Preferred Term and CDISC The NCI Preferred Term needed to be changed, but instead
Definition for PKUNIT Code=C85641. Both the CDISC Definition was changed. Now both do not match
do not match the current Submission Value. the Submission Value.
Change code in column A from 101829 to Change code in column A from 101829 to C101829
C101829
C67154/C65047 Laboratoy Test - CDISC one word missing

definition mistmacht for code C74686
LIPASE The assay we use for LIPASE will measure any lipase activity
in plasma or serum. It cannot determine the origin so it is not
specific for pancreatic lipase.
LIPASE should be a new term by itself with a new defintion: A

measurement of the lipase in a biological specimen.
LBTESTCD LIPASE, LBTEST Lipase
Please consider changing the the CDISC LBTESTCD for

Triacylglycerol Lipase to something else like TRIGRLIP.
EYE, AQUEOUS and BULBAR Please consider adding the follwing terms: EYE, AQUEOUS
CONJUNCTIVA and BULBAR CONJUNCTIVA
Please see attached spreadsheet. Please see attached spreadsheet.
C67255; Synonym Remove torr and Torr from published term. This should have
been removed with P16 but were not on the spreadsheet for
the VSSTRESU codelist.
C49670; Synonym Add space between semi-colon and second synonym.
C12499; NCI Preferred Term Remove torr and Torr from published term. This should have
been removed with P16 but were not on the spreadsheet for
the VSSTRESU codelist.
C64488; NCI Preferred Term Change NCI PT to Calcium Measurement
C74686; Definition Update definition to: 'A measurement of the blood in body
products such as a urine or stool sample, not detectable on
gross examination.' This was already okay'd with P16 but
didn't get updated in spreadsheet.
C42928; Definition Definition in spreadsheet should have single quotes around
shell, not double.
C67372; NCI Preferred Term Change NCI PT to Gram per 24 Hours
C111264; CDISC Submission Value Remove carriage return in spreadsheet.
C67410; NCI Preferred Term Change NCI PT to Milliliter per 24 Hours
C71059; NCI Preferred Term Change NCI PT to Brugada Syndrome Ventricular Arrhythmia
by ECG Finding
C12499; NCI Preferred Term in SEND file Change NCI PT to Inner Ear
Modify several TEST values and CDISC File emailed separately. I’ve also attached the reference
Definitions for the Kurtzke Functional article that the questionnaire was published in and the CRF
Systems Scores Questionnaire. that will be annotated and posted along with the Supplement
for the KFSS.
Also add terms for an additional two File emailed separately. I’ve also attached the reference
questions that are in the original KFSS article that the questionnaire was published in and the CRF
questionnaire but were missing on the CRF that will be annotated and posted along with the Supplement
that was used to create the KFSS for the KFSS.
terminology. See the emailed Excel
spreadsheet for details.
Remove terms C52749; C52758; C52754; There is no reason to keep these on the list that the general
C12295 from Anatomical Location. team can see.
C73742; Synonym Add synonym 'Milligram per Minute' so that UNIT and PKUNIT
codelists are aligned.
C49671; Synonym make the P in 'per' lowercase to make it consistent with

synonym in UNIT codelist.
C112395; synonym remove carriage return in synonym column

C112523; definition remove carriage return in definition column
Multiple Terms Submitted in separate email File emailed separately on 23-Jan-2014
GASTRIC Remove the term GASTRIC from the Anatomical Location

codelist. This term is a descriptor rather than a location. Other
descriptor terms, such as Hepatic, were previously removed
from this codelist.
EVERY 7 WEEKS Please add the term EVERY 7 WEEKS to the Frequency
codelist with the synonym Q7S.
/YEAR; mL/mmHg/min/L; mmol/min/kPa; Please add the following terms to the Unit codelist:
mmol/min/kPa/L /YEAR - per year
mL/mmHg/min/L; mmol/min/kPa; mmol/min/kPa/L are units
used to capture the results from the diffusing capacity of the
lung for carbon monoxide (DLCO)
IN SITU HYBRIDIZATION Our clinical team feel that the similar terms currently available
in the CDISC Method dictionary and are found to be too
specific, thus the broader term of ?IN SITU
HYBRIDIZATION? is required. Existing CDISC terms which
were evaluated by the team are:
CISH and FISH: CISH is a dual stain (colorimetric and
fluorescent) and FISH is a fluorescent stain. Both involve
fluorescence that one doesn?t necessarily need to do for in
situ hybridization. In situ hybridization could involve
colorimetric only.
Nucleic acid hybridization: This is a technique where you
detect DNA imprinted on a filter paper using a radioactive
probe (as opposed to detecting in tissue or cells, as with in
situ hybridization)
PR INTERVAL; RR INTERVAL; QRS Please consider adding the following new terms for Veterinary
INTERVAL; QT INTERVAL ECGs: EGTEST, EGTESTCD.
PR INTERVAL
RR INTERVAL
QRS INTERVAL
QT INTERVAL
These are not summary means, summary max, summary min
or summary median. We are just selecting on one PR interval,
rr interval, QRS interval QT interval and reporting it.
Intraventricular and Intraatrial Conduction The existing test name Intraventricular and Intraatrial
Conduction is greater than 40 characters. Recommend
updating test name to Intraventricular Intraatrial Conduction
Change C102404 to C25397 Concept merged in NCIt
Re-code C2271 to C581 (Insulin) Incorrect mapping in NCIt.
/nL A volume unit equal to one nanoliter used as a denominator

to build a derived unit expressed as a ratio.
FT Needed for the new "Functional Tests" domain. This domain

has gone through internal review and will be reviewed by the
SRC in February.
Add term to QS GAD-7 code lists and PHQ- File emailed separately
9 code lists for total score.
PHOTOTOXICITY Please consider adding PHOTOTOXICITY to the study type

list.
TRICHOFOLLICULOMA, BENIGN; Suggestion from INHAND OWG member to add these other
TRICHOEPITHELIOMA, BENIGN; types of hair follicle neoplasms to the NEOPLASM codelist.
TRICHOEPITHELIOMA, MALIGNANT;
TRICHOLEMMOMA, BENIGN;
TRICHOLEMMOMA, MALIGNANT;
PILOMATRICOMA, BENIGN;
PILOMATRICOMA, MALIGNANT
Multiple Anatomical Location terms - File File emailed separately

emailed separately
NASAL This term is needed to represent the nasal quadrant of the

eye
TEMPORAL This term is needed to represent the temporal quadrant of the
eye
Re-assign c-codes for a handful of concepts C65184; C4147; C35382; C3463; C26919; C66772; C67107;
in the Neoplasm codelist. These are C66746 - All of these terms will have new c-codes in the P17
experimental organism concepts only and release.
should be specified as such in the NCI PT.
New SEND LBTESTCD and LBTEST for Add the following excretion LBTESTCD, LBTEST and
excretion tests. definition. The definition for clearance tests indicate the
volume of serum or plasma that would be cleared of the
substance by excretion and the calculation considers the
amount of the substance recorded in the serum or plasma
along with the amount that is excreted. The excretion tests
are only measuring the amount of the substance in the urine.
ALBEX: Albumin Excretion: Measurement of albumin being

excreted in urine over a defined amount of time.
CAEX: Calcium Excretion: Measurement of calcium being
CLEX: Chloride Excretion: Measurement of chloride being
CREATEX: Creatinine Excretion: Measurement of creatinine
being excreted in urine over a defined amount of time.
GLUCEX: Glucose Excretion: Measurement of glucose being
IRONEX: Iron Excretion: Measurement of iron being excreted
in urine over a defined amount of time.
PHOSEX: Phosphorus Excretion: Measurement of
phosphorus being excreted in urine over a defined amount of
time.
KEX: Potassium Excretion Measurement of potassium being
SODIUMEX: Sodium Excretion: Measurement of sodium
being excreted in urine over a defined amount of time.
PROTEX: Total Protein Excretion: Measurement of total
protein being excreted in urine over a defined amount of time.
DD synonym and definition is wrong in CT. Term def is incorrect with respect to IG.
Should be Death Details (not Death
Diagnosis) and definition should be: This
domain captures information pertaining to
the death of a subject.
HO domain is new in SDTM IG. Should be New domain in new IG.
Healthcare Encounters. Definition is: The
Healthcare Encounters dataset includes
inpatient and outpatient healthcare events.
C56270 and C85627 are mathematically Dennis suggests to remove C85620 as it uses the non-
synonymous. standard concentration form "mg/L"; the standard form,
"ng/mL" is used in C85627. These terms will be merged in
NCIt.
C85710 mg/L/mg Change submission value of this term from mg/L/mg to
ng/mL/mg because this is the PK team's standard form.
retinal nerve fiber layer Need this for the MS TA standard. Retinal nerve fiber layer
thickness is often measured in MS clinical trials.
PALPEBRAL CONJUNCTIVA Add so that all Conjunctiva parts are on the codelist.
VGPR Please add the term VGPR with the synonym Very Good
Partial Response to the Tumor Response Result codelist.
This is a standard response criteria for multiple myeloma

(Reference:
http://www.myelomabeacon.com/news/2009/03/13/current-
information-on-response-criteria-for-multiple-myeloma/)
Knee Height Requesting this for TB studies for adult subjects who cannot
stand, usually because they are weakened by the disease.
Apparently there is a validated method to convert knee height
to standing height. Here is one source but we are not experts
and are happy to defer to you for a standard definition.
http://most.ucsf.edu/docs/
KneeHghtLegLgth_v1.0pMay2009.pdf
HEARTBEATS PREMATURE; Please add the following terms to the ECG Result codelist:
PACEMAKER GENERATED ARRHYTHMIA HEARTBEATS PREMATURE - a type of arrhythmia. It is a
beat that occurs earlier than expected, briefly interrupting the
normal heart rhythm.
PACEMAKER GENERATED ARRHYTHMIA - An
electrocardiographic finding in which a variation in heartbeat
is due to an artificial cardiac pacemaker.
Please either remove one or clarify the need The definition doesn't really differentiate between them
for 2 seemingly identical result codes:
SINUS RHYTHM, NORMAL SINUS
RHYTHM
Please correct the NCI Preferred Term In the line about calcium, I can see "Eosinophil to Leukocyte
about Calcium. Ratio" as the NCI Preferred Term. I think it must be "Calcium
Measurement".
C16634; NCI Preferred Term needs to Change NCI PT from 'Georgia' to 'Georgia (Republic)'
change.
Please add CIGAR, CIGARETTE, and PIPE The UNIT codelist does not provide values for the collection
to the UNIT codelist or provide guidance for and tabulation of the number of certain products like cigars,
SDTM Submission values for collecting the cigarettes, pipes, etc. smoked. Please either add these units
number of a given substance smoked. to the codelist or provide guidance for the collection and
tabulation of the number of a certain substance consumed.
Ideal Weight A person's optimum weight as defined by the Metropolitan

Life Tables which include a combination of factors for height,
age, frame size, and gender.
IDEALWT A person's optimum weight as defined by the Metropolitan
Life Tables which include a combination of factors for height,
age, frame size, and gender.
Request for new SDTM_LBTEST and File emailed separately

SDTM_LBTESTCD entries submitted in a
separate e-mail titled CDSIC Controlled
Terminology Multiple Term Request
Speadsheet SharonBroderick 24Feb2014.
mm Add the unit of mm (millimeter) to the Vital Signs Result Unit

codelist. This unit is used in the measurement of newborns.
C Reactive Protein, High Sensitivity (Test Please add the term C Reactive Protein, High Sensitivity to
Code: CRPHS) the Laboratory Test Name codelist with the corresponding
test code of CRPHS.
C98869 - please consider changing code to In C96679, C96680, C74661, C74911, C74619, PLS is being
PLSCECE (see additional information) used to represent plasma cells. PLSIxxxx for immature
plasma cells, PLSMxxxx for Mature Plasma cells. Please
reconsider the code for C98869 from PLSMCECE to
PLSCECE otherwise how will you create a code for Mature
Plasma Cells/Total Cells
cells/nL Please add the unit cells/nL to the Unit codelist.
Definition: A unit of cell concentration expressed in cells per
unit of volume equal to one nanoliter.
This unit is associated with results in the WBC differential
tests.
DARTSEX (Nonclinical DART Sex): To be File emailed separately.
used as the Standardized Result (--
STRESC) of tests for determining the sex of
fetuses and/or neonates in Developmental
and Reproductive Toxicology studies.
Currently used in the draft FX domain (Fetal
Pathology Exami
10^6/mm3 Please add 10^6/mm3 as a synonym to the submission value

of 10^12/L.
Update definition for um3 um3 has the synonym of cubic micrometer.
1 cubic micrometer = 1 femtoliter

The definition of femtoliter states that it is a unit of volume
equal to 10E-15 liter while the definition for cubic micrometer
states that it is a unit of volume equal to 10E-18 liter. The
definition for cubic micrometer should be a unit of volume
equal to 10E-18 liter cubic meter ? which is equivalent to 10E-
15L.
cubic micron Add cubic micron as a synonym to the unit um3
Request for new LBTEST and LBTESTCD A semi quantitative analysis of bilirubin in urine is not a
for SEND use. Microalbumin, segmented measurement of the total bilirubin. A change is needed to
leukocytes, and semi quantitative bilirubin C38037. Request to Change to C38037 to ?Total Bilirubin?
and keep definition as ?A measurement of the total bilirubin in
a biological specimen.?
Change LBTESTCD to BILITOT. Add new LBTEST = called ?
Semi Quantitative Bilirubin? or just ?Bilirubin? with a definition
of ?A semi quantitative measurement of the bilirubin in a
biological specimen.? Corresponding new LBTESTCD =
BILISEMI
For C64431 Albumin, remove ?Microalbumin? as a synonym.

Add new LBTEST = Microalbumin with a definition of ?A
measurement of the microalbumin in a biological specimen.?
Corresponding new LBTESTCD = MICROALB. Add new
LBTEST = Segmented Leukocytes with a definition of ?A
measurement of the
segmented leukocytes in a biological specimen.?
Corresponding new LBTESTCD = WBCSG
For SEND use, C64526 and C67069 appear For FREQ, codes C64526 and C67069, appear synonymous.
synonymous. The definitions do not explain the difference between 1 time
per week and every week.
Disability Rating Scale (DRS) Questionnaire The TBI Standards project has requested this questionnaire
for implementation. It is in the public domain. I have sent the
draft spreadsheet, CRF, the public domain verification
document and the URL reference.
Microscopic Test Terminology The Microscopic Domain was released in SDTM 3.2. This
request is to setup the MITESTCD/MITEST terminology
based on the examples in the domain document. I will send
the New Terminology request spreadsheet to E. Muhlbradt &
B. Yost.
New LBTESTCD and LBTEST for SEND The current terms available (C64831 and C82045)are a
use for segmented and non-segmented percentage to the leukocytes. The test code and test we are
neutrophils percent requesting to add for segmented neutrophils is for segmented
neutrophils as a percentage of neutrophils counted
(segmented and non segmented) not as a percentage of
leucocytes so if it tied to leucocytes in any way (similar for the
nonsegmented percentage).
Request to add the following:

LBTESTCD = NEUTSGNE
LBTEST = Neutrophils, Segmented/Neutrophils
Definition = A relative measurement (ratio or percentage) of
segmented neutrophils to neutrophils counted (segmented
and band form) in a biological specimen.
LBTESTCD = NEUTBNE
LBTEST = Neutrophils Band Form/ Neutrophils
Definition = A relative measurement (ratio or percentage) of
band form neutrophils to neutrophils counted (segmented and
band form) in a biological specimen.
Keratoacanthoma, Benign Suggested definition:

A benign neoplasm in the superficial dermis with direct
association to the epidermis,composed of well differentiated
squamous epithelium and a central cavity filled with
concentric layers of keratin; a pore (opening in the epidermis)
may be present.
HEMOLYMPHORETICULAR TUMOR suggested definition:

A malignant neoplasm of hematopoietic or lymphoreticular
cells.
RIU - Relative Intensity Unit Used for Microarray data
1. Can a term be added for Total Protein? The LBTESTCD PROT refers to Protein. The NCI Preferred
Or can Total Protein be in the synonym? 2. Tem is Total Protein Measurement. The physicians would
The LBTESTCD Bili refers to Bilirubin. Can like to clarify in CT that this is Total Protein - or that a new test
LBTEST be set to Total Bilirubin? be added for Total Protein. They want it to be clear to the
sites. Even adding a synonym of Total Protein would help.
The LBTESTCD Bili refers to Bilirubin. The NCI Preferred
Term is Total Bilirubin Measurement and the synonym is Total
Bilirubin. The definition denotes total bilirubin. The
physicians would like to use the synonym rather than the
submission value to be clear that this is a total bilirubin
measurement. Is this acceptable - as long as the submission
value in SDTM is Bilirubin? Can the LBTEST value be
updated to state Total Bilirubin?
BU; Synonym = Bethesda Unit Definition = biologic activity of factor VIII inhibitor (source =
UCUM)
GPL-U/ml Definition = IgG, biologic activity of anticardiolipin (source =

UCUM) per milliliter
MPL-U/ml Definition = IgM, biologic activity of anticardiolipin(source =

UCUM) per milliliter
multiple File submitted seperately
The lab terminology team would like to the cells are described in the test value, so you do not need
remove C67242 - cells/uL cells in the unit code.
For all of QS: Codelist Name column: all All entries currently in QS Terminology (except for
rows, (except for the Questionnaire Questionnaire Category) should have "QS-" at the beginning
Category codelist rows) of each row in the Codelist Name column. This is to
distinguish the rows from "FT-" for functional tests.
Questionnaire Category codelist rows Change all rows in the Codelist name column to "Category of
Questionnaire".
BIOPSY; ASPIRATION Biopsy - here are many different types of biopsy procedures.
The most common types include: (1) incisional biopsy, in
which only a sample of tissue is removed; (2) excisional
biopsy, in which an entire lump or suspicious area is
removed; and (3) needle biopsy, in which a sample of tissue
or fluid is removed with a needle. When a wide needle is
used, the procedure is called a core biopsy. When a thin
needle is used, the procedure is called a fine-needle
aspiration biopsy. (From the NCI website)
Aspiration - Removal of fluid or tissue through a needle (from
NCI website)
Please reduce length of new EGTEST value --TEST values should be 40 characters or less.
of EGTEST='Intraventricular and Intraatrial
Conduction' which has a length of 43
characters.
MUGA Multi Gated Acquisition Scan designed to evaluate the
function of the right and left ventricles of the heart
Request to add the existing terms, in the File emailed separately. These terms were requested and
attached file, to the new Species codelist. approved, for the Species code list, by the CT Virology team.
Coronary Angiography; Peripheral CV ENDPOINTS Standards project request. I sent the

Angiography multiple term request spreadsheet to B, Yost & E. Muhlbradt
Creating a new code list for the TBI TA File emailed separately - The proposed terminology, copyright
project for Satisfaction With Life Scale verification page, and pdf of questionnaire will be sent via
Questionnaire email.
C74664; Change definition for consistency Change definition to: Examination of a biological specimen to
with other YEAST terms detect the presence of yeast cells in a biological specimen.
PRESENT; ABSENT PRESENT and ABSENT are qualitative results for RBC
Morphology tests such as Acanthocytes, Basophilic Stippling,
etc.
Please find attached a request for 2 new File emailed separately. Please find attached a request for 2
ADaM codelists Analysis Reason and new ADaM codelists Analysis Reason and Analysis Purpose
Analysis Purpose required for analysis results metadata that I submit on behalf
of the CDISC ADaM metadata sub-team. Both codelists
should be extensible. The suggested terms for the codelist
Analysis Purpose are a subset of values from the SDTM Trial
Summary Parameter Test Name Codelist (C67152).
DSDECOD definition changes for the Repro File emailed separately.

Pilot Terminology only. Not for public review
until the Repro pilot is completed and the
final feedback received.
IMMUNO FLORESCENCE TEST Immunofluorescence is a powerful technique that utilizes

fluorescent-labeled antibodies to detect specific target
antigens.
new term for QSCAT and new MPAI codelist The TBI standards project requested the Mayo-Portland
Adaptability Inventory (MPAI-4)questionnaire for
implementation. I am sending draft QS terminology
spreadsheet, the public domain verification document and the
CRF via e-mail.
BAR Bar unit of pressure
Cup (unit of volume) Cup Unit of volume
Remove the CDISC Clinical Data Element There has been discussion in the past about deprecating this
Glossary from CDISC terminology. subset (which includes just one codelist of the same name) as
the terminology is not linked to any existing CDISC domain
standards.
The Virology CT team requested disease The Virology CT team requested disease specific bacteria
specific bacteria species from Jordan (NCI). species from Jordan (NCI). See attached list from Jordan.
See attached list from Jordan.
Is CDISC developing controlled terminology As flow cytometry costs have dropped and the demand for
to support the representation of flow personalized medicine has risen, flow cytometry-based
cytometry-based biomarkers? biomarker testing is becoming more common. My previous
and current employers have both struggled to standardize this
data as the internal test codes from the various laboratories
differ and, at times, it can be challenging to determine if
similar looking test codes from different laboratories are
actually the same. Is the CDISC CT Team looking at this
space or have plans to do so?
MS TA - Multiple Term Request File emailed separately
Please add the following sentence to the DNA Microarray was recently added to the Method codelist
definition for Microarray. "Used when a more and the Virology team felt that it is necessary to update the
specific microarray methodology is not Microarray definition.
specified."
GOSE - Extended Glasgow Outcome Scale File emailed separately. The TBI standards project requested
the Extended Glasgow Outcome Scale (GOSE) questionnaire
for implementation. I have submitted the request in the
NCI/EVS system to be tracked.
Please add COLUMBIA-SUICIDE Missing in the latest QS Terminology
SEVERITY RATING SCALE (C-SSRS)
Lifetime/Recent Version Version 1/14/09 to
the Questionnaire Category (QSCAT)
codelist and add new Test Code and Test
Name codelists with values for this scale to
the QS Terminology.
File emailed separatly File emailed separatly
Varicella Zoster Virus DNA (test code: Request the addition of the test name Varicella Zoster Virus
VZVDNA) DNA to the laboratory test name codelist with the test code
VZVDNA. Proposed definition: A measurement of varicella
zoster virus DNA in a biological specimen.
File emailed separately File emailed separately
See atttached multi-term request File emailed separately

ENDARTERECTOMY; CARDIAC STENT ENDARTERECTOMY (NCI Code C52002)
PLACEMENT Definition: Excision of an atheromatous plaque.
CARDIAC STENT PLACEMENT (NCI Code C100080)

Definition: A procedure performed during a percutaneous
coronary intervention in which a device is deployed into the
lumen of a coronary artery to expand and support the vessel
wall such that the vessel remains patent and blood flow is
uninhibited.
/pL Per picoliter. A volume unit equal to one picoliter used as a

denominator to build a derived unit expressed as a ratio.
mmol/mol HGB Millimole per mole Hemoglobin.

A unit of substance concentration defined as the
concentration of millimoles of solute per mole of hemoglobin.
NO UNIT No unit given
File emailed separately I am part of the CDISC Hepatitis C TAUG group. Attached
please find the request for controlled terminology for the
Hepatic Encephalopathy test for CDISC Hep-C TAUG.
Antimitochondrial Antibody Subtype 2 A measurement of the antimitochondrial antibodies subtype 2

To be used with LBTESTCD AMA2AB
Anti-Neutrophil Cytoplasmic Antibody A measurement of the anti-neutrophil cytoplasmic antibody in

To be used with LBTESTCD ANCAB.
Bactericidal/Permeability-Increasing Protein A measurement of the bactericidal/permeability-increasing

Antibody protein antibody in a biological specimen.
To be used with LBTESTCD BPIPAB
Cathepsin Antibody A measurement of the cathepsin antibody in a biological

specimen.
To be used with LBTESTCD CATHPSAB
Elastase Antibody A measurement of the granulocyte elastase antibody in
autoimmune diagnostics in a biological specimen.
To be used with LBTESTCD ELAAB
Inactivated blood coagulation factor-II A measurement of the inactivated factor II in a biological

specimen.
To be used with LBTESTCD FACT2IAT
Lactoferrin Antibody A measurement of the lactoferrin antibody in a biological

specimen
To be used with LBTESTCD LTFAB
Lysozyme A measurement of lysozyme in a biological specimen.

To be used with LBTESTCD LYSOZYM
Nucleosome Antibody A measurement of the nucleosome antibody in a biological

specimen.
To be used with LBTESTCD NUCSLMAB
Proliferating Cell Nuclear Antigen A measurement of the proliferating cell nuclear antigen in a
To be used with LBTESTCD PCNAG
Polymyositis -Scl Antibody A measurement of the polymyositis -Scl antibody in a

biological specimen
To be used with LBTESTCD PMSCLAB
Proteinase-3-Antibody A measurement of the proteinase 3 antibody in a biological

specimen.
To be used with LBTESTCD PRN3AB
Ribosomal P Protein Antibody A measurement of the ribosomal P-protein antibody in a

To be used with LBTESTCD RIBSPAB
Ribonucleoprotein-70 Antibody A measurement of the ribonucleoprotein 70 antibody in a

To be used with LBTESTCD RNP70AB
Ribonucleoprotein - Smith Complex A measurement of the ribonucleoprotein - Smith complex
Antibody antibody in a biological specimen.
To be used with the LBTESTCD RNPSMAB
Sjogrens SS-A52 Antibody A measurement of the Sjogrens SS-A52 antibody in a

To be used with LBTESTCD SJSA52AB
Sjogrens SS-A60 Antibody A measurement of the Sjogrens SS-A60 antibody in a

To be used with LBTESTCD SJSA60AB
MIU - part of the E2B units of measure This term is part of the E2B units of measure terminology and
terminology and CDISC has not published it CDISC has not published it yet. It is needed for the CDASH
yet. Synonym of iu(1,000,000s) [From E2B SAE standard. E2B Synonym of iu(1,000,000s)
Change C16805 to C16290 CDISC is publishing the term ANGIOGRAM with the correct
definition but we coded it to the concept of Lymphangiogram
in error (Angiogram deals with blood vessels,
Lymphangiogram deals with the lymphatic system). The c-
code for the current concept C16805 will be changing to
C16290. The NCI PT will be updated to Angiogram.
SDTM-LBTEST; SDTM-LOC - File emailed File emailed separately

separately
RADIAL IMMUNODIFFUSION Radial immunodiffusion is an immunodiffusion technique used

in immunology to determine the quantity of an antigen by
measuring the diameters of circles of precipitin complexes
surrounding samples of the antigen that mark the boundary
between the antigen and an antibody suspended in a
medium, such as an agar gel.
ANGIOGRAM Since X-Ray is a specific type of modality used in angiograms

(others can be used like MRI), please update the CDISC
definition of ANGIOGRAM to something like: An image of
blood vessels made after the injection of a radiopaque
substance. This was brought up as part of CV therapeutic
area terminology review.
Re-open discussion about the Submission From Ron Fitzmartin: Clearly E3 Q&A document that you
value change in P17 from PROTOCOL reference below implies that “violation” should be replaced
VIOLATION to PROTOCOL DEVIATION with “deviation”. E6 is makes it clear that the term is, in fact
(C48251). This has caused some “deviation” (except in the appendix where it has a reference to
consternation in the user community. “violation”). Then we have E9 which implies, by its use of both
protocol “deviation” and “violation”, that there is a clear
difference between the two terms and provides some
examples. I agree with E3 Q&A document that some use the
terms interchangeably, but, personally, I have not. Perhaps it
should be discussed a bit further.
Intraventricular and Intraatrial Conduction This term is greater than 40 characters. Per CDISC SDTMIG,
EGTEST (like all --TEST variables) is required to be 40
characters or less
Calcium Corrected for Albumin CTC 4.0.3 grades for lab values, Hypocalcemia and
hypercalcemia, would be arrived at using this lab result. For
instance, a serum calcium of 10.4 mg/dL is normal, yet an
albumin of 3.6 results in a corrected calcium of 11.2, which is
CTC grade 1.
EGTESTCD = EGFND / EGTESTCD = ECG A request for EGTEST = "ECG Abnormality" was made by
Findings Erin Muhlbradt in March of 2011 per the change request
tracker, but I can't find the final decision for this. Some results
may not be abnormal, so a "Finding" would be a better fit. It
appears that the terminology team expects the users to
assign an appropriate EGTEST value for each type of
finding/issue, but the current set of EGTEST values make this
challenging. At a minimum, the team should ensure there is at
leaset one appropriate EGTEST value for each result.
Guidance for assigning values in a consistent manner could
also help.
dpm/0.5 mL Please add the term dpm/0.5 mL to the Unit codelist with the
synonym of disintegrations per half a milliliter. This is used as
a unit for radioactivity on a study medication form.
QS Domain "Requesting 4 new questionnaires be added to the SDTM QS

Terminology spreadsheet:
-EORTC Quality of Life Questionnaire C30 (EORTC QLQ-
C30)
-EORTC Quality of Life Questionnaire LC13 (EORTC QLQ-
LC13)
-EORTC Quality of Life Questionnaire STO22 (EORTC QLQ-
STO22)
-EORTC Quality of Life Questionnaire H&N35 (EORTC QLQ-
H&N35)"
Estrogen Receptor For the newly created SDTM-MITEST/CD codelists (not yet
available on the drop-down list, please consider the addition
of the following:
Estrogen Receptor is a protein that is found inside cells. It is a
receptor that is activated by the hormone estrogen.
To be used with MITESTCD = ER; MITEST = Estrogen
Receptor
Human Epidermal Growth Factor Receptor 2 For the newly created SDTM-MITEST codelist (not yet
available on the drop-down list), please consider the addition
of the following:
Human Epidermal Growth Factor Receptor 2: is a member of
the epidermal growth factor receptor (EGFR/ERBB) family.
To be used with MITESTCD = HER2; MITEST = Human
Epidermal Growth Factor Receptor 2
Ki-67 For the newly created SDTM-MITEST codelist (not yet
of the following:
Ki-67 : is a protein that in humans is encoded by the MKI67
gene. Antigen KI-67 is a nuclear protein that is associated
with and may be necessary for cellular proliferation.
Furthermore it is associated with ribosomal RNA transcription.
Inactivation of antigen KI-67 leads to inhibition of ribosomal
RNA synthesis.
To be used with MITESTCD = KI-67; MITEST = Ki-67
Progesterone Receptor For the newly created SDTM-MITEST codelist (not yet
of the following:
Progesterone Receptor is a protein that is found inside cells.
It is a receptor that is activated by the hormone progesterone.
To be used with MITESTCD = PGR; MITEST = Progesterone
Receptor
QS-HADS TEST and QS-HADS TESTCD, File emailed separately; QS-HADS TEST and QS-HADS
need variables for subtotals, found in TESTCD, need variables for subtotals, found in author's
author's documentation and printed versions documentation and printed versions.
The definition for TSPARMCD=REGID; The definition for REGID says "Identification numbers
TSPARM=Registry Identifier, has a typo that assigned to the protocol by ct.gov, EudraCT, or other
should be fixed. registries." "ct.gov" is the official website for the State of
Connecticut (try it); it isn't relevant. The correct website
reference is "clinicaltrials.gov". The 2 are not interchangeable.
C98714
HBVVLD (C92542) and HBDNA (C103404) I HBVVLD (C92542) and HBDNA (C103404) I think are used
think are used synonymously. HBVVLD synonymously. HBVVLD measures the amount of Hep B DNA
mesaures the amount of Hep B DNA in a in a specimen and I am not sure how HBDNA differs as this is
specimen and I am not sure how HBDNA also a measure of HBDNA. It is true that HBVVLD suggest an
differs. absolute measurement and HBDNA suggests a qualitative
measurement, but we should not be creating different test
codes for quantitative vs qualitative). I would suggest HBDNA
is retired as a term and that a synonym is added to HBVVLD
of Hepatitis B DNA (this is similar to what we did with Hep C
where Hepatitis C RNA is a synonym for Hepatisis Viral Load
Urinalysis Macroscopic Examination Requesting the addition of a general term to capture the Urine
(TESTCD: UAMAEXAM) Color, Appearance and Dipstick results as Normal instead of
entering a result of normal for each test. The same idea as
the existing term of Sediment Examination - used for
microscopic examination.
Draft Definition: An observation, assessment or examination
of the physical properties and chemical properties (ie. dipstick
tests) in a urine specimen.
umol/dL; IU/dL; umol/L/min Requesting the addition of the units: umol/dL; IU/dL;
umol/L/min which are used for the measurement of Chemistry
tests.
The submission value for C62954 and The submission value for C62954 and C112361 needs to be
C112361 needs to be in upper-case. in upper-case.
Update Category Name = BPI SHORT The Category Name should be updated to include the
FORM to read as BPI SHORT FORM (24H) timepoint of (24H) as we have been given permission by the
copyright owner to also collect (7D) for the BPI Short Form.
Other timepoints could be requested in the future so the
category name should reflect this as the timepoint is included
in the questions as well as a few of the TEST NAMES.
kg/cm The Dual Energy X-Ray Absorptiometry (DXA) test ""Lean

Body Mess Femur Ratio"" is with regards to a weight divided
by the length. Normally, we get the LBM in kg and the femur
length in cm. Therefore, the LBM / femur length ratios are
calculated in kg/cm.
Concerning this ratio, it was proposed by Ronenn in a
previous BYM338 study and it has been included in all TM
studies with BYM. The normalization is often done as skeletal
mass index (SMI: total lean body mass per height square) or
appendicular skeletal mass index (ASMI: appendicular LBM
per height square). Sometimes femur length is used as
surrogate measure of patient size for additional normalization.
m/sec2 The Actibelt test "Mean mediolateral body sway test" traces
acceleration in 3D with reference to G (gravitation), hence the
unit is m/sec2. This is a direct output from the device.
Knee For the orthopedic indication for hip fracture study, Exercise
Adherence Diary data is collected for each of the
exercise/therapy sessions. Each exercise session consists of
"Hip range of motion exercises" and "Strengthening
exercises", which includes the Knee extension test.
Also multiple new term requests for SDTM-LOC, please see

attached file.
Failure to meet protocol continuation criteria An option is needed at a Washout EPOCH which is directly
followed by a Run In Phase, to allow sites to indicate when a
Subject has not met Protocol defined Blood Pressure
criteria.The option """"Failure to meet randomization
criteria"""" is not generic enough to cover an EPOCH/Phase
which occur before Randomization, but not directly before it.
For example """"Failure to meet randomization criteria"""" is
not appropriate to use on a Washout Disposition page in a
trial design where there is a Screening Phase, then a
Washout phase and then a Run In phase prior to
Randomization. When Novartis originally requested the option
of """"Failure to meet randomization criteria"""" this situation
was not considered. Therefore a more generic term is now
being requested which would be usable at any visit where
there is defined criteria which must be met in order for a
Subject to continue into the next EPOCH/Phase.
Please add BUFFY COAT to the SDTM http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?

Specimen Type CL dictionary=NCI_Thesaurus&code=C84507&ns=NCI_Thesaur
us
Specimen type is relevant to Biogen analyses of certain virus

antibodies. The buffy coat is one of the specimens in which
Biogen tests for certain antibodies. Please note the NCI
Thesaurus reference.
Please add HEPATITIS C VIRUS Need to differentiate methods of HCV testing.
RECOMBINANT IMMUNOBLOT ASSAY to
SDTM Method Codelist http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?
dictionary=NCI_Thesaurus&code=C95525&ns=NCI_Thesaur
us
Please make the SEND OMTEST and Please make the SEND OMTEST and OMTESTCD codelists
OMTESTCD codelists extensible [Change extensible [Change Property from No to Yes]
Property from No to Yes] The SEND team has already agreed to this change and will
expect this change to go out with P19 public review.
SEND wants to re-use some concepts from SEND wants to re-use some concepts from the SDTM-LOC
the SDTM-LOC codelist for the SEND-SPEC codelist for the SEND-SPEC codelist. The definitions as
codelist. The definitions as published now published now are too human-centric.
are too human-centric.
Add new Term COTTON RAT (C77117) to SEND team agreed to add COTTON RAT with Definition: The
SEND-SPECIES codelist rat of the genus and species Sigmodon hispidus.
SEND team has agreed to proposed SEND team has agreed to proposed updates to the STRAIN
updates to the STRAIN codelist. codelist. File emailed separately.
Addition of 3 new codelists and associated Addition of 3 new codelists and associated terms for SEND
terms for SEND MI variables including MI variables including NONNEO, CHRNCTY, DSTRBN.
NONNEO, CHRNCTY, DSTRBN. SEND SEND team has developed and finalized these terms and
team has developed and finalized these they will go out for P19 public review.
terms and they will go out for P19 public
review. File emailed separately
Addition of 4 new codelists and associated Addition of 4 new codelists and associated terms for SEND
terms for SEND safety pharm work including safety pharm work including SCVTST, SCVTSTCD, SRETST,
SCVTST, SCVTSTCD, SRETST, SRETSTCD. SEND team has developed and finalized these
SRETSTCD. SEND team has developed terms and they will go out for P19 public review.
and finalized these terms and they will go
out for P19 public review.
Please consider adding the following term: An inorganic anion of fluorine with the chemical formula F? It
Fluoride contributes no color to fluoride salts. Fluoride is the main
component of fluorite (apart from calcium ions; fluorite is
roughly 49% fluoride by mass), and contributes a distinctive
bitter taste, but no odor to fluoride salts. Its salts are mainly
mined as a precursor to hydrogen fluoride. As it is classified
as a weak base, concentrated fluoride solutions will cause
skin irritation.
Remove the word MIXED and CARCINOMA This was discussed at the SEND F2F. This is in response to
from "CARCINOMA, MIXED, ACINAR- a public review comment for P18.
ISLET CELL, MALIGNANT" and add
TUMOR after "CELL". C6878
Naming convention question for Viral Load, I?m looking at the existing LBTESTCD/LBTEST terms for
DNA and RNA terms Viral tests and need some clarification. Based on the 28th
March release, there are the terms that exist related to RNA,
DNA and viral load tests. Can you tell me what the current
convention for naming these tests? It looks like things have
changed over time. HCVVLD has a synonym of HCV RNA.
But Hepatitis G has a submission value of ?Hepatitis G
RNA?, not ?Hepatitis Viral Load?.
Hepatitis B has a test for ?HBV Viral Load? and one for ?
Hepatitis B DNA?. Our virology expert at GSK has said that
DNA is a measure of Viral Load, so which one should I
choose? She also said that both DNA and RNA can be
classified as ?Viral Load?, but that by converting them to that
term, we are losing a bit of information ? the fact that it was
the RNA or DNA. Should we have specific tests (either RNA
or DNA since they cannot have both) for ALL the viral tests
and retire the ?---VLD? LBTESTCD terms and ?.....Viral
Load? LBTEST terms? Or should the term ?Viral Load? be
retained and the RNA/DNA synonym added? Either way I
think we need to be consistent across the board.
I am also querying the use of Acronyms ? HBV versus

Hepatitis B for example. Can we be consistent and go back
and change these? This is critical for us because we have a
large group of viral tests which are not currently in the SDTM
terminology list and we cannot wait for the next release ? I
need to finalise them now. I?m just not sure how to name the
LBTESTCD or LBTEST to be consistent with the CDISC
SDTM standard. Do I call them all Viral Load, or use the
DNA/RNA naming convention?
Adenovirus DNA PCR
Epstein-Barr virus DNA PCR
Hepatitis E Virus RNA PCR
Hepatitis E RNA PCR
Human herpesvirus 6 DNA PCR
Herpes Simplex Virus 1 /2 DNA PCR
SEND Repro team would like to include the SEND Repro team would like to include the following terms in
following terms in the new codelist the new codelist FXSTRESC for fetal findings terminology.
FXSTRESC for fetal findings terminology.
Several new SPEC terms with definitions Muscle, Plantaris: One of three superficial muscles at the
suggested back of the leg, between the soleus and the gastrocnemius.
Assists in flexing the foot and knee.
Muscle, Extensor Digitorum Longus: Muscle located on the

lateral part of the rear leg. Its actions involve the extension of
the digits and dorsiflexion of the foot.
Brain, Visual Cortex: A brain region in the occipital cortex that

receives visual stimuli from the retina.
Brain, Optic Chiasm/Tract: The nerves that travel from the

place in the brain where some of the optic nerve fibers cross
into certain parts of the brain involved in vision.
Pleura, Parietal: The outermost of the two pleural

membranes, lines the wall of the pleural cavity.
Pleura, Visceral:The innermost of the two pleural membranes,

lines the surface of the lungs in the pleural cavity.
Duodenal Papilla, Minor: The opening of the accessory

pancreatic duct into the duodenum, located anterior to and
slightly superior to the major papilla.
Duodenal Papilla, Major: The opening of the commmon bile

duct and pancreatic duct into the duodenum.
Duct, Pancreatic: The major pancreatic duct joining the

pancreas to the common bile duct
Duct, Common Bile: The duct formed by the union of the

common hepatic duct and the cystic duct
Duct, Common Hepatic: The duct formed by the union of the

right and left hepatic ducts.
Request to differentiate between treated and Requesting to separate the treated and untreated SPECs
untreated Skin and Skin/Subcutis below. There isn't an alternative place to indicate ""treated""
or ""untreated"" because it isn't an anatomical region.
Treated Skin: A treated organ that constitutes the external

surface of the body. It consists of the epidermis, dermis, and
skin appendages.
Untreated Skin: An untreated organ that constitutes the

external surface of the body. It consists of the epidermis,
dermis, and skin appendages.
Treated SKIN/SUBCUTIS: A treated tissue sample that

contains the epidermis, dermis, and subcutaneous adipose
tissue.
Untreated Skin/subcutis: An untreated tissue sample that

contains the epidermis, dermis, and subcutaneous adipose
tissue.
Functional Tests (FT) CDISC Definition: Named, stand-alone task-based
evaluations designed to provide an assessment of mobility,
dexterity, or cognitive ability.
Procedure Agents (AG) CDISC Definition: Captures the agents administered to the
subject as part of a procedure or assessment as opposed to
drugs, medications and, therapies administered with
therapeutic intent.
FI02/Fraction of Inspired Oxygen A measurement of the proportion of oxygen contained in the

inspired air.
PAO2FIO2/Partial Pressure of Arterial A relative measurement (ratio or percentage) of the force per
Oxygen/Fraction of Inspired Oxygen unit area (pressure) of oxygen dissolved in arterial blood to
the percentage oxygen of an inhaled mixture of gasses.
SAO2/Arterial Oxygen Saturation A measurement of the percentage of hemoglobin in the

arterial blood which is bound with oxygen.
Points SHORT PHYSICAL PERFORMANCE BATTERY is a

standard test to measure the mobility disability. Points is the
unit from SHORT PHYSICAL PERFORMANCE BATTERY
score calculation.
Multiple terms request New terms proposed for the SDTM LOC codelist.
Multiple terms request New terms proposed for the SDTM UNIT codelist.
EGALL When whole assessment is not performed,the data will be

collected on a single record. The parameter name will be
'EGALL', Status should be 'NOT DONE' and REASON should
be provided
New LBTESTCD = CTX11CRT New Proposed definition is "A relative measurement (ratio or
LBTEST = Type II Collagen C- percentage) of the Type II Collagen C-Telopeptides to the
Telopeptides/Creatinine creatinine in a biological specimen."
INTERVIEWER, SINGLE PROFESSIONAL, These terms are part of two new questionnaires being
PROFESSIONAL CONSENSUS, PERSON developed for traumatic brain injury, GOSE and MPAI. They
WITH BRAIN INJURY, SIGNIFICANT are the evaluator choices given on the CRFs. Interviewer is
OTHER on GOSE whereas the others are all options on the MPAI.
Tumor Response Result: Please remove Team decides to remove this from existing terminology.
NA, C48660
Breathalyzer Use when LBTEST=ETHANOL
Add 3 new terms to LBTEST/CD and UNIT Add 3 new terms to LBTEST/CD and UNIT codelists.
codelists Please see attached spreadsheet in separate email.
preputial/clitoral gland INHAND talks about them as a single entity "preputial/clitoral
gland". They are currently separate SPEC terms in CDISC.
Biologically it is the same gland in both males and females -
the name is just different in the different sexes. Some sites
use one term to make things simpler, so we only need one list
of findings rather than replicating the findings in two separate
tissues.
Please make the following CDISC Does not conform to STDM nomenclature. Should read:
Submission Value terms uppercase: C62954 DEVICE OPERATIONAL ISSUE
Device Operational Issue C112361 Non- NON-STUDY EQUIPMENT ISSUE
Study Equipment Issue
LBTEST = Interleukin 1 Alpha; LBTESTCD Request content is modeled after the content of the CDISC
= INTLK1A term for Interleukin 1 Beta. Definition of new term: A
measurement of interleukin 1 alpha in a biological specimen.
BPI SHORT FORM - Category (QSCAT) BPI SHORT FORM is currently the QSCAT but the developer
of the questionnaire has allowed Merck to use the 24 Hour
version that you have posted and a 7 Day version. We ask
that the QSCAT be updated to read as: BPI SHORT FORM
(24H)since the timepoint is inbedded within the test name and
the questions. Merck will be submitting a request to add BPI
SHORT FORM (7D) as another option.
Add terms to LBTEST/CD Add terms to LBTEST/CD
TRANSPOSON Should Transposon be updated to all upper case

(TRANSPOSON) to be consistent with the other terms in
codelist (e.g.RIBOZYME)
TSPARM-CD. Multiple new term requests TSPARM-CD. Multiple new term requests for Trial Summary
for Trial Summary Parameter Test Codes Parameter Test Codes and Test Names. QT Studies TA team
and Test Names. request. This information is requested by the FDA for TQT
studies as part of the FDA Study Level Specification. File
emailed separately.
MELD Score Please add the test name MELD Score with the test code
MELDSCR to the laboratory test name codelist.
The MELD (Model for End-Stage Liver Disease) Score is a
numerical scale used for liver allocation. The MELD score is
based on a patient's risk of dying while waiting for a liver
transplant, and are based on objective and verifiable medical
data. The MELD Score is calculated using Creatinine,
Bilirubin and INR results.
The MELD formula is: MELD Score = (0.957 * ln(Serum Cr) +
0.378 * ln(Serum Bilirubin) + 1.120 * ln(INR) + 0.643 ) * 10 (if
hemodialysis, value for Creatinine is automatically set to 4.0)
This looks like a similiar concept as the existing term of
FibroTest Score that uses the value of lab tests to calculate a
score.
ug/mmol Currently a term or synonym is not available for mapping. The
suggested definition would be "A unit of substance
concentration defined as the number of micrograms of a
substance per millimole of substance". This unit was used for
LBTEST= Type II Collagen C-Telopeptides/Creatinine.
New terms add to multiple codelists New Terms add to the SDTM-UNIT and Route of
Administration Codelists; File emailed separately
Add 'LOW PANIC', 'LOW NORMAL', 'HIGH Lab data often describe relationships to numeric reference
NORMAL', and 'HIGH PANIC' values with terms which are more descriptive that simply
'LOW', 'HIGH', or 'NORMAL'. Conforming to current controlled
terminology requires mapping both 'LOW PANIC' and 'LOW
NORMAL' to 'LOW' and both 'HIGH PANIC' and 'HIGH
NORMAL' to 'HIGH'. This results in a loss of information or
the need to include additional information in a supplemental
qualifier.
Draft Definition for 'LOW PANIC': Reported value below a

critical value indicating the result may be medically important
Draft Definition for 'LOW NORMAL': Reported value below the

typical range but above a critical value indicating the result
may be medically important
Draft Definition for 'HIGH PANIC': Reported value above a

critical value indicating the result may be medically important
Draft Definition for 'HIGH NORMAL': Reported value above

the typical range but below a critical value indicating the result
may be medically important
New QS Codelist = BPI Short Form (7D) New QS Codelist = BPI Short Form (7D)

Angiography The General Terminology Team decided to remove
ANGIOGRAM (C16805) from the Method codelist. And they
want to add ANGIOGRAPHY.
Add terms to C-SSRS Children's Baseline Add terms to C-SSRS Children's Baseline; File emailed
separately
Add terms to C-SSRS Children's Add terms to C-SSRS Children's Baseline/Screening; File
Baseline/Screening emailed separately
Add terms to C-SSRS Children's Since Last Add terms to C-SSRS Children's Since Last Visit; File emailed
Visit separately
Add terms to C-SSRS Screening Add terms to C-SSRS Screening; File emailed separately
Add terms to FAQ Add terms to FAQ; File emailed separately.
Add terms to FAQ-NACC Add terms to FAQ-NACC; File emailed separately
Add terms to MRS Add terms to MRS; File emailed separately
Add terms to SDS Add terms to SDS; File emailed separately
Add terms to AQ20 Add terms to AQ20; File emailed separately
Add term to QS-DS Add term to QS-DS; File emailed separately
Add term to QS-EDSS Add term to QS-EDSS; File emailed separately
Add terms to FAMS Add terms to FAMS; File emailed separately
Add terms to KFSS Add terms to KFSS; File emailed separately
Add terms to MHIS-NACC Add terms to MHIS-NACC; File emailed separately
Add term to QS-PDDS Add term to QS-PDDS; File emailed separately
Add terms to QS-SGRQ Past 3 months Add Add terms to QS-SGRQ Past 3 months
terms to QS-SGRQ Past 4 weeks Add terms to QS-SGRQ Past 4 weeks; File emailed
separately
Add new terms to VFQ24-IA Add new terms to VFQ24-IA; File emailed separately
Add new terms to VFQ25-SA Add new terms to VFQ25-SA; File emailed separately
Add terms to QS-BLCS Add terms to QS-BLCS; File emailed separately

Add terms to QS-BORG CR-10 Scale Add terms to QS-BORG CR-10 Scale; File emailed separately
Add terms to QS-BWCS Add terms to QS-BWCS; File emailed separately
Add terms to QS-C-SSRS Add terms to QS-C-SSRS Pediatrc/Cognitively Impaired

Pediatrc/Cognitively Impaired Lifetime/Recent; File emailed separately
Lifetime/Recent
Add terms to QS-EQ-5D-3L Add terms to QS-EQ-5D-3L; File emailed separately
Add terms to QS-EQ-5D-5L Add terms to QS-EQ-5D-5L; File emailed separately
Add terms to QS-FSS Add terms to QS-FSS; File emailed separately
Add terms to QS-IVIS Add terms to QS-IVIS; File emailed separately
Add terms to QS-MFIS Add terms to QS-MFIS; File emailed separately
Add terms to QS-MSQOL-54 Add terms to QS-MSQOL-54; File emailed separately
Add terms to RAND-36 V1.0 Add terms to RAND-36 V1.0; File emailed separately
Add terms to FT-CAT SIXMW Add terms to FT-CAT SIXMW; File emailed separately
Add terms to QS-DRS Add terms to QS-DRS; File emailed separately
Add terms to QS-GOSE Add terms to QS-GOSE; File emailed separately
Add new terms to FTCAT QS-HAI Add new terms to FTCAT QS-HAI; File emailed separately
Add terms to QS-MPAI Add terms to QS-MPAI; File emailed separately
Add terms to FTCAT QS-NHPT Add terms to FTCAT QS-NHPT; File emailed separately
Add terms to FTCAT QS-PASAT Add terms to FTCAT QS-PASAT; File emailed separately
Add term to FTCAT QS-SDMT Add term to FTCAT QS-SDMT; File emailed separately
Add new terms to QS-SWLS Add new terms to QS-SWLS; File emailed separately
Add terms to FTCAT QS-T25FW Add terms to FTCAT QS-T25FW; File emailed separately
Add term to FTCAT QS-TUG Add term to FTCAT QS-TUG; File emailed separately
Change submission term for the unit Change submission term for the unit concept uIU/mL to mIU/L
concept uIU/mL to mIU/L since the latter is since the latter is SI compliant and the former is not.
SI compliant and the former is not
CH50 unit Please add this specific arbitrary unit is support of
Complement Hemolytic CH50. Please consider adding both
CH50 unit and CH50 unit/mL.
PROXY File emailed separately; Questionnaires can be completed by
a subject's proxy, as with the EQ5D.
nmol/day nmol/day is supported in PK units but not the general unit

codelist. Can it please be added.
Oronasal Inhalation Aerosol Administration through a mask.
WholeBody, Inhalation Aerosol Administration through a whole-body chamber.
Add new terms to the Unit Codelist Add new terms to the Unit Codelist; File emailed separately.
Update CDISC DEF for C84507/BUFFY C84507 BUFFY COAT Current Definition: The upper clear
COAT layer of fluid which is separated from a blood clot following
density gradient centrifugation. It contains most of the white
blood cells. (NCI) Can the definition be changed to : The
upper clear layer of fluid middle fraction which is when
separated from an anticoagulated blood clot specimen
following density gradient centrifugation. It contains most of
the white blood cells and platelets.
The LAB Terminology Team is asking if the definition could be

changed to: The upper clear layer of fluid middle fraction
which is when separated from an anticoagulated blood clot
specimen following density gradient centrifugation. It contains
most of the white blood cells and platelets.
DLQI to be added to QS Domain DLQI to be added to QS Domain; File emailed separately.
EORTC QLQ-MY20 to be added to QS EORTC QLQ-MY20 to be added to QS Domain terminology;

Domain terminology File emailed separately.
Asthma Control Diary (ACD )to be added to Asthma Control Diary (ACD) to be added to QS Domain
QS Domain terminology terminology; File emailed separately.
SF-36 V2 Acute to be added to QS Domain SF-36 V2 Acute to be added to QS Domain terminology; File
terminology emailed separately.
New QSCAT and Codelist for CHART-SF New QSCAT and Codelist for CHART-SF questionnaire used
questionnaire used in traumatic brain injury in traumatic brain injury assessment. Can the QS team also
assessment. help with accessing the original article reference for this
questionnaire?
C48475 Submission Value currently is BAR C48475 Submission Value currently is BAR (A dosing
(A dosing measurement based on the bar measurement based on the bar unit.). The lab terminology
unit.). The lab terminology team would like team would like to change the submission value to DBAR.
to change the submission value to DBAR. BAR is for the BAR Unit of Pressure, which is currently being
BAR is for the BAR Unit of Pressure, which added as a new unit code. This request is from the lab
is currently being added as a new unit code. terminology team.
FACT-B: For patients with Breast cancer to FACT-B: For patients with Breast cancer to be added to QS
be added to QS Domain terminology Domain terminology; File emailed separately
FACT-Bl to be added to QS Domain FACT-Bl to be added to QS Domain; File emailed separately
Request FACT-G to be added to QS Request FACT-G to be added to QS Domain; File emailed

Domain separately
Request NCCN-FACT FBSI-16 to be added Request NCCN-FACT FBSI-16 to be added to QS Domain;

to QS Domain File emailed separately
Request FACT-Taxane to be added to QS Request FACT-Taxane to be added to QS Domain; File

Domain emailed separately
New synonym for existing term "Smooth New synonym for existing term "Smooth Muscle Antibody".
Muscle Antibody". Add "F-Actin Antibody Add "F-Actin Antibody"
LBTESTCD and LBTEST Add new terms to LBTESTCD and LBTEST; File emailed
separately.
New test and test codes for the Respiratory New test and test codes for the Respiratory Test Codelists;
Test Codelists File emailed separately.
C67380, IU/mg, International Unit per CDISC and NCI definitions appear to be in error; this is not a
Milligram concentration unit.
Existing Definition: Unit of arbitrary substance concentration

(biologic activity concentration) defined as the concentration
of one international unit per one milligram of substance.(NCI)
Correct definition: A unit of measure of quantity of substance

per unit mass, expressed in terms of International Units per
milligram.
This request is from the PK Terminology Team.
C101002 C101002 C105250 C107075 File emailed separately.
C106752 C111553 C111417 C113932 Several definition updates for multiple C-SSRS
C101001 C105249 C103796 C107073 questionnaires.
C107074 C106750 C106751
CYTOMEGALOVIRUS CYTOMEGALOVIRUS is a submission value and Human
Cytomegalovirus is a synonym to the term HUMAN
HERPESVIRUS 5.Is this a duplicate? Or does the submission
value of CYTOMEGALOVIRUS represent Unclassified
Cytomegalovirus?
Update SY for Pseudocowpox Virus Pseudocowpox Virus (C112401) has a SY that's all
uppercase: PARAVACCINIA VIRUS. Change this to
lowercase. Change implemented in P18.
APP, APPA, APPB please consider updating the LBTESTCD APP to reflect total
Amyloid Precursor Protein. As the current version consider
APP to be only Amyloid Precusor Protein Beta, to
accomodate this change i suggest to add APPA (Amyloid
Precusor Protein Alpha) and APPB (Amyloid Precusor Protein
Beta) so that both amyloid precursors can be referenced.
so in short:
APP = Total Amyloid Precusor Protein

APPA= Amyloid Precusor Protein Alpha
APPB= Amyloid Precusor Protein Beta
Add new terms to LBTEST/CD codelist Add new terms to LBTEST/CD codelist; file emailed
separately.
Add new CDISC SY Add new CDISC SY to 'Smooth Muscle Antibody'.
Add new terms to MICROORG codelist Add new terms to MICROORG codelist; File emailed
separately.
hispidus, fulviventer Now that we have upgraded COTTON RAT to a species, we

need to include strains: Please include the following strains:
hispidus, fulviventer
Add 4 new TEST/CDs to FIQR Add 4 new TEST/CDs; File emailed seperately.
Add 2 new TEST/CDs to HADS Add 2 new TEST/CDs; File emailed separately.
New Term Request = Disease Outcome: New Term Request = Disease Outcome: Virologic Failure,
Virologic Failure, Sustained Virologic Sustained Virologic Response. File emailed seperately.
Response
New Codelist Request = Transplant New Codelist Request = Transplant Outcome; and two new
Outcome; and two new terms in this terms in this codelist: Success, Re-Transplant; File emailed
codelist: Success, Re-Transplant separately.
Add new terms to the RACE codelist I’ve attached a request to add three additional terms to the
RACE code list: MULTIPLE, OTHER, UNKNOWN. The
implementation guide for DM domain mentions these values
in the assumptions and examples, and does a very good job
of explaining how they should be used appropriately. The IG
approach is more consistent with how subjects respond when
asked about their race, and how the data is often collected. At
any rate, the RACE code list and the implementation guide
should be consistent with each other.
ENTEROBACTER TAYLORAE The term ENTEROBACTER TAYLORAE is a submission

value as well as a synonym to ENTEROBACTER
CANCEROGENUS.
The NCBI considers ENTEROBACTER TAYLORAE a

synonym to the term ENTEROBACTER CANCEROGENUS,
therefore the submission value of ENTEROBACTER
TAYLORAE should be removed and it should remain as a
synonym to ENTEROBACTER CANCEROGENUS.
LBTESTCD= CD161ALY, CD45RALY, New LBTESTCD and LBTEST terms requested that currently
CD34LY, CD38LY, CD161LY, and CD45LY aren't available.
LBTESTCD = CD161ALY, LBTEST = CD161a/Lymphocytes,

Description = A relative measurement (ratio or percentage) of
CD161a cells to all lymphocytes in a biological specimen
LBTESTCD = CD45RALY, LBTEST = CD45RA/Lymphocytes,
CD45RA cells to all lymphocytes in a biological specimen.
LBTESTCD = CD34LY, LBTEST = CD3/4/Lymphocytes,
CD3/4 expressing cells to all lymphocytes in a biological
specimen.
LBTESTCD = CD38LY, LBTEST = CD3/8/Lymphocytes,
CD3/8 expressing cells to all lymphocytes in a biological
specimen.
LBTESTCD = CD161LY, LBTEST = CD161/Lymphocytes,
CD161 cells to all lymphocytes in a biological specimen.
LBTESTCD = CD45LY, LBTEST = CD45/Lymphocytes,
CD45 cells to all lymphocytes in a biological specimen.
Why is the controlled terminology called Why is the controlled terminology called
'CVEXAMCD/CVEXAM' when it is attached 'CVEXAMCD/CVEXAM' when it is attached to the
to the CVTESTCD/CVTEST variables? CVTESTCD/CVTEST variables. That is inconsistent with all
the other xxTESTCD/xxTEST codelists - the 3.3 IG refers to
CVTESTCD/CVTEST CT not CVEXAMCD/CVEXAM.
Influenza TA - New terms to be added This is for the influenza TA. Please add: RETEST = Peak
nasal inspiratory flow; RETESTCD = PNIF
For C105485, C105486, and C85744, This request comes from the Lab Terminology Team. The lab
please remove Creatinine from the rule is that if the test code/name has Creatinine or HGB in it
submission value, synonym, and definition. then it does not need to be in the unit code.
Muscle, Long digital extensor Add muscle, extensor digitorum longus.
Short form: TOTSUBJ Long form: Total Suggested definition: Total number of animals purchased for
Number of Subject purchased the study, including replacement animals.
This Parameter code is suggested added as it is necessary

regulatory information to certain regulatory authorities in
Europe.
Education level and years of education Education level and years of education; File e-mailed
separately. The TBI team is submitting this request because
the current EDLEVEL Subject Characteristic Test Code/Name
has a conflicting synonym (Education Level) and definition
(Years of education that a person has completed.). The name
also implies that EDLEVEL is for a person's highest level of
education completed, which matches the synonym, but not
the definition.
We would like to change the definition of EDLEVEL to match

it's name and synonym, or drop this variable and create a
new one for education level as per the general terminology
team's decision. The values for the new codelist would need
to be developed by the general terminology team as this
would affect many therapeutic areas.
We would also like to create a new Subject Characteristic

Test Code/Name which contains the years of education that a
person has completed.
Please remove NAG as a synonym from Please remove NAG as a synonym from C103419. It already
C103419 exists as a Submission Value for C79459 in the same
codelist. This goes against our rule that we cannot have a
synonym for one ccode be a submission value for a different
ccode in the same codelist.
There is also another request from a different source that also

complains about the NAG synonym.
Update C12389, Esophagus CDISC This request is for SEND-FXLOC (Fetal Pathology
Definition Examination Test Location) team. The CDISC definition for
C12389, Esophagus, needs to be updated to remove the
25cm. This length of the esophagus is for adults. For animals
and kids, the Esophagus is much shorter and different in
length.
Here is the updated DEF from SEND: The portion of the

digestive canal between the pharynx and stomach. It consists
of three parts: the cervical part, from the cricoid cartilage to
the thoracic inlet; thoracic part, from thoracic inlet to the
diaphragm; and abdominal part, below the diaphragm to the
cardiac opening of the stomach. (NCI)
PREALB - Prealbumin - delete this term and Please see: http://en.wikipedia.org/wiki/Transthyretin

create it as a new term of TTR Transthyretin is the current name for this test.Pre-albumin and
-'Transthyretin'. Thyroxine-binding Pre-albumin should be synonyms.
If this proposal is not accepted please add TTR Transthyretin

as a synonym of PREALB Prealbumin.
CDISC Submission Value should be File emailed separately;

capitalized CDISC_Multi_Term_Request_2014-07-03_Robert Dempsey
C42554 Ohm Please remove Ohm from the Vital Sign Units codelist.
Multiple Term Request for LOC New terms to be added to the SDTM-LOC codelist; File
emailed separately.
change CVEXAMCD (C101847) to CVTESTCD: change CVEXAMCD (C101847) to CVTESTCD

CVTESTCD
Change CVEXAM (C101846) to CVTEST CVTEST: Change CVEXAM (C101846) to CVTEST
Short form: CONSC Long form: Contributing Definition: A person actively involved in a specific study
Scientist activity without having formal GLP responsibility. Example:
Pathology peer review, TK evaluation in the absence of a
formal TK delegated phase, or other non-GLP study activities.
needle tract lesion Definition: focal lesions to the vessel wall due to the passage
of the needle into the vessel at the injection site.
CORD BLOOD; CORD SERUM; GASTRIC Please add the following terms to the Specimen Type
SECRETION; GASTRIC JUICE; VAGINAL codelist:
FLUID CORD BLOOD - Blood from the umbilical cord of a newborn
baby.
CORD SERUM - The clear portion of the blood that remains
after the removal of the blood cells and the clotting proteins
from the umbilical cord of a newborn baby.
GASTRIC SECRETION - The digestive secretions of the
gastric glands in the stomach, consisting mainly of pepsin,
hydrochloric acid, rennin, and mucin. GASTRIC JUICE -
synonym to GASTRIC SECRETION
VAGINAL FLUID - a fluid produced by glands in the vaginal
wall and cervix that drains from the opening of the vagina.
Change C48500 CDISC Submission Value CDISC Submission Value capitalization change, should read
from "IN" to "in" "in".
The SDS Extended Leadership team is The team feels that since there is a term of ""Other Event""
requesting that the DSCAT codelist be made that this would cover what does not fit into the two other
NOT EXTENSIBLE. choices in the codelist: ""Disposition Event"" and ""Protocol
Milestone"".
The FDA has complained about the additional terms that
have appeared in this codelist during a submission.
The SDS Extended Leadership team is Should this codelist be NOT EXTENSIBLE? And also should
concerned about having the DATESTCD there be additional terms like LOST or something else?
codelist extensible. There are two entries:
"Dispensed Amount" and "Returned
Amount"
Multiple changes to definitions associated File emailed separately
with different C-SSRS QS instruments. C-SSRS (QS-FT) Terminology definition updates.
Term: ONCE The CDISC Definition for "Once" refers to an intervention (i.e.
A one time intervention. (NCI)). This frequency could also
apply to an Event. Note: The CDISC Notes for AEPATT
(SDTM IG v3.2) state: "Used to indicate the pattern of the
event over time. Examples: INTERMITTENT, CONTINUOUS,
SINGLE EVENT.". For "single event", "ONCE" could be used
as the controlled terminology. The BRIDG model includes the
same 3 values for occurrencePatternCode associated with
Adverse Events.
Codelist MOTESTCD/MOTEST are not Please add ICV and Intracranial Volume to MOTESTCD and
present in the drop-down. Please add ICV MOTEST codelist respectively OR confirm the representation
and Intracranial Volume to MOTESTCD and of Intracranial Volume in SDTM. Please add ICVNF and
MOTEST codelist respectively Intracranial Volume Normalization Factor to MOTESTCD and
MOTEST codelist respectively OR confirm the representation
of Intracranial Volume Normalization Factor in SDTM. Total
intracranial volume may be included as part of structural MRI
results. I have seen this referred to in the literature as ICV
(http://web.mit.edu/daz/Public/O'Brien,%20Ziegler%20et
%20al%20(2011)%20Psychiatry%20Res
%20Neuroimaging.pdf) or TIV
(http://www.ajnr.org/content/22/8/1483.full). In my opinion,
ICV could be represented as a unique test code or using the
existing MOTESTCD = VOLUME and MOLOC = SKULL.
As noted in the second article, ""variations in individual head

size may be corrected by normalization with use of a total
intracranial volume (TIV) measurement."" I have seen the ICV
normalization value collected on multiple studies. In theory,
this could be represented using a test code and location, but
that seems cumbersome. Please advise.
Please add ASL FUNCTIONAL MRI to Please add ASL FUNCTIONAL MRI or ARTERIAL SPIN
SDTM METHOD LABELING FUNCTIONAL MRI to SDTM METHOD.
http://fmri.research.umich.edu/research/main_topics/asl.php
http://fmri.ucsd.edu/UserTools/asl.html
add NA Please add NA (as a representation for Not Applicable) to the

EGLEAD codelist.
The CDISC Definition for AUCPEO is The CDISC Definition for AUCPEO is incorrect. It is currently
incorrect the same value as AUCPBEO (back extrapolation). The
definition should be "The area under the curve (AUC) from
the last observed non-zero concentration value to infinity as a
percentage of the area under the curve extrapolated to
infinity."
The same applies for the corresponding PKPARM code.
The definition should be "The area under the curve (AUC)

from the last observed non-zero concentration value to infinity
as a percentage of the area under the curve extrapolated to
infinity."
The same applies for the corresponding PKPARM code.
Adoption of ICD-O-3 Sites and Histologies, It will be beneficial to have terminology that uncouples the site
in addition to the existing "Neoplasm Type" and histology of neoplasms from each other, if for example
that combines the information for sites and analysis of Adenocarinomas from multiple anatomical sites
histologies are to be compared with Squamous cell carcinomas from
multiple sites.
For NCI code C67255 please add 'GI/L' to Our vendors provide these codes all the time.
the list of CDISC synonyms. For NCI code
C67308 please add 'TI/L' to the list of
CDISC synonyms.
Add new terms to the Unit codelist; Sent a Add new terms to the Unit codelist; Sent a separate eMail to
separate eMail to Bernice Yost and Erin Bernice Yost and Erin Muhlbradt containing list of new unit
Muhlbradt containing list of new unit terms terms requested.
requested.
RETEST Multiple term request RETEST Multiple term request; File emailed separately
RETEST = Peak Nasal Inspiratory Flow Peak Nasal Inspiratory Flow is defined as: The maximal
RETESTCD = PNIF instantaneous airflow achieved during forced inspiration
through the nose.
FACE C13071 SEND team would like to replace the word 'chin' with
'mandible' in the definition so that this concept can be re-used
for SEND purposes. Animals do not all have chins.
C12671 Forelimb SEND team would like to change published definition to: 'The
anterior or upper limb of an animal.' To make it less human-
centric.
C77625 HINDLIMB SEND team would like to update published definition to: 'The
posterior or lower limb of an animal.' so that SEND can use
this for animals that are quadrapedal.
C12725 Gonad Replace published definition with: 'A reproductive system

organ that produces and releases either sperm (testis) or
eggs (ovary). (NCI)'. Team didn't like the MeSH definition as
much and would prefer to cite NCI.
To Erin: The FXLOC team likes the current NCI DEF rather
than the NCI MeSH DEF which is published as the CDISC
DEF for this term. FXLOC would like to update the CDISC
DEF for this term, which is currently used by SEND-SPEC
only, need SEND-SPEC approval.
uM There are multiple occurrences of this throughout various

codelists. CT has terms that include umol/L, but really that's
just the long way of saying "uM" (micromolar). 1mol/L=1M, 1
umol/L = 1 uM, and so on. At the very least, these should be
added as synonyms (even if you don't want to change the
submission value) as they are standard units throughout labs
around the world.
g/mmol Creatinine This unit was used to measure Urine Protein/Creatinine.

Suggested definition would be "A unit of substance
concentration defined as the number of grams per millimole of
creatinine.
New terms to be added to the UNIT Codelist New terms to be added to the UNIT Codelist; File emailed
separately.
Hepatitis C Virus RNA is missing from lab "Hepatitis G Virus" relates to a request for a seperate labtest
codelist and "Hepatitis G Virus" is missing under the review.
from micro org codelist" "Hepatitis C Virus RNA"" HCVRNA This test detects active
hepatitis C viral (HCV) replication (RNA). At Lilly we report in
a Unit of 'International Unit per Milliliter' (313), a specimen
type of 'Plasma'(PLS), and using the method 'PCR TAQMAN
HCV/HPS 2.0'"
RETEST = Predicted Peak Expiratory Flow Currently using these terms at Merck for a respiratory study.
RETESTCD = PEFPR
New multiple term request File e-mailed separately, for a multiple term request. Thank
you!
Hi Bob and Bernice, this term request was submitted on May

29 to add 226 'new terms' to multiple codelists. The actual
submitted request file does not follow the format of the
standard CDISC new term request template (in fact this
person did not use the CDISC template posted on the NCI
EVS site). Also, when I counted the # of new terms I noticed
that the only relevant INFO provided by this request is the
submission values of the new terms. There are NO use
cases, examples or draft definitions for any of the proposed
terms. Also from a quick glance I think a lot of the terms she
requested are already in the published SDTM. I responded to
the requester on May 29 asking whether she could provide
more use case examples for the terms. I then followed up with
her on June 25th to check if she is ready to re-submit the term
request. She has not gotten back to me since then. This
change request is now logged in this file. Bernice and Bob,
perhaps you could get in touch with her again for the
appropriate submission.
COARTDOM Coronary Artery Dominance: Remove Coronary Anatomy Dominance because it is not a
the synonym Coronary Anatomy Dominance synonym of Coronary Artery Dominance according to Dr.
should be removed. Tcheng.
Remove Coronary Anatomy Dominance Dr. Tcheng said that Coronary Anatomy Dominance is not a
from the synonyms. synonym for Coronary Artery Dominance.
PKPARMCD and PKPARM: remove We only need to have extra synonyms for PKPARMCD and
Hemodialysis CL from the synonyms. PKPARM when we believe that it is absolutely necessary for
the public to understand what the test is.
PKPARM and PKPARMCD: for C85575, For Test Code/Test name or Long Name/Short Name or
Average Conc: please change the Parameters/Parameters Code codelists: there should only be
submission value to Average Concentration one synonym if possible.
for PKPARM and remove the synonym of
Average Conc for PKPARM and
PKPARMCD.
VSTEST and VSTESTCD: C84372, Knee to For Test Code/Test name or Long Name/Short Name or
Heel Length - please remove the synonym Parameters/Parameters Code codelists: there should only be
of lower leg length. one synonym if possible.
C74298, Field of View - please remove the The requestor did not ask for this. It was added by the Device
synonym of FOV. Terminology team.
For Test Code/Test name or Long Name/Short Name or
Parameters/Parameters Code codelists: there should only be
one synonym if possible
TSPARM and TSPARMCD: C49696, Sex of There are 2 synonyms: Sex of Participants and Sex Of
Participants - please remove the synonym of Participants. The only difference is the upper case of the O in
Sex Of Participants. the word Of.
VSTEST and VSTESTCD: C12472, testcd = Either the testname should be changed to Body Fat or the
BODYFAT, testname = Adipose Tissue. test code should be changed to something like ADIPOSET.
Usually the test code is an abbreviation of The synonyms are Adipose Tissue, Body Fat, Fat Tissue. For
the test name. But not in this case - WHY? Test Code/Test name or Long Name/Short Name or
one synonym if possible.
DUTEST and DUTESTCD: C106563, The requestor did not ask for these synonyms, they were
Receiver Bandwidth - please remove the added by the Device Terminology Team.
synonym of RXBW and rBW For Test Code/Test name or Long Name/Short Name or
one synonym if possible.
Update definitions for C12392, C12468, C12392 New Definition: A triangular-shaped organ located
C13272 and C12782. The repro team made under the diaphragm in the right hypochondrium.
updates to simplify or de-specify the
definitions. C12468 New Definition: One of a pair of viscera occupying
the pulmonary cavities of the thorax, the organs of respiration
in which aeration of the blood takes place.
C13272 New Definition: An organ present in true mammals

during embryonic development that provides the fetus with
nutrients and oxygen, facilitates gas and waste exchange
between the fetus and mother.
C12782 New Definition: Any one of the paired bones

extending from the thoracic vertebrae toward the median line
on the ventral aspect of the trunk.
Repro team suggests updates to definitions C12392 New Definition: A triangular-shaped organ located
C12392, C12468, and C12782 to simplify or under the diaphragm in the right hypochondrium.
remove human-specific information from the
definition. These terms are also in the C12468 New Definition: One of a pair of viscera occupying
SEND-SPEC and new (under development) the pulmonary cavities of the thorax, the organs of respiration
SEND-FXLOC codelists. in which aeration of the blood takes place.
C12782 New Definition: Any one of the paired bones

extending from the thoracic vertebrae toward the median line
on the ventral aspect of the trunk.
C9003 and C4049: There are spaces before ADENOMA, ADRENOCORTICAL , BENIGN and
commas in the CDISC Submission value. EPENDYMOMA, ANAPLASTIC , MALIGNANT. Remove the
This is a type I request to remove them. space after Adrenocortical and Anaplastic respectively.
C103421 and C104441; Changes to these This is a two item request. 1. The oncology team began
terms removed from P19. Discuss the discussing why the phrase 'by other methods or modalities'
phrase 'by other methods or modalities' in was added to the definition for these two terms when
these two definition. Discuss the change to confirmation could be done using the same imaging modality
the submission value as was done when the tumor was first identified. Team needs
to revisit why this phrase was added to the definition initially.
2. Team needs to determine how to deal with update to
codelist name in relation to New Tumor Confirmed value:
either create a new concept 'New Tumor or Lesion Confirmed'
and retire C103421 or keep C103421 and create a term New
Lesion Confirmed.
CARDIAC CATHETERIZATION Please add the term CARDIAC CATHETERIZATION to the

Method codelist. This method is used for the measurement of
Ejection Fraction (EF).Test used to measure EF include:
echocardiogram, cardiac catherization, magnetic resonance
imaging (MRI), computed tomography (CT), and nuclear
medicine scans. (Reference: http://www.hrsonline.org/Patient-
Resources/The-Normal-Heart/Ejection-
Fraction#axzz38rpBW4fs)
I wasn't sure if this should be a procedure or method but
since there are other tests used to measure EF in the Method
codelist, I am asking for the term to be added there.
Pdu Please add the term PDu with the synonym Progressive
Disease Unconfirmed to the Tumor Result Response codelist.
This response criteria is used to support imaging results using

PCWG2 (prostate cancer working group 2) criteria.
CYTOMEGALOVIRUS CULTURE How should tests that are specific for one organism and are
capturing only a absent/present result be captured? For
example, a culture testing only for Cytomegalovirus and be
reported as absent or present. A similiar secenario is
capturing RNA replication for a specific organism. Discussed
briefly in Virology Terminology meeting as possibly adding
Species/strain field to LB domain.
Add new terms to the MICROORG Codelist Add new terms to the MICROORG Codelist; File emailed
separately.
See attached HEP C TA new term request See attached HEP C TA new term request for Morphology
for Morphology and Microscopy test name and Microscopy test name and test code; File emailed
and test code. separately.
Supraventricular Rhythm definition - a condition presenting as a heart rhythm
originating at or above the atrioventricular node.
OEFOCID OEFOCID; File emailed separately.

PDc; Non-PD The terms PDc (Progressive Disease Confirmed) and Non-PD
are used for Prostate Oncology trials using PCGW2 criteria.
PDc: PD is a term that captures progressive disease per

RECIST related to a new lesion, unequivocal progression of
non target, or an increase in tumor burden of ?20% compared
to nadir. The proposed work around solution was to use this
existing term for PC-C per PCWG2, though they are not truly
equivalent. Per PCWG2, PD-C or Progressive Disease-
Confirmed implies that the patient has a previous timepoint of
New LBTESTCD and LBTEST terms for Progression
Please create asnew
noted by at
terms asleast one bone lesions by bone
follows:
DESMOGLEIN 1 Ab and DESMOGLEIN 3 scan which
DSG1AB was subsequently
- Desmoglein confirmed by the development
1 Antibody
Ab of at least-2Desmoglein
DSG3AB additional bone lesions, per bone scan.
3 Antibody
Please remove toxicity grading codelist or The SDTM
Non-PD: Non implementation
CR/Non PD isguide a termrequires
in RECISTthat wethatplace the
explain logic for including them in the CT name
specifically refers to non target disease only with define
and version of the AE grading scale in the XML
an overall
and confirm that we need to submit all (in a similar way that it asks that we put the coding
response that is not response or progression. The proposed
grading scales and versions as new CT dictionaries
work aroundand versions
solution wasintothe
usedefine XML). For
this existing termthis
for reason
Non-PDit
requests makes
term per noPCWG2
sense to, though
actuallythey
storearethe
notgrading scales as Per
truly equivalent.
controlled
PCWG2, non terminology,
PD is the since theyrefers
term that are governed
to a timeby external
point that
controlled
follows a PD-Unconfirmed and this time point is not removed
lists. Can this be explained. Will these be
and if not, would you like me to submit values for other
confirmed.
versions of CTC and also all version fo DAIDs, DMID etc?
Clotting Time Homeostasis Definition: A physiologic assessment of platelet function that

measures the amount of time required to achieve hemostasis
following application of a small incision to a test subject?s
skin.
A comparable term would also need to be added for

VSTESTCD.
Bazett's Correction for beat 1 A formula which takes into account the physiologic shortening
of the QT interval which occurs as the heart rate increases,
using the Bazett's Correction formula (QTcB =
QT/SqRootRR(seconds)) for beat 1.
To be used with EGTESTCD=QTCB1
QTCB1 A formula which takes into account the physiologic shortening
To be used with EGTEST=Bazett's Correction for beat 1


using the Bazett's Correction formula for beat 3.

Summary (MEAN) Bazett's Correction The mean duration (time) of the QTc interval, obtained from a
set of measurements of the QT interval and corrected using
the Bazett's Correction formula (QTcB =
QT/SqRootRR(seconds)).
To be used with EGTESTCD=QTCBMEAN
QTCBMEAN The mean duration (time) of the QTc interval, obtained from a
the Bazett's Correction formula (QTcB =
QT/SqRootRR(seconds)).
To be used with ECGTEST=Summary (MEAN) Bazett's
Correction
Frederica's Correction for beat 1 A formula which takes into account the physiologic shortening
using the Frederica's Correction formula
(QTcF=QT/CubeRootRR(seconds)) for beat 1.
To be used with EGTESTCD=QTCF1
QTCF1 A formula which takes into account the physiologic shortening
To be used with EGTEST=Frederica's Correction for beat 1

Summary (MEAN) Frederica's Correction The mean duration (time) of the QTc interval, obtained from a
the Frederica's Correction formula
(QTcF=QT/CubeRootRR(seconds)) .
To be used with EGTEST=QTCFMEAN
QTCFMEAN The mean duration (time) of the QTc interval, obtained from a
the Frederica's Correction formula
(QTcF=QT/CubeRootRR(seconds)) .
To be used with EGTEST=Summary (MEAN) Frederica's
Correction
Please add "Cardiolipin IgA Antibody" to the The terms suggested in this request are modeled after the
LBTEST list. Please also add "CRDIGAAB" existing terms for Cardiolipin IgG Antibody and Cardiolipin
to the LBTESTCD list. IgM Antibody.
LBTESTCD = HIV1RNA LBTEST = HIV-1 The sample is either fresh plasma or dried blood. The method
RNA is PCR (QUANTITATIVE REVERSE TRANSCRIPTASE
POLYMERASE CHAIN REACTION, I think).
The only test we see for this now is HIV Viral Load but this is
not specific enough. We modeled this pair after these:
HGRNA/Hepatitis G RNA.
INFORMANT A person who has observed and/or interacted with the study
subject and supplies information regarding their
characteristics or behavior.
Updates to first 100 rows of SEND-SPEC Updates to first 100 rows of SEND-SPEC terms to de-specify
terms to de-specify and remove functional and remove functional information from published SEND
information from published SEND definitions; File emailed separately.
definitions.
Pancreas C12393: SEND Repro team is Old DEF: An organ behind the lower part of the stomach that
suggesting a change to definition to de- is the shape of a fish and about the size of a hand. It is a
specify and shorten. compound gland composed of both exocrine and endocrine
tissues. The endocrine pancreas makes insulin so that the
body can use glucose (sugar) for energy. The exocrine
pancreas makes enzymes that help the body digest food.
Spread all over the pancreas are areas called the Islets of
Langerhans. The cells in these areas each have a special
purpose. The alpha cells make glucagon, which raises the
level of glucose in the blood; the beta cells make insulin; the
delta cells make somatostatin. There are also PP cells and
D1 cells, about which little is known. (NCI)
Change to: An organ located behind the lower portion of the

stomach that contains both exocrine and endocrine tissue;
the exocrine tissue produces enzymes that help digest food
and the endocrine tissue produces insulin.
Pancreas C12393: SEND Repro team is Old DEF: An organ behind the lower part of the stomach that
suggesting a change to definition to de- is the shape of a fish and about the size of a hand. It is a
specify and shorten. compound gland composed of both exocrine and endocrine
tissues. The endocrine pancreas makes insulin so that the
body can use glucose (sugar) for energy. The exocrine
pancreas makes enzymes that help the body digest food.
Spread all over the pancreas are areas called the Islets of
Langerhans. The cells in these areas each have a special
purpose. The alpha cells make glucagon, which raises the
level of glucose in the blood; the beta cells make insulin; the
delta cells make somatostatin. There are also PP cells and
D1 cells, about which little is known. (NCI)
Change to: An organ located behind the lower portion of the

stomach that contains both exocrine and endocrine tissue;
the exocrine tissue produces enzymes that help digest food
and the endocrine tissue produces insulin.
Pulmonary Artery C12774; Slight update the Old DEF: An artery arising from the right ventricle of the heart
definition to make it different from that carries deoxygenated blood to the lungs. (NCI)
Pulmonary Trunk.
Change to: Either one of two arteries arising from the
pulmonary trunk that carry deoxygenated blood to the lungs.
Skull C12789; SEND Repro team is Remove Bone, Cranial from CDISC SYs.
suggesting a removal of a synonym as it
isn't a 1:1 relationship.
Skull C12789; SEND Repro team is Remove Bone, Cranial from CDISC SYs.
suggesting a removal of a synonym as it
isn't a 1:1 relationship.
Small Intestine C12386: SEND Repro team Old DEF: The section of the intestines between the pylorus
is suggesting a change to definition to de- and cecum. The small intestine is approximately 20 feet long
specify and remove functional information and consists of the duodenum, the jejunum, and the ileum. Its
for consistency. main function is to absorb nutrients from food as the food is
transported to the large intestine. (NCI)
Change to: The section of the intestines between the pylorus

and cecum. The small intestine consists of the duodenum, the
jejunum, and the ileum.
Stomach C12391: SEND Repro team is Old Def: An organ located under the diaphragm, between the
suggesting a change to definition to deliver and the spleen as well as between the esophagus and
specify and remove functional information the small intestine. The stomach is the primary organ of food
for consistency. digestion. (NCI)
Change to: An organ located under the diaphragm, between

the liver and the spleen as well as between the esophagus
and the small intestine.
ARTERY, SUBCLAVIAN C33643: De- Old Def: An artery located below the clavicle that supplies
specify definition. Innominate is used more blood to the head and the arms forelimbs. The right
frequently in animals though is synonmous subclavian artery originates from the innominate
with Brachiocephalic. brachiocephalic artery and the left subclavian artery originates
from the aortic arch. (NCI)
Change to: An artery located below the clavicle that supplies

blood to the head and the forelimbs. The right subclavian
artery originates from the innominate artery and the left
subclavian artery originates from the aortic arch. (NCI)
Tail C77663: Repro team wants to update Old Def: The flexible prolongated structure of the posterior
definition. Likes Dorland's better. part of an animal's body. (NCI)
Change to: The appendage that extends from the posterior

trunk of animals. (Dorland, W. A. N. (2007). Dorland's
illustrated medical dictionary. Philadelphia, PA: Saunders.)
Forelimb C12671: Update definition for use Old Def: The region of the body that includes the arm, the
in all cases. forearm, and hand. (NCI)
Change to: The anterior, front or upper limb of an animal.

SpO2 Arterial oxygen saturation - This could be a LBTESTCD but
most health systems and HL7 CDA categorizes this as a Vital
Signs measurement. [Peripheral capillary oxygen saturation
(SpO2) is an estimation of the oxygen saturation level usually
measured with a pulse oximeter device.] See Wikipedia
http://en.wikipedia.org/wiki/Oxygen_saturation_(medicine).
Add new terms to the SDTM-Method File emailed separately.

Codelist CDISC_Multi_Term_Request(METHOD terms for opthalmic
data) Marcelina Hungria 2014-08-18.xls
Modify 2 terms in the SDTM-Method File emailed separately.

Codelist CDISC_Multi_Term_Request(METHOD terms for opthalmic
data) Marcelina Hungria 2014-08-18.xls
Add 3 new terms to the TCNTRL codelist; BOTH: Use of an active comparator control and an inactive
This is also an urgent request. placebo control.
DOSE: Use of a dose control, or study product comparing

dosage.
NONTRT: A control group not receiving intervention. (possible

Synonym = Non Treatment)
Summary (Max) Heart Rate (C39779) Is this an error in the published definition of "Summary (MAX)
(Applies to EGTESTCD HRMAX as well); Heart Rate" (C39779)? (Capitalization has added to aid in
Summary (Min) Heart Rate (C62096) your review.)
(Applies to EGTESTCD HRMIN as well)
The MINIMUM time between successive cycles of contraction
and subsequent relaxation of the heart, usually expressed as
beats per minute, obtained from a set of measurements of the
heart rate. (NCI)
If yes, then please also check the definition of "HRMIN" and

"Summary (MIN) Heart Rate" (C62096) - "The MAXIMUM
time between successive cycles of contraction and
subsequent relaxation of the heart, usually expressed as
beats per minute, obtained from a set of measurements of the
heart rate. (NCI)"
Efferent Duct small ducts leading from the testis to the head of the
epididymis.
Spectrophotometry Submitted on behalf of LAB team. New method for LB Test
Mapping (Albumin)
Repro team would like to re-use these C12432 Spleen Updated Definition: An organ of the
concepts for non-clinical studies. Therefore, hematopoietic and immune systems that consists of two types
they are suggesting these changes to de- of tissue, red and white pulp, and is bounded by a fibrous
specify the terms and make them more capsule. It is located in the left diaphragmatic region of the
consistently defined based on location (and abdomen.
not structure, function, etc.)
C12433 Thymus Updated Definition: A bi-lobed organ of the
immune system located in the upper anterior portion of the
chest, behind the sternum.
C12405 Uterus Updated Definition: A hollow, thick-walled,

muscular organ located within the pelvic cavity. Within the
uterus the fertilized egg implants and the fetus develops
during pregnancy.
C12813 Vas Deferens Updated Definition: Duct carrying

spermatozoa from each epididymis to the urethra.
Add synonym to C33816 TRUNK. This is Please add Torso as a synonym to the existing term.
requested by the SEND Repro team.
SEND Repro team would like to propose the C12405 Uterus proposed updated definition: A hollow, thick-
following changes to SEND-SPEC terms to walled, muscular organ located within the pelvic cavity. Within
de-specify the definitions. the uterus the fertilized egg implants and the fetus develops
during pregnancy.
C12813 Vas Deferens proposed updated definition: Duct

carrying spermatozoa from each epididymis to the urethra.
OETEST/OETESTCD and Ophthalmology Sub-team is part of the MS team, this counts
MOTEST/MOTESTCD terms as a TA request. OETEST/OETESTCD and
MOTEST/MOTESTCD terms; File emailed separately.
Buprenorphine with the test code BUPREN Please add the term Buprenorphine to the Laboratory Test
Name codelist with the test code BUPREN.
Buprenorphine is a semi-synthetic opioid analgesic that can

be ordered as a stand-alone test or can be added to an
existing drugs-of-abuse testing panel.
HBD2 To be used with SDTM_LBTEST Human beta-defensin 2
Definition: The measurement of the Human beta-defensin 2

peptide in a biological sample
Additional Info: Beta-defensin 2 (BD2) is also know as skin-

antimicrobial peptide 1 (SAP1).
Human ?-Defensin 2 (HBD-2) is a 4.3 kDa cysteine-rich

cationic
low-molecular weight peptide recently discovered in psoriatic
lesional skin and in the infected lung epithelia of patients with
cystic
fi brosis. Human ?-Defensin 2 is produced by stimulation of
Epithelial
cells with microorganisms such as cytokines TNF-alpha and
IL-1
beta. It is speculated that Human ?-Defensin 2's role is to
protect
the local epithelial and respiratory tract from infection,
providing a
possible reason why skin and lung infections with Gram-
negative
bacteria are rather rare. In addition to their direct antimicrobial
activities,
they are chemoattractant towards immature dendritic cells
and
memory T cells.
Human beta-defensin 2 To be used with SDTM_LBTESTCD HBD2
Definition: The measurement of the Human beta-defensin 2

peptide in a biological sample
Additional Info: Beta-defensin 2 (BD2) is also know as skin-

antimicrobial peptide 1 (SAP1).
Human ?-Defensin 2 (HBD-2) is a 4.3 kDa cysteine-rich

cationic
low-molecular weight peptide recently discovered in psoriatic
lesional skin and in the infected lung epithelia of patients with
cystic
fi brosis. Human ?-Defensin 2 is produced by stimulation of
Epithelial
cells with microorganisms such as cytokines TNF-alpha and
IL-1
beta. It is speculated that Human ?-Defensin 2's role is to
protect
the local epithelial and respiratory tract from infection,
providing a
possible reason why skin and lung infections with Gram-
negative
bacteria are rather rare. In addition to their direct antimicrobial
activities,
they are chemoattractant towards immature dendritic cells
and
memory T cells.
ngeq/mL nanogram equivalents per milliliter
See attached Spreadsheet. These terms See attached Spreadsheet. These terms already exist in the
already exist in the CV Terminology CV Terminology spreadsheet but we need to assign request
spreadsheet but we need to assign request codes to them; File emailed separately.
codes to them.
See attached Spreadsheet. These terms See attached Spreadsheet. These terms already exist in the
already exist in the CV Terminology CV Terminology spreadsheet but we need to assign request
spreadsheet but we need to assign request codes to them.File emailed separately.
codes to them.
Move some existing terms to the Move some existing terms to the Morphology Test codelists;
Morphology Test codelists. File emailed separately.
Move some existing terms to the Move some existing terms to the Morphology Test codelists;
Morphology Test codelists. File emailed separately.
PK team wants to update the CDISC PK team wants to update the CDISC definitions for terms that
definitions are used by both SDTM-UNIT and SDTM-PKUNIT codelists;
PK team wants to add a new term PK team wants to add a new term to the SDTM-UNIT
codelist. This term already exists in the SDTM-PKUNIT
codelist; File emailed separately.
This is for the Oncology team. All of these This is for the Oncology team. All of these terms are already
terms are already in the Oncology in the Oncology Terminology Spreadsheet. They are being
Terminology Spreadsheet. They are being submitted to get a request number; File Emailed Separately.
submitted to get a request number.
Add new terms Add new terms to EGTEST/CD and ECG Result codelists.
Already exists in the ECG spreadsheet, just need a request #.
Modify terms Modify terms in EGTEST/CD and ECG Result codelists.

Already exists in the ECG spreadsheet, just need a request #.
Remove from CVEXAM/CD Codelists Remove green shaded concepts from the current codelist.
They will be moved to the MO domain.
Create new terms in MO domain Green shaded columns are propose to be moved to and
created in the MO domain based on strucutre as part of their
definition.
See attached spreadsheet of CVEXAMCD See attached spreadsheet of CVEXAMCD code-list. File
code-list EMAILED separately. Yellow shaded rows need confirmation
that they are physiology based tests.
COTTON RAT Update definition to broaden concept to include multiple
species of COTTON RAT: The rat of the genus Sigmodon.
RAT To broaden its use and since the term 'Rat' is non-taxanomic,
update definition to: Any of numerous species of small
rodents belonging to the genus Rattus and various related
genera of the family Muridae.
CDISC Submission Values that contain a I was asked to confirm the use of single quotes ( ? ) in the
special character CDISC Submission values for various codelists. According to
our statisticians - a single quote causes issues in SAS by
turning the character into an upside question mark ( � ).
There are certain other characters that create issues in SAS.

But the only other one that we are seeing besides the single
quote ( ' ) is the greater than sign ( > ).
Single quote is seen in both the general terminology codelists

as well as the questionnaire codelists. Greater than sign is
seen in the general terminology spreadsheet.
Is it OK to remove the single quotes and > signs from the

terminology or how should it be handled during submissions.
Thanks in advance for your help in answering our questions.

Lysine Please add Lysine as a LBTEST/LBTESTCD. Lysine is an
essential amino acid produced in the body that has multiple
functions such as calcium absorption, muscle repair and
growth and production of hormones, enzymes and antibodies.
It also acts as a depressant on the nervous system and
contains anti-seizure properties. A urine amino acid test or a
plasma amino acid test can measure the levels of all amino
acids in your body and determine whether you have an
imbalance. Normal lysine levels in children should be 19 to
140 micromol/dL while adults should be 32 to 290
micromol/dL. Suggested LBTEST NAME: Lysine and
LBTESTCD: LYSINE
http://www.ehow.com/how_7984564_test-serum-lysine.html
Add New terms Add new terms to the SDTM Microorganism codelist; Multiple
Term Request, file emailed separately.
Two new QSCATs requested DLQI1:

Dermatology Life Quality Index (DLQI) (copyright AY Finlay,
GK Khan, April 1992).
WLQ01:
Work Limitations Questionnaire (WLQ) (copyright 1998. The
Health Institute; Debra Lerner, PhD., Benjamin Amick, III,
PhD., and GlaxoWellcome, Inc. All rights reserved).
Copies of the CRFs will be mailed to Bernice Yost and Jordan

Li separately.
Copyright permissions for CDISC use are being purused, but
have not yet been secured.
For "%" Please add the word 'Percent' as a For % 'Percentage', Please add the word 'Percent' as a
Synonym. Synonym. Although it's comprehensible, having
'Percentage'as a decode on a CRF just feels 'clunky'.
Add new terms Add new terms; file emailed separately.

Please add controlled terminology for The Tanner Scale could probably fit into multiple domains,
Tanner Scale to SDTM MO, PE, RP, a TBD physiological Findings Class domain. I
MOTESTCD/MOTEST have selected MO for the purpose of the new term request.
Please note, the NCI-T has defined a term for the Tanner
Scale: http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?
us.
Additional information about the Tanner Scale can be found
here: http://healthvermont.gov/family/toolkit/tools%5CJ-
1%20CARD%20Tanner%20Stages.pdf.
As noted in literature, the Tanner Scale is location based. I

am assuming one TESTCD/TEST will be defined and LOC
will differentiate the scale being reported. As CDISC has done
for ECG findings, it would be helpful to define standardized
results for each scale.
Retired Having withdrawn from employment at the conclusion of one's

working or professional career.
Friend A person whom an individual knows, likes, and trusts.
C103446: Add synonym to both TEST and By default the test name should also be the synonym for both
TESTCD value that is identical to TEST the TEST and TESTCD. This default was missed so
name: Thyroglobulin Thyroglobulin needs to be added as a CDISC synonym to
C103446. This is a type I request and should be fixed with
P19.
Proposed updates to CDISC submission Proposed updates to CDISC submission values and synonym
values and synonym for the SEND trial for the SEND trial summary parameter name and code
summary parameter name and code codelists. 'of' shouldn't be capitalized in CDISC submission
codelists. values; File emailed Separately.
TREATMENT PERIOD 1 A period in a clinical study, for example with a crossover
design, during which the subject receives a first treatment.

design, during which the subject receives a second treatment.
design, during which the subject receives a third treatment.

design, during which the subject receives a fourth treatment.

design, during which the subject receives a fifth treatment.
POST TREATMENT A period in a clinical study during which information about the
health status of an individual is obtained after treatment has
concluded, however study procedures are ongoing.
WASHOUT PERIOD 1 A period of time in a clinical study between Treatment

Periods, for example with a crossover design, when a
participant is first taken off study drug or other medication to
eliminate the effects of the treatment.

participant is taken off study drug or other medication for the
second time to eliminate the effects of the treatment.

third time to eliminate the effects of the treatment.

fourth time to eliminate the effects of the treatment.
fifth time to eliminate the effects of the treatment.
C12998 SPINAL COLUMN Add Spinal Column as a synonym. The repro team is using
VERTEBRAL COLUMN as their submission value in FXLOC
codelist so they felt it was necessary to add Spinal Column as
a synonym.
C13071 FACE; Change the word Chin to Repro team is suggesting this update to make the definition
Mandible in definition to de-specify the less human specific.
definition.
C26726 INFECTION Modify CDISC A disorder resulting from the presence and activity of a
Definition delete '-- (NCI' replace with '. microbial, viral, or parasitic agent. It can be transmitted by
(NCI)' direct or indirect contact. -- 2003 (NCI)
A disorder resulting from the presence and activity of a

microbial, viral, or parasitic agent. It can be transmitted by
direct or indirect contact. (NCI)
ASPERGILLUS TERREUS; RHIZOMUCOR; ASPERGILLUS TERREUS - Any fungal organism that can be
CANDIDA INTERMEDIA assigned to the species Aspergillus terreus.
RHIZOMUCOR - Any fungal organism that is not assigned to

the species level but can be assigned to the Rhizomucor
genus level.
CANDIDA INTERMEDIA - Any fungal organism that can be

assigned to the species Candida intermedia.
(mg/kg/day)/(hr*ng/mL) Our clearance unit in Phoenix / PKS is

(mg/kg/day)/(hr*ng/mL); we cannot see any reasonable
conversion factor to transform the value into an available
PKUNIT in Controlled Terminology relevant to ""Clearance"".
Therefore, we are asking for a new PKUNIT to be added.
Currently we need it for SEND Terminology, but I see
PKUNIT is in the SDTM CT.
We need this new PKUNIT for our corresponding pk
parameter; PKPARMCD=CLFO
Attached are the Influenza TA terminology Attached is our terminology request for the Influenza TAUG
new term request files. and a copy of the guide for context. I tried to complete as
much of the spreadsheet as possible but neither I nor our
SMEs are great at definition writing so we left many of them
blank. Our SMEs did say that they would be happy to review
any draft definitions that were created. Please let me know if
you have questions.
LARGE INTESTINE, CECUM WITH Measurement of the weight of the cecum with content
CONTENTS
HEP C TA requests a new codelist for Create new codelist and new terms in this codelist. Virologic
Virologic Response Response terms, synonyms, and definitions are attached.
New questionnaires for EXACT-PRO, E-RS, New questionnaires for EXACT-PRO, E-RS, CRQ-SR, CRQ,
CRQ-SR, CRQ, CAT, SOBDA, CCQ (24 CAT, SOBDA, CCQ (24 hours and 1 week versions), PGA,
hours and 1 week versions), PGA, and and PSQI. The request, copyright permission info/URL and
PSQI. CRF supporting information are attached.
ug/g A unit of a mass fraction expressed as a number of

micrograms of substance per gram of mixture.
/min PKUNIT currently has only "/h" as an inverse time unit (to be
used with LAMZ). It is desirable to add "/min" and "/day" to
provide for alternative time scales. All three time scales are
provided in various other units (eg AUC units).
/day PKUNIT currently has only "/h" as an inverse time unit (to be
used with LAMZ). It is desirable to add "/min" and "/day" to
provide for alternative time scales. All three time scales are
provided in various other units (eg AUC units).
MIDPTLST I suggest changing this submission value and the
accompanying synonym.
MIDPTLST is defined as ""The midpoint of collection interval,
which is associated with last Measurable rate"". This definition
is very similar to the definition for ERTMAX, ""The midpoint of
collection interval associated with the maximum excretion
rate"". I suggest changing MIDPTLST to ERTLST using
ERTMAX as the model. Since there are many terms
beginning with ER (excretion rate), it seems reasonable to
suggest changing MIDPTLST to look like ERTMAX rather
than changing ERTMAX to look like MIDPTLST. Further, I
suggest changing the synonym for MIDPTLST from
""Midpoint of Collection Interval"" to ""Time of Last Nonzero
Excretion Rate"" using the synonym of TLST as the model.
18F NaF PET; SPECT SCAN; BONE SCAN 18F NaF PET
Definition: A procedure used to find out if cancer has spread
to the bone. A small amount of a radioactive substance called
fluorine F 18 sodium fluoride is injected into a vein. A PET
scan is then used to make detailed pictures of the bones.
Bones with cancer in them take up more fluorine F18 sodium
fluoride than normal bones do. NCI Thesaurus Code: C93202
SPECT SCAN
Definition: A type of tomography in which gamma photon-
emitting radionuclides are administered to the patient and
then detected by one or more gamma cameras rotated
around the patient. From the series of two-dimensional
images produced, a three-dimensional image can be created
by computer reconstruction. NCI Thesaurus Code: C17203
BONE SCAN
Definition: A nuclear imaging method used to evaluate
pathological bone metabolism. NCI Thesaurus Code: C17646
CHEWING Definition : Administration after biting something continuously.
INTRAVENOUS AND INTRAMUSCULAR Definition : Administration within or into a vein or veins or

Administration within a muscle.
I have the case which we cannot know either INTRAVENOUS

or INTRAMUSCULAR.
In this case, how we convert this data to SDTM?
VRTESCD = IC50S/VRTEST = IC50 Subject We need to either add a term or replace the existing term
Sample Result (IC50T/IC50 Treatment Result; ccode = C116247). The term
"Treatment Result" is too generic as both the subject sample
and the lab control are exposed to the treatment drug. The
corresponding IC95T variable should also be modified.
Should OESTESTCD codelist name actually The corresponding codelist with full text decodes of
be OETESTCD Ophthalmic Exams is OETEST. Shouldn't the codelist of
Ophthamic Exam codes be OETESTCD? This would also
make the codelist name as 8 characters.
HEFATESTCD and MSFATESTCD codelist Are the names of these codelists too long at 8 characters? All
names other xxTESTCD-type codelist names in SDTM CT are 8
characters.
SCTESTCD = "SCPOSTCD"; SCTEST= This is needed for the dyslipidemia TAUG. The ASSIGN
"Scottish Postcode"; Definition: Scottish Score will be represented in the CC domain but some of the
Postcode as a surrogate for Scottish Index components need to represented in the SC domain. See the
of Multiple Deprivation following website: http://www.assign-score.com/estimate-the-
risk/
SCTESTCD = "SIMD"; SCTEST = "Scottish This is needed for the dyslipidemia TAUG. The ASSIGN
Index of Multiple Deprivation"; Definition: Score will be represented in the CC domain but some of the
Scottish Index of Multiple Deprivation components need to represented in the SC domain. See the
following website: http://www.assign-score.com/estimate-the-
risk/
C78725; Autolized Change submission value to AUTOLYZED. Spelling it with a

'Y' is more common practice.
Platelet Derived Growth Factor Isoform AB Please update this term to comply with the length limitation of
(C116208) 40 chars. Thanks!
We need to change the value of QSCAT for At the request of NINDS, we will be developing a separate
the CHART-SF to CHART-SF INTERVIEW. supplement for the interview and paper forms of the CHART-
SF so we need to change the value of QSCAT from CHART-
SF to CHART-SF INTERVIEW for the supplement we already
developed terminology for.
Ccode = C25473 in the Unit Codelist. Ccode = C25473 in the Unit Codelist. The submission value is
/day. The definition is "Occurring or done each day". The PK
Terminology team would like to change the definition to "A
rate of occurrences of something within a period of time equal
to one day."
The PK Terminology team would like to change the definition

to "A rate of occurrences of something within a period of time
equal to one day."
Ccode = C66966, in the Unit Codelist. Ccode = C66966, Submission value is /h. The definition is "A
rate of occurrences of something within a period of time equal
to sixty minutes." The PK team would like to change the
definition to "A rate of occurrences of something within a
period of time equal to one hour."
The PK team would like to change the definition to "A rate of

occurrences of something within a period of time equal to one
hour."
Oncology team is requesting to update the Oncology team is requesting to update the CDISC definitions
CDISC definitions for 3 terms. for 3 terms in the attached file, all the changes and updates to
the existing terms have already been reviewed and approved
by the Oncology team; Jordan will add these changes to the
'MODIFY Codelist' tab in the 'Oncology High Level Scope -
Response Criteria_Full Bibliography' file; File emailed
separately.
C85769 MRTIFO MRT Infinity Obs When a drug is administered extravascularly, MRTev (mean
residence time following extravascular administration), equals
MRTiv (mean residence time following intravascular
administration) PLUS MAT (mean absorption time) from the
extravascular site. A complete set of variables to characterize
these statisitical moment PK parameters consists of MAT,
MRTev, and MRTiv. I suggest adding MAT and MRTev to
Controlled Terminology and using the existing MRT terms to
denote MRTiv.
For MRTIFO change definition to read:

The mean residence time (MRT) extrapolated to infinity for a
substance administered by intravascular dosing, calculated
using the observed value of the last non-zero concentration.
C85793 MRTIFP MRT Infinity Pred When a drug is administered extravascularly, MRTev (mean
denote MRTiv.
For MRTIFP, change definition:

The mean residence time (MRT) extrapolated to infinity for a
substance administered by intravascular dosing, calculated
using the predicted value of the last non-zero concentration.
C85700 MRTLST MRT to Last Nonzero When a drug is administered extravascularly, MRTev (mean
Conc residence time following extravascular administration), equals
denote MRTiv.
For MRTLST change definition:

Mean residence time (MRT) from the time of dosing to the
time of the last measurable concentration, for a substance
administered by intravascular dosing.
MAT When a drug is administered extravascularly, MRTev (mean
denote MRTiv.
Create term for MAT:

submission value: MAT
synonym: Mean Abs Time
definition: Mean absorption time of a substance administered
by extravascular dosing.
MRTEVIFO MRTEVIFP MRTEVLST When a drug is administered extravascularly, MRTev (mean

denote MRTiv.
Create terms for MRTev:
submission value: MRTEVIFO

synonym: MRT Extravasc Infinity Obs
definition: The mean residence time (MRT) extrapolated to
infinity for a substance administered by extravascular dosing,
calculated using the observed value of the last non-zero
concentration.
submission value: MRTEVIFP

synonym: MRT Extravasc Infinity Pred
definition: The mean residence time (MRT) extrapolated to
infinity for a substance administered by extravascular dosing,
calculated using the predicted value of the last non-zero
concentration.
submission value: MRTEVLST

synonym: MRT Extravasc to Last Nonzero Conc
definition: Mean residence time (MRT) from the time of dosing
to the time of the last measurable concentration for a
substance administered by extravascular dosing.
RHINOVIRUS Definition: Any viral organism that can be assigned to the
genus Rhinovirus.
Need help determining the copyright status We need help with copyright determination for an additional
for the "Reynolds Risk Score" which is a clinical composite for dyslipidemia. The 'Reynolds Risk Score'
clinical classification needed for dyslipidemia (http://www.reynoldsriskscore.org/home.aspx) does not
appear to be copyrighted but I am having trouble finding a
statement saying it is in the public domain. Two things to
consider 1. It was developed with partial funding from the NIH
and 2. There is not a case report form that we are going to
show so what is actually considered copyrighted material?
We have already determined we can create a CCCAT and a
score test code without violating the copyright. C-Path will do
the terminology and supplement work.
Add new terms to the Tumor Response Add new terms to the Tumor Response Result codelist; File
Result codelist emailed separately.
CV Terminology team agreed to add the I forgot to make this request earlier this year. I will send the
following new METHOD values based on spreadsheet that documents that I needed to make this
the need relate these with the CV request when the CV ENDPOINTS MOTESTs were included
ENDPOINTS MOTESTs. QUANTITATIVE in CT Package 18
PERIPHERAL ANGIOGRAPHY
General_controlled_terminology_Package_18_DRAFT_2014-
03-16_Steve_Loc_Synonym.xls
Please add RENAL GLOMERULUS to the Please add RENAL GLOMERULUS to the LOC codelist to
LOC codelist. support analysis of kidney biopsies. The NCI Thesaurus
includes this term:
us; however, the preferred name is Glomerulus. I have found
references to both olfactory glomerulus and renal glomerulus
online and believe specificity would avoid future confusion.
SEND IG Version 3.1 Needed when SEND IG 3.1 is released.
Need to create new terms for the AUDIT-C Need to create new terms for the AUDIT-C and Rivermead
and Rivermead questionnaires. questionnaires; File e-mailed separately.
BLADDER WALL Please add the term BLADDER WALL to the Anatomical
Location codelist.
Definition: The tissue layers that form the urinary bladder.
They include the mucosa, submucosa, smooth muscle, and
serosa.(NCI)
NCI Code: C48941
GOLDMANN OCULAR TANOMETRY Definition: Goldmann tonometry is considered to be the gold

standard test and is the most widely accepted method to
determine intraocular pressure (IOP). This method requires
that a special disinfected prism is mounted on a tonometer
head, then placed against the cornea. The examiner then
adjusts the instrument until certain criteria are met, and the
IOP is determined.
Additional supporting information as noted on the internet

15Oct2014 at Wikipedia, the free encyclopedia: Goldmann
tonometry is considered to be the gold standard test and is
the most widely accepted method to measure intraocular
pressure. A special disinfected prism is mounted on the
tonometer head and then placed against the cornea. The
examiner then uses a cobalt blue filter to view two green semi
circles. The force applied to the tonometer head is then
adjusted using a dial connected to a variable tension spring
until the inner edges of the green semicircles in the viewfinder
meet. When an area of 3.06mm has been flattened, the
opposing forces of corneal rigidity and the tear film are
roughly approximate and cancel each other out allowing the
pressure in the eye to be determined from the force applied.
Like all non-invasive methods, it is inherently imprecise.
The CHART-SF PAPER CRF standards are The CHART-SF PAPER CRF standards are being developed
being developed for the TBI team. A new for the TBI team. A new QSCAT and new synonym are
QSCAT and new synonym are needed for needed for the CHART-SF PAPER form and hence new
the CHART-SF PAPER form and hence new TEST/TESTCDs; File e-mailed separately.
TEST/TESTCDs
I already sent in the terminology request for QSCAT for the
CHART SF Interview CRF, but had not submitted the request
for CHART-SF PAPER yet as I need to receive copyright
permission first. I've gone ahead and submitted the multiple
term request and attached to this e-mail the draft terminology
I have for the CHART-SF PAPER form tho in case you want
to look at these at the terminology meeting. Obviously nothing
will be published until we have permission. The big difference
in the Interview and Paper forms is the response choices for
items 18 and 19 (the questions are the same) so does not
affect the definition. There is one very small difference in
question 14 which I noted on the TEST/TESTCD sheet. I
have made the synonym CHSF2 for the Paper form.
Both the Interview and Paper forms are in the CHART

Manual. The Interview one is the form we've already done
that is public domain. The Paper form is the copyrighted one.
C2/C3 Anatomical location between Cervical Vertebrae 2 and

Cervical Vertebrae 3 in the human spine.
There will be 23 Location requests in total, to allow for data

collection using the Spondyloarthritis Research Consortium of
Canada (SPARCC) Magnetic Resonance Imaging Index and
subsequent scoring of inflamation of the spine and sacroiliac
joints.

Cervical Vertebrae 4 in the human spine.

Cervical Vertebrae 5 in the human spine


C7/T1 Anatomical location between Cervical Vertebrae 7 and
Thoracic Vertebrae 1 in the human spine
T1/T2 Anatomical location between Thoracic Vertebrae 1 and










T12/L1 Anatomical location between Thoracic Vertebrae 12 and

Lumbar Vertebrae 1 in the human spine
L1/L2 Anatomical location between Lumbar Vertebrae 1 and




L5/S1 Anatomical location between Lumbar Vertebrae 5 and Sacral

Vertebrae 1 in the human spine
C106984 Submission Value in TEST C106984 Submission Value in TEST codelist and SYs for
codelist and SYs for both TEST and both TEST and TESTCD codelists need to be updated;
TESTCD codelists need to be updated
ADL02 Usual Physically Dressing Perform, missing the
"hyphen" after ADL02.
Please generalize EGCOMP (e.g. This is being submitted for Scott Bahlavooni. This was
INTCOMP or INTPCMP) such that (a) the originally submitted as a comment in the public comment
test code is specific to the interpretation as tracker.
other resutls could be compared to previous
and (b) the same test code can be used in
other domains that include the test code
INTP.
Laryngeal Pouch Requested based on discussion around changes to AIR SAC
on meeting 2014-10-20.
C105443, Remove FibroTest Score from C105443, Remove FibroTest Score from LBTEST/CD, this
LBTEST/CD, this will be housed by CC; This will be housed by CC; SEND does not use this item hence
is a TA request. can be moved out of LAB.
A clinical classification instrument contains a recognized,

arbitrary standard/classification system based on finding(s)
that may correlate to a specific disease pheno- or genotype or
clinical/disease outcome. The classification system may be in
the form of scores, grades, or classes. Composite scores
should go into CC.
For example: a FibroTest Total Score (based on 6 lab results,

also combine the subject's gender and age) of 0.75-1.00
(arbitrary score) indicates Cirrhosis (disease phenotype, or
outcome), which is the late stage of scarring (fibrosis) of the
liver.
COCKCROFT-GAULT APPROXIMATION A surrogate marker for estimation of creatinine clearance

which employs serum creatinine measurements and a
patients weight to predict the creatinine clearance
CRYOSCOPY A technique for determining the molecular weight of a

substance by dissolving it and measuring the freezing point of
the solution. Also, the determination of the freezing points of
certain bodily fluids, as urine, for diagnosis
GC/MS-CI GC-MS Chemical Ionization: An analytical technique where

gas chromatography is coupled with chemical ionization mass
spectrometry in order to separate, identify, and quantify
substances in a sample.
GC/MS-EI GC-MS Electron Ionization: An analytical technique where

gas chromatography is coupled with electron ionization mass
spectrometry in order to separate, identify, and quantify
substances in a sample.
GC/MS/MS Gas Chromatography Coupled to Tandem Mass

Spectrometry: An analytical technique where gas
chromatography is coupled with tandem mass spectrometry in
order to separate, identify, and quantify substances in a
sample.
HICN Hemoglobin is converted to hemiglobin cyanide (HiCN),
whose concentration is measured by spectrophotometry. To
carry out this conversion, blood is dissolved in a solution of
potassium ferricyanide and potassium cyanide which oxidizes
the hemoglobin to hemiglobin (Hi; methemoglobin) and then
converts it to hemiglobin cyanide, (HiCN).
HPLC-FL HPLC-Fluorescence Detection: An analytical technique
wherein high performance liquid chromatography with a
fluorescence detector is used to separate, identify, and
quantify substances in a sample.
IEX-HPLC Ion-exchange chromatography is a liquid chromatographic

technique in which proteins are separated depending on their
net charge. It can be used to monitor charge variants and
quantify each charge isoform.
HPLC/MS/MS HPLC Tandem Mass Spectrometry: An analytical chemistry

technique that combines the physical separation capabilities
of liquid chromatography (or HPLC) coupled to Tandem Mass
Spectrometry
HPLC-UV High-Performance Liquid Chromatography with UV Detector:

An analytical technique wherein high performance liquid
chromatography with a UV detector is used to separate,
identify, and quantify substances in a sample.
ICP-MS Inductively coupled plasma mass spectrometry is a type of

mass spectrometry which is capable of detecting metals and
several non-metals at concentrations as low as one part in
10^12 (part per trillion). This is achieved by ionizing the
sample with inductively coupled plasma and then using a
mass spectrometer to separate and quantify those ions.
ISE An ion-selective electrode (ISE), also known as a specific ion

electrode (SIE), is a transducer (or sensor) that converts the
activity of a specific ion dissolved in a solution into an
electrical potential, which can be measured by a voltmeter or
pH meter.
JAFFE Jaffe reaction is a method of creatinine assay based on the
orange-red color produced by creatinine reacting with alkaline
picrate. Creatinine present in serum or plasma directly reacts
with alkaline picrate resulting in the formation of a red colour,
the intensity of which is measured at 505nm/green filter.
Protein interference is eliminated using sodium lauryl
sulphate. A second absorbance reading after acidifying with
30% acetic acid corrects for non-specific chromogens in the
samples.
LC-FLD Liquid Chromatography-Fluorescence Detection: An analytical

technique wherein liquid chromatography with a fluorescence
detector is used to separate, identify, and quantify substances
in a sample.
LC/MS/MS Liquid Chromatography Tandem Mass Spectrometry : An

analytical technique wherein liquid chromatography is coupled
to tandem mass spectrometry in order to separate, identify,
and quantify substances in a sample.
HEMOCYTOMETER The Neubauer chamber or Hemocytometer is a device for
counting cells
PEAK FLOW METER A peak flow meter is a device to measure the amount of air
that can be expelled from the lungs.
LSC Liquid scintillation counting is an analytical technique which is

defined by the incorporation of the radiolabeled analyte into
uniform distribution with a liquid chemical medium capable of
converting the kinetic energy of nuclear emissions into light
energy.
SPIROMETRY Pulmonary function test (PFT) tool used for measuring lung
function, specifically the amount (volume) and/or speed (flow)
of air that can be inhaled and exhaled. The spirometry test is
performed using a device called a spirometer.
U-HPLC-MS/MS Ultrahigh-performance liquid chromatography coupled to

tandem mass spectrometry
CENTRIFIGATION The process of separating lighter portions of a solution,

mixture, or suspension from the heavier portions by
centrifugal force.
SURGICUTT Surgicutt bleeding time devices are used to screen for platelet
function. The device features a surgical blade that produces a
uniform incision, not a puncture, improving reproducibility of
test results.
New terms add to LAB URIAPPRC Urine Appearance

BASOCE Basophils/Total Cells
BASOABS Basophils Absolute
LYMWBC Lymphocyte/WBC
MOCYCECE Monocytoid Cells/Total Cells
CALNRALB Calcium Normalized for Low Albumin
PROTQ Protein Qualitative
ETHANOLQ Ethanol Qualitative;
Need new tests.
Will send Bernice Yost a spreadsheet with test code, name

and definition.
Update the C-SSRS codelist blue rows Please update the C-SSRS codelist blue rows; File emailed
separately
Remove C96644 - UPD from codelist Remove C96644 - UPD from codelist, and people should use
PD. Team should present a good explanation for removal to
Bernice. Bernice will inform the users during her webinar and
explain why this term is removed during the public review
process. Melanie to write a description for this. Team already
agreed to this, just need a request code.
C12805; Tricuspid Valve The definition is wrong so this is a Type I request that should
be handled in P20 publication. Change 'dual-flap' to 'three-
cusp' within the definition.
MYOCARDIAL ISCHEMIA Infarction (tissue death of a certain part of the heart) are
included in the SDTM terminology but not ischemia (damage
or destruction with heart tissue). I checked the Excel
workbook of Change Request Tracker and found that Brian V.
Harrington at eRT requested for adding this term. May I know
why it has not yet been added? Many thanks.
Changes to previously approved CHART SF Changes to previously approved CHART SF terminology, now
terminology, now calling it the CHART SF calling it the CHART SF Interview Version; File e-mailed
Interview Version separately.
QS-GDS SHORT FORM TESTCD, QS-GDS Need to include total score calculation, including coded terms,
SHORT FORM TEST in ADaM QS supplement addenda that are being developed.
The GDS Short Form is the first questionnaire being
developed. Please contact me to work out a process for this,
as there will be more to come.
IMMUNOGENICITY For vaccine studies this is a common value.
uV/msec Please add the unit uV/msec with the synonym microVolt per
millisecond to the Unit codelist. This unit is used in EEG
studies to capture the Area under the Curve measurements.
Please delete ANGIOGRAM Now that we have a METHOD term for ANGIOGRAPHY, can
you please remove the term for ANGIOGRAM?
This seems like duplication and isn't really a method.
Thanks
Possible duplication of terms in We have an existing pair of terms: RETIHGB (Reticulocyte
LBTESTCD/LBTEST Hemoglobin) with the definition of 'A measurement of the
amount of hemoglobin in reticulocytes'.
The latest Oct 14 release has a new pair: RETICH (Ret.
Corpuscular Hemoglobin Content) with a definition of 'A
quantitative measurement of the total amount of hemoglobin
in the reticulocyte population.' These seem the same to me.
Can you please explain the difference more clearly in the
definition or remove one of them. Many thanks
TRANSCRIPTION-MEDIATED Possible definition: A nucleic acid amplification technique
AMPLIFICATION involving RNA transcription (via RNA polymerase) and DNA
synthesis (via reverse transcriptase) to produce RNA
amplicon from a target nucleic acid.
Used for Chlamydia trachomatis RNA and Neisseria

gonorrhoeae RNA testing by Quest
ARTERIAL CORD BLOOD; VENOUS We are collecting data from both specimens, so the generic
CORD BLOOD CORD BLOOD will not be sufficient for us.
ASPERGILLUS NIGER; CRYPTOCOCCUS Please add these two terms to the Microorganism codelist:
ASPERGILLUS NIGER - Any fungal organism that can be
assigned to the species Aspergillus niger.
CRYPTOCOCCUS - Any fungal organism that is not assigned
to the species level but can be assigned to the Cryptococcus
genus level.
AUDIT TEST/TESTCDs and definitions as AUDIT TEST/TESTCDs and definitions as per the request of
per the request of the TBI team. the TBI team; File e-mailed seperately.
Single RR Heart Rate or Individual RR Heart This request is from the ECG Terminology Team. EGHRIDV:
Rate An electrocardiographic measurement of a heart rate derived
from a single RR interval (interval between two consecutive
QRS complexes).
C64251 Left ventricular systolic dysfunction This was a comment from wfriggle in the P20 public comment
(LVSD) is usually defined as an LV ejection review.
fraction <40% on echocardiography.
Suggest updating the defintion for both A measurement of the inequality in the size of the red blood
LBTESTCD and LBTEST (C65047 and cells in a whole blood specimen.
C67154)
Reads better as:
A measurement of the variability in the size of the red blood
cells in a whole blood specimen.
This was received as a comment in the Public Comment

Tracker from Audrey Walker.
Various LOC requests Various LOC requests; Fiel emailed separately

RESPIRATORY SYSTEM and LOWER There is an existing term for UPPER RESPIRATORY
RESPIRATORY SYSTEM SYSTEM.(The sinuses and those parts of the respiratory
system above the trachea. It includes the nares,
nasopharynx, oropharynx, larynx, vocal cords, glottis and
upper trachea.)
We would like to expand this to cover:
LOWER RESPIRATORY SYSTEM: Synonym LOWER
RESPIRATORY TRACT. Definition: The lower respiratory
system consists of, the trachea, bronchi (primary, secondary
and tertiary), bronchioles (including terminal and respiratory),
and lungs (including alveoli.
RESPIRATORY SYSTEM: Synonym: VENTILATORY
SYSTEM. Definition: A biological system consisting of specific
organs and structures used for the process of respiration in
an organism. The respiratory system is involved in the intake
and exchange of oxygen and carbon dioxide between an
organism and the environment.
LESIONS Any abnormality in the tissue of an organism, usually caused

by disease or trauma.
BODE Index Category, Test Code and Tests BODE Index Category, Test Code and Tests names; File
names emailed separately
Phadiatop Screen Phadiatop (Phadia Differential Atopy Test) is a commercially
available qualitative serological test employed for screening of
allergic sensitization in patients with suspected allergic
diseases.
Reference URL: http://www.srlworld.com/medimail/2010-11-

ImmunoCAP-Phadiatop.pdf
Additional information regarding the Phadiatop inhalant

allergy blood screen: a multi-allergen inhalant allergy
screening test useful for assessing if inhalant allergy is
present in conditions such as asthma and rhinitis. It doesn’t
tell us which individual allergens are implicated but rather
whether there is respiratory allergy or not. The screening
panel has extracts of Housedust Mite, Cat and Dog dander,
Mold spores, Tree Grass and Weed Pollen and can be
adapted to include locally implicated aero-allergens such as
Cockroach.
Suggested LBTESTCD: PHADIATP

LBTESTNAME: Phadiatop Screen
Synonym: Inhalant Atopy Screen
Definition: Examination of a biological specimen to determine
the absence or presence of atopic allergy.
INTERSTITIAL FLUID Synonym: TISSUE FLUID.

Def: A solution that bathes and surrounds the cells of
multicellular animals.
Used to measure Glucose in the Interstitial fluid by
Transdermal sensor
TRANSDERMAL MONITORING A METHOD OF MONITORING FOR SUBSTABCES
THROUGH THE DERMAL WALL.
Used for monitoring Glucose
Add OCI QSCAT only; QS team agreed to CDISC Submission Value: OCI
add this CAT already, this will be published Synonym(s): OCI01
in P20. Just getting a request number here. CDISC Definition: Ocular Comfort Index (OCI) (The copyright
owner of the Ocular Comfort Index is Dr. Michael Edward
Johnson. Michael E. Johnson and Paul J. Murphy.
Measurement of Ocular Surface Irritation on a Linear Interval
Scale with the Ocular Comfort Index. Investigative
Ophthalmology & Visual Science, October 2007, Vol. 48,
No.10).
Also 'File emailed separately'.
ASPERGILLUS Please add the term ASPERGILLUS to the Microorganism

Codelist.
Definition: Any fungal organism that is not assigned to the
species level but can be assigned to the Aspergillus genus
level.
CYSTOSCOPY Please add the term CYSTOSCOPY to the Method codelist.
Definition is: Endoscopic examination of the urinary bladder or
urethra.
This is similiar to the existing Method term of

PANENDOSCOPY which is an endoscopic examination in a
different body area and uses a different type of scope.
Please add "FLU-IIQ ONCE DAILY" and Please add "FLU-IIQ ONCE DAILY" and "FLU-IIQ TWICE
"FLU-IIQ TWICE DAILY" to QSCAT. DAILY" to QSCAT.
; File emailed separately.
This is a request from the 2014 Bethesda This is a request from the 2014 Bethesda Interchange for
Interchange for removing published units of removing published units of measure that contain test
measure that contain test information like information like TCID50, CCID50, Creatinine, etc. The request
TCID50, CCID50, Creatinine, etc. contains removals of 28 terms from the existing published
codelist and requests to add 8 new terms to the Unit codelist;
Multiple term request for RPTEST and Multiple term request for RPTEST and RPTESTCD; File
RPTESTCD. emailed separately.
Dyslipidemia TA team is requesting 22 new Dyslipidemia TA team is requesting 22 new terms for the
terms for the LBTEST/LBTESTCD and LBTEST/LBTESTCD and METHOD codelists to support the
METHOD codelists to support the Dyslipidemia therapeutic area user guide; File emailed
Dyslipidemia therapeutic area user guide. separately.
Multiple term request for SCTEST and Multiple term request for SCTEST and SCTESTCD; File
SCTESTCD. emailed separately.
Add ENZYMATIC as a method for lipid A chemical process, typically mediated by an enzyme, in
measurements. Covance has this in their which one or more substances (a substrate) are transformed
dictionary. by covalent modification into another substance(s) (a product)
or in which the state of a substance is transformed.
MITRAL VALVE A valve that is located between and controls the flow of blood
from the left atrium and left ventricle of the heart.
Please add GUAGE to the SDTM Unit The Alzheimer's Disease TAUG contains modeling for CSF
Codelist collection that includes the needle gauge. Biogen is collecting
this information for another TA and needs to represent the
needle gauge.
The unit gauge exists in the NCI-T:

us
Temporal Artery Temperature is recorded using a temporal thermometer which
reads the temperature of the temporal artery.
Remove FDGPET and FLTPET (C103400 This request is from the general team meeting discussion on
and C103401) from the METHOD codelist. 2014-11-21. The team did not agree to add 18F NaF PET as
There is now an AG domain that supports a method because the AG domain will now handle contrast
the description of contrast agents used in agents. If we need to wait a little while to remove them (wait
PET and other scans. until the domain becomes final) that is fine.
File emailed separately for new terms for File emailed separately
LBTESTCD and LBTEST
WHO Functional Classification for WHO Functional Classification for Pulmonary Arterial
Pulmonary Arterial Hypertension (NOT the Hypertension (NOT the same as NYHA Classification; Means
same as NYHA Classification) of classifying disease severity in PAH developed by the World
Health Organisation and modified after the New York Heart
Association functional classification according to level of
function and associated symptoms. Increasing WHO FC
reflects more severe symptoms and greater restriction in
activity.)
Reference -- http://www.pah-info.com/Assessing-the-severity-
of-PAH
Class I - Patients with pulmonary hypertension but without

resulting limitation of physical activity. Ordinary physical
activity does not cause undue dyspnea or fatigue, chest pain,
or near syncope.
Class II - Patients with pulmonary hypertension resulting in

slight limitation of physical activity. These patients are
comfortable at rest, but ordinary physical activity causes
undue dyspnea or fatigue, chest pain or near syncope.
Class III - Patients with pulmonary hypertension resulting in

marked limitation of physical activity. They are comfortable at
rest. Less than ordinary activity causes undue dyspnea or
fatigue, chest pain, or near syncope.
Class IV - Patients with pulmonary hypertension with inability

to carry out any physical activity without symptoms. These
patients manifest signs of right heart failure. Dyspnea and/or
fatigue may be present even at rest. Discomfort is increase by
any physical activity.
Change controlled terminology from QS to Per Steve Kopko and COA/CC sub team - after review of the
CC: C100129; C117991; C117990 QS Supplement for the ESRS-A instrument, it was agreed
that the instrument should be mapped to the CC domain
instead of QS.
Please add BICEPS BRACHII MUSCLE to Biceps is need for both a location of dose administration as
the LOC codelist. well as a location of a neurological assessment.
This term is present in the NCI-T:

us
It is also part of the SEND Specimen codelist as MUSCLE,
BICEPS BRACHII.
Changes to terms 101-150 of the SEND- Changes to terms 101-150 of the SEND-SPEC codelist to
SPEC codelist to align definitions with new align definitions with new rules. File emailed separately.
rules.
Long form: Sperm DNA Fragmentation An assessment of the DNA fragmentation of sperm is used as
Index; Short form: DFI a biomarker for fertility in men. The DNA Fragmentation Index
(DFI) as assessed by the flow cytometric Sperm Chromatin
Structure Assay (SCSA) can be used for evaluation of sperm
chromatin integrity. The result is indicated in percent (%)
fragmentation. Above 20% fertility is said to be impaired in
humans.
This test is performed in clinical and nonclinical studies and
will be reported as a laboratory test result. Uncertain if
'Sperm' should be part of the LBTEST or if this only recide in
the LBSPEC.
Update existing test name from Brain According to our Clinical team, Brain Natriuretic Peptide is the
Natriuretic Peptide to B-Type Natriuretic antiquated term and no longer used by the scientific
Peptide community. We are asking to have the test name updated
from Brain Natriuretic Peptide to B-Type Natriuretic Peptide.
This will also be consistent with the other existing B-Type
Natriuretic Peptide terms (ProB-type Natriuretic Peptide, N-
Terminal ProB-type Natriuretic Peptide)
FUNGI; YEAST; MOLD Please add the following terms to the Microorganism codelist:
FUNGI, MOLD, YEAST. Definitions:
FUNGI - Any organism assigned to the kingdom Fungi.
YEAST - A microscopic fungus consisting of single oval cells
that reproduce by budding, and are capable of converting
sugar into alcohol and carbon dioxide.
MOLD - A fungal hyphae occurring typically in moist warm
conditions, especially on food or other organic matter.
POST STUDY The period after a clinical study when all study procedures,
treatments and observations have concluded.
ESCAPE The period of a clinical study when a subject is administered

open label treatment after not achieving a pre-defined clinical
response with blinded treatment.
Propose C106580 be changed from I find the DSDECOD Unplanned terminal sacrifice (C106580)
"Unplanned Terminal Sacrifice" to confusing. I propose the removal of the ?terminal? from this
"Unplanned Sacrifice". code. The use of terminal in the code when the definition of
the code states it is to be used ?before the end of the
protocol-defined treatment or observation period? makes the
term and its definition a contradiction.
If the word ?terminal? was used in C106580, to reaffirm that

the animal is dead, then the C90465 term of Terminal
Sacrifice should be changed to Terminal Terminal Sacrifice ?
where one terminal refers to the end of the protocol-defined
treatment period and the 2nd terminal refers to the death of
the animal.
Propose C106580 be changed to Unplanned Sacrifice.

C67401; add ug/g as a synonym To go along with the removal of ug/g Creatinine as a valid unit
of measure (already submitted as a change request and
agreed upon by the team). Want to ensure ug/g is in the
synonym column for mapping purposes.
URETHRA, PROXIMAL Please add the term URETHRA, PROXIMAL to the
Anatomical Location codelist.
This term is available in the NCI thesaurus with the definition:
The part of the urethra that is closer to the bladder.
ABERRANTLY CONDUCTED COMPLEXES This is a request from the ECG terminology team. This item
(C116132): update definition to - An already exists in the spreadsheet but we need to have a
electrocardiographic finding of an request number.
abnormally wide QRS complex(es) of
supraventricular origin with prolonged QRS
duration due to aberrant AV conduction.
I have attached a spreadsheet for creating 2 I have attached a spreadsheet for creating 2 new codelists for
new codelists for the ECG Terminology the ECG Terminology Team. These terms already exist in the
Team. These terms already exist in the ECG ECG Terminology spreadsheet. I am submitting these to get a
Terminology spreadsheet. I am submitting request number and to have the terms counted.
these to get a request number and to have File emailed separately.
the terms counted.
10 additional terms to be added to the new 10 additional terms to be added to the new codelist Holter
codelist Holter Findings About Results. Findings About Results. These terms already exist in the ECG
These terms already exist in the ECG spreadsheet. We need a request number and we need them
spreadsheet. We need a request number to be counted.
and we need them to be counted. File emailed separately.
Modify existing terms for oncology core These changes have already been approved by the oncology
team. Just getting a request number. core team so we are just getting a request number; File
emailed separately.
New term for CCCAT, new test New term for CCCAT, new test name/codelist for PANSS; File
name/codelist for PANSS emailed separately.
This request is from the Schizophrenia therapeutic area team.
ENZYMATIC ULTRACENTRIFUGATION Definition: An ultracentrifugation based method that uses

enzymatic catalytic reaction to quantify a sustance, which has
been separated in solution by an ultracentrifugation process.
This request is from the Dyslipidemia therapeutic area team.

It is the appropriate method to be used for Beta-quantification
of LDL cholesterol.
ECG team decided to update the definition ECG team decided to update the definition for C116136 and
for C116136 and C116137. C116137. Remove "This may be observed in hypercalcemia."
We normally do not put examples in the definition.
Change synonyms to proper case, instead This is consistent with the change made in P20 to the
of upper case. NEOPLASM codelist.
DAS 28 DAS28 (Disease Activity Score 28) is a composite score that
includes physical examination, laboratory tests, questionnaire
and imaging. Currently, there is no means of capturing the
overall DAS28 score in CDISC.
The PK terminology team would like to add The PK terminology team would like to add some new terms
some new terms and to modify some and to modify some existing terms in the PK Unit codelist. All
existing terms in the PK Unit codelist. All of of these terms are already in the PK spreadsheet for P21.
these terms are already in the PK They just need a request number. File emailed separately.
spreadsheet for P21. They just need a
request number.
The PK terminology team would like to add The PK terminology team would like to add some new terms
some new terms and to modify some and to modify some existing terms in the PK Unit codelist. All
existing terms in the PK Unit codelist. All of of these terms are already in the PK spreadsheet for P21.
these terms are already in the PK They just need a request number. File emailed separately.
spreadsheet for P21. They just need a
request number.
CCCAT, CCTESTCD and CCTEST for the CCCAT, CCTESTCD and CCTEST for the Child-Pugh
Child-Pugh instrument instrument; File emailed separately. This is for HEP-C TA.
CCCAT, CCTESTCD and CCTEST for the CCCAT, CCTESTCD and CCTEST for the MELD instrument;
MELD instrument File emailed separately. This is for HEP-C TA.
Columbia-Suicidality Severity Rating Scale, We have a Phase II Study using C-SSRS assessment that
Baseline/Screening Version --> Wish to be has the TEST - Wish to be Dead, Describe in the Past 6
Dead, Describe P_M - CSS0401D Months. As per the published CT for QS test codes, we have
CSS0401A, B, C, but don't see the test code CSS0401D.
Since this is not extensible, request for the new term.
If I can add little more - My question is more like why do you

have a separate TEST/TESTCDOE for similar assessments
Describe, P_M where we don’t have a separate
TEST/TETSCD for a few other like the one I raised.
For example, we have a separate test code for CSS0406D -

CSS04-Most Severe Idea, Desc-P_M for the test Intensity of
Ideation. Whereas, for the one that I raised CSS0401 /
CSS04-Wish to be Dead-P_M there is no CSS0401D. Instead
we are expected to use QSEVALINT for capturing the period.
Brief Assessment of Cognition in Brief Assessment of Cognition in Schizophrenia (BACS)

Schizophrenia (BACS) Functional Test Functional Test Instrument; This instrument is required for the
Instrument Schizophrenia TA Standards Project
Interruption followed by a Reduction Needed for AstraZeneca Adverse Event Reporting. Draft
Definition: Dose interruption where the drug is re-started at a
lower dosage. Thank you for your consideration. Anna Pron-
Zwick/17-Dec-2014
Interruption followed by Permanently Term would be useful in counting interruptions/reductions
Stopped where changes in AE's are not captured. The event would
start with a drug interruption, and then AEACN would be
changed to a reduction or be permanently stopped. In such
cases, we only capture the reduction or permanent stoppage,
and miss the interruption. Draft Definition: Dose interruption
where the drug is not re-started. Thank you for your
consideration. Anna Pron-Zwick/17-Dec-2014
Please remove SITEID from this codelist Please remove SITEID from this codelist and the associated
and the associated entry "Study Site entry "Study Site Identifier" from STSPRM codelist per SEND
Identifier" from STSPRM codelist per SEND 3.1 IG change. to comply with SEND IG 3.1
3.1 IG change.
This has already been added to the General This has already been added to the General P21 Public
P21 Public Review document. We only need Review document. We only need to add the request numbers.
to add the request numbers. This request is This request is to move test names and test codes from the
to move test names and test codes from the Consensus Cardiac Classification System codelists to the
Consensus Cardiac Classification System COA CC codelists. File emailed separately.
codelists to the COA CC codelists.
This has already been added to the General This has already been added to the General P21 Public
P21 Public Review document. We only need Review document. We only need to add the request numbers.
to add the request numbers. This request is This request is to move test names and test codes from the
to move test names and test codes from the Consensus Cardiac Classification System codelists to the
Consensus Cardiac Classification System COA CC codelists. File emailed separately.
codelists to the COA CC codelists.
Change
Final Outcome
Type
I SEND, SDTM-Published in P17
III SEND, SDTM-Published in P17

I SDTM-Published in P17
III P18-Do not remove at this time.

What to do with these compound
terms will be discussed in future.

III SDTM-Published with P18, P19
III SDTM-Published with P19
II SEND, SDTM-Published in P18

III QS-Published with P17
III Do not add (SDTM, SEND-P18):

Team agrees not to add the Benign
or Malignant variants of these terms
at this time since it is thought that
they are rarely used.

II Update published in SDTM P33.

III Do not add (SDTM, SEND-P18):

Review the ventricular arrhythmias
and supraventricular arrhythmias
groups in the already released
terminology.
II Do not add (SDTM, SEND-P18): As

the difference in definition explains,
normal sinus rhythm is a subset of
sinus rhythm. Normal sinus rhythm
requires that there be no other
rhythm or AV conduction
disturbances.
III SDTM SEND-Published in P18


P21, P24, P30
Platelet Aggregation, ADP: Do not
add (P21): Platelet Aggregation is
the test. The agonist for the
reaction (ADP) should be added as
a suppqual on the method of
Aggregometry.
Platelet Aggregation with PFA-100,
Collagen/Epinephrine: Do not add
(P21): Platelet Aggregation is the
test. The agonist for the reaction
(PFA-100 Collagen/Epinephrine)
should be added as a suppqual on
the method of Aggregometry.
Integrin Alpha M, CD11B,
Stimulated: Do not add (P21): Use
the existing CD11B and put
"Stimulated by presence of xxx" in
the supplemental qualifier and
emphasis use of high and low
reference range units to separate.
Integrin Alpha M, CD11B,
Unstimulated: Do not add (P21):
Use the existing CD11B and put
"Unstimulated" in the supplemental
qualifier and emphasis use of high
and low reference range units to
separate.
Do not add (P30) HCVMRNA and
HEVMRNA - Please look at the
modelling in the Influenza TAUG
and the Virology TAUG. They have
Viral Load in the LBCAT variable.
The LBTEST can contain RNA,
DNA, etc.. The new variable NHOID
holds the non-host organism
III P21-Do not add. High Sensitivity

can be in the Suppqual of the
Method. This maps to existing term
of C-Reactive Protein.
III P21 - Do not add.
The unit here is per nanoliter (cells
is implied in the test numerator)
which is already published
C116243.

Do not add/change. The indication
that urine dipsticks measure direct
bilirubin will be specified in the
SHARE metadata.
LBTEST/LBTESTCD only contains
the analyte being measured and
should be independent of
specimen, method, etc. Therefore,
Microalbumin should not be a
separate term. Use the existing
term of Albumin.
III Do not change. 1 TIME PER WEEK
is more specific than EVERY
WEEK. EVERY WEEK does not
imply something is done once
EVERY WEEK.
III Removed by Requester - P20

II
II QS-FT-Published in P18
II QS-FT-Published in P18
III P19-Do not add. requestor's use

case doesn’t coincide with PRTRT.
Requestor will pursue an
appropriate place to put "Method
used to obtain specimen".

III
II SDTM, SEND-Published with P20
III Do not add (SDTM-P19): These are

coded result values that should map
to existing terms ("Positive" and
"Negative") in the Laboratory Test
Standard Character Result codelist.
CDISC decided not to get into all
the ways of expressing this
Boolean, and settled on just the
Positive/Negative pair.
III ADaM-Published with P19
III
III
III
III
III
III Yes. This terminology will be

published in a future package.
III SDTM-Published with P19, P28,

P29
II

P20, P26
Do not add (SEND-P25) - TUMOR,
BASAL CELL, MALIGNANT; Please
use existing term C111199.
III Do not add (SDTM, SEND P25) -

Already exists. Please use C71091.
III

III

This is not a true unit.
III Do not add (SDTM-P23): No

response received for additional
information - [Is subtype 2
equivalent of M2?].
III SDTM, SEND-Published with P21
III
information - [Can you please be
more specific, what is this the
antibody to - Neutrophil Elastase?].

information - [Is this prothrombin
that has been specifically
inactivated by a microorganism?].

III
III SDTM, SEND-Published with P19,

P20, P21
II
III Do not add (SDTM-P19): The ECG

team has a mapping list that will be
displayed on the website after it
goes through public review.
III
III
III
II SDTM, SEND-Published in p29
III P22-Do not add.

A dipstick might contain different
tests and those tests should be
listed separately with
dipstick/observation as a method.
The users can define and manage
their own terminology for this
concept.

Do not add umol/dL. This is not SI
compliant, please use umol/L.
II
III SDTM-Published with P19, P20,

P21
III
II SDTM-Published with P19
III


Other

Do not add (SEND P27):
SUPERNUMERARY
OSSIFICATION SITE - Do not add
until someone from user community
requests this term and can provide
context.
III SEND-Published in P19, P20, P21
III Do not add (SEND P20). Follow-up

with core team required.
III
III
III
III
III
III
II
III

P22
II
II


P22, P24
III
III

III
III
III
III
III
III
III
III
III
III

III
II
III
III
III

P24
II
III
III

II
III
III
III

Do not add (SDTM-P23): FVCPR /
Predicted FVC / FEV1PR /
Predicted Forced Expiratory
Volume 1 Sec / DLCOPR /
Predicted DLCO-As per Asthma
TAUG - The predicted values for all
tests were mapped into the
REORREFR, RESTREFR variables
(REFR=Reference Result Value).

QRS-Published in P19
II P21 - Do not add.

Cytomegalovirus is the genus. For
the Human Herpesvirus 5 there is
the synonym of human
cytomegalovirus which is at the
species level.
III
II
III Do not add (SEND P20) - do not

add. Instead we will make
definitions of Rat and Cotton Rat
more inclusive.
III
III
III
II

III SDTM-Published in P20, 21
III

VAGINAL FLUID: Do not add (P20).
Please use specimen type of FLUID
and anatomical location of VAGINA
(C12407). Vaginal fluid has
multiple sources and is not able to
be isolated as just the glandular
excretion.
III
II
III P22-Do not add.
This can be handled with
MOTEST=VOLUME (already exists)
and LOC=Intracranial space (new
location).
There are implementation examples
where this type of information is
added as additional qualifier
variables. We do not want to set
precedent for an approach with
terminology. This should be
discussed and settled by an
appropriate TAUG.
III Remove by Requester - P20
III SEND agrees in theory. Wait for

requester to send new tumors for
consideration.
II Removed by Requester - P21
II Do not add (SEND P20) - Team

does not agree. The updated
definition does not add anything
that the existing published definition
doesn't already have. Keep as is;
no change.
II

P23, P24

P22-Do not add.
This test should go into the
microbiology domain and would
have a test for virus detection, an
organism species name of HCV,
and a method of RNA PCR.
III Do not add (SDTM-P23): As per

Asthma - The predicted values for
all tests were mapped into the
REORREFR, RESTREFR variables
(REFR=Reference Result Value).
III
II
II
II
I SDTM, SEND-Published with P19

II

This is not a method, it is a
procedure that has a result.
“Cardiac catheterization” refers to
any procedure by which catheters
are advanced to the heart via a
central artery and/or central vein.
III P22-Do not add.

organism species name of CMV,
and a method of culture.
III SDTM-Published in P20, P21, P23,

P24, P25, P26
Do not Add (SDTM-P21):
ACHROMOBACTER SPECIES,
CDC GROUP VD-This term is very
III old
SDTM,and SEND-Published
has been supercededin P20by
several other species level names.
III Do not Add
SDTM, SEND (SDTM-P23):
- PublishedGROUP
in P21
D NON-ENTEROCOCCAL
STREPTOCOCCUS - This is not a
true taxonomic classification;
III SDTM-Published in P20 include
HELMINTHS-Helminths
members of the following taxa:
monogeneans, cestodes
nematodes, and trematodes. There
is no helminth classification, it is an
“artificial” term, not a real taxonomic
term.; NEISSERIA
SICCA/SUBFLAVA-Please break
this out into Neisseria sicca and
Neisseria subflava which are
already published.
Do not add (SDTM-P23): PDc maps
to PD, which is already published.
The Oncology team will add a
description to the IG to explain the
use of PDc, why and how to map
PDc to PD.

LBTEST-CD codelists

Do not add; Please see all new
terms added in Package 19.

















III P22-Do not add.

organism species name of HIV and
the strain/subtype of 1, and a
method of RNA PCR.
III
II SEND-Published with P21, P23,

P24, P25, P26, P29
II
II
II

III
III
II SDTM-Published with P21

Do not add (SDTM-P23): CIRRUS
OTC; STRATUS OTC: Do not add.
OPTICAL COHERENCE
TOMOGRAPHY (OCT) is the
method (already in METHOD list),
CIRRUS/STRATUS belongs in the
Device Identifier domain.
STEREOSCOPIC HIGH
MAGNIFICATION
OPHTHALMOSCOPY: Do not add.
This is really a device setting,
appropriate for the Device in Use
domain.
SPECULAR BIOMICROSCOPY:
Do not add. Same meaning as
SPECULAR MICROSCOPY.
Do not add (SDTM-P23): DILATED
OPHTHALMOSCOPY/UNDILATED
OPHTHALMOSCOPY-This maps to
the existing published method of
OPHTHALMOSCOPY. Use
SUPPQUAL for testing condition
qualifier (Dilated vs Undilated).

BOTH: IG says to use 2 rows in this
situation. If there are 2 control
types, in TS there would be 2 rows
for TCNTRL, one for each type.
NONTRT: The existing NONE is
equivalent, per the definitions in
ICH E10, and synonyms should
only be used when the concept is
not clear.
III SEND-Published with P21
II
II

Do not add (P33):
Hyperemia Indicator: Do not add.
This term did not make it into the
final SDTMIG 3.3 example.
Edema Indicator: Do not add. This
term did not make it into the final
SDTMIG 3.3 example.

P22

III
III

III
III
III
II
II
II P21 - Do not add.

Synonyms should only be used
when the concept may not be clear
without them. A synonym should
add additional meaning not
otherwise covered by existing
synonyms, submission values, and
definition.

"Immediately" is timing, not
frequency. The list is extensible.
Users should add new terms using
the convention of existing terms but
the possible combinations are
endless.
III P22-Do not add.
This will be modeled in Clinical
Classifications (CC).

Existing term NOT EMPLOYED
covers RETIRED. (RETIRED isn't
really Employment Status; it is more
like Life Status. In the same way,
"SEMI-RETIRED" is equivalent to
PART-TIME employment status).
I SDTM, SEND-Published with P19

We aren't adding "n" to the
standard terms - the list is
extensible so the user should add
"n" to the standard term as needed.




The standard term FOLLOW-UP
(C99158) should be used here. The
definition for that term is a little
ambiguous but the concept is the
same and is used commonly for the
requested purpose.




I SDTM-Published with P19

The formula for calculating single-
dose clearance is: dose / AUCIFO
or dose / AUCIFP. The value of
"dose " in this formula equals the
amount of drug administered at time
zero. Since the AUC to be used for
this formula is AUCIFO/P, i.e. the
AUC extrapolated to infinite time,
there needs to be adequate post-
dose period of drug washout to
allow reliable estimation of LAMZ.
III SDTM-Published
Subsequent dosing in must
P21 be
Do not add until
postponed KNEE theHEIGHT - Do not
the necessary
add.
periodUse Kneewashout
of drug to Heel Length
is complete.
(C84372).
The formula Theforcase for including as
calculating
a
clearance in the steady stateisis:
new test or as a synonym not
compelling,
dose / AUCTAU, and we don'tAUCTAU
where want is
unnecessary
the AUC of a proliferation
dosing interval of once
synonyms.
steady-state conditions apply. The
Do
valuenotofadd (P30):
"dose " in TCID50,
this formula
VPQUANT
equals the amount ofdiscussions
- Current drug on
whether this belongs
administered per dosing in the LB or
interval,
MB
whichdomain.
equalsThethe Influenza
dosing rate TAUG
times
will
the contain a KnownFor
dosing interval. Issue
example,
statement.
consider a subject receiving 1
Do not addon
mg/kg/day (P42):
a BID Influenza
dosing
Microneutralization
regimen. AUCTAU equals Titer-Dothe notAUC
add. Please
for the re-model
half day this concept
(12 hours) following
Map this to LARGE INTESTINE,
CECUM as SPEC and put contents
into --ANTREG for this unique
situation. This is qualifier on the
specimen as to whether it has
contents or not but not necessarily
a specific specimen (from SEND
perspective) in and of itself.
III QRS-Published in P20, P21, P23
III

P24

18F NaF PET: Do not add. Contrast
agents will be handled differently in
SDTM in near future (AG domain).
BONE SCAN: Do not add. Existing
term SCINTIGRAPHY with a LOC
of BONE covers this concept.

The ROUTE is "ORAL".

These should be represented using
the SDTM "MULTIPLE" convention.
Or, for an INJECTION (which is a
DOSFRM), you may not need to
populate ROUTE at all; you already
have the fact that it is an
INJECTION in DOSFRM so if you
don't know more, don't populate
ROUTE.
II
II
Concerned about PII (patient
privacy) issues. The info may be
used by the investigator for
calculations but shouldn't be in
submission data.

Concerned about PII (patient
privacy) issues. The info may be
used by the investigator for
calculations but shouldn't be in
submission data.
II



III P22-Do not add.
Rhinovirus at the genus level is no
longer recognized by the ICTV. It
has been replaced with Enterovirus.
III QRS-Published in P24.

The oncology team reviewed the
Wolchok paper and ultimately
determined that these responses
should map to the existing
published terms CR, PR, SD and
PD since the meaning was
essentially analogous except for
slight differences in percentages.
The CDISC terms and definitions
are kept deliberately vague in order
to facilitate re-use of these terms
across multiple tumor types,
imaging modalities, therapeutic
agents, response criterion, etc. It is
expected that clinicians should use
the criterion definitions outlined in
the individual papers to assign
response values. The response
criterion used to assign a response
should be submitted in the RSCAT
variable field and the expectation is
that reviewers will need to look at
both RSSTRESC and RSCAT for
review, comparison and analysis.

III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
III
II P21-Do not add.

The results that we are expecting
are improved, no change, or
deteriorated. This is often a
subjective comparison and may not
be applicable for other domains.
II
III Do not add (SDTM-P23): Please

use SUPPQUAL for the calculation
method.
III P22-Do not add.

The method here is
Spectrophotometry. This request is
describing specimen
preparation/assay materials, which
does not belong in the METHOD
codelist.


Do not add (P21): The lab team
defines the lbtest/lbtestcd value as
the analyte only. Currently, the
qualitative, semi-quantitative or
quantitative aspects of the test are
implied in the results
(present/absent vs numeric). The
key for labs is lbtest/lbtestcd,
method, and specimen.

This is not an ECG diagnosis which
can be made just from the review of
ECG.
III
II

II

III
III

III P22-Do not add.
The codelist is extensible. These
methods are very early in
development and we agreed to
revisit this in the future.
III

P23
III SDTM-Published in P21, P22
III
III
III
III
III
III
II QRS-Published in P24.
II SEND-Published in P25, P29

II P21 - Do not change.

B-Type Natriuretic Peptide is a
synonym.
III P22-Do not add.

Anytime that we are collecting data
on a subject that implies that it is
part of the study.
III P22-Do not add.

This appears to be open label
treatment.
II P22-Do not add. Synonym already
exists.
II
III QRS-Published in P24.
III

P23, P24
II SDTM, SEND-Published in P21,

P24
III
III P22-Do not add.

Use Dose Reduced, this list came
from ICHE2B and is not extensible.
III P22-Do not add.
Use Drug Withdrawn, this list came
from ICHE2B and is not extensible.
II ON HOLD
II ON HOLD
Date of Request
Status Submitter Name Submitter Affiliation Submitter E-mail
Submission Code
Closed Friday, 9 Jan CDISC- Anthony Chow CDISC achow@cdisc.org

2015 10:29 AM 1572
Closed Friday, 9 Jan CDISC- Kristin Kelly Accenture kristin.c.kelly@acce

2015 10:31 AM 1573 nture.com
Closed Friday, 9 Jan CDISC- Scott Biogen scott.bahlavooni@bi

2015 10:32 AM 1574 Bahlavooni ogenidec.com
Closed Friday, 9 Jan CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2015 10:34 AM 1575
Closed Friday, 16 Jan CDISC- Cliff Reinhardt UCB Biosciences, cliff.reinhardt@ucb.c

2015 03:26 PM 1576 Inc. om
Closed Friday, 16 Jan CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2015 03:34 PM 1577 nih.gov
Closed Friday, 16 Jan CDISC- Carrie Neeley Covance Labs carrie.neeley@cova
2015 03:38 PM 1578 nce.com
Closed Friday, 16 Jan CDISC- Sharon Boehringer sharon.broderick@b

2015 03:42 PM 1579 Broderick Ingelheim oehringer-
Pharmaceuticals, ingelheim.com
Inc.
Closed Friday, 16 Jan CDISC- Carrie Neeley Covance Labs carrie.neeley@cova
2015 03:45 PM 1580 nce.com
Closed Friday, 16 Jan CDISC- Gordon Krall Allergan krall_gordon@allerg

2015 03:54 PM 1581 an.com

2015 03:56 PM 1582 nih.gov
2015 03:57 PM 1583 nih.gov

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.
Open Friday, 16 Jan CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Inc.
Inc.
Inc.

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.
Inc.
Inc.
Inc.
Closed Friday, 16 Jan CDISC- Anita Umesh Illumina aumesh@illumina.c
2015 05:29 PM 1619 om
Closed Friday, 16 Jan CDISC- Anita Umesh Illumina aumesh@illumina.c

2015 05:30 PM 1620 om
Closed Friday, 23 Jan CDISC- Jordan Li MSC jvl1230@gmail.com

2015 12:45 PM 1621
Open Friday, 23 Jan CDISC- Bob Dempsey CDISC rdempsey@cdisc.or

2015 12:48 PM 1622 (for Sharon g
Broderick)
Closed Friday, 23 Jan CDISC- Erin Muhlbradt MSC muhlbradtee@mail.
2015 12:49 PM 1623 (on behalf of the nih.gov
lab team)
lab team)
general team)

general team)
Closed Friday, 23 Jan CDISC- Jordan Li (on MSC jvl1230@gmail.com

2015 12:52 PM 1627 behalf of the
virology team)
Closed Friday, 23 Jan CDISC- Debbie O'Neill Merck debra_oneill@merc
2015 12:54 PM 1628 k.com
Closed Friday, 23 Jan CDISC- Debbie O'Neill CDISC skopko@cdisc.org

2015 12:55 PM 1629
Closed Friday, 23 Jan CDISC- Diane Corey Critical Path dcorey@c-path.org

2015 12:57 PM 1630 Institute

SEND Repro
team)
Closed Friday, 23 Jan CDISC- Steve Kopko CDISC skopko@cdisc.org

2015 12:59 PM 1632
Closed Friday, 23 Jan CDISC- Steve Kopko CDISC skopko@cdisc.org

2015 12:59 PM 1633
Open Friday, 23 Jan CDISC- Gordon Krall Allergan krall_gordon@allerg

2015 01:00 PM 1634 an.com

2015 01:58 PM 1635 nih.gov
Open Friday, 30 Jan CDISC- Carrie Neeley Covance Labs carrie.neeley@cova
2015 02:33 PM 1636 nce.com
Closed Friday, 30 Jan CDISC- Rihab Kordane CRL Rihab.Kordane@crl.

2015 02:34 PM 1637 com
Open Friday, 30 Jan CDISC- Emily Hartley Critical Path ehartley@c-path.org

2015 02:35 PM 1638 Institute
Open Friday, 30 Jan CDISC- Erin Muhlbradt MSC muhlbradtee@mail.

2015 02:36 PM 1639 (On behalf of nih.gov
SDS oncology
team)
Closed Friday, 30 Jan CDISC- Bess LeRoy C-Path bleroy@c-path.org
2015 02:36 PM 1640
Closed Friday, 30 Jan CDISC- Bess LeRoy C-Path bleroy@c-path.org

2015 02:37 PM 1641
Closed Friday, 30 Jan CDISC- Janet Siani jsiani@shire.com
2015 02:38 PM 1642
Closed Friday, 6 Feb CDISC- Deborah CSL Behring Deborah.Rittenhous
2015 11:49 AM 1643 Rittenhouse e@cslbehring.com
Closed Friday, 6 Feb CDISC- Deborah CSL Behring Deborah.Rittenhous

2015 11:50 AM 1644 Rittenhouse e@cslbehring.com
Closed Friday, 6 Feb CDISC- Monika Kawohl Accovion GmbH monika.kawohl@ac

2015 11:55 AM 1645 covion.com
Closed Friday, 6 Feb CDISC- Monika Kawohl Accovion GmbH monika.kawohl@ac
2015 11:59 AM 1646 covion.com
Closed Friday, 6 Feb CDISC- Jozef Aerts University of Applied Jozef.Aerts@fh-

2015 12:02 PM 1647 Sciences FH joanneum.at
Joanneum
Closed Friday, 6 Feb CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Inc.

Inc.
Open Friday, 6 Feb CDISC- Abhijeet BioMarin Abhijeet.Sarvaiya@
2015 12:08 PM 1651 Sarvaiya Pharmaceutical Inc bmrn.com
Open Friday, 6 Feb CDISC- Sharon Boehringer sharon.broderick@b

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.

Inc.

Inc.
Inc.

Inc.

Inc.

Inc.
Inc.
Closed Friday, 6 Feb CDISC- Erin Muhlbradt CRL muhlbradtee@mail.
2015 12:34 PM 1670 (on behalf of nih.gov
Carol Detrisac)
Open Sunday, 8 Feb CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2015 04:02 PM 1671

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.
Inc.

Inc.
Inc.

Inc.
Closed Friday, 13 Feb CDISC- Steve Kopko CDISC skopko@cdisc.org
2015 03:24 PM 1686
Closed Friday, 13 Feb CDISC- Robert Dempsey CDISC rdempsey@cdisc.or

2015 03:26 PM 1687 g
Closed Friday, 13 Feb CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2015 03:27 PM 1688 behalf of COPD
TA Team)
2015 03:29 PM 1689 behalf of PK
team)
Closed Friday, 13 Feb CDISC- Carol Vaughn Sanofi Carol.Vaughn@san

2015 03:31 PM 1690 ofi.com
Closed Friday, 13 Feb CDISC- Carol Vaughn Sanofi Carol.Vaughn@san

2015 03:31 PM 1691 ofi.com
Open Friday, 20 Feb CDISC- Steve Kopko CDISC skopko@cdisc.org
2015 12:35 PM 1692
Open Friday, 20 Feb CDISC- Steve Kopko CDISC skopko@cdisc.org

2015 12:36 PM 1693
Closed Friday, 20 Feb CDISC- Bess LeRoy C-Path bleroy@c-path.org

2015 12:40 PM 1694
Closed Friday, 20 Feb CDISC- Anna Pron- AstraZeneca anna.pron-
2015 12:42 PM 1695 Zwick Pharmaceuticals zwick@astrazeneca
.com
Closed Friday, 20 Feb CDISC- claire west GSK claire.m.west@gsk.

2015 12:51 PM 1696 com
Closed Friday, 20 Feb CDISC- claire west GSK claire.m.west@gsk.

2015 12:52 PM 1697 com
Open Friday, 20 Feb CDISC- claire west GSK claire.m.west@gsk.

2015 12:53 PM 1698 com
Closed Friday, 20 Feb CDISC- Carol Detrisac CRL muhlbradtee@mail.

2015 12:55 PM 1699 nih.gov
Closed Friday, 20 Feb CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2015 12:57 PM 1700 nih.gov
Open Friday, 20 Feb CDISC- Scott Biogen scott.bahlavooni@bi

2015 12:59 PM 1701 Bahlavooni ogenidec.com
Closed Thursday, 26 CDISC- Daniel DiPrimeo Puma ddiprimeo@pumabi

Feb 2015 06:40 1702 Biotechnology otechnology.com
PM
Closed Thursday, 26 CDISC- Anna Pron- AstraZeneca anna.pron-
Feb 2015 06:42 1703 Zwick Pharmaceuticals zwick@astrazeneca
PM .com
Closed Thursday, 26 CDISC- Sharon Boehringer sharon.broderick@b

Feb 2015 06:45 1704 Broderick Ingelheim oehringer-
PM Pharmaceuticals, ingelheim.com
Inc.

Inc.
Inc.

Inc.
Closed Thursday, 5 CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

Mar 2015 06:47 1708 behalf of the
PM COPD TA team)
Open Thursday, 5 CDISC- Christine UCB christine.fleeman@u

Mar 2015 06:48 1709 Fleeman cb.com
PM
Closed Thursday, 5 CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
Mar 2015 06:50 1710 nih.gov
PM
Mar 2015 06:51 1711 nih.gov
PM
Closed Thursday, 5 CDISC- claire west GSK claire.m.west@gsk.

Mar 2015 06:53 1712 com
PM
Open Thursday, 5 CDISC- Scott Biogen scott.bahlavooni@bi
Mar 2015 06:54 1713 Bahlavooni ogenidec.com
PM
Closed Thursday, 5 CDISC- Carrie Neeley Covance carrie.neeley@cova

Mar 2015 06:57 1714 nce.com
PM

Mar 2015 06:58 1715 nce.com
PM
Closed Thursday, 5 CDISC- Audrey Walker Charles River Audrey.Walker@crl.

Mar 2015 07:00 1716 com
PM
Mar 2015 07:03 1717 com
PM
Open Thursday, 5 CDISC- Barbara Lentz Bayer Healthcare barbara.lentz1@bay

Mar 2015 07:06 1718 er.com
PM

Mar 2015 07:09 1719 er.com
PM
Mar 2015 07:11 1720 er.com
PM
Closed Thursday, 5 CDISC- Scott Biogen scott.bahlavooni@bi

Mar 2015 07:14 1721 Bahlavooni ogenidec.com
PM
Open Thursday, 5 CDISC- Beatrice Chiu Illumina bchiu@illumina.com

Mar 2015 07:16 1722
PM
Closed Thursday, 5 CDISC- Beatrice Chiu Illumina bchiu@illumina.com

Mar 2015 07:18 1723
PM
Open Thursday, 5 CDISC- Beatrice Chiu Illumina bchiu@illumina.com
Mar 2015 07:19 1724
PM
Closed Friday, 6 Mar CDISC- veronique Bayer Healthcare veronique.bourcier

2015 11:39 AM 1725 bourcier @bayer.com
Closed Friday, 13 Mar CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2015 10:44 AM 1726 (on behalf of nih.gov
SEND)
Open Friday, 13 Mar CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

Breast Cancer
TA Team)
Breast Cancer
TA Team)
Closed Friday, 13 Mar CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2015 10:50 AM 1729
Open Friday, 13 Mar CDISC- Anna Pron- AstraZeneca anna.pron-
2015 10:54 AM 1730 Zwick Pharmaceuticals zwick@astrazeneca
.com
Closed Friday, 13 Mar CDISC- Debbie O'Neill Merck debra_oneill@merc

2015 10:56 AM 1731 k.com
Closed Friday, 13 Mar CDISC- Anna Pron- AstraZeneca anna.pron-

2015 10:58 AM 1732 Zwick Pharmaceuticals zwick@astrazeneca
.com

2015 11:02 AM 1733 nih.gov

2015 11:04 AM 1734 nih.gov
Closed Friday, 13 Mar CDISC- Janet Siani Shire jsiani@shire.com
2015 11:11 AM 1735

SEND team)

SEND team)

Dyslipidemia TA
team)
SEND team)
Closed Friday, 13 Mar CDISC- Diane Corey Critical Path dcorey@c-path.org

2015 11:20 AM 1740 Institute
Closed Friday, 13 Mar CDISC- Carol Detrisac Charles River Carol.Detrisac@crl.

2015 11:22 AM 1741 com
SEND team)
Closed Friday, 20 Mar CDISC- Bess LeRoy C-path bleroy@c-path.org

2015 11:42 AM 1743

INHAND)
Closed Friday, 20 Mar CDISC- Bernice Yost CDISC byost@cdisc.org

2015 11:45 AM 1745
Closed Friday, 20 Mar CDISC- Debra O'Neill Merck debra_oneill@merc

2015 11:49 AM 1746 k.com
Closed Saturday, 21 CDISC- Erin Muhlbradt MSC muhlbradtee@mail.

Mar 2015 10:49 1747 nih.gov
AM
Closed Friday, 27 Mar CDISC- Debra O'Neill Merck debra_oneill@merc
2015 02:46 PM 1748 k.com
Closed Friday, 27 Mar CDISC- Karin LaPann Theorem Clinical karin.lapann@theor

2015 02:49 PM 1749 Research/ Member emclinical.com
of ADaM Team
Closed Friday, 27 Mar CDISC- Kit Howard CDISC khoward@cdisc.org

2015 02:56 PM 1750
Closed Friday, 27 Mar CDISC- Melanie Paules GSK melanie.a.paules@g

2015 03:03 PM 1751 sk.com
Closed Friday, 27 Mar CDISC- Melanie Paules GSK melanie.a.paules@g

2015 03:12 PM 1752 sk.com
Open Friday, 27 Mar CDISC- Audrey Walker Charles River Audrey.Walker@crl.
2015 03:21 PM 1753 com
Closed Friday, 27 Mar CDISC- Diane Corey C-path dcorey@c-path.org

2015 03:22 PM 1754

2015 03:22 PM 1755
Closed Friday, 27 Mar CDISC- Nicholas Pemble Janssen npemble@its.jnj.co

2015 03:40 PM 1756 m
Open Friday, 27 Mar CDISC- Gbenga Novartis Pharma Gbenga.Ogunsulire
2015 03:42 PM 1757 Ogunsulire @novartis.com
Open Friday, 27 Mar CDISC- Gbenga Novartis Pharma Gbenga.Ogunsulire
Open Friday, 27 Mar CDISC- Scott Biogen scott.bahlavooni@bi

2015 03:44 PM 1759 Bahlavooni ogen.com
Closed Friday, 27 Mar CDISC- Audrey Walker Charles River Audrey.Walker@crl.

2015 03:45 PM 1760 Laboratories com
Closed Thursday, 2 Apr CDISC- Anna Pron- AstraZeneca anna.pron-

.com
Closed Thursday, 2 Apr CDISC- Sharon Boehringer sharon.broderick@b

Inc.

Inc.

Inc.
Inc.

Inc.
Inc.
Inc.

Inc.
Closed Thursday, 2 Apr CDISC- claire west GSK claire.m.west@gsk.

2015 07:26 PM 1770 com
Closed Thursday, 2 Apr CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2015 07:27 PM 1771
Closed Thursday, 2 Apr CDISC- Bob Dempsey CDISC rdempsey@cdisc.or

2015 07:29 PM 1772 g
Closed Thursday, 2 Apr CDISC- Joyce Joyce Hernandez joyce.hernandez_00

2015 07:31 PM 1773 Hernandez Consulting Inc. 29@yahoo.com
Closed Thursday, 2 Apr CDISC- Dana Booth CDISC dbooth@cdisc.org

2015 07:32 PM 1774
Closed Friday, 3 Apr CDISC- Bernice Yost CDISC byost@cdisc.org
2015 12:20 PM 1775

2015 12:20 PM 1776
Closed Friday, 10 Apr CDISC- Bob Dempsey CDISC rdempsey@cdisc.or

2015 11:17 AM 1777 g
Closed Friday, 10 Apr CDISC- Carsten Junge Ferring Consultant.Carsten.

2015 11:19 AM 1778 Pedersen Pharmaceuticals Pedersen@ferring.c
A/S om
Closed Friday, 10 Apr CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2015 11:20 AM 1779
Closed Friday, 10 Apr CDISC- Colleen Bonjo Merck colleen_bonjo@mer

2015 11:22 AM 1780 ck.com
Closed Friday, 10 Apr CDISC- Sharon Boehringer sharon.broderick@b

2015 11:25 AM 1781 Broderick Ingelheim oehringer-
Inc.

Inc.
Inc.

Inc.
Closed Friday, 10 Apr CDISC- Colleen Bonjo Merck colleen_bonjo@mer

2015 11:30 AM 1785 ck.com
Closed Friday, 10 Apr CDISC- Gloria Jones Johnson and gjones38@its.jnj.co

2015 11:33 AM 1786 Johnson m
Closed Friday, 10 Apr CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2015 11:36 AM 1787 nih.gov

2015 11:37 AM 1788 (on behalf of the nih.gov
Lab team)

2015 11:38 AM 1789 nih.gov
Open Thursday, 16 CDISC- Debbie O'Neill CDISC debra_oneill@merc

Apr 2015 03:47 1790 k.com
PM
Open Thursday, 16 CDISC- Debbie O'Neill CDISC debra_oneill@merc
Apr 2015 03:47 1791 k.com
PM
Closed Thursday, 16 CDISC- JOrdan Li (on NCI EVS jordan.li@nih.gov

Apr 2015 03:49 1792 behalf of the
PM DKD TA team)

Apr 2015 03:50 1793 (on behalf of nih.gov
PM INHAND)

Apr 2015 03:52 1794 (on behalf of nih.gov
PM INHAND)
Closed Thursday, 16 CDISC- Frank Baldino ERT fbaldino@ert.com

Apr 2015 03:53 1795
PM
Closed Friday, 17 Apr CDISC- Erin Muhlbradt MSC muhlbradtee@mail.
INHAND)
Closed Thursday, 23 CDISC- Bernice Yost CDISC byost@cdisc.org

Apr 2015 05:36 1797
PM

Apr 2015 05:38 1798
PM
Closed Thursday, 23 CDISC- Manu Horas AstraZeneca manu.horas@astraz

Apr 2015 05:42 1799 eneca.com
PM
Closed Thursday, 23 CDISC- Manu Horas AstraZeneca manu.horas@astraz
Apr 2015 05:44 1800 eneca.com
PM
Closed Thursday, 23 CDISC- Beatrice Chiu Illumina bchiu@illumina.com

Apr 2015 05:47 1801
PM
Closed Thursday, 23 CDISC- Diane Wold CDISC diane.wold@cdisc.o

Apr 2015 05:50 1802 rg
PM
Open Thursday, 23 CDISC- Sharon Boehringer sharon.broderick@b

Apr 2015 05:53 1803 Broderick Ingelheim oehringer-
Inc.

Apr 2015 05:56 1804 (on behalf of the nih.gov
PM BrCa TA Team)
Open Thursday, 23 CDISC- claire west GSK claire.m.west@gsk.
Apr 2015 05:59 1805 com
PM
Closed Friday, 1 May CDISC- Amy Klopman Genentech, a klopman.amy@gen

2015 12:56 PM 1806 member of the e.com
Roche group
Closed Friday, 1 May CDISC- Amy Klopman Genentech, a klopman.amy@gen

2015 12:57 PM 1807 member of the e.com
Roche group
Closed Friday, 1 May CDISC- Adam Fleet adamfleet@datama

2015 12:58 PM 1808 gik.co.uk
Closed Friday, 1 May CDISC- Anita Umesh Illumina aumesh@illumina.c
2015 01:03 PM 1809 om
Closed Friday, 1 May CDISC- Anna Pron- AstraZeneca anna.pron-

.com
Closed Friday, 1 May CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Open Friday, 1 May CDISC- Sharon Boehringer sharon.broderick@b
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Closed Friday, 1 May CDISC- Thomas Novartis thomas.eggmann@
2015 02:56 PM 1831 Eggmann novartis.com
Closed Friday, 1 May CDISC- Debbie O'Neill Merck debra_oneill@merc

2015 02:58 PM 1832 k.com
Closed Friday, 1 May CDISC- Manu Horas Astrazeneca manu.horas@astraz

2015 02:59 PM 1833 eneca.com
Closed Friday, 1 May CDISC- Anna Pron- AstraZeneca anna.pron-

.com
Closed Friday, 1 May CDISC- Diane Wold CDISC diane.wold@cdisc.o
2015 03:08 PM 1835 rg

May 2015 1836 behalf of the
04:13 PM COPD TA team)

May 2015 1837 Zwick Pharmaceuticals zwick@astrazeneca
04:15 PM .com
Closed Thursday, 7 CDISC- Nicholas Pemble npemble@its.jnj.co

May 2015 1838 m
04:17 PM
Open Thursday, 7 CDISC- Scott Biogen scott.bahlavooni@bi

May 2015 1839 Bahlavooni ogen.com
04:19 PM

May 2015 1840 Broderick Ingelheim oehringer-
04:26 PM Pharmaceuticals, ingelheim.com
Inc.
May 2015 1841 Broderick Ingelheim oehringer-
04:27 PM Pharmaceuticals, ingelheim.com
Inc.
Closed Friday, 8 May CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2015 12:11 PM 1842
Closed Thursday, 14 CDISC- Audrey Walker Charles River audrey.walker@crl.c

May 2015 1843 om
05:47 PM
Open Thursday, 14 CDISC- Audrey Walker Charles River audrey.walker@crl.c
May 2015 1844 om
05:48 PM
Closed Thursday, 14 CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell
May 2015 1845 as.com
05:50 PM
Open Thursday, 14 CDISC- Lacey Wallace Eli Lilly and wallace_lacey_m@li

May 2015 1846 Company lly.com
05:52 PM
Closed Friday, 15 May CDISC- Manu Horas AstraZeneca manu.horas@astraz

2015 11:50 AM 1847 Pharmaceuticals eneca.com
Closed Friday, 15 May CDISC- Manu Horas AstraZeneca manu.horas@astraz

2015 11:51 AM 1848 Pharmaceuticals eneca.com
Closed Friday, 22 May CDISC- Scott Biogen scott.bahlavooni@bi

2015 11:13 AM 1849 Bahlavooni ogen.com
Closed Friday, 22 May CDISC- Bernice Yost CDISC byost@cdisc.org

2015 11:15 AM 1850
2015 11:16 AM 1851
Closed Friday, 22 May CDISC- Madhu Kumar NOVUM PRS mkkomuravelli@nov

2015 11:18 AM 1852 Komuravelli umprs.com
Closed Friday, 22 May CDISC- Nik Pemble Janssen npemble@its.jnj.co

2015 11:19 AM 1853 m
Closed Friday, 29 May CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

Breast Cancer
Team)
2015 10:15 AM 1855

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.
Closed Friday, 29 May CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell

2015 12:00 PM 1862 as.com

Inc.

Inc.
Nick Sioutos)
Open Friday, 29 May CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
CDISC oncology
team)
Open Friday, 5 Jun CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Closed Friday, 5 Jun CDISC- Sharon Boehringer sharon.broderick@b
Inc.

Inc.
Inc.

Inc.

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Closed Friday, 5 Jun CDISC- Carrie Neeley Covance carrie.neeley@cova
2015 09:47 AM 1880 Laboratories nce.com
Open Friday, 5 Jun CDISC- Bernice Yost CDISC byost@cdisc.org

2015 09:49 AM 1881
Closed Friday, 5 Jun CDISC- Bernice Yost CDISC byost@cdisc.org

2015 09:55 AM 1882
Closed Friday, 5 Jun CDISC- Linda Barrett Amgen barrettl@amgen.co
2015 09:57 AM 1883 m
Open Friday, 5 Jun CDISC- Linda Barrett Amgen barrettl@amgen.co

2015 09:59 AM 1884 m
Closed Friday, 5 Jun CDISC- claire west GSK claire.m.west@gsk.
2015 10:20 AM 1885 com
Closed Friday, 5 Jun CDISC- Bernice Yost CDISC byost@cdisc.org

2015 10:22 AM 1886

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.

Inc.
Inc.

Inc.
Inc.

Inc.
Inc.

Inc.

Inc.

Inc.
Closed Friday, 5 Jun CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2015 11:02 AM 1911 nih.gov

Oncology team)
Closed Monday, 8 Jun CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2015 03:44 PM 1913

SEND)

SEND)
Inc.

Inc.
Inc.
Inc.

Inc.
Inc.
Closed Friday, 12 Jun CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2015 10:43 AM 1922
Closed Friday, 12 Jun CDISC- Carrie Neeley Covance Labs carrie.neeley@cova

2015 10:48 AM 1923 nce.com
Closed Friday, 12 Jun CDISC- Carrie Neeley Covance Labs carrie.neeley@cova

2015 10:49 AM 1924 nce.com
Closed Friday, 12 Jun CDISC- Audrey Walker CRL Audrey.Walker@crl.

2015 10:50 AM 1925 com

2015 10:51 AM 1926
Closed Friday, 12 Jun CDISC- Nik Pemble Janssen npemble@its.jnj.co

2015 10:54 AM 1927 m
Inc.

Inc.
Closed Friday, 19 Jun CDISC- Lacey Wallace Lilly wallace_lacey_m@li

2015 11:15 AM 1930 lly.com
Closed Friday, 19 Jun CDISC- Bess LeRoy C-path bleroy@c-path.org

2015 11:19 AM 1931

2015 11:35 AM 1932

2015 11:53 AM 1933

2015 11:55 AM 1934
2015 11:57 AM 1935
2015 11:57 AM 1936
2015 11:59 AM 1937
Closed Friday, 19 Jun CDISC- Brian Argo MPI Research, Inc. brian.argo@mpirsea
2015 12:00 PM 1938 rch.com
Closed Friday, 19 Jun CDISC- Linda Barrett Amgen barrettl@amgen.co

2015 12:03 PM 1939 m
Closed Friday, 19 Jun CDISC- Catherine Roy Merck Research catherine.roy@merc

2015 12:04 PM 1940 Laboratories k.com
Closed Friday, 19 Jun CDISC- Audrey Walker Charles River audrey.walker@crl.c

2015 12:28 PM 1941 om

2015 12:29 PM 1942 nih.gov
Closed Friday, 19 Jun CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov
Oncology Team)
Closed Friday, 26 Jun CDISC- Mihaela Simion Genzyme, a Sanofi mihaela.simion@ge

2015 03:51 PM 1944 company nzyme.com

Open Friday, 26 Jun CDISC- Mihaela Simion Genzyme, a Sanofi mihaela.simion@ge

Open Friday, 26 Jun CDISC- Mihaela Simion Genzyme, a Sanofi mihaela.simion@ge

Closed Friday, 26 Jun CDISC- Joyce JHC joyce.hernandez_00
2015 03:56 PM 1949 Hernandez 29@yahoo.com

2015 03:58 PM 1950 nih.gov

2015 03:59 PM 1951 nih.gov
Open Friday, 26 Jun CDISC- Ellen J. Schatz Eli Lilly schatz_ellen_j@lilly.
2015 04:01 PM 1952 com
Closed Friday, 26 Jun CDISC- Julie Dzierzynski Premier Research julie.dzierzynski@ho
2015 04:03 PM 1953 tmail.com
Open Friday, 26 Jun CDISC- claire west GSK claire.m.west@gsk.

2015 04:05 PM 1954 com
Closed Friday, 26 Jun CDISC- Steve Kpoko CDISC skopko@cdisc.org

2015 04:07 PM 1955
Closed Friday, 26 Jun CDISC- Mary Jo Brucker Merck mj.brucker@merck.

2015 04:09 PM 1956 com

2015 04:11 PM 1957 com
2015 04:12 PM 1958 com
Closed Thursday, 2 Jul CDISC- Diane Corey Critical Path dcorey@c-path.org

2015 10:39 AM 1959 Institute
Closed Thursday, 2 Jul CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

PGx team)
Closed Thursday, 2 Jul CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Closed Thursday, 2 Jul CDISC- Brian Argo MPI Research brian.argo@mpirsea

2015 11:32 AM 1962 rch.com

2015 11:32 AM 1963 rch.com

2015 11:37 AM 1964 rch.com
Closed Thursday, 2 Jul CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2015 11:57 AM 1965
Closed Friday, 10 Jul CDISC- Simon Lebeau Danone Research simon.lebeau@ivida
2015 12:18 PM 1966 ta.com
Closed Friday, 10 Jul CDISC- Simon Lebeau Danone Research simon.lebeau@ivida

2015 12:19 PM 1967 ta.com
Closed Friday, 10 Jul CDISC- Sharon Boehringer sharon.broderick@b

Inc.

Inc.
Closed Friday, 10 Jul CDISC- Christine n/a christine.connolly@t

2015 12:23 PM 1970 Connolly akeda.com
Closed Friday, 10 Jul CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

SEND)
Open Friday, 10 Jul CDISC- Julie Dzierzynski Premier Research julie.dzierzynski@pr

2015 12:26 PM 1972 emier-research.com
Open Friday, 10 Jul CDISC- Osamu Kotera Kyowa Hakko Kirin osamu.koter@kyow
2015 12:27 PM 1973 Co.,Ltd a-kirin.co.jp
Open Friday, 10 Jul CDISC- Claire West GSK claire.m.west@gsk.
2015 12:28 PM 1974 com
Open Friday, 10 Jul CDISC- Debbie O'Neill Merck debra_oneill@merc

2015 12:30 PM 1975 k.com
Closed Friday, 10 Jul CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2015 12:31 PM 1976
Closed Friday, 10 Jul CDISC- Osamu Kotera Kyowa Hakko Kirin osamu.kotera@kyo
2015 12:32 PM 1977 Co.,Ltd wa-kirin.co.jp

Lab and PK CT
teams)
Closed Friday, 10 Jul CDISC- Debbie O'Neill Merck debra_oneill@merc
2015 12:35 PM 1979 k.com

2015 12:36 PM 1980 k.com
Open Friday, 10 Jul CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

Diane Wold)
Closed Friday, 10 Jul CDISC- Michael Amgen mmorozew@amgen
2015 12:40 PM 1982 Morozewicz .com
Closed Friday, 10 Jul CDISC- Michael Amgen mmorozew@amgen

2015 12:41 PM 1983 Morozewicz .com
Closed Friday, 10 Jul CDISC- Erin (on behalf NCI EVS muhlbradtee@mail.
2015 12:42 PM 1984 of SEND Repro) nih.gov
Closed Friday, 10 Jul CDISC- claire west GSK claire.m.west@gsk.

2015 12:43 PM 1985 com
Closed Friday, 10 Jul CDISC- Gary Walker Quintiles gary.walker@quintil

2015 12:44 PM 1986 es.com
2015 11:19 AM 1987 nih.gov
Closed Friday, 17 Jul CDISC- Bob Dempsey CDISC rdempsey@cdisc.or

2015 12:04 PM 1988 (on behalf of g
Bernice Yost)
Closed Friday, 17 Jul CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell
2015 12:05 PM 1989 as.com
Closed Friday, 17 Jul CDISC- Anita Umesh Illumina, Inc. aumesh@illumina.c

2015 12:08 PM 1990 om

2015 12:10 PM 1991 om

2015 12:11 PM 1992 om
2015 12:12 PM 1993 om

2015 12:13 PM 1994 om

2015 12:13 PM 1995 om

2015 12:14 PM 1996 om

2015 12:15 PM 1997 om
2015 12:15 PM 1998 om

2015 12:16 PM 1999 om

2015 12:16 PM 2000 om
Closed Friday, 17 Jul CDISC- Bernice Yost CDISC byost@cdisc.org

2015 12:17 PM 2001

Oncology team)
Closed Friday, 24 Jul CDISC- Bess LeRoy C-path bleroy@c-path.org

2015 12:39 PM 2003
Closed Friday, 24 Jul CDISC- claire west GSK claire.m.west@gsk.
2015 03:38 PM 2004 com
Open Friday, 24 Jul CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

Carol Detrisac
for SEND)
Closed Friday, 24 Jul CDISC- Audrey Walker Charles River Audrey.Walker@crl.
2015 03:43 PM 2006 com
Closed Friday, 24 Jul CDISC- Colleen Bonjo Merck colleen_bonjo@mer

2015 03:44 PM 2007 ck.com
Closed Friday, 24 Jul CDISC- Colleen Bonjo Merck colleen_bonjo@mer

2015 03:45 PM 2008 ck.com
Closed Friday, 24 Jul CDISC- Bernice Yost CDISC byost@cdisc.org

2015 03:46 PM 2009
Open Friday, 24 Jul CDISC- Sharon Boehringer sharon.broderick@b

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.
Inc.
Inc.
Closed Friday, 24 Jul CDISC- Anna Pron- AstraZeneca anna.pron-
2015 03:55 PM 2018 Zwick zwick@astrazeneca
.com
Open Friday, 24 Jul CDISC- Anna Pron- AstraZeneca anna.pron-

.com

.com

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.
Closed Friday, 31 Jul CDISC- Diane Corey Critical Path dcorey@c-path.org

2015 12:13 PM 2029 Institute
Open Friday, 31 Jul CDISC- Steve Kopko CDISC skopko@cdisc.org

2015 12:15 PM 2030
.com

.com

Aug 2015 10:15 2033 behalf of the
AM Virology Team)

Aug 2015 01:36 2034 Broderick Ingelheim oehringer-
Inc.

Inc.
Open Thursday, 6 CDISC- Carrie Neeley Covance carrie.neeley@cova

Aug 2015 01:38 2036 nce.com
PM
Aug 2015 01:39 2037 (On behalf of the nih.gov
PM BrCa TA Team)
Aug 2015 01:40 2038
PM

Aug 2015 01:42 2039 nih.gov
PM
Open Thursday, 6 CDISC- Anna Pron- AstraZeneca anna.pron-

Aug 2015 01:43 2040 Zwick Pharmaceuticals zwick@astrazeneca
PM .com
Open Thursday, 6 CDISC- Anna Pron- AstraZeneca anna.pron-

PM .com

PM .com
Inc.
Open Thursday, 6 CDISC- Janet Siani Shire jsiani@shire.com

Aug 2015 05:33 2044
PM
Closed Thursday, 6 CDISC- Janet Siani Shire jsiani@shire.com

Aug 2015 05:34 2045
PM
Closed Friday, 14 Aug CDISC- Beatrice Chiu Illumina bchiu@illumina.com

2015 01:41 PM 2046
Closed Friday, 14 Aug CDISC- Bernice Yost CDISC byost@cdisc.org

2015 01:42 PM 2047
Closed Friday, 14 Aug CDISC- Audrey Walker Audrey.Walker@crl.

2015 01:43 PM 2048 com
Closed Friday, 14 Aug CDISC- Jozef Aerts University of Applied Jozef.Aerts@fh-

2015 01:45 PM 2049 Sciences FH joanneum.at
Joanneum, Graz,
Austria
Closed Friday, 14 Aug CDISC- Sanofi Devi.Gohimukkula@

2015 01:46 PM 2050 sanofi.com
Open Friday, 14 Aug CDISC- Dana Booth CDISC dbooth@cdisc.org

2015 01:47 PM 2051
Closed Friday, 14 Aug CDISC- Dana Booth CDISC dbooth@cdisc.org
2015 01:48 PM 2052
Closed Friday, 14 Aug CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

QRS team)
Closed Friday, 14 Aug CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

Jozef Aerts)
Closed Thursday, 20 CDISC- Julie Ann Hood Frontier Science hood@fstrf.org

Aug 2015 10:51 2055 Technology and
AM Research
Foundation, Inc.

Aug 2015 10:54 2056 nih.gov
AM
Closed Thursday, 20 CDISC- Audrey Walker Audrey.Walker@crl.
Aug 2015 10:56 2057 com
AM
Open Thursday, 20 CDISC- Carrie Neeley Covance carrie.neeley@cova

Aug 2015 11:00 2058 nce.com
AM
Closed Thursday, 20 CDISC- Debbie O'Neill Merck debra_oneill@merc
Aug 2015 11:02 2059 k.com
AM
Closed Thursday, 20 CDISC- Gitte Frausing Data Standards gfrausing@datastan

Aug 2015 11:08 2060 Decisions dardsdecisions.com
AM
Closed Thursday, 20 CDISC- Ben Sefing Merck benjamin_sefing@m

Aug 2015 11:10 2061 erck.com
AM

Aug 2015 11:11 2062 nih.gov
AM

AM Pharmaceuticals, ingelheim.com
Inc.
Closed Thursday, 27 CDISC- Bob Dempsey CDISC rdempsey@cdisc.or

Aug 2015 08:13 2064 g
PM

Aug 2015 08:16 2065
PM
Aug 2015 08:17 2066
PM

Aug 2015 08:18 2067
PM
Closed Friday, 28 Aug CDISC- Gitte Frausing Data Standards gfrausing@datastan

2015 09:57 AM 2068 Decisions dardsdecisions.com
Open Friday, 28 Aug CDISC- Debbie O'Neill Merck debra_oneill@merc

2015 11:51 AM 2069 k.com
Closed Wednesday, 2 CDISC- Jozef Aerts Jozef.Aerts@fh-

Sep 2015 08:40 2070 joanneum.at
PM
Closed Wednesday, 2 CDISC- Sharon Boehringer sharon.broderick@b
Sep 2015 08:41 2071 Broderick Ingelheim oehringer-
Inc.

Inc.
Open Wednesday, 2 CDISC- Sharon Boehringer sharon.broderick@b

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.

Inc.

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.
Inc.

Inc.

Inc.
Inc.
Inc.

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.

Inc.

Inc.
Inc.
Inc.

Inc.

Inc.
Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.

Inc.
Inc.

Inc.
Closed Wednesday, 2 CDISC- Bernice Yost CDISC byost@cdisc.org
Sep 2015 10:00 2133
PM
Sep 2015 10:01 2134
PM
Sep 2015 10:02 2135
PM
Closed Thursday, 3 CDISC- in Muhlbradt (on MSC muhlbradtee@mail.

Sep 2015 11:34 2136 behal of Repro nih.gov
AM team)
Closed Friday, 4 Sep CDISC- Erin Muhlbradt MSC muhlbradtee@mail.

Oncology team)

BrCa TA team)
Closed Tuesday, 8 Sep CDISC- Erin Muhlbradt MSC muhlbradtee@mail.
SEND Repro
Team)
Open Thursday, 10 CDISC- Bernice Yost CDISC byost@cdisc.org
Sep 2015 05:48 2140
PM
Closed Thursday, 10 CDISC- Marcelina DIcore Group, LLC mhungria@dicoregr

Sep 2015 05:49 2141 Hungria oup.com
PM
Closed Thursday, 10 CDISC- Jozef Aerts Jozef.Aerts@fh-

Sep 2015 05:50 2142 joanneum.at
PM
Open Thursday, 10 CDISC- Debbie O'Neill Merck debra_oneill@merc
Sep 2015 05:52 2143 k.com
PM
Closed Thursday, 10 CDISC- Brandy Harter Instem brandy.harter@inste

Sep 2015 05:54 2144 m.com
PM
Open Friday, 11 Sep CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Open Friday, 11 Sep CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Closed Friday, 11 Sep CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Inc.

Inc.
Inc.

Inc.
Inc.

Inc.
Closed Friday, 11 Sep CDISC- Debbie O'Neill Merck debra_oneill@merc

2015 12:04 PM 2154 k.com

2015 12:05 PM 2155 k.com
Open Friday, 11 Sep CDISC- Bernice Yost CDISC byost@cdisc.org
2015 12:08 PM 2156
Open Friday, 11 Sep CDISC- Anita Umesh Illumina, Inc. aumesh@illumina.c

2015 12:09 PM 2157 om
Closed Thursday, 17 CDISC- Rene CDISC rdahlheimer@cdisc.

Sep 2015 06:17 2158 Dahlheimer org
PM

Sep 2015 06:19 2159 nce.com
PM

Sep 2015 06:20 2160 nce.com
PM
Closed Thursday, 17 CDISC- Colleen Bonjo Merck colleen_bonjo@mer

Sep 2015 06:21 2161 ck.com
PM

Sep 2015 06:21 2162 ck.com
PM
Open Thursday, 17 CDISC- Colleen Bonjo Merck colleen_bonjo@mer

Sep 2015 06:22 2163 ck.com
PM
Sep 2015 06:23 2164 ck.com
PM
Closed Thursday, 17 CDISC- Bob Dempsey CDISC rdempsey@cdisc.or
Sep 2015 06:25 2165 g
PM
Open Friday, 18 Sep CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

SEND NV team)

Sep 2015 09:18 2167
PM
Sep 2015 09:20 2168 k.com
PM
Closed Thursday, 24 CDISC- Lou Florio Purdue Pharma LP lou.florio@pharma.c

Sep 2015 09:21 2169 om
PM
Closed Thursday, 24 CDISC- Jasmine Ho PMI RL PTE LTD jasmine.ho@pmi.co
Sep 2015 09:23 2170 m
PM
Closed Thursday, 24 CDISC- Mihaela Simion Sanofi mihaela.simion@ge

Sep 2015 09:25 2171 nzyme.com
PM
Closed Thursday, 24 CDISC- Jozef Aerts University of Applied Jozef.Aerts@fh-

Sep 2015 09:27 2172 Sciences FH joanneum.at
PM Joanneum, Graz,
Austria
Sep 2015 09:28 2173 (on behalf of nih.gov
PM Lab team)

PM Lab team)

PM Lab team)

Sep 2015 09:31 2176 ck.com
PM
Closed Friday, 2 Oct CDISC- Dana Booth cdisc dbooth@cdisc.org

2015 01:41 PM 2177
Closed Friday, 2 Oct CDISC- Debbie O'Neill Merck debra_oneill@merc
2015 01:43 PM 2178 k.com
Closed Friday, 2 Oct CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

SEND team)

SEND team)
Closed Friday, 2 Oct CDISC- John Covance john.swithenbank@
2015 01:48 PM 2181 Swithenbank covance.com

2015 01:54 PM 2182 k.com

BrCa TA team)

2015 02:01 PM 2184 nih.gov
Closed Friday, 9 Oct CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Closed Friday, 9 Oct CDISC- Sharon Boehringer sharon.broderick@b
Inc.
Closed Friday, 9 Oct CDISC- Colleen Bonjo Merck colleen_bonjo@mer
2015 12:20 PM 2187 ck.com

2015 12:21 PM 2188 ck.com
Closed Friday, 9 Oct CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

DKD TA team)
Closed Friday, 9 Oct CDISC- Audrey Walker Charles River Audrey.Walker@crl.
2015 12:22 PM 2190 com
Closed Friday, 9 Oct CDISC- Bob Dempsey CDISC rdempsey@cdisc.or
2015 12:23 PM 2191 (on behalf of g
Bernice Yost)
Open Friday, 16 Oct CDISC- Olga VOVK NIH/CIT/BRICS/ olga.vovk@nih.gov
2015 08:23 AM 2192 FITBIR
Closed Friday, 16 Oct CDISC- Gary Walker Quintiles gary.walker@quintil

2015 08:24 AM 2193 es.com
Closed Friday, 16 Oct CDISC- Bernice Yost CDISC byost@cdisc.org

2015 08:25 AM 2194
Open Friday, 16 Oct CDISC- Mihaela Simion Genzyme, a Sanofi Mihaela.Simion@ge

2015 08:25 AM 2195 company nzyme.com
Open Friday, 16 Oct CDISC- Mihaela Simion Genzyme, a Sanofi Mihaela.Simion@ge

2015 08:26 AM 2196 company nzyme.com
Open Friday, 16 Oct CDISC- Lauren AbbVie, Inc. lauren.shinaberry@
2015 08:27 AM 2197 Shinaberry abbvie.com
Closed Friday, 16 Oct CDISC- Lauren AbbVie, Inc. lauren.shinaberry@
2015 08:27 AM 2198 Shinaberry abbvie.com

2015 08:28 AM 2199 ck.com
Closed Friday, 16 Oct CDISC- Erin Muhlbradt MSC muhlbradtee@mail.

Oncology team)

2015 12:44 PM 2201 nih.gov

2015 11:29 AM 2202 ck.com
Open Friday, 23 Oct CDISC- Mary Jo Brucker Merck mj.brucker@merck.

2015 11:30 AM 2203 com
Closed Friday, 23 Oct CDISC- Amy Palmer CDISC apalmer@cdisc.org

2015 11:31 AM 2204
Open Friday, 23 Oct CDISC- Linda Barrett Amgen barrettl@amgen.co
2015 11:32 AM 2205 m

Repro team)
2015 11:34 AM 2207 k.com

2015 11:35 AM 2208 k.com
2015 02:40 PM 2209 k.com

2015 02:45 PM 2210 k.com

2015 02:47 PM 2211 k.com
Closed Friday, 30 Oct CDISC- Bess Leroy C-path bleroy@c-path.org

2015 12:59 PM 2212
2015 01:00 PM 2213
Open Friday, 30 Oct CDISC- Bess Leroy C-path bleroy@c-path.org

2015 01:01 PM 2214
2015 01:02 PM 2215
Closed Friday, 30 Oct CDISC- Jon Neville C-path jneville@c-path.org
2015 01:03 PM 2216
Closed Friday, 30 Oct CDISC- Jon Neville C-path jneville@c-path.org

2015 01:04 PM 2217
Open Friday, 30 Oct CDISC- Audrey Walker Charles River Audrey.Walker@crl.

2015 01:05 PM 2218 com
Open Thursday, 5 CDISC- Audrey Walker CRL Audrey.Walker@crl.
Nov 2015 04:10 2219 com
PM
Closed Thursday, 5 CDISC- Audrey Walker CRL Audrey.Walker@crl.
Nov 2015 04:12 2220 com
PM
Open Thursday, 5 CDISC- Audrey Walker CRL Audrey.Walker@crl.

Nov 2015 04:14 2221 com
PM
Closed Thursday, 5 CDISC- Bess Leroy C-path bleroy@c-path.org
Nov 2015 04:15 2222
PM
Nov 2015 04:16 2223
PM
Nov 2015 04:16 2224
PM
Nov 2015 04:17 2225
PM

Nov 2015 04:18 2226 k.com
PM

Nov 2015 04:20 2227 Broderick Ingelheim oehringer-
Inc.

Inc.

Inc.

Inc.
Inc.

Inc.
Open Thursday, 5 CDISC- Marna Celgene mterblanche@celge

Nov 2015 04:24 2233 Terblanche ne.com
PM
Closed Friday, 13 Nov CDISC- Bess LeRoy C-path bleroy@c-path.org

2015 12:22 PM 2234
Closed Friday, 13 Nov CDISC- Jasmine Ho PMI Jasmine.Ho@pmi.c
2015 12:24 PM 2235 om
Closed Friday, 13 Nov CDISC- Sharon Boehringer sharon.broderick@b

Inc.

Inc.

Inc.
Open Friday, 13 Nov CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Open Friday, 13 Nov CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Inc.

Inc.

Inc.
Inc.

Inc.

Inc.
Closed Friday, 13 Nov CDISC- Colleen Bonjo Merck colleen_bonjo@mer
2015 12:55 PM 2247 ck.com
Closed Friday, 13 Nov CDISC- Mike Ward Eli Lilly mjward@lilly.com

2015 01:03 PM 2248
Closed Friday, 13 Nov CDISC- Mike Ward Eli Lilly mjward@lilly.com

2015 01:03 PM 2249
Closed Friday, 13 Nov CDISC- MIGLIORE PRA Health miglioremelanie@pr

2015 01:06 PM 2250 Melanie Sciences ahs.com
Closed Friday, 13 Nov CDISC- MIGLIORE PRA Health miglioremelanie@pr

2015 01:07 PM 2251 Melanie Sciences ahs.com
Open Friday, 13 Nov CDISC- claire west GSK claire.m.west@gsk.
2015 01:08 PM 2252 com
Closed Friday, 13 Nov CDISC- Bob Dempsey CDISC rdempsey@cdisc.or

2015 01:09 PM 2253 (for Bernice g
Yost)
Closed Friday, 20 Nov CDISC- Erin Muhlbrad NCI EVS muhlbradtee@mail.
2015 03:13 PM 2254 nih.gov
Closed Friday, 20 Nov CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2015 03:27 PM 2255 nih.gov
Closed Friday, 20 Nov CDISC- Debbie O'Neill Merck debra_oneill@merc

2015 03:28 PM 2256 k.com

2015 03:29 PM 2257 k.com
2015 03:30 PM 2258 k.com

2015 03:30 PM 2259 k.com
Closed Friday, 27 Nov CDISC- Cathy Bezek Astellas cathy.bezek@astell

2015 08:54 AM 2260 as.com
Closed Friday, 27 Nov CDISC- Bob Dempsey CDISC rdempsey@cdisc.or

2015 08:56 AM 2261 (for PK team) g
Closed Friday, 27 Nov CDISC- Bernice Yost CDISC byost@cdisc.org

2015 08:57 AM 2262

2015 08:58 AM 2263

2015 08:59 AM 2264
Open Friday, 27 Nov CDISC- Bernice Yost CDISC byost@cdisc.org

2015 08:59 AM 2265

2015 09:00 AM 2266

2015 09:00 AM 2267

2015 09:01 AM 2268

2015 09:02 AM 2269
Closed Friday, 27 Nov CDISC- Nathan Cognizant ThirumalaiNathan.Si
2015 09:03 AM 2270 Technology Solution varamakrishnan@c
ognizant.com
Closed Friday, 27 Nov CDISC- Thamarai selvan Navitas LLp Thamaraiselvan.pal

2015 09:04 AM 2271 anisamy@navitas.n
et
Closed Friday, 4 Dec CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Closed Friday, 4 Dec CDISC- Manuel Horas AstraZeneca manu.horas@astraz
2015 09:36 AM 2291 eneca.com
Inc.
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.
Open Friday, 4 Dec CDISC- Sharon Boehringer sharon.broderick@b

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.

Inc.

Inc.
Inc.
Inc.

Inc.

Inc.
Inc.
Inc.
Inc.
Inc.
Closed Friday, 11 Dec CDISC- Amy Nelson Novartis amy.nelson@novarti

2015 11:18 AM 2321 Pharmaceuticals s.com
Closed Friday, 11 Dec CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2015 11:19 AM 2322 nih.gov
Closed Friday, 11 Dec CDISC- Debbie Oneill Merck debra_oneill@merc

2015 11:21 AM 2323 k.com
2015 11:22 AM 2324 k.com

2015 11:23 AM 2325 k.com
Closed Friday, 11 Dec CDISC- Peter Schaefer Independent pschaefernet@yaho
2015 11:24 AM 2326 Consultant o.com
Open Thursday, 17 CDISC- Dana Booth CDISC dbooth@cdisc.org

Dec 2015 05:45 2327
PM
Closed Thursday, 17 CDISC- Nancy Brucken inVentiv Health Nancy.Brucken@inv
Dec 2015 06:15 2328 Clinical entivhealth.com
PM
Open Thursday, 17 CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov
Dec 2015 06:21 2329 behalf of the
PM COPD TA team)
Closed Thursday, 17 CDISC- Debbie Oneill Merck debra_oneill@merc

Dec 2015 06:23 2330 k.com
PM
CDISC New Term or Codelist/Existing Term
Request Type
Codelist or Code Number
Modify SEND- Update CDISC Submission Value for

Existing Term STSPRM C49696 to be identical between
C90007 and C67152
Create New Multiple CCCAT CCTESTCD for NSA-16

Codelist
Create New SDTM- Add term to METHOD Codelist

Term METHOD
Modify SDTM- Remove CDISC SY from Existing

Existing Term MICROORG MICROORG codelist Terms
Modify COA-QSCAT C102118 (HAM-A) and C102119

Existing Term (HAMD 21) -> Move from Codelist
Code C100129 (QSCAT) to Codelist
Code C118971 (CCCAT)
Modify SDTM-FRM C42950: CDISC does not have a

Existing Term definition for this concept as long as I
have been working on its terminology,
Probably time to do something about
it.
Create New SEND-SPEC Muscle, Vastus Intermedius
Term
Create New SDTM-LOC Tarsus Joints

Term
Create New SEND- New terms requested for STRAIN

Term STRAIN
Create New SDTM- SE_AUCall SE_AUClast SE_Cmax

Term PKPARM/CD
Modify SDTM- C74714: Slight grammatical error in

Existing Term LBTEST/CD definition
Create New SDTM- Team agreed to add the concept
Term LBTEST/CD Borrelia burgdorferi IgA Antibody on
the team meeting on 2015-01-14. We
just need a request code for this
concept.
Create New SDTM- AG1_5

Term LBTESTCD
Create New SDTM- 1,5-Anhydroglucitol

Term LBTEST
Create New SDTM- APLIGMAB

Term LBTESTCD
Create New SDTM- ARR

Term LBTESTCD
Create New SDTM- Aldosteron Renin ratio

Term LBTEST
Create New SDTM- APLIGGAB

Term LBTESTCD
Create New SDTM- Anti-Phospholipid IgM antibodies

Term LBTEST
Create New SDTM- Anti-Phospholipid IgG antibodies

Term LBTEST
Create New SDTM- CAMP

Term LBTESTCD
Create New SDTM- Cyclic adenosine-monophosphate

Term LBTEST (cAMP)
Create New SDTM- FAI

Term LBTESTCD
Create New SDTM- FAI
Term LBTEST
Create New SDTM- HOMA_B

Term LBTESTCD
Create New SDTM- HOMA-%B

Term LBTEST
Create New SDTM- ICAM

Term LBTESTCD
Create New SDTM- Soluble intracellular adhesion

Term LBTEST molecule
Create New SDTM- ICAM1EIA

Term LBTESTCD
Create New SDTM- Sol. Intracell. Adhes. Mol.1, Serum,

Term LBTEST EIA
Create New SDTM- OSTEOP

Term LBTESTCD
Create New SDTM- Osteopontin, ELISA

Term LBTEST
Create New SDTM- PROTC

Term LBTESTCD
Create New SDTM- Protein C, chromogenic assay

Term LBTEST
Create New SDTM- UBJPROK
Term LBTESTCD
Create New SDTM- Urine Bence-Jones protein, kappa

Term LBTEST
Create New SDTM- UBJPROL

Term LBTESTCD
Create New SDTM- BLD

Term LBTESTCD
Create New SDTM- Blood

Term LBTEST
Create New SDTM- BLTM

Term LBTESTCD
Create New SDTM- Bleeding Time

Term LBTEST
Create New SDTM- RENCLINT

Term PKPARMCD
Create New SDTM- AUCTACUM

Term PKPARMCD
Create New SDTM- Accumulation Ratio AUC from T1 to

Term PKPARM T2
Create New SDTM- LININDX

Term PKPARMCD
Create New SDTM- Linearity index

Term PKPARM
Create New SDTM- Renal CL from T1 to T2
Term PKPARM
Create New Multiple For addition to the FREQ codelist (eg

Term CMDOSFRQ): QHS
Create New Multiple For addition to the FREQ codelist (eg

Term CMDOSFRQ): QAM
Modify SDTM- Per Virology CT team discussion,

Existing Term MICROORG update CDISC DEF for all 'complex'
terms.
Create New SDTM- LBTEST : Urine Bence-Jones protein,
Term LBTEST lambda
Modify SDTM- C103351

Existing Term LBTEST
Modify SDTM- C111317; C74916; C100436;

Existing Term LBTEST C100458
Create New SDTM- Add a new RPTEST to complete the

Term RPTEST set: Number of Early Term Births
Create New SDTM- Split originally requested term of

Term RPTEST 'Miscarriage or Stillbirth' (CDISC-
1531) into two separate items. Add
'Miscarriage Indicator'
Modify SDTM- Update CDISC definitions for the
Existing Term MICROORG following 2 terms
Create New SDTM-LOC WARD'S TRIANGLE
Term
Create New Multiple TBI Standards COA CC Instrument

Codelist Request: Glasgow Coma Scale
(GCS)
Create New NEW FHS CVD 10-YEAR RISK TEST and
Codelist FHS CVD 10-YEAR RISK TESTCD
COA codelists and terms
Modify SDTM-LOC SEND Repro team would like to
Existing Term revise definitions for shared concepts
across SDTM-LOC and SEND-SPEC
to make the published CDISC
definitions less human-centric.
Create New Multiple New MOTESTs and OETESTs based

Term on requirements from the TBI
Standards Team
Create New Multiple TBI Standards Team request for the

Term JFK Coma Recovery Scale Revised
(CRS-R)
Create New SDTM- kg*ng/ml/mg
Term PKUNIT
Create New SDTM- Body Fat Measurement

Term VSTEST
Create New SDTM- CD3-NK and CD3-NK/LY
Term LBTESTCD
Create New SDTM- Please consider adding the attached

Codelist MISTRESC terms.
Create New New APACHE II TEST and APACHE II

Codelist TESTCD codelists and terms for the
CC domain.
Create New SDTM-LOC Addition of 3 new terms to LOC
Term codelist and a question about an
existing term.
Create New SDTM- For TB TA area -
Term SRTEST SRTESTCD=INDURDIA,
SRTEST=Induration Diameter
Create New SDTM- SRTESTCD=BLISTER;

Term SRTESTCD SRTEST=Blistering
Other SDTM- The EGTESTCD, HRMEAN has been
EGTESTCD removed from CDISC/NCI
Terminology. A new term, EGHRMN,
has been added.
Create New SDTM-DIR Add terms to DIR codelsit
Term
Create New SDTM-LOC Add terms to LOC codelsit

Term
Create New Multiple New term + modification of existing

Term term for Codelist "General
Observation Class" maintained in the
SDTM terminology file.
Modify Multiple New term + modification of existing
Existing Term term for Codelist "General
Observation Class" maintained in the
SDTM terminology file.
Create New SDTM- I request following

Term TSPARMCD TSPARMCD/TSPARM new terms
Create New SDTM- AMSLER GRID

Term METHOD
Create New SDTM- ISHIHARA COLOR PLATES

Term METHOD
Create New SDTM- SNELLEN EYE CHART

Term METHOD
Create New New Hi, I want to request a new SDTM
Codelist controlled terminology for Functional
Tests (FT domain).
Create New SDTM- DLCO

Term RETESTCD
Create New SDTM- Diffusing Capacity of the Lung for CO

Term RETEST
Create New SDTM- DLCOM

Term RETESTCD
Create New SDTM- Mean DLCO

Term RETEST
Create New SDTM- DLCOPP
Term RETESTCD
Create New SDTM- Percent Predicted DLCO

Term RETEST
Create New SDTM- DLCOPR

Term RETESTCD
Create New SDTM- Predicted DLCO

Term RETEST
Create New SDTM- FVCPR

Term RETESTCD
Create New SDTM- Predicted FVC

Term RETEST
Create New SDTM- IOSXRS5

Term RETESTCD
Create New SDTM- IOS Reactance at 5 Hz

Term RETEST
Create New SDTM- IOSRRS5

Term RETESTCD
Create New SDTM- IOS Resistance at 5 Hz
Term RETEST
Create New SDTM- RINT

Term RETESTCD
Create New SDTM- Rint

Term RETEST
Create New SDTM- RINTZ

Term RETESTCD
Create New SDTM- Z-Score for Rint

Term RETEST
Modify SEND-SPEC Proposed edits to 127 definition in

Existing Term SEND-SPEC codelist.
Modify Multiple Remove QS-PDQUALIF, YMRS and

Existing Term SOWS SHORT TEST and TESTCD
codelists from publication in P21, but
do not touch CATs.
Create New SDTM- EDV
Term MOTESTCD
Create New SDTM- End diastolic volume
Term MOTEST
Create New SDTM- ESV

Term MOTESTCD
Create New SDTM- End systolic volume

Term MOTEST
Create New SDTM- EF

Term MOTESTCD
Create New SDTM- Ejection Fraction

Term MOTEST
Create New SDTM- MAPSEM

Term MOTESTCD
Create New SDTM- Annulus displacement medial/septal

Term MOTEST
Create New SDTM- MAPSEL

Term MOTESTCD
Create New SDTM- Annulus displacement lateral

Term MOTEST
Create New SDTM- SMV

Term MOTESTCD
Create New SDTM- Systolic medial annular velocity

Term MOTEST
Create New SDTM- LC
Term MOTESTCD
Create New SDTM- Longitudinal contraction

Term MOTEST
Other Multiple Remove QS AVLT Codelist and

replace with FT Rey AVLT codelist
Modify SDTM- Synonym case/capitalization

Existing Term MICROORG change(s)
Other Multiple New term request from COPD TA

team to create new codelists and add
new terms
Create New SDTM- This request is from the PK team.
Term PKPARM/CD Team already reviewed and agreed
to add these terms, we just need to
get a request number.
Create New SDTM-UNIT fmol/mg
Term
Create New SDTM-UNIT mg/mmol

Term
Create New New FAOCCUR, this is for TBI
Codelist
Create New New FAOCCUR, this is for TBI

Term
Create New New Dyslipidemia TA - Need terminology

Codelist for the "Tanner Scale"
Create New SDTM- Galactose Half-Life (with synonym for
Term LBTEST/CD lab test as Galactose Elimination
Capacity)
Modify SDTM- Please change SUBMISSION VALUE

Existing Term EGSTRESC to UPPERCASE for 'BORDERLINE
QTcB' and 'BORDERLINE QTcF'
Other SDTM-UNIT Please clarify use of 'sec' vs 's' for

seconds
Modify SDTM-UNIT Please remove the following terms:

Existing Term mEq/g Creatinine mg/g Creatinine
mmol/g Creatinine mmol/mol
Creatinine U/g Creatinine
Modify SEND-SPEC Review of terms from FORELIMB to

Existing Term LYMPH NODE,
SUPRAPHARYNGEAL by CJD to de-
specify definitions.
Modify SEND- Changes to synonyms for C4326 and
Existing Term NEOPLASM C8559
Create New QS-EDSS Please add ambulation assessment

Term TEST/CD to the EDSS TESTCD/TEST Codelist.
Biogen collects the ambulation
assessment that is part of the EDSS
Score separately.
Create New SDTM- chr3, chr7, chr17, chr9p21, or

Term LBTEST/CD something to that effect, for each of
the tests Chromosome 3,
Chromosome 7, Chromosome 17,
and chromosome 9p21, each tumor
markers in bladder/urinary tract
cancer.
Create New SDTM-UNIT Anson unit
Term
Create New SDTM- IVC

Term RETESTCD
Create New SDTM- Inspiratory Vital Capacity

Term RETEST
Create New SDTM- IVCPP

Term RETESTCD
Create New SDTM- Percent Predicted IVC

Term RETEST
Create New SDTM- Create new terms for BODY BOX

Term RETEST/CD respiratory tests for COPD TA project
Other SDTM-UNIT Review spreadsheet of 26 lab tests

for METHOD and UNIT confirmations.
Create New SDTM-LOC PUPIL / C33429

Term
Create New SDTM-LOC CRANIAL CAVITY / C77638
Term
Modify SDTM- "new' and 'legacy' terminology

Existing Term EGTEST/CD duplication
None SDTM- blood flow question
MOTEST/CD
Create New SEND-SPEC Ear, Canal

Term
Create New SEND- Nude

Term STRAIN
Create New SEND-SPEC TENDON SHEATH

Term
Other SDTM- Please clarify the use of QTAGG and
EGTEST/CD QTC
Modify SDTM- umol/L in PKUNIT

Existing Term PKUNIT
Modify SDTM- Exceeding 41 charaters

Modify SDTM- The Submission Value of umol/L
Existing Term PKUNIT (Code C85756) in PKUNIT (C85494),
should be the same code as in the
UNIT (C76120) codelist for umol/L
(C48508).
Create New SDTM- Please add Deoxyhemoglobin to

Term LBTEST/CD LBTESTCD/LBTEST
Create New None Mayo Scoring System for

Term Assessment of Ulcerative Colitis
Activity
Create New None Psoriasis Area and Severity Index

Term (PASI)
Create New None Crohn's Disease Activity Index (CDAI)
Term
None SDTM-UNIT BEATS/MIN => beats/min

BREATHS/MIN => breaths/min
Modify SEND- C9477. C4049, C4051, C4326; SEND

Existing Term NEOPLASM team to discuss Neoplasms with
'ANAPLASTIC' in the submission
values.
Create New NEW Request for new CC instrument from
Codelist BrCa TA team: Residual Cancer
Burden Index
Create New NEW The BrCa TA team is requesting a

Codelist new CC instrument for the AJCC
TNM Staging system v7.0
Modify SDTM- Modify the QTC terms, should be

Existing Term EGTEST lower case 'c' in these submission
values and synonyms
Create New SDTM- Protein S, Free
Term LBTEST/CD
Create New SDTM- ANAEROBIC GRAM-NEGATIVE

Term MICROORG COCCOBACILLUS;STREPTOCOCC
US MITIS
Create New SDTM- Monocytes

Term SPECTYPE
Create New SDTM- Add term SPERM to SPECTYPE

Term SPECTYPE codelist. This is being requested by
the lab team to support the LBTEST
(or PFTEST?) of DNA Fragmentation
Index, which has already been
submitted.
Modify SDTM- C85744; Request to remove term

Existing Term PKUNIT from PKUNIT codelist. Generally the
analyte information goes elsewhere
and should not be included in the
Unit.
Create New QS-QSCAT QSCAT: C-SSRS
Term PEDIATRIC/COGNITIVELY
IMPAIRED - LIFETIME/RECENT -
CLINICAL Synonym: CSS12 And
QSCAT: C-SSRS
PEDIATRIC/COGNITIVELY
IMPAIRED - SINCE LAST VISIT -
CLINICAL Synonym: CSS13
Modify SDTM- C35708; Update definition. SEND is

Existing Term SPECTYPE using this concept in the SEND-
NONNEO codelist and would like to
propose a definition update based on
input from INHAND (goRENI)
pathologists
Modify SDTM- C25757; Update definition. SEND is

Existing Term PHSPRP using this concept in the SEND-
NONNEO codelist and would like to
propose a definition update based on
input from INHAND (goRENI)
pathologists
Create New SDTM- Please add Apolipoprotein A to the

Term LBTEST/CD LBTEST/LBTESTCD codelist. This
request is made on behalf of the
Dyslipidemia TA team.
Modify Multiple C41372; Update definition
Existing Term
Create New Multiple FCVD1-Framingham CVD 10-Year

Codelist Risk Score
Modify SEND-SPEC Request for modifications to

Existing Term definitions for a subset of the
published terms on the Specimen
codelist.
Modify Multiple C119248
Existing Term
Create New SDTM- 'TB TAUG - Request for two terms:

Term EPOCH INDUCTION TREATMENT,
CONTINUATION TREATMENT
Create New SEND- 'Add 5 terms to SEND-NONNEO

Term NONNEO codelist. This codelist was published
with P21 so is not 'new' anymore.
Create New SDTM- This is a request to get request

Term PKPARM numberds for a new term and to
modify some terms in the
PKPARM/PKPARMCD codelists.
These additions/changes are already
in the spreadsheet.
Create New SDTM- CARDIAC CATHETERIZATION

Term PROCEDUR
Create New SDTM- Create three additional terms for

Term METHOD SDTM-METHOD codelist from work
associated with request number
CDISC-1500
Create New SDTM- Left Ventricular Volume, End-
Term CVEXAM Diastole; LVVOLED; Left Ventricular
Volume, End-Systole; LVVOLES;
Stroke Volume; STROKVOL
Create New NEW ADaM - ENDSTAT . The decodes for

Term ENDSTAT are to be 'COMPLETED' ,
'DISCONTINUED', 'ONGOING'
Create New Multiple LOCDTH, Location of Death, add to

Term DDTESTCD, DDTEST
Modify QS-Borg CR- Change the CDISC submission

Existing Term 10 Scale values from "Borg CR-10 Scale
TESTCD TESTCD" to "Borg CR-10 TESTCD".
Likewise, change "Borg CR-10 Scale
TEST" to "Borg CR-10 TEST"
Modify QS-QSCAT Typo in word VISIT. Change "C-

Existing Term SSRS CHILDREN'S SINCE LAST
VIST" to "C-SSRS CHILDREN'S
SINCE LAST VISIT
Other SEND-SPEC "Remove GLAND, PROSTATE
DORSOLATERAL GLAND,
PROSTATE VENTRAL"
Create New Multiple ASSG01-ASSIGN CVD Risk Score;

Codelist this is for Dyslipidemia
Create New Multiple ASCVD1- ASCVD 10-Year Risk

Codelist Estimator; this is for Dyslipidemia
Create New SDTM- CYCASULP - Calcium Sulphate

Term LBTEST/CD Crystals
Create New SDTM- C Reactive protein Standardized
Term LBTEST Value
Create New SDTM- CRPSTDVL
Term LBTESTCD
Create New SDTM- Please add INTRAVENOUS

Term ROUTE PIGGYBACK
Create New SDTM-UNIT copies/�g

Term
Create New SDTM- Carbohydrate-Deficient

Term LBTEST/CD Transferrin/Total Transferrin
Create New SDTM- LCI

Term RETESTCD
Create New SDTM- Lung Clearning Index

Term RETEST
Create New SDTM- VO2

Term RETESTCD
Create New SDTM- Oxygen Consumption
Term RETEST
Create New SDTM- O2PULSE

Term RETESTCD
Create New SDTM- Oxygen Pulse

Term RETEST
Create New SDTM- RER

Term RETESTCD
Create New SDTM- Respiratory Exchange Ratio

Term RETEST
Modify Multiple Please correct the spelling of

Existing Term classificationn in the following COA
test Names from the latest package
release
Modify SDTM- Update CDISC definition for

Existing Term RSSTRESC C18058/PR
Create New Multiple New Term Request & Changes to

Term Existing - ECG
Create New SDTM- LBTESTCD = CAIONN LBTEST =

Term LBTEST/CD Ionized pH Normalized Calcium
Create New Multiple This is a request to make the PHQ-15

Term terminology consistent with the PHQ-
9 terminology by adding a new Test
Code/Name called PHQ0216
(PHQ02-Total Score)
Modify SDTM-UNIT The PK team would like to request
Existing Term some changes to units that are
shared with the Lab team.
Modify SDTM-UNIT The PK team would like to request a
Existing Term change to the Lab Unit codelist for C-
code C73725.
Modify Multiple COA/CC codelist spelling errors

Existing Term
Modify SDTM- Laboratory Test Name / Code,

Existing Term LBTEST/CD C100425
Create New SDTM- Please create new TEST/CD for

Term LBTEST/CD 'Macrophages/Leukocytes'
Create New New New COA terminology: Brief

Codelist Psychiatric Rating Scale (BPRS)
Create New SDTM- Total Score of Lesions per Subject

Term MOTEST
Create New SDTM- TOTDVU

Term MOTESTCD
Create New SDTM- Total SIJ Score BME
Term MOTEST
Create New SDTM- SUMSIJ2

Term MOTESTCD
Create New New New COA terminology for: Global

Codelist Dystonia Severity Rating Scale
(GDRS)
Other Multiple "FA - C117747, C117738 C117746 -
C117824, C117825, C117826,
C17827, C117828"
Modify SEND- Please to remove the CDISC

Existing Term NEOPLASM synonym Pinealoma from the term
Pineocytoma C6966
Modify SDTM- Please update the definition of FLOW
Existing Term METHOD CYTOMETRY to better differentiate it
from FLOW MICROSCOPY.
Create New Multiple Multiple term request for Oncology

Term team: Add new terms to RSSTRESC
and RSTEST/RSTESTCD codelists.
Create New SDTM- PENICILLIUM

Term MICROORG
Create New SDTM- CTU; MRU
Term METHOD
Other SDTM- Please consider creating the

LBTEST/CD proposed 7 new lab tests to support
DKD TA standards; Also please
consider modifying the existing test
for HOMA-IR
Create New SEND- Request from INHAND for additional
Term NONNEO Female Repro terms - request
submitted to get a request number
only
Create New SEND- Add three terms to NONNEO
Term NONNEO codelist: Hydromyelia; Syringomyelia;
Syringomyelia/Hydromyelia. These
terms were on hold with INHAND
organ working group and have been
okay'd to be added to NONNEO.
Create New SDTM-EVAL Requesting that the term

Term CARDIOLOGIST be added to either
the Evaluator or Medical Evaluator
codelist.
Create New SEND- Multiple term request containing ~25
Term NEOPLASM new terms and 4 changes to existing
term.
Create New SDTM- FVC6 Forced Vital Capacity in 6

Term RETEST/CD Seconds The volume of gas or air
that can be forcibly exhaled during
the first six seconds following
maximal inhalation.
Modify SDTM- Modify Concepts in the RETEST/CD
Existing Term RETEST/CD codelists
Create New SDTM- Percent Predicted FRC (Functional

Term RETEST/CD residual capacity)
Create New SDTM-UNIT 1/(sec x kPa)
Term
Modify Multiple For the "Anatomical Location" and

Existing Term "Specimen Type" codelists, would
you add "Whole Blood" as a synonym
of "BLOOD"?
Modify SDTM-UNIT Change DEFs for UNITs
Existing Term
Create New COA-CCCAT Histopathology

Term
Modify SDTM- SAXIS/Short Axis vs LPERP/Longest

Existing Term TRTEST Perpendicular
Other Multiple Clarity on lowercase words in Title
case sentences
Create New SDTM- VSTEST = Bioimpedance,

Term VSTEST/CD VSTESTCD = BMPDNC
Create New SDTM- VSTEST = Basal Metabolic Rate,

Term VSTEST/CD VSTESTCD = BMR
Create New SDTM- PaO2/FiO2 Ratio

Term RETEST/CD
Other SDTM- MITEST>Knodell Fibrosis Score (and
MITEST/CD perhaps other liver disease-related
scores in the MITEST codelist eg.
Ishak, Metavir, etc...?)
Create New SDTM-UNIT Absorbance Units per Milliliter

Term
Create New SDTM- Epidermis

Term SPECTYPE
Create New SDTM- Dermis

Term SPECTYPE
Create New SDTM- K16K

Term MITESTCD
Create New SDTM- K16 Positive Keratinocytes

Term MITEST
Create New SDTM- LCN2K

Term MITESTCD
Create New SDTM- Lipocalin-2 in Keratinocytes

Term MITEST
Create New SDTM- S100A7K
Term MITESTCD
Create New SDTM- S100-A7 in Keratinocytes

Term MITEST
Create New SDTM- BD2K

Term MITESTCD
Create New SDTM- Beta Defensin 2 in Keratinocyte

Term MITEST
Create New SDTM- KI67K

Term MITESTCD
Create New SDTM- Ki-67 Positive Keratinocytes

Term MITEST
Create New SDTM- CD3T

Term MITESTCD
Create New SDTM- CD3+ T Lymphocytes

Term MITEST
Create New SDTM- CD11D

Term MITESTCD
Create New SDTM- CD11+ Dendritic Cells

Term MITEST
Create New SDTM- CDLAMP

Term MITESTCD
Create New SDTM- CD-LAMP

Term MITEST
Create New SDTM- THICK

Term MITESTCD
Create New SDTM- Thickness
Term MITEST
Create New Multiple Add new terms

Term
Create New SDTM-UNIT um/day; mm3/mm2/year

Term
Create New SDTM-UNIT "g" unit for Movement intensity

Term representation
Create New SDTM- NORMAL FLORA

Term MICROORG
Other SDTM-UNIT Create subsets of the unit code list
based on what property the unit
measures.
Create New Multiple Request to create 14 new concepts

Term for the COPD TA team
Modify SDTM- Streptococcus dysgalactiae

Existing Term MICROORG
Other SDTM- Please consider removing

LBTEST/CD AFACTXAA.
Create New SDTM-UNIT Add "INJECTION" to unit codelist or

Term add "INJECTION" as a synonym for
SYRINGE.
Create New SDTM-UNIT cells/mm

Term
Create New SDTM-UNIT /mm
Term
Create New Multiple Request to create CAT terminology

Term for 19 new COA instruments
Create New SDTM- EGTEST, EGTESTCD QTca:

Term EGTEST/CD Distribution-based rate-correction -
Hank Holzgrefe
Create New SDTM- qPCR/qRT-PCR
Term METHOD
Modify SDTM- HRMED
Existing Term EGTEST/CD
Create New SDTM- Ib/III A safety lead-in for a registration

Term TPHASE trial.
Create New SDTM-UNIT MET

Term
Create New SDTM-UNIT MET min

Term
Create New SDTM-LOC Please add LEPTOMENINGES to

Term LOC
Modify COA-ARC Please remove the following from

Existing Term STC Timing COA: C119106, C119078, C119197,
TEST C119077, C119197
Modify SDTM- C74734 Apolipoprotein B Change
Existing Term LBTEST/CD definition to: A measurement of the
total apolipoprotein B in the low
density lipoproteins of a biological
specimen.
Modify SDTM-FREQ Frequency
Existing Term
Modify SDTM- urine urea nitrogen question

Existing Term LBTEST/CD
Create New Multiple Batch 1 terminology from the CDISC

Term Breast Cancer TA team
Create New SDTM- Submission Value =12 LEAD ECG

Term EGMETHOD DERIVED FROM HOLTER, Synonym
= Holter Extracted ECG, Definition =
A standard duration (typically 10
seconds) 12 lead electrocardiogram
(ECG) extracted from a 12 lead
holter.
Create New SDTM- FEV1REVP

Term RETESTCD
Create New SDTM- Percent FEV1 Reversibility

Term RETEST
Create New SDTM- FEV1REV

Term RETESTCD
Create New SDTM- FEV1 Reversibility
Term RETEST
Create New SDTM- PEFREF

Term RETESTCD
Create New SDTM- PEF Reference Threshold Value

Term RETEST
Modify SDTM- LBTESTCD=HAABIGM /

Existing Term LBTEST/CD LBTEST=Hepatitis A Virus Antibody
IgM
Create New SDTM- BASELINE

Term EPOCH
Create New COA-QSCAT Asthma Monitor ACQ5

Term
Modify SEND- C3738 - Remove all three synonyms.

Existing Term NEOPLASM These are not 1:1 matches anymore.
The nomenclature has been updated
and these are now synonymous with
the 'Intermediate Osteoclastic Giant
Cell-Rich Tumor of Bone' (C121932)
(not published by CDISC).
Modify SDTM- The oncology team would like to
Existing Term REASTINT propose an amendment to the
definition of C48226, which is
currently published in the REASTINT
codelist.
Create New SDTM- BLOOD EDTA

Term SPECTYPE
Create New SDTM- BRAIN

Term SPECTYPE
Create New SDTM- BUFFER

Term SPECTYPE
Create New SDTM- EBC

Term SPECTYPE
Create New SDTM- LIQUOR/PLASMA EDTA

Term SPECTYPE
Create New SDTM- PLASMA CITRATE

Term SPECTYPE
Create New SDTM- PLASMA EDTA

Term SPECTYPE
Create New SDTM- PLASMA EDTA/DPP4 INH

Term SPECTYPE
Create New SDTM- PLASMA EDTA/TRASYLOL

Term SPECTYPE
Create New SDTM- PLASMA HEPARIN

Term SPECTYPE
Create New SDTM- PLASMA LI-HEPARIN
Term SPECTYPE
Create New SDTM- PLASMA NAF

Term SPECTYPE
Create New SDTM- SKIN

Term SPECTYPE
Create New SDTM- Calbindin

Term LBTEST/CD
Modify SDTM- Change the definition for the following

Existing Term VRTEST tests: Diastolic Blood Pressure,
Systolic Blood Pressure
Create New SDTM- Just need a request number

Term EGMETHOD
Create New SDTM- Multiple Term Requests for ECG Test
Term EGTEST/CD name
Create New SDTM- Request is to add "Radiographic

Term METHOD Evaluation" to the codelist for
METHOD.
Modify SDTM- Update Definition for some
Existing Term EGTESTCD AGGREGATE & SINGLE BEAT
EGTESTCD/EGTEST terms
Modify SDTM- Needing request codes for lab tests.

Create New SDTM-LOC Choroid

Term
Create New SDTM-LOC Iris

Term
Create New SDTM-LOC Pupil

Term
Create New SDTM-LOC Retinal pigmented epithelial layer

Term
Create New SDTM-UNIT mL/beat

Term
Create New SDTM- FEF

Term RETESTCD
Create New SDTM- Forced Expiratory Flow
Term RETEST
Create New SDTM- FEV1PR

Term RETESTCD
Create New SDTM- Predicted FEV1

Term RETEST
Create New SDTM- FIV1PR

Term RETESTCD
Create New SDTM- Predicted FIV1

Term RETEST
Create New SDTM- PEFMTH

Term RETESTCD
Create New SDTM- Peak Expiratory Flow Mean
Term RETEST Threshold
Create New SDTM- PFTDR

Term RETESTCD
Create New SDTM- PFT Discontinuation Reason

Term RETEST
Create New SDTM-UNIT mN

Term
Create New SDTM- ALLPLCOR

Term OETESTCD
Create New SDTM- All Plates Read Correctly

Term OETEST
Create New SDTM- LNDISMIS

Term OETESTCD
Create New SDTM- Grid Lines Distorted or Missing

Term OETEST
Create New SDTM- LNSMFONT
Term OETESTCD
Create New SDTM- Line Number Smallest Font Read

Term OETEST
Create New SDTM- NUMPLCOR

Term OETESTCD
Create New SDTM- Number of Plates Correct

Term OETEST
Modify SEND- C3358; Modify definition.

Existing Term NEOPLASM Rhabdomyoma can arise from either
skeletal or cardiac muscle. The
definition should encompass both for
completeness..
Modify SDTM- Retire codelist C96780/Tumor and

Existing Term TUMIDENT Lesion Identification
Results/TUMIDENT and create a new
codelist CNEW/Tumor and Lesion
Identification Test
Results/TUSTRESC. The team
decided that only one results codelist
would be required for this domain.
Create New COA-QSCAT Need a request number for 4 SF-36

Term CAT requests
Create New SEND- Submitting request to get a request

Term DSDECOD number only: SEND team agrees to
add NON-MORIBUND SACRIFICE to
the DSDECOD codelis 2015-05-26
Modify SEND- Just getting a request number.

Existing Term DSDECOD Update definitions and remove
synonyms from C90436, C90445.
Remove synonym from C90465.
Create New SDTM- THERASCREEN
Term METHOD
Create New SDTM- COBAS

Term METHOD
Create New SDTM- AGENA MASSARRAY ONCOCARTA

Term METHOD
Create New SDTM- SNAPSHOT

Term METHOD
Create New SDTM- SANGER SEQUENCING

Term METHOD
Create New SDTM- HIGH RESOLUTION MELT
Term METHOD ANALYSIS
Modify COA-C-SSRS The submission value for C111467 is

Existing Term Screening wrong, should be changed to
TESTCD CSS0904A to be consistent with the
rest
Create New SDTM- Beta-2 Microglobulin/Creatinine

Term LBTEST/CD
Create New SEND-SSTYP Cardiovascular and Respiratory

Term Pharmacology
Create New SDTM- Please consider adding the following

Term LBTEST/CD LBTESTCD and LBTEST: CHCM;
Hemoglobin Concentration Mean CH;
Corpuscular Hemoglobin Content
Modify COA-QSCAT Please update the existing CDISC

Existing Term definition for C103524, OAB-Q
SHORT FORM QSCAT CDISC DEF
Create New SDTM- SERUM/PLASMA

Term SPECTYPE
Create New SDTM- GFRCYCRR
Term LBTESTCD
Create New SDTM- GFR Cystatin C/Creatinine Ratio

Term LBTEST
Modify SDTM- C49606 SDTM Domain Abbreviation

Existing Term DOMAIN PC change "Pharmacokinetic
Concentration" to "Pharmacokinetic
Concentrations".
Create New SDTM- for TB TAUG - Birth Gender

Term SCTEST
Create New New TB TAUG - We need COA

Term terminology/supplement for WHO HIV
Staging -
Create New New TB TAUG - CDC HIV Staging (CC

Term domain)
Create New SDTM- TB TAUG - Mycobacterium

Term LBTEST/CD tuberculosis IgA Antibody
Term LBTEST/CD tuberculosis IgG Antibody
Term LBTEST/CD tuberculosis IgE Antibody
None Multiple TB TAUG - VSTESTCD
=MUAC ;VSTEST = Mid-Upper Arm
Circumference
Create New SEND- Please add "CARDIAC
Term NEOPLASM SCHWANNOMA, MALIGNANT"
Create New SDTM- please add "PULSE OXIMETRY" to

Term METHOD the METHOD code list
Create New Multiple Multiple new terms reuqested

Term
Create New SDTM- vector genome

Term LBTEST/CD
Modify SDTM- C74733; lab team agreed to update

Existing Term LBTEST/CD definition for consistency with all
other Apolipoprotein definitions
Create New Multiple Just need a request number; Request
Term to create new RSTEST of 'MDR
Response' as well as 6 new 'MDR
Response terms' which are in the
RSSTRESC codelist
Create New SDTM-LOC requesting 3 different anatomical
Term locations to be created: DELTOID
MUSCLE; MENINGES; UMBILICAL
CORD
Create New ADaM- TIME MATCHED

Term DTYPE
Create New SDTM- Requesting multiple terms: FIRST

Term EPOCH SCREENING, SECOND
SCREENING, FIRST WASH-OUT,
SECOND WASH-OUT, FIRST RUN-
IN, SECOND RUN-IN, FIRST
TREATMENT, SECOND
TREATMENT, FIRST FOLLOW-UP,
SECOND FOLLOW-UP
Create New SDTM- INTRANODAL

Term ROUTE
Create New SDTM- Requesting multiple terms: ALIVE,
Term NCOMPLT ELIGIBLE, NOT COMPLETED,
INCONVENIENCE OF INJECTION,
POOR COMPLIANCE TO
PROTOCOL, REFUSED FURTHER
TREATMENT, RUN-IN FAILURE
Other New PGx Codelist Spreadsheet based on
IG sent to Erin and Bernice as
baseline.
Create New SEND-SPEC GLAND, LACRIMAL,

Term INTRAORBITAL; GLAND,
LACRIMAL, EXTRAORBITAL
Create New Multiple New TEST terminology codelists for

Codelist PY, FX, and FM domain in SEND.
Create New Multiple PGx new term request
Term
Create New SDTM-OUT Worsened/Worsening
Term
Other SDTM- Clarification of CD terms

LBTEST/CD
None Multiple Schizophrenia TA controlled

terminology request. Multiple term
spreadsheet sent separately. Please
include Amy Palmer and me in the
general terminology meeting to
review these requests.
Create New SEND- "SEND Implementation Guide:

Term SNDIGVER Developmental and Reproductive
Toxicology v1.0 "
Create New SDTM- New terms required for use in the

Term EGTEST/CD ECG Codetable mapping
Other None Proposed changes to the ECG
Codetable mapping between
EGSTRESC and EGTEST(CD)
Create New Multiple Reynolds CVD 10-Year Risk Score -

Codelist CCCAT; This is for Dyslipidemia TA
team.
Modify SDTM- C40353; C25639: Update definitions
Existing Term DTDECOD by removing first 3 words from
existing published definitions.
Create New SDTM-FREQ QHS

Term
Modify SEND- SPRAGUE-DAWLEY has a typo of

Existing Term STRAIN "right lunch". This should be "right
lung".
lung".
lung".
None This is a test
Create New SDTM- LBTEST = Klotho Protein LBTESTCD
Term LBTEST/CD = KLOTHO
Create New SDTM- LBTEST = Copeptine LBTESTCD =

Term LBTEST/CD COPEP
Create New SDTM- DCLAMP

Term MITESTCD
Create New SDTM- DC-LAMP

Term MITEST
Create New Multiple I am a member of the PGx

Term terminology team and would like to
submit some terms for team review.
Modify SEND- SEND CT team has agreed to retire

Existing Term NEOPLASM C3789 from NEOPLASM Codelist
Modify SDTM-OUT Worsened/Worsening

Existing Term
Create New SDTM- TD, Trial Disease Assessments

Term DOMAIN
Other SDTM- Why is NYHAC in SDTM terminology
NYHAC rather than QRS (as a CC)?
Create New SDTM- DEFINITIVE THERAPY

Term METHOD
Modify SDTM- Please modify the CDISC definitions

Existing Term MICROORG for 7 Microorg terms
Create New SDTM- INJECTION
Term ROUTE
Modify SDTM-UNIT C102695;C67219; C96619; C96620;

Existing Term C105516 - Upper case the 'p' in 'per'
in the synonyms
Create New SDTM- Human Papillomavirus 6 Antibody;

Term LBTEST/CD Human Papillomavirus 11 Antibody;
Human Papillomavirus 16 Antibody;
Human Papillomavirus 18 Antibody
Create New SDTM-UNIT mMU/mL

Term
Modify Multiple Please review the terms in the

Existing Term C101853 and C101854 codelists:
Cardiac Valvular Regurgitation
Severity; Cardiac Valvular Stenosis
Severity.
Other Multiple I think METHOD and PROCEDUR
should be combined into one list.
Modify SDTM-NRIND Should NRIND be extended to match

Existing Term the lab model examples or could the
lab model be updated to add a
variable for the adminisrative
information?
Create New Multiple Submitting to get a request number
Codelist for 26 additions across 6 new SEND
codelists: FXRESCAT, PYRESCAT,
PYSTRESC, ICTEST-CD,
ICRESCAT, ICSTRESC. Also for the
addition of two new terms to existing
SEND codelists: BGTEST, BWTEST.
Other Multiple HE terminology query
Create New New QRS-APGAR / "American Pediatric

Codelist Gross Assessment Record"
Create New New "New codelist reqest: ECMOOD with
Codelist valid values: SCHEDULED,
PERFORMED "
Other None Move new codelist MISTRESC from

General to Lab
Create New SDTM- INVESTIGATIONAL

Term EPOCH
Create New Multiple Tumor Grade

Term
Create New SDTM- Perineural Invasion

Term MITEST
Create New SDTM- MITEST=Vascular Invasion [with

Term MITEST values of Y or N]
Create New SDTM- MITEST=Lymphatic Invasion [with
Term MITEST values of Y or N]
Create New Multiple TEST=Percentage of Tumor Cells

Term [with numeric values, and % as units
(or no units if the test contains the
unit name, ie. "Percentage")]
Create New Multiple "TEST=Percentage of Stromal Cells

unit name, ie. ""Percentage"")] "
Create New Multiple "TEST=Percentage of Normal Cells

unit name, ie. ""Percentage"")] "
Create New Multiple QRSTEST=Lung Cancer Symptom

Term Scale QRSTESTCD=LCSS
Create New Multiple TEST=Harvey-Bradshaw Index This
Term could be modeled in either (or both)
CC or QRS domain(s)?
Create New Multiple TEST=Crohn's Disease Activity Index

Term (CDAI) This could be modeled in
either (or both) CC or QRS
domain(s)?
Create New SDTM-UNIT CH50 Unit Synonym=Hemolytic Unit

Term of Complement
Create New SDTM- "Type I Collagen

Term LBTEST/CD C-Telopeptides/Creat (CTXICRT) A
relative measurement (ratio or
percentage) of the type I collagen C-
telopeptides to creatinine in a
biological specimen."
Create New SDTM- "PALPSTAT/Palpable State: A

Term TRTEST condition or state of the tumor with
regards to its palpability status at a
particular point in time. "
Create New SDTM- Need for TB TAUG - Gestational Age
Term SCTEST at Birth
Other SDTM-LOC HEART, RIGHT ATRIUM or
HEART,ATRIUM and LAT=RIGHT?
Modify SEND-SPEC SEND Specimen codelist definition

Existing Term review to de-specify the definitions:
SEMINAL FLUID to end.
Create New SDTM- ELECTROPORATION
Term METHOD
Create New SDTM- Test Name = Forced Expiratory

Term RETEST Volume in 3 Seconds TESTCD =
FEV3
Create New SDTM- Test Name - Forced Expiratory Time

Term RETEST TESTCD = FET
Modify SDTM-UNIT "Change the synonyms to match the

Existing Term NCI Preferred Term for the following
dosing units: Biscuit, Fingertip Unit,
Nebule, Puff, Shock Wave, "
Create New SDTM- BVISFUNC

Term OETESTCD
Create New SDTM- Best Visual Function

Term OETEST
Create New SDTM- NUMLCOR

Term OETESTCD
Create New SDTM- Number of Letters Correct
Term OETEST
Create New SDTM- RESPHERE

Term OETESTCD
Create New SDTM- Spherical Refractive Error

Term OETEST
Create New SDTM- TOTERSCR

Term OETESTCD
Create New SDTM- Total Error Score

Term OETEST
Other SDTM- Synonym for BACTERIA (C14187)

MICROORG
Other SDTM- STREPTOCOCCUS CANIS (C86786)

MICROORG
Other SDTM- BACTEROIDES TECTUS (C86178)

MICROORG
Create New SDTM- ASDEFIN

Term SCTESTCD
Create New SDTM- Definite AS
Term SCTEST
Create New SDTM- SKNPHTYP

Term SCTESTCD
Create New SDTM- Skin Phototype Classification

Term SCTEST
Create New SDTM-UNIT Letters

Term
Create New SDTM-EVAL Adjudicator

Term
Create New SDTM-EVAL Central reader

Term
Create New SDTM-EVAL Site

Term
Create New SDTM- SCTESTCD = SIMD SCTEST =

Term SCTEST/CD Scottish Index of Multiple Deprivation
Create New QRS-QSCAT TBI QRS Measures Expanded DRS -

Term Post Acute Caregiver QS
Terminology and Expanded DRS -
Post Acute Survivor QS Terminology
Create New SDTM-UNIT log10 TCID 50/mL and log10 TCID
Term 50/uL
Create New SDTM-LOC CHOROID; CILIARY BODY; IRIS;

Term MENINGES; SUPRAGLOTTIS
Modify SDTM- Just need request numbers: request

Existing Term MICROORG to update the definitions and
synonyms for C86671, C86962, and
C118935.
Create New SDTM-LOC Pleural effusion

Term
Create New SDTM-LOC Primary tumor site

Term
Create New Multiple LBTESTCD and LBTEST requested

Term for bone marrow evaluations
Create New Multiple Batch 2 Terminology from the Breast

Term Cancer Therapeutic Area Team. 14
Additions to multiple codelists and
two requests for changes to existing
terms.
Modify SDTM- Change the codelist name from
Existing Term DECAT Device Events Category to Category
of Device Events. This is to be
consistent with other domain category
variable codelists which start with the
word Category
Modify SDTM- Retire existing viral load terms in

Existing Term LBTESTCD LBTEST/LBTESTCD and replace
with a new VIRAL LOAD/VLD test
value.
Create New SDTM-UNIT MET (CDISC Submission Value);

Term Metabolic Equivalent as CDISC
Synonym
Create New SDTM-UNIT MET min (CDISC Submission Value);

Term MET-minute and Metabolic
Equivalent Minute as CDISC
Synonyms
Create New SDTM-UNIT MET-hour (CDISC Submission

Term Value); Metabolic Equivalent hour as
CDISC synonym
Create New SDTM- JAEGER EYE CHART
Term METHOD
Modify Multiple "QRS Codelists: Update the Codelist

Existing Term Name, Synonym, and Definition for
the C-SSRS Instruments "
Modify Multiple QSCAT, QSTEST, QSTESTCD

Existing Term
Create New Multiple Waist to Hip Ratio

Term
Modify SDTM- C120825 remove the synonym

Existing Term RETEST "DLCO Corrected for Hemoglobin".
C120827 remove the synonym
"DLCO/VA Corrected for
Hemoglobin".
Create New SEND-SPEC inguinofemoral lymph node
Term
Create New Multiple Trial summary parameter term for

Term "Therapeutic Area"
Create New SDTM- HSCRP/Highly Sensitive C Reactive

Term LBTEST/CD Protein
Other Multiple "new request for new codelists H-

Score TEST/TESTCD, CCCAT H-
SCORE on behalf of breast cancer
team "
Modify Multiple Borg CR-10 TEST/TESTCD
Existing Term
Create New SDTM- Just need request numbers for the

Term QSCAT CAT terminology going out for P23;
CAT terminology has been reviewed
and approved by the QRS team.
Create New SDTM- Please add ACCIDENTAL

Term RELSUB ASSOCIATION to RELSUB codelist.
See AP IG v1.0 Section 3.3.2
example 1.
Create New SDTM- Add term for LDL direct

Term LBTEST/CD
Modify SDTM- Add synonyms to C38083: 'TLCO'

Existing Term RETEST and 'Transfer Factor of Lung for CO'
Create New SDTM- New term for LBTEST/CD codelists
Term LBTEST/CD
Create New SDTM- PLSCE and PLSCELE

Term LBTESTCD
Create New SDTM- METAPNEUMOVIRUS;
Term MICROORG PNEUMOCYSTIS JIROVECII;
HUMAN HERPESVIRUS
Create New SEND- Epithelial Thickness

Term OMTEST
Other Multiple Please add back the following code

lists into the SEND published
documents. These lists are still
needed for SENDIG v3.0. We can
change the definition to indicate that
these code lists are needed for
version 3.0 if it is felt that this is
helpful.
Modify SDTM- "C85673: Type I change to CDISC

Existing Term PKUNIT definition. The definition is not
consistent with the submission value.
"
Create New SDTM- FARNSWORTH-MUNSELL 100 HUE
Term MITEST TEST
Create New SDTM- SDTMIG-AP v1.0 Terminology used

Term RELSUB in examples for SREL (RELSUB
codelist) not found in SDTM
Modify SDTM- C111331 Please correct the definition

Existing Term EGTEST/CD to: An electrocardiographic
assessment of ventricular
tachyarrhythmias.
Modify SDTM- C85754 update definition to
Existing Term PKUNIT "Nanomoles per kilogram or
picomoles per gram". This is already
in the PK spreadsheet and has been
agreed to. We only needed a request
number.
Modify SDTM- C86782 change definition to: Any

Existing Term MICROORG bacterial organism that can be
assigned to the species
Streptococcus anginosus. C86782
change submission value to
STREPTOCOCCUS ANGINOSUS.
Create New SEND- Thickness, Mean THICKMN C120721

Term OMTEST
Create New SDTM- GRAM-POSITIVE DIPLOCOCCUS

Term MICROORG
Create New Multiple File e-mailed separately September

Term 1, 2015
Create New SDTM- TUMOR RELATED CONDITION
Term NCOMPLT
Create New SDTM- NMR

Term METHOD
Create New SDTM- CD19PBRI

Term LBTEST/CD
Create New SDTM- CD19/CD27 bright/CD38

Term LBTEST/CD bright/Lymphocytes
Create New SDTM- CD19P27P

Term LBTEST/CD
Create New SDTM- CD19/CD27+/Lymphocytes

Term LBTEST/CD
Create New SDTM- CD19PBRI
Term LBTEST/CD
Create New SDTM- CD19/CD27 bright/CD38

Term LBTEST/CD bright/Lymphocytes
Create New SDTM- CD3453C3

Term LBTEST/CD
Create New SDTM- CD3+CD45+CD3/CD3

Term LBTEST/CD
Create New SDTM- CD3454

Term LBTEST/CD
Create New SDTM- CD3+CD45+CD3

Term LBTEST/CD
Create New SDTM- CD3458C3

Term LBTEST/CD
Create New SDTM- CD3+CD45+CD8/CD3

Term LBTEST/CD

Term LBTEST/CD
Create New SDTM- CD3+CD45+CD8
Term LBTEST/CD
Create New SDTM- CD3M19LY

Term LBTEST/CD
Create New SDTM- CD3-CD19/Lymphocytes

Term LBTEST/CD
Create New SDTM- CD3M56LY

Term LBTEST/CD
Create New SDTM- CD3-CD56/Lymphocytes

Term LBTEST/CD
Create New SDTM- CD5657MK

Term LBTEST/CD
Create New SDTM- CD56+CD57 red. by Nat. Killer T-Cell

Term LBTEST/CD Ct
Create New SDTM- CD5657+K

Term LBTEST/CD
Create New SDTM- CD56+CD57 incl. Natural Killer T

Term LBTEST/CD cells
Create New SDTM- FACTIIM
Term LBTEST/CD
Create New SDTM- Factor II Mutation

Term LBTEST/CD
Create New SDTM- GFR Cystatin C/Creatinine Ratio

Term LBTEST/CD
Create New SDTM- GFRCYCRR

Term LBTEST/CD
Create New SDTM- HBAB

Term LBTEST/CD
Create New SDTM- Hepatitis B Antibody

Term LBTEST/CD
Create New SDTM- HBCABIG

Term LBTEST/CD
Create New SDTM- Hepatitis B Virus Core Antibody IgG

Term LBTEST/CD
Create New SDTM- HCGENOT

Term LBTEST/CD
Create New SDTM- HCV Genotype

Term LBTEST/CD
Create New SDTM- HCVMRNA

Term LBTEST/CD
Create New SDTM- HCV mRNA

Term LBTEST/CD
Create New SDTM- HDABIGG
Term LBTEST/CD
Create New SDTM- Hepatitis D Virus Antibody IgG

Term LBTEST/CD
Create New SDTM- HDABIGM

Term LBTEST/CD
Create New SDTM- Hepatitis D Virus Antibody IgM

Term LBTEST/CD
Create New SDTM- HEVMRNA

Term LBTEST/CD
Create New SDTM- Hepatitis E mRNA

Term LBTEST/CD
Create New SDTM- HIVGENOT

Term LBTEST/CD
Create New SDTM- HIV Genotype

Term LBTEST/CD
Create New SDTM- IPPRT10

Term LBTEST/CD
Create New SDTM- Interferon gamma-induc. Prot. 10 (IP-

Term LBTEST/CD 10)
Create New SDTM- LEUKSH

Term LBTEST/CD
Create New SDTM- Leukocyte Shadow Cells
Term LBTEST/CD
Create New SDTM- LEUKSHLE

Term LBTEST/CD
Create New SDTM- Leukocyte Shadow Cells/Leukocytes

Term LBTEST/CD
Create New SDTM- PROTC

Term LBTEST/CD
Create New SDTM- Protein C

Term LBTEST/CD
Create New SDTM- TESTOSFP

Term LBTEST/CD
Create New SDTM- Testosterone/Protein, Free

Term LBTEST/CD
Create New SDTM- TNFR

Term LBTEST/CD
Create New SDTM- Tumor Necrosis Factor Receptor R1

Term LBTEST/CD
Create New SDTM- BLD

Term LBTEST/CD
Create New SDTM- Blood
Term LBTEST/CD
Create New SDTM- P3NP

Term LBTEST/CD
Create New SDTM- Procollagen 3 N-Terminal Propeptide

Term LBTEST/CD
Create New SDTM- CYFRA18

Term LBTEST/CD
Create New SDTM- Cytokeratin Fragment 18

Term LBTEST/CD
Modify SDTM- C86811 - remove the two synonyms

Modify SDTM- C78741 - Please add "Expired

Existing Term SPECTYPE Breath" as a synonym.
Modify SDTM- 82037 - Please add "total" to the

Existing Term SPECTYPE definition. A measurement of the total
transferrin in a biological specimen.
Create New New Create New Codelist for SEND

Codelist Codelist Name: Nonclinical DART
Trial Phases/NCDPHASE (This has
already been developed in the
working documents for P24. Just
getting a change request Number.)
Create New SDTM- Create new terms for TRSTRESC

Term TRSTRESC codelist - Already in P24, just need a
request number.
Create New New Batch 3a Multiple Term Request

Codelist Spreadsheet for BrCa TA Team
Create New New SEND FXLOC Codelist for P24. Work
Codelist already done and integrated in P24
working files. Just getting a request
code for public review.
Other Multiple changes/additions for RS domain
codelists; These changes/additions
are already in the P24 public review
document. They do not have a
request number.
Modify Multiple File "Multiple Term
Existing Term Request(MarcelinaHungria_2015-09-
08).xlsx" containing a total of 15
cases of the same type of issue
mailed separately.
Create New TSPARM/CD New terms to be added to
Term TSPARM/CD
Create New SDTM- VIRUS

Term MICROORG
Create New Multiple Cumulative Body Weight Gain

Term Cumulative Food Consumption
Create New SDTM- BODYPLETHYSMOGRAPHY

Term METHOD
Create New SDTM- DLCO

Term METHOD
Create New SDTM- MULTIPLE BREATH WASHOUT

Term METHOD
Create New SDTM- FRC
Term RETEST/CD
Create New SDTM- Functional Residual Capacity

Term RETEST/CD
Create New SDTM- SCONDVT

Term RETEST/CD
Create New SDTM- Conductive Ventilation Index

Term RETEST/CD Normalized
Create New SDTM- SACINVT
Term RETEST/CD
Create New SDTM- Acinar Ventilation Index Normalized

Term RETEST/CD
Modify SDTM- STREPTOCOCCUS ANGINOSIS

Create New SDTM- ANAEROBIC GRAM-NEGATIVE

Term MICROORG COCCOBACILLUS; AEROBIC
GRAM-NEGATIVE
COCCOBACILLUS
Modify SEND- C96371 and C120925: the
Existing Term SNDIGVER submission value should be all upper
case, this is for P24.
Create New Multiple POINT OF CARE

Term
Other SDTM- "Lab Terminology request for

LBTEST/CD Biomedical Concepts in DKD
(Diabetic Kidney Disease) TAUG "
Create New SEND- CROSS

Term STRAIN
Modify SEND- Marmoset

Existing Term SPECIES
Create New SDTM- Apgar Score at One Minute

Term VSTEST/CD
Create New SDTM- Apgar Score at Five Minutes

Term VSTEST/CD
Create New SDTM-LOC Hepatic Vein

Term
Create New SDTM-LOC Inferior Vena Cava
Term
Other Multiple (Non-SREL) Terms present in

SDTMIG-AP v1.0 not found / do not
match SDTM
Create New SDTM-UNIT SEND NV domain team asking for a

Term new UNIT code = BEAM BREAKS
with proposed definition: The unit of
measure for the number of times in
which light paths are interrupted by
movement.
Modify SDTM- TOXGRV3 was removed in P23.

Existing Term TOXGRV4 Please also remove TOXGRV4.
Create New SDTM-LOC INTRACRANIAL CAVITY
Term
Create New Multiple NCOMPLT Please Add

Term ADMINISTRATIVE
Create New Multiple New terms to be added

Term
Create New SDTM- HR Interval, Aggregate/EGHRAG

Term EGTEST/CD
Create New Multiple Needed for CTR standard

Term
Create New SDTM- Lab team agreed to create Urea
Term LBTEST/CD Nitrogen / UREAN and Urea
Nitrogen/Creatinine / UREANCRT on
2015-09-23
Modify SDTM- Lab team agreed to remove C74753
Existing Term LBTEST/CD from LBTEST-CD codelist on
9/9/2015.
Modify SDTM- Lab team agrees to update definitions

Existing Term LBTEST/CD for C100441, C100440, and C100439
on 9/23/2015.
Create New SDTM-LOC New Location = MAIN PORTAL VEIN

Term
Create New Multiple new FTCAT (TMT) and TESTCDs

Term (TMT0101 and TMT0102)
Create New SDTM- COPRINELLUS RADIANS
Term MICROORG
SEND-SPEC Please add GLAND, ANAL SAC to

the SEND-SPEC codelist. This will
replace the existing term GLAND,
PERINEAL which is being retired
from the codelist.
Create New SEND-SPEC Please add FLUID, THORACIC to the
Term SEND Specimen codelist with
definition: The fluid within the thoracic
cavity, which may include fluid in the
pleural cavity.
Create New Multiple Add new term
Term
Create New SDTM- ENTERIC BACTERIA

Term MICROORG
Create New New Please add 'PRESENT WITHOUT

Term UNEQUIVOCAL PROGRESSION' to
the TRPROPRS codelist, which is a
new codelist within P24.
Modify New Please change c-code of C27477 to
Existing Term C121932. The nomenclature has
been updated and now this mapping
is obsolete. No changes needed to
the SEND submission value,
synonyms, or definition.
Create New SDTM- CLINPROG

Term RSTESTCD
Create New SDTM- Clinical Progression

Term RSTEST
Create New SDTM- TRIPLE-PHASE SPIRAL CT SCAN

Term METHOD
Create New SDTM- TRIPLE-PHASE MRI SCAN

Term METHOD
Create New SDTM- Please create two new method terms

Term METHOD for DKD TA project
Create New SDTM-UNIT uL/dose; uL/kg/day
Term
Modify Multiple COA codelist name association
Existing Term CHANGES tentatively agreed to by
COA Team
Create New Multiple Patient Health Questionnaire
Term (Kroenke K, Spitzer RL, Williams
JBW, L�we B. The Patient Health
Questionnaire somatic, anxiety, and
depressive symptom scales: a
systematic review. Gen Hosp
Psychiatry 2010)
Create New SDTM- EXHALED BREATH CONDENSATE

Term SPECTYPE
Modify SEND- C2978 CYST, please remove the

Existing Term NONNEO synonym Cysts.
Create New SDTM-LOC Circulatory System

Term
Create New SDTM-LOC Musculoskeletal System

Term
Create New SDTM-LOC ENDOMETRIUM
Term
Create New SDTM-LOC OVARIAN FOLLICLE
Term
Create New SDTM-LOC RETROPHARYNGEAL LYMPH

Term NODE
Create New SDTM- Please add Too Small to Measure,

Term TRPROPRS Pathological, Non-Pathological, and
No Enlargement to TRPROPRS
codelist.
Create New SDTM- New term values for ONCRSCAT
Term ONCRSCAT codelist
Create New SDTM- We are requesting more generic term

Term EGTEST for local ecg tests.
Create New SEND- Add the term "Hemorrhage" to the

Term FXFINDRS FXFINDRS codelist that is a new
codelist in package 24.....
Create New Multiple This is the first round of CV Imaging
Term TA CT requests, it includes the
ANMETH, METHOD, LOC, and
CVTEST/TESTCD codelist requests.
Modify SDTM- Currently, NCMPLT has a value
Existing Term NCOMPLT 'PROGRESSIVE DISEASE'. Amgen
uses 'DISEASE PROGRESSION' and
propose adding as a synonym.
Modify Multiple Please revise definition of BRAIN

Existing Term C12439. This term is in both SDTM-
LOC and SEND-SPEC codelists.
Create New SDTM- Percent Change Nadir in Sum of Area
Term TRTEST (TC: PCNSA)
Create New SDTM-LOC CEREBRAL WHITE MATTER;

Term PERIVENTRICULAR WHITE
MATTER
Create New SDTM- NON-TARGET ENHANCING; NON-
Term TUIDRS TARGET NON-ENHANCING
Other None Requesting update to the Oncology

Mapping Codetable - Addition of the
response of PR (C18058) to the test
name Non-target Response (C94535)
Modify SDTM- Synonym of Improved for the term PR

Existing Term RSSTRESC
Create New SDTM- Need for TB TAUG - INDUCED

Term SPECTYPE SPUTUM
Create New SDTM- Need for TB TAUG -
Term LBTEST/CD LBTESTCD=LAM; LBTEST =
Lipoarabinomannan
Term DUTEST/CD DUTESTCD=VIEW; DUTEST=View
Create New SDTM- Need for TBTAUG - EDUCATOR
Term RELSUB
Create New SDTM- Needed for TAUG-TB v2.0*
Term TUTEST/CD TUTESTCD= FBLESIND;
TUTEST=Fibrotic Lesion Indicator
Create New SDTM- Needed for TAUG-TBv2.0*

Term TRTEST/CD TRTESTCD=CALCIF;
TRTEST=Calcification
Create New SEND- New SEND term requests

Term NONNEO
Create New SDTM- New terms to be added to ROUTE
Term ROUTE
Create New SDTM- New terms to be added to

Term LBTEST/CD LBTEST/CD
Create New SDTM- New terms to be added to METHOD

Term METHOD
Create New SDTM- Need to TB TAUG - CHILD CARE

Term SETCON CENTER
Create New SDTM- Need for TB TAUG - HOSPITAL
Term SETCON
Create New SDTM- Need for TB TAUG - SHELTER

Term SETCON
Modify SDTM-UNIT C73686 change the submission value

Existing Term from AU to Absorbance U C73687
change the submission value from
AU/min to Absorbance U/min
Create New SDTM-LOC SUPRAPUBIC REGION

Term
Create New SDTM- EPICCE

Term LBTESTCD
Create New SDTM- Epithelial Cells/Total Cells

Term LBTEST
Create New SDTM- TOTCE

Term LBTESTCD
Create New SDTM- Total Cells

Term LBTEST
Create New SDTM- VIABCE
Term LBTESTCD
Create New SDTM- Viable Cells

Term LBTEST
Create New SDTM- Requesting to add new terms "BONE

Term METHOD SCAN" and "RADIONUCLIDE SCAN"
to METHOD codelist
Create New Multiple Need for TB - File emailed separately

Term
Create New SDTM- Create New Terms for LBTEST,
Term LBTEST LBTEST
Create New SDTM- XAW

Term RETEST/CD
Create New SDTM- Airway Reactance

Term RETEST/CD
Create New SDTM- CELL BASED ASSAY

Term METHOD
Create New SDTM- TIRM

Term RETEST/CD
Create New SDTM- Turbo-Inversion Recovery-Magnitude

Term RETEST/CD
Create New SDTM- VOT
Term RETEST/CD
Create New SDTM- Volume Over Threshold

Term RETEST/CD
Create New SDTM- OTF

Term RETEST/CD
Create New SDTM- Oxygen Transfer Function
Term RETEST/CD
Create New SDTM- O2WASH

Term RETEST/CD
Create New SDTM- Oxygen Washout Time

Term RETEST/CD
Create New SDTM-LOC PORTAL VEIN BRANCH
Term
Create New New Create new codelist called CRACE

Codelist (Collected Race).
Create New New Create new codelist CETHNIC

Codelist (Collected Ethnicity)
Create New SDTM- SS for Subject status

Term DOMAIN
Create New SDTM- EC for Exposure as Collected

Term DOMAIN
Other SDTM-UNIT Use of UNIT synonyms - Thoughts
please
Modify Multiple QRS_Controlled_Terminology_Packa

Existing Term ge_24_FINAL_2015-11-12 changes /
need request code only
Other Multiple This is a multiple term request
spreadsheet that contains an addition
to the SEND STSPRM-CD codelist as
well as modifications to 9 existing
terms. These items are already in the
working documents; request numbers
just need to be added.
Create New SDTM-LOC SEND team is requesting a change to

Term the definition of CLAVICLE (C12695)
in the SDTM-LOC codelist in order to
be species-independent. SEND
would like to add the term to the
SPEC codelist.
Create New SDTM- PARAINFLUENZA VIRUS;

Term MICROORG TOXOPLASMA GONDII
Create New SDTM- POPULATION SEQUENCING

Term METHOD
Create New SDTM-LOC ANAL CANAL
Term
Create New SDTM-UNIT OI

Term
Create New SDTM- RANDOMIZED IN ERROR

Term NCOMPLT
Create New Multiple Create New codelists for PK (Norm

Term by...), new terms, modify existing
terms
Modify SDTM- C103386 - remove percentage from

Modify SDTM- C74761 - remove percentage from

Modify SDTM- C92242 - remove ratio from test

Existing Term LBTEST/CD name
Modify SDTM- C111299 - remove ratio from test

Existing Term LBTEST/CD name
Modify SDTM- C98792 - review the long list of

Existing Term LBTEST/CD synonyms
Modify SDTM- C120652 - ""antibody"" should be last

Modify SDTM- C120653 - "antibody" should be last

Modify SDTM- C120654 - "antibody" should be last

Existing Term LBTEST/CD in the test name
Modify None SDTM Domain Abbreviation for DD is
Existing Term 'Death Diagnosis' but as per SDTM
IG v3.2 it is 'Death Details' please
update
Modify SDTM- Mismatch between SDTM IG 3.2
Existing Term DOMAIN Domain label with Controlled
terminology DOMAIN Codelist
Create New SDTM-LOC Lung, right, S1 apical segment

Term
Create New SDTM-LOC Lung, right, S2 posterior segment

Term
Create New SDTM-LOC Lung, right, S3 anterior segment

Term
Create New SDTM-LOC Lung, right, S4 lateral segment

Term
Create New SDTM-LOC Lung, right, S5 medial segment

Term
Create New SDTM-LOC Lung, right, S6 superior segment

Term (Fowler)
Create New SDTM-LOC Lung, right, S7 medial basal segment

Term
Create New SDTM-LOC Lung, right, S8 anterior basal

Term segment
Create New SDTM-LOC Lung, right, S9 lateral basal segment

Term
Create New SDTM-LOC Lung, right, S10 posterior basal

Term segment
Create New SDTM-LOC Lung, left, S1+S2 apicoposterior
Term segment
Create New SDTM-LOC Lung, left, S3 anterior segment

Term
Create New SDTM-LOC Lung, left, S4 superior lingular

Term segment
Create New SDTM-LOC Lung, left, S5 inferior lingular

Term segment
Create New SDTM-LOC Lung, left, S6 superior segment

Term (Fowler)
Create New SDTM-LOC Lung, left, S7 medial basal segment

Term
Create New SDTM-LOC Lung, left, S8 anterior basal segment

Term
Create New SDTM-LOC Lung, left, S9 lateral basal segment

Term
Create New SDTM-LOC Lung, left, S10 posterior basal

Term segment
Create New New NULLFLAVOR

Codelist
Create New SDTM- AUTOPSY
Term DDTEST/CD
Create New SDTM- Autopsy Performed

Term DDTEST/CD
Create New SDTM- DTHCERT

Term DDTEST/CD
Create New SDTM- Death Certificate

Term DDTEST/CD
Create New SDTM- HOSPREC

Term DDTEST/CD
Create New SDTM- Hospital Medical Record

Term DDTEST/CD
Create New SDTM- OTHERSRC

Term DDTEST/CD
Create New SDTM- Other Source

Term DDTEST/CD
Create New SDTM- DTHGRP

Term DDTEST/CD
Create New SDTM- Cause of Death Group
Term DDTEST/CD
Create New SDTM- PBF

Term RETEST/CD
Create New SDTM- Pulmonary Blood Flow

Term RETEST/CD
Create New New SDTM-BSTESTCD : WEIGHT

Term
Create New New SDTM-BSTEST : Weight of Specimen

Term
Create New New SDTM-BSTESTCD : SOLUTION

Term
Create New New SDTM-BSTEST : Added Solution

Term
Create New New SDTM-BSTESTCD : QUANTITY

Term
Create New New SDTM-BSTEST : Quantity
Term
Create New New SDTM-BSTESTCD : VIABLE

Term
Create New New SDTM-BSTEST : Viability of Sample

Term
Create New New SDTM-BSTESTCD : QUALITY

Term
Create New New SDTM-BSTEST : Quality

Term
Create New New SDTM-BSCAT : Specimen Collection

Term
Create New New SDTM-BSCAT : Specimen Handling

Term
Create New SDTM-UNIT /large square

Term
Create New SDTM-UNIT mL/min/100 mL lung volume
Term
Create New SDTM- Evaluator 1

Term MEDEVAL
Create New SDTM- Evaluator 2

Term MEDEVAL
Create New SDTM-EVAL Evaluator

Term
Create New SDTM- TNF-beta

Term LBTEST
Modify SEND- Please recode C3430: Obstructive

Existing Term NONNEO Uropathy
Create New SDTM-LOC Add new terms to LOC

Term
Create New SDTM- RHIZOPUS ORYZAE
Term MICROORG
Create New SEND- Thin Prep Papanicolaou Test (test

Term MITEST code: PAPTP)
Create New SDTM- It seems that there is no term for use
Term PKPARM in the PPTEST column for the
PPTESTCD value of AUCIFOD.
Create New Multiple ODI v2.1A TEST/TESTCD ODI0111

Term Oswestry Disability Index
Other ADaM- Requesting additional code list terms,

DTYPE plus a change to an existing term.
Create New SDTM- This is for the COPD TA project.

Term RETEST/CD Please add to the TESTEST-CD
codelists: TEST = Peak Inspiratory
Flow Rate; TESTCD = PIFR
Create New SDTM-LOC DIAPHRAGMATIC LYMPH NODE;
Term Flank
Final Outcome
Change
Type
While loading CT into SHARE, we noticed the CDISC II SEND-Published in P21

Submission Value for C49696 are different in these
codelists:
SEND-STSPRM (C90007): Sex Of Participants

SDTM-TSPARM (C67152): Sex of Participants
Suggest updating to use the same text case.
File emailed separately; Attached is the proposed III QRS-Published in P21

CDISC CT for the Negative Symptoms Assessment-
16 (NSA-16) for Schizophrenia. The code lists that
will be affected are CCCAT and CCTESTCD.
Please add Electromyography to the METHOD III SDTM-Published in P22

codelist. A new drug program that I am working on
will be using this procedure. This term exists in the
NCI-T:
dictionary=NCI_Thesaurus&code=C38056&ns=NCI_
Thesaurus
Upon Virology team's request, remove CDISC SY II SDTM-Published in P22

from Existing MICROORG Terms that follow this
naming convention: first letter of genus, followed by a
period and space, followed by the full spelled name of
the species; File emailed separately.
There are a number of COA instruments that will be III QRS-Published in P24.
remapped from the QS domain to the CC domain
(and one to FT). I am in charge of updating the
CDISC supplements for HAM-A and HAMD-21 which
have been deemed by the CDISC QS subteam to
belong in CC. I assume besides the update to the
CAT codelist, references to the values for all codes in
the "Codelist Name" column for C101819 (HAMA
TESTCD), C101820 (HAMA TEST), C101821 (HAMD
21 TESTCD) and C101822 (HAMD 21 TEST) will
need the "QS-..." updated to "CC-..."
CDISC has had [Definition Pending] in the definition II SDTM-Published in P22

field for a very long time. Not sure what is pending
exactly. I'd like to suggest that CDISC updates their
definition to the NCI one: A substance composed of
complexed active and/or inert ingredient(s) with
natural or synthetic lipids that is intended for injection.
Request to add a new term ""Muscle, Vastus III SEND-Published in P22, P23
Intermedius"" with the following definition: The fourth, Do not Add (SEND-P23):
small and inconspicuous head of the quadriceps C57BL/6 DIO-Do not add as
femoris muscle group that extends from the lateral new and do not change
shaft of the femur to the quadriceps tendon to the definition of existing. The
base of patella and onto the tibial tuberosity via the requestor should use the
patellar ligament. This fourth head of the quadriceps existing published term
femoris muscle lies beneath the vastus medialis. C57BL/6 and discussing
This muscle currently isn't available, except at a where the DIO information
higher level of ""MUSCLE, QUADRICEPS should go. Use Substrain
FEMORIS"". However, we will be including the details for now. The existing
muscles that comprise the quadriceps in one study. published definition is not
specific to a high fat diet.
Includes all tarsus joints like e.g. the transverse tarsal III SDTM-Published in P22
joint etc.
New terms requested for STRAIN; File emailed III SEND-Published in P21, P22
separately. P22-Do not add TSG-p53.
Use CROSS as the term for
this codelist and put genetic
information into substrain
details.
In certain animal studies where we use non-serial (or III Do not add (SDTM-P22) -
sparse) sampling, we will have to pool data from This will be discussed in the
different animals, and the PK parameters in PP are future with the population
actually mean data. PK discussions.
Standard errors for PK parameters will also be

generated due to the mean procedures, however, the
current Controlled Terminology supporting SEND /
SDTM format does not appear to have a variable
name assigned for these standard error terms in
PKPARMCD.
Though, they don?t show up in Controlled
Terminology; though it does appear NCI has
reviewed these types of term in the past 2009, but not
added them. Perhaps there was a reason these types
of PK parameters were rejected.
Can you find out if there is a way to address this?
Change definition to: A measurement of the antibody II SDTM, SEND-Published in

reaction of a biological specimen to either the HIV-1 P22
or HIV-2 virus. (Remove second 'the' in the definition
between 'to' and 'either').
Team agreed to the following on the meeting 2015- III SDTM, SEND-Published in
01-14 P22
CDISC Submission value TEST: Borrelia burgdorferi
IgA Antibody
CDISC Submission value TESTCD: BBRIGAAB
CDISC SY: Lyme IgA Antibody
CDISC Definition: A measurement of the Borrelia
burgdorferi IgA antibody in a biological specimen.
A measurement of 1,5-anhydroglucitol in a biological III SDTM, SEND-Published in

specimen. P24
To be used with LBTEST : 1,5-Anhydroglucitol
A measurement of 1,5-anhydroglucitol in a biological III SDTM, SEND-Published in

specimen. P24
To be used with LBTESTCD : AG1_5
A measurement of the antiphospholipid Ig M III SDTM, SEND-Published in

antibodies in a biological P24
To be used with LBTEST : Anti-Phospholipid IgM
antibodies
A relative measurement (ratio or percentage) of the III SDTM, SEND-Published in
aldosteron to the renin in a biological specimen. P24
To be used with LBTEST : Aldosteron Renin ratio

aldosteron to the renin in a biological specimen. P24
To be used with LBTESTCD : ARR
A measurement of the antiphospholipid Ig G III SDTM, SEND-Published in

antibodies in a biological specimen. P24
To be used with LBTEST : Anti-Phospholipid IgG
antibodies
A measurement of the antiphospholipid Ig M III SDTM, SEND-Published in
To be used with LBTESTCD : APLIGMAB
A measurement of the antiphospholipid Ig G III SDTM, SEND-Published in

To be used with LBTESTCD : APLIGGAB
A measurement of cyclic Adenosin Monophoshpat in III SDTM, SEND-Published in

a biological specimen P24
To be used with LBTEST : Cyclic adenosine-
monophosphate (cAMP).
A measurement of cyclic Adenosin Monophoshpat in III SDTM, SEND-Published in
a biological specimen P24
To be used with LBTESTCD : CAMP
A calculation of the free androgen index that III SDTM, SEND-Published in

expresses the ratio of testosterone to SHBG to be P24
used to summarize the activity of free testosterone.
To be used with LBTEST : FAI
A calculation of the free androgen index that III SDTM, SEND-Published in
expresses the ratio of testosterone to SHBG to be P24
used to summarize the activity of free testosterone.
To be used with LBTESTCD : FAI
An assessment of beta-cell function and insulin III Do not add (SDTM-P25) -

secretion based on fasting blood glucose and insulin Lab test code/name codelists
concentrations. will contain the analytes of
To be used with LBTEST : HOMA-%B Insulin Resistance and
Insulin Sensitivity and Beta-
Cell Function. The method
will be Homeostatic Model
Assessment. The calcuation
can currently go into
SUPPQUAL.
An assessment of beta-cell function and insulin III

secretion based on fasting blood glucose and insulin
concentrations.
To be used with LBTESTCD : HOMA_B
A measurement of the soluble intracellular adhesion III SDTM, SEND-Published in
molecule in a biological specimen. P24
To be used with LBTEST : Soluble intracellular
adhesion molecule
To be used with LBTESTCD : ICAM

To be used with LBTEST : Sol. Intracell. Adhes.
Mol.1, Serum, EIA

To be used with LBTESTCD : ICAM1EIA
A measurement of the osteopontin in a biological III SDTM, SEND-Published in

specimen. P24
To be used with LBTEST Osteopontin, ELISA
A measurement of the osteopontin in a biological III SDTM, SEND-Published in

specimen. P24
To be used with LBTESTCD : OSTEOP
A functional measurement of protein C in a biological III

specimen.
To be used with LBTEST : Protein C, chromogenic
assay
A functional measurement of protein C in a biological III
specimen.
To be used with LBTESTCD : PROTC
A measurement of the kappa Bence-Jones protein in III SDTM. SEND-Published in
a biological specimen. P25
To be used with LBTEST : Urine Bence-Jones
protein, kappa
A measurement of the kappa Bence-Jones protein in III

To be used with LBTESTCD : UBJPROK
A measurement of the lamba Bence-Jones protein in III SDTM. SEND-Published in

a biological specimen. P25
To be used with LBTEST : Urine Bence-Jones
protein, lamba
A measurement of the blood present in a urine III
specimen.
To be used with LBTEST : Blood
A measurement of the blood present in a urine III

specimen.
To be used with LBTESTCD : BLD
A measurement of the bleeding time according to the III

Duke method.
To be used with LBTEST : Bleeding Time
A measurement of the bleeding time according to the III

Duke method.
To be used with LBTESTCD : BLTM
The clearance of a substance from the blood by the III SDTM, SEND-Published in
kidneys from T1 to T2. P22
To be used with PKPARM : Renal CL from T1 to T2
The area under the curve from T1 to T2 at steady III SDTM, SEND-Published in
state divided by the area under the curve from T1 to P22
T2 after single dose.
To be used with PKPARM : Accumulation Ratio AUC
from T1 to T2
The area under the curve from T1 to T2 at steady III
state divided by the area under the curve from T1 to
T2 after single dose.
To be used with PKPARMCD : AUCTACUM
The area under the curve (AUCTAU) at steady state III SDTM, SEND-Published in
divided by the area under the curve (AUC) P22
To be used with PKPARM : Linearity index
The area under the curve (AUCTAU) at steady state III
divided by the area under the curve (AUC)
To be used with PKPARMCD : LININDX
The clearance of a substance from the blood by the III
kidneys from T1 to T2.
To be used with PKPARMCD : RENCLINT
Reason: the frequency codelist have this term, and III Do not add (SDTM-P23): This
this is a type of frequency for which some is timing, not frequency. You
medications are prescribed. could possibly use a FREQ of
QD.
Definition: Every night at bedtime
Synonym: quaque hora somni
Reason: the frequency codelist have this term, and III Do not add (SDTM-P23): This
this is a type of frequency for which some is timing, not frequency. You
medications are prescribed. could possibly use a FREQ of
QD.
Definition: Every day before noon
Synonym: quaque die ante meridiem
Per Virology CT team discussion, update CDISC DEF II SDTM-Published in P24

for all 'complex' terms; File emailed separately.
A measurement of the lambda Bence-Jones protein III

Add Alpha-2 Antiplasmin as a synonym. This is the II SDTM, SEND-Published in

LBTEST submission value and should also be a P22
synonym by default.
Add 'total' into definition. We are adding subtype II SDTM, SEND-Published in
terms to list so these need to become 'total' as per P22
the lab definition conventions.
Number of Early Term Births/EARLYTERM with III SDTM-Published in P22
definition: A measurement of the total number of birth
events at which the gestational age of the neonate is
37 weeks and 0 days through 38 weeks and 6 days.
Miscarriage Indicator/MSCGIND with definition: An III SDTM-Published in P22

indication as to whether any pregnancies resulted in
stillbirths.
Mansonella perstans (Code C119326) II SDTM-Published in P24

Change DEF to: Any nematode parasite that can be
assigned to the species Mansonella perstans.
Amoeba (Code C119581)

Change to: Any unicellular, eukaryotic organism that
is not assigned to the species level but can be
assigned to the Amoeba genus level.
Bone Mineral Density (BMD) results for the proximal III SDTM-Published in P22
femur (Hip) scans are reported for five different
anatomical areas: Total Hip, Femoral Neck,
Trochanter, Inter-Trochanter, and WARD'S
TRIANGLE. The WARD'S TRIANGLE is a small box
approximately 1cm x 1cm at the area of minimum
density in the femoral neck region.
Definition: An area of diminished density in the
trabecular pattern of the neck of the femur evident by
x-ray as well as by direct inspection of a specimen.
Draft Public Domain Verification Document and CC III QRS-Published in P24.

Terminology spreadsheet sent via EMAIL
file emailed separately. For the Dyslipidemia TA III QRS-Published in P24.

standard.
file emailed separately. II SDTM-Published in P22
This is a General terminology Team request for III SDTM-Published in P22

additions to the MO domain MOTESTS and the
Ophthalmic Examinations (OE) physiology OETESTs.
The OE domain team should request the
OETESTCD/OETEST codelist upon release of that
domain that recently completed public Review. The
use case in the request is based on the TBI pupil
measurements collected together with the Glasgow
Coma Scale. This CRF and draft spreadsheet wee
sent via EMAIL.
The Public Domain Verification, Syllabus and draft III QRS-Published in P24.
CC Terminology spreadsheet were sent via EMAIL
CMAXD kg*ng/ml/mg III

This is our normalized unit ouput from Phoenix PKS
for CMAXD. I see it to be an industry standard term.
We have these values as a standard output from
Nonclinical Studies where the data is to be submitted
via SEND PP domain.
Definition: A measurement of the fat mass within the III SDTM-Published in P22
subject's body.
Synonymous terms are currently not available. III
Request for 2 new LBTESTCD and LBTEST:
LBTESTCD= CD3NKLY; LBTEST=

CD3NK/Lymphocytes; Definition: A relative
measurement (ratio or percentage) of CD3
expressing cells and total natural killer cells to all
lymphocytes in a biological specimen.
LBTESTCD= CD3NK; LBTEST= CD3NK; Definition:

A count of the CD3 and total natural killer cells per
unit in a biological specimen.
file emailed separately III Do not add (SEND-P25) -

SEND team agrees that all
non-neoplastic findings
should go into the NONNEO
codelist. We will not create a
third codelist for MISTRESC.
Defer. Please submit
corresponding TEST values
along with result values so
CT can be developed
together. This will be
developed post 3.1 with an
update to the MI domain
within SEND. Extend CT as
needed at sponsor company
during the interim period.
File emailed separately III

The induration diameter is measured as part of a TB III SDTM-Published in P22
skin test reading.
(http://www.cdc.gov/tb/publications/Posters/images/M
antoux_wallchart.PDF)
Draft definition NCI: The quality of being hard, the

process of hardening, or an abnormally hard spot or
place, particularly of the skin. This is often associated
with inflammation and infiltration of a neoplasm (NCI).
The induration diameter is measured as part of a TB
skin test reading.
(http://www.cdc.gov/tb/publications/Posters/images/M
antoux_wallchart.PDF)
Draft definition NCI: The quality of being hard, the

process of hardening, or an abnormally hard spot or
place, particularly of the skin. This is often associated
with inflammation and infiltration of a neoplasm (NCI).
The presence of blistering is sometimes assessed III SDTM-Published in P22

during the reading of a TB skin test
The EGTESTCD, HRMEAN has been removed from I Question answered in P23 -
CDISC/NCI Terminology. A new term, EGHRMN, has Question answered in an
been added. Going forward, we plan to use email. This is difficult to
EGHRMN. However, we have used HRMEAN in the answer without seeing the
past to collect mean Heart Rate values collected as actual data.
part of the ECG. Is there any guidance regarding In general, the two terms
integrating data collected using the different can be combined, but you
controlled terms? should look into the specifics
We did not raise this comment during the review of the previous data to
period. When submission values are determine exactly what was
changed/removed, data integration challenges are captured.
introduced. Guidance is needed. You need to be consistent
with the terminology that
you are using in your
submission to the FDA.
CDISC Terminology team, III Do not add (SDTM-P23):
ANTERIOR
1. I have a need for several ""compound"" UPPER/POSTERIOR
directionality (DIR) choices (e.g., Posterior Upper, UPPER/ANTERIOR
Anterior Lower...). Or, please propose how this would LOWER/POSTERIOR LOWER-
appear in SDTM if it is to be separate fields. Please use the "multiple"
convention. For example:
2. I am also asking for you to consider 3 new anterior and upper belong in
anatomical locations (LOC) which are really the directionality variable
""specimens"", however this will be for patient self- but multiple convention
reporting of hemophilia bleeds in Sputum, Stool, and should be used to convey
Urine. this.
This will be used to indicate the location of internal

and muscle bleeds in hemophilia subjects; the bleed
locations are self-reported by the subject in a diary.
File attached.
CDISC Terminology team, III Do not add (SDTM-P23):

Sputum/Urine/Stool-This is a
1. I have a need for several ""compound"" specimen type, not an
directionality (DIR) choices (e.g., Posterior Upper, anatomical location. Since
Anterior Lower...). Or, please propose how this would you do not know the exact
appear in SDTM if it is to be separate fields. source, you cannot use
anatomical location.
2. I am also asking for you to consider 3 new
anatomical locations (LOC) which are really
""specimens"", however this will be for patient self-
reporting of hemophilia bleeds in Sputum, Stool, and
Urine.
This will be used to indicate the location of internal

and muscle bleeds in hemophilia subjects; the bleed
locations are self-reported by the subject in a diary.
File attached.
File emailed separately III SDTM-Published in P23
The CDISC ADaM Team is requesting modifications

due to the upcoming pulbication of a new ADaM
Standard Data Structure "OCCURRENCE DATA
STRUCTURE" (synonym: OCCDS).
"File emailed separately II SDTM-Published in P22
The CDISC ADaM Team is requesting modifications

due to the upcoming pulbication of a new ADaM
Standard Data Structure "OCCURRENCE DATA
STRUCTURE" (synonym: OCCDS).
I request following TSPARMCD/TSPARM new terms III SDTM-Published in P23, P24

- Whether the Study is a Pediatric Study (Y/N)
- Whether the Study is a Pediatric Postmarket Study
(Y/N)
- Whether the study is about an FDA-Regulated
Device (Y/N)
- Whether the study is about an FDA-Regulated Drug
(Y/N)
- Country where the poduct is manufactured
This is information that is required by clinical trial

registries and probably can best be treated by
TSPARMCD/TSPARM. It is not only useful for SDTM,
but will then also be used in the new CTR-extension
to the ODM/SDM-XML standard, using:
"sdm:Parameter" in "sdm:Summary"
A grid of horizontal and vertical lines used to monitor III SDTM-Published in P23
a person's central visual field.
Colored plates, each of which contains a circle of III SDTM-Published in P23

dots appearing randomized in color and size. Within
the pattern are dots which form a number or shape
clearly visible to those with normal color vision, and
invisible, or difficult to see, to those with a red-green
color vision defect, or the other way around.
An eye chart used to measure visual acuity. III SDTM-Published in P23

I want to request a new SDTM controlled terminology III
for Functional Tests (FT domain).
I have a CRF Page for collecting 'Elbow Joint Range

of Motion' where below 4 tests along with the results
and it's units are collected.
1) Extension
2) Flexion
3) Pronation
4) Supination
Results of these tests/tasks are numeric (e.g. 19, -20,

-11, 30 etc) with all tests/tasks having units in
'Degree'.
Reason for suggesting this data or CT in Functional

Tests FT domain is because these tasks are related
to mobility/dexterity and so can fit this domain.
I am not sure how exactly the controlled terminology

(--TEST and --TESTCD) should be but the terms
Extension, Flexion, Pronation and Supination are
commonly used terms and we use them for reporting
the tests/tasks results. May be some thing can be
build around those terms.
e.g.
FTTEST=
Elbow Joint-Extension
Elbow Joint-Flexion
Elbow Joint-Pronation
Elbow Joint-Supination
Please let me know if any follow-up questions or if

you think this data doesn't fit FT domain (which
domain in that case?).
DLCO measures the ability of the lungs to transfer III
gas from inhaled air to the red blood cells in
pulmonary capillaries
To be used with RESEST: Diffusing Capacity of the

Lung for CO
DLCO measures the ability of the lungs to transfer III

gas from inhaled air to the red blood cells in
pulmonary capillaries
To be used with RETESTCD: DLCO

Mean value of DLCO, which measure the ability of III SDTM-Published in P23
the lungs to transfer gas from inhaled air to the red
blood cells in pulmonary capillaries.
To be used with RETEST: Mean DLCO

Mean value of DLCO, which measure the ability of III SDTM-Published in P23
the lungs to transfer gas from inhaled air to the red
blood cells in pulmonary capillaries.
To be used with RETESTCD: DLCOM

The ability of the lungs to transfer gas from inhaled III
air to the red blood cells in pulmonary capillaries as a
proportion of the predicted normal value.
To be used with RETEST: Percent Predicted DLCO
The ability of the lungs to transfer gas from inhaled III

air to the red blood cells in pulmonary capillaries as a
To be used with RETESTCD: DLCOPP

The predicted ability of the lungs to transfer gas from III
inhaled air to the red blood cells in pulmonary
capillaries.
To be used with RETEST: Predicted DLCO

The predicted ability of the lungs to transfer gas from III
inhaled air to the red blood cells in pulmonary
capillaries.
To be used with RETESTCD: DLCOPR

The predicted maximum volume of air that can be III
exhaled after forced maximum inhalation.?
To be used with RETEST: Predicted FVC

The predicted maximum volume of air that can be III
exhaled after forced maximum inhalation.?
To be used with RETESTCD: FVCPR

Impulse oscillometry measurement of the energy III SDTM-Published in P23
generated by the recoil of the lungs after distention by
a pressure wave out of phase with airflow.
To be used with RETEST: IOS Reactance at 5 Hz

Impulse oscillometry measurement of the energy III SDTM-Published in P23
generated by the recoil of the lungs after distention by
a pressure wave out of phase with airflow.
To be used with RETESTCD: IOSXRS5

Impulse oscillometry measurement of the energy III Do not add (SDTM-P23):
required to propagate a pressure wave through the Please use "Airway
airways; to pass through the bronchi and bronchioles, Resistance" released in P22.
and to distend the lung parenchyma. Resistance is
determined when a pressure wave is unopposed by
airway recoil and is in phase with airflow.
To be used with RETEST: IOS Resistance at 5 Hz

Impulse oscillometry measurement of the energy III Do not add (SDTM-P23):
required to propagate a pressure wave through the Please use "Airway
airways; to pass through the bronchi and bronchioles, Resistance" released in P22.
and to distend the lung parenchyma. Resistance is
determined when a pressure wave is unopposed by
airway recoil and is in phase with airflow.
To be used with RETESTCD: IOSRRS5
Measurement of total airway resistance, using the III SDTM-Published in P24

interrupter technique (Rint). Do not add (SDTM-P23): The
method should be
To be used with RETEST : Rint Interrupter Technique and
the RETEST should be Airway
Resistance which was
released in P22. Interrupter
Technique is being
requested as a method.
Measurement of total airway resistance, using the III SDTM-Published in P24

interrupter technique (Rint). Do not add (SDTM-P23): The
method should be
To be used with RETESTCD : RINT Interrupter Technique and
the RETEST should be Airway
Resistance which was
released in P22. Interrupter
Technique is being
requested as a method.
Z-score of total airway resistance measured using the III Do not add (SDTM-P23): This
interrupter technique (Rint). belongs in ADaM.
To be used with RETEST: Z-Score for Rint

Z-score of total airway resistance measured using the III Do not add (SDTM-P23): This
interrupter technique (Rint). belongs in ADaM.
To be used with RETESTCD: RINTZ

Proposed edits to 127 definition in SEND-SPEC II SEND-Published in P24, P25,
codelist; file emailed separately P26, P29
Remove QS-PDQUALIF, YMRS and SOWS SHORT III

TEST and TESTCD codelists from publication in P21,
but do not touch CATs.
The volume of blood in the right and/or left ventricle III SDTM-Published in P30
at end load or filling in (diastole) or the amount of
blood in the ventricles just before systole.
To be used with MOTEST : End diastolic volume

The volume of blood in the right and/or left ventricle III SDTM-Published in P30
at end load or filling in (diastole) or the amount of
blood in the ventricles just before systole.
To be used with MOTESTCD : EDV

The volume of blood in a ventricle at the end of III SDTM-Published in P30
contraction, or systole, and the beginning of filling, or
diastole.
To be used with MOTEST : End systolic volume
The volume of blood in a ventricle at the end of III SDTM-Published in P30

contraction, or systole, and the beginning of filling, or
diastole.
To be used with MOTESTCD : ESV

The ratio of the volume of blood the heart empties III Do not add (SDTM P27):
during systole to the volume of blood in the heart at Already exists as Left
the end of diastole expressed as a percentag Ventricular Ejection Fraction
(C99524)
To be used with MOTEST : Ejection Fraction
The ratio of the volume of blood the heart empties III Do not add (SDTM P27):
during systole to the volume of blood in the heart at Already exists as Left
the end of diastole expressed as a percentage Ventricular Ejection Fraction
(C99524)
To be used with MOTESTCD : EF
Mitral annular plane systolic excursion, medial/septal III Do not add (SDTM P27):
Removed by Requestor
To be used with MOTEST : Annulus displacement
medial/septal
Mitral annular plane systolic excursion, medial/septal III Do not add (SDTM P27):
To be used with MOTESTCD : MAPSEM
Mitral annular plane systolic excursion, lateral III Do not add (SDTM P27):
To be used with MOTEST : Annulus displacement
lateral
Mitral annular plane systolic excursion, lateral III Do not add (SDTM P27):
To be used with MOTESTCD : MAPSEL
Measurement of the systolic medical annular velocity III Do not add (SDTM P27):
via Echocardiography Removed by Requestor
To be used with MOTEST : Systolic medial annular

velocity
Measurement of the systolic medical annular velocity III Do not add (SDTM P27):
via Echocardiography Removed by Requestor
To be used with MOTESTCD : SMV

Measurement of the longitudinal contraction via III Do not add (SDTM P27):
Echocardiography Removed by Requestor
To be used with MOTEST : Longitudinal contraction
Measurement of the longitudinal contraction via III Do not add (SDTM P27):
Echocardiography Removed by Requestor
To be used with MOTESTCD : LC

The EMAIL filed separately contains the Rey AVLT III QRS-Published in P23
Supplement request form and FT Terminology
spreadsheet for this instrument. Explanations are
provided in these documents.
Synonym case/capitalization change(s); File emailed II SDTM-Published in P23
separately
New term request from COPD TA team to create new III SDTM, SEND-Published in
codelists and add new terms to support COPD P22, P23
TAUG; File emailed separately
This request is from the PK team. Team already III SDTM, SEND-Published in
reviewed and agreed to add these terms, we just P22
need to get a request number. File emailed
separately.
For the lab test of Progesterone Receptor III SDTM, SEND-Published in
(Biochemistry) we represent the results in the unit of P24
fmol/mg.
For Urine Albumin Corrected by Creatinine we III SDTM, SEND-Published in
represent these results in mg/mmol. P25
Based on review of the TBI CDEs and alignment to III
SDTM, I was requested to submit this new codelist
request for the general FAOCCUR variable that
indicator whether a pre-specified EVENT or
INTERVENTINON exists. This is an extension of the
current NO_YES CODLIST, which is not sufficient to
cover the FAOCCUR use case.
I( have sent spreadsheet describing this separately.
Based on review of the TBI CDEs and alignment to III

SDTM, I was requested to submit this new codelist
request for the general FAOCCUR variable that
indicator whether a pre-specified EVENT or
INTERVENTINON exists. This is an extension of the
current NO_YES CODLIST, which is not sufficient to
cover the FAOCCUR use case.
I( have sent spreadsheet describing this separately.
This is a CC to support the dyslipidemia TA. It has III QRS-Published in P24.

been confirmed that it is in the public domain and
draft terminology has been created.
Please considering adding this lab test. Currently not III SDTM, SEND-Published in
available in CDISC Controlled Terminology for Lab. P24
Lab test required for AZ clinical trials.
Reference:
http://onlinelibrary.wiley.com/doi/10.1111/j.1432-
2277.2012.01529.x/pdf
All other terms for QTCB and QTCF in this codelist II SDTM, SEND-Published in
are uppercase e.g. QTCB PROLONGATION, SHORT P22
QTCB, QTCF PROLONGATION, SHORT QTCF
There are 15 UNIT terms that contain 'sec' e.g. III SDTM, SEND-Question
cycle/sec or msec. There are also 6 where 's' is used answered by email. For
to denote seconds, e.g. cm/s, L/s, cs. In these cases future, CDISC will use s to
the synonym contains the 'sec' variety. denote second in new units
Would it be possible to standardise on the convention of measure.
please? Or provide guidance on when one should be
used rather than the other. When I need to create an
extensible term that includes seconds its not clear
which I should use.
As per the Dec 14 removal of: III

g/g Creatinine
g/mol Creatinine
my assumption is that the 5 terms above should now
be deleted and the 'non-creatinine' versions used in
their place e.g. mEq/g,mg/g etc.
If this is not the case please explain rational.
Review of terms from FORELIMB to LYMPH NODE, II SEND-Published in P24, P25,

SUPRAPHARYNGEAL by CJD to de-specify P26, P29
definitions. File emailed separately.
Changes to synonyms for C4326 and C8559; File II SDTM-Published in P22

emailed separately.
QSTESTCD = EDSS0102 III

QSTEST = EDSS01-EDSS Ambulation Assessment
chr3, chr7, chr17, chr9p21, or something to that III Do not add (P30): No
effect, for each of the tests Chromosome 3, response received from
Chromosome 7, Chromosome 17, and chromosome requester after 3 attempts to
9p21, each tumor markers in bladder/urinary tract get more information.
cancer.
See above request. The tests above do not have

representation in CDISC CT yet. thanks,
Please consider adding Anson unit to CDISC III SDTM, SEND-Published in
controlled terminology. It is a unit used for the P22
standardization of trypsin and proteinases. Erin
Muhlbradt's research: One Anson unit is defined as
the amount of enzyme which, under specified
conditions, digests urea-denatured hemoglobin at an
initial rate such that there is liberated an amount of
TCA-soluble product per minute which gives the
same color with Folin-Ciocalteu Phenol reagent as
one milliequivalent of tyrosine at 25 C at pH 7.50.).
See more at: http://www.sigmaaldrich.com/life-
science/metabolomics/enzyme-explorer/analytical-
enzymes/subtilisin.html#sthash.mPR0UgzX.dpuf.
Thank you. APZ/25-Feb-2015
The maximum volume of air inhaled from the point of III SDTM-Published in P24
maximum expiration.
To be used with RETEST : Inspiratory Vital Capacity
maximum expiration.
To be used with RETESTCD : IVC

maximum expiration as a proportion of the predicted
normal value.
To be used with RETEST : Percent Predicted IVC
maximum expiration as a proportion of the predicted
normal value.
To be used with RETESTCD : IVCPP
Create new terms for BODY BOX respiratory tests for III SDTM-Published in P23, P24
COPD TA project; File emailed separately.
Request made on behalf of the COPD TAUG team III

from Rene Dahlheimer. File emailed separately.
Please add PUPIL to the LOC codelist. It is required III SDTM-Published in P23
metadata for 3 TEST values in MO and OE domains
as part of TBI standard. Proposed definition: The
round opening in the center of the iris.
This is the LOC information for the proposed TEST III SDTM-Published in P23
value of Intracranial Volume (see request CDISC-
1282). The team determined that this mapped to the
TEST=Volume, with Intracranial Space as the
Anatomical Location. NCI suggests CRANIAL
CAVITY as the better PT. The published CDISC
definition is: The atrium that is formed by the bones of
the skull, and contains the brain. [This term is
published in the SEND subset only]
Relates to email string regarding 'new' and 'old' III Discussed in P23.
terminology e.g.
New = JT Interval, Aggregate
Old = Summary (Mean) JT Interval
How do users know which to use? Is there

documentation at the list_name/term level? These
things may be covered in webinars or information
given at the time of a load release. But the people
actually doing the mapping and choosing the terms to
map to are not necessarily the ones who will attend
webinars. And new people come on board all the time
who will not know the history. If the expectation is that
we must choose between terms there needs to be
clear guidance when this should happen and which
are considered legacy and which preferred. My
preference is to remove 'old' terms and always move
forward. I think the ECG terminology is the only one
right now that is taking the dual approach. I think the
terminology needs to administered consistently.
Why are the terms 'duration' and 'interval' used

interchangeably? If there are no plans to standardise
them, can the alternative be added as a synonym?
I have worked on two studies that have measured III
blood flow in two different anatomical locations: Renal
Blood Flow and Cerebral Blood Flow. The NCI-T
includes a concept for Blood Flow Rate:
Thesaurus
1. Should this be modeled as TEST = Blood Flow

Rate and LOC = the Location of Measurement or
should each location have a unique TESTCD.
2. I am not certain this belongs in the MO domain.
Blood Flow may be more appropriate for a
physiological findings domain. In the PKD TAUG, a
provisional UR domain was proposed; however, I
have not seen that domain in the SDTM 3.3 batches.
3. The provisional UR domain in the PKD TAUG
includes a URTESTCD=RBLDFLW, URTEST=Renal
blood flow. Although URTEST does not follow SDTM
TEST conventions, I did want to make you aware of
this.
Either add terminology for location independent blood

flow or add terminology to for cerebral blood flow and
renal blood flow.
Request to add a new term to SPEC for "ear, canal". III SEND-Published in P22
A proposed definition would be "A tubular structure
that runs from the outer ear to the tympanic
membrane."
Synonym = external auditory meatus
"Request to add new rat strain called "Nude" III SEND-Published in P22
Description is "The NIH nude rat was developed in
1979?1980 through a series of matings involving 8
inbred rat strains. To Charles River from the National
Institutes of Health in 2001. Taconic received stock
from NIH Animal Genetic Resource in 1981. This
athymic nude rat is T-cell deficient and shows
depleted cell populations in thymus-dependent areas
of peripheral lymphoid organs." Although this
definition may not follow the STRAIN rules.
Synonyms would include "Hsd:RH-Foxn1rnu (r-n-u),
Crl:NIH-Foxn1rnu, Athymic Nude (from harlan),
Ntac:NIH
Please consider adding the following term: TENDON III SEND-Published in P22
SHEATH
I was trying to find an 'aggregated' version of QTC as III Do not add (SDTM-P22) - Do
per QTCBAG and QTCFAG but there is not a not add aggregate for QT
QTCAG. Interval, Corrected. The
I did find QTAG but this doesn't mention that it is sponsor needs to determine
corrected: An aggregate QT value based on the what the correction is. If the
measurement of QT intervals from multiple beats correction is not known, this
within a single ECG. The method of aggregation, codelist is extensible.
which can vary, is typically a measure of central QTAG is not corrected.
tendency such as the mean.
Can you please let me know if QTAG is 'corrected'? If
so, please amend the definition to say so. If not,
please create a new term for QTCAG (QTC Interval,
Aggregate)
The entry umol/L in PKUNIT looks like a duplicate, II

but when comparing the NCI Preferred Term, there is
a difference. I suspect that the CDISC Submission
Value is incorrect for the PKUNIT entry of umol/L as
the NCI Preferred Term is Nanomole per millimeter
and not Micromole per Liter.
The difference is that UNIT is Micromole per liter, but

for PKUNIT it is Nanomole per millimeter. I suspect
that entry of umol/L is incorrect for the PKUNIT and
should be umol/mL.
Codelist LBTEST (C67154), Code (C116208) Platelet II

Derived Growth Factor Isoform AB is 41 characters in
length. As per the SDTM IG, the LBTEST is limited to
40 characters. Please shorten this CDISC
Submission value so that it meets the requirement.
The CDISC Submission value exceeds the length of

40 characters.
The Submission Value of umol/L (Code C85756) in II
PKUNIT (C85494), should be the same code as in
the UNIT (C76120) codelist for umol/L (C48508).
Both the CDISC Definition and the NCI Preferred
Term are also different even though the Submission
Value is the same in the two codelists. This is not the
case for other matches between the UNIT and
PKUNIT codelists. I suspect that the Submission
Value is incorrect for the PKUNIT entry of umol/L as
the NCI Preferred Term descritbes it as Nonomole
per milliliter. Therefore I believe that the Submission
Value should be corrected to umol/mL
The other submission values match between the

UNIT and PKUNIT codelists. This entry is
inconsistent,
LBTESTCD = DHGBOXY III SDTM, SEND-Published in

LBTEST = Deoxyhemoglobin P24.
A drug program will be measuring blood gases

including Deoxyhemoglobin. A term exists for
Oxyhemoglobin. Other "Deoxy" terms (e.g.
Deoxypyridinoline) use a prefix of "D"
I'd like to know whether the Mayo Scoring System for III
Assessment of Ulcerative Colitis Activity would be an
appropriate term for the Clinical Classifications
domain.
Mayo "scores can range from 0 to 12, with higher

scores indicating more severe disease activity"
(PMID16339095,
http://www.nejm.org/doi/full/10.1056/NEJMoa050516
#t=article). The subscore sections include stool
frequency, rectal bleeding, findings on endoscopy,
physician's global assessment, and each subscore
ranges from 0 to 3.
Original article for the Mayo Scoring System for

Assessment of Ulcerative Colitis Activity:
PMID3317057,
http://www.nejm.org/doi/full/10.1056/NEJM19871224
3172603
I'd like to know whether the Psoriasis Area and III QRS-Published in P30
Severity Index (PASI) would be an appropriate term
in the Clinical Classifications domain.
"PASI combines the assessment of the severity of

lesions and the area affected into a single score in
the range 0 (no disease) to 72 (maximal disease)."
(http://en.wikipedia.org/wiki/Psoriasis_Area_and_Sev
erity_Index)
The Crohn's Disease Activity Index (CDAI) may be an III
appropriate term for use in the Clinical Classifications
domain.
http://en.wikipedia.org/wiki/Crohn
%27s_Disease_Activity_Index
It would also be useful to include the Harvey-

Bradshaw index, which is a simpler version of the
CDAI.
Same case as other units (e.g. cycle/min). It makes it II SDTM, SEND-Published in

more consistent on the CRF and also in listings P22
The team is not sure that these are valid for animal II Request withdrawn by
studies. requester in P25
File emailed separately. BrCa team requests that the III

CC team review this instrument to determine if it
belongs in CC.
We are getting a copy of the instrument on a disk III SDTM-Published in P32.

from a member of the BrCa team. It contains the
official version 7 copy of the AJCC TNM staging
manual.
Here is the link to the AJCC Staging Manual website:

http://cancerstaging.org/references-tools/deskreferen
ces/Pages/default.aspx
Here is a link to the copyright permissions page on

the AJCC site for using this instrument:
http://cancerstaging.org/Pages/Permission-Req.aspx
Modify the QTC terms, should be lower case 'c' in II SDTM, SEND-Published in
these submission values and synonyms; File emailed P22
separately.
Hello, Please consider adding Free Protein S to III
CDISC Controlled terminology for LAB. Also suggest
amending definition of current Protein S term to
include word "total" in the Protein S definition. There
are several types of Protein S deficiency which can
include bound vs. free vs. total Protein S. Types of
hereditary protein S deficiency include:
Type I - decreased protein S activity: decreased total
protein S (=both bound and free protein S) levels
AND decreased free protein S levels (quantitative
defect)
Type II - decreased protein S activity: normal free
protein S levels AND normal total protein S levels
(qualitative defect)
Type III - decreased protein S activity: decreased free
protein S levels AND normal total protein S levels
(quantitative defect)
Thank you. Anna Pron-Zwick/10-Mar-2015
Please add the following terms to the Microorganism III SDTM-Published in P25
codelist:
ANAEROBIC GRAM-NEGATIVE COCCOBACILLUS
(Definition: Any short, thick bacterial rod having the
shape of an oval or slightly elongated coccus that
does not require oxygen to grow or respirate and has
a cell wall that contains low levels of peptidoglycan
and stains pink with the Gram staining technique.)
STREPTOCOCCUS MITIS (Definition: Any bacterial
organism that can be assigned to the species
Streptococcus mitis.)
Please consider adding "Monocytes" as a specimen III SDTM-Published in P25

type. cGMP can be measured in various cell types
including monocytes. MSH Definition: Large,
phagocytic mononuclear leukocytes produced in the
vertebrate BONE MARROW and released into the
BLOOD; contain a large, oval or somewhat indented
nucleus surrounded by voluminous cytoplasm and
numerous organelles. Thank you. Anna
Pron-Zwick/11-Mar-2015
Maps to C12602 with proposed definition: The male III SDTM-Published in P25
reproductive cell that is formed in the testicle. A
sperm consists of a head, a body, and a tail that
provides propulsion.
Also, add synonym 'Spermatozoon'
The lab team has removed Units of this type from the II
UNIT codelist and is proposing that the PK team do
likewise.
Create 2 new QSCAT values for C-SSRS III QRS-Published in P23
Pediatric/Cognitively Impaired instruments
(Lifetime/Recent and Since Last Visit). These were
both used recently in Shire studies. They were
created for clinical practice.
Instruments will be provided separately. Terminology

will be provided after copyright approval is received.
Update Definition to: A concretion of material in the II SDTM - Published in P23

body, usually composed of mineral salts.
Representative examples include gallbladder stones,
kidney stones, and salivary gland stones.
Change definition to: Destruction of an epithelial II SEND - Published in P23

surface extending into or beyond the basement
membrane.
The PHSPRP and PHSPRPCD codelist is an orphan
codelist. I'd also like to suggest that we figure out
what to do with the rest of the terms in this codelist. If
it isn't in use for a particular variable, test, or
parameter it doesn't make sense to keep it around.
Submission Values: APOA/Apolipoprotein-a III

Definition: A measurement of the total apolipoprotein-
a in a biological specimen.
C41372; Update definition. SEND is using this II Do not change (SEND-P23):

concept in the SEND-SRETST/CD codelist and would Do not change definition.
like the SDTM team to look at their proposed The definitions mean the
definition to see if it is more appropriate than the same thing but the published
existing published definition. This term is currently definition is more consistent
published in the SDTM-RETEST and RETESTCD with other definitions for
codelist. terms of this type.
Change definition to: The maximal flow (or speed)

achieved during the maximally forced expiration
initiated at full inspiration.
File emailed separately III QRS-Published in P24.

This is an update from a previously submitted request
Changes to terms MASS to SEMEN; File emailed II SEND-Published in P25, P29

separately
C119248; On behalf of SEND team, please add a II SDTM, SEND - Published in
synonym so that the SEND SCVTST value is also P23
present in the synonym column. This term is, as of
P21, published in both SDTM-CVTEST/CD and
SEND-SCVTST/CD codelists. Also, please have
SDTM review SEND proposed definition to determine
which is most appropriate.
Addition of Synonym: Total Peripheral Resistance

(This is identical to the SEND TEST name)
SEND proposed definition: The sum of the resistance
of all peripheral vasculature in the systemic
circulation.
All TB studies categorize whether medication was III SDTM-Published in P23

given during the induction or continuation phase. It is
important to keep this information with each subject
record.
Add 5 terms to SEND-NONNEO codelist. This III SDTM-Published in P23
codelist was published with P21 so is not 'new'
anymore; File emailed separately.
This is a request to get request numberds for a new III SDTM, SEND-Published in
term and to modify some terms in the P22
PKPARM/PKPARMCD codelists. These
additions/changes are already in the spreadsheet.
This term was originally requested to be added to the III SDTM-Published in P24
Method codelist. It was rejected with the reason:Do
not add. This is not a method, it is a procedure that
has a result. ?Cardiac catheterization? refers to any
procedure by which catheters are advanced to the
heart via a central artery and/or central vein.
Therefore, we are requesting to add this term to the
Procedure codelist.
We are creating 3 additional terms associated with III SDTM-Published in P22

request number CDISC-1500. The general team
agreed to add these three terms along with a general
term for incision method. IVY INCISION METHOD,
DUKE INCISION METHOD, TEMPLATE INCISION
METHOD. These terms will be going out for public
review with P22.
Please add the following test names (and test codes) III SDTM-Published in P23
to the Cardiovascular Test Name (and Cardiovascular Do not add (SDTM P26) - Left
Test Code) codelists: Ventricular Volume, End-
Left Ventricular Volume, End-Diastole (LVVOLED) - Diastole and Left Ventricular
definition: The volume of blood in the ventricle at Volume, End-Systole: Use
diastole or the amount of blood in the ventricle just the new terms 'Volume, End
before systole. Ventricular Diastole' and
'Volume, End Ventricular
Left Ventricular Volume, End-Systole (LVVOLES) - Systole' that are out for P26
definition: The volume of blood in the ventricle at the public review. Use "Heart,
end of systole and the beginning of diastole. Left Ventricle" as the
anatomical location.
Stroke Volume (STROKVOL) - definition: The
difference in a cardiac ventricle's blood capacity
taken at times of minimum and maximum blood
content. This is end diastolic volume less end systolic
volume.
We have some new variables for ADSL that record III ADaM-Published in P24, P25
the status of a subject during the trial. if there is a
data cutoff analysis the ADSL will show the status of
the subject at that point in time. Variables that will
have this CT are EOTSTT (label = End of Treatment
Status), and other supporting variables with xx, such
as EOTxxSTT.
This CT term is found in the DD domain examples in III SDTM-Published in P24

SDTM; would be preferable to have CT for all the
examples
The word scale appears in the TEST(CD) description II QRS-Published in P23
making them unlinkable to the synonym in : C113872
C100129 Category of Questionnaire BORG CR10.
C111379 C100129 Category of Questionnaire C- II QRS-Published in P22

SSRS CHILDREN'S SINCE LAST VIST CSS08
Remove GLAND, PROSTATE DORSOLATERAL III
GLAND, PROSTATE VENTRAL
One should map to --SPEC = GLAND, PROSTATE

and the use the --DIR variable to indicate
directionality.
Code Codelist Code Codelist Extensible (Yes/No)
Codelist Name CDISC Submission Value
C90376 C99074 Directionality DORSOLATERAL
C45875 C99074 Directionality VENTRAL
Please consider removing the following terms:
Code Codelist Code Codelist Extensible (Yes/No)

Codelist Name CDISC Submission Value
C77622 C77529 Specimen GLAND, PROSTATE
DORSOLATERAL
C77623 C77529 Specimen GLAND, PROSTATE
VENTRAL
ASSG01-ASSIGN CVD Risk Score, here is the III QRS-Published in P24.

spreadsheet that goes along with the request made
today for the ASSIGN CVD 10-Year risk; file emailed
separately
ASCVD1- ASCVD 10-Year Risk Estimator, Here is III QRS-Published in P24.
the spreadsheet that goes along with the request
made today for the ASCVD 10-Year estimator, file
emailed separately.
Terminology available for Calcium Sulphate III SDTM, SEND-Published in
(C96590), but not Calcium Sulphate Crystals. P24
A calculated measurement of the C reactive protein in III
a biological specimen, standardized result.
C Reactive protein (CRP) Standardized Value will be

used to assess the flares/disease progression in the
Hereditary Periodic Fever (HPF) study and is part of
efficacy/end point to explore the effect of study drug.
C Reactive protein Standardized Value is a

calculated value based on raw CRP value, its unit
and normal ranges. The raw CRP value is
standardized to: 0.0 - 10 mg/L.
A calculated measurement of the C reactive protein in III
a biological specimen, standardized result.
C Reactive protein (CRP) Standardized Value will be

used to assess the flares/disease progression in the
Hereditary Periodic Fever (HPF) study and is part of
efficacy/end point to explore the effect of study drug.
C Reactive protein Standardized Value is a

calculated value based on raw CRP value, its unit
and normal ranges. The raw CRP value is
standardized to: 0.0 - 10 mg/L.
Study treatment is being given by a secondary IV. III

The NCI-T includes INTRAVENOUS PIGGYBACK:
Thesaurus
Please consider adding this requested unit as all III SDTM, SEND-Published in
molecular biology studies, the data is reported in P25
copies/�g
Please consider adding Carbohydrate-Deficient III SDTM, SEND-Published in
Transferrin/Total Transferrin to CDISC controlled P25
terminology for LAB. Unsure what to propose as an
LBTEST. Proposed LBTESTCD: CDTTFERN.
Proposed Definition: A relative measurement (ratio or
percentage) of the carbohydrate-deficient transferrin
to total transferrin in a biological specimen. Thank
The cumulative expired volume at the point where III SDTM-Published in P24
end-tidal inert gas concentration (TD) falls below
1/40th of the original concentration, divided by the
functional residual capacity (FRC).
To be used with RETEST : Lung Clearning Index
The cumulative expired volume at the point where III SDTM-Published in P24
end-tidal inert gas concentration (TD) falls below
1/40th of the original concentration, divided by the
functional residual capacity (FRC).
To be used with RETESTCD : LCI
Amount of oxygen taken up and utilized by the body. III SDTM-Published in P23
To be used with RETEST : Oxygen Consumption

Amount of oxygen taken up and utilized by the body. III SDTM-Published in P23
To be used with RETESTCD : VO2
Volume of oxygen consumed by the body per III SDTM-Published in P23

heartbeat.
To be used with RETEST : Oxygen Pulse

Volume of oxygen consumed by the body per III SDTM-Published in P23
heartbeat.
To be used with RETESTCD : O2PULSE

The ratio of carbon dioxide production to oxygen III SDTM-Published in P23
consumption (VCO2/VO2).
To be used with RETEST: Respiratory Exchange

Ratio
The ratio of carbon dioxide production to oxygen III SDTM-Published in P23
consumption (VCO2/VO2).
To be used with RETESTCD : RER
C120984 APACHE II TEST CC-Acute Physiology and II QRS-Published in P22

Chronic Health Evaluation II Clinical Classificationn
Test Name
C120988 CHILD-PUGH CLASSIFICATION TEST
CC-Child-Pugh Clinical Classificationn Test Name
C120992 NSA-16 TEST CC-Negative Symptom
Assessment-16 Clinical Classificationn Test Name
C120990 MELD TEST CC-Model for End Stage Liver
Disease Clinical Classificationn Test Name
A finding indicating that there is a decrease based on II SDTM-Published in P23

a predetermined threshold in the size and the extent
of tissue involvement by cancer.
Team already agreed to this change, just need a

request code.
File emailed separately Multiple Term Request_Bob III SDTM-Published in P23

Dempsey_2015-03-31
Please add this to the CDISC terminology for III SDTM, SEND-Published in
laboratory tests. P25
Based on discussions with Bernice, the current test
does not include the pH normalization.
This is a request to make the PHQ-15 terminology III QRS-Published in P24.
consistent with the PHQ-9 terminology by adding a
new Test Code/Name called PHQ0216 (PHQ02-Total
Score); To add a test/cd in the Patient Health
Questionnaire - 15 Item Test Code/Test Name
codelists; File emailed separately
The PK team would like to request some changes to II SDTM, SEND-Published in
units that are shared with the Lab team.; file emailed P24
separately
Submission value = L/kg II SDTM, SEND-Published in
Synonym = Liter per Kilogram (remove synonym) P24
Change Definition from
A dose calculation unit expressed in liter(s) per
kilogram. (NCI)
to
Liters (volume), divided by kilograms (weight).
C119073 CC-Coronary Thrombus TIMI Grade Clinical II QRS-Published in P22

Classificationn Test Name
C120986 CC-The Body-Mass Index, Airflow
Obstruction, Dyspnea, and Exercise Capacity Index
Clinical Classificationn Test Name
For the code C100425, please remove "Ratio" as this II SDTM, SEND-Published in
is not alligned with all other "ratio-TESTCDs", and P24
please alligned this with C121182.
TEST: Macrophages/Leukocytes III SDTM-Published in P23
TESTCD: MCPHGLE
Definition: A relative measurement (ratio or
percentage) of the macrophages to leukocytes in a
This is a request from the COPD TA team.
File emailed separately - also sent email request III SDTM-Published in P40
(April 09, 2015) to Steve and Gary on the QS
terminology team.
The total score of lesions as measured by SPARCC III Do not add (P35): Do not
spine or CANDEN MRI scoring methods. add. Please consult the RA
TAUG for how to model
To be used with MOTESTCD : TOTDVU these tests. The name of the
criterion should be pre-
coordinated into the Test
name.
The total score of lesions as measured by SPARCC III Do not add (P35): Do not
spine or CANDEN MRI scoring methods. add. Please consult the RA
TAUG for how to model
To be used with MOTEST : Total Score of Lesions these tests. The name of the
per Subject criterion should be pre-
name.
The total SIJ score, including depth and intensity III Do not add (P35): Do not
(BME), as measured by the SPARCC SIJ MRI add. Please consult the RA
scoring method. TAUG for how to model
these tests. The name of the
To be used with MOTESTCD : SUMSIJ2 criterion should be pre-
name.
The total SIJ score, including depth and intensity III Do not add (P35): Do not
(BME), as measured by the SPARCC SIJ MRI add. Please consult the RA
scoring method. TAUG for how to model
these tests. The name of the
To be used with MOTEST : Total SIJ Score BME criterion should be pre-
name.
File emailed separately - also sent email request III QRS, SDTM-Published in P50
(April 09, 2015) to Steve and Gary on the QS
terminology team.
West Haven Hepatic Encephalopathy Grade was III QRS, SDTM-Published in P24
originally assigned controlled terminology as a
Findings About Test and controlled terms for the
responses (Grade 0, Grade 1, etc.). The recent
review of existing CT transitioning to Clinical
Classifications exercise resulted in the approval to
move the West Haven Hepatic Encephalopathy
Grade from FA to CC.
Spreadsheet file mailed separately.
This synonymy is no longer valid. II SEND-Published in P24
Proposed Updated Definition: A technique for II SDTM-Published in P23

counting, examining or sorting microscopic particles
suspended in a stream of fluid. The cells are stained
with a light-sensitive dye, placed in a fluid, and
passed in a stream before a laser or other type of
light. The measurements are based on how the light-
sensitive dye reacts to the light.
Multiple term request for Oncology team: Add new III SDTM-Published in P23
terms to RSSTRESC and RSTEST/RSTESTCD
codelists.
Please add the term PENICILLIUM to the III

Microorganism codelist. Source is NCBI Taxonomy
website.
Proposed definition: Any fungal organism that is not
assigned to the species level but can be assigned to
the Penicillium genus level.
Please add the terms CTU and MRU to the Method III
codelist.
CTU is Computed Tomographic Urography and MRU
is Magnetic Resonance Urography. Computed
tomography urography and magnetic resonance
urography use CT and MR images, respectively, after
intravenous contrast material to obtain images of the
urinary tract.
Please consider creating the proposed 7 new lab III SDTM, SEND - Published in
tests to support DKD TA standards; Also please P23, P24
consider modifying the existing test for HOMA-IR; File
emailed separately
Request from INHAND for additional Female Repro III SEND-Published in P23, P25
terms - request submitted to get a request number
only.; File emailed separately
Terms and definitions agreed to by SEND team: III SEND-Published in P23
Hydromyelia: Dilation of the central canal of the spinal

cord.
Syringomyelia: Cavitation of the spinal cord
parenchyma.
Syringomyelia/Hydromyelia: A finding that generally
has features of syringomyelia and hydromyelia.
This will enable users to populate the EGEVAL III SDTM-Published in P25
variable in the EG domain with an accurate and most
appropriate value.
File emailed separately III SDTM, SEND-Published in
P24, P25, P26, P35
Do not add (SDTM, SEND-
P24) - TUMOR, BASAL CELL,
MALIGNANT; Please use
existing term C111199.
Do not add (P35):
ASTROCYTOMA,
MALIGNANT, LOW GRADE -
Do not add. Please use
ASTROCYTOMA, MALIGNANT
or ASTROCYTOMA, DIFFUSE,
MALIGNANT.
ASTROCYTOMA,
MALIGNANT, HIGH GRADE -
ASTROCYTOMA, MALIGNANT
or ASTROCYTOMA, DIFFUSE,
MALIGNANT.
OLIGODENDROGLIOMA,
MALIGNANT, LOW GRADE;
OLIGODENDROGLIOMA,
MALIGNANT, HIGH GRADE -
OLIGODENDROGLIOMA,
MALIGNANT.
This has already been agreed to and just needed a III SDTM-Published in P24
request number.
Change definition for FEV1, FVC, and FEV1FVC: II SDTM-Published in P24

FEV1 - The volume of gas or air that can be forcibly
exhaled during the first second following maximal
inhalation.
FVC - The volume of gas or air that can be forcibly
exhaled following maximal inhalation.
FEV1FVC - The ratio of the forced expiratory volume
during the first second of exhalation to the largest
observed expired volume during a forced vital
capacity maneuver.
This already exists in the spreadsheet but needed a
request number.
In Boby plethiysmography test is also important the III SDTM-Published in P25

percent of predicted FRC in a lot of trials as inclusion
criteria
1/(sec x kPa) are the unit that is used for SGAW III SDTM-Published in P26
parameter. This parameter SGAW has been included
in the review package 22 (for RETESTCD and
RETEST) but in this package has not been included
the requested unit
If Peripheral Blood is a synonym of blood, I would II SDTM - Published in P23
expect Whole Blood to be one also.
Change definitions (or add new terms) for the II SDTM-Published in P24
following when used as units, rather than as building
blocks for other units: /dL, /L, /mL, /nL, /pL, /uL
Current definitions in the form: "A volume unit equal
to <unit of volume> used as a denominator to build a
derived unit expressed as a ratio. More appropriate
definition: "A unit of measurement equal to one entity
per unit of volume equal to one <unit ofvolume>". In
addition, some of these units are synonymous to
other units already in the CDISC UNIT code list. For
example, "/ml" is synonymous to "10^3/L" and "/uL" is
synonymous to "10^6/L".
Current definitions do not accurately define these

terms when used alone as units. Current code list
does not recognize synonym of some units.
Histopathology is the microscopic examination of III

tissue in order to study the manifestations of disease.
To be used when catagorizing the Global
Assessment of Histopathological Score in the Clinical
Classifications domain.
SAXIS and LPERP were both published in P6 and II SDTM - Published in P23
added by the Oncology team as part of the initial list
of TRTEST values. Breast Cancer Team would like
the Oncology team to review these two terms and
definitions and discuss the question of synonymy. In
BrCa, these are effectively synonymous (redundant)
so please advise on which they should use. Should
Short Axis only be used for Lymph Nodes as per
RECIST? Discuss whether to keep both on the list
and if so, we may need to update the definition(s) to
better differentiate these terms.
Hi. We need to generate a large amout of COA TEST II
submission values and we are trying to follow CDISC
formatting conventions. But for words such as 'with'
and 'due' there is inconsistency in the COA list;
some are 'with' e.g. HADS01-Look Forward with
Enjoyment, others 'With' e.g. GDS02-Satisfied With
Life.
some are 'due' e.g. AIMS01-Incapacitation due Abn
Movements, other are 'Due' e.g. AQ01-Feel Restless
Due to Chest Trouble
Since 'with' and 'due' are not in your guidelines as
lowercase words can you please confirm that these
are incorrect in the term lists? Are there any plans to
correct them?
Many thanks
This term exists as Bioelectric Impedance Analysis III Do not add (SDTM-P25):
(C43545) in the NCI Thesaurus. Their definition is "A Please use C71258 Lean
method to assess body composition, i.e., the relative Body Mass.
percentages of body weight comprised of fat tissue
and lean body mass. It is based on the principle that
the resistance to an applied electric current is
inversely related to the amount of lean body mass
within the body. Impedance is greatest in fat tissue,
which contains only 10-20% water, while lean body
mass, which contains 70-75% water, allows the signal
to pass much more easily."
Often measured in units kcal/day. Possible definitions III SDTM, SEND - Published in
are P25
"minimal rate of energy expenditure per unit time by a
subject at rest"
"measurement of a subject's energy expenditure
when at rest"
This measurement is being collected in our study but III Do not add (SDTM P25) -
is not in the Controlled Terminology for RETEST. The Already exists in the lab test
ratio of partial pressure arterial oxygen and fraction of code/name codelist
inspired oxygen, sometimes called the Carrico index, (C119293).
is a comparison between the oxygen level in the
blood and the oxygen concentration that is breathed.
MITEST>Knodell Fibrosis Score is a composite score III SDTM, SEND-Published in
of necrosis, inflammation, and fibrosis. P26
Should the final "Score" be captured in the CC
domain? If so, perhaps the original results for
components of necrosis, inflammation, fibrosis
original scores can be captured in MI domain, and the
score for these components of necrosis,
inflammation, fibrosis be captured in CC domain as
well?
This might be applicable to the other liver disease-

related scores in the MITEST codelist such as
METAVIR,et.
The BrCA TAUG team was having a similar

discussion on how to model Estrogen Receptor
Scoring recently, so it might be nice to get clarity on
how to handle these types of scoring systems.
At AstraZeneca, we collect Absorbance Units per III SDTM, SEND - Published in

Milliliter for some of our antibody lab tests. We use P25
AU/mL as the abbreviation for this lab unit; however,
CDISC already has AU/mL as Allergy Unit per
Milliliter. I will leave it up to the CDISC Lab Team to
suggest an appropriate CDISC Submission Value for
Absorbance Units per Milliliter. Thank you. Anna
Pron-Zwick/27-Apr-2015
The outermost layers of cells in the skin. III SDTM, SEND-Published in

P26
The layer of skin between the epidermis and III SDTM, SEND-Published in
subcutaneous tissue. P26
Stain (presence) of K16 Positive Keratinocytes III SDTM, SEND-Published in

P26
Stain (presence) of K16 Positive Keratinocytes. III SDTM, SEND-Published in

To be used with MITESTCD : K16K P26
Lipocalin-2 in keratinocytes III SDTM, SEND-Published in

To be used with MITEST : Lipocalin-2 in P26
Keratinocytes
Lipocalin-2 in keratinocytes III SDTM, SEND-Published in

To be used with MITESTCD: LCN2K P26
S100-A7 S11 calcium binding protein A7 in III SDTM, SEND-Published in
keratinocytes P26
To be used with MITEST : S100-A7 in Keratinocytes
S100-A7 S11 calcium binding protein A7 in III SDTM, SEND-Published in

keratinocytes P26
To be used with MITESTCD : S100A7K
Beta Defensin 2 in Keratinocytes III SDTM, SEND-Published in

To be used with MITEST : Beta Defensin 2 in P26
Keratinocytes
Beta Defensin 2 in Keratinocytes III SDTM, SEND-Published in

To be used with MITESTCD : BD2K P26
Stain (number) of Ki-67 Positive Keratinocytes III

To be used with MITEST : Ki-67 Positive
Keratinocytes
Stain (number) of Ki-67 Positive Keratinocytes III

To be used with MITESTCD : KI67K
Number of CD3+ T Lymphocytes III SDTM - Published in P47

To be used with MITEST : CD3+ T Lymphocytes
Number of CD3+ T Lymphocytes III SDTM - Published in P47

To be used with MITESTCD : CD3T
Number of CD11+ Dendritic Cells III SDTM - Published in P47

To be used with MITEST : CD11+ Dendritic Cells
Number of CD11+ Dendritic Cells III SDTM - Published in P47

To be used with MITESTCD : CD11D
Number of cells showing Dentritic Cell-Lysosomal- III

Associated Membrane Protein
To be used with MITEST : CD-LAMP
Number of cells showing Dentritic Cell-Lysosomal- III

Associated Membrane Protein
To be used with MITESTCD : CDLAMP
Thickness III SDTM, SEND-Published in

To be used with MITEST : Thickness P26
Thickness III SDTM, SEND-Published in
To be used with MITESTCD : THICK P26
SDTM-LOC PENIS, GLANS III SDTM, SEND-Published in

SDTM-LOC PENIS, SHAFT P23, P24, P25, P26
SDTM-FRM INFUSION Do not add (SDTM-P24):
SDTM-EGMETHOD 12 LEAD HOLTER FRM INFUSION - Infusion is
SDTM-UNIT umol/kg/min not a valid pharmaceutical
SDTM-DIR HEMI dosage form as per US
SDTM-LOC Ward's triangle Pharmacopeia.
SDTM-LOC Intertrochanter
SDTM-UNIT Pheresis
SDTM-LBTEST ABO group / type, blood
SDTM-LBTEST RH type, blood
SDTM-LBTEST Amyloid A
SDTM-LBTESTCD ABO
SDTM-LBTESTCD RHD
SDTM-LBTESTCD AMYLA
The unit um/day (micron per day) is used for the test III SDTM, SEND-Published in
mineral apposition rate. The unit mm3/mm2/year is P25
used for the test bone formation rate.
Both of these units are used in clinical trials for bone
histomorphometry assessments.
The requested unit is used to measure the Movement III SDTM, SEND-Published in
intensity (MI). In physical activity trials (MI) can be P25
measured using different devices ( e.g. Dynaport)
In the Dynaport documentation is stated that ?The
acceleration signal is expressed relative to g (1g =
9.81m/s2)?.
The requested term is not yet included In CDISC
SDTM controlled terminology,
In the NCI thesaurus is included the term "Unit of
Gravity" (NCI Thesaurus Code: C73772) and it has
"g" as synonym
In Wikipedia, for the definition of ?standard
gravity?, ?Accelerometer? or ?G-force? there are
different references to use ?g? ( and other units)
Please consider adding NORMAL FLORA. CDISC III SDTM, SEND-Published in

currently has a term for MIXED FLORA in the P25
Microorganism Codelist. This term is frequently
reported on culture of fecal specimens. Normal flora
is the mixture of organisms regularly found at any
anatomical site. The normal flora of humans consists
of a few eucaryotic fungi and protists, but bacteria are
the most numerous and obvious microbial
components of the normal flora. Thank you. APZ/30-
Apr-2015
I am e-mailing a spreadsheet with proposed code list III Work completed.
sub-sets which also includes some comments on
issues to be resolved by the controlled terminology
team.
Request to create 14 new concepts for the COPD TA III SDTM-Published in P24
team, also please consider updating definitions for 2 Do not add (SDTM-P27):
RETEST/CDs; File emailed separately CPFATS-CD terms of OCCUR,
FREQCAT, SEV, VOLCAT,
COLOR, NUMDOSAD will not
be controlled. Removed by
requestor.
Currently Streptococcus dysgalactiae is listed as a II SDTM-Published in P24

synonym to Streptococcus canis. I am not sure they
are true synonyms and request that Streptococcus
dysgalactiae be added as its own term in the
Microorganism Codelist. Thank you. Anna Pron-
Zwick/05-May-2015
Please consider removing AFACTXAA. This is a test III SDTM, SEND-Published in

used to estimate blood concentrations of therapeutic P25
drugs such as Heparin and Rivaroxaban. Results
associated with this test are estimates of non-
naturally occurring anticoagulants and for me this
information does not belong in the LB domain
LB is only used to collect drugs of abuse. All other

drug estimations (whether PK related ot monitoring
related do not belong in LB
I acknowledge that "INJECTION" is a formulation. In III

my experience with both legacy data conversions and
collection of prior and concomitant medications using
a CDASH compliant CRF, sites will record the dose
and dose unit a the number of injections given (e.g. 1
injection, 2 injections, etc.). This is often sufficient for
analysis purposes (i.e. the site is not queried to enter
the actual dose amount and unit such as 0.5 mL), but
does not comply with CDISC Controlled Terminology.
Please consider adding INJECTION as a dose unit or
as a synonym for SYRINGE or provide guidance for
representing this in SDTM.
A unit of measure equal to the number of cells per III Do not add (SDTM, SEND-
millimeter of epidermis surface length. P25) - Use /mm (new c-code)
and put cells in the lab test.
The attached diagram shows how this unit of
measure is applied to normal skin.
A unit of measure equal to the instances of an entity III SDTM, SEND-Published in
per millimeter of surface length of a biological sample. P28
Request to create CAT terminology for 19 new COA III QRS-Published in P22, P23
instruments. These instruments do not have copyright
permissions (denied or not received.) Terminology file
will be sent later. Just need a request number now.
"ASTHMA TA: Asthma Control Questionnaire

(specific to asthma) ACQ"
"ADHD Rating Scale-IV Home Version ADHD-RS"
"ASTHMA TA: Asthma Quality of Life Questionnaire
(specific to asthma) AQLQ"
"Alzheimer's TA: MontreaL Cognitive Assessment
MOCA"
"HAEMO-QOL, Questionnaire for Children and
Teenagers, Kids' Long Version I, age: 4-7
HAEMO-QOL KIDS I LONG"
Teenagers, Kids' Long Version II, age: 8-12
HAEMO-QOL KIDS II LONG"
Teenagers, Kids' Long Version III, age: 13-16
HAEMO-QOL KIDS III LONG"
Teenagers, Kids' Short Version I, age: 4-7
HAEMO-QOL KIDS I SHORT"
Teenagers, Kids' Short Versions II and III, age: 8-16
HAEMO-QOL KIDS II AND III SHORT"
Teenagers, Parent's Long Version I, age: 4-7
HAEMO-QOL PARENTS I LONG"
Teenagers, Parent's Long Version II, age: 8-12
HAEMO-QOL PARENTS II LONG"
Teenagers, Parent's Long Version III, age: 13-16
HAEMO-QOL PARENTS III LONG"
"HAEMO-QOL, Questionnaire for Adults
File emailed separately to explain more about QTca. III SDTM, SEND-Published in
Meyer_Olivier_2013_ED414.pdf P24
Please consider adding the following as a method. III

qPCR/qRT-PCR should be a method. They stand for
quantitative polymerase chain reaction/quantitative
real-time polymerase chain reaction. Quantitative
detection of amplified deoxyribonucleic acid (DNA) or
ribonucleic acid (RNA). Frequently used to assess
biodistribution, viral shedding, or gene expression.
For EGTESTCD, there is EGHRMAX, EGHRMIN, II SDTM-Published in P23
EGHRMN, but there is no EGHRMED. However there
is HRMED (even though HRMAX, HRMIN, HRMEAN
have been removed). Should HRMED be replaced by
EGHRMED? The terminology seems inconsistent.
Please clarify.
This Trial Phase terminology was approved by the III

FDA in a recently excepted Lilly protocol. We would
like to have this added to SDTM CT so we can use it
as a component to our new system pre-built with
CDISC compliant items.
MET refers to metabolic equivalent, and 1 MET is the III SDTM, SEND-Published in
rate of energy expenditure while sitting at rest. It is P26
taken by convention to be an oxygen uptake of
3.5 milliliters per kilogram of body weight per minute.
Physical activities frequently are classified by their
intensity using the MET as a reference.
the unit requested is "MET min" ( according the same III SDTM, SEND-Published in
rule followed for "Pack year") P26
MET-minutes, a unit useful for describing the energy

expenditure of a specific physical activity.
METs and MET-minutes

A well-known physiologic effect of physical activity is
that it expends energy. A metabolic equivalent, or
MET, is a unit useful for describing the energy
expenditure of a specific activity. A MET is the ratio of
the rate of energy expended during an activity to the
rate of energy expended at rest. For example, 1 MET
is the rate of energy expenditure while at rest. A 4
MET activity expends 4 times the energy used by the
body at rest. If a person does a 4 MET activity for 30
minutes, he or she has done 4 � 30 = 120 MET-
minutes (or 2.0 MET-hours) of physical activity. A
person could also achieve 120 MET-minutes by doing
an 8 MET activity for 15 minutes.
Presence of disease is being analyzed in this III SDTM-Published in P25

location. Term exists in NCI:
Thesaurus
The COA Core team and the COA Terminology team III SDTM-Published in P22, P23
agreed that the Stent Thrombosis Coronary ARC
Timing does not belong in the COA domain. It
belongs in the CV Findings About.
Would like to add total to the definition. Also, is low II SDTM, SEND - Published in
density correct? P23
This entry already exists in the spreadsheet, waiting
for a request number.
Concomitant Medications - Frequency Code: As per II Do not add (SDTM-P25) - QS

the controlled terminology "Frequency" codelist item means Quaque Septimanae
"QS" means "Every Week" or "Per Week". In reality I (every week) but is not used
believe "QS" means Quantity Sufficient. Can anyone very much any more. QW is
throw some light why QS is called as Per Week or not yet considered standard,
Every Week in Controlled Terminology/NCI. Can we just medical jargon. It is not
change this to "QW" which I believe Once a Week or a standard abbreviation.
Per Week?
I recently had a need to create a test code for urine II SDTM, SEND-Published in
urea nitrogen. CDISC currently has BUN/Blood Urea P25
Nitrogen. I could add UUN/Urine Urea Nitrogen but
that would seem wrong (two test codes for the same
thing with a different spec. Please consider changing
BUN to UREAN so it can be used for other
specimens.
Batch 1 terminology from the CDISC Breast Cancer III SDTM, SEND-Published in
TA team; File emailed separately P23, P24
This already exists in the ECG terminology team III SDTM, SEND-Published in
spreadsheet. It needs a request number. P23
The percent change in FEV1 following administration III Do not add (SDTM P25) -
of a bronchodilator relative to the pre-treatment FEV1 Already exists; C112285
value. (FEV1Reversibility)
To be used with RETEST : Percent FEV1

Reversibility
The percent change in FEV1 following administration III Do not add (SDTM P25) -
of a bronchodilator relative to the pre-treatment FEV1 Already exists; C112285
value. (FEV1Reversibility)
To be used with RETESTCD : FEV1REVP

The change in FEV1 following administration of a III Do not add (SDTM P25) -
bronchodilator relative to the pre-treatment FEV1 already exists C112285
value.
To be used with RETEST : FEV1 Reversibility

The change in FEV1 following administration of a III Do not add (SDTM P25) -
bronchodilator relative to the pre-treatment FEV1 already exists C112285
value.
To be used with RETESTCD : FEV1REV
70% of the mean value of daily PEF values as III Do not add (P30) - Given the
calculated over a pre-specified number of previous variability of the %
days parameter within the test
itself and the fact that this is
To be used with RETEST : PEF Reference Threshold company and trial specific,
Value this does not seem
appropriate to be adding as
CDISC controlled
terminology at this time.
70% of the mean value of daily PEF values as III Do not add (P30) - Given the
calculated over a pre-specified number of previous variability of the %
days parameter within the test
itself and the fact that this is
To be used with RETESTCD : PEFREF company and trial specific,
this does not seem
appropriate to be adding as
CDISC controlled
terminology at this time.
Please consider changing LBTESTCD=HAABIGM / II SDTM, SEND-Published in

LBTEST=Hepatitis A Virus Antibody IgM, to P24.
LBTESTCD=HAIGMAB / LBTEST=Hepatitis A Virus
IgM Antibody, to be consistent with other antibody
terms that are in the format of xxIGxAB.
A period or time point in a clinical study after eligibility III SDTM-Published in P25
has been met and before the start of treatment,
during which initial measurements are taken for
comparison to measurements taken after
administration of study medication.
Asthma Control Questionnaire - 5 question version III
C3738 - Remove all three synonyms. These are not II SDTM, SEND-Published in
1:1 matches anymore. The nomenclature has been P23
updated and these are now synonymous with the
'Intermediate Osteoclastic Giant Cell-Rich Tumor of
Bone' (C121932) (not published by CDISC).
The oncology team would like to add this term to the II
RSSTRESC codelist but wanted to update the
definition to make it clearer based on the tumor
response criterion papers it is used in. The proposed
definition change is: The lack of expected or desired
effect of a therapy, which may be caused by the
ineffectiveness of the therapeutic agent,
unmanageable adverse events or death.
Blood with EDTA (Ethylenediaminetetraacetic acid) III
Brain tissue III Do not add (SDTM, SEND-

P25) - Please use Tissue as
the specimen type and
BRAIN as the anatomical
location.
A chemical system that prevents change in the III

concentration of another chemical substance.
Exhaled breath condensate (EBC) is the exhalate III SDTM-Published in P25

from breath, that has been condensed, typically via
cooling using a collection device and reflects the
composition of the airway lining fluid and alveoli.
Liquor with Plasma EDTA. Liquor is additive used in III

the collection of blood. EDTA, is an additive placed in
lavender-top Vacutainer tubes that can be used as a
receptacle when drawing human whole blood. EDTA
is an anticoagulant and will help to separate blood
cells from the plasma.
Citrated plasma is blood plasma treated with sodium III

citrate, which prevents clotting.
Plasma with EDTA (Ethylenediaminetetraacetic acid) III
Plasma EDTA/DPP4 inhibitor III
Plasma EDTA with Trasylol III
Plasma with heparin III

Plasma with lithium-heparin III
Plasma with sodium fluoride III
Skin III SDTM-Published in P25
LBTESTCD= CABIND III SDTM, SEND-Published in

LBTEST= Calbindin P25
Definition= A measurement of Calbindin, a calcium
binding protein, in a biological specimen.
Reason: Synonymous term is currently not available.
Change the definition for the following tests: II

Diastolic Blood Pressure - The lowest blood pressure
after the contraction of the heart while the chambers
of the heart refill with blood.
Systolic Blood Pressure - The highest blood pressure
during the contraction of the left ventricle of the heart.
Just adding the word LOWEST and HIGHEST to the

definitions.
This recommendation comes from Dr. Tcheng.
CONTINUOUS AMBULATORY ECG - A continuous III SDTM, SEND-Published in

electrocardiographic (ECG) recording utilizing 1 or P23
more leads that records and stores data directly to
the device. The subject need not be restricted to a
medical facility, and may be able to participate in their
customary activities of daily living.
This request already exists in the ECG spreadsheet.

We just needed a request number.
Multiple Term Requests for ECG Test name; File III Do not add (SDTM, SEND
emailed separately. P24) - ATRIAL
FIBRILLATION WITH RAPID
VENTRICULAR RESPONSE
Do not add; We recommend
that this should be mapped
to the term Atrial Fibrillation
(C111092). The information
about ventricular response is
already provided in the ECG
Mean Heart Rate (C119259).
To identify cases of Atrial
Fibrillation with rapid
ventricular response, one
would filter for Atrial
Fibrillation and ECG Mean
Heart Rate greater than a
specific value.
ATRIAL FLUTTER WITH
RAPID VENTRICULAR
RESPONSE - Do not add;
We recommend that this
should be mapped to the
term Atrial Flutter (C111094).
The information about
ventricular response is
already provided in the ECG
Mean Heart Rate (C119259).
To identify cases of Atrial
Flutter with rapid ventricular
response, one would filter for
Atrial Flutter and ECG Mean
Heart Rate greater than a
specific value.
some studies only collect 'Radiographic Evaluation' III

and not the specific method (e.g. x-ray, CT, etc).
The Defintitions for the following terms is minimal and II SDTM, SEND-Published in
not in line with others in this codelist (and EGTEST of P23
course):
JTCBAG
JTCBSB
JTCFAG
JTCFSB
QTCBAG
QTCBSB
QTCFAG
QTCFSB
e.g. for QTCFAG it just says: A QTAG interval
corrected for heart rate using Fridericia's formula.
I would expect it to define the Formula (as it does for
QTCF) and to define the differences between
AGGREGATE and SINGLE BEAT (as it does for
PRAG and PRSB). Otherwise it makes understanding
the test very difficult for users.
Please ensure that the new AGGREGATE/SINGLE
BEAT tests will also be fully defined. Thanks
C112312 - new definition - A measurement of HER2 II SDTM, SEND-Published in

protein in a biological specimen. P23
C112274 - new definition - A measurement of
estrogen receptor protein in a biological specimen.
This already exists in the lab spreadsheet. We just

need a request number.
The vascular layer of the eye, containing connective III SDTM-Published in P25
tissue, and lying between the retina and the sclera.
A thin, circular structure in the eye, responsible for III SDTM-Published in P25
controlling the diameter and size of the pupil and thus
the amount of light reaching the retina.
A hole located in the center of the iris of the eye that III Do not add (SDTM P25) -
allows light to strike the retina. Already exists as C33429.
The pigmented cell layer just outside the III SDTM-Published in P25
neurosensory retina that nourishes retinal visual cells,
and is firmly attached to the underlying choroid and
overlying retinal visual cells.
Milliliters per beat III SDTM, SEND-Published in
P26
Flow or speed of air coming out of the lung during the III Do not add (SDTM P27) -
middle portion of a forced expiration. Requestor Removed
To be used with RETEST : Forced Expiratory Flow

Flow or speed of air coming out of the lung during the III Do not add (SDTM P27) -
middle portion of a forced expiration. Requestor Removed
To be used with RETESTCD : FEF

The predicted forced expiratory volume that a subject III Do not add (SDTM-P25) - The
can breathe out during the first second of exhalation predicted values for all tests
after maximum inhaltation. were mapped into the
REORREFR, RESTREFR
To be used with RETEST : Predicted FEV1 variables (REFR=Reference
Result Value).
The predicted forced expiratory volume that a subject III Do not add (SDTM-P25) - The
can breathe out during the first second of exhalation predicted values for all tests
after maximum inhaltation. were mapped into the
REORREFR, RESTREFR
To be used with RETESTCD : FEV1PR variables (REFR=Reference
Result Value).
The predicted normal value for the volume of air that III Do not add (SDTM-P25) - The
a subject can breathe in during the first second of predicted values for all tests
inhalation after maximum exhalation. were mapped into the
REORREFR, RESTREFR
To be used with RETEST : Predicted FIV1 variables (REFR=Reference
Result Value).
The predicted normal value for the volume of air that III Do not add (SDTM-P25) - The
a subject can breathe in during the first second of predicted values for all tests
inhalation after maximum exhalation. were mapped into the
REORREFR, RESTREFR
To be used with RETESTCD : FIV1PR variables (REFR=Reference
Result Value).
Calculated PEF threshold valid for the corresponding III Do not add (P30): Do not
phase add; This appears to be very
study specific to support the
To be used with RETEST : Peak Expiratory Flow capturing of derived values
Mean Threshold and is not reusable enough
across industry for CDISC to
control this term at present.
Calculated PEF threshold valid for the corresponding III Do not add (P30): Do not
phase add; This appears to be very
study specific to support the
To be used with RETESTCD : PEFMTH capturing of derived values
and is not reusable enough
Reason for Discontinuation of a Pulmonary Function III Do not add (P30) - This
Test should be a nonstandard
variable that can be
To be used with RETEST : PFT Discontinuation associated with a particular
Reason record(s) and not a separate
test.
Reason for Discontinuation of a Pulmonary Function III Do not add (P30) - This
Test should be a nonstandard
variable that can be
To be used with RETESTCD : PFTDR associated with a particular
record(s) and not a separate
test.
A millinewton (mN) is equal to one thousandth of a III SDTM, SEND-Published in

newton. P26
All plates read correctly on color discrimination test III
To be used with OETEST : All Plates Read Correctly
All plates read correctly on color discrimination test III
To be used with OETESTCD : ALLPLCOR
Distorted, blurry or missing lines reported for the III

Amsler Grid test
To be used with OETEST : Grid Lines Distorted or

Missing
Distorted, blurry or missing lines reported for the III

Amsler Grid test
To be used with OETESTCD : LNDISMIS

Line number of smallest font read on visual acuity III
test
To be used with OETEST : Line Number Smallest

Font Read
Line number of smallest font read on visual acuity III

test
To be used with OETESTCD : LNSMFONT
Number of plates read correctly on color III

discrimination test
To be used with OETEST : Number of Plates Correct
Number of plates read correctly on color III

discrimination test
To be used with OETESTCD : NUMPLCOR

Original CDISC Def: A benign neoplasm arising from II SDTM, SEND-Published in
skeletal muscle, characterized by the presence of P23
rhabdomyoblasts.
Modified CDISC Def: A benign neoplasm arising from
skeletal or cardiac muscle, characterized by the
presence of rhabdomyoblasts.
Retire codelist C96780 Tumor and Lesion III SDTM-Published in P23

Identification Results/TUMIDENT and create a new
codelist CNEW Tumor and Lesion Identification Test
Results/TUSTRESC. All items in the existing
TUMIDENT codelist will go under the new
TUSTRESC codelist.
Oncology team already agreed to make this change. I
just need a request number.
Need a request number for 4 SF-36 CAT terminology III SDTM-Published in P22
requests; These CAT terminology will be published in
P22 QRS release, I just need a request number.
NON-MORIBUND SACRIFICE: An indication that a III SEND-Published in P23

subject was euthanized due to factors not associated
with the general health of the subject.
Just getting a request number. This change is already II SEND-Published in P23

reflected in P23 working file.
Therascreen (Qiagen) III
Reference :
http://www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/Recently-
ApprovedDevices/ucm360819.htm
Cobas (Roche) III

Reference :
http://molecular.roche.com/assays/Pages/
cobasEGFRMutationTest.aspx
Agena MassARRAY Oncocarta III
Reference :
http://agenabio.com/oncocarta-panel
SNaPShot (Life Technologies) III Do not add (P30): The

Reference : terminology team is
http://www.ncbi.nlm.nih.gov/pmc/articles/ undecided about this term.
PMC3070558/ There is a special SDS
Method Sub-Team working
on the many issues of
METHODS. If a method
domain is created than this
term would be put into the
method domain, it really is
three different methods.
There might be future new
variables created or possibly
individual domain method
codelists created. But this is
to be determined by the SDS
Method Sub-Team. Until the
Method Sub-Team
completes their work, you
might consider that the
Method codelist is
extensible. The SDS
METHOD Sub-Team agrees
with this decision. Once the
decisions are made, they will
be documented in the
SDTMIG.
Sanger sequencing III SDTM-Published in P28

Reference :
http://journals.plos.org/plosone/article?id=10.1371/
journal.pone.0069604
High Resolution Melt Analysis (HRMA) III SDTM-Published in P28
Reference :
The TESTCD submission value for C111467 is II QRS-Published in P23

wrong; This TESTCD should be changed from
CSS0904B to CSS0904A to be consistent with the
rest of the TESTCD values in this codelist.
Request to add LBTEST=Beta-2 III SDTM, SEND-Published in

Microglobulin/Creatinine with P26
LBTESTCD=B2MCREAT. Suggested definition is A
relative measurement (ratio or percentage) of the
beta-2 microglobulin to creatinine in a biological
specimen.
Requesting this new term to cover safety III Do not add (SEND P26) -
pharmacology telemetry studies where both Please use the MULTIPLE
cardiovascular and respiratory parameters are convention or list two trial
collected in a single study. summary parameters of
Currently, the individual pharmacology codes SSTYP in your dataset (which
available for SSTYP do not address this scenario. ? can be Identified individually
Cardiovascular Pharmacology? alone and ? with TSSEQ).
Respiratory Pharmacology? alone both exist, but
there is no code that can address both in a single
study, nor is there a more general code available
under ?SSTYP?, such as ?Safety Pharmacology? or
"Cardiovascular and Respiratory Pharmacology".
Please see additional documentation to support the III SDTM, SEND-Published in

information below? P31
I will submit a change request and refer to this email.
http://www.healthcare.siemens.com/hematology/
systems/advia-120-hematology-system/assays
www.accessdata.fda.gov/cdrh_docs/pdf/K971998.pdf
www.accessdata.fda.gov/cdrh_docs/reviews/
K102644.pdf
www.accessdata.fda.gov/cdrh_docs/reviews/
K090346.pdf
Please update the existing CDISC definition for II QRS-Published in P23

C103524, OAB-Q SHORT FORM to its correct, 2015
reference article; File emailed separately.
This is a specimen type request for when a blood III SDTM-Published in P25
component that is either plasma or serum is utilized,
but where neither one nor the other is specifically
detailed. Frequently observed in local labs where
specimen type is often not detailed. Also, this
specimen is aligned with LOINC terminology
An estimation of the glomerular filtration rate adjusted III SDTM, SEND-Published in
for body size based on cystatin C and creatinine. P26
To be used with LBTEST : GFR Cystatin C/Creatinine

Ratio

To be used with LBTESTCD : GFRCYCRR
C49606 SDTM Domain Abbreviation PC change II SDTM, SEND-Published in

"Pharmacokinetic Concentration" to "Pharmacokinetic P33
Concentrations" to match the CDISC Synonym for
PP. As we add domains in the PK area we should be
sure we continue with a plural CDISC Synonym.
TB TAUG - NIAID has requested that we add this as III SDTM-Published in P24.
they always collect this information. It is possible that
the sex reported would be different than birth gender
if subject underwent a sex change.
The TB TA needs terminology for WHO HIV Staging III QRS-Published in P24
https://en.wikipedia.org/wiki/
WHO_Disease_Staging_System_for_HIV_Infection_a
nd_Disease_in_Adults_and_Adolescents
The TB TAUG needs CDC HIV Staging (CC domain) III QRS-Published in P24
https://en.wikipedia.org/wiki/
CDC_classification_system_for_HIV_infection
Needed for TB TAUG III SDTM, SEND-Published in

P24.
Needed for the TB TAUG III SDTM, SEND-Published in
P24.
Needed for the TB TAUG III SDTM, SEND-Published in
P24.
Needed for TB TAUG - III SDTM, SEND-Published in
http://www.unsystem.org/scn/archives/adults/ch06.ht P24.
m
Reason for suggestion: "CARDIAC SCHWANNOMA, III SDTM, SEND-Published in
BENIGN" exits in the codelist, but not P25
"CARDIAC SCHWANNOMA, MALIGNANT".
Definition: "A malignant peripheral nervous system

neoplasm that is composed of well-differentiated
Schwann cells and affects the heart."
Pulse Oximetry is a non-invasive method for III SDTM-Published in P28

monitoring O2 saturation.

P25, P26, P29
Request withdrawn by
requester in P25
Do not add (SDTM, SEND
P26) - BASOPHILIC
NEUTROPHILS - Please use
existing term (C111166)
Cytoplasmic Basophilia
Neutrophil.
P26) - females, males, plugs
requested as Units of
measure - The test should
contain the information
about what you are
counting. These would be
unitless.
P27) - Interleukin-2b: do not
add; We can find no
evidence that this is a valid
protein name. Interleukin 2b
does not exist in standard
databases such as SwissProt
or Genecards.
Do not add (P30) - Sacculus
Rotundus - This structure is
covered in villi and is most
often associated with the
ileum, hence it is part of the
small intestine. The team
acknowledges that there are
competing information out
there but will not change the
concept. See:
https://linkinghub.elsevier.c
Please consider adding vector genome like viral III SDTM, SEND-Published in
particles P24.
Just getting a change request number. Lab team II SDTM, SEND-Published in

already agree to this change on 2015-06-17. Team P24.
agreed to change existing definition to: A
measurement of the apolipoprotein A1 in a biological
specimen.
Request to create new RSTEST of 'MDR Response' III SDTM-Published in P24.
as well as 6 new 'MDR Response terms' which are in
the RSSTRESC codelist; The oncology team already
agreed to add these terms just need a request
number
DELTOID MUSCLE: A rounded, triangular muscle III SDTM-Published in P25
located on the uppermost part of the arm and the top
of the shoulder.
MENINGES: The three membranes enclosing the
brain and the spinal cord, comprising the dura mater,
the pia mater, and the arachnoid membrane.
UMBILICAL CORD: A long, narrow tube that
connects the developing fetus with the placenta while
the fetus is in the uterus.
Definition: When measurements are taken at III ADaM-Published in P25

specified timepoints and comparisons of
measurements or observations for a test are relevant
only for the matching timepoint, ?time matched?
indicates that only those measurements/observations
where the times and/or timepoints are the same will
be used in the derivation/comparison. ��
Example of how this term is used: May be used when
measurements are taken at specified timepoints and
comparisons of measurements or observations for a
test are relevant only for the matching timepoint.�
For example, in selecting a time matched baseline,
only that measurement taken at the same
time/timepoint on the day prior to study drug
administration as the measurement taken on the day
of treatment will be selected as baseline.
Additional EPOCH terms are needed to distinguish III

between multiple periods in a study.
New term needed for ROUTE. III

Please consider adding the terms above to III SDTM-Published in P29
NCOMPLT codelist, which are needed as specified in Do not add (SDTM-P25):
the protocol documentation. ALIVE - Subject Status Test
has Survival Status. Subject
Status Response codelist is
currently out for public
review and it contains Alive.;
NOT COMPLETED - This
codelist contains the reason
for not completing the study.
Please choose a reason from
the Completion/Reason for
Non-Completion codelist for
not completing.;
INCONVENIENCE OF
INJECTION, POOR
COMPLIANCE TO PROTOCOL,
REFUSED FURTHER
TREATMENT - Please use
Withdrawal by Subject.
See email for more details III SDTM-Published in P23, P24,
P30, P38
Do not add (SDTM P27):
Amino Acid, Codon,
Nucleotide, Observed Level,
Raw Ct Value, Mean Ct
Value, Copy Number,
Normalized Intensity 1
Value, Normalized Intensity
2 Value - Request removed
by requester.
Do not add (P30) - Please use
Genetic Sub-Region
Sequence as above
(GSRSEQ / Genetic Sub-
Region Sequence) instead of
Exon Sequence.
Do not add (P35):
FLASH FREEZE MATERIAL -
Do not add. Temperature is
already published as a
BSTEST value; the material
used to flash freeze a
specimen has an inherent
temperature so the addition
of this as a BSTEST seems
redundant.
Do not add (P43):
PFRESCAT codelist: Do not
develop. PGx team has
decided not to develop CT
for PFRESCAT and instead
leave it sponsor defined.
differentiate definitions from gland of third eyelid. III Do not add (SEND-P25)-
Team already agreed to add on meeting 2015-06-22. Intraorbital and Extraorbital
Just getting a request number. are ANTREGs.
New TEST terminology codelists for PY, FX, and FM III SEND-Published in P24
domain in SEND; File Emailed Separately
"Code list for Biospecimen Event: III
? Collected from Patient

? Fixed - <insert fixative agent & time>
? Embedded
? Sectioned
? Stained ? <insert stain>
? Scored - <insert stain>
? Extracted - <insert DNA or RNA"
Joyce sent on behalf of Ellie Schatz.

An adverse event is worsened in severity, and is III Do not add (P30): This
being captured as a new event. codelist is not extensible and
this topic would need to be
discussed with the FDA.
Can you please confirm that all existing single CD II

terms are synonymous with being positively
expressed?
We are getting large quantities of multiple CD
markers which are both positively and negatively
expressed e.g. CD20-CD5+ or CD23+CD5-
I just want to be sure I can map a CD4+ cells source
test to CD4. And that it doesn't need the +.
FYI, all the long CD strings are very difficult to keep
within the 40 char limit. The LBTESTCD is assigned
as a counter only e.g. CDX101 with the LBTEST
providing the details.
Are there any guidelines with how CDISC will
manage these in future? e.g. do you prefer the
BRIGHT/DIM or LO/HI?
Schizophrenia TA Standards controlled terminology III SDTM-Published in P24, P29
There is a separate SEND Implementaion Guide for III SEND-Published in P24

Developmental and Reproductive Toxicology Studies,
also known in short as SENDIG-DART.
Please add: III Do not add (SDTM, SEND

ABNNOS - Abnormality Not Otherwise Specified P24) - This is not very precise
CONDNOS - Conduction Not Otherwise Specified for a controlled codelist.
MORPHNOS - Morphology Not Otherwise Specified This list is extensible.
These cover ECG free text fields on our ECG
Abnormalities CRF where the investigator is unable to
find a suitable term for the abnormality. I'm following
the examples of RHYNOS - Rhythm Not Otherwise
Specified
The GSK standards group met with the GSK CV II Question answered with P24
Medics yesterday to review the mapping of -
EGSTRESC to EGTESTCD/EGTEST terms.
There were 2 mappings which we were not in
agreement with and would like your feedback on:
1. We have an abnormality of 'WIDE QRS
TACHYCARDIA (DIAGNOSIS UNKNOWN)'. Based
on the ECG Codetable for WIDE QRS
TACHYCARDIA, this would map to VTTARRY
(Ventricular Tachyarrhythmias)
The team felt that since this is an unknown diagnosis
we prefer Rhythm NOS. This is because it could be a
Ventricular or a Supraventricular tachyarrythmia.
2. We have an abnormality of ACCESSORY

PATHWAY (WOLFF-PARKINSON-WHITE, LOWN-
GANONG-LEVINE)'. Based on the ECG Codetable
for WOLFF-PARKINSON-WHITE SYNDROME this
would map to: IVTIACD (Intraventricular-Intraatrial
Conduction).
The team felt that it would be more appropriate to
map to AVCOND (Atrioventricular Conduction)
because tThe most common accessory pathways are
usually AV pathways, not intrventraveatricular or
intraatrial.
Reynolds CVD 10-Year Risk Score - CCCAT; File III QRS-Published in P24.
emailed separately. This is for Dyslipidemia TA team.
This change will allow the term to be re-used by new II SDTM-Published in P23, P24
DEDECOD codelist in development by PGx team.
Every night at bedtime III Do not add (SDTM-P25) -

This is timing, not frequency.
You could possibly use a
FREQ of QD.
correction of typo II SEND-Published in P23
This is a test Disregard

Please consider adding this lab test and code. III SDTM, SEND-Published in
Currently not available in CDISC Controlled P26
Terminology
Please consider adding this lab test and code. III SDTM, SEND-Published in
Currently not available in CDISC Controlled P26
Terminology
Number of cells showing Dentritic Cell-Lysosomal- III SDTM, SEND-Published in
Associated Membrane Protein P26
To be used with MITEST: DC-LAMP
Number of cells showing Dentritic Cell-Lysosomal- III SDTM, SEND-Published in

Associated Membrane Protein P26
To be used with MITESTCD: DCLAMP
I am a member of the PGx terminology team and III SDTM-Published in P28

would like to submit some terms for team review. File Do not add (P30) - MRD data
emailed separately. File emailed separately. should always be in RS,
regardless of method.
PFREFID could be used to
relate a genomic record in
PF to data in RS; use
PFREFID as a NSV in RS
domain.
They are aligning with INHAND and instead using a II SDTM, SEND-Published in
more generic concept called: CARCINOMA, P24.
NEUROEPITHELIAL, MALIGNANT, which will be
going out for public review with P24.
An Event has increased in severity/intensity, and a II

new record is being recorded.
The Trial Disease Assessments domain provides III

information on the protocol-specified disease
assessment schedule, and will be used for
comparison with the actual occurrence of the efficacy
assessments in order to determine whether there was
good compliance with the schedule.
Hi, Can you please explain why the New York Heart II
Association Classification terminology is mapped in
SDTM spreadsheet rather than the QRS
spreadsheet? As per the 3.3 IG draft - 4 Nov 2014,
the target domain for NYHAC is CC. Since the NHYA
is a classification that is where we expect to see it.
Howver, there are terminology for CCRCLS(CD)
(Consensus Cardiac Classification System Test
Code/Name) as well as NYHAC in the SDTM
Terminology spreadsheet.
Please clarify asap where this data should reside as
we need it for submission.
Many thanks
We are requesting to add the term 'DEFINITIVE III

THERAPY' to the Method codelist. Subjects will be
referred for cervical definitive therapy per clinical trial
protocol (vaccine study). If cervical definitive therapy
is performed, on the day of the procedure, pre-
definitive cervical biopsies must be taken of the areas
with the most severe abnormalities prior to performing
the cervical definitive therapy. Loop Electrosurgical
Excision Procedure (LEEP) is the preferred method
for cervical definitive therapy. LEEP has
contraindications for subjects with the following
conditions: allergy to all local anesthetics; pregnancy;
severe acute cervicitis (severe acute cervicitis should
be diagnosed and treated, and excision conducted
after the infection has resolved); obvious invasive
cancer; significant glandular neoplasia (AGUS favor
neoplasia, AIS, Adenocarcinoma); and microinvasive
cancer. In addition to LEEP, laser conization is also
acceptable as a definitive therapy if it is the standard
of care at the study site. Cold-knife conization and
ablative cervical definitive therapy (e.g., cervical
cryotherapy or cervical laser vaporization) should be
reserved for rare instances where cervical definitive
therapy is required and LEEP or laser conization is
not indicated. LEEP, laser conization, and coldknife
conization are study procedures, but ablative cervical
definitive therapy is not a study procedure because
this procedure is not tissue preserving.
Please modify the CDISC definitions for 7 Microorg II SDTM-Published in P24.

terms; File emailed separately.
The IDF (Japanese Drug Dictionary Files) has a III Do not add (SDTM P27) - Do
category of "Injection", which is a complex concept of not add. This is a dosage
INTRA-s(INTRA-ARTERIAL,INTRA- form, not a route of
ARTICULAR,INTRAVENOUS etc.) , means administration. Please
"administration directly into a tissue or organ" via choose the most appropriate
injection needle. (similar to "PARENTERAL", but route from the route of
does not include "implantation" .) administration codelist.
Most IDF users collect route of administration as
"INJECTION", so please consider adding
"INJECTION" to SDTM-ROUTE.
When Per comes first in the synonym it should be II SDTM, SEND-Published in

capitalized. This will make all synonyms of this type P24.
consistent in the UNIT codelist.
Please add the following test names (and test codes) III SDTM, SEND-Published in
to the Laboratory Test Name codelist: P26
Human Papillomavirus 6 Antibody (HPV6AB)
These tests are needed for a vaccine clinical trial.
Please add the unit of mMU/mL to the Unit codelist III SDTM, SEND-Published in
with the synonym of milliMerck unit per milliliter. P29
This unit is used for reporting titer by Merck's
competitive luminex immunoassay (cLIA) for HPV
vaccine trials. This unit can be referenced outside of
Merck as a valid unit for HPV antibody testing (ie.
HPV 6 Ab).
If the valid values in these codelists came from a II

published source, they should have citations within
the definitions. I believe these were created as part of
the very first cardiovascular TA using ACC/Duke data
elements. As it is written now with generic definitions,
there is concern that a precedence has been set that
anyone can submit controlled terminology for
severity.
Also, the values of 'No' [C99991 and C99992] may

need to be removed. These aren't severity as such,
they are merely indicating that something didn't
happen, which would probably best be dealt with by
an OCCUR type variable. The modeling may have
been wrong when these were initially set up.
I think METHOD and PROCEDUR should be II Do not add (P30): Do not
combined into one list. The definition for METHOD is agree. The method codelist
"Method is any technique or procedure (an action) is supposed to be used by
that determines how an observation or clinical finding the method variable in a
was made." and the definition for PROCEDUR is "A findings domain. The
terminology codelist to describe any activity procedure codelist is
considered to be a therapeutic or diagnostic supposed to be used by the
procedure." PRDECOD variable in the
Procedure domain.
The definition for METHOD is basically the same
thing as a diagnostic procedure, so there is overlap
with the two codelists. I am not sure how you will
make decisions as to what belongs in one over the
other. From the looks of the current terms, it looks like
you are trying to slit diagnostic from therapeutic,
however I am not sure why you would do this
considering it was debated in CDISC and decided to
have one Procedure domain. If you look in METHOD
there are many terms for MRI. When I check the NCI
definition it says "A procedure in which radio waves
and a powerful magnet linked to a computer are used
to create detailed pictures of areas inside the body.
These pictures can show the difference between
normal and diseased tissue. NMRI makes better
images of organs and soft tissue than other scanning
techniques, such as computed tomography (CT) or x-
ray. NMRI is especially useful for imaging the brain,
the spine, the soft tissue of joints, and the inside of
bones." So if that was not part of METHOD and a
request was made today, how would you know where
to put it?
For LBNRIND, why does the Lab Model suggest II Do not add (SDTM-P25): This
additional values to be used? It would be more is administrative information
efficient and appropriate to have a direct mapping used during the conduct of
instead of translating H - High Normal, HT - High the trial to manage actions
Telephone, HP - High Panic to High. Wouldn?t it that might be taken with the
make sense to align the terminology across the subject. After the trial is
different standards so that translations are not completed this level of
required? granularity may not be
useful and may be confusing.
The FDA has not requested
this level of granularity.
This terminology is being finalized by the Repro team III SEND-Published in P24
to go out for public review with P24. Just submitting Do not add (SEND P26) -
this to get a request number. ONLY PLACENTAL TISSUE AT
IMPLANTATION SITE - This is
a type of Intrauterine Death
so please use INTRAUTERINE
DEATH as the ICSTRESC
value. This term could be put
in as an original result value,
a comment, or a modifier.
I noticed that there are 3 codelists related to Holter II Question answered with P24
Monitoring. However, there is no HE domain - 2015-07-14: The ECG team
information in the 3.2 IG, or proposed in 3.3 that I can is working with other CDISC
see. teams to either create a new
At GSK we do have holter monitoring data and we domain for HOLTERS or to
are currently mapping it to a sponsor defined domain. add a new variable to the
The data in HETESTCD/HETEST is minimal and ECG domain that would let
appears to be purely for the purposes of categorising us know if this was a holter.
HESTRESC (as has been done for EG) We do not have a decision
We are reluctant to use these 3 codelists until there is yet. Depending on the result
more guidance in an IG about Holter monitoring. Do of the meetings, these holter
you have any guidance for us? codelists might stay or they
might be removed. We do
not know when this will be
resolved.
The APGAR score quickly summarizes the health of III QRS-Published in P44
newborn children. The Apgar score is determined by
evaluating the newborn baby on five simple criteria
on a scale from zero to two, then summing up the five
values thus obtained. The resulting Apgar score
ranges from zero to 10. The five criteria are
summarized using words chosen to form a
backronym (Appearance, Pulse, Grimace, Activity,
Respiration). From each column in the table below,
the infant is given a score of 0, 1 or 2. The scores are
added up and the total is their Apgar score. See
https://en.wikipedia.org/wiki/Apgar_score. Useful in
studies where subjects might be pregnant, such as in
MS or other non-curable diseases that can affect
women of child-bearing age.
This is a new variable in SDTMIG 3.2 and has valid III SDTM-Published in P25.
values published in the IG but no published CT
codelist associated with it. This issue was identified
within the Metadata Tools team and a request was
asked to be submitted by that team.
Just need a request number II Completed.
A period in a clinical study during which major III Do not add (P30) - We
interests of protocol objectives are obtained for recommend using the
subjects. Treatment Epoch since the
definition does not require
the treatment to be
continuous. If this is not
acceptable, the codelist is
not extensible.
Tumor Grade (as a test code/test name), with values III SDTM-Published in P30
of:
1. Grade X [synonyms: GX, Grade cannot be
assessed, Undetermined]
2. Grade 1 [synonyms: G1, Well differentiated, Low
grade]
3. Grade 2 [synonyms: G2, Moderately differentiated,
Intermediate grade]
4. Grade 3 [synonyms: G3, Poorly differentiated, High
grade]
5. Grade 4 [synonyms: G4, Undifferentiated, High
grade]
Should this be modeled in both MI and the oncology
domains?
This is requested in the context of assessing tumor III SDTM, SEND-Published in

biopsies by pathology. Perineural invasion can have P26
prognostic implications.
http://www.omicsonline.org/prognostic-factors-in-
pancreatic-cancer-the-role-of-perineural-vascular-
and-lymphatic-invasion-and-of-ca-2161-069X-3-
134.pdf"

biopsies by pathology. Vascular Invasion can have P26
134.pdf
biopsies by pathology. Lymphatic Invasion can have P26
134.pdf
This is in relation to tumor biopsies determined III SDTM, SEND-Published in

microscopically, and is used to determine whether a P26
biospecimen should be used for further molecular
analyses.
So it may be modeled in MI domain and related to

some records in the PGx-related domains?
It can also be of prognostic value:


microscopically, and can be of prognostic value. P26


microscopically, and is used to determine if a P26
biospecimen should be used for molecular analysis or
not.

Please see the following sites for the details of the III QRS, SDTM-Published in P50
test: Do not add (P50): CDISC is
http://www.lcss-ql.com/ unable to obtain copyright
http://phi.uhce.ox.ac.uk/pdf/CancerReviews/ permission for this
PROMs_Oxford_Lung%20Cancer_012011.pdf instrument at this time,
consequently, the CDISC QRS
CT team had only created a
CAT value for this instrument
in Package 50. Because of
this, CDISC will NOT develop
TEST and TESTCD
terminology associated with
this questionnaire.
This is a simplified index of Crohn's disease activity, III Do not add (P30) - This
see following links for details: appears to be very study
http://www.janssenmedicalinformation.ca/assets/ specific to support the
pdf/HarveyBradshaw_English.pdf capturing of derived values
http://www.gastrotraining.com/calculators/harvey- and is not reusable enough
bradshaw-index-hbi across industry for CDISC to
http://www.crohnsforum.com/wiki/Harvey-Bradshaw- control this term at present.
Index
This is an index of Crohn's disease activity, see III Do not add (P30) - This
following link for details: appears to be very study
http://www.ibdjohn.com/cdai/ specific to support the
capturing of derived values
and is not reusable enough
Definition of CH50 Unit: (taken from: III Do not add (SDTM P27): Do
http://www.wako-chemicals.de/DWD/_111327/upload/ not add. CH50 is the test
media_133092.pdf) name. Please use Unit
The hemolytic unit of complement, CH50, is defined (C44278).
as that amount in milli1iters which will lyse 2.5 x 10E8
optimally sensitized red cells out of a total of 5 x 10E8
cells in one hour?s incubation at 37�C in a total
volume of 7.5 mL.
This request is for Anna Pron-Zwick. She had III SDTM, SEND-Published in
originally requested a unit code of ug/mmol P26
Creatinine for the test Alpha CTx Telopeptide Type I
Collagen/Creatinine in a urine specimen. CDISC-
1297
Added by oncology team on 2015-07-17 as a TEST III SDTM-Published in P24

code to support the new TRSTRESC values of
PALPABLE and NONPALPABLE.
Need for TB TAUG III SDTM-Published in P24
I've been asked to create an extensible term for II SDTM-Published in P26

HEART, RIGHT ATRIUM.
Can you please tell me if this would be acceptable as
a CDISC term? Or are the LEFT and RIGHT
ATRIUMs identical and therefore we should use LAT
to differentiate them?
Thanks
SEND Specimen codelist definition review to de- II

specify the definitions: SEMINAL FLUID to end; File
emailed separately.
"Please consider adding: III Do not add (P30) - Exposure
Electroporation methods do not belong in
a few defintions below. the SDTM METHOD codelist.
A technique in which electric pulses cause a The requester could submit a
temporary loss of the semipermeability of cell request to SEND CT team to
membranes, thus leading to ion leakage, escape of create a new Exposure
metabolites, and increased uptake by cells of drugs, Method codelist and put this
molecular probes, and DNA. term in there; since the use
of --METHOD in EX is only
A method for transferring DNA (or other small allowable in SEND.
molecules) into cells by exposure to a rapid pulse of
high voltage, which causes the transient formation of
small pores in the cell membrane.
A technique by which cell membranes are made

permeable by rapid pulses of high-voltage current.
Has been used to treat cancers."
A test of lung function, the FEV3 is the volume III SDTM-Published in P29
exhaled during three seconds of a forced expiratory
maneuver started from the level of total lung capacity.
Definition = The time taken to expire a given volume III Do not add (P30)-request
or a given fraction of vital capacity during removed by requester.
measurement of forced vital capacity.
Change the synonyms to match the NCI Preferred II SDTM, SEND-Published in

Term for the following dosing units: Biscuit, Fingertip P24
Unit, Nebule, Puff, Shock Wave,
Highest level of visual acuity testing achieved by the III

subject.
To be used with OETESTCD = Best Visual Function
Highest level of visual acuity testing achieved by the III

subject.
To be used with OETESTCD = BVISFUNC
Number of letters correctly read by subject from a III

visual acuity eye chart.
To be used with OETESTCD = Number of Letters

Correct
Number of letters correctly read by subject from a III
visual acuity eye chart.
To be used with OETESTCD = NUMLCOR
Measurement of the curvature of the optic lens. III
To be used with OETESTCD = Spherical Refractive

Error
Measurement of the curvature of the optic lens. III
To be used with OETESTCD = RESPHERE
Total error score III
To be used with OETESTCD = Total Error Score
Total error score III
To be used with OETESTCD = TOTERSCR
CDISC Submission Value is BACTERIA (C14187). II SDTM-Published in P24

Please check spelling of Synonym "Cubacteria" in
Package 22. I believe it should be "Eubacteria".
Thank you. Anna Pron-Zwick/23-Jul-2015
Please consider removing synonym Streptococcus II

dysgalactiae from CDISC term STREPTOCOCCUS
CANIS (C86786). Promote term Streptococcus
dysgalactiae to CDISC Submission Value. NCBI
considers Streptococcus dysgalactiae its own
genus/species term. Thank you. Anna Pron-Zwick/24-
Jul-2015
Requesting a swap. Please consider promoting II SDTM-Published in P24

synonym BACTEROIDES PYOGENES to CDISC
Submission Value and demoting current preferred
term BACTEROIDES TECTUS (C86178) to synonym
to BACTEROIDES PYOGENES. Source: NCBI.
Thank you. Anna Pron-Zwick/24-Jul-2015
Part of NY criteria for the Diagnosis of Ankylosing III Do not add (P30) - Since this
Spondylitis (1984) is part of inclusion/exclusion
criteria, please put this into
To be used with SCTEST : Definite AS medical history domain.
Part of NY criteria for the Diagnosis of Ankylosing III Do not add (P30) - Since this
Spondylitis (1984) is part of inclusion/exclusion
criteria, please put this into
To be used with SCTESTCD : ASDEFIN medical history domain.
A classification system used to categorize the photo III Do not add (P30) - Not
sensitivity of a subject's skin to sunlight enough information from
requestor.
To be used with SCTEST : Skin Phototype
Classification
A classification system used to categorize the photo III Do not add (P30) - Not
sensitivity of a subject's skin to sunlight enough information from
requestor.
To be used with SCTESTCD : SKNPHTYP
Characters representing one or more of the sounds III Do not add (SDTM, SEND
used in speech; any of the symbols of an alphabet P26) - Please use 'Number of
Letters Correctly Read' as the
test and the units will be
blank.
An external, independent specialist whose purpose is III SDTM-Published in P29

to evaluate conflicting assessments between trial site
and central reader.
A third party centrally evaluating response to III

treatment for all subjects from all trial sites, based on
images submitted to the central reader by the trial
sites.
Any authorized member of the team conducting the III Do not add (P30): Choose
clinical trial at a trial site. either Clinical Research
Associate or Clinical
Research Coordinator or
Investigator.
This is for the ASSIGN CVD 10-YEAR RISK through III P21 - Do not add.
the Dyslipidemia TA. The SIMD is one of the Concerned about PII (patient
variables need to calculate the ASSIGN risk. privacy) issues. The info may
be used by the investigator
for calculations but shouldn't
be in submission data.
Request TBI Standards Project - QRS QS III

Terminology
CT Terminology spreadsheet sent separately

Hello. Please consider adding thes two units of III SDTM, SEND-Published in
measure to the SDTM-Unit Code List. Submitted on P29
behalf of the Virology Version 2.0 TAUG Team. The
team will be using these units as examples in the
updated user guide. Thank you. Anna Pron-Zwick/31-
Jul-2015
Please consider adding five new terms to the III Do not add (SDTM P27):
Anatomical Location Code List. File eMailed CHOROID, IRIS, MENINGES
separately. Thank you. Anna Pron-Zwick/31-Jul-2015 already exist.
Just need request numbers: request to update the II SDTM-Published in P24

definitions and synonyms for C86671, C86962, and
C118935.
These items have already been reviewed and
approved by the virology team, just need request
numbers.
Fluid that accumulates in the pleural cavity III Do not add (SDTM P27): Do
not add. This is not an
anatomical location. You
could have pleural cavity
(which already exists) as the
anatomical location and you
could have the specimen
type be pleural fluid. You
could also review the Breast
Cancer Therapeutic Area
User Guide for examples of
how to model this type of
data.
The original tumor site where the tumor first arose. III Do not add (SDTM P27): Do
anatomical location. Please
review the Oncology section
of the SDTMIG.
LBTESTCD and LBTEST requested for bone marrow III

evaluations; File emailed separately
Batch 2 Terminology from the Breast Cancer SDTM-Published in P24

Therapeutic Area Team. 14 Additions to multiple
codelists and two requests for changes to existing
terms; File emailed separately
Change the codelist name from Device Events II SDTM-Published in P24
Category to Category of Device Events. This is to be
consistent with other domain category variable
codelists which start with the word Category.
This request will support lab team decision made in III SDTM, SEND-Published in
Nov 2014 at the Interchange F2F and the Virology P29
v2.0 TA standard. Virus species information will go Do not add (SDTM P25) - do
into the newly approved for LB variable SPCIES. not add; The text "Viral
Load" will go into LBCAT.
LBTEST will contain the
analyte such as RNA or DNA
or cDNA etc.
Definition: MET or the standard metabolic equivalent III

is a unit used to estimate the amount of oxygen used
by the body during physical activity. 1 MET = the
energy (oxygen) used by the body at rest, while
sitting quietly or reading a book, for example. The
harder your body works during the activity, the more
oxygen is consumed and the higher the MET level.
Thank you for your consideration. Anna
Pron-Zwick/06-Aug-2015
Physical activity can be measured in MET-minutes III

(METs and MET-minutes). A well-known physiologic
effect of physical activity is that it expends energy. A
metabolic equivalent, or MET, is a unit useful for
describing the energy expenditure of a specific
activity. A MET is the ratio of the rate of energy
expended during an activity to the rate of energy
expended at rest. For example, 1 MET is the rate of
energy expenditure while at rest. A 4 MET activity
expends 4 times the energy used by the body at rest.
If a person does a 4 MET activity for 30 minutes, he
or she has done 4 times 30 = 120 MET-minutes (or
2.0 MET-hours) of physical activity. A person could
also achieve 120 MET-minutes by doing an 8 MET
activity for 15 minutes. A range of 500 to 1,000 MET-
minutes of activity per week provides substantial
benefit. Thank you for your consideration. Anna Pron-
Zwick/06-Aug-2015
Please refer to rationale for requesting additions of III SDTM, SEND-Published in

MET and MET-min, e.g. 120 MET-minutes can be P26
expressed as 2.0 MET-hours of physical activity.
Thank you for your consideration. Anna
Pron-Zwick/06-Aug-2015
A hand-held card consisting of short blocks of text in III SDTM-Published in P28
various type sizes. Visual acuity is determined by the
smallest type the subject is able to read when the
card is held at a specified reading distance.
The Codelist Names, Synonyms, and Definitions for II

each C-SSRS Questionnaire includes the word
"Suicidality" instead of the word "Suicide". This
should be corrected to match the instrument. This is
the first of 2 requests.
The definitions for the C-SSRS QRS instruments II QRS-Published in P23

include the word "Suicidality", but the instrument
includes the word "Suicide". This is the 2nd of 2
requests. The first request included the codelist
names along with the associated synonyms and
definitions.
Would you consider adding "Waist to Hip Ratio" as a III SDTM-Published in P30
Vital Signs Test Name since it can be used as a
health indicator?
https://en.wikipedia.org/wiki/Waist
%E2%80%93hip_ratio
Remove the above synonym in the retest and II SDTM-Published in P25

retestcd codelists. The test name and the definition
make it very clear what this test is for. The synonym
is not needed.
A superficial or deep lymph node located in the III Do not add (SEND-P25) - This
inguinal or femoral area is archaic terminology.
Please use existing concept
C32801.
EudraCT requires the submission of the "therapeutic III SDTM-Published in P25.

area". This is a typical "trial summary parameter"
code. We urgently need it for the development of the
new CTR (Clinical Trial Registries) standard (ODM-
extension).
Proposal: THERAREA.
LBTEST for high-sensitivity C-reactive protein III Do not add (SDTM, SEND
(hsCRP).TERM C Reactive Protein/CRP exist in P27): Please use C Reactive
CDISC CT. Therefore requesting a new term Protein (C64548). High
Sensitivity (LLQ - Lower Limit
of Quantification) can be in
the SDTM variable LLOQ.
new request for new codelists H-Score III

TEST/TESTCD, CCCAT H-SCORE on behalf of
breast cancer team; File e-mailed separately
On behalf of the Asthma and COPD teams, I'd like to II QRS-Published in P24
request a change in the terminology for the Borg CR-
10 to generalize it rather than just having it for
breathlessness. File emailed separately.
Just need request numbers for the CAT terminology III QRS-Published in P23
going out for P23; The following 5 CAT terminologies
have been reviewed and approved by the QRS team:
ACT; MMSE; MSWS-12; MSIS 29 v1; MSIS 29 v2
From AP IG v1.0: a relationship that helps to explain III SDTM-Published in P28

how the accidental exposure or involvement occurred
may be collected. For example, a person exposed to
a study treatment may have a familial relationship to
a study subject, or a person injured by an
investigational device may be the technician
operating that device. If there is no such relationship,
then by default, the AP has an ACCIDENTAL
ASSOCIATION with the study. This might occur, for
instance, if study treatment was delivered to the
wrong hospital patient through a clerical error.
Modify existing LBTESTCD and LBTEST for LDL III Do not add (SDTM, SEND
because this can be calculated or direct P27): Please use LDL
(C105588). The method is
either Calculation or a true
method such as Colorimetry
or Immunoprecipation.
From P23 public review comment, the team agreed II SDTM-Published in P25
that 'TLCO' and 'Transfer Factor of Lung for CO' are
valid synonyms of C38083. These are used
commonly in Europe.
New term for LBTEST/CD codelists; File emailed III SDTM, SEND-Published in
separately P26
P27): Granulocyte Colony
Stimulation Factor - Already
exists. C82018; Granulocyte
Macrophage Colony
Stimulation Factor - Already
exists. C82019; Total
Immunoglobulin IgA - Do not
add. Please use C81969.
The definition has been
updated to include the word
total.; Total Immunoglobulin
IgG - Do not add. Please use
C81971. The definition has
been updated to include the
word total.; Total
Immunoglobulin IgM - Do
not add. Please use C81972.
The definition has been
updated to include the word
total.;
New LBTESTCD and LBTEST terms requested: III

LBTESTCD: PLSCE
LBTEST: Plasma Cells
Description: A measurement of the plasma cells in a
LBTESTCD: PLSCELE
LBTEST: Plasma Cells/Leukocytes
Description: A relative measurement (ratio or
percentage) of the plasma cells to leukocytes in a
These term requests are for testing for plasma cells in

regular and do not split them into different staging.
Requesting to add the following terms used in Clinical III SDTM-Published in P25
trial to the Microorganism codelist: Do not add (SDTM P25) -
METAPNEUMOVIRUS (Reference: NCBI; Definition: HUMAN HERPESVIRUS: Do
Any viral organism that can be assigned to the genus not add. This is already a
Metapneumovirus.) synonym to Simplexvirus
PNEUMOCYSTIS JIROVECII (Reference: NCBI; (C112419).
Definition: Any fungal organism that can be assigned
to the species Pneumocystis jirovecii.)
HUMAN HERPESVIRUS (Reference: NCBI as
Unidentified Herpesvirus; Used for Herpesvirus
infection identified only by clinical symptoms;
Definition: Any viral organism that can be assigned to
the species Human Herpesvirus.)
A discussion among core SEND team members III SDTM-Published in P25

resulted in a recommendation that Morphometric
measurements of organs be included in the OM
domain. The requested term is a generic
morphometric measurement that can apply across
organs. In line with the domain structure, the organ
under investigation will be populated in the required
variable OMSPEC, and further specified in
OMANTREG.
As an alternative, "Thickness" can be used as
OMTEST, if epithelia is contained in OMANTREG.
Please add back the following code lists into the III SEND-Published in P24
SEND published documents. These lists are still
needed for SENDIG v3.0. We can change the
definition to indicate that these code lists are needed
for version 3.0 if it is felt that this is helpful.
VSTEST
VSTESTCD
VSRESU
submissions for SENDIG v3.0 still need these

codelist.
Change 'day' to 'hour' in the definition. I SDTM, SEND-Published in

P23
A color vision test which tests the ability to isolate and III SDTM-Published in P28
arrange minute differences in various color targets
with constant value and chroma that cover all the
visual hues described by the Munsell color system.
SDTMIG-AP v1.0 III SDTM-Published in P28, P29

Terminology used in examples for SREL (RELSUB
codelist) not found in SDTM; File emailed separately.
The definition needs to remove the text "supra". I SDTM, SEND-Published in

P23
We only need a request number. II SDTM, SEND-Published in
P24
Replace anginosis with anginosus. This already II SDTM-Published in P24

exists in the spreadsheet. We needed a request
number.
The mean number in a group of values that represent III SDTM-Published in P25
the thickness of an object.
Please consider adding the term GRAM-POSITIVE III

DIPLOCOCCUS to the Microorganism codelist.
Definition is: Any spherical-shaped bacteria in the
form of two joined cells that has a peptidoglycan-rich
cell wall that stains dark purple with the Gram staining
technique.
File e-mailed separately September 1, 2015 - needed SDTM-Published in P25, P26,

for Clinical Trial Registration project P30, P35
Do not add (SDTM P26) -Add
as synonym STUDY CHAIR
(C51878), which is being
proposed as new with P26.
Do not add (SDTM P27) -
Safety/Efficacy;
Pharmacokinetics/dynamics -
Do not add. Please follow
the directions given in the
SDTMIG Section 7.4 page 4:
For some trials, there will be
multiple records in the Trial
Summary dataset for a single
parameter. For example, a
trial that addresses both
Safety and Efficacy could
have two records with
TSPARMCD = TTYPE, one
with the TSVAL = "SAFETY"
and the other with TSVAL =
"EFFICACY."
To be used with DSCAT=DISPOSITON EVENT when III Do not add (P30) - Use
Treatment was Prematurely Discontinued due to Physician Decision or Lack or
Tumor Related Clinical Condition not fuliflling Efficacy. Please put 'Tumor
Progressive Disease Criteria According to RESIST Related Condition' into
1.1 DSTERM.
Synonym: Nuclear Magnetic Resonance III SDTM-Published in P28

Spectroscopy
Definition: Nuclear magnetic resonance spectroscopy

is an analytical research technique that exploits the
magnetic properties of certain atomic nuclei. It
determines the physical and chemical properties of
substance, which are provided in solution or as solid
state. NMR spectra can provide detailed information
about the structure, dynamics, reaction state, and
chemical environment of molecules.
A relative measurement (ratio or percentage) of CD19 III

B cells reduced by the number of CD 27 B-cells to all
B-lymphocytes in a biological specimen.
To be used with LBTEST : CD19/CD27 bright/CD38

bright/Lymphocytes

B cells reduced by the number of CD 27 B-cells to all
B-lymphocytes in a biological specimen.
To be used with LBTESTCD : CD19PBRI

B cells including the CD27 B-cells to all B-
To be used with LBTEST :

CD19/CD27+/Lymphocytes

B cells including the CD27 B-cells to all B-
To be used with LBTESTCD : CD19P27P

B cells including the CD27 bright cells and CD38
bright cells to all B-lymphocytes in a biological
specimen.
To be used with LBTEST : CD19/CD27 bright/CD38

bright/Lymphocytes

B cells including the CD27 bright cells and CD38
bright cells to all B-lymphocytes in a biological
specimen.
To be used with LBTESTCD : CD19PBRI
A relative measurement (ratio or percentage) of III

CD3+CD45+CD4 T cells to CD3 T cells in a biological
specimen.
To be used with LBTEST : CD3+CD45+CD3/CD3

specimen.
To be used with LBTESTCD : CD3453C3
A count of the CD3+CD45+CD4 T cells per unit of a III

To be used with LBTEST : CD3+CD45+CD3

To be used with LBTESTCD : CD3454

specimen.
To be used with LBTEST : CD3+CD45+CD8/CD3

specimen.
To be used with LBTESTCD : CD3458C3

To be used with LBTEST : CD3+CD45+CD8

To be used with LBTESTCD : CD3458
A relative measurement (ratio or percentage) of CD3- III

CD19 T cells to all lymphocytes in a biological
specimen.
To be used with LBTEST : CD3-CD19/Lymphocytes

specimen.
To be used with LBTESTCD : CD3M19LY

specimen.
To be used with LBTEST : CD3-CD56/Lymphocytes

specimen.
To be used with LBTESTCD : CD3M56LY
A count of the CD56+CD57 T cells reduced by the III

number of natural killer T cells per unit of a biological
specimen.
To be used with LBTEST : CD56+CD57 red. by Nat.

Killer T-Cell Ct
A count of the CD56+CD57 T cells reduced by the III

number of natural killer T cells per unit of a biological
specimen.
To be used with LBTESTCD : CD5657MK
"A count of the CD56+CD57 T cells including natural III

killer T cells per unit of a biological specimen.
To be used with LBTEST : CD56+CD57 incl. Natural

Killer T cells"
A count of the CD56+CD57 T cells including natural III

killer T cells per unit of a biological specimen.
To be used with LBTESTCD : CD5657+K

A determination ofa mutation of factor II in a III Do not add (P30): Request
biological specimen. removed by requester.
To be used with LBTEST : Factor II Mutation

A determination ofa mutation of factor II in a III Do not add (P30): Request
biological specimen. removed by requester.
To be used with LBTESTCD : FACTIIM

To be used with LBTESTCD : GFRCYCRR

To be used with LBTEST : GFR Cystatin C/Creatinine

Ratio
To be used with LBTEST : Hepatitis B Antibody III Do not add (SDTM, SEND
P27): Already exists
(C125944).
To be used with LBTESTCD : HBAB III Do not add (SDTM, SEND

(C125944).
A measurement of hepatitis B virus core antibody IgG III Do not add (SDTM, SEND
in a biological specimen. P27): Already exists
(C119280).
To be used with LBTEST : Hepatitis B Virus Core
Antibody IgG
A measurement of hepatitis B virus core antibody IgG III Do not add (SDTM, SEND
in a biological specimen. P27): Already exists
(C119280).
To be used with LBTESTCD : HBCABIG
A measurement of the genotype of the hepatitis C III Do not add (P30): Removed
virus in a biological specimen. by requester.
To be used with LBTEST : HCV Genotype

A measurement of the genotype of the hepatitis C III Do not add (P30): Removed
virus in a biological specimen. by requester.
To be used with LBTESTCD : HCGENOT

A measurement of the mRNA of the hepatitits C virus. III Do not add (P30): Removed
by requester.
To be used with LBTEST : HCV mRNA
A measurement of the mRNA of the hepatitits C virus. III Do not add (P30): Removed
by requester.
To be used with LBTESTCD : HCVMRNA
A measurement of hepatitis D virus antibody IgG in a III Do not add (SDTM, SEND
biological specimen. P27): Already exists
(C119281).
To be used with LBTEST : Hepatitis D Virus Antibody
IgG
A measurement of hepatitis D virus antibody IgG in a III Do not add (SDTM, SEND
(C119281).
To be used with LBTESTCD : HDABIGG
A measurement of hepatitis D virus antibody IgM in a III Do not add (SDTM, SEND
(C119282).
To be used with LBTEST : Hepatitis D Virus Antibody
IgM
A measurement of hepatitis D virus antibody IgM in a III Do not add (SDTM, SEND
(C119282).
To be used with LBTESTCD : HDABIGM
A measurement of the hepatitis E virus mRNA in a III Do not add (SDTM, SEND
biological specimen using polymerase chain reaction P27): Removed by requester.
technology.
To be used with LBTEST : Hepatitis E mRNA

A measurement of the hepatitis E virus mRNA in a III Do not add (SDTM, SEND
biological specimen using polymerase chain reaction P27): Removed by requester.
technology.
To be used with LBTESTCD : HEVMRNA

A measurement of the genotype of the HIV virus in a III Do not add (SDTM, SEND
biological specimen. P27): Removed by requester.
To be used with LBTEST : HIV Genotype

A measurement of the genotype of the HIV virus in a III Do not add (SDTM, SEND
biological specimen. P27): Removed by requester.
To be used with LBTESTCD : HIVGENOT

A measurement of the protein 10 that was induced by III Do not add (SDTM, SEND
interferon gamma in a biological specimen. P27): Already exists
(C112238).
To be used with LBTEST : Interferon gamma-induc.
Prot. 10 (IP-10)
A measurement of the protein 10 that was induced by III Do not add (SDTM, SEND
interferon gamma in a biological specimen. P27): Already exists
(C112238).
To be used with LBTESTCD : IPPRT10
A measurement of leukocyte shadow cells in a III Do not add (SDTM, SEND

(C74627).
To be used with LBTEST : Leukocyte Shadow Cells
A measurement of leukocyte shadow cells in a III Do not add (SDTM, SEND
(C74627).
To be used with LBTESTCD : LEUKSH
A relative measurement (ratio or percentage) of the III Do not add (SDTM, SEND
leukocyte shadow cells to leukocytes in a biological P27): Already exists
specimen. (C119294)
To be used with LBTEST : Leukocyte Shadow

Cells/Leukocytes
A relative measurement (ratio or percentage) of the III Do not add (SDTM, SEND
leukocyte shadow cells to leukocytes in a biological P27): Already exists
specimen. (C119294)
To be used with LBTESTCD : LEUKSHLE

To be used with LBTEST : Protein C III Do not add (SDTM, SEND
(C102272).
To be used with LBTESTCD : PROTC III Do not add (SDTM, SEND

(C102272).
A relative measurement of the free testosterone to III

the proteins in a biological specimen.
To be used with LBTEST : Testosterone/Protein,

Free
A relative measurement of the free testosterone to III

the proteins in a biological specimen.
To be used with LBTESTCD : TESTOSFP
A measurement of the total tumor necrosis factor III Do not add (SDTM, SEND
(cachexin) cytokine receptor R1 in a biological P27): Already exists
specimen. (C120666)
To be used with LBTEST : Tumor Necrosis Factor

Receptor R1
A measurement of the total tumor necrosis factor III Do not add (SDTM, SEND
(cachexin) cytokine receptor R1 in a biological P27): Already exists
specimen. (C120666)
To be used with LBTESTCD : TNFR

A measurement of the blood present in a urine III Do not add (SDTM, SEND
specimen. P27): Already exists
(C74686).
To be used with LBTEST : Blood
A measurement of the blood present in a urine III Do not add (SDTM, SEND
specimen. P27): Already exists
(C74686).
To be used with LBTESTCD : BLD
A measurement of the procollagen 3 N-terminal III
propeptide in a biological specimen.
To be used with LBTEST : Procollagen 3 N-Terminal

Propeptide
To be used with LBTESTCD : P3NP

A measurement of the cytokeratin 18 fragment in a III SDTM, SEND-Published in
biological specimen. P28
To be used with LBTEST : Cytokeratin Fragment 18
A measurement of the cytokeratin 18 fragment in a III SDTM, SEND-Published in

To be used with LBTESTCD : CYFRA18

This already exists in the Virology spreadsheet. It just II SDTM-Published in P24
needs a request number.
This request is from the lab terminology team. II SDTM-Published in P25
This already exists on the spreadsheet. Need a II SDTM-Published in P24

request number.
Codelist Description: Terminology related to intervals III SEND-Published in P24

of time associated with the defined phases of
Developmental and Reproductive Toxicology (DART)
studies.
Codelist Extensible: Yes
Codelist Values: PREMATING, PAIRING,
POSTPAIRING, POSTNATAL
Oncology SDS team agrees to create EQUIVOCAL, III SDTM-Published in P24

UNEQUIVOCAL, and UNEQUIVOCAL
PROGRESSION as TRSTRESC values for the
TRTESTCD=TUMSTATE. These terms are already in
the working documents. Just need a request number.
File emailed separately. This multiple term request III SDTM-Published in P25
spreadsheet contains a request for a new codelist
MITSTDTL with 5 items. BrCa team wanted the lab
terminology team to develop the CT because they felt
that that team would have better
experience/knowledge with the subject matter.
File emailed separately. III SEND-Published in P24, P29
changes/additions for RS domain codelists; These III

changes/additions are already in the P24 public
review document. They do not have a request
number; File emailed separately
File "Multiple Term Request(MarcelinaHungria_2015- II SDTM-Published in P28

09-08).xlsx" containing a total of 15 cases of the
same type of issue mailed separately; File emailed
separately
New terms to be added to TSPARM/CD; File emailed III SDTM-Published in P26

separately
Please add the term VIRUS to the Microorganism III

codelist. This is used as a generic term for
unclassified virus. This was be used in similiar
situations as the existing generic terms of BACTERIA
and FUNGI.
Cumulative body weight gain and food consumption III Do not add (SEND-P25) - The
are routine recorded and analyzed separately from existing published term
the individual weekly values. should be used, FC/Food
Consumption. The interval is
Body Weight Gain Test Code: BWGAINC/Cumulative defined elsewhere. The
Body Weight Gain - A cumulative change in body existing published term
weight for a specific period should be used,
Food and Water Consumption Test Code: BWGAIN/Body Weight Gain.
CUMFC/Cumulative Food Consumption - A The interval is defined
cumulative measurement of a subject's nutritional elsewhere.
intake over a specific period.
A method used to measure the intrathoracic gas III

volumes like the functional residual capacity, volume
changes and airway resistance in the lung by means
of a bodyplethysmograph.
A test to measure the diffusing capacity of the lungs III

for carbon monoxide (DLCO) which is designed to
reflect properties of the alveolar-capillary membrane,
specifically the ease with which oxygen moves from
inhaled air to the red blood cells in the pulmonary
capillaries.
A method used to measure the functional residual III SDTM-Published in P28

volume and the degree of nonuniformity of gas
distribution in the lungs by means of a multiple breath
washout.
The volume of air present in the lungs at the end of III Request withdrawn by
passive expiration. requester in P25
To be used with RESTST : Functional Residual

Capacity
The volume of air present in the lungs at the end of III Request withdrawn by
passive expiration. requester in P25
To be used with RESTSTCD : FRC

Conductive Ventilation Inhomogeneity Index III Do not add (P40): Do not
normalized by the turnover value of the first breath add. We could not find
published references to this
To be used with RESTST : Conductive Ventilation respiratory test. Can the
Index Normalized requester please provide a
reference or citation for this
respiratory test, which
seems to not be in common
use. The codelist is
extensible so the term can
be used as an extensible
term in the meantime.
Conductive Ventilation Inhomogeneity Index III Do not add (P40): Do not

normalized by the turnover value of the first breath add. We could not find
To be used with RESTSTCD : SCONDVT respiratory test. Can the
requester please provide a
Acinar Ventilation Inhomogeneity Index normalized III Do not add (P40): Do not
by the turnover value of the first breath add. We could not find
To be used with RESTST : Acinar Ventilation Index respiratory test. Can the
Normalized requester please provide a
Acinar Ventilation Inhomogeneity Index normalized III Do not add (P40): Do not
by the turnover value of the first breath add. We could not find
To be used with RESTSTCD : SACINVT respiratory test. Can the
Update the existing term STREPTOCOCCUS II SDTM-Published in P24.

ANGINOSIS to STREPTOCOCCUS ANGINOSUS.
ANAEROBIC GRAM-NEGATIVE COCCOBACILLUS III SDTM-Published in P25

(definition: Any bacteria intermediate in morphology
between a spherical-shaped coccus and a rod-
shaped bacillus that does not require oxygen to grow
or respirate and has a cell wall that contains low
levels of peptidoglycan and stains pink with the Gram
staining technique.)
AEROBIC GRAM-NEGATIVE COCCOBACILLUS

(definition: Any bacteria intermediate in morphology
between a spherical-shaped coccus and a rod-
shaped bacillus with an oxygen-based metabolism
and has a cell wall that contains low levels of
peptidoglycan and stains pink with the Gram staining
technique.)
For P24 - Upper case submission value: SEND II
Implementation Guide Version 3.0 and SEND
Implementation Guide Version 3.1.
This is going out for public review for P24. Please
add to the P24 spreadsheet.
Synonym: POC (perhaps additional synonyms might III

be: Point-of-care testing, POCT)
Definition: Medical testing at or near the site of
patient care
Lab Terminology request for Biomedical Concepts in III SDTM, SEND-Published in

DKD (Diabetic Kidney Disease) TAUG; File emailed P25
separately
TSG-p53 was denied as a new term request for III Do not add (SEND-P25) -
STRAIN and the reason was "Use CROSS as the Sponsor should extend at
term for this codelist and put genetic information into their company with guidance
substrain details." from SEND as to what to put
The archives of the change request log haven't into STRAIN and SBSTRAIN.
included the term CROSS and isn?t included in the
recent package release.
Erin provided notes from a team meeting on 2014-04-
03: 2014-04-30 Team agrees to put this change ON
HOLD until a use case presents itself.
Craig suggested we revisit this.
When the species is monkey and defined as ?Any II SEND-Published in P25

haplorhine primate not belonging to the family
Tarsiidae, Hylobatidae, Pongidae, or Hominidae; this
does not correspond to any taxon. This group is
divided into Old World monkeys (Cercopithecidae)
and New World monkeys (Callitrichidae and
Cebidae)?, it is not clear why the Marmoset as a
Callitrichidae (Callitrix jacchus) is on the same level
as the monkey, and not listed as a strain as the other
monkey species like Cynomolgus, rhesus and
squirrel. Baboon would also be a monkey. It is
suggested that it should read: Species ? Monkey;
strain: Baboon, Cynomolgus, Cynomolgus Mauritus;
Rhesus; squirrel; marmoset.
Test Name = Apgar Score at One Minute; Test Code III QRS-Published in P44
= APGAR1M. Already in NCI Thesauraus with the
following C Code = C98816
Test Name = Apgar Score at Five Minutes; Test Code III QRS-Published in P44
= APGAR5M. Already in NCI Thesauraus with the
following C Code = C98821
Hepatic Vein is NCI Thesaurus with the C Code = III

C32736
Inferior Vena Cava is in the NCI Thesaurus with the C III SDTM, SEND-Published in
Code = C12815 P26
File emailed separately III SDTM-Published in P30, P31

Do not add (P30)-
SDTMIG-AP Number of Late Fetal
v1.0_CDISC_Multi_Term_Request_2015-09- Deaths-do not add. Already
16_Robert Dempsey exists C120834.
Number of Spontaneous
Abortions-do not add.
Already exists C120837.
Number of Elective
Abortions-do not add.
Already exists C120835.
Please change IG wording to
update to published CT.
Number of Ectopic
Pregnancies-do not add.
Already exists C120832
Congenital Abnormalities-do
not add. Already exists
C122187
Blood Group-Do not add.
Please see Kidney Transplant
TAUG for the appropriate
way to model this data.
Blood Type-Do not add.
Match Type-Do not add.
Number of Children-Do not
add. The CRF and dataset in
the published IG are
inconsistent. Team will need
to determine whether
'number of children' is
Total number of beams broken; This is a unit of III
measure required for the proposed NVTEST values
of Fine Movement; Basic Movement. The animal
subject is placed in a special box with light beams
going across it. The number of times the animal
moves is recorded by beam breaks and the machine
reports an absolute value of beam breaks.
The SDTM implementation guide requires that we II SDTM-Published in P25

place the name and version of the AE grading scale
in the define XML (in a similar way that it asks that we
put the coding dictionaries and versions in the define
XML). For this reason it makes no sense to actually
store the grading scales as controlled terminology
because they are governed by external controlled
lists.
Please add the term INTRACRANIAL CAVITY to the III
Anatomical Location codelist. The definition is: the
space within the cranium occupied by the brain, its
coverings, and cerebrospinal fluid.
We'd like to distinguish Administrative reasons from III SDTM-Published in P31
OTHER.
New terms to be added; File emailed separately III SEND - Published in P28
Do not add (SEND P27) -
LARYNX/TRACHEA/LUNG -
Do not add. Use
LUNG/BRONCHUS/TRACHEA
/LARYNX (new term with
P27).
Do not add (SEND P27)
EYE/NERVE, OPTIC /GLAND,
HARDERIAN; MUSCLE,
SKELETAL/NERVE, SCIATIC -
The CT team does not feel
that this is a commonly
enough used combined
specimen to warrant
publication with SEND CT.
The codelist is extensible and
the SENDIG contains
guidance on how combined
terms should be handled.
Do not add (P30): MATRIX
METALLOPRETEINASE,
TOTAL - Requestor has not
reponded to email
questions. Please resubmit
this request.
An aggregate HR value based on the measurement III Do not add (SDTM-P25) - The
of HR intervals from multiple beats within a single team has already discussed
ECG. The method of aggregation, which can vary, is this and decided to use the
typically a measure of central tendency such as the legacy specific terms related
mean. to min, max, mean, and
median.
File emailed separately with text: "Please find III SDTM-Published in P26
(urgent) request for 3 more TSPARMCD/TSPARM
pairs needed for the CTR (Clinical Trial Registries)
standard.
These are all about study design information that
needs to be submitted to EMA EudraCT."
Just getting a request number. These two terms are III SDTM, SEND-Published in
already present in the P25 LBTEST-CD tab. P25
Just getting a request number. These changes are III SDTM, SEND-Published in
already present in the Changes to existing codelists P25
tab for lab P25 document.
These changes are already present in the changes to II SDTM, SEND-Published in

existing tab in the P25 lab document. Just need to get P25
a request code.
The current location (PORTAL VEIN) does not clearly III Do not add (SDTM P27):
define the location for Main Portal Vein. Our Clinical already exists as C33343
Monitor provided the following: Portal Vein. Please use this
existing term.
The Portal vein originates behind the neck of the
pancreas and is usually formed by the confluence of
the superior mesenteric and splenic veins, and also
receives blood from the inferior mesenteric, gastric,
and cystic veins. Main Portal Vein defines the portal
vein before dividing into left an right portal veins.
Publications using Main Portal Vein:
http://www.ncbi.nlm.nih.gov/pmc/articles/
PMC4375567/
File e-mailed separately III QRS-Published in P24
Please add COPRINELLUS RADIANS to the III SDTM-Published in P26

Microorganism codelist.
Definition: Any fungal organism that can be assigned
to the species Coprinellus radians.
Item already in working document. Just getting a III SEND-Published in P25
request number.
This request goes along with request CDISC-1543 to III SEND-Published in P25, P26
remove C77613 from the spec codelist and replace it
with this new term.
Please consider adding Framingham's correction to III Do not add (SDTM P26)-
EGTEST and EGTESTCD for use in reporting of Please use C123448 and
ECG's Framingham's is defined as QTc = QT + C123449. This request is a
0.154(1-RR)] - suggested terms are EGTESTCD = subset of QTcL Interval,
QTCFM EGTEST = QTcFm - Framingham's Aggregate and QTcL Interval,
Correction Formula Single Beat (linear correction
formulas).
Suggested as we are commonly recieveing data
reported in Framingham's correction so aliging this to
CT would make sense considering other QTc
corrections are documented in CT
Please add the term ENTERIC BACTERIA to the III SDTM-Published in P26
Microorganism codelist.
Proposed Definition: A grouping of rod-shaped, gram-
negative, bacteria that occurs normally or
pathogenically in the intestines of humans and other
animals.
Definition agreed to by the BrCa team: There is III SDTM-Published in P25

evidence of disease without any indication or sign of
unequivocal progression.
Please change c-code of C27477 to C121932. The II SDTM, SEND-Published in

nomenclature has been updated and now this P25
mapping is obsolete. No changes needed to the
SEND submission value, synonyms, or definition.
To be used with RSSTST : Clinical Progression III Do not add (SDTM-P25) -

Please use existing
published term Symptomatic
Deterioration.
To be used with RSSTSTCD : CLINPROG III Do not add (SDTM-P25) -
Please use existing
published term Symptomatic
Deterioration.
Synonym - Triphasic CT Scan III SDTM-Published in P28
Definition - NCI C19907 - A type of computed
tomography whereby images of three separate
phases of contrast medium perfusion are taken. In
general, the phases examined are the arterial,
venous and exitatory phase.
Synonymn - Triphasic MRI III SDTM-Published in P28

Defineition - A type of magnetic resonance whereby
images of three separate phases of contrast medium
perfusion are taken. In general, the phases examined
are the arterial, venous and exitatory phase.
http://pubs.rsna.org/doi/full/10.1148/
radiol.2262011593
Please create two new method terms for DKD TA III SDTM-Published in P25, P28
project; File emailed separately.
P29
File emailed separately (SDTM Terminology 2015-06- II QRS-Published in P24
26 COA codelist name association CHANGES_2015-
10-07_Robert Dempsey)
Dear all, I created new terminology for Patient Health III
Questionnaire - big PHQ CRF which is different from
PHQ8, PHQ9 and PHQ15. The spreadsheet is
emailed separately
Exhaled breath condensate (EBC) is the exhalate III Duplicate request of CDISC-
from breath, that has been condensed, typically via 1870
cooling using a collection device (commonly to 4�C
or subzero temperatures using a refrigerating device).
EBC reflects changes in the respiratory fluid that lines
the airways and is an inexpensive, non-invasive tool
that has potential for scientific research, screening or
diagnosing diseases of the lung and other conditions.
(wikipedia) - also see
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC217089
8/ regarding its use as a source of biomarkers.
This is similar to existing value of "EXPIRED AIR" but

it more specific than EXPIRED AIR (just as SERUM,
PLASMA or PLATELET RICH PLASMA is more
specific than BLOOD).
The Repro team has already agreed to remove this II SEND-Published in P25
synonym from the term in the FXFINDRS codelist.
Definition (NCI): The system that contains the heart III

and the blood vessels and moves blood throughout
the body. This system helps tissues get enough
oxygen and nutrients, and it helps them get rid of
waste products. The lymph system, which connects
with the blood system, is often considered part of the
circulatory system.
The system that contains the muscles, bones, III

tendons, ligaments, joints, and cartilage.
"Rationale: the thickness of the endometrium is III
measured in endometriosis studies. Assuming
mapping to MO domain with MOTESTCD=THICK
there is no existing value in LOC to assign to
MOLOC. Existing term of ENDOMETRIAL CAVITY is
not appropriate as it is the wall of this cavity that is
being measured, not the cavity itself.
Proposed definition: The mucous membrane lining
the uterus that is composed of three layers: the
stratum basale stratum compactum, stratum
spongiosum."
Rationale: endometriosis and PCOS studies III SDTM, SEND-Published in
collecting measurements of diameters of specific P28
ovarian follicles can map the diameters to the MO
domain but there is no appropriate value in the LOC
code list for OVARIAN FOLLICLE.
Proposed definition: A cavity in the ovary containing a
maturing ovum surrounded by encasing thecal and
granulosa cells
A lymph node located in the retropharyngeal space III SDTM, SEND-Published in

behind the upper part of the pharynx. NCI - C77649 P28
Terms already in P25 Oncology working file; just III SDTM-Published in P25
need a change request number
File emailed separately; values are already added to III SDTM-Published in P25
the Oncology P25 working document. Only need a
request number.
File emailed separately III Do not add (SDTM-P25):
I was wondering if you could answer a question in Email sent to requestor to
regards to the terminology contained within the ECG attend an ECG terminology
Test Codelists. Currently at Merck we have numerous team meeting to answer all
trials where local ECGs are run on subjects. The test questions.
code/test names that we currently use on our eCRF is
very generic:
Atrial Rate
Ventricular Rate
RR Interval
PR Interval
QRS Interval
QT Interval
QTc Interval Bazett
QTc Interval Fridericia
Our clinical teams feel that the terminology contained
in the Codelists are very specific and more relevant
for Central Vendor reported results instead of the
results provided in a local doctor’s office. They feel
that the local doctor would not know if this result
provided are Mean, Max, Min or Median. We were
wondering if CDISC would consider adding more
generic tests to the list or if you could provide
guidance on how to translate the generic test names
into the specific tests names provided within the
codelist. Any guidance that you could provide would
be greatly appreciated.
Need the diagnostic term "Hemorrhage" as a III

separate submission value from "Red Material".
File emailed separately… III SDTM-Published in P26, P30

Amgen uses 'DISEASE PROGRESSION' in their II
studies. if our assumption is correct that it is a
synonym, then we would like to use the synonym in
the documentation.
Remove reference to 'billions of neurons' since this II SDTM, SEND-Published in

might not be true in all species. P26
Requesting the following test name/test code be III SDTM-Published in P25

added to Tumor or Lesion Properties Test
Name/Code codelists: Percent Change Nadir in Sum
of Area (PCNSA)
Definition: The (current sum of areas minus the
lowest sum of areas previously recorded) divided by
the lowest sum of areas previously recorded,
multiplied by 100.
Please add the following locations that are being III SDTM, SEND-Published in
captured in an Oncology Imaging study for different P29
parts of the brain:
CEREBRAL WHITE MATTER - as part of the study
measuring Subcortical White Matter(definition from
NCI: A type of brain tissue in the cerebrum consisting
of myelinated axons and glial cells.) NCI Code:
C49347
PERIVENTRICULAR WHITE MATTER (Definition:
The white matter that is immediately to the side of the
two lateral (side) ventricles of the brain.)
These 2 terms are used with RANO criteria III SDTM-Published in P29
NON-TARGET ENHANCING
Rationale: Contrast enhancing lesions that do not
meet the minimum target lesion size requirements
and/or have poorly defined margins, or measureable
lesions not selected as target lesions at baseline.
Proposed Definition: The identification of a contrast-
enhancing tumor, lesion, or site of disease that is
present at baseline and not considered a target, but
may be part of the objective assessment of the
response to the therapeutic intervention.
NON-TARGET NON-ENHANCING
Rationale: Non-contrast enhancing lesions which are
ill defined and non measureable on MRI images.
The Response Assessment in Neuro-Oncology
(RANO) Working Group considered non-enhancing
disease important to consider as evidence of
progression, distinctly from enhancing disease, but
noted that a precise objective measure of non-
enhancing disease was not possible at present given
the limitations of current technology (RANO: Wen
et.al. JCO 2010, p. 5)
Proposed Definition: The identification of a non-
contrast-enhancing tumor, lesion, or site of disease
that is present at baseline and not considered a
target, but may be part of the assessment of the
Used for RANO Criteria - the response values for III Do not add (P30) - Please see
non-target non-enhancing lesions are loosely defined draft RANO examples for
in the RANO paper and for the read criteria as ? valid responses for new
Improved (PR)?, ?Stable (SD)?, ?Progressive tests, Non-Target Response
Disease (PD)? and ?Not Evaluable (NE)? Enhancing and Non-Target
Response Non-Enhancing.
Request adding synonym ?Improved? for the III Do not add (SDTM-P25) -
assessment of Non-Enhancing Non-Target lesions This is not a 1:1 match as
per the RANO criteria (see the above description of per RANO criteria.
the disease category) when RSTESTCD =
NTRGRESP. The best defined response for the
disease category per the criteria is ?stable or
improved? which does not match the existing
definition for, or use of, CR.
When a subject can't cough up enough sputum on III Do not add (SDTM-P25) -
their own, a saline spray can be used to cough up a Please use SPUTUM
sputum sample. (C13278). INDUCED could be
put into SUPPQUAL for
Collection Method.
Lipoarabinomannan (LAM) is a component of the III SDTM, SEND-Published in
Mycobacterium cell wall and, when shed, can be P25
detected in urine.
We need to be able to represent which x-ray view III
generated the chest radiograph findings .
We need this for an example where an educator III SDTM-Published in P26
exposed a child to TB.
This request supports modeling of a chest radiograph III Do not add (SDTM P26) -
imaging example in TAUG-TBv2.0. The example was Please use the TUTEST of
developed by consensus with the oncology Targeted Tumor/Lesion
terminology team in order to accommodate data for Examination with a
pre-specified findings where the "NOs" also need to TUTESTCD of TRGTUEXM.
be recorded. And to use the new variable
Draft definition: "An indication as to whether or not a of TURESTRG with a result of
finding of fibrotic lesion(s) was made." Fibrotic Lesion.
This request supports development of TAUG-TBv2.0. III SDTM-Published in P25

It is used to indicate a finding of calcification of body
tissue (in our case, lesions of the lung). Calcification
is typically abnormal outside of bone.
Draft definition: "The accumulation of calcium in body
tissue."
New SEND term requests III
New terms to be added to ROUTE III

New terms to be added to LBTEST/CD III SDTM, SEND-Published in

File emailed separately P28, P30, P31
Do not add (P33):
RUBBAS; Rubricyte,
Basophilic: Do not add.
Please use existing term
'Prorubricyte' C128976.
RUBPC; Rubricyte,
Polychromatophilic: Do not
add. Please use existing
term 'Rubricyte' C128978.
RUBRIB; Rubriblasts: Do not
add. Already exists as
C100446.
METARUB; Metarubricytes:
Do not add. Already exists as
C128972.
New terms to be added to METHOD III


C73686 change the submission value from AU to II SDTM, SEND-Published in

Absorbance U P25
C73687 change the submission value from AU/min to
Absorbance U/min. Requested by lab terminology
team.
This already exists in the UNIT spreadsheet.
Please add SUPRAPUBIC REGION to Anatomical III SDTM, SEND-Published in

Location codelist. P29
Proposed definition: The abdominal region that is
inferior and central in location, below the umbilical
region and between the two iliac(inguinal) regions.

epithelial cells to total cells in a biological specimen P28
To be used with LBTEST : Epithelial Cells/Total Cells

epithelial cells to total cells in a biological specimen P28
To be used with LBTESTCD : EPICCE
Total cells in a biological specimen III SDTM, SEND-Published in

P28
To be used with LBTEST : Total Cells
Note: This reference cell count is required as

documentation for Bronchoalveolar lavage. e.g.
similar to the differentials (WBC as reference for
EOSLE). We also use the reference cell count for
measurements in other specimen (e.g.Lavage fluid,
Sputum)
Total cells in a biological specimen III SDTM, SEND-Published in

P28
To be used with LBTESTCD : TOTCE

Sputum)
Viable cells in a biological specimen III SDTM, SEND-Published in
P28
To be used with LBTEST : Viable Cells

Sputum)
Viable cells in a biological specimen III SDTM, SEND-Published in

P28
To be used with LBTESTCD : VIABCE

Sputum)
BONE SCAN III

Def: A bone scan is an imaging test that uses a very
small amount of a radioactive substance (tracer) to
find or monitor cancer that started in the bones or that
has spread to the bones from another part of the
body.
Rationale for adding: Scan options currently available
in CT does not detect cancer in bones.
RADIONUCLIDE SCAN
Def: A radionuclide scan is a way of imaging bones,
organs and other parts of the body by using a small
dose of a radioactive chemical.
Rationale for adding: Radionuclide scan provides a
quantitative imaging from the perspective of response
measurements and is different from e.g. SPECT Scan
Need for TB - File emailed separately III SDTM-Published in P25, P26,

P29
Transverse Diameter -
Removed by Requestor. We
could not find any consistent
description or use of
Transverse Diameter.
GASTRIC LAVAGE and
TRANSBRONCHIAL BIOPSY -
Use LAVAGE. Use BIOPSY.
Create New Terms for LBTEST, LBTESTCD III SDTM, SEND-Published in
codelists; Two files emailed separately P28, P29
A measurement of the energy generated by the recoil III Do not add (P30) - Already
of the lungs after distention by a pressure wave out of exists; please use C123567.
phase with airflow.
To be used with RETEST : Airway Reactance
A measurement of the energy generated by the recoil III Do not add (P30) - Already
of the lungs after distention by a pressure wave out of exists; please use C123567.
phase with airflow.
To be used with RETESTCD : XAW
An assay using live cells to measure or assess the III Do not add (P30) - The team
biological response, such as receptor binding, feels that this term is too
receptor activation, cell signaling, drug internalization generic to be of much use in
and subcellular localization. a dataset (This term applies
to an entire class of
methods) and as such does
not think it worth controlling
by CDISC at this time. The
codelist is extensible.
Turbo-Inversion Recovery Magnitude sequence is a III

type of inverstion recovery MRI pulse sequence.
To be used with RETEST : Turbo-Inversion

Recovery-Magnitude
Turbo-Inversion Recovery Magnitude sequence is a III

type of inverstion recovery MRI pulse sequence.
To be used with RETESTCD : TIRM

The volume which is above the threshold of the entire III Do not add (P40) - Do not
lung volume (mean + 2*(standard deviation of all add. We could not find
segments)) published references to this
respiratory test. Can the
To be used with RETEST : Volume Over Threshold requester please provide a
The volume which is above the threshold of the entire III Do not add (P40) - Do not
lung volume (mean + 2*(standard deviation of all add. We could not find
segments)) published references to this
To be used with RETESTCD : VOT requester please provide a
A measurement of the oxygen transfer from the lungs III Do not add (P40) - Do not
into the blood. add. We could not find
To be used with RETEST : Oxygen Transfer Function respiratory test. Can the
A measurement of the oxygen transfer from the lungs III Do not add (P40) - Do not
into the blood. add. We could not find
To be used with RETESTCD : OTF respiratory test. Can the
The wash-out time is the time it takes until the 100% III Do not add (P40) - Do not
oxygen is washed out and the MRI signal is again to add. We could not find
normal room air. published references to this
To be used with RETEST : Oxygen Washout Time requester please provide a
The wash-out time is the time it takes until the 100% III Do not add (P40) - Do not
oxygen is washed out and the MRI signal is again to add. We could not find
normal room air. published references to this
To be used with RETESTCD : O2WASH requester please provide a
Main Portal Vein divides into two branches: left and III SDTM, SEND-Published in
right. We need the location Portal Vein Branch for P29
macrovascular invasion. We need to differentiae
between the Main Portal Vein and the Portal Vein
Branch. We do not need to differentiate between left
and right.
You can find explanation with image on

http://www.daviddarling.info/encyclopedia/P/portal_ve
in.html
Create new codelist called CRACE (Collected Race). III SDTM, CDASH-Published in
This would support the CRACE (Collected Race) P28, P31
variable being proposed to be added to the CDASH Do not add (P30):
Model v1.0. This is being requested to standardize SOUTH ASIAN - Request
additional collected values for RACE that are more removed by requester.
specific than the 5 RACE Submission values. NORTH AMERICAN - We
don't think this is commonly
File is being emailed separately. used as a collected racial
category so will not add at
this time.
Create new codelist CETHNIC (Collected Ethnicity) to III SDTM, CDASH-Published in

support the CETHNIC (Collected Ethnicity) variable P28
being proposed to be added to the CDASH Model
v1.0. This is being requested to standardize
additional collected values for ETHNICITY that are
more specific than the 2 ETHNICITY Submission
values.
File is being emailed separately.
As the subject status is part of 3.2 it should be in the III SDTM, SEND-Published in
domain CT. P33
New domain part of SDTM IG 3.2 III SDTM, SEND-Published in

P33
At GSK we are trying to use SDTM terms at study II
setup, rather than mapping for reporting/submission.
Study teams have raised concerns over the use of
UNIT synonyms. When the synonym is just
standardising on the format/convention of the unit this
is fine e.g. mcg/mL = ug/mL and gm/L = g/L. But
there is concern over changing the units entirely,
mg/g being a synonym of g/kg being a perfect
example. Drugs are not specified as g/kg and we
cannot expect investigators to use this unit if the drug
label says mg/g. This makes using SDTM terms
difficult for study use. It means we have to map it at
the back end. But it also raises the question of
whether we should be mapping mg/g to g/kg at all. Is
this what we want to see in the report? I'd appreciate
your thoughts.
Needing request codes; File emailed separately II QRS-Published in P24
This is a multiple term request spreadsheet that III SDTM, SEND-Published in

contains an addition to the SEND STSPRM-CD P25
codelist as well as modifications to 9 existing terms.
These items are already in the working documents;
request numbers just need to be added.
Please change existing definition to: The paired bone III SDTM, SEND-Published in
that is situated between the sternum and the P26
shoulder.
PARAINFLUENZA VIRUS (reference: NCI) Definition: III SDTM-Published in P26

A non-taxanomic group of paramyxoviruses (genus
Respirovirus and Rubulavirus) that are a frequent
cause of infections of the lower respiratory tract.
TOXOPLASMA GONDII (reference: NCBI) Definition:

Any protozoan parasite that can be assigned to the
species Toxoplasma gondii.
Reference: Illumina III SDTM-Published in P30

Proposed Definition: The use of probabilistic
matching tools in combination with large volumes of
sequence information to identify genomes present,
based on DNA analysis across entire genomes to
determine genome assignments, to calculate
confidence scores of major and minor genome
content.
Definition: The terminal section of the alimentary III SDTM, SEND-Published in
canal, which extends from the anorectal junction and P29
ends at the anal opening. Source: NCI (C12375)
OI III SDTM, SEND-Published in

Synonym: Opsonization Index P28
Definition: the serum dilution that kills 50% of bacteria
Usage: The results from a MOPA assay are
expressed in CFU (colony forming units). To facilitate
data analysis, the raw data in CFU are processed by
a program (Opso Titer3) converting CFU into OI
(opsonization index)
Discontinuation reason for subjects randomized in III

error.
Do not add (P30) - lease use
RANDOMIZED BY MISTAKE in
the NCOMPLT codelist (out
for public review with P31).
Create New codelists for PK (Norm by...), new terms, III SDTM, SEND, CDASH-
modify existing terms; File emailed separately Published in P25, P28
from the lab terminology team II SDTM, SEND-Published in

P26

P26

P26
from the lab terminology team II

P26

P25

P25

P25
For consistency between IG and CT term II SDTM, SEND-Published in
P33
Domain label is mismatched between IG 3.2 and CT II SDTM, SEND-Published in

dated 2015-09-25 for below Domains P33
EG, IE, LB, PE, QS, DD, MB, MO, PC, TU, CM, PR, Do not add (P35):
SE MO - do not change - the
MO domain will not be
included in SDTMIG v3.3
Right lung, superior lobe, apical segment (S1) III SDTM, SEND-Published in
P29
Right lung, superior lobe, posterior segment (S2) III SDTM, SEND-Published in
P29
Right lung, superior lobe, anterior segment (S3) III SDTM, SEND-Published in
P29
Right lung, middle lobe, lateral segment (S4) III SDTM, SEND-Published in
P29
Right lung, middle lobe, medial segment (S5) III SDTM, SEND-Published in
P29
Right lung, inferior lobe, superior segment (Fowler) III SDTM, SEND-Published in
(S6) P29
Right lung, inferior lobe, medial basal segment (S7) III SDTM, SEND-Published in
P29
Right lung, inferior lobe, anterior basal segment (S8) III SDTM, SEND-Published in
P29
Right lung, inferior lobe, lateral basal segment (S9) III SDTM, SEND-Published in
P29
Right lung, inferior lobe, posterior basal segment III SDTM, SEND-Published in
(S10) P29
Left lung, superior lobe, apicoposterior segment III SDTM, SEND-Published in
(S1+S2) P29
Left lung, superior lobe, anterior segment (S3) III SDTM, SEND-Published in
P29
Left lung, superior lobe, superior lingular segment III SDTM, SEND-Published in
(S4) P29
Left lung, superior lobe, inferior lingular segment (S5) III SDTM, SEND-Published in
P29
Left lung, inferior lobe, superior segment (Fowler) III SDTM, SEND-Published in
(S6) P29
Left lung, inferior lobe, medial basal segment (S7) III SDTM, SEND-Published in
P29
Left lung, inferior lobe, anterior basal segment (S8) III SDTM, SEND-Published in
P29
Left lung, inferior lobe, Lateral basal segment (S9) III SDTM, SEND-Published in
P29
Left lung, inferior lobe, posterior basal segment (S10) III SDTM, SEND-Published in
P29
for variable TSVALNF in TS domain, the codelist III Do not add (P30) - CDISC is
name defined in SDTM metadata version 3.1 and 3.3 intending users to use the
is NULLFLAVOR, but this codelist is not still included ISO21090 NullFlavor valid
in the latest version of SDTM CT. in the following link values and will not be
you can see the different availables values according controlling their own
to the HL7 standards: codelist. In the TS
specification “NULLFLAVOR”
http://www.hl7.org/fhir/v3/NullFlavor/index.html will be changed to
something like “ISO 21090”
or perhaps “ISO 21090
NullFlavor.”
Information collected to determine if an autopsy was III SDTM-Published in P30
performed.
Information collected to determine if an autopsy was III SDTM-Published in P30

performed.
To be used with DDTESTCD : AUTOPSY
Information collected to determine if a death III SDTM-Published in P30

certificate was obtained.
To be used with DDTEST : Death Certificate
Information collected to determine if a death III SDTM-Published in P30

certificate was obtained.
To be used with DDTESTCD : DTHCERT
Information collected to determine if hospital medical III SDTM-Published in P30

records were obtained.
To be used with DDTEST : Hospital Medical Record
Information collected to determine if hospital medical III SDTM-Published in P30

records were obtained.
To be used with DDTESTCD : HOSPREC
Information collected to determine if a source other III Do not add (P30) - Flavors of
than those pre-specified was used to determine the other are not included in
cause of death. CDISC codelists because the
codelists are extensible.
To be used with DDTEST : Other Source
Information collected to determine if a source other III Do not add (P30) - Flavors of
than those pre-specified was used to determine the other are not included in
cause of death. CDISC codelists because the
codelists are extensible.
To be used with DDTESTCD : OTHERSRC
A study specific grouping of cause of death. For III Do not add (P31) - No one on
example: Progression of AE of underlying cancer team is familiar with the
disease; AE not related to PD nor underlying cancer usage of this term within
disease; Unknown other companies. Team
recommends keeping as
To be used with DDTEST : Cause of Death Group sponsor specific terminology
for now.
A study specific grouping of cause of death. For III Do not add (P31) - No one on
example: Progression of AE of underlying cancer team is familiar with the
disease; AE not related to PD nor underlying cancer usage of this term within
disease; Unknown other companies. Team
recommends keeping as
To be used with DDTESTCD : DTHGRP sponsor specific terminology
for now.
Assessment of pulmonary perfusion within a lung III SDTM-Published in P30

segment.
To be used with RETEST : Pulmonary Blood Flow
Assessment of pulmonary perfusion within a lung III SDTM-Published in P30

segment.
To be used with RETESTCD : PBF
Weight of specimen III
To be used with BSTEST : Weight of Specimen
Weight of specimen III
To be used with BSTESTCD : WEIGHT
Volume of solution added to a specimen for III Do not add (P35): Do not
processing. add. Request removed by
requester.
To be used with BSTEST : Added Solution
Volume of solution added to a specimen for III Do not add (P35): Do not
processing. add. Request removed by
requester.
To be used with BSTESTCD : SOLUTION
Quantity (number) of collected/prepared samples. III Do not add (P30) - BS
domain is used to collect the
To be used with BSTEST : Quantity characteristics of individual
samples, not metadata on
how many samples were
collected. If you are trying to
link this back to a pathology
report, then you would
include a suppqual in the MI
domain that would have the
number of slides
examined/evaluated to
produce the report.
Quantity (number) of collected/prepared samples. III Do not add (P30) - BS
domain is used to collect the
To be used with BSTESTCD : QUANTITY characteristics of individual
samples, not metadata on
how many samples were
collected. If you are trying to
link this back to a pathology
include a suppqual in the MI
domain that would have the
number of slides
produce the report.
A measurement of the percent of a sample that is III SDTM-Published in P31

viable for further processing/testing.
To be used with BSTEST : Viability of Sample
A measurement of the percent of a sample that is III SDTM-Published in P31

viable for further processing/testing.
To be used with BSTESTCD : VIABLE
Quality of the specimen. III
To be used with BSTEST : Quality
Quality of the specimen. III
To be used with BSTESTCD : QUALITY
Specimen Collection III Do not add (SDTM P27):

CDISC will not control this
codelist. Sponsors can use
sponsor-defined terminology
for this variable.
Specimen handling III Do not add (SDTM P27):

CDISC will not control this
codelist. Sponsors can use
sponsor-defined terminology
for this variable.
Per large square' is a unit of measure used when III SDTM, SEND-Published in
counting the number of cells via the Neubauer P28
chamber.
millimeters per minute per 100 millimeters of lung III
volume
A qualified person performing an evaluation that is III Do not add (P30): Use
given the designation of one. MEDEVAL Reader 1.
A qualified person performing an evaluation that is III Do not add (P30): Use
given the designation of two. MEDEVAL Reader 2.
A person qualified to perform a specific evaluation III Do not add (P30): Use
Independent Assessor or
Clinical Research Associate
or Clinical Research
Coordinator or Investigator.
Reason for suggestion: I cannot find this test in the III SDTM, SEND-Published in
CDISC Naming Convention spreadsheet. P29
Draft definition: Tumor Necrosis factor beta --or--
TNF-?.
Example of how new term will be used: it will be
added to a cytokine lab CRF page.
This is an experimental organism specific concept II SEND-Published in P26

and as such requires a new c-code. This was
incorrectly coded.
Add new terms to LOC; File emailed separately III SDTM, SEND-Published in
P29
RHIZOPUS ORYZAE - Reference: NCBI Taxonomy III SDTM-Published in P26
website
Proposed Definition: Any fungal organism that can be
assigned to the species Rhizopus oryzae.
Request to add Thin Prep Papanicolaou Test. This is III SDTM-Published in P26
different than the conventional Pap Smear test. In the
ThinPrep Pap test, cell samples are collected using a
special brush that is immediately washed in a special
fluid. The ThinPrep machine then filters out the cells
from the solution and deposits them in a thin uniform
monolayer (a single layer of cells) on a glass slide.
The slide is then read for abnormal cervical cells.
This is the first liquid-based pap test. An important
benefit of the ThinPrep Pap Test is the ability to do
additional testing, like the HPV test, from the same
pap test sample.
It seems that there is no term for use in the PPTEST III Do not add (SDTM P27):
column for the PPTESTCD value of AUCIFOD. I think already exists as C96695
the term should be something like "AUC Infinity Obs
Norm by Dose". Maybe I'm missing something here;
missing term for completeness
File e-mailed separately III
File emailed separately. III ADaM-Published in P29
This is for the COPD TA project. DEF: The fastest III

flow rate noted during the inspiratory cycle
Add DIAPHRAGMATIC LYMPH NODE as a III SDTM, SEND-Published in

Submission Value. Proposed Definition: One of three P29
groups of thoracic parietal lymph nodes, situated on
the thoracic side of the diaphragm and consisting of
the anterior set, the middle set, and the posterior set.
The anterior set includes about three nodes dorsal to
the base of the xiphoid process. The middle set of
about three nodes on each side is close to the
diaphragmatic entry of the phrenic nerves. The
posterior set of diaphragmatic nodes consists of a
few nodes on the crura of the diaphragm, connecting
with the lumbar nodes and the posterior mediastinal
nodes.
Add Flank as a synonym to the existing term of

LUMBAR REGION
Date of Request
Submission Code
Closed Monday, 4 Jan CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 11:44 AM 2331 behalf of Carol nih.gov
Detrisac)
Closed Monday, 4 Jan CDISC- Bob Dempsey CDISC rdempsey@cdisc.o
2016 11:45 AM 2332 rg
Closed Monday, 4 Jan CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2016 11:46 AM 2333 rg
Closed Thursday, 7 Jan CDISC- Lisbeth Nielsen Novo Nordisk A/S lbtn@novonordisk.c
2016 06:19 PM 2334 om
Closed Thursday, 7 Jan CDISC- Sharon Broderick Boehringer sharon.broderick@

2016 06:20 PM 2335 Ingelheim boehringer-
Inc.
Open Friday, 8 Jan CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2016 12:57 PM 2336 nih.gov
Closed Friday, 8 Jan CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 12:58 PM 2337 behalf of SEND) nih.gov

2016 12:59 PM 2338 nih.gov
Closed Friday, 8 Jan CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2016 04:02 PM 2339 behalf of the CV
Imaging TA team)
Closed Friday, 15 Jan CDISC- Debbie Oneill Merck debra_oneill@merc
2016 02:42 PM 2340 k.com
Closed Friday, 15 Jan CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.
Inc.
Inc.

Inc.

Inc.

Inc.
Inc.

Inc.
2016 03:20 PM 2359 behalf of BrCa nih.gov
Team)

2016 03:21 PM 2360 k.com
Closed Friday, 15 Jan CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

2016 03:22 PM 2361 Pharmaceuticals zwick@astrazenec
a.com
Open Wednesday, 20 CDISC- Joe Hilber Covance joe.hilber@covance

Jan 2016 01:00 2362 .com
PM
Closed Wednesday, 20 CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.

Jan 2016 01:10 2363 behalf of SEND) nih.gov
PM
Closed Wednesday, 20 CDISC- Sharon Broderick Boehringer sharon.broderick@
Jan 2016 01:12 2364 Ingelheim boehringer-
Inc.
Jan 2016 01:14 2365 Ingelheim boehringer-
Inc.
2016 11:27 AM 2366 behalf of the CV
Imaging Team)
2016 12:45 PM 2367 k.com

2016 12:46 PM 2368 nih.gov
Closed Thursday, 28 CDISC- Lacey Wallace Eli Lilly and wallace_lacey_m@

Jan 2016 03:39 2369 Company lilly.com
PM
Open Thursday, 28 CDISC- Lorena Corradin Merck KGaA lorena.corradin@m

Jan 2016 03:40 2370 (Merck Ivrea) erckgroup.com
PM

Jan 2016 03:42 2371 nih.gov
PM

Jan 2016 03:43 2372 nih.gov
PM
Open Thursday, 28 CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

Jan 2016 03:45 2373 nih.gov
PM
Open Thursday, 28 CDISC- Amy Palmer CDISC apalmer@cdisc.org
Jan 2016 03:46 2374
PM
Open Friday, 5 Feb CDISC- Bernice Yost CDISC byost@cdisc.org

2016 03:47 PM 2375
Closed Friday, 5 Feb CDISC- Angelo Tinazzi Cytel Inc angelo.tinazzi@cyt

2016 03:48 PM 2376 el.com
Closed Friday, 5 Feb CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.

Inc.

Inc.

Inc.
2016 03:54 PM 2381 nih.gov
Closed Friday, 5 Feb CDISC- Audrey Walker Charles River Audrey.Walker@crl

2016 03:55 PM 2382 .com
Closed Friday, 5 Feb CDISC- Bob Dempsey (for CDISC rdempsey@cdisc.o
2016 03:58 PM 2383 the Lab team) rg
Open Friday, 5 Feb CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2016 03:59 PM 2384 rg
Open Friday, 5 Feb CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2016 04:23 PM 2385 nih.gov
Open Friday, 5 Feb CDISC- Debbie Oneill Merck debra_oneill@merc

2016 04:26 PM 2386 k.com

2016 04:27 PM 2387 nih.gov
Closed Friday, 12 Feb CDISC- James Kramer (on Janssen R&D jkramer2@its.jnj.co
2016 01:53 PM 2388 behalf of PrCa TA) m
Closed Friday, 12 Feb CDISC- Audrey Walker Charles River Audrey.Walker@crl
2016 01:56 PM 2391 .com
Closed Friday, 12 Feb CDISC- Joan Berger Alexion BergerJ@alxn.com
2016 01:57 PM 2392 Pharmaceuticals

2016 01:58 PM 2393 nih.gov
Closed Friday, 12 Feb CDISC- Magdalena Litwin- Roche litwinwm@roche.co
2016 01:59 PM 2394 Wojciechowska m
Closed Friday, 12 Feb CDISC- Debbie O'Neill Merck debra_oneill@merc

2016 02:00 PM 2395 k.com

Feb 2016 05:29 2396 k.com
PM
Closed Thursday, 18 CDISC- Linda Barrett Amgen barrettl@amgen.co
Feb 2016 05:30 2397 m
PM

Feb 2016 05:32 2398 nih.gov
PM
Open Thursday, 18 CDISC- Pat Wozniak Advanced Clinical pwozniak@advanc

Feb 2016 05:38 2399 (submitting updated edclinical.com
PM terminology for
QRS team)

2016 01:39 PM 2400 k.com
2016 01:40 PM 2401 k.com
Closed Friday, 26 Feb CDISC- Philip Pochon Covance phil.pochon@covan

2016 01:44 PM 2402 ce.com
Closed Friday, 26 Feb CDISC- Philip Pochon Covance phil.pochon@covan
2016 01:45 PM 2403 ce.com
Open Friday, 26 Feb CDISC- Lorena Corradin Merck - Italy lorena.corradin@m
2016 01:47 PM 2404 erckgroup.com
Closed Friday, 26 Feb CDISC- Bernice Yost CDISC byost@cdisc.org

2016 01:48 PM 2405
Open Friday, 26 Feb CDISC- Gitte Frausing Data Standards gfrausing@datasta

2016 01:49 PM 2406 Decisions Aps ndardsdecisions.co
m
Closed Friday, 26 Feb CDISC- Gitte Frausing Data Standards gfrausing@datasta
2016 01:50 PM 2407 Decisions Aps ndardsdecisions.co
m

2016 05:06 PM 2408 k.com
Open Friday, 4 Mar CDISC- Debbie O'Neill Merck debra_oneill@merc

2016 05:07 PM 2409 k.com

2016 05:07 PM 2410 k.com
Closed Friday, 4 Mar CDISC- Joan Berger Alexion BergerJ@alxn.com

2016 05:08 PM 2411 Pharmaceuticals
Open Friday, 4 Mar CDISC- Rhonda Facile CDISC rfacile@cdisc.org
2016 05:10 PM 2412
Closed Friday, 4 Mar CDISC- Rhonda Facile CDISC rfacile@cdisc.org
2016 05:10 PM 2413
Closed Friday, 4 Mar CDISC- Rhonda Facile CDISC rfacile@cdisc.org

2016 05:11 PM 2414

2016 05:12 PM 2415
Closed Friday, 4 Mar CDISC- Covamce alexandre.soulan@

2016 05:13 PM 2416 covance.com
Closed Friday, 4 Mar CDISC- Lauren Shinaberry AbbVie Lauren.shinaberry

2016 05:14 PM 2417 @abbvie.com
2016 12:52 PM 2418 k.com

2016 12:53 PM 2419

2016 12:54 PM 2420

2016 12:55 PM 2421
2016 12:56 PM 2422
Open Friday, 11 Mar CDISC- Audry Walker Charles River Audrey.Walker@crl

2016 12:58 PM 2423 .com
Closed Friday, 11 Mar CDISC- Alexandre Soulan Covance CLS alexandre.soulan@
Open Friday, 11 Mar CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 01:01 PM 2425 behalf of Oncology nih.gov
team)

2016 01:02 PM 2426
Closed Monday, 14 Mar CDISC- Erin Muhlbradt (on MSC muhlbradtee@mail.

2016 03:51 PM 2427 behalf of SEND nih.gov
team)
Closed Monday, 14 Mar CDISC- Erin Muhlbradt (on MSC muhlbradtee@mail.
2016 03:53 PM 2428 behalf of Mary Jo nih.gov
Brucker)

2016 12:01 PM 2429

2016 12:58 PM 2430
Closed Friday, 18 Mar CDISC- Carol Detrisac CRL carol.detrisac@crl.c

2016 01:02 PM 2431 om

Open Thursday, 24 CDISC- Bess Leroy C-Path bleroy@c-path.org

Mar 2016 11:51 2434
AM

Mar 2016 11:54 2435
AM
Open Thursday, 24 CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.

Mar 2016 11:55 2436 behalf of Oncology nih.gov
AM SDS team)
Closed Thursday, 24 CDISC- Lex Jansen SAS Institute Inc lex.jansen@sas.co
Mar 2016 11:57 2437 m
AM
Closed Thursday, 24 CDISC- Sharon Broderick Boehringer sharon.broderick@

Mar 2016 11:59 2438 Ingelheim boehringer-
Inc.

Inc.
Open Thursday, 24 CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.
Closed Friday, 1 Apr CDISC- Steve Kopko CDISC skopko@cdisc.org

2016 11:26 AM 2446

2016 11:27 AM 2447
Closed Friday, 1 Apr CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

2016 11:29 AM 2448 Pharmaceuticals zwick@astrazenec
a.com

a.com
Open Friday, 1 Apr CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com
Closed Friday, 1 Apr CDISC- Kimberley Holich AbbVie Inc. kimberley.holich@a

2016 11:32 AM 2451 bbvie.com
Open Friday, 1 Apr CDISC- Joe Hilber Covance joe.hilber@covance

2016 11:33 AM 2452 .com
Closed Friday, 1 Apr CDISC- Sharon Broderick Boehringer sharon.broderick@
2016 11:34 AM 2453 Ingelheim boehringer-
Inc.
Inc.

Inc.
Closed Friday, 8 Apr CDISC- Steve Kopko CDISC skopko@cdisc.org
2016 04:26 PM 2456
Closed Friday, 8 Apr CDISC- Dana Booth CDISC dbooth@cdisc.org

2016 04:27 PM 2457
Closed Friday, 8 Apr CDISC- Debbie O'Neill Merck debra_oneill@merc

2016 04:28 PM 2458 k.com
Open Thursday, 14 Apr CDISC- Line Berthelsen Novo Nordisk A/S lbth@novonordisk.c
2016 06:35 PM 2459 om
Open Thursday, 14 Apr CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.

Inc.

Inc.

Inc.
Closed Thursday, 14 Apr CDISC- Sharon Broderick Boehringer sharon.broderick@
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Open Thursday, 14 Apr CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 07:11 PM 2485 behalf of RA TA nih.gov
team)
Open Thursday, 14 Apr CDISC- Diane Wold CDISC diane.wold@cdisc.
2016 07:12 PM 2486 org
Open Thursday, 14 Apr CDISC- Bess LeRoy C-Path bleroy@c-path.org

2016 07:13 PM 2487
Closed Thursday, 14 Apr CDISC- Bess Leroy C-Path bleroy@c-path.org

2016 07:14 PM 2488
Open Thursday, 21 Apr CDISC- Audrey Walker Charles River Audrey.Walker@crl

2016 05:56 PM 2489 .com
Closed Thursday, 21 Apr CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2016 05:58 PM 2490 nih.gov
Open Thursday, 21 Apr CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2016 05:58 PM 2491 nih.gov
Open Thursday, 21 Apr CDISC- Bess LeRoy Critical Path bleroy@c-path.org

2016 05:59 PM 2492 Institute
Open Friday, 22 Apr CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2016 10:49 AM 2493 nih.gov

2016 10:50 AM 2494 nih.gov
Closed Friday, 29 Apr CDISC- Hajime Takeda hajime.shimizu@ta

2016 11:21 AM 2495 Pharamaceutical keda.com
Closed Friday, 29 Apr CDISC- Carrie Neeley Covance carrie.neeley@cov
2016 11:22 AM 2496 ance.com

2016 11:26 AM 2497 k.com
Open Thursday, 5 May CDISC- Joe Hilber Covance joe.hilber@covance

2016 04:58 PM 2498 .com
Closed Thursday, 5 May CDISC- Joe Hilber Covance joe.hilber@covance

2016 04:59 PM 2499 .com
Open Thursday, 5 May CDISC- Joe Hilber Covance joe.hilber@covance

2016 04:59 PM 2500 .com
Open Thursday, 5 May CDISC- Debbie O'Neill Merck debra_oneill@merc

2016 05:01 PM 2501 k.com
Closed Thursday, 5 May CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.

Inc.
Inc.

Inc.
Open Thursday, 5 May CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.

Inc.
Inc.
Inc.
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Open Thursday, 5 May CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2016 05:11 PM 2516 nih.gov
Closed Thursday, 5 May CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2016 05:13 PM 2517 nih.gov
Closed Thursday, 5 May CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2016 05:14 PM 2518 behalf of the KT TA
Team)
Closed Friday, 6 May CDISC- Gbenga (Ben) Novartis gbenga.ogunsulire

Closed Thursday, 12 CDISC- n/a fdong@esperion.co

May 2016 04:54 2520 m
PM
Closed Friday, 20 May CDISC- Steve Kopko CDISC skopko@cdisc.org

2016 11:00 AM 2521
Closed Friday, 20 May CDISC- Daniel Olson C-Path dolson@c-path.org

2016 11:44 AM 2522
Closed Friday, 20 May CDISC- Audrey Walker Charles River Audrey.Walker@crl

2016 11:47 AM 2523 .com
Open Friday, 27 May CDISC- Takuya Kita Shionogi takuya.kita@shiono
2016 11:19 AM 2524 gi.co.jp
Closed Friday, 27 May CDISC- Nicholas Pemble J&J npemble@its.jnj.co

2016 11:22 AM 2525 m
Closed Friday, 27 May CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.
Closed Wednesday, 1 CDISC- Jordan Li NCI EVS jordan.li@nih.gov

Jun 2016 11:13 2528
AM

2016 12:54 PM 2529
Open Friday, 3 Jun CDISC- Bob Dempsey (on CDISC rdempsey@cdisc.o

2016 12:56 PM 2530 behalf of Bernice rg
Yost)
Closed Friday, 3 Jun CDISC- Debbie O'Neill Merck debra_oneill@merc
2016 12:57 PM 2531 k.com
Open Friday, 3 Jun CDISC- Debbie O'Neill Merck debra_oneill@merc
2016 12:57 PM 2532 k.com

2016 12:58 PM 2533
Open Friday, 3 Jun CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2016 01:00 PM 2534 nih.gov

2016 10:13 AM 2535 nih.gov
Closed Friday, 10 Jun CDISC- Diane Wold CDISC diane.wold@cdisc.

2016 10:14 AM 2536 org
Closed Friday, 10 Jun CDISC- Diane Wold CDISC diane.wold@cdisc.

2016 10:15 AM 2537 org
2016 10:16 AM 2538 nih.gov
Closed Friday, 10 Jun CDISC- Deborah Bauer Sanofi deborah.bauer@sa

2016 10:17 AM 2539 nofi.com

2016 12:05 PM 2540 nih.gov
Open Thursday, 16 CDISC- Luc Dekie Biomedical ldekie@biomedsys.
Jun 2016 04:16 2541 Systems com
PM
Closed Thursday, 16 CDISC- Luc Dekie Biomedical ldekie@biomedsys.

PM
Open Thursday, 16 CDISC- Luc Dekie Biomedical ldekie@biomedsys.
PM
Open Thursday, 16 CDISC- Joan Berger Alexion bergerj@alxn.com

Jun 2016 04:27 2544 Pharmaceuticals,
PM Inc.
Closed Thursday, 16 CDISC- Deborah Bauer sanofi deborah.bauer@sa

Jun 2016 04:28 2545 nofi.com
PM
Closed Thursday, 16 CDISC- Diane Wold CDISC diane.wold@cdisc.

Jun 2016 04:29 2546 org
PM
Jun 2016 04:34 2547 org
PM
Open Thursday, 16 CDISC- Diane Wold CDISC diane.wold@cdisc.

Jun 2016 04:35 2548 org
PM
Closed Thursday, 16 CDISC- Yamini Babu Otsuka yamini.babu-

Jun 2016 04:36 2549 Pharmaceutical cw@otsuka-us.com
PM Development &
Commercialization,
Inc.

2016 02:35 PM 2550

Jun 2016 04:51 2551 k.com
PM
Closed Thursday, 23 CDISC- Joe Hilber Covance joe.hilber@covance
Jun 2016 04:54 2552 .com
PM
Closed Thursday, 23 CDISC- Jordan Li NCI EVS jordan.li@nih.gov

Jun 2016 04:59 2553
PM
Open Thursday, 23 CDISC- Jordan Li NCI EVS jordan.li@nih.gov

Jun 2016 04:59 2554
PM

Jun 2016 05:00 2555
PM
Open Wednesday, 29 CDISC- Sharon Broderick Boehringer sharon.broderick@

Jun 2016 08:37 2556 Ingelheim boehringer-
Inc.
Inc.

Inc.
Inc.

Inc.

Inc.
Open Wednesday, 29 CDISC- Theresa isaacs Covance Central theresa.isaacs@co

Jun 2016 08:44 2562 Lab vance.com
AM
Open Wednesday, 29 CDISC- Theresa isaacs Covance Central theresa.isaacs@co

Jun 2016 08:45 2563 Lab vance.com
AM
Closed Wednesday, 29 CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

Jun 2016 08:46 2564 rg
AM

2016 11:29 AM 2565 as.com

2016 11:29 AM 2566 as.com
Closed Friday, 8 Jul CDISC- Joan Berger Alexion bergerj@alxn.com

2016 01:17 PM 2567 Pharmaceuticals,
Inc.
Closed Friday, 8 Jul CDISC- Joan Berger Alexion bergerj@alxn.com
2016 01:18 PM 2568 Pharmaceuticals,
Inc.
Closed Friday, 8 Jul CDISC- Claire West GSK claire.m.west@gsk.

2016 01:19 PM 2569 com

2016 01:19 PM 2570 com
Closed Friday, 8 Jul CDISC- Debbie Oneill Merck debra_oneill@merc

2016 01:20 PM 2571 k.com
Closed Friday, 8 Jul CDISC- Carrie Neeley Covance carrie.neeley@cov
2016 01:22 PM 2572 ance.com
Closed Friday, 8 Jul CDISC- John Gaeddert Frontier Science gaeddert@fstrf.org

2016 01:29 PM 2573
Closed Friday, 15 Jul CDISC- Sharon Broderick Boehringer sharon.broderick@
Inc.

2016 11:24 AM 2575
Closed Friday, 15 Jul CDISC- Emily Hartley Critical Path ehartley@c-

2016 11:27 AM 2576 Institute path.org
Closed Friday, 22 Jul CDISC- Carrie Neeley carrie.neeley@cov

2016 02:32 PM 2577 ance.com
Open Friday, 22 Jul CDISC- Carrie Neeley carrie.neeley@cov

2016 02:33 PM 2578 ance.com
Closed Friday, 22 Jul CDISC- Bob Dempsey CDISC rdempsey@cdisc.o
2016 02:33 PM 2579 rg

2016 02:36 PM 2580
Closed Friday, 29 Jul CDISC- Barrie Nelson CDISC bnelson@cdisc.org

2016 01:32 PM 2581

2016 01:32 PM 2582

2016 01:33 PM 2583
Closed Friday, 29 Jul CDISC- Baljit Kamboj Celgene Corp. bkamboj@celgene.
2016 01:34 PM 2584 com
Closed Friday, 29 Jul CDISC- Rohit Dhanjal Vertex rohit.dhanjal@vrtx.

2016 01:35 PM 2585 Pharmaceuticals com
Closed Friday, 29 Jul CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2016 01:36 PM 2586 behalf of Bess
LeRoy)
Closed Thursday, 4 Aug CDISC- Audrey Harris Charles River Audrey.Harris@crl.

2016 01:14 PM 2587 com
Closed Thursday, 4 Aug CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2016 01:15 PM 2588 nih.gov
Closed Thursday, 4 Aug CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2016 01:16 PM 2589 behalf of Bess
LeRoy)
Closed Thursday, 4 Aug CDISC- Nate Freimark the griesser group nfreimark@thegries
2016 01:20 PM 2590 sergroup.com
Closed Thursday, 4 Aug CDISC- Carrie Neeley Covance carrie.neeley@cov
2016 01:21 PM 2591 ance.com
Open Friday, 5 Aug CDISC- Carmen On Philip Morris Carmen.On@pmi.c

2016 12:33 PM 2592 International om
Research
Laboratories Pte
Ltd
Open Friday, 12 Aug CDISC- Roberta Rosenberg Pfizer roberta.e.rosenberg

2016 02:31 PM 2593 @pfizer.com
Open Friday, 12 Aug CDISC- Amy Palmer CDISC apalmer@cdisc.org

2016 02:32 PM 2594
Open Friday, 12 Aug CDISC- William Stevens Nuffield will.stevens@ndph.

2016 02:34 PM 2595 Department of ox.ac.uk
Population Health,
University of Oxford
Open Friday, 12 Aug CDISC- William Stevens Nuffield will.stevens@ndph.
2016 02:35 PM 2596 Department of ox.ac.uk
Population Health,
Closed Friday, 19 Aug CDISC- Steve Kopko CDISC skopko@cdisc.org

2016 11:37 AM 2597
Closed Friday, 19 Aug CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com
Closed Friday, 19 Aug CDISC- Carmen On Philip Morris Carmen.On@pmi.c

2016 11:42 AM 2599 International om
Research
Laboratories Pte
Ltd
Closed Friday, 26 Aug CDISC- Gitte Frausing gfrausing@datasta
2016 01:56 PM 2600 ndardsdecisions.co
m
Closed Friday, 26 Aug CDISC- Steve Kopko CDISC skopko@cdisc.org
2016 01:57 PM 2601
Open Friday, 26 Aug CDISC- Steve Kopko CDISC skopko@cdisc.org

2016 02:00 PM 2602
Closed Friday, 26 Aug CDISC- Audrey Walker Audrey.Walker@crl

2016 02:02 PM 2603 .com
Closed Friday, 26 Aug CDISC- Angelo Tinazzi Cytel Inc angelo.tinazzi@cyt
2016 02:03 PM 2604 el.com
Closed Friday, 26 Aug CDISC- Nik Pemble npemble@its.jnj.co

2016 02:05 PM 2605 m
Closed Friday, 26 Aug CDISC- Theresa Isaacs Covance Central theresa.isaacs@co
2016 02:07 PM 2606 Lab vance.com


Closed Friday, 26 Aug CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.
Inc.

Inc.

Inc.
Closed Friday, 26 Aug CDISC- Thomas Gade Toxicology tgb@novonordisk.c
2016 02:18 PM 2615 Bjerregaard Development om
Projects
Closed Thursday, 1 Sep CDISC- Roberta Rosenberg Pfizer, Inc roberta.e.rosenberg

2016 08:10 PM 2616 @pfizer.com
Open Thursday, 1 Sep CDISC- Sharon Broderick Boehringer sharon.broderick@
Inc.

Inc.
Closed Thursday, 1 Sep CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Closed Thursday, 1 Sep CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.

Inc.
Open Thursday, 1 Sep CDISC- claire west "GSK " claire.m.west@gsk.

2016 09:14 PM 2623 com
Closed Thursday, 1 Sep CDISC- Emily Hartley Critical Path ehartley@c-

2016 09:19 PM 2624 Institute path.org
Closed Wednesday, 7 CDISC- Bob Dempsey (for CDISC rdempsey@cdisc.o

Sep 2016 02:09 2625 Bernice Yost) rg
PM

PM

PM
PM

PM
Closed Wednesday, 7 CDISC- Joe Hilber Covance joe.hilber@covance
Sep 2016 02:35 2630 .com
PM
Closed Wednesday, 7 CDISC- Joe Hilber Covance joe.hilber@covance
Sep 2016 02:36 2631 .com
PM
Closed Friday, 16 Sep CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2016 01:15 PM 2632 nih.gov
Closed Friday, 16 Sep CDISC- Carrie Neeley Covance carrie.neeley@cov

2016 01:16 PM 2633 ance.com
Open Friday, 23 Sep CDISC- Bernice Yost CDISC byost@cdisc.org

2016 01:43 PM 2634
Closed Friday, 23 Sep CDISC- Steve Kopko CDISC skopko@cdisc.org

2016 01:44 PM 2635
Closed Friday, 23 Sep CDISC- Nik Pemble Janssen npemble@its.jnj.co

2016 01:45 PM 2636 Pharmaceuticals m
Closed Friday, 23 Sep CDISC- Sharon Broderick Boehringer sharon.broderick@
Inc.

Inc.
Inc.

Inc.
Inc.

Inc.
Closed Friday, 23 Sep CDISC- Carmen On Philip Morris Carmen.on@pmi.c
2016 01:50 PM 2643 International om
Research
Laboratories Pte
Ltd
Closed Friday, 23 Sep CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 01:51 PM 2644 behalf of SDS nih.gov
oncology team)
Closed Friday, 30 Sep CDISC- Alexdandre Soulan PMI alexandre.soulan@

2016 11:21 AM 2645 pmi.com
Closed Friday, 7 Oct CDISC- Nikki Flores Gilead Sciences, nikki.flores@gilead.

2016 11:50 AM 2646 Inc, com
Closed Friday, 7 Oct CDISC- Diane Corey C-Path dcorey@c-path.org
2016 11:51 AM 2647
Closed Friday, 7 Oct CDISC- Nik Pemble Janssen npemble@its.jnj.co

2016 11:53 AM 2648 m

2016 11:54 AM 2649 nih.gov

2016 11:54 AM 2650 nih.gov
Closed Friday, 7 Oct CDISC- claire west gsk claire.m.west@gsk.

2016 11:55 AM 2651 com
Closed Friday, 7 Oct CDISC- Bernice Yost CDISC byost@cdisc.org

2016 11:56 AM 2652
Open Friday, 14 Oct CDISC- Debbie Oneill Merck debra_oneill@merc

2016 01:44 PM 2653 k.com
Closed Friday, 14 Oct CDISC- Craig Zwcikl Eli Lilly and zwickl@lilly.com
2016 01:45 PM 2654 Company
Closed Friday, 14 Oct CDISC- claire west GSK claire.m.west@gsk.

2016 01:46 PM 2655 com
Closed Friday, 14 Oct CDISC- Maura Kush PharmaStat mkush@pharmasta

2016 01:52 PM 2656 t.com
2016 02:00 PM 2657 nih.gov
Closed Friday, 14 Oct CDISC- Claire Kent Astra Zeneca claire.kent@astraz

2016 02:03 PM 2658 eneca.com

2016 02:05 PM 2659

2016 02:06 PM 2660
Open Friday, 21 Oct CDISC- Carrie Neeley Covance carrie.neeley@cov
2016 12:31 PM 2661 ance.com
Closed Friday, 21 Oct CDISC- Gitte Frausing Data Standards gfrausing@datasta
2016 12:31 PM 2662 Decisions ndardsdecisions.co
m
Closed Friday, 21 Oct CDISC- Christine Connolly Takeda christine.connolly@

2016 12:32 PM 2663 Pharmaceuticals takeda.com
Closed Friday, 21 Oct CDISC- Rohit Dhanjal Vertex rohit.dhanjal@vrtx.
2016 12:36 PM 2665 k.com

2016 12:37 PM 2666 k.com
Closed Friday, 21 Oct CDISC- Eanna Kiely inVentiv Health eanna.kiely@invent

2016 12:39 PM 2667 Clinical ivhealth.com
Closed Friday, 21 Oct CDISC- Diane Corey C-path dcorey@c-path.org

2016 12:41 PM 2668
Closed Thursday, 27 Oct CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 04:08 PM 2669 behalf of INHAND) nih.gov
Closed Thursday, 27 Oct CDISC- Rhonda Facile CDISC rfacile@cdisc.org

2016 04:10 PM 2670
Closed Thursday, 27 Oct CDISC- thomas eggmann novartis thomas.eggmann@

2016 04:11 PM 2671 novartis.com
Open Thursday, 27 Oct CDISC- Bernice Yost CDISC byost@cdisc.org
2016 04:12 PM 2672
Closed Thursday, 27 Oct CDISC- Joe Hilber Covance joe.hilber@covance

2016 04:13 PM 2673 .com
Closed Wednesday, 2 CDISC- Ben Sefing Merck & Co. benjamin_sefing@
Nov 2016 03:51 2674 merck.com
PM
Closed Wednesday, 2 CDISC- Fazal Hussein Covance fazal.hussein@cov

Nov 2016 03:53 2675 ance.com
PM
Closed Wednesday, 2 CDISC- Fazal Hussein Covance fazal.hussein@cov
Nov 2016 03:53 2676 ance.com
PM
Closed Wednesday, 2 CDISC- claire west GSK claire.m.west@gsk.

Nov 2016 03:54 2677 com
PM
Closed Wednesday, 2 CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

Nov 2016 03:55 2678 nih.gov
PM
Closed Wednesday, 2 CDISC- Nikki Flores Gilead Sciences nikki.flores@gilead.

Nov 2016 03:56 2679 Inc. com
PM
Closed Friday, 4 Nov CDISC- Dana Booth CDISC dbooth@cdisc.org
2016 03:00 PM 2680

2016 03:01 PM 2681
Closed Friday, 4 Nov CDISC- Fazal Hussein Covance fazal.hussein@cov

2016 03:02 PM 2682 ance.com
Closed Friday, 4 Nov CDISC- Magdalena Litwin- Roche magdalena.litwin-

2016 03:03 PM 2683 Wojciechowska wojciechowska@ro
che.com
2016 03:04 PM 2684 ance.com

2016 03:04 PM 2685 ance.com
Closed Thursday, 10 CDISC- Astellas Cathy Bezek cathy.bezek@astell
Nov 2016 04:22 2686 as.com
PM

Nov 2016 04:25 2687 .com
PM
Closed Thursday, 10 CDISC- Shaoyan Wang Covance Shaoyan.Wang@c

Nov 2016 04:26 2688 ovance.com
PM
PM

PM

PM

PM

PM

PM
Closed Thursday, 10 CDISC- Magdalena Litwin- Roche magdalena.litwin-

Nov 2016 04:39 2695 Wojciechowska wojciechowska@ro
PM che.com
Closed Friday, 18 Nov CDISC- Brett Coupland Envigo brett.coupland@en

2016 02:17 PM 2696 vigo.com
Closed Friday, 18 Nov CDISC- Brett Coupland Envigo brett.coupland@en
2016 02:18 PM 2697 vigo.com
Closed Friday, 18 Nov CDISC- Michael Ward Eli Lilly mjward@lilly.com

2016 02:22 PM 2698

2016 02:39 PM 2699 nih.gov

Nov 2016 11:35 2700 Ingelheim boehringer-
Inc.

Nov 2016 11:36 2701 Ingelheim boehringer-
Inc.
Closed Wednesday, 23 CDISC- Erin Muhlbradt(On NCI EVS muhlbradtee@mail.
Nov 2016 11:36 2702 behalf of PrCa nih.gov
AM TAUG)
Closed Friday, 2 Dec CDISC- claire west GSK claire.m.west@gsk.
2016 03:42 PM 2703 com
Open Friday, 2 Dec CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 03:43 PM 2704 behalf of SEND NV nih.gov
team)
Closed Friday, 2 Dec CDISC- Craig Zwickl Eli Lilly and zwickl@lilly.com
2016 03:45 PM 2705 Company
Closed Friday, 2 Dec CDISC- Shelley Dunn Regulus sdunn@regulusrx.c

2016 03:46 PM 2706 Therapeutics om
Open Friday, 2 Dec CDISC- TAKASHI MISAWA JAPAN TOBACCO takashi.misawa@jt.
2016 03:45 PM 2707 INC. com
Closed Friday, 2 Dec CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Closed Friday, 2 Dec CDISC- Theresa isaacs Covance Central theresa.isaacs@co

Closed Friday, 2 Dec CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2016 03:49 PM 2710 behalf of SEND nih.gov
team)
Closed Friday, 2 Dec CDISC- David B. Radtke Eli Lilly and dbr@lilly.com
2016 03:51 PM 2711 Company
Closed Friday, 2 Dec CDISC- Debbie O'Neill Merck debra_oneill@merc

2016 03:52 PM 2712 k.com
Oncology team)
Closed Thursday, 8 Dec CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2016 07:30 PM 2714
Closed Thursday, 8 Dec CDISC- Deborah Bauer Sanofi deborah.bauer@sa

2016 07:31 PM 2715 nofi.com
Closed Thursday, 8 Dec CDISC- Eanna Kiely inVentiv Health eanna.kiely@invent

2016 07:32 PM 2716 Clinical ivhealth.com
Closed Thursday, 8 Dec CDISC- Dana Booth cdisc dbooth@cdisc.org

2016 07:34 PM 2717
Closed Thursday, 8 Dec CDISC- Bernice Yost CDISC byost@cdisc.org

2016 07:35 PM 2718

Inc.
Inc.
Closed Thursday, 15 CDISC- Erin Muhlbradt (On MSC muhlbradtee@mail.

Dec 2016 10:25 2721 behalf of Protocol nih.gov
AM Entities team)
Closed Friday, 16 Dec CDISC- Joe Hilber Covance joe.hilber@covance
2016 11:59 AM 2722 .com

2016 12:00 PM 2723 .com

2016 12:01 PM 2724 .com

2016 12:02 PM 2725 .com
2016 12:03 PM 2726 .com

2016 12:03 PM 2727 .com
Closed Friday, 16 Dec CDISC- Colleen Bonjo Merck colleen_bonjo@me

2016 12:05 PM 2728 rck.com

2016 12:05 PM 2729 rck.com
Closed Friday, 16 Dec CDISC- Dana Booth CDISC dbooth@cdisc.org

2016 12:06 PM 2730

2016 12:08 PM 2731 nih.gov
Closed Thursday, 22 CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

Dec 2016 12:10 2732 rg
PM
Closed Thursday, 22 CDISC- Will Greenway Covance william.greenway@
Dec 2016 12:13 2733 covance.com
PM
Dec 2016 11:23 2734 rg
AM

Dec 2016 11:24 2735 rg
AM

Dec 2016 11:24 2736 behalf of KT TA
AM team)
Request Type
Modify SEND-SPEC Suggested changes from Carol

Existing Term Detrisac to final 100 terms in SPEC
codelist.
Modify Multiple SDTM- LBTEST/LBTESTCD Add
Existing Term synonyms.
Modify Multiple SDTM- LBTEST/LBTESTCD Add

Existing Term synonyms.
Create New SDTM- LACTATE

Term LBTESTCD
Create New SDTM-UNIT s^-1(%02)^-1

Term
Modify SDTM- Re-code C124416 to C42577

Existing Term PKUNIT
Modify Multiple In STSPRM and STSPRMCD
Existing Term codelists (SEND) for concept
C90458, please add a synonym
'SEND Implementation Guide
Version
Modify Multiple C86071 - Remove synonym. It is

Existing Term identical to the submission value in
both codelists that this term is
published in.
Create New Multiple Please consider adding these new
Term terms, this is for the CV imaging TA
project
Create New SDTM-LOC EPIDURAL SPACE;
Term PERIURETERAL REGION
Create New SDTM- WHOVER

Term TSPARM/CD
Create New SDTM- Version Number of WHO Dictionary
Term TSPARM/CD
Create New SDTM- MEDVER
Term TSPARM/CD
Create New SDTM- Version Number of MedDRA
Term TSPARM/CD Dictionary
Create New SDTM- CTDTC
Term TSPARM/CD
Create New SDTM- Version Date of Controlled
Term TSPARM/CD Terminology
Create New SDTM- BLINDED

Term TSPARM/CD
Create New SDTM- Blinded Data

Term TSPARM/CD
Create New SDTM- CTARDTC

Term TSPARM/CD
Create New SDTM- Clinical Trial Report Archive Date

Term TSPARM/CD
Create New SDTM- EXTTRL
Term TSPARM/CD
Create New SDTM- Extension Trial

Term TSPARM/CD
Create New SDTM- REPDUR

Term TSPARM/CD
Create New SDTM- Residual Effect Period Duration

Term TSPARM/CD
Create New SDTM- PASS

Term TSPARM/CD
Create New SDTM- Post Authorisation Safety Study

Term TSPARM/CD
Create New SDTM- TRTDUR

Term TSPARM/CD
Create New SDTM- Planned Treatment Duration

Term TSPARM/CD
Create New New New codelist request for BrCa TA
Codelist team = Disease Presentation Type
Create New SDTM-LOC INFERIOR PUBIC RAMUS;

Term SUPERIOR PUBIC RAMUS
Create New SDTM- Wilson Disease ATP7B Gene

Term LBTEST/CD Mutation
Create New Multiple ION SELECTIVE ELECTRODE AS

Term CDISC METHOD NAME
Modify SEND-SPEC Changes to existing - combined

Existing Term specimens and tissue-specific
specimens.
Create New SDTM-UNIT mL/(min*100mL)
Term
Create New SDTM-UNIT ngeq/L

Term
Create New Multiple Please add new terms to CVTEST-

Term CD and LOC codelists. This is for the
CV Imaging TA team
Create New SDTM-LOC UROTHELIUM
Term
Modify SDTM- C17653 and C17255 have identical

Existing Term COUNTRY definitions. We'll need to update
both.
Create New SDTM-UNIT nmol/mL

Term
Create New Multiple Naive T Helper, Naive T Cytotoxic,

Term Memory T Helper, Memory T
Cytotoxic, Treg.
Create New Multiple Batch 1 of Rheumatoid Arthritis

Term Therapeutic Area terminology: 11
new terms and 2 changes to existing.
Modify SDTM-LOC Batch 1 of Rheumatoid Arthritis

Existing Term Therapeutic Area terminology: 11
new terms and 2 changes to existing.
Modify SDTM- C74753: Definition has an

Existing Term LBTEST/CD error/inconsistency for both LBTEST
and LBTESTCD value
Create New New QRS-ASEXM and QRS-ASEXF
Codelist
Modify SDTM- Remove this codelist. The

Existing Term COUNTRY information is already handled by
ISO 3166 3-letter country codelist.
Create New SDTM-LAT Lateral

Term
Create New SDTM- Phase-Contrast Magnetic

Term METHOD Resonance
Create New SDTM- INTP

Term SRTEST/CD
Create New SDTM- Interpretation

Term SRTEST/CD
Create New SDTM- Phase-Contrast Magnetic

Term SRTEST/CD Resonance
Other SDTM-UNIT C44278: Is this synonymous with
Arbitrary Unit or should the lab team
add Arbitrary Unit as a new CDISC
Unit code?
Create New SDTM- Platelet Mass Distribution Width
Term LBTEST/CD
Modify SDTM- C96641TOXGRAN / Toxic
Existing Term LBTESTCD Granulation modify definition
Modify Modify QRS codelist CDISC

Existing Term Submission Values
Modify SDTM- Update C107097 synonym and

Existing Term DOMAIN definition to be consistent with
merging of CC and RS
Create New SDTM- PAPANICOLAOU STAIN
Term METHOD
Modify Multiple Retire FATEST and FATESTCD

Existing Term codelists: C101832 and C101833
Create New Multiple controlled terminology for

Term PROSQOLI questionnaire
Create New Multiple controlled terminology for FACT-G
Term Version 4 questionnaire
Create New Multiple controlled terminology for FACT-P
Term Version 4 questionnaire
Create New SDTM- AUC
Term LBTEST/CD
Create New SDTM- Request for new test code, HGBFR,
Term LBTEST/CD or else FHGB, to correspond to "Free
Hemoglobin", distinct from the
current code of HGB, which now
shows a CDISC synonym of "FHGB;
Free Hemoglobin; Hemoglobin".
Modify SDTM- Synonym of C71115 looks strange.

Existing Term EGMETHOD
Other SDTM- NRADPROG and SYMPTDTR
ONCRTSCD
Create New SDTM- Adiponectin, High Molecular Weight

Term LBTEST/CD (Test Code: ADPHMW)
Create New SDTM- BOCAPARVOVIRUS; Streptococcus

Term MICROORG Group R
Modify SDTM- in SDTMIG v3.2.pdf, under DM, the
Existing Term COUNTRY Codelist is COUNTRY with ISO
3166. However, the decode in
CDISC does not follow ISO 3166.
would it be possible to align NCI PT
with ISO 3166?
Create New New Please add 'Staining Intensity' to the

Term SDTM-MIFTSDTL codelist.
Modify Multiple This is a change control for QS

Existing Term PANSS terminology, which is being
changed from the CC to RS domain.
Create New SDTM- Glycerol (TESTCD: GLYCEROL)

Term LBTEST/CD
Create New SDTM- PAP TEST; LIQUID-BASED PAP
Term METHOD TEST
Create New SDTM- Please add new Microorg terms to

Term MICROORG SDTM-MICROORG
Modify SDTM- Changes to be made to published
Existing Term MICROORG terms in SDTM-MICROORG
Create New SEND- NMRI
Term STRAIN
Create New SDTM- Please add Raji Cell Radio

Term METHOD Immunoassay and Raji Cell Enzyme
Immunoassay as a method with a
submission value of RAJI CELL RIA
and a RAJI CELL EIA.
Create New SEND- NORMAL or UNREMARKABLE

Term MIRESCAT
Create New SEND- UNREMARKABLE
Term NONNEO
Create New SDTM-UNIT 10^6/ejaculate

Term
Create New SDTM- PRL

Term ONCRSR
Create New SDTM-UNIT umol/dL

Term
Create New SDTM-UNIT "HPF" (code C67274): request for

Term deletion or clarification of this code
for High Power Field. S
Create New SDTM- Need a new term for the question "Is
Term RPTEST the Subject Pregnant".
Create New SDTM- Need new terms for methods of
Term METHOD deterring gestational age. FUNDAL
HEIGHT and LAST MENSTRUAL
PEROD (LMP)
Create New SDTM- Need new terms terms for parasite

Term METHOD and gametocyte counts. Parasite
Count - A measurement for the
amount of parasites in blood.
Gametocyte Count - A measurement
for the amount of gametocytes in
blood.
Create New SDTM- KERATINOCYTE

Term SPECTYPE
Create New SDTM- Multiplexed Bead Based

Term METHOD Immunoassay

Term
Create New SDTM- FUSARIUM SOLANI
Term MICROORG
Create New SDTM- Proliferating Myeloid Cells/Total

Term LBTEST/CD Cells; Proliferating Myeloid Cells;
Maturing Myeloid Cells; Proliferating
Erythroid Cells; Maturing Erythroid
Cells;
Create New SDTM- Granulocytes Band Form;
Term LBTEST/CD Granulocytes, Segmented
Modify SDTM- Remove "quantitative" from the

Existing Term LBTEST/CD definition for the following tests:
C64797, C64798, C64799, C98776.
C117855
Modify SDTM- The PGx team would like to change
Existing Term DEACNDEV the definition for C61575 (submission
value = Removal) to "The act of
removing a component of an item."
Modify SDTM- DIETARY: Administration by way of

Existing Term ROUTE food or water stuff.
Create New SDTM- GC/FID
Term METHOD
Modify SDTM- Rediscuss the upcasing of the word

Existing Term ONCRSR NON in the following c-code: C96700
Modify Multiple See multiple term request

Existing Term spreadsheet.
Modify SEND- For SEND-NEOPLASM codelist:

Existing Term NEOPLASM C6433, please remove all CDISC
synonyms from term.
Create New SEND- Add HEMORRHAGE to this codelist,
Term FXFINDRS with definition: The presence of
extravascular erythrocytes. SEND
team already agreed to this term
being added and it is going out for
public review with P26.
Modify SDTM- Updated definition for C41372 to

Existing Term RETEST/CD "The maximum rate of exhalation.
Modify Multiple The Contact Setting codelist and the

Existing Term Directly Observed Therapy Location
codelist are being retired and all of
the existing terms are being
combined into the new codelist called
Environmental Setting.
Create New SEND- Radiculoneuropathy

Term NONNEO
Create New SDTM- BDGCAN / B-D Glucan

Term LBTESTCD
Create New SDTM- Kinetic Interaction of Microparticles in
Term LBTESTCD Solution
Modify Multiple TB v2.0: Retire codelists:

Existing Term REASTRTF; RSTRTNA; TRTEPSD
Modify SEND- Update submission values

Existing Term NEOPLASM
Modify SEND- On behalf of SDS oncology team:

Existing Term NEOPLASM please remove the NEOPLASM
codelist from the SDTM publication.
It should stay as a SEND-only
codelist.
Create New SDTM- Please add "FINDINGS ABOUT" to
Term GNRLOBSC the GNRLOBSC (C103329) CodeList
Create New SDTM- SICAM1

Term LBTEST/CD
Create New SDTM- Soluble Intracellular Adhesion

Term LBTEST/CD Molecule 1
Create New SDTM- PMSCLAB

Term LBTEST/CD
Create New SDTM- Polymyositis -Scl Antibody

Term LBTEST/CD
Create New SDTM- ELFSC

Term LBTEST/CD
Create New SDTM- Enhanced Liver Fibrosis Score

Term LBTEST/CD
Create New SDTM- h*mmol/L/mg
Term PKUNIT
Create New SDTM-UNIT gpELISA unit/mL

Term
Modify QRS-QSCAT Revise the existing HAMD17 QSCAT

Existing Term to a CCCAT code list value. This
supplement is being converted from
a QS Supplement to a CC
Supplement based on the QRS
Team review of published QS
supplements needing revisions.
Modify SDTM- The MOTEST/MOTESTCD codelists

Existing Term MOTESTCD will be retired. All of the terms will
need to be moved to another
codelist.
Modify SDTM- C86513 KOCURIA RHIZOPHILA
Create New SDTM- Micrococcus luteus

Term MICROORG
Create New SDTM- Zika virus

Term MICROORG
Create New SDTM- New LBTEST and LBTESTCD for

Term LBTEST measurement of anti-keyhole limpet
hemocyanin IgM and IgG antibodies
Create New SDTM- CD20BCLY CD20 B

Term LBTEST Cells/Lymphocytes and more
Create New SDTM- day*ug/mL/mg
Term PKUNIT
Create New SDTM- TPAB

Term LBTEST/CD
Create New SDTM- Treponema Pallidum Antibody

Term LBTEST/CD
Create New New MCGI01TC/MCGI01TN

Codelist
None Multiple correct typo
Create New SDTM- OPTOMETRIST;

Term MEDEVAL OPHTHALMOLOGIST
Create New SEND- Rarefaction
Term NONNEO
Create New SDTM- CD56TCE

Term LBTEST/CD
Create New SDTM- CD56/T-Lymphocytes

Term LBTEST/CD
Create New SDTM- CD14NSCE

Term LBTEST/CD
Create New SDTM- CD14/Non-Squamous Cells

Term LBTEST/CD
Create New SDTM- EOSNSCE
Term LBTEST/CD
Create New SDTM- Eosinophils/Non-Squamous Cells

Term LBTEST/CD
Create New SDTM- EPICNSCE

Term LBTEST/CD
Create New SDTM- Columnar Epith Cells/Non-

Term LBTEST/CD Squamous Cells
Create New SDTM- EPISQCET

Term LBTEST/CD
Create New SDTM- Squamous Epithelial Cells/Total

Term LBTEST/CD Cells
Create New SDTM- LYMNSCE

Term LBTEST/CD
Create New SDTM- Lymphocytes/Non-Squamous Cells
Term LBTEST/CD
Create New SDTM- MCPNSCE

Term LBTEST/CD
Create New SDTM- Macrophages/Non-Squamous Cells

Term LBTEST/CD
Create New SDTM- MONONSCE

Term LBTEST/CD
Create New SDTM- Monocytes/Non-Squamous Cells

Term LBTEST/CD
Create New SDTM- NEUTNSCE

Term LBTEST/CD
Create New SDTM- Neutrophils/Non-Squamous Cells

Term LBTEST/CD
Create New SDTM- NSCE

Term LBTEST/CD
Create New SDTM- Non-Squamous Cells
Term LBTEST/CD
Create New SDTM- P3NP

Term LBTEST/CD
Create New SDTM- Procollagen 3 N-Terminal Propeptide

Term LBTEST/CD
Create New SDTM- BEPINSCE

Term LBTEST/CD
Create New SDTM- Bronchial Epith Cells/Non-Squam

Term LBTEST/CD Cells
Create New SDTM- EOSNSCE

Term LBTEST/CD
Create New New Please create four new TEST-CD

Term terms for the MUSCTS-CD codelist,
which is out for public review with
P26.
Modify SDTM- MK
Existing Term DOMAIN
Other SDTM- TB TAUG - It has been decided that

VRTEST the VR domain will be deprecated
and all VR terminology should be
moved to a new MSTEST/CD
codelist. A separate request has
been made to add an MSTEST/CD
codelist
Create New SDTM- TB TAUG -

Term RETEST/CD RETESTCD=TRGREEXM;
RETEST=Targeted Respiratory
Examination
None SEND-CLCAT Food Evaluation

Modify SEND-SPEC C13010; C12725; C12771 - Modify
Existing Term definitions such that they are not
citing MeSH.
Modify SDTM-LOC C12451; C12355; C12452 - Modify
Existing Term definitions such that they are not
citing MeSH.

Term SPECCOND CONCENTRATED
Modify Multiple TUTEST and TUTESTCD: Update

Existing Term Codelist long name and definition to
include 'Tumor or Lesion' instead of
just 'Tumor'
Modify SDTM- Change the codelist long name and

Existing Term TUIDRS definition slightly
Create New SDTM- EC

Term DOMAIN
Create New SDTM- LBTESTCD= TOXICNE
Term LBTEST/CD
Create New RATER; RATER 1; RATER 2

Term
Create New SDTM- HEMOGRAM

Term METHOD
Create New SDTM- FREEZING POINT DEPRESSION

Term METHOD
Create New SDTM- ION SELECTIVE ELECTRODE

Term METHOD
Create New SDTM- ASPERGILLUS VERSICOLOR

Term MICROORG
Create New SDTM- SITE

Term BSTEST/CD
Create New SDTM- Site

Term BSTEST/CD
Create New SDTM- QUANTITY
Term BSTEST/CD
Create New SDTM- Quantity

Term BSTEST/CD
Create New SDTM- SIZE

Term BSTEST/CD
Create New SDTM- Size

Term BSTEST/CD
Create New SDTM- TYPE
Term BSTEST/CD
Create New SDTM- Type

Term BSTEST/CD
Create New SDTM- Fixative

Term BSTEST/CD
Create New SDTM- FIXATIVE

Term BSTEST/CD
Create New SDTM- THICK

Term BSTEST/CD
Create New SDTM- Thickness

Term BSTEST/CD
Create New SDTM- QUALITY

Term BSTEST/CD
Create New SDTM- Quality

Term BSTEST/CD
Create New SDTM- Team agrees to add two new terms

Term BSTEST to the BSTEST-BSTESTCD codelist:
MASS and CONCENTRATION
Modify SEND- C19924; Retire this concept from
Existing Term STSPRM SEND STSPRM codelist and code a
new concept called Principal
Investigator Name.
Create New Multiple This is a new term request for the

Term Kidney Transplant TA team
Create New SDTM- New terms to be added to

Term SCTEST/CD SCTEST/CD
Other None Does CDISC have plans to introduce

CTs for AE Causality - Related to
Study Treatment? Will 'Unlikely' be
allowed since there is no ICH
definition for it?
Create New Multiple "New QRS Terminology codelist for:

Codelist HAMD 24 HAMD3TC/HAMD3TN
HAMD 6 HAMD4TC/HAMD4TN"
Create New SDTM- Pls add terms to LBTEST-CD

Term LBTEST/CD codelists
Create New SDTM- day*ug/mL/(mg/kg)

Term PKUNIT
Modify SDTM- [C86089] ACINETOBACTER
Existing Term MICROORG ANITRATUS should be changed to
ACINETOBACTER BAUMANNII
Other Multiple "Please can you clarify the reason for

the difference in approach between
the following 2 C codes C96696
C103386 Is there any chance on of
these can be updated so that we can
have some consistency "
Create New SEND- CD31

Term MITEST/CD
Create New SEND- PECAM-1
Term MITEST/CD
Create New New Just need a request code, these

Codelist instruments will go out for P26
QRS/SDTM release; This request is
for the Prostate Cancer TA
Modify SDTM- C38101 Please remove the synonym

Existing Term METHOD of "Radiography".
Create New Multiple Need CDISC Request #s. Terms

Term located on exiting spreadsheet
LBTESTCD / Changes
Create New SDTM- STREPTOCOCCUS, GROUP D;
Term MICROORG ENTEROBACTERIACEAE;
FILAMENTOUS FUNGI
Create New SDTM- STOMATOCOCCUS;
Term MICROORG PEPTOSTREPTOCOCCUS
PREVOTII; YEAST LIKE
ORGANISM
Create New New "Request to create new DKD

Codelist Findings About TEST/CD codelists;
This is for the DKD TA Project "
Modify SEND- C51878: Not sure this is the correct

Existing Term STSPRM code to use here. Is this asking for
the Study Chair Name? If so, I think it
may be appropriate to recode this
concept to something along the lines
of a question. As defined now, it
seems more pertinent as a response.
Modify SEND-SPEC Add Ductus Deferens as a synonym

Existing Term to Vas Deferens (C12813). This is a
true synonym.
Create New SDTM- Domain code: TM
Term DOMAIN
Create New SDTM- Domain code: SM

Term DOMAIN
Modify SEND- C90463; C95107 - See also CDISC-
Existing Term STSPRM 2534.
Create New New ADaM-ANLCAT

Codelist
Create New SDTM- Add 'No Evidence of Disease' or 'No

Term ONCRSR Disease' to codelist.
Create New SDTM- ECG unable to be evaluated
Term EGSTRESC
Create New SDTM- Left ventricular hypertrophy by

Term EGSTRESC voltage criteria only
Create New SDTM- non-specific T wave abnormality
Term EGSTRESC
Create New SDTM- DRIED BLOOD SPOT (to be used

Term SPECTYPE for Lab test specimens)
Create New SDTM- INTEGRATED SUBJECT LEVEL

Term GNRLOBSC (IADSL) INTEGRATED
OCCURRENCE DATA STRUCTURE
(IOCCDS) INTEGRATED BASIC
DATA STRUCTURE (IBDS)
Create New SDTM- New LB requests; This is a TA

Term LBTEST/CD request from the Asthma TAUG
Create New SDTM- WHLRSP (Wheal Positive-Negative);
Term SRTEST/CD This is a TA request from the Asthma
TAUG
Create New SDTM- SPIREFEQ (Spirometric Reference

Term DUTEST/CD Equation); This is a TA request from
the Asthma TAUG
Create New SDTM- SS- Subject Status

Term DOMAIN
Modify SDTM- Move terms from PKUNIT to 4 new

Existing Term PKUNIT codelists. Also retire true
mathematical synonyms. This
request is from the PK team. These
terms already exist in the PK file, we
just need a request number
Create New SDTM- ECG Findings, Not Otherwise

Term EGTEST/CD Specified with TESTCD ECGFNOS
Create New SDTM- Urine Immunofixation Impression-2
Term LBTEST/CD
Create New Multiple New term request from the CV

Term Imaging team; This is a TA request.
Create New Multiple Request to add terms to the

Term TR/TUTEST codelists; This is a TA
request from the CV Imaging team
Create New SDTM- Request to add new terms to the

Term METHOD METHOD codelist. This is a TA
request from the Kidney Transplant
Team
Create New SDTM- HOMEOSTATIC MODEL
Term METHOD ASSESSMENT
Create New SDTM- DSC-MRI

Term METHOD
Create New SDTM- DWI

Term METHOD
Create New SDTM- DTI
Term METHOD
Create New SDTM- MRE

Term METHOD
Create New SDTM- PCMR

Term METHOD

Term METHOD Serum Chloride, CHEMISTRY,
Electrolytes LBTESTCD - CL
NAME-CHLORIDE
Term METHOD Serum Potassium, CHEMISTRY,
Electrolytes LBTESTCD K - name -
Potassium
Create New Multiple Need request codes for P27 Public
Term Review terms & P28 spreadsheets
Create New LBTESTCD=HCCAG;

Term LBTEST=Hepatitis C Core Virus
Antigen
Create New LBTESTCD=NGF; LBTEST=Nerve

Term Growth Factor
Create New SDTM- Thrombomodulin

Term LBTEST
Create New SDTM- Sumbmission value: "Complement
Term LBTEST Ba" (and LBTESTCD= CBA). This
would be directly parallel to similar,
current term of Complement Bb (and
lbtestcd= CBB).
Modify SDTM- Pleae remove ESR as a synonym for

Existing Term LBTESTCD ESTRCPT (Estrogen Receptor)
Other SDTM-LOC Questions over use of PROXIMAL &

DISTAL in relation to bones and
ordering of joints in the hand
Create New SDTM- LONG TERM CARE HOSPITAL

Term DISCHDX
Create New SDTM-FREQ TWICE
Term
Create New New Edinburgh Postnatal Depression

Term Scale (EPDS)
Create New SDTM- h*nmol/L/mg
Term PKUNIT
Modify SDTM- Request to remove terms from the

Existing Term CVTEST CVTEST/CD codelists.
Other Multiple Move 3 QRS measures (DISEASE

STEPS, EDSS, and KFSS) from QS
to RS as clinical classifications.
Create New SDTM- 8 LEAD STANDARD

Term EGMETHOD
Create New SEND- MASSCFM

Term MATEST/CD
Create New Multiple ECG & PGx term requests
Term
Modify SDTM- Request to modify published

Existing Term CVTEST/CD CVTEST/CD - This is a TA request
from the CVI team
Modify SDTM- Please update the CDISC Definition

Existing Term DOMAIN for the TU domain to "This domain
represents data that uniquely
identifies tumors/lesions.
Modify SDTM- Please update the CDISC Definition
Existing Term DOMAIN for the TR domain to "This domain
represents quantitative
measurements and/or qualitative
assessments of the tumors/lesions
identified in the tumor identifier (TU)
domain
Modify Multiple Please update the synonyms for the

Existing Term following SDTM Domain
Abrvaiations: TU - new synonym =
"Tumor/Lesion Identifier" TR - new
synonym = "Tumor/Lesion Results"
Create New CVTEST/CD Please add new submission value
Term LVSF - 'Left Ventricular Shortening
Fraction' in codelist (Cardiovascular
Test Code)
Create New SDTM- LBTEST: Cannabinoids, Synthetic

Term LBTEST/CD LBTESTCD: CANNABS
Create New Multiple Request to add new terms and

Term create new codelist for the KT TA
project
Create New SDTM- Add new terms

Term LBTEST/CD
Modify SDTM- C116161; Weird spacing issue in
Existing Term METHOD definition
Create New Multiple KT TA team Request to add new

Term terms to SCTEST/CD and
DDTEST/CD codelists
Other ADaM-DTYPE DTYPE=TIME MATCHED

Create New SDTM- TNFa TNFb
Term LBTEST/CD
Create New SDTM- New LBTESET-CD requests

Term LBTEST/CD
Create New Multiple CT including QSCATs, for 6

Term additional Functional Assessment of
Cancer Therapy instruments
Modify Multiple Add terms

Existing Term
Create New SDTM-UNIT mg/mmol : milligrams per millimole

Term
Modify SDTM-UNIT DAYS
Existing Term
Other Multiple MDD TA QRS Request
Create New SDTM- Hemoglobin Tetramer

Term LBTEST
Create New SDTM- New terms request for Laboratory

Term LBTEST/CD Test Code
Create New SEND- APOPTOSIS

Term NONNEO
Create New Multiple Questionnaires, Ratings, and Scales:
Codelist WHO Disability Assessment
Schedule 2.0 (WHODAS 2.0)
Create New Multiple Request new questionnsires

Codelist
SDTM- h*umol/L/(mg/kg)
PKUNIT
Other SDTM- RANDQT
TSPARMCD
Create New SDTM- CELLS

Term SPECTYPE
Term LBTESTCD

Term LBTESTCD
Term LBTEST

Term LBTEST
Modify SDTM- Please add h*nmol/L/mg as a

Existing Term PKUNIT synonym to the already existing term
h*umol/L/g (C116063)
Modify SDTM- Please add h*pmol/L/ug as a

Existing Term PKUNIT synonym to the already existing term
h*umol/L/g (C116063)
Create New SDTM- HGF
Term LBTESTCD
Create New SDTM- Hepatocyte Growth Factor

Term LBTEST
Create New SDTM- pmol

Term PKUNIT
Create New Multiple Request for new terms for LB and

Term PKUNIT
Create New New Add Terminology for 3 FACT family

Codelist questionnaires; These have already
been reviewed and approved by the
QRS terminology team.
Create New SDTM- AUC Last Nonzero Conc to Infinity
Term PKPARM Pred
Create New SDTM- AUCLTIFP

Term PKPARM/CD
Create New SDTM- Pct Rec to Last Nonzero Conc

Term PKPARM/CD
Create New SDTM- RCPCLST

Term PKPARM/CD
Create New SDTM- Pct Rec from Last Nonzero Conc-Inf
Term PKPARM/CD Pred
Create New SDTM- RCPCLIFP

Term PKPARM/CD
Modify SDTM-UNIT Querying submission value for code

Existing Term C122230 (ugeq/L)
Create New Multiple New CCCAT term and new RS TEST

Codelist and TESTCD codelists for the Kidney
Donor Profile Index (KDPI).
Modify SDTM- TSPARM-CD INDIC / Trial Indicator

Existing Term TSPARM/CD change Just need request # for P29
General spreadsheet
Create New SDTM- Just need request #'s. Already

Term LBTEST/CD approved; needed for Lab P28 Public
Review
Modify SDTM- Lab Changes tab for P28 Lab Public

Existing Term LBTEST/CD Review Request #s
Create New SDTM- Need request #s P28 Public Review

Term LBTEST/CD LBTEST-CD
Create New SDTM- Rows 15 - 18 Lab P28 Public Review

Term LBTEST/CD
Create New SDTM- Autoantibody a-IA2

Term LBTEST/CD
Create New SDTM- AUTOAB
Term LBTEST/CD
Create New Multiple Multiple term request for Malaria

Term TAUG: Batch 1
Create New SEND- Hemolymphoreticular tumor,

Term NEOPLASM malignant
Modify SDTM- Remove this codelist. This comment

Existing Term TDIGRP came during the P27 review from
Joan Berger.
Create New Multiple "Quality of Life Enjoyment and

Codelist Satisfaction Questionnaire (Q-LES-
Q) Quality Of Life Enjoyment And
Satisfaction Questionnaire - Short
Form (Q-LES-Q-SF)"
Create New SDTM- HBVVLDR - HBV RNA Viral Load

Term LBTEST/CD
Create New SDTM- MEDASS
Term DATEST/CD
Create New SDTM- Medication Assigned

Term DATEST/CD
Create New SDTM- MEDDIS
Term DATEST/CD
Create New SDTM- Medication Dispensed

Term DATEST/CD
Create New SDTM- MEDREP
Term DATEST/CD
Create New SDTM- Medication Replaced

Term DATEST/CD
Create New Multiple New Test Name and Test Code and
Term units request for RE.
Create New Multiple Please file 28 new term requests for

Term multiple codelists across oncology
domains. File emailed separately.
IMPORTANT: These terms are
already in the Oncology P29 working
documents. We just need a request
number.
Create New SDTM- New lab terms might be added to

Term LBTEST/CD complete the current lab test list
Create New SDTM- Thymidine Kinase 1 (TK1) and

Term LBTEST/CD Thymidine Kinase 2 (TK2)
Create New Multiple This new term request is for the
Term PODCI instrument being used in the
Duchenne Muscular Dystrophy
TAUG.
Other Multiple INFAAG,INFABAG and INFBAG are
all influenza antigen that have been
added to the Microbiology test code
list. Prior to the addition of these, all
antigens were entered and are still
present as Laboratory test code
Modify Multiple Default synonyms for TEST/CD

Existing Term pairings not added as part of P27.
These will need to go into P28
publication.
Create New Multiple This is batch 1 of the new terms
Term requested for the Ebola Virus TAUG.
Modify SDTM- The submission value is THICKNSS,

Existing Term DOTESTCD but it should be THICK as per other
C41145 codes
Modify SDTM- For LABTESTCD and LABTEST,

Existing Term LBTEST/CD please remove all synonyms for the
following C-codes: C128972,
C128976, and C128978.
Create New SDTM-UNIT U/g Hb
Term
Create New SEND-SPEC Dried Blood Spot (DBS)
Term
Modify Multiple These are situations where we have

Existing Term found a term also expressed as a
synonym for a different term.
Create New SDTM- Dysmorphic Erythrocytes. The

Term LBTEST/CD LBTESTCD could be RBCDYS
perhaps.
Other Multiple Need request number
None SDTM- h*umol/L/(mg/kg)

PKUNIT
Create New Multiple CCCAT='BUERS';CCTESTCD and

Term CCTEST
Create New Multiple CCCAT='VLERS'CCTESSTCD and

Term CCTEST
Create New SDTM- Standard error of the mean for AUC
Term PKPARM/CD
Create New SDTM-DIR THORACIC
Term

Term
Create New SDTM- Add new lab terms
Term LBTEST/CD
Create New SDTM- Strain (TESTCD = NSTRN)
Term PFTEST/CD
Create New SDTM- Organism Present (TESTCD =

Term MBTEST/CD ORGANISM)
Create New Multiple Questionnaire: Treatment

Codelist Satisfaction Questionnaire for
Medication (TSQM) V1.4
Create New Multiple CCCAT='NORTH STAR

Term AMBULATORY
ASSESSMENT';CCTESTCD and
CCTEST for multiple questions
Create New SEND- New requests for SEND-NONNEO
Term NONNEO codelist from INHAND GI publication.
Content already in P29 working
document. Just need a request code.
Create New New Add an OCCUR indicator to a

Term general Occur list or request to add a
specific FA list by TA - create a code
list for ASTHMA.
Create New Multiple File emailed separately
Term
Create New SDTM- Add new term
Term EGMETHOD
Create New SDTM- KINETIC CHROMOGENIC

Term METHOD
Create New SEND- MESOBLASTIC NEPHROMA
Term NEOPLASM
Create New SDTM- Beta-D Glucan, NaHepWB IUO-473

Term LBTEST
Create New SDTM- Beta-D Glucan
Term LBTESTCD
Create New SDTM-UNIT MAC - Minimum alveolar

Term concentration10^6 U - Million Units
Other SDTM- Find requests for new terms and

LBTEST/CD changes for lab test terminology -
these tests are based off of the Advia
120 CBC and reticulocyte
measurements.
Create New SDTM- CMVDNA

Term LBTEST/CD
Modify Multiple Change submission value for
Existing Term QSCAT HAQ01 to HAQ-DI WITH
VAS and add, "... With Pain Visual
Analog Scale" to the Codelist name
and CDISC definiton for the HAQ-DI
test code and test name.
Create New Multiple New qscat as well as testcode and

Term testname codelists for HAQ-DI
WITHOUT VAS
Create New SDTM- BETADGLUC
Term LBTESTCD
Create New SDTM-UNIT This is a multiple term submission.

Term
Create New SDTM- FNT
Term LBTESTCD
Create New SDTM- Finasteride

Term LBTEST
Create New SDTM- Add LBTESTCD=ANC
Term LBTEST/CD
Create New SDTM- Double Negative

Term LBTEST/CD T-Lymphocytes/Lymph
Create New SDTM- DNTLYCLY

Term LBTEST/CD
Create New SDTM- DNTLYCE
Term LBTEST/CD
Create New SDTM- Double Negative T-Lymphocytes

Term LBTEST/CD
Create New SDTM- CD8PNKLY

Term LBTEST/CD
Create New SDTM- CD8 Positive Natural Killer

Term LBTEST/CD Cells/Lymph
Create New SDTM- CD8PNKCE

Term LBTEST/CD
Create New SDTM- CD8 Positive Natural Killer Cells

Term LBTEST/CD
Modify SDTM- Code: C41145Change submission

Existing Term DOTEST/CD value from THICKNSS to THICK
Create New SEND- LENGTH/Length

Term OMTEST
Create New SEND-SPEC BONE, FEMUR/JOINT
Term
Create New None The RACEC codelist was not

Term available in the above pull-down
list.Per feedback from CDASH v2.0
Public Review, we request that
'UNKNOWN' be added as an option
to the RACEC codelist.
Create New SDTM- Batch 1 of Flow Cytometry work

Term LBTEST/CD
Create New SDTM- FEV0.5

Term RETESTCD
Create New SDTM- Forced Expiratory Volume in 0.5

Term RETEST Second
Create New Multiple I will be sending Batch 2 of PrCa

Term TAUG terminology as a change
request file.
Create New SDTM-UNIT Request In relation to the removal of
Term existing terms /dL, /L and /uL
Create New Multiple Multiple term request for new

Term codelists for new SEND NV domain -
this request includes 117 new term
requests across 5 new codelists.
Already in the SEND working file, just
Modify SEND- Check definition of PARMCD:

Existing Term STSPRM SPREFID.
Modify Multiple Can the NCI Preferred Term be

Existing Term updated to "Protocol Deviation" for
consistency?
None Multiple intravenous injection, percutaneous
injection
None SDTM- EC
DOMAIN
Create New SDTM- Chemistry test 'Angiotensin

Term METHOD Converting Enzyme'has LBMETHOD
of'CAPILLARY
ELECTROPHORESIS' confrimed by
lab. Please add CAPILLARY
ELECTROPHORESIS as valid
SDTM LBMETHOD
Other Multiple Please see email with multiple term

request for SEND P29 16 changes to
existing and 1 new term addition.
These are already in working
document, just need a request code.
Create New SDTM- Half Tmax and Half Cmax (HTMAX,

Term PKPARM HCMAX)
Create New SDTM- RE-RANDOMIZATION

Term PROTMLST
Other Multiple Submitting a multiple term request

containing 6 changes to existing and
1 new term. These rows are already
in the working document; just getting
a request number.
Modify Multiple Update codelist names; These
Existing Term changes will be implemented and
published with P28, just need a
request number.
Create New ADaM-DTYPE EXTRAP for Extrapolation

Term
Create New QRS-CCCAT Lansky Play-Performance Status

Codelist Scale
Other Multiple New QSCAT=EPDS and new EPDS

TESTCD/TESTNM codelists for
Edinburgh Postnatal Depression
Scale for the HIV TA team
Create New SDTM- This exists in the lab spreadsheet but

Term LBTEST/CD it needs a request number.
Create New SDTM-FRM TABLET, FILM COATED, FIXED

Term DOSE COMBINATION
Create New SDTM-FRM TABLET, FILM COATED,
Term EXTENDED RELEASE, FIXED
DOSE COMBINATION
Create New Multiple This is a request for batch P1 of the

Term Protocol Entities terminology. It
includes 24 new terms.
Create New SDTM- LATEX IMMUNOASSAY
Term METHOD
Create New SDTM- FIBRINAC

Term LBTESTCD
Create New SDTM- Fibrinogen Activity

Term LBTEST
Create New SDTM- CLAUSS METHOD

Term METHOD
Create New SDTM- FIBRINAG
Term LBTESTCD
Create New SDTM- Fibrinogen Antigen

Term LBTEST
Create New SDTM- RETEST = Forced Inspiratory Vital

Term RETEST/CD CapacityRETEST CD = FIVC
Create New SDTM- RETEST = Maximal Inspiratory

Term RETEST/CD PressureRETESTCD = MIP
Create New Multiple Request for new QSCAT,

Term QSTESTCD/QSTESTNM for PTSD
Modify SDTM- Duplicate codelist short names

Existing Term DDTEST/CD across SEND and SDTM for different
codelist concepts: DDTEST and
DDTESTCD
Create New Multiple P29 Public Review - Need request

Term numbers only
Modify SDTM-UNIT Request for consitency of use

Existing Term between the synonyms ng/mL and
ug/L between UNIT and the various
PKUNIT codelists
Modify SDTM- C128687 MSTEST/CD
Existing Term MSTEST
Modify SDTM- C96778 SDTM-TRTEST correct

Existing Term TRTEST definition
Create New Multiple Request to add new terms to multiple

Term codelists; This is a TA request from
the Kidney Transplant team
Final Outcome
Change
Type
File emailed separately II SEND-Published in P29
Rule: the test name submission value should also II SDTM, SEND-Published
exist in the test code synonym and the test name in P26
synonym.
Rule: the test name submission value should also II SDTM, SEND-Published
exist in the test code synonym and the test name in P26
synonym.
Definition: A measurement of the concentration of III Do not add (P30) -
lactate in a biological specimen, where lactate is LOINC and CDISC are
the conjugated base of lactic acid. harmonized in that both
standards treat these as
Reason: Lactic acid and lactate are not the same the same analyte. Some
as lactic acid is (as the name implies) an acid and sponsor companies treat
lactate is the corresponding conjugated base. these as separate
There is very little lactic acid present in the blood analytes but this is
stream as it disassociates into lactate and merely a difference in
hydrogen almost immediately, therefore, the code semantics across
lactate is needed. different specimen
types. Please use the
existing concept
C79450.
A unit of the oxygen transfer function expressed III SDTM, SEND-Published

as the reciprocal of T1 relaxation time and divided in P28
by the oxygen concentration where the T1
relaxation time from T1 Maps at different oxygen
concentrations in the lung is obtained by
magnetic resonance imaging (MRI).
C124416 will be merged into C42577 II
In STSPRM and STSPRMCD codelists (SEND) II SEND-Published in P26

for concept C90458, please add a synonym
'SEND Implementation Guide Version? for
consistency with the submission value. Discuss
removal of existing synonym too. Probably don't
need both.
This term exists in 2 SDTM codelists: Oncology II SDTM-Published in P26

Response Assessment Result and Tumor or
Lesion Properties Test Result.
Please consider adding these new terms, this is III SDTM-Published in P26
for the CV imaging TA project
Please add the following terms to the Anatomical III SDTM, SEND-Published
Location codelist. They are being used In Imaging in P29
data for Oncology trials.
EPIDURAL SPACE (proposed definition: a fat-

filled space immediately external to the dura
mater ensheathing the spinal cord; contains the
internal vertebral (epidural) venous plexus, and is
the target site for epidural anesthesia.)
PERIURETERAL REGION (proposed definition:

The tissue surrounding the ureter.)
The version number of the WHO-DD dictionary III Do not add (P34): CDISC
used for coding in SDTM datasets. has not yet come to a
To be used with TSPARM : Version Number of conclusion on whether
WHO Dictionary this is data or metadata
and whether it belongs
in TS. Therefore CDISC
CT will deny this request
for now. The codelist is
extensible so these
terms can still be
submitted in TS as
extensible terms. Going
forward CDISC will
convene a working
group to discuss this
issue and to ensure that
information about
where to store
metadata is consistenly
articulated in the
SDTMIG, Define.xml,
and the FDA Technical
Conformance Guide.
The version number of the WHO-DD dictionary III Do not add (P34): CDISC
conclusion on whether
To be used with TSPARMCD : WHOVER this is data or metadata
extensible so these
terms can still be
submitted in TS as
forward CDISC will
convene a working
information about
where to store
articulated in the
SDTMIG, Define.xml,
Conformance Guide.
The version number of the MedDRA dictionary III Do not add (P34): CDISC
To be used with TSPARM : Version Number of this is data or metadata
MedDRA Dictionary and whether it belongs
extensible so these
terms can still be
submitted in TS as
forward CDISC will
convene a working
information about
where to store
articulated in the
SDTMIG, Define.xml,
Conformance Guide.
The version number of the MedDRA dictionary III Do not add (P34): CDISC
To be used with TSPARMCD : MEDVER this is data or metadata
extensible so these
terms can still be
submitted in TS as
forward CDISC will
convene a working
information about
where to store
articulated in the
SDTMIG, Define.xml,
Conformance Guide.
Version date of CDISC Controlled Terminology III Do not add (P34): CDISC
used in SDTM datasets. has not yet come to a
To be used with TSPARM : Version Date of this is data or metadata
Controlled Terminology and whether it belongs
extensible so these
terms can still be
submitted in TS as
forward CDISC will
convene a working
information about
where to store
articulated in the
SDTMIG, Define.xml,
Conformance Guide.
Version date of CDISC Controlled Terminology III Do not add (P34): CDISC
used in SDTM datasets. has not yet come to a
To be used with TSPARMCD : CTDTC this is data or metadata
extensible so these
terms can still be
submitted in TS as
forward CDISC will
convene a working
information about
where to store
articulated in the
SDTMIG, Define.xml,
Conformance Guide.
Flag for the actual blinding status of a trial when III SDTM-Published in P31
the SDTM datasets were generated.
To be used with TSPARM : Blinded Data
Flag for the actual blinding status of a trial when III SDTM-Published in P31
the SDTM datasets were generated.
To be used with TSPARMCD : BLINDED
The date when the trial report was archived III SDTM-Published in P31
To be used with TSPARM : Clinical Trial Report

Archive Date
The date when the trial report was archived III SDTM-Published in P31
To be used with TSPARMCD : CTARDTC"

Trial is an extension trial. III SDTM-Published in P31
To be used with TSPARM : Extension Trial
Trial is an extension trial. III SDTM-Published in P31
To be used with TSPARMCD : EXTTRL
Duration of the residual effect period (e.g. 7 days) III
To be used with TSPARM : Residual Effect

Period Duration Do not add (P30): Do
not add. This
information may be
better represented
elsewhere; team does
not believe this is a
characteristic of the
trial, hence doesn't
belong in TS.
Duration of the residual effect period (e.g. 7 days) III
To be used with TSPARMCD : REPDUR

Do not add (P30): Do
not add. This
information may be
better represented
elsewhere; team does
not believe this is a
characteristic of the
trial, hence doesn't
belong in TS.
Trial is a Post Authorisation Safety Study III SDTM-Published in P31
To be used with TSPARM : Post Authorisation

Safety Study
Trial is a Post Authorisation Safety Study III SDTM-Published in P31
To be used with TSPARMCD : PASS
Planned treatment duration per subject III SDTM-Published in P31
To be used with TSPARM : Planned Treatment

Duration
Planned treatment duration per subject III SDTM-Published in P31
To be used with TSPARMCD : TRTDUR

File Emailed Separately III SDTM-Published in P26,
P31
Do not add (SDTM P26)
- Simple Cystic Lesion:
RECIST 1.1 does not
consider simple cysts as
malignant lesions,
hence they would not
be reported as a disease
presentation type.
INFERIOR PUBIC RAMUS III SDTM, SEND-Published

Definition: The inferior extension from body of in P29
pubic bone that meets with the ramus of the
ischium to form the ischiopubic ramus.
Synonym: ramus inferior ossis pubis
SUPERIOR PUBIC RAMUS

Definition: A bar of bone, triangular in section,
which extends posterosuperiorly from the body of
the pubis to form the superior boundary of the
obturator foramen; developmentally, it contributes
about one fifth of the articular surface of the
acetabulum.
Synonyms: ramus superior ossis pubis, superior
branch of the pubic bone
Mutations in the gene ATP7B cause Wilson III Do not add (P29) - This
disease, a copper storage disorder. Importnat for belongs in PF. Please
Hy's Law tests. Proposed definition: The see PGx IG for how to
presence of mutation in the ATP7B gene in a model this type of
biological specimen is indicative of Wilson information. PGx team
Disease. Proposed LBTEST: Wilson Disease recommends use of the
ATP7B Gene Mutation; Proposed LBTESTCD: Biomarker domains (PB
ATP7BGM. References: and SB).
http://www.wilsonsdisease.org/wilson-disease/wil
sondisease-inheritance.php -and-
https://www.labcorp.com/wps/wcm/connect/IntGe
neticsLib/integratedgenetics/resources/
diseases/wilson+disease?Wilson%20Disease
"LBTESTCD LBTEST LBCAT LBSCAT LBSPEC III

LBMETHOD
CL Chloride CHEMISTRY ELECTROLYTES
SERUM ION SELECTIVE ELECTRODE "
File Emailed Separately II SEND-Published in P29

A unit of measure expressed in milliliters per III SDTM, SEND-Published
(minutes times 100 milliliters). in P28
A concentration unit measured as a number of III SDTM, SEND-Published

nanogram equivalent of solute per liter of in P28
solution.
Please add new terms to CVTEST-CD and LOC III SDTM, SEND-Published
codelists. This is for the CV Imaging TA team; in P26
Definition: Transitional epithelium lining the renal III
pelvis, bladder, ureter, and part of the urethra.
(NCI) Do not add (P31) -
Removed by requester
until she gets more
contextual information.
C17653 and C17255 have identical definitions. Do not add (SDTM
We'll need to update both to make clear the P27): Do not change.
distinction between the British Virgin Islands and Instead codelist is being
the US Virgin Islands. retired.
We still use nmol/mL for reporting of ?Carnitine? III SDTM, SEND-Published

& ?Carnitine, Free? Labs I also see the unit of ? in P28
nmol/mL/min? is still in the unit codelist (and
nmol/mL is a base unit).
I need to "map" some terms for the "Immune cell III

phenotyping", but I'm unable to find them in the
current SEND Terminology (2015-09-25).
Batch 1 of Rheumatoid Arthritis Therapeutic Area III SDTM, SEND-Published

terminology: 11 new terms and 2 changes to in P26
existing; File Emailed Separately
Batch 1 of Rheumatoid Arthritis Therapeutic Area II SDTM, SEND-Published

terminology: 11 new terms and 2 changes to in P26
existing; File Emailed Separately
Current published definition is: A relative II

measurement (ratio or percentage) (ratio) of the
blood urea nitrogen (BUN) to the creatinine in a
It should be either (ratio or percentage) or (ratio),

but not both.
Create new QRS codelist for Arizona Sexual III
Experiences Scale (ASEX) for both the male and
female versions for the MDD, GAD, and Bipolar
Disease TAs.
One of our terminology rules is to not create a II

codelist if the information is handled by an
outside source.
Hi, III SDTM, SEND-Published

in P30
a study with injection on the knee, in the
exposure form the Investigator should specify
which knee has been injected, LEFT or RIGHT
and this was mapped to EXLAT (LAT codelist),
and the approach for injection, either Medial or
Lateral. This later info was mapped in EXDIR
(DIR codelist) where 'Medial' exist in the CT while
'Lateral' does not. 'Lateral' however is a term
available in LAT codelist. Do you have any
suggestion or could term be added to DIR
codelist?
An MRI technique used to determine blood III SDTM-Published in P30

velocity and blood flow. A phase shift between
static tissue and flowing tissue is generated by a
bipolar magnetic field gradient. The generated
phase shift is in principle proportional to the blood
velocity.
Proposed CDSIC Synonym: PCMR
Interpretation of the skin test. III SDTM-Published in P30

[As shown in the SDTM-IG V3.2, SR Domain,
Example #3.]
To be used with SRTEST : Interpretation
Interpretation of the skin test III SDTM-Published in P30

[As shown in the SDTM-IG V3.2, SR Domain,
Example #3]
To be used with SRTESTCD : INTP
An MRI technique used to determine blood III SDTM-Published in P30

velocity and blood flow. A phase shift between
static tissue and flowing tissue is generated by a
bipolar magnetic field gradient. The generated
phase shift is in principle proportional to the blood
velocity.
Proposed CDSIC Synonym: PCMR

This request came from a lab team discussion of II SDTM, SEND-Published
a P25 unit public review comment. in P28
2 Standard deviations of the platelet dry mass. III SDTM, SEND-Published

in P29
Already on spreadsheet just need request II SDTM, SEND-Published
number in P26
Modify QRS codelist CDISC Submission Values - II

Character length restriction
Refer to SDTMIG update for new long name of II

RS domain.
A multichromatic stain used principally on III

exfoliated cytologic specimens and based on
aqueous hematoxylin with multiple
counterstaining dyes in 95% ethyl alcohol, giving
great transparency and delicacy of detail;
important in cancer screening, especially of
gynecologic smears.
This codelist was created by the first TB TAUG III

team before the rule was instituted that all TA
teams would have their own standalone
FATEST/CD codelists. The TB team wants to
retire this codelist and create TB-specific
FATEST/CD codelists for their own use.
to support PrCa TAUG III QRS-Published in P26
Area contained between the baseline and III

reactivity curve of the Chronolog aggregometer
Do not add (P30): No
response from
requester for additional
information after 3
attempts.
Request for new test code, HGBFR, or else III SDTM, SEND-Published
FHGB, to correspond to "Free Hemoglobin", in P26
distinct from the current code of HGB, which now
shows a CDISC synonym of "FHGB; Free
Hemoglobin; Hemoglobin". The purpose is to
have separate term for Hemoglobin versus the
one for Free Hemoglobin.
For the current code of LBTESTCD= HGB, the

synonym shown of "FHGB; Free Hemoglobin;
Hemoglobin" has combined extracellular
hemoglobin (external to erythrocytes) and
hemoglobin within a single test code. The CDISC
definition for HGB states "A measurement of the
non-cellular hemoglobin in a biological
specimen." The distinction between hemoglobin
and extracellular hemoglobin should be explicit
using separate test codes. Measurement of non-
cellular hemoglobin is important for certain
disease conditions that involve hemolysis. Note
also, the LOINC system includes separate test
coding for these, such as 721-1, for Free
Hemoglobin [Mass/volume] in Plasma, and 4635-
9, for Free Hemoglobin [Mass/volume] in Serum.
A simple definition would be "A measurement of
the hemoglobin external to erythrocytes, in a
biological specimen".
The CDISC definition seems to have been II SDTM, SEND-Published

superimposed onto the synonym. Suggest to in P25
remove it altogether.
NRADPROG (Non-Radiological Progression) was II Do not add (SDTM P26)
retired and a new term SYMPTDTR - Question answered.
(Symptomatic Deterioration) was added to The reviewer is correct
ONCRTSCD. It is exceptionally disruptive to in that Non-Radiological
change something as fundamental as this to a Progression is the term
new test code. This is already in place in the specified in the SDTM IG
SDTM-IG as a descriptor on how to map this type and RECIST. However,
of data and will have been widely implemented. in the broader context
This has a significant negative impact on both of different response
sponsors and reviewers and data will no longer criteria and even for
be comparable. Please clarify the rationale for RECIST (to an extent)
this change. the term is incorrect, or
at least imprecise. The
purpose of the test is to
flag cases of
investigators
determining a patient’s
disease has progressed
based on other
symptoms which do not
meet the specific
criteria of the standard.
The CDISC oncology
team settled on
“symptomatic
deterioration” as a
more precise value to
use. The SDTM IG will
be updated to reflect
this change in
terminology.
HMW Adiponectin is the primary bioactive form III SDTM, SEND-Published

with insulin-sensitizing activity. Adiponectin in P29
circulates in plasma as low molecular weight
(LMW) trimers, medium molecular weight (MMW)
hexamers, and HMW multimers. This test is
specific for the HMW isomer.
LOINC Number: 55819-7
Proposed Definition: A measurement of the high
molecular weight isomer of the adiponectin
hormone in a biological specimen.
BOCAPARVOVIRUS - synonym of Bocavirus and III

definition - Any viral organism that can be
assigned to the family Bocaparvovirus.
Add Streptococcus Group R as a synonym for

STREPTOCOCCUS SUIS.
when COUNTRY is coming from different II Do not add (SDTM
sources, it may have differences based on ISO P27): Do not change.
3166 or other; thus, making this difficult to align Instead codelist is being
retired.
This is in conjunction with the K16 MITEST III

request discussion submitted earlier. The SDTM-
MIFTSDTL will be published with P25 so will not
be 'new' as of 2016-03 publication FYI.
This is a change control for QS PANSS II

terminology, which is being changed from the CC
to RS domain.
I will send the excel files by email. File emailed
separately.
Proposed Definition: A measurement of the total III SDTM, SEND-Published

glycerol in a biological specimen. in P29
These tests are needed to support the MITEST of III Do not add (SDTM
Abnormal Cells that was recently discussed at the P27): Do not add.
CDISC Lab Terminology meeting. Please use PAP STAIN
as the method and put
the liquid based info into
SUPPQUAL.
File E-mailed Separately III SDTM-Published in P26
File E-mailed Separately II SDTM-Published in P26
need to add mouse strain because is not present III

in the list
Request is from the lab team. III SDTM-Published in P30
The current terms on the MIRESCAT codelist all III

account for an abnormality. There is currently no
code on the MIRESCAT codelist that can be
assigned to a finding of "UNREMARKABLE". In
SEND 3.1 we recommend that 'Normal' be
assigned an MISTRESC value of
"UNREMARKABLE". I am unsure if the same
term should be used on the MIRESCAT code list
or if it should be something else.
In SEND 3.1 we indicate that a finding of 'Normal' III SEND-Published in P29
for a tissue should be assigned a value of
"UNREMARKABLE" in MISTRESC. I suggest that
this term be adopted on the NONNEO codelist,
similar to what has been done for fetal pathology
findings.
This unit is needed for semen analysis. It is used III SDTM, SEND-Published
to capture the total number of sperm available in in P28
the ejaculate as described by the normal values
of semen variables (WHO 1992). Link:
http://humupd.oxfordjournals.org/content/16/3/23
1.full
Please add the submission value of PRL to the III

Oncology Response Assessment Result codelist
with the synonym of Partial Response with
lymphocytosis.
This is used for CLL. Reference is the article
Ibrutinib for previously untreated and relapsed or
refractory chronic lymphocytic leukaemia with
TP53 aberrations: a phase 2, single-arm trial in
www.thelancet.com/oncology Vol 16 February
2015
The unit umol/dL is used for lab tests such as III SDTM, SEND-Published
Creatinine and Albumin. This unit is currently in P28
available in NCI Thesaurus (C code: C67407)
Definition: Unit of concentration (molarity unit)
equal to one millionth of mole of a solute in one
deciliter of the solution.
""HPF"" (code C67274): request for deletion or III SDTM, SEND-Published

clarification of this code for High Power Field. in P28
Since there is a code already for ""/HPF"" (code
C96619) for ""Per High Powered Field"", what is
gained by having a second code for HPF. It is
causing us to place essentially duplicate check-
box or radio button fields for a single test on our
CRF page. Similar question for ""LPF"" (code
C67307): request for deletion. There is already a
code for ""/LPF"" (Per Low Powered Field) in the
SDTM codelist. It is understood that some results
are quantitative, and some are qualitative
(TRACE or NEGATIVE or POSITIVE), but it
seems /HPF or /LPF would provide all the
information needed. As it is, tests that are the
same for test name and method are being
reported with multiple units (/HPF or HPF) that
are the same and should be unified. Thank you.
New term for the malaria TA project. III
Needed for the Malaria TA project III Do not add (SDTM

P27): Do not add. Keep
modeling as is (use
METHOD) within the
Malaria CRF but do not
control the value as
CDISC CT until the
METHOD scrum is
resolved.
Suspect that these would be lab test given the C- III Do not add (SDTM,
code is C-100452 for ova and parasite. Needed SEND P27): Removed
for the Malaria TA project by Requester.
This has already been discussed and agreed to III SDTM-Published in P26
by the Lab terminology team. We just needed a
request number.
the current METHOD codelist does not have this III SDTM-Published in P30
method commonly used for plenty of Covance
Central Laboraty Tests.
file e-mailed separately III QRS-Published in P36
Please add the term: FUSARIUM SOLANI III Published

Synonym: Neocosmospora solani
Reference: NCBI Taxonomy
Proposed Definition: Any fungal organism that
can be assigned to the species Fusarium solani.
These tests already exist in the P26 lab team III SDTM, SEND-Published
working document. They just needed a request in P26
number. These tests are going out for public
review for P26.
There labs already exist in the lab team working III SDTM, SEND-Published
document. They just needed a request number. in P26
They will be going out for public review for P26.
This already exists in the lab document. We just II SDTM, SEND-Published

needed a request number. This will be going out in P26
for public review for P26.
This already exists in the team document. We just II Do not add (SDTM P27):
need a request number. Removed by Requestor
To add water in the definition. II
Gas Chromatography/Flame Ionization Detector III SDTM-Published in P30
Given the recent publication of C123599 and II

C124431, team to re-discuss the decision to keep
'Non' in proper case in C96700. Slight
inconsistency as published currently. Is it worth
changing the submission value of C96700?
See multiple term request spreadsheet. The II SDTM, SEND-Published

general team has agreed to these changes but in P26
we need a request number.
For SEND-NEOPLASM codelist: C6433, please II

remove all CDISC synonyms from term.
SEND team already agreed to this term being III SEND-Published in P26
added and it is going out for public review with
P26. Just getting request number. Already in P26
working documents.
Row already exists in the changes tab with no II SDTM-Published in P28

request number.
This already exists in the spreadsheet, it just III SDTM-Published in P26

needs a request number.
A spontaneous change commonly in spinal III SEND-Published in P43

nerves and peripheral nerves in rats over a year
of age. Much more common in some strains of
rats (Sprague-Dawley).
A glucan molecule is a polysaccharide of D- III SDTM, SEND-Published

glucose monomers,[1] linked by glycosidic bonds. in P29
The method is extensively used at Covance CLS III
for detecting drugs in urine.
Do not add (P32) - KIMS

is a trademarked name
for the method of
KINETIC
MICROPARTICLE
IMMUNOASSAY, which
is already published.
Please use existing
published term.
These three codelists were created for TB v1.0 III
but NSVs were not created or published for them
in v1.0 of the TAUG. V2.0 of TB will not be using
them either. Please retire these three codelists
from SDTM.
SEX CORD STROMAL TUMOR, MIXED, II Do not add (SEND P27):

BENIGN C124614 Do not change. Going
SEX CORD STROMAL TUMOR, MIXED, forward 'MIXED' will be
MALIGNANT C124615 put in the middle of the
These submission values are incorrect. The word CDISC submission
""MIXED"" should be first to follow the naming value. 'MIXED' is a
convention of all other Mixed tumors. modifier on the base
P25 publication just changed a group of terms to finding and so for
follow this naming convention of MIXED being purposes of searching,
first in the submission value. the team prefers to see
MIXED in the middle of
the submission value.
III
It was agreed at the CDISC Intrachange March
2016 that the NEOPLASM codelist should be
removed from the SDTM publication. The SEND
team has previously agreed that the NEOPLASM
codelist should be SEND-specific also. Please
add this request into the Oncology P27 working
document. The SDS oncology team will discuss
how tumors should be modeled for clinical
submissions and whether outside references
should be used.
This value needs to be used in Define-XML v2 in III SDTM-Published in P30
ItemGroupDef/@def:Class attribute in case of an
FA data set. This value is also used in the
eSHARE download for the FA domain.(Define-
XML v2 format)
This SDTM class is a specialization of the

Findings General Observation Class. It is
intended, as its name implies, to be used when
collected data represent ?findings about? an
Event or Intervention that cannot be represented
within an Event or Intervention record or as a
Supplemental Qualifier to such a record.
A measurement of the soluble intracellular III SDTM, SEND-Published

adhesion molecule 1 in a biological specimen. in P29
To be used with LBTEST : Soluble Intracellular

Adhesion Molecule 1
A measurement of the soluble intracellular III SDTM, SEND-Published

adhesion molecule 1 in a biological specimen. in P29
To be used with LBTESTCD : SICAM1
A measurement of the polymyositis-scleroderma III

overlap syndrome-associated autoantigen
antibody in a biological specimen.
To be used with LBTEST : Polymyositis -Scl

Antibody
A measurement of the polymyositis-scleroderma III

overlap syndrome-associated autoantigen
To be used with LBTESTCD : PMSCLAB
Enhanced liver fibrosis score test to determine III SDTM, SEND-Published

liver functionality. in P29
To be used with LBTEST : Enhanced Liver

Fibrosis Score
Enhanced liver fibrosis score test to determine III SDTM, SEND-Published

liver functionality. in P29
To be used with LBTESTCD : ELFSC

Defintion: Hours times millimoles per liter (area III SDTM, SEND-Published
under the curve), divided by milligrams (dose in P29
normalized).
Preferred Term: Hour times Millimole Per Liter
Per Milligram
The unit of gpELISA unit/mL (Glycoprotein III SDTM, SEND-Published

Enzyme-Linked Immunosorbent Assay Unit per in P28
Milliliter) is used to measure antibody levels for
the test 'Varicella Zoster Virus Antibody'.
Conversion of the HAMD 17 QS Supplement to a III QRS-Published in P26

CC Supplement.
file emailed separately III SDTM-Published in P28
Please investigate the term KOCURIA II SDTM - Published in

RHIZOPHILA (C86513) with synonyms P26
Micrococcus luteus and Sarcina lutea. According
to NCBI taxonomy KOCURIA RHIZOPHILA has
no synonyms. Micrococcus luteus is its own
preferred microorganism name and Sarcina lutea
is a synonym to Micrococcus luteus. Thank you.
Anna Pron-Zwick/28-Mar-2016
Please add new bacterial term to the III SDTM - Published in

Microorganism Codelist: Micrococcus luteus. P26
Please add synonyms of Sarcina lutea,
Micrococcus lysodeikticus, and Bacteridium
luteum to this term as well. Reference: NCBI
Taxonomy Browser. Thank you. Anna Pron-
Zwick/28-Mar-2016
Please add Zika virus to the Microorganism III

Codelist. Zika virus is a species in the Genus:
Flavivirus. Reference: NCBI Taxonomy Browser
and International Committee on Taxonomy of
Viruses. Thank you. Anna Pron-Zwick/28-Mar-
2016
File emailed separately III SDTM, SEND-Published

in P29

Definition: Days times micrograms per milliliter III SDTM, SEND-Published
(area under the curve), divided by milligrams in P29
(dose).
A measurement of the total Treponema pallidum III SDTM, SEND-Published

antibody in a biological specimen. in P29
To be used with LBTEST : Treponema Pallidum

Antibody
A measurement of the total Treponema pallidum III SDTM, SEND-Published

To be used with LBTESTCD : TPAB

New QRS Terminology for the CDISC Modified III QRS-Published in P30
Clinical Global Impression (MCGI) QRS measure
Expanded Disability Rating Scale - Postacute II QRS-Published in P26

Interview Survivor Version Questionnaire Test
Code (CDISC Synonym) and Test Name(CDISC
Submission Value and Synonym)
to correct typo in 'accomodations'. File e-mailed

separately.
The terms OPTOMETRIST and III SDTM-Published in P29

OPHTHALMOLOGIST are needed for
Ophthalmology trials.
Proposed Definitions:
OPTOMETRIST: An individual who examines
eyes to determine if they need eyeglasses or
medical treatment.
OPHTHALMOLOGIST: A physician who
specializes in the diagnosis and treatment of eye
disorders. (NCI C17822)
Changes in hepatocellular rarefaction level III
(increased/decreased) observed under standard
histopathological evaluation� can be
spontaneous or related to treatment. This finding
is indicative for glycogen accumulation. Current
INHAND terminology for diagnosing glycogen
accumulation is� "Cytoplasmic alteration",
however as the "Cytoplasmic alteration" term
describes several cytoplasmic changes (including
degenerative changes) we consider it an umbrella
term without sufficient modifiers and suggest to
add the morphology "Rarefaction" as a
description of changes solely in rarefaction level.
This is needed to ensure description of these
specific changes in the hepatocytes and thereby
ensuring its? presence in incidence tables. The
definition of Rarefaction would then be ?Extent of
clear, not well-defined spaces in the cytoplasm
around a centrally located nucleus?. Examples of
use: "Rarefaction, hepatocyte, increased,
periportal", "Rarefaction, hepatocyte, decreased".
A relative measurement of theof CD56 III

expressing cells to T-lymphocytes in a biological
specimen.
To be used with LBTEST : CD56/T-Lymphocytes
A relative measurement of theof CD56 III

expressing cells to T-lymphocytes in a biological
specimen.
To be used with LBTESTCD : CD56TCE

CD14 expressing cells to non-squamous cells in
a biological specimen (for example a LAVAGE
FLUID).
To be used with LBTEST : CD14/Non-Squamous

Cells

CD14 expressing cells to non-squamous cells in
FLUID).
To be used with LBTESTCD : CD14NSCE

A relative measurement (ratio or percentage) of III SDTM, SEND-Published
eosinophils to non-squamous cells in a biological in P30
specimen
To be used with LBTEST : Eosinophils/Non-

Squamous Cells

eosinophils to non-squamous cells in a biological in P30
specimen
To be used with LBTESTCD : EOSNSCE

columnar epithelial cells to non-squamous cells in in P30
FLUID).
To be used with LBTEST : Columnar Epith

Cells/Non-Squamous Cells

columnar epithelial cells to non-squamous cells in in P30
FLUID).
To be used with LBTESTCD : EPICNSCE

squamous epithelial cells to non-squamous cells in P29
in a biological specimen (for example a LAVAGE
FLUID).
To be used with LBTEST : Squamous Epithelial

Cells/Total Cells

squamous epithelial cells to non-squamous cells in P29
in a biological specimen (for example a LAVAGE
FLUID).
To be used with LBTESTCD : EPISQCET

lymphocytes to non-squamous cells in a in P30
biological specimen
To be used with LBTEST : Lymphocytes/Non-

Squamous Cells
lymphocytes to non-squamous cells in a in P30
biological specimen
To be used with LBTESTCD : LYMNSCE

macrophages to non-squamous cells in a in P30
biological specimen
To be used with LBTEST : Macrophages/Non-

Squamous Cells

macrophages to non-squamous cells in a in P30
biological specimen
To be used with LBTESTCD : MCPNSCE

monocytes to non-squamous cells in a biological in P30
specimen
To be used with LBTEST : Monocytes/Non-

Squamous Cells

monocytes to non-squamous cells in a biological in P30
specimen
To be used with LBTESTCD : MONONSCE

neutrophils to non-squamous cells in a biological in P30
specimen
To be used with LBTEST : Neutrophils/Non-

Squamous Cells

neutrophils to non-squamous cells in a biological in P30
specimen
To be used with LBTESTCD : NEUTNSCE
A measurement of the non-squamous cells in a III SDTM, SEND-Published

biological specimen. in P30
To be used with LBTEST : Non-Squamous Cells

A measurement of the non-squamous cells in a III SDTM, SEND-Published
To be used with LBTESTCD : NSCE

To be used with LBTEST : Procollagen 3 N-

Terminal Propeptide

To be used with LBTESTCD : P3NP

bronchial epithel cells to non-squamous cells in a in P30
biological specimen
To be used with LBTEST : Bronchial Epith

Cells/Non-Squam Cells

bronchial epithel cells to non-squamous cells in a in P30
biological specimen
To be used with LBTESTCD : BEPINSCE

eosinophils to non-squamous cells in a biological
specimen
To be used with LBTEST : Eosinophils/Non-

Squamous Cells
Please create four new TEST-CD terms for the III

MUSCTS-CD codelist, which is out for public
review with P26. Team agreed to pre-coordinate
the scoring system name into the TEST value
since this is a body system domain. File Emailed
Separately. TA request.
Change definition from "A domain for II
physiological findings related to the system of
muscles, tendons, ligaments, bones, joints and
associated tissues." to "A domain for
morphological and physiological findings related
to the system of muscles, tendons, ligaments,
bones, joints and associated tissues." This
change is needed as a consequence of the
decision to deprecate the MO domain and
represent morphological findings in the relevant
body-system based domains.
"TB TAUG - It has been decided that the VR III

domain will be deprecated and all VR terminology
should be moved to a new MSTEST/CD codelist.
A separate request has been made to add an
MSTEST/CD codelist. This is a TA request.
Hi Bernice and Jordan,
I just submitted a request for new terms and the

addition of an MS codelist which I know will go to
the virology team. When this comes up in the
queue can you invite me to the meeting? There is
a bit of background that was too complicated to
try to explain in a spread sheet. "
This TESTCD/TEST is used when the exam is III Do not add (P30): This
pre-specified. This type of TESTCD/TEST will be is being discussed by
needed for all morphology/physiology domains the SDS team and
and the MI domain. This is a TA request. involves the creation of
a new SDTM variable.
Please put this in the
TAUG as a known
issue.
To be used to categorize the qualitative and III

seme-quantitave food
C13010; C12725; C12771 - Modify definitions II SEND-Published in P29
such that they are not citing MeSH. MeSH
definitions were used as placeholders when NCI
Thesaurus was first set up and so by default
CDISC used those definitions as the CDISC
definitions. NCI has since updated the NCI
definitions. Since CDISC by and large does not
use MeSH definitions, we are suggesting these
definitions should be updated within CDISC
codelists.
C13010 - A compound tubular gland located in
the submucosa of the duodenum, proximal to the
sphincter of Oddi, that produces and secretes an
alkaline mucus that neutralizes stomach acid.
C12725 - A reproductive system organ that
produces gametes.
C12771 - Lymphoid follicles located in the
mucosa of the small intestine, usually in the
ileum.
All other SEND-SPEC definitions that cite MeSH
are being modified with the Specimen definition
work currently undertaken by SEND.
C12451; C12355; C12452 - Modify definitions II
such that they are not citing MeSH. MeSH
definitions were used as placeholders when NCI
Thesaurus was first set up and so by default
CDISC used those definitions as the CDISC
definitions. NCI has since updated the NCI
definitions. Since CDISC by and large does not
use MeSH definitions, we are suggesting these
definitions should be updated within CDISC
codelists.
C12451 - The grey matter adjacent to each lateral
ventricle of the brain that comprises the medial
dorsal striatum of the basal ganglia. The caudate
nucleus is primarily involved in body and limb
posture and movement.
C12355 - One of the four regions of cortex in
each cerebral hemisphere. It is located posterior
to the temporal lobe and inferior to the parietal
lobe.
C12452 - The grey matter, located between the
globus pallidus and the external capsule of the
brain, that comprises the lateral dorsal striatum of
the basal ganglia.The putamen is involved in
learning and regulating movement.
All other SDTM-LOC definitions that cite MeSH
are being modified with the Specimen definition
work currently undertaken by SEND (for shared
terms).
Often a sample is concentrated before using it in III

a test so that more of the bacteria are present in
relation to sample volume. This is a TA request.
TUTEST and TUTESTCD: Update Codelist long II

name and definition to include 'Tumor or Lesion'
instead of just 'Tumor'. This is already in the
oncology document, just need to add the request
number.
Change the codelist long name and definition II

slightly: 'Tumor and Lesion' to 'Tumor or Lesion'
for consistency with TR domain codelists. This
item is already in the Oncology working
documents. Just need to add the request number.
EC domain (Exposure as collected) is added in III SDTM, SEND-Published

SDTM 1.4 (SDTM IG 3.2). This is not found in in P33
terminology of 2016-03-25.
Proposed definition is "A measurement of any III SDTM, SEND-Published
type of toxic change in cells of the neutrophilic in P29
lineage collectively including one or more of the
following: cytoplasmic granulation, Dohle bodies,
and increased cytoplasmic
basophilia/vacuolation.
Request to add the terms RATER, RATER 1, III SDTM-Published in P29

RATER 2 to the Medical Evaluator codelist.
These terms are used for the collection of
questionnaire data. The rater assesses the
individual and completes the questionnaire. The
rater may need to be a certified rater depending
upon the questionnaire.
RBCMORPH Erythrocyte Cell Morphology III
OSMLTY Osmolality URINALYSIS III SDTM-Published in P30
CAION Calcium, Ionized CHEMISTRY III
Addition of term ASPERGILLUS VERSICOLOR III

Proposed definition: Any fungal organism that can
be assigned to the species Aspergillus versicolor.
Physical location or place of biospecimen III SDTM-Published in P30

sampling (e.g. Oncology indication: Primary site,
Metastatic site)
To be used with BSTEST : Site
Physical location or place of biospecimen III SDTM-Published in P30

sampling (e.g. Oncology indication: Primary site,
Metastatic site)
To be used with BSTESTCD : SITE

The physical amount or number of something III Do not add (P30) - BS
being collected or processed (i.e. number of domain is used to
cores, number of biopsies, number of slides) collect the
characteristics of
To be used with BSTEST : Quantity individual samples, not
metadata on how many
samples were collected.
If you are trying to link
this back to a pathology
include a suppqual in
the MI domain that
would have the number
of slides
produce the report.
The physical amount or number of something III Do not add (P30) - BS

being collected or processed (i.e. number of domain is used to
cores, number of biopsies, number of slides) collect the
characteristics of
To be used with BSTESTCD : QUANTITY individual samples, not
metadata on how many
samples were collected.
If you are trying to link
this back to a pathology
include a suppqual in
the MI domain that
would have the number
of slides
produce the report.
The physical dimension, proportion, magnitude or III

extend of something
To be used with BSTEST : Size
The physical dimension, proportion, magnitude or III

extend of something
To be used with BSTESTCD : SIZE

Classification or characterization of something III
To be used with BSTEST : Type
Classification or characterization of something III
To be used with BSTESTCD : Type
Substance used to preserve or stabilize the III

material prior to microscopy or other examination
To be used with BSTESTCD : FIXATIVE
Substance used to preserve or stabilize the III

material prior to microscopy or other examination
To be used with BSTEST : Fixative
The dimension between two surfaces of an III

object, usually the smallest dimension as
opposed to the width or the length. (from
Morphology Test Code, concept C41145)
To be used with BSTEST : Thickness
The dimension between two surfaces of an III

object, usually the smallest dimension as
opposed to the width or the length. (from
Morphology Test Name, concept C41145)
To be used with BSTESTCD : THICK
The inherent or distinguishing characteristic of the III

specimen
To be used with BSTEST : Quality
The inherent or distinguishing characteristic of the III

specimen
To be used with BSTESTCD : QUALITY
Terms already present in PGx working document; III

just needed to get a request code to add these
two terms to BSTEST-CD codelist.
General team looking at adding this term to the III SEND-Published in P28
new 'Contact Role' codelist and suggested that
this trial summary is incomplete as coded. SEND
to clarify the use of this term as a TSPARM value.
This is a new term request for the Kidney III SDTM-Published in P29
Transplant TA team; File emailed seperately. Do not add (SDTM P27)
Channel to UNIT
Pls let Jordan know when these terms are being codelist: The lab test
discussed by the Lab team so she can show the details contains the
KT TAUG for use cases. Thanks. word "channel" and it is
not needed as a unit
code.
New terms to be added to SCTEST/CD; File III SDTM-Published in P30

emailed separately.
"The company would like to use the following II Question Answered

categories: (SDTM P27): At this time
Unrelated there are no plans for
Unlikely CDISC to control this.
Definite
Probable
Possible
The company is concerned that 'Unlikely' may be

not allowed by CDISC in the near future. Any
information will be appreciated."
Draft QRS Public Domain_Copyright Verification II QRS-Published in P28

Document, example CRFs and QRS Terminology
Spreadsheet sent in separate EMAIL. This is for
the MDD TA.
Pls add terms to LBTEST-CD codelists; File II SDTM, SEND-Published

emailed separately. in P30
Do not add (P30) -
Please use existing
concept C127636. We
will add a synonym
however for mapping
purposes.
This unit will be used for dose normalized AUC II SDTM, SEND-Published
in P29
1- antimicrobe.org . Acinetobacter species II
Infectious Disease and Antimicrobial Agents
2016. ?The genus Acinetobacter has undergone
extensive and confusing changes in taxonomic
nomenclature over many years, with strains being
designated previously as Bacterium anitratum,
Herellea vaginicola, Mima polymorpha,
Achromobacter, Micrococcus calcoaceticus, anit
Diplococcus, B5W and Cytophaga. The use of
modern molecular based taxonomic methods has
allowed the identification of at least 34 different
named species (www.bacterio.cict.fr) (Table 1),
with the likelihood that further species will be
discovered in the future.?
2- Clin. Microbiol. Rev. July 2008vol. 21 no. 3
538-5821 July 2008. ?The current genus
designation, Acinetobacter (from the
Greek ???????? [akinetos], i.e., nonmotile), was
initially proposed by Brisou and Pr�vot in 1954
to separate the nonmotile from the motile
microorganisms within the genusAchromobacter
(61). It was not until 1968 that this genus
designation became more widely accepted (21).
Baumann et al. published a comprehensive
survey and concluded that the different species
listed above belonged to a single genus, for
which the name Acinetobacter was proposed,
and that further subclassification into different
species based on phenotypic characteristics was
not possible (21). These findings resulted in the
official acknowledgment of the genus
Acinetobacterby the Subcommittee on the
Taxonomy of Moraxella and Allied Bacteria in
1971 (324). In the 1974 edition of Bergey's
Manual of Systematic Bacteriology (312), the
genus Acinetobacter was listed, with the
description of a single species,Acinetobacter
C96696 C65047 Laboratory Test Code DRVVT II SDTM, SEND-Published
Dilute Russell's Viper Venom Time; Lupus in P26
Anticoagulant Test
C103386 C65047 Laboratory Test Code
DRVVTRT Lupus Anticoagulant Ratio
Ideally we should have Lupus Anticoagulant Ratio

changed to Dilute Russell's Viper Venom Time to
Control Ratio as per NCI, then the LBTESTCD
and LBTEST would be consistent for the
C103386 code and the two C codes would be
consistent with each other
A measurement of CD31 protein in a biological II SDTM-Published in P30

specimen.
To be used with MITEST : PECAM-1

A measurement of CD31 protein in a biological II SDTM-Published in P30
specimen.
To be used with MITESTCD : CD31
Expanded Prostate Cancer Index Composite for II QRS-Published in P26

Clinical Practice/EPIC-26
Expanded Prostate Cancer Index Composite for
Clinical Practice/EPIC-CP""
National Comprehensive Cancer
Network/Functional Assessment of Cancer
Therapy-Prostate Symptom Index 17 Version
2/NCCN FACT-FPSI-17
These are for Prostate Cancer TA.
A new concept will be created for "Radiography". II
File emailed separately II
Please add the following terms to the II SDTM-Published in P28

Microorganism Codelist. These terms are used in
clinical trials.
STREPTOCOCCUS, GROUP D (Proposed
Definition: A non-taxonomic grouping of alpha- or
gamma-hemolytic species within the
Streptococcus genus that are assigned to the D
group.)
ENTEROBACTERIACEAE - this is a large family

of Gram-negative bacteria that includes, along
with many harmless symbionts, many of the more
familiar pathogens, such as Salmonella,
Escherichia coli, Yersinia pestis, Klebsiella and
Shigella. (Proposed Definition: Any bacteria that
is not assigned to the species level but can be
assigned to the Enterobacteriaceae genus level.)
FILAMENTOUS FUNGI - generally appearing as

a circular colony that may be cottony, wooly, or
glabrous, but with filaments that are not
organized into large fruiting bodies, such as
mushrooms. The three major groups of fungi are:
multicellular filamentous molds, macroscopic
filamentous fungi that form large fruiting bodies,
and single celled microscopic yeasts. YEAST is
already available. Requesting generic term of
FILAMENTOUS FUNGI to account for other types
of fungi.
Please add the following terms as synonyms to II
existing terms in the Microorganism Codelist:
Add STOMATOCOCCUS as a synonym to
ROTHIA
Add PEPTOSTREPTOCOCCUS PREVOTII as a
synonym to ANAEROCOCCUS PREVOTII
Add YEAST LIKE ORGANISM as a synonym to
YEAST (or should this be a submission value
instead of a synonym?)
Request to create new DKD Findings About II SDTM-Published in P28

TEST/CD codelists; This is for the DKD TA
Project; File emailed separately
Study Chair: Not sure this is the correct code to II

use here. Is this asking for the Study Chair
Name? If so, I think it may be appropriate to
recode this concept to something along the lines
of a question. As defined now, it seems more
pertinent as a response.
This is published in both the SEND-SPEC and II SEND-Published in P28

SDTM-LOC codelists.
This domain is used to describe Disease II SDTM-Published in P33

Milestones, which are observations or activities
expected to occur in the course of the disease
under study, and whose timing is of interest for
the study.
This is the wording included in SDTM 1.5. This
domain is planned to inclusion in the next version
of the SDTMIG.
The Subject Disease Milestones domain is II SDTM-Published in P33

designed to record the timing, for each subject, of
Disease Milestones that have been defined in the
Trial Disease Milestones (TM) dataset in Section
3.6.
The above is the wording in the SDTM 1.5.
Clearly the definition should not include the
section number.
This special purpose domain is planned to be
included in SDTMIG 3.3.
Not sure this is the correct coding to use here. Is II
this SEND trial summary parameter asking for the
Name of this person or organization? If so, I think
it may be appropriate to recode this concept to
something along the lines of a question. As
defined now, it seems more pertinent as a
response.
ANLCAT (Analysis Category) is a proposed II Do not add (P30):

codelist from the ADaM Integration subteam for Removed by requester.
use in IADSL (integrated ADSL). It describes the
categorization of the study, period or phase for
analysis. Examples include DB (Double Blind),
DB+EXT (Double Blind + Extension), ADJ (Dose
Adjustment), etc.
Request by Oncology team to add this term. II SDTM-Published in P28
The current ECG STDM terminology list has three II

codes for why an ECG cannot be evaluated
(C114181, C114180, C114178) however there
can be other reasons as well. In many clinical
studies the ECGs are transferred digitally and
also in these files the ECG quality can be poor.
Code C114180 is for when an ECG cannot be
evaluated due to poor quality of the printed ECG,
i.e. a paper file, not digital.
I would therefore propose that a generic code is
created ""ECG cannot be evaluated"" that could
then be used in case the quality is insufficient or
there are technical reasons that do not allow the
ECG to be analysed.
The current codes about left ventricular II SDTM, SEND-Published

hypertrophy, C71076 and C102655, both include in P28
secondary findings (e.g. ST and T changes)
besides the large QRS amplitudes. Large
amplitudes can also occur with secondary
findings and can but is not necessary an
abnormal finding. Therefore we would propose
this code to be added.
Non-specific T wave abnormality is a terminology II
that is frequently used during the interpretation of
ECGs to give a comment that the T wave
morphology is not what it should be in normal
population but without further indication of more
defined abnormalities like infarction. The current
SDTM code list has the term repolarization
abnormality which may have been created for the
same use but we believe that having the code
non-specific T wave abnormality would be a good
and valid addition.
Our Clinical Data Management department has II

requested a term be available for lab test
specimens. Here is the info request they sent:
"The process is to collect the blood by finger
prick, sometimes venipuncture, and place the
sample on a filter paper and allowed to air dry.
The area of the paper having the blood is
punched out and sent through the automated or
manual analysis tool." The department poses the
question also whether DRIED BLOOD SPOT
should be dealt with as a method or as specimen.
The ADaM integration subteam requests these II SDTM-Published in P29

new classes for new models for integrated
datasets.
These are tests used in the Asthma TA User II SDTM, SEND-Published

Guide which were apparently never requested: in P28
FENO (Fractional Exhaled Nitric Oxide). I think
this is the standard name for this test.
Multiple allergen-specific IgE tests. I suspect
these may require developing some principles.
IEMIX IgE Mixed Allergens
IECATD IgE Cat Dander
IEDOG IgE Dog Dander
IEDFAR IgE D. farinae
IEDPTER IgE D. Pteronyssinus
IEAMNCK IgE American Cockroach
IEAFUMIG IgE A. fumigatus
IEPEN IgE Penicillium notatum
IEATEN IgE A. tenuis alternata
See this page in the wiki version of the Asthma
TAUG:
http://wiki.cdisc.org/display/asthma/Biomarkers+2
This test was used in the Asthma TA User Guide, II SDTM-Published in P28
but apparently no term was requested.
Explanation of test: "In this example, the wheal
diameter for each allergen was assessed as a
positive or negative response for each allergen
tested based on a threshold wheal size"
See
http://wiki.cdisc.org/display/asthma/Skin+Respon
se+2
In the original TAUG the test name was
WHLRSP, but at some point apprently WHLINT
(presumably short for "wheal interpretation") was
suggested as an alternative.
A test code used in the Asthma TA User Guide II

which was not requested at the time.
See
http://wiki.cdisc.org/display/asthma/Spirometry+1
and
http://wiki.cdisc.org/display/asthma/Spirometry+1
Request to add Subject Status domain II SDTM, SEND-Published

abbreviation (SS) to the DOMAIN codelist. in P33
Currently the domain is in SDTM IG 3.2, but
terminology is missing in the codelist.
Definition: Domain for data relating to general
subject characteristics that are evaluated
periodically to determine if they have changed.
Move terms from PKUNIT to 4 new codelists. II

Also retire true mathematical synonyms.
This request is from the PK team. These terms
already exist in the PK file, we just need a
request number.
We are requesting the addition of a new test II

'ECG Findings, Not Otherwise Specified' with the
test code ECGFNOS to capture any additional
items found on the ECG for which there is no test
available. We followed the same type of format as
the existing test of Rhythm Not Otherwise
Specified.
Proposed Definition: An electrocardiographic
assessment of cardiac findings not otherwise
specified.
Result is Alpha Numeric such as Not Detected in II
support of Myeloma testing. The Specimen type
is urine and the method is ELECTROPHORESIS
Do not add (P32). Please

use existing term
C92291/MCPROT as the
test, IMMUNOFIXATION
ELECTROPHORESIS is
the method, urine is the
specimen, and
Interpretation or
Impression is a test
detail.
New term request from the CV Imaging TA team; II SDTM-Published in P28,
This is a TA request. File emailed separately P30, P31, P32, P33
The CV Imaging team would appreciate help from II

the Oncology team on where to map the data in
the attached file. These are cardiovascular
common data elements from DUKE and the CV
team thinks that the concepts presented here are
not appropriate for the CV domain, but more align
with the content in the TR/TU domain. Please
advice. File emailed separately
Request to add new terms to the METHOD II SDTM-Published in P28

codelist. This is a TA request from the Kidney
Transplant Team; File emailed separately
A method used to quantify insulin resistance and II

beta-cell function
Dynamic susceptibility-contrast II SDTM-Published in P30
Dynamic susceptibility-contrast magnetic

resonance imaging) An MRI technique in which
the first pass of a contrast agent is monitored by
a series of T2- or T2*-weighted MR images, from
which perfusion can be derived
Diffusion weighted imaging II SDTM-Published in P30
An MRI technique that maps the diffusion process

of water caused by Brownian motion by using
additional magnetic field gradients. Quantitative
assessment of water diffusion is expressed by the
apparent diffusion coefficient (ADC).
Diffusion tenor imaging II SDTM-Published in P30
An DWI-based MRI technique to measure the

spatial anisotropy of water diffusion by which
structural alterations can be assessed. From at
least 6 diffusion measurements in different
directions a diffusion tensor is calculated.
Magnet resonance elastography II SDTM-Published in P30
An MRI technique used for quantitatively

assessing the mechanical properties of tissue.
MRE obtains information about stiffness of tissue
by assessing the propagation of shear waves
through the tissue.
Phase-contrast magnetic resonance II SDTM-Published in P30
An MRI technique used for the determination of

blood velocity and blood flow. A phase shift,
which is proportional to the blood velocity, is
generated by magnetic field gradients between
static tissue and flowing blood.
ION SELECTIVE ELECTRODE II

Serum Chloride, CHEMISTRY, Electrolytes
LBTESTCD - CL NAME-CHLORIDE
ION SELECTIVE ELECTRODE II

Serum Potassium, CHEMISTRY, Electrolytes
LBTESTCD K - name - Potassium
Need request codes for P27 Public Review terms II SDTM-Published in P28
& P28 spreadsheets
A measurement of the hepatitis C Core virus II SDTM, SEND-Published

antigen in a biological specimen. in P30
Synonyms: Hepatitis C Core Antigen; Anti-HCV
Core Protein; Anti-Hepatitis
A measurement of the nerve growth factor in a II SDTM, SEND-Published

Term is not available in present codelist. II SDTM, SEND-Published

Thrombomodulin is a protein expressed on the in P30
surface of endothelial cells that serves as a
cofactor for thrombin, and circulates in blood.
Note, if a fuller definition is needed, contact me
and I will refer you to our scientists for biomarkers
- thanks.
Definition: "A measurement of the Ba fragment of II SDTM, SEND-Published
complement factor B in a biological specimen." in P30
CDISC Synonyms: "Ba Fragment of
Complement Factor B; Ba Fragment of Factor B;
Complement Ba". All of this is entirely parallel to
the current handling of lbtestcd= CBB, for lbtest
of Complement Bb in the existing SDTM terms
list. Note, it is possible that a longer term is
clearer than the short "Complement Ba" or
"Complement Bb". The longer form is, "Ba
Fragment of Complement Factor B", or "Ba
Fragment of Factor B". Both are within 40
characters.
ESR is a code in its own right (C74611) so having II Do not add (P30) - It
it as a synonym to another LBTESTCD is would be too disruptive
confusing to change submission
value. Going forward we
will be more careful with
assigning TESTCDs that
could not be used for
other acronyms.
We have a study where density readings are I

being taken of all the bones and joints in the
hand. I have 2 questions:
1. In th June 2016 release you have just created
3 of the many joints in the palm of the hand e.g.
SCAPHOID-CAPITATE JOINT. I need to create
the rest as extensible for now and I'll request for
them to be added, but how do you define which
way around the bones are represented e.g.
SCAPHOID-CAPITATE JOINT vs CAPITATE-
SCAPHOID JOINT? Is there a
rationale/convention? It would be good to get the
extensible terminology correct.
2. We are measuring density on the proximal and
distal ends of the metacarpal bone. But I'm not
sure if the proximal/distal in this instance would
be classed as a Directionality or part of the LOC
e.g. LOC=DISTAL METACARPAL BONE 2 or
LOC=METACARPAL BONE 2 and DIR=DISTAL.
I'd be grateful for your advice.
Currently the term that exists is MEDICARE- II SDTM-Published in P30

CERTIFIED LONG TERM CARE HOSPITAL
(LTCH). Requesting the addition of a more
generic term of LONG TERM CARE HOSPITAL if
the Medicare certification status is unknown.
Request to add a new term called "TWICE" to II SDTM-Published in P30
FREQ codelist. Definition would be "A two time
intervention". The use case for this frequency are
for toxicology studies including KLH dosing,
where the KLH dose is administered on Day 57
and Day 78.
File emailed separately II QRS-Published in P29
Hours times nanomoles per liter (area under the II SDTM, SEND-Published
curve), divided by milligrams (dose normalized). in P29
Proposed NCI Preferred Term : Hour times
Nanomole Per Liter Per Milligram
Request to remove terms from the CVTEST/CD II SDTM-Published in P30

codelists. File emailed separately
Move 3 QRS measures (DISEASE STEPS, II QRS-Published in P38,

EDSS, and KFSS) from QS to RS as clinical P43
classifications; File emailed separately.
Here is our proposal for a CDISC Definition for an II SDTM, SEND-Published

8-lead ECG collection method: in P29.
An electrocardiogram (ECG) lead placement

whereby 8 leads are recorded consisting of three
standard limb leads (leads I, II, and III), three
augmented leads (leads aVR, aVF, and aVL),
and two chest leads (typically CV5RL [rV2] and
CV6LL [V2] for canines or MV1 and MV2 for non-
human primates). These leads are used to elicit
an electrical view of the heart.
New term request for II

MATESTCD=MASSCFM
MATEST= Mass Confirmation
Proposed definition= The process by which a

mass identified during the inlife phase is
macroscopically confirmed at necropsy.
Reason: The current definition for clinical signs

follow up does not describe the process used for
mass confirmation.
File emailed separately II SDTM, SEND-Published
CDISC_Multi_Term_Request_2016-07- in P28, P29, P30, P31
19_Robert Dempsey.xlsx Do not add (P30):
Submission Reference
Document - This was
intended as a field in
which you could put a
document name or URL
to any additonal
submission document
that further defined the
testing methods (lab or
analytic). With the
work the METHOD team
is doing, we do not see
carrying it forward in a
primary domain. It
would be at the trial
level, e.g. apply to all
instances of a particular
genetic test.
Do not add (P47): -
Clonotypic Cells/Total
Cells, Clonotypic
Cells/Leukocytes,
Clonotypic Cells/Plasma
Cells: Do not add. Wait
for someone with a
valid use case to
request this term.
Do not add (P47): -
Clonotypic Cells: Do not
add. Wait for someone
with a valid use case to
request this term.
Do not add (P47): -
Myeloma Cells/Leuk: Do
Request to modify published CVTEST/CD; File II SDTM-Published in P30
emailed separately; This is a TA request from the
CVI team.
This is to align the definition with updates made II SDTM-Published in P28

to the TU domain.
This is to align the definition with updates made II SDTM-Published in P28

to the TR domain.
The reason for this suggestion is to align with II SDTM-Published in P28

recent domain updates.
Celgene is using this term in II SDTM-Published in P29
Echocardiogram/Multigated Acquisition Scan
assessment form for Childern's cardio
assessment.
Cannabinoids, Synthetic' is testing the man-made II SDTM, SEND-Published

marijuana vs. marijuana from the cannabis plant. in P30
Following are examples of what is being tested:
JWH-018 and metabolites, JWH-073 and
metabolites, JWH-122 metabolites, JWH-200
metabolites, JWH-250 metabolites, JWH-398
metabolites, RCS-4 metabolites, AN-2201
metabolites, UR-144 metabolites, XLR-11
metabolites etc.. The Screening threshold is 1.0
ng/mL and the analysis is performed by Liquid
Chromatography with Tandem Mass
Spectrometry (LC/MS/MS). Reported as Positive
or Negative.
Request to add new terms and create new II SDTM-Published in P28,

codelist for the KT TA project; File emailed P30
separately
Add new terms; File emailed separately II SDTM-Published in P30
Existing definition: A type of high-throughput , II SDTM-Published in P28

multiplex PCR method that uses a single pair of
PCR primers to amplify multiple targets and to
determine changes in complex genomes.
Remove space after 'high-throughput' at

beginning of definition.
Request to add new terms to SCTEST/CD and II

DDTEST/CD codelists; This is a KT TA request.
Do not add (P30):
Deceased Donor Criteria
- Request removed by
requester.
this value does not appear to indicate how a II ADaM-Published in P28
analysis value was derived which is the purpose
of this codelist - you possible might have TIME
MATCHED - LOCF or TIME MATCHED - BLOCF
as a valid value but TIME MATCHED in and of
itself does not appear to be a valid DTYPE value
- please remove this value from the codelist
2 new term requests: II SDTM, SEND-Published
LBTESTCD= TNFa in P29
LBTEST= Tumor necrosis factor alpha Do not add (P30) -
Proposed definition= A measurement of tumor Already published as
necrosis factor alpha in a biological specimen. C74751. TNF is
synonymous with TNF
LBTESTCD= TNFb alpha.
LBTEST= Tumor necrosis factor beta (http://www.genecards.o
Proposed definition= A measurement of tumor rg/cgi-bin/carddisp.pl?
necrosis factor beta in a biological specimen gene=TNF&keywords=T
NF)
Approval of these terms and definitions may
require revisions for the definition for C74751 or
retirement of C74751.
Please find attached completed Multiple Term II

Request form for addition of New test name and
test code. Could you please review and provide
me your feedback asap? As instructed, I have
also submitted a CDISC New Term Request on
the web indicating ""File emailed separately"" in
the Additional Information field.
FACIT-F V4 (FAC071); NCCN-FACT FKSI-19 V2 II

(FAC042); NCCN-FACT FBLSI-18 V2 (FAC028);
FACT-B V4 (FAC005); FOSI (FAC049);
NCCN-FACT FOSI-18 V2 (FAC050)
"Arizona Sexual Experiences Scale ? Female II

Questionnaire Test Code (ASEX01TC) - add
ASEX0106-Comments
Arizona Sexual Experiences Scale ? Female
Questionnaire Test Name (ASEX01TN) - add
ASEX01-Comments
Arizona Sexual Experiences Scale ? Male
Questionnaire Test Code (ASEX02TC) - add
ASEX0206-Comments
Arizona Sexual Experiences Scale ? Male
Questionnaire Test Name (ASEX02TN) - add
ASEX02-Comments
Additional field on form provided with references."
The UNIT codelist already has g/mol, which is II

numerically equivalent to mg/mmol, but if the
reported units are mg/mmol, I would like to record
it as mg/mmol, not as g/mol. (There are other
instances in the UNIT codelist where two
numerically equivalent units are both present: e.g.
L/kg and ml/g)
The current definition of DAYS is: "The time for II
Earth to make a complete rotation on its axis;
ordinarily divided into twenty-four hours. This also
refers to a specific day. (NCI)"
This is incorrect, this defines a siderial day which

is approx. 23 hours 56 minutes long, whereas the
normal everyday usage for 'day' is the 24 hour
day.
This is a TA request from the MDD team. II QRS-Published in P28

IDS-C (Inventory of Depressive Symptoms-
Clinician);
IDS-SR (Inventory of Depressive Symptoms-Self
Report);
QIDS-C (Quick Inventory of Depressive
Symptoms-Clinician);
QIDS-SR (Quick Inventory of Depressive
Symptoms-Self Report)
QRS Terminology spreadsheets and CRF sent
separately
Please consider adding "Hemoglobin Tetramer" II SDTM, SEND-Published

to CDISC Controlled Terminology for LAB. Most in P30
clinical laboratories measure hemoglobin in
monomer form; however, some laboratories will
measure the hemoglobin tetramer which has a
different molecular weight (MW of hemoglobin
tetramer = 64,458) than the hemoglobin monomer
(MW of hemoglobin monomer = 16,114) and,
therefore, has a different normal range. This
should probably be considered a different
analyte. Keeping in mind CDISC LAB team
discussions regarding Free Hemoglobin vs.
Hemoglobin. Proposed CDISC LBTEST:
Hemoglobin Tetramer and LBTESTCD: HGBT.
Thank you. Anna Pron-Zwick/16-Aug-2016
New terms request for Laboratory Test Code; File II SDTM, SEND-Published
emailed separately in P30
The programmed and controlled cell death; the II SEND-Published in P29

death of cells which occurs as a normal and
controlled part of an organism's growth or
development.
7 versions of the measure: II QRS-Published in P28
WHO Disability Assessment Schedule 2.0 - 12
Item Interview (WHODAS 2.0 12 ITEM
INTERVIEW)
Item Proxy (WHODAS 2.0 12 ITEM PROXY)
Item Self (WHODAS 2.0 12 ITEM SELF)
WHO Disability Assessment Schedule 2.0 -
12+24 Item Interview (WHODAS 2.0 12+24 ITEM
INTERVIEW)
Item Interview (WHODAS 2.0 36 ITEM
INTERVIEW)
Item Proxy (WHODAS 2.0 36 ITEM PROXY)
Item Self (WHODAS 2.0 36 ITEM SELF)
Thius QRS measure was requested by the MMD
TA standards team; draft copyright verification,
CRFs and terminology spreadsheets are sent
separately
4 Versions of the Inventory of Depressive II

Symptoms:
IDS-C (Inventory of Depressive Symptoms-
Clinician)
IDS-SR (Inventory of Depressive Symptoms-Self)
QIDS-C (Quick Inventory of Depressive
Symptoms-Clinician)
QIDS-SR (Quick Inventory of Depressive
Symptoms-Self Report)"
This QRS measure was requested by the MMD
TA standards team; draft copyright verification,
CRFs and terminology spreadsheets are sent
separately
This QRS measure was requested by the MMD
TA standards team. Attached are the copyright
verification, draft QS terminology spreadsheets
and annotated CRFs for review.
Hours times micromoles per liter (area under the II SDTM, SEND-Published
curve), divided by milligrams per kilogram (daily in P29
dose normalized by body weight)
The definition of RANDQT is as follows: "The II Do not add (P30) - In TS
randomization quotient is the number of planned domain description
subjects to be exposed to investigational therapy, (Appendix C1: Required
independent of dose or other factors, divided by only when there is only
the total number of planned subjects.". We were one investigational
wondering at Cytel what is meant by treatment. The value is
'investigational therapy' if this as per GCP (A always a number
pharmaceutical form of an active ingredient or between 0
placebo being tested or used as a reference in a and 1. There are cases
clinical trial) and in particular if Placebo is where the ratio is 1
considered as 'Invetsigational therapy' (it is as per (e.g., crossover study or
GCP), given the fact were getting different open label study where
interpretation by working with different companies all subjects are exposed
to investigational
therapy).), this is
required only when
there is only 1
investigational
treatment, e.g. leaving
the placebo out (no
placebo trials). Subjects
exposed to placebo are
always excluded from
this analysis, otherwise
the result would always
be 1. Therefore, use of
'investigational therapy'
within this definition
was never meant to
encompass the GCP
definition of
'investigational
therapy'. In the CDISC
definition,
'investigational therapy'
was meant to
encompass the active
When performing a nasal swab in the nasal cavity II SDTM-Published in P29
to collect cells which are then subject to culture
and/or analysis for the present of genetic viral
material, I am wondering what specimen type
should be used. I feel mucus is not appropriate.
One proposal is to use tissue, but that seems to
lack specificity. Another proposal therefore is to
add a new SPECTYPE of Cells (or maybe
Epithelial Cells). There is a precendent for cells
as a specimen RBCs as a spec type (C12521).
Would be interested to hear the teams opinion.
Covance test code IMT1946. The package insert II Do not add (P30) -
for the Geenius HIV 1/2 Supplemental Assay Already published as
says that it ?? is a single-use HIV-1 antibody
immunochromatographic assay for the (C74713), HIV-1/2
confirmation and differentiation of individual Antibody (C74714) or
antibodies to Human Immunodeficiency Virus HIV-2 Antibody
Types 1 and 2 (HIV-1 and HIV-2)??. The method (C74715). Please
is listed as immunochromatographic assay but choose the appropriate
this is a type of immunoassay. Proposed test based on the result
LBTESTCD HIV1ABG value received. It looks
like (from the package
insert) that HIV-1 and
HIV-2 are reported
separately so please
use C74713 or C74715.
The trademarked
packaging name is not
included within CDISC
LBTEST terminology.
Covance test code IMT1947. II Do not add (P30) -

The package insert for the Geenius HIV 1/2 Already published as
Supplemental Assay says that it ?? is a single- HIV-1 antibody
use immunochromatographic assay for the (C74713), HIV-1/2
Types 1 and 2 (HIV-1 and HIV-2)??. (C74715). Please
The method is listed as immunochromatographic choose the appropriate
assay but this is a type of immunoassay. test based on the result
Proposed LBTESTCD HIV2ABG value received. It looks
HIV-2 are reported
use C74713 or C74715.
The trademarked
LBTEST terminology.
Proposed LBTEST HIV-1 Ab Geenius value received. It looks
HIV-2 are reported
use C74713 or C74715.
The trademarked
LBTEST terminology.

Proposed LBTEST HIV-2 Ab Geenius value received. It looks
HIV-2 are reported
use C74713 or C74715.
The trademarked
LBTEST terminology.
Please add h*nmol/L/mg as a synonym to the II SDTM, SEND-Published

already existing term h*umol/L/g (C116063) in P29.
Please add h*pmol/L/ug as a synonym to the II SDTM, SEND-Published

already existing term h*umol/L/g (C116063) in P29
A measurement of Hepatocyte Growth Factor in a II SDTM, SEND-Published
biological specimen (HGNC:4893) in P30
To be used with LBTEST : Hepatocyte Growth

Factor
A measurement of Hepatocyte Growth Factor in a II SDTM, SEND-Published

biological specimen (HGNC:4893) in P30
To be used with LBTESTCD : HGF
A unit of amount of substance equal to one II SDTM, SEND-Published

trillionth (10E-12) of a mole.(NCI) in P29
I hereby forward multiple CT requests based : II SDTM, SEND-Published

1) One full set of dose normalised accumulation in P33
ratios â€“ relevant to discriminate between crude
and adjusted accumulation ratios when doses are
lowered, e.g. during a toxicity study
2) One full set that will model Anti-Drug-

Antibodies in LB, both directed against test article
and cross reacting with endogenous substances
3) One stand-alone PKUNIT; File emailed

separately
Terminology for 3 FACT family questionnaires: II QRS-Published in P28

Functional Assessment of Cancer Therapy-
Leukemia Version 4 (FACT-LEU V4)
Hepatobiliary Version 4 (FACT-HEP V4)
Lymphoma Version 4 (FACT-LYM V4)
CDISC has already obtained appropriate

copyright permission for all FACT instruments.
CT for these 3 instruments has not yet been
developed. All Controlled Terminology for these
instruments has been forwarded to Jordan Li and
Bernice Yost in a separate email.
The area under the curve (AUC) from the last II
measurable concentration extrapolated to infinity,
calculated using AUC Infinity Pred - AUC to Last
Nonzero Conc.
To be used with PKPARMCD : AUCLTIFP
The area under the curve (AUC) from the last II

measurable concentration extrapolated to infinity,
calculated using AUC Infinity Pred - AUC to Last
Nonzero Conc.
To be used with PKPARM : AUC Last Nonzero

Conc to Infinity Pred
The percentage of the administered dose that is II Do not add (P30): Since
recovered from the specimen type specified in we have already defined
PPSPEC from the time of dosing to the last amount recovered over
measurable concentration. an interval, we did not
think that it was
To be used with PKPARMCD : RCPCLST necessary to define
amount recovered from
0 to T Last because the
amount recovered over
an interval can be used
to express that value.
Please see C102359
(Amt Rec from T1 to T2)
(RCAMINT).
The percentage of the administered dose that is II Do not add (P30): Since
recovered from the specimen type specified in we have already defined
PPSPEC from the time of dosing to the last amount recovered over
measurable concentration. an interval, we did not
think that it was
To be used with PKPARM : Pct Rec to Last necessary to define
Nonzero Conc amount recovered from
0 to T Last because the
amount recovered over
an interval can be used
to express that value.
Please see C102359
(Amt Rec from T1 to T2)
(RCAMINT).
The percentage of the administered dose that is II
recovered from last measurable concentration
The initial thought for PKPARM was 'Pct Rec

from Last Nonzero Conc to Infinity Pred', but this
is too long, therefore we are suggesting the
proposed abbreviation
To be used with PKPARMCD : RCPCLIFP
The percentage of the administered dose that is II

recovered from last measurable concentration
To be used with PKPARM : Pct Rec from Last

Nonzero Conc-Inf Pred
Can you please explain why ugeq/L isn't II

represented as ugEq/L. This would be in synch
will all the other 'Eq' terms e.g. ugEq
If an error please amend.
New CCCAT term and new RS TEST and II QRS-Published in P28

TESTCD codelists for the Kidney Donor Profile
Index (KDPI).
2016-09- II SDTM-Published in P28

02_CDISC_Multi_Term_Request_Robert
Dempsey
Just need request #'s. Already approved; needed II SDTM, SEND-Published

for Lab P28 Public Review; File emailed in P28
separately
Lab Changes tab for P28 Lab Public Review II SDTM, SEND-Published
Request #s; File emailed separately in P28
File emailed separately (2016-09- II SDTM, SEND-Published

05_CDISC_Multi_Term_Request_Robert in P28
Dempsey)
Rows 15 - 18 Lab P28 Public Review; File II SDTM, SEND-Published

emailed separately in P28
Seropositivity for IA-2 autoantibody (> 0.02 II SDTM, SEND-Published

nmol/L) is supportive of: in P30
-A diagnosis of type 1 diabetes

Seropositivity for IA-2 autoantibody (> 0.02 II SDTM, SEND-Published
nmol/L) is supportive of: in P30
-A diagnosis of type 1 diabetes
Multiple term request for Malaria TAUG: Batch 1; II SDTM, SEND-Published

File emailed separately in P28, P29, P31
Requesting new term that is currently not II SEND-Published in P29

available:
Hemolymphoreticular tumor, malignant
Suggested Definition: A malignant neoplasm of

hematopoietic or lymphoreticular cells. A general
term for which the transformed cell types have
not been specified
This codelist currently has an item for HEALTHY II

SUBJECTS (C49651). However, all values for
param TDIGRP are supposed to be SNOMED
diagnoses. It seems that if the Healthy Subject
Indicator in TS domain (HLTSUBJI) has value of
'Y', then
the TDIGRP parm is not expected in the dataset
at all (per I.G. instruction). Therefore, the
HEALTHY SUBJECTS entry in C.T. is confusing
and leads to validation errors if implemented.
This QRS measure request came from the Bi- II QRS-Published in P28
Polar TA Standards team. The copyright
verification document, examples CRFs and draft
QRS Terminology spreadsheets are sent in
separate EMAIL.
We recently started to make viral load II Do not add (P30) -

assessment of Hep B using RNA.....the typical LBTEST will be RNA,
method uses DNA Viral Load goes into
There is an existing term HBVVLD C65047 - LBCAT variable, and
described as A measurement of the hepatitis B NHOID holds HBV
viral load in a biological specimen. We need information.
however to find a way to distinguish HBV DNA
Viral Load from HBV RNA Viral Load. I wonder if
we need to consider changing the published term
to something like HBVVLDD - HBV DNA Viral
Load. Or we need to use a qualifying variable to
differentiate DNA from RNA. I am open to ideas
The product that has been assigned to subject, II Do not add (P30) - The
either by IRT system or manually. DA domain was
To be used with DATEST : Medication Assigned modeled to capture
information around how
much was dispensed
and how much was
returned. The
medication name that is
assigned, dispensed, or
returned should be
considered more as a
qualifier on the
dispensing records and
not as individual test
codes in and of
themselves. This
information should be
added as non-standard
variables within
suppda.xpt.
The product that has been assigned to subject, II Do not add (P30) - The
either by IRT system or manually. DA domain was
To be used with DATESTCD : MEDASS modeled to capture
much was dispensed
and how much was
returned. The
returned should be
qualifier on the
codes in and of
themselves. This
variables within
suppda.xpt.
The product that has been dispensed to the II Do not add (P30) - The
subject. DA domain was
To be used with DATEST : Medication Dispensed modeled to capture
much was dispensed
and how much was
returned. The
returned should be
qualifier on the
codes in and of
themselves. This
variables within
suppda.xpt.
The product that has been dispensed to the II Do not add (P30) - The
subject. DA domain was
To be used with DATESTCD : MEDDIS modeled to capture
much was dispensed
and how much was
returned. The
returned should be
qualifier on the
codes in and of
themselves. This
variables within
suppda.xpt.
The replaced product when actually assigned II Do not add (P30) - The
product could not be dispensed to subject. DA domain was
To be used with DATEST : Medication Replaced modeled to capture
much was dispensed
and how much was
returned. The
returned should be
qualifier on the
codes in and of
themselves. This
variables within
suppda.xpt.
The replaced product when actually assigned II Do not add (P30) - The
product could not be dispensed to subject. DA domain was
To be used with DATESTCD : MEDREP modeled to capture
much was dispensed
and how much was
returned. The
returned should be
qualifier on the
codes in and of
themselves. This
variables within
suppda.xpt.
New RETEST and UNIT requests; File emailed II SDTM-Published in P30,
separately P31
Do not add (P30)-
Forced Vital Capacity -
Already exists as
C111361
Resistance-Do not add.
Already exists. Please
use C120927.
Do not add (P35):
Area in PV Loops; Quasi-
static Elastance; Tissue
Damping - Do not add.
Additional information
required from requester
not provided. Please re-
submit with references.
Please file 28 new term requests for multiple II SDTM-Published in P29,

codelists across oncology domains. File emailed P30, P31
separately. IMPORTANT: These terms are Do not add (P33):
already in the Oncology P29 working documents. ORGAN OF INTEREST:
We just need a request number; File emailed Do not add. Use
separately TUMIDENT as the test
with the organ of
Just need CDISC request numbers! interest as the result
value.
LBTESTCD: MHBMA II Do not add (P30) -

LBTEST: Monohydroxybutenyl Mercapturic Acid Please use PC domain
LBTESTCD: HBMA for this analyte.
LBTEST: Hydroxybutyl Mercapturic Acid
LBTESTCD: THCOTGU
LBTEST: Trans-3?-Hydroxycotinine-O-
Glucuronide
I would like to request that the following new II SDTM-Published in P29,

terms be added: Thymidine Kinase 1 (TK1) and P30
Thymidine Kinase 2 (TK2) as specific subtypes of
TK. TK1 and TK2 are isozymes of TK. TK1 is a
common universal marker for cancer and there
may be different assays to determine TK1 or TK2
concentrations.
File emailed separately II QRS-Published in P30
INFAAG,INFABAG and INFBAG are all influenza II SDTM-Published in P29,

antigen that have been added to the Microbiology P30
test code list. Prior to the addition of these, all
antigens were entered and are still present as
Laboratory test code (typical examples HBsAg,
ENV Nuclear Antigen).....is there some reason for
this dual approach. Will it be resolved. Can we
add INFAAG, INFABAG and INFBAG into lab
tests also?
File emailed separately. Already added to P28 I SDTM-Published in P28

documentation by Bernice; just need a request
number.
File emailed separately. II SDTM-Published in P29,

P30, P31
For consistency with other C41145 codes II Do not add (SDTM

P29): Do not change. A
concept consists of the
C-code, Synonym, and
Definition. The
Submission Value is
allowed to be different in
different codelists, as
long as the C-code,
Synonym, and Definition
are the same.
This is a request from the lab terminology team. II SDTM, SEND-Published

in P33
Requesting the addition of the unit U/g Hb which II

will be used for the test Acetylcholinesterase,
RBC.
Currently the term IU/g Hb exists in the CDISC

unit codelist but the this test can be referenced
with the unit IU/g Hb and U/g Hb. Currently the
CDISC unit codelist has IU/g and U/g as two
different submission values.
Proposed Definition: An arbitrary unit of

substance content expressed in unit(s) per gram
per gram of hemoglobin.
This is a recently developed specimen used by II Do not add (P30):
bioanalytical to measure the amount of test article Please use
and/or metabolites in a blood specimen. It allows C41067/WHOLE
for collecting a very small volume of blood so BLOOD which is already
serially bleeding from the same animal on the present in the codelist.
same day is possible for creating blood-level Depending on domain,
curves. Since it is a small amount of dried blood DRIED should either be
that is analyzed, the ADME/TK analysts would a specimen preparation
like to differentiate this specimen from the (NSV) or use existing
WHOLE BLOOD specimen, which still contains Specimen Condition
the fluid phase and blood gases. Variable and
SPECCOND codelist.
These are situations where we have found a term II SDTM-Published in P29,

also expressed as a synonym for a different term. P30
File emailed separately Do not add (P30): No
modification is
necessary. The
correction is in
C124398. It would be
too disruptive to change
submission value. Going
forward we will be more
careful with assigning
TESTCDs that could not
be used for other
acronyms.
Dysmorphic Erythrocytes. II SDTM, SEND-Published

in P30
This is a more general category than various
types of erythrocytes with dystopic morphology,
such as (all in CDISC):
Dacrocytes
Elliptocytes
Acanthocytes
Something similar (but not identical) that is

currently published is C117853:
RBCDIPOP/Dimorphic Erythrocyte Population.
The results seem to be cell counts and include
values such as the below with no units.
5-6
8-10
10-15
13-15
15-20
This is a multiple term request containing batch 1 II SDTM-Published in P29,
of the Prostate Cancer TAUG new term requests. P30
It contains new terms and changes to two
existing, published terms. This content is already
in the Oncology working document. Just need a
request
File emailed separately. This content is already in

the Oncology working document. Just need a
request number.
Hours times micromoles per litre (area under the SDTM, SEND-Published
curve), divided by milligrams per kilogram (dose in P29
normalized by body weight)
This is the standardised unit that we use to

describe AUC/dose in all of our TK phases of
pivitol toxicology studies and will be used to
describe the AUC parameter normalised by the
dose of compound given per kg of animal body
weight. The data is used to describe the
proportionality relationship between different dose
group. The reason we want to suggest the new
term is because it is very commonly used by our
group so will be reported in the SEND data but
the unit doesn?t appear on the unit codelist ?
adding the term is preferable to using an
alternative term in order to keep the values and
units the same in SEND and the written report.
For the Duchenne Muscular Dystrophy TAUG II QRS-Published in P28

For Duchenne Muscular Dystrophy TAUG II QRS-Published in P28

file emailed separately
PKPARMCD= SEMAUC II
PKPARM= Standard Error of the Mean for AUC
Proposed Definition= The standard error of the
mean for the area under the curve (AUC).
No current terminology exists that is synonymous.

Having to do with the chest. II Do not add (P31) -
Based on the context
supplied by the
requester, this is not
appropriate for DIR
variable. We do not
believe that the usage
of THORACIC here is
directionality, instead
we think it is more of an
anatomical location
descriptor of the fact
that the injection site
was located around the
thoracic region.
Therefore we believe
that THORACIC, in this
context, belongs in a
suppqual, since it
doesn't fit the usage of
the available variables.
Add new terms; File emailed separately. II SDTM-Published in P29,

P30
Add new terms; File emailed separately. II SDTM, SEND-Published
in P30
Do not add (P30) -
Vitamin E Gamma
Tocopherol-Do not add.
Already published as
C116211.
Amphetamine/
Methamphetamine -
Please use existing
concept C74687, which
is defined as any
amphetamine class
drug.
CINGULATE CORTEX
GREY: This would map
to a LOC of Cingulate
Cortex (C52713) -
already published; and a
SPECTYPE of Grey
Requesting the addition of the Test Strain with II Do not add
Matter (P30) - We
(already
the Test Code NSTRN to the Pharmacogenomics are publishing the
requested).
Findings Test Name/Test Code codelists to MBTEST
ANTERIORofCINGULATETaxonomic
capture the genotyping of HCV (e.g. 1a, 2b). This Ident Below
GREY: This would Speciesmap
test name and test code are used for an example Level
to a LOC in P29. This test is
of Anterior
in the Therapeutic Area Data Standards User used
Cingulateto identify
(CNEW) an - new;
Guide for Chronic Hepatitis C Virus Infection on organism
and a SPECTYPE below theof Grey
page 32. species level, including
Matter (already
strain information. There
requested).
is no need for
TEMPORAL a GREY:
LOBE
MBTEST
This wouldofmap Strain.
to a
LOC of Temporal Lobe
Please add the test name Organism with the test II (C12353)
SDTM-Published - already in P29
code ORGANISM to the Microbiology Test published; and a
Name/Test Code codelists. This test is used to SPECTYPE of Grey
capture the Culture results. Listed in example in Matter (already
the SDTM 3.2 IG for the MB domain (Section 6.6 requested).
- page 8) AMYGDALA GREY: This
would map to a LOC of
Amygdala (C12440) -
Questionnaire: Treatment Satisfaction II already
QRS-Publishedpublished; and a
in P29
Questionnaire for Medication (TSQM) V1.4; File SPECTYPE of Grey
emailed separately Matter (already
requested).
CEREBELLUM GREY: This
for the Duchenne Muscular Dystrophy II would map to a in
QRS-Published LOC of
P29
Consortium Cerebellum (C12445) -
File emailed separately already published; and a
SPECTYPE of Grey
Matter (already
File emailed separate; content already in P29 II SEND-Published
requested). in P29,
working document. Just need a request code. P31, P37
BRAIN GREY: This would
Do
mapnot to add
a LOC (P30):
of Brain
Ectopic
(C12439) - already gland
sebaceous
-published;
Already exists and aas
C132486.
SPECTYPE of Grey
Matter (already
requested).
Need for the ASTHMA TAUG. II SDTM-Published
CORTICAL WHITEin P29
MATTER: This would
map to a LOC of
Cerebral Cortex
File emailed separately II (C124443) - already
published, and a
SPECTYPE of White
Matter (need to request
this).
Add new term 6 LEAD NEHR-SPORI with a II
definition of An electrocardiogram (ECG) lead
configuration that is primarily used to record
ECGs in animals, and which uses six (6)
electrodes to generate eight (8) ECG leads (ECG
wave forms). The six electrode configuration
includes the following: four (4) limb electrodes,
which are placed analogous to an Einthoven
configuration in humans, and two (2) chest
electrodes. The eight (8) ECG leads recorded
comprise three standard limb leads (leads I, II,
and III), three augmented leads (Leads aVr, aVF,
and aVL), and two chest leads, which are
generated using two unipolar chest leads,
typically CV5RL [rV2] and CV6LL [V2] for
canines, or MV1 and MV2 for primates. This
already exists in the ECG spreadsheet. We just
Recently, colorimetric assays have been II SDTM-Published in P32

commercialized (15) to detect (1?3)-?-D-glucans
(BG), which are major cell wall components of
various medically important fungi. The Fungitell
test (Associates of Cape Cod, Inc., Cape Cod,
MA) is a chromogenic kinetic test that was
approved in 2003 by the U.S. Food and Drug
Administration for the presumptive diagnosis of
IFI.
Definition: A congenital, benign renal neoplasm II SEND-Published in P32
microscopically characterized as
nonencapsulated tissues and composed of
neoplastic spindle cells arranged in interlacing
bundles within a loose myxoid to dense
collagenous stroma that displace and entrap
glomeruli and tubules.
Has been reported in the scientific literature:

a. Human:
i. Bolande, R. P., A. J. Brough, et al. (1967).
"Congenital mesoblastic nephroma of infancy. A
report of eight cases and the relationship to
Wilms' tumor." Pediatrics 40(2): 272-8.
ii. Anunobi, C. and Badmos, K. et al. (2014)?
Congenital mesoblastic nephroma in a premature
neonate: A case report and review of literature.?
Nigerian Journal of Clinical Practice. 17(2):255-
259
b. Veterinary:
i. Soldati, S., Radaelli E., et al.
(2012)"Congenital mesoblastic nephroma in a
young basset hound dog." J Small Anim Pract
53(12): 709-13
ii. Yoshizawa K, Oishi Y, et al. (1996)
Congenital mesoblastic nephroma in a young
beagle dog. J Toxicol Pathol. 9:101?105
iii. Suzuki, Y., Takaba T., et al.
"Histopathological, immunohistochemical and
ultrastructural studies of a renal mesenchymal
tumor in a young beagle dog." J Vet Med Sci
74(1): 89-92.
iv. Takeda, T., Makita T., et al. (1989).
"Congenital mesoblastic nephroma in a dog: a
Need to verify Lab Category this is a measure for II Do not add (P30) - Do
fungi Recently, colorimetric assays have been not add. Being
commercialized (15) to detect (1?3)-?-D-glucans published in P29 as
(BG), which are major cell wall components of GLUBD13/1,3-Beta-D-
various medically important fungi. The Fungitell Glucan.
IFI.
IFI.
MAC is an industry abbreviation for this unit II SDTM, SEND-Published

(referenced in multiple internet articles). We feel in P30, P31
the full label as the submission value is too long
and unnecessary if the unit is used in context
(with the appropriate TESTCD/TEST)
10^6 U has been used in our studies. We cannot
use existing code C67335 (10^6 IU) as CDISC
differentiates between U and IU.
Find requests for new terms and changes for lab II SDTM, SEND-Published
test terminology - these tests are based off of the in P30, P31
Advia 120 CBC and reticulocyte measurements.
Draft definition: A measurement of the II SDTM, SEND-Published

Cytomegalovirus DNA in a biological specimen. in P30
Additional info:
Cytomegalovirus (CMV) testing is used to
determine whether someone with signs and
symptoms has an active CMV infection.
Sometimes it may be ordered to help determine
whether someone had a prior CMV infection.
Direct detection of CMV
Viral detection involves determining the presence
of CMV in a blood, fluid, or tissue sample. This
can be done either by culturing the virus or by
detecting the virus's genetic material (CMV DNA).
Molecular methods such as polymerase chain
reaction (PCR) may be used to detect and
measure the amount of viral DNA in a person's
sample. Testing can be qualitative, determining
the presence or absence of CMV, or quantitative,
measuring the amount of virus present.
File e-mailed separately. II QRS-Published in P28
File e-mailed separately. II QRS-Published in P29
IFI.
Do not add (P30):

/uL - Please use existing
unit 10^6/L (C67452)
which has a synonym of
1/uL, which fits the use
case provided by the
requester.
Per Deciliter - The
requester has not
provided a use case for
the use of 1/dL as a unit
of measure used with a
lab test.
Per Liter - The requester
has not provided a use
case for the use of 1/L
as a unit of measure
used with a lab test.
Determination of Finasteride in Human Plasma II Do not add (P30) - If this
using Liquid Chromatography with Tandem Mass is the test article, it
Spectrometric Detection. belongs in PC/PP
domains. If it is
determined that this test
goes into lab, controlled
terminology will not be
created to support
therapeutic drug levels.
Please use sponsor
terminology in your
submission.
Determination of Finasteride in Human Plasma II Do not add (P30) - If this

using Liquid Chromatography with Tandem Mass is the test article, it
Spectrometric Detection. belongs in PC/PP
domains. If it is
determined that this test
goes into lab, controlled
terminology will not be
created to support
therapeutic drug levels.
Please use sponsor
terminology in your
submission.
Dear CDISC Terminology Team, II SDTM, SEND-Published
Please consider adding a new LBTESTCD called in P31
ANC. Do not add (P30) -
1) ANC is the standard acronym for Absolute C63321.
Neutrophil Count.
As an example, the Common Terminology
Criteria for Adverse Events (CTCAE) Version 4.0
has criteria for ANC and neutrophil count:
For Febrile Neutropenia, it would be more
intuitive to use an LBTESTCD called ANC.
For Neutrophil count decreased, it would be more
intuitive to use an LBTESTCD called NEUT.
2) The NCI Preferred Term for NEUT is ?
Absolute Neutrophil Count?, but this is confusing.
When neutrophils were first added to the SDTM
Terminology in 2007, there were 4 neutrophil test
codes (NEUT, NEUTLE, NEUTB, NEUTBLE):
Laboratories commonly report the segmented
neutrophils as ?Neutrophils? and the band
neutrophils as ?Bands?.
Given the available controlled terminology at the
time, it was logical to assume that the NEUT and
NEUTLE were intended to be the segmented
neutrophils as an (absolute) count and ratio,
respectively, and NEUTB and NEUTBLE were
intended to be for the band neutrophils absolute
count and ratio. The same convention is used for
absolute counts and ratios for BASO and
BASOLE, EOS and EOSLE, etc.
The NCI Preferred Term of ?Absolute Neutrophil
Count? is confusing because ANC is the total
count of segmented neutrophils + band
neutrophils. The NCI Preferred Term for NEUT
would be better as ?Neutrophil Count?, i.e. the
absolute count for segmented neutrophils.
Currently, we do see that a test code for the
This is for Flow Cytometry DoubleNegativeTcell% II Do not add (P47): Do
not add. Please use
TLym Sub/Lym as the
TEST and put the
markers into the marker
string variables.
This request is for test 'DoubleNegativeTcell II Do not add (P47): Do

%,CC-RUO-CL'. Its result format: Numeric. not add. Please use
Convential Unit is %. SI Unit is %. TLym Sub/Lym as the
TEST and put the
markers into the marker
string variables.
This request is submitted for test II Do not add (P47): Do
'DoubleNegativeTcellAbCC-RUO-CL'. Its result not add. Please use
format is numeric. Conventional Unit is Cells/uL. TLym Sub as the TEST
SI Unit is Cells/uL. and put the markers into
the marker string
variables.

'DoubleNegativeTcellAbCC-RUO-CL'. Its result not add. Please use
format is numeric. Conventional Unit is Cells/uL. TLym Sub as the TEST
SI Unit is Cells/uL. and put the markers into
the marker string
variables.
This request is submitted for test 'CD8+NKcell II SDTM, SEND - Published

%,CC-RUO-CL'. Its result format is numeric. in P47
Conventional Unit is %. SI Unit is %.
This request is submitted for test 'CD8+NKcell II SDTM, SEND - Published

%,CC-RUO-CL'. Its result format is numeric. in P47
Conventional Unit is %. SI Unit is %.

'CD8+NKcellAbs,CC-RUO-CL'. Its result format is not add. Maps to
numeric. Conventional Unit is Cells/uL. SI Unit is Natural Killer Cells/NKCE
Cells/uL. below.

'CD8+NKcellAbs,CC-RUO-CL'. Its result format is not add. Maps to
numeric. Conventional Unit is Cells/uL. SI Unit is Natural Killer Cells/NKCE
Cells/uL. below.
This term exists in a few other codelists: C89974, II Do not add (P30): A
C116104, C117743 and in all of them the CDISC concept consists of the
Submission Value is "THICK". There is no reason C-code, Synonym, and
to have a different submission value in the Device Definition. The
Properties Test Code codelist. Submission Value is
allowed to be different in
different codelists, as
long as the C-code,
Synonym, and Definition
are the same.
Specimen lengths have been recorded at II SEND-Published in P30

Necropsy, we feel the best domain to include
these is the OM. OMTESTCD = LENGTH,
OMTEST = Length
Potential definition: "The linear extent in space
from one end of something to the other end, or
the extent of something from beginning to end."
Specimen is regularly collected at Necropsy, no II SEND-Published in P30
individual findings go against either BONE,
FEMUR or JOINT, KNEE. Additional CT required
to bridge gap
Potential Definition: "The upper leg bone

positioned between the pelvis and the knee,
including the knee joint"
Rationale: to collect certain null flavors such as II SDTM, CDASH-

"unknown" which is needed for data cleaning. Published in P31
This is needed when the data are not be reported
due to various reasons - privacy concerns,
subject refusal.
Batch 1 of Flow Cytometry work; File Emailed II SDTM-Published in P47,

Separately P48
These items are already in the P29 lab
spreadsheet, just need request numbers.
The volume of air that can be forcibly exhaled II SDTM-Published in P31

during the first half second following maximal
inhalation.
To be used with RETEST : Forced Expiratory
Volume in 0.5 Second
The volume of air that can be forcibly exhaled II SDTM-Published in P31

during the first half second following maximal
inhalation.
To be used with RETESTCD : FEV0.5
File Emailed Separately. This request includes 19 II SDTM-Published in P29,
new terms. P31
We have a number of source unit codes which II Do not add (P30): Please
clarified the numerator e.g. CELLS/UL. When use existing unit 10^6/L
cells/uL was retired in a previous SDTM release, (C67452) which has a
we were left with /uL so we mapped to this. We synonym of 1/uL. The
already convert the source original unit 'cells' is explicit in the
(LBORRESU) to a source GSK standard unit in lab test value, hence
LBSTRESU. But we would like the original source should not be part of
unit to bear some resemblance to the unit that the the unit of measure.
laboratory used. e.g.
SI
TESTCD LBORUNIT LBSTUNIT
NEUT_BLC CELLS/UL GI/L (multiplied by
0.001)
SDTM
TESTCD LBORUNIT LBSTUNIT
NEUT /UL 10^9/L
If there is concern that /uL doesn't indicate the

numerator maybe it could be created as 1/uL? Or
put CELLS/UL back??
Multiple term request for new codelists for new II

SEND NV domain - this request includes 117 new
term requests across 5 new codelists. Already in
the SEND working file, just need a request
number.
Inconsistency between the SENDIG and CT II SEND-Published in P30

codelist definition. IG states "The reference
identifier by which the study is known to the
sponsor. This may be different from the STUDYID
if the data were collected under a different
identifier in the GLP protocol (e.g., used in a
situation where a contract facility performs the
study and provides a final report)." CT states
"Character(s) used to identify a specific sponsor."
For the SDTM codelist NCOMPLT II Do not add (P30) -

(Completion/Reason for Non-Completion, Instead the CT team is
Codelist Code = C66727), when the CDISC going to retire C48251
Submission Value is "PROTOCOL DEVIATION" from the codelist and
the NCI Preferred Term is "Protocol Violation" create two new terms
which seems incorrect. Can the NCI Preferred whose submission
Term be updated to "Protocol Deviation" for values NCI preferred
consistency? terms match exactly.
In almost all other cases the NCI Preferred Term

for this codelist is simply a proper case version of
the CDISC Submission Value.
INJECTION cannot be found in II
ROUTE(C66729) . PARENTERAL may be use if
INJECTION was collected in CRF. on the other
hand, in pulmonary hypertension, some drug may
be choose intravenous injection or percutaneous
injection. In this case, do we need to choose
same terminology? or is it same that
percutaneous injection and
SUBCUTANEOUS(C38299)? I think that
PARENTERAL is confusion, but E2b chose
PARENTERAL... in my opinion, it is better that
intravenous injection and percutaneous injection
are added in ROUTE(C66729) .
Please include the EC abbreviation for Exposure II SDTM, SEND-Published

as Collected (as defined in the SDTM IG version in P33
3.2). The absence of this abbrevation in the
Domain codelist is causing validator findings.
Chemistry test 'Angiotensin Converting II Do not add (P32):

Enzyme'has LBMETHOD of'CAPILLARY Already published.
ELECTROPHORESIS' confrimed by lab. Please
add CAPILLARY ELECTROPHORESIS as valid
SDTM LBMETHOD
File emailed separately; all these rows are II SDTM, SEND-Published

already in P29 working documents. Just need a in P29, P30, P33
request code
These term are defined as the midway point II SDTM, SEND-Published

between dose time zero and the maximum in P30
observed or model estimated concentration.
These are used for dosage delivery (formulation)
comparisons were there is a need to quantify
differences in the absorption curve. For example
a rapid acting insulin would have a higher Half-
Cmax than a slow acting one.
Requesting this term to be added to be used for II

mid-study re-randomizations, after the initial
randomization visit/assessment, where subjects
expect to be re-randomized. Do not add (P30) - lease
use RANDOMIZED BY
MISTAKE in the
NCOMPLT codelist (out
for public review with
P31).
File emailed separately. These are already in the II SDTM-Published in P29
working document. Just getting the request
number.
European Quality of Life Five Dimension Three II QRS-Published in P28
Level Scale Questionnaire Test Code, change to
European Quality of Life Five Dimension Three
Level Scale test code.
European Quality of Life Five Dimension Five
Level Scale Questionnaire Test Code, change to
European Quality of Life Five Dimension Five
Level Scale test code.
There already exists DTYPE of INTERP for II ADaM-Published in P31

Interpolation but not DTYPE for extrapolation.
We have used linear extrapolation in our studies
and would suggest this be added. Extrapolation:
A method of imputation involving populating an
analysis value that is outside the range of
observed values and is estimated by a function of
those observed values.
Lansky Play-Performance Status Scale ; File II QRS-Published in P31

emailed separately
New QSCAT=EPDS and new EPDS II QRS-Published in P29

TESTCD/TESTNM codelists for Edinburgh
Postnatal Depression Scale for the HIV TA team;
This exists in the lab spreadsheet but it needs a II

request number. Please add the following lab
tests: Antinuclear Antibodies - Nucleolar Pattern;
Antinuclear Antibodies - Speckled Pattern;
Antinuclear Antibodies - x Pattern; Antinuclear
Antibodies - y Pattern. The lab team does not Do not add (P30): Please
want to create a test detail codelist for ANA. use LBTESTCD=ANA
The lab team does not want to create a test detail (C74916) and put
codelist for ANA. puttern information into
the result variable. The
dilution information can
go into a NSV=DILUFACT
or RESMOD.
Tablet containing multiple active ingredients to II
distinguish from tablets with only one active
ingredient administered in combination Do not add (P31) -
Please use existing
concept C42931. The
information about the
fixed dose would go into
EX or other intervention
domain.
Tablet containing multiple active ingredients to II
distinguish from tablets with only one active
ingredient administered in combination Do not add (P31) -
Please use existing
concept C42931. The
fixed dose would go into
EX or other intervention
domain.
This is a request for batch P1 of the Protocol II Protocol Entities-
Entities terminology. It includes 24 new terms. Published in P29
Name of referred assay: von Willebrand Factor II SDTM-Published in P32
Antigen
This is a measure of Fibrinogen activity the II

method is Clot-Based (Modification of the Clauss
Method)
Do not add (P30): This is

a synonym of the new
term Fibrinogen,
Functional since the unit
of measure is mg/dL
even though this may
be done via clot
detection methods. The
activity is then
transformed into a mass
concetration
measurement.
This is a measure of Fibrinogen Activity the II
method is Clot-Based (Modification of the Clauss
Method)

term Fibrinogen,
of measure is mg/dL
be done via clot
activity is then
concetration
measurement.
Reagent kit manufacturer: Siemens Healthcare II SDTM-Published in P32
Methodology: Clot-Based (Modification of the
Clauss Method)
For measure of Fibrinogen Activity
Unit mg/dL
Measure if Fibrinogen Antigen II SDTM, SEND-Published
Method NEPHELOMETRY in P31
Unit mg/dL
Measure of Fibrinogen Antigen II SDTM, SEND-Published

Method NEPHEOLMETRY in P31
mg/dL
Definition = The volume change of the lung II SDTM, SEND-Published

between a maximal expiration to residual volume in P31
and a full inspiration to total lung capacity. The
measurement is performed during forceful
inhalation; the preceding maximal exhalation
need not be performed forcefully. The volume
assessed is the forced inspiratory vital capacity
(FIVC).
Definition = Maximal inspiratory pressure (MIP) II SDTM-Published in P30

MIP, also known as negative inspiratory force
(NIF), is the maximum pressure that can be
generated against an occluded airway beginning
at functional residual capacity (FRC). It is a
marker of respiratory muscle function and
strength.
Request for new QSCAT, II QRS-Published in P29

QSTESTCD/QSTESTNM for PTSD; File e-mailed
separately
The Death Details TEST/CD codelist and Death II SDTM-Published in P30

Diagnosis TEST/CD across SDTM and SEND
both have codelist short names of DDTEST and
DDTESTCD. The SDTM codelist is younger and
so will need to have its codelist short-name
updated to ensure no duplicate of codelist names
across standards. See C116108 and C89966.
P29 Public Review - Need request numbers only II SDTM-Published in P29
Request for consitency of use between the II Do not add (P30): The
synonyms ng/mL and ug/L between UNIT and the UNIT codelist is aligned
various PKUNIT codelists (where it can be) to be
File emailed separately SI compliant and so the
team specific chose /L
as the denominator for
this submission value.
Error in Definition, should read: II SDTM-Published in P30
Terminology relevant to the test names that

define microorganism responses to antimicrobial
agents.
Should read: II SDTM-Published in P30

describe the assessment or measurement of a
tumor, lesion or site of disease.
Request to add new terms to multiple codelists; II SDTM-Published in P30

This is a TA request from the Kidney Transplant
team;
Date of Request
Submission Code
Closed Friday, 6 Jan CDISC- Carrie Neeley Covance carrie.neeley@cov

2017 02:17 PM 2737 ance.com
Open Friday, 6 Jan CDISC- Carrie Neeley Covance carrie.neeley@cov

2017 02:19 PM 2738 ance.com

2017 02:24 PM 2739 ance.com
Closed Friday, 6 Jan CDISC- Helene SERVIER helene.bertheux@s

2017 02:25 PM 2740 BERTHEUX ervier.com














Closed Friday, 6 Jan CDISC- Joe Hilber Covance joe.hilber@covance

2017 04:59 PM 2759 .com

2017 05:00 PM 2760 .com
2017 05:01 PM 2761 .com

2017 05:02 PM 2762 .com

2017 05:03 PM 2763 .com
2017 05:04 PM 2764 .com

2017 05:06 PM 2765 ance.com
Open Friday, 6 Jan CDISC- Debbie Oneill Merck & Co. debra_oneill@merc
2017 05:07 PM 2766 k.com
Closed Friday, 13 Jan CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 12:09 PM 2767 rg
Closed Friday, 13 Jan CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 12:10 PM 2768 org
Closed Friday, 13 Jan CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 12:13 PM 2769 rg
Closed Friday, 13 Jan CDISC- TAKASHI MISAWA JAPAN TOBACCO takashi.misawa@jt.
2017 12:15 PM 2770 INC. com
Closed Friday, 13 Jan CDISC- Nicholas Pemble Janssen (J&J) npemble@its.jnj.co

2017 12:20 PM 2771 m
Open Friday, 13 Jan CDISC- Magdalena Litwin- Roche litwinwm@roche.co

Closed Friday, 13 Jan CDISC- Nicholas Gatto Merk nicholas_gatto@m

2017 12:26 PM 2773 erck.com
Closed Friday, 13 Jan CDISC- Barrie Nelson CDISC bnelson@cdisc.org
2017 12:28 PM 2774
2017 12:29 PM 2775 behalf of protocol nih.gov
entities team)
Closed Thursday, 19 CDISC- Audrey Walker CRL audrey.walker@crl.

Jan 2017 04:20 2776 com
PM
Closed Thursday, 19 CDISC- Linda Grasfeder Nuventra, Inc lgrasfeder@nuventr
Jan 2017 04:23 2777 a.com
PM
Closed Thursday, 19 CDISC- Carmen On PMI R&D carmen.on@pmi.co

Jan 2017 04:25 2778 m
PM
Closed Friday, 27 Jan CDISC- Richard Marshall GSK

2017 10:44 AM 2779
Inc.
Inc.
Closed Friday, 27 Jan CDISC- claire west GSK claire.m.west@gsk.

2017 10:48 AM 2782 com

2017 10:48 AM 2783 .com
Closed Tuesday, 31 Jan CDISC- Vineet Sharma Sunovion vineet.sharma@su

2017 07:09 PM 2784 Pharmaceuticals novion.com
Inc
Closed Tuesday, 31 Jan CDISC- Bob Dempsey CDISC rdempsey@cdisc.o
2017 07:10 PM 2785 rg
Closed Friday, 3 Feb CDISC- Joe Hilber Covance joe.hilber@covance

2017 09:05 AM 2786 .com

Inc.
2017 09:11 AM 2788 behalf of Duchenne
Muscular Dystrophy
TA team)
Open Friday, 3 Feb CDISC- Debbie Oneill Merck debra_oneill@merc

2017 09:11 AM 2789 k.com

Inc.
Closed Friday, 10 Feb CDISC- Bess LeRoy CDISC bleroy@cdisc.org
2017 02:07 PM 2791
Open Friday, 10 Feb CDISC- Varia Cartledge Amgen vcartled@amgen.c
2017 02:08 PM 2792 om
Closed Friday, 10 Feb CDISC- Kimberley Holich AbbVie kimberley.holich@a

2017 02:10 PM 2793 bbvie.com
Closed Friday, 10 Feb CDISC- Kimberley Holich AbbVie kimberley.holich@a

2017 02:10 PM 2794 bbvie.com
Closed Friday, 10 Feb CDISC- Dana Booth CDISC dbooth@cdisc.org

2017 02:11 PM 2795
Closed Friday, 17 Feb CDISC- Erin Mulhbradt (on NCI EVS muhlbradtee@mail.
2017 11:27 AM 2796 behalf of protocol nih.gov
entities team)
Closed Friday, 17 Feb CDISC- Erin Mulhbradt (on NCI EVS muhlbradtee@mail.
2017 11:30 AM 2797 behalf of protocol nih.gov
entities team)
Closed Friday, 17 Feb CDISC- William Stevens Clinical Trial will.stevens@ndph.
2017 11:31 AM 2798 Service Unit ox.ac.uk
Closed Friday, 17 Feb CDISC- Nik Pemble Janssen npemble@its.jnj.co

2017 11:33 AM 2799 m
Closed Friday, 17 Feb CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 11:34 AM 2800 rg
2017 11:35 AM 2801 rg

2017 11:36 AM 2802 rg
Closed Friday, 17 Feb CDISC- Kunihito Ebi FUJITSU ebi.kunihito@jp.fujit
2017 11:37 AM 2803 su.com
Closed Thursday, 23 CDISC- Diane Corey C-Path dcorey@c-path.org

Feb 2017 10:38 2804
AM

Feb 2017 10:38 2805
AM
Closed Friday, 24 Feb CDISC- Audrey Walker Charles River audrey.walker@crl.
2017 12:34 PM 2806 com
Closed Friday, 24 Feb CDISC- Joe Hilber Covance joe.hilber@covance

2017 12:35 PM 2807 .com
Closed Friday, 24 Feb CDISC- Fugui Dong Otsuka fugui.dong@otsuka
2017 12:37 PM 2808 Pharmaceutical -us.com
Development &
Commercialization,
Inc.
Closed Friday, 24 Feb CDISC- Fugui Dong Otsuka fugui.dong@otsuka

2017 12:38 PM 2809 Pharmaceutical -us.com
Development &
Commercialization,
Inc.
Closed Friday, 24 Feb CDISC- Colleen Bonjo Merck colleen_bonjo@me
2017 12:41 PM 2810 rck.com

2017 12:42 PM 2811 rck.com

2017 12:43 PM 2812 rck.com
2017 12:45 PM 2813 behalf of Jim
Kramer)
Open Monday, 27 Feb CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2017 01:31 PM 2814
Closed Monday, 27 Feb CDISC- Stephen Kopko CDISC skopko@cdisc.org

2017 01:32 PM 2815
Open Tuesday, 28 Feb CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 12:55 PM 2816 rg
Closed Friday, 3 Mar CDISC- Carrie Neeley Covance carrie.neeley@cov

2017 11:15 AM 2817 ance.com
Closed Friday, 3 Mar CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

Muscular Dystrophy
TA team)
Closed Friday, 3 Mar CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 11:24 AM 2819 rg
Closed Friday, 3 Mar CDISC- Bouhadouza Hays assia.bouhadouza-
2017 11:35 AM 2820 ext@sanofi.com
Closed Friday, 3 Mar CDISC- Audrey Walker Charles River audrey.walker@crl.

2017 11:36 AM 2821 com
Closed Friday, 3 Mar CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 11:38 AM 2822 rg
Closed Friday, 3 Mar CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2017 11:42 AM 2823 om
Closed Friday, 3 Mar CDISC- Debbie Oneill Merck debra_oneill@merc

2017 11:45 AM 2824 k.com
2017 11:47 AM 2825 k.com
Open Friday, 3 Mar CDISC- Debbie Oneill Merck debra_oneill@merc

2017 11:48 AM 2826 k.com

2017 11:50 AM 2827
Closed Friday, 3 Mar CDISC- Audrey Walker Charles River audrey.walker@crl.

2017 11:51 AM 2828 com
Closed Thursday, 9 Mar CDISC- Diane Corey C-Path dcorey@c-path.org

2017 02:28 PM 2829
Closed Thursday, 9 Mar CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 03:54 PM 2830 rg
2017 03:56 PM 2831 rg

2017 03:58 PM 2832 rg
Closed Thursday, 9 Mar CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2017 03:59 PM 2833 nih.gov
2017 04:03 PM 2834 rg
Closed Thursday, 9 Mar CDISC- Ryan Lee Puma rlee@pumabiotech

2017 04:18 PM 2835 Biotechnology, Inc nology.com
Closed Thursday, 9 Mar CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2017 04:19 PM 2836
Closed Thursday, 9 Mar CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 04:21 PM 2837 nih.gov
Open Thursday, 9 Mar CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 04:25 PM 2838 rg
Closed Wednesday, 15 CDISC- Dana Booth CDISC dbooth@cdisc.org

Mar 2017 09:22 2839
AM
Open Wednesday, 15 CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

Mar 2017 12:23 2840 behalf of Claire
PM West)
Closed Thursday, 16 CDISC- Ian Black Quotient Clinical ian.black@quotient
Mar 2017 10:45 2841 clinical.com
AM

Inc.

Inc.
Open Thursday, 16 CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
Mar 2017 10:48 2844 behalf of lab team) nih.gov
AM
Closed Thursday, 16 CDISC- Diane Boram GlaxoSmithKline diane.e.boram@gs

Mar 2017 07:51 2845 k.com
PM

Inc.

Inc.
Closed Thursday, 16 CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba
Mar 2017 07:54 2848 yer.com
PM
Mar 2017 07:56 2849 behalf of the CV-I
PM TA team)
Closed Friday, 17 Mar CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2017 11:28 AM 2850 yer.com

2017 01:28 PM 2851 nih.gov

2017 02:15 PM 2852

2017 02:52 PM 2853
2017 03:35 PM 2854
Closed Monday, 20 Mar CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2017 09:01 AM 2855 behalf of vaccines nih.gov
team)

Mar 2017 04:28 2856
PM

Mar 2017 02:48 2857 .com
PM
Closed Thursday, 23 CDISC- Audrey Walker Charles River audrey.walker@crl.

Mar 2017 07:36 2858 com
PM

Inc.
Closed Thursday, 23 CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

Mar 2017 07:42 2860 yer.com
PM
Closed Thursday, 23 CDISC- Denise Reichert Covance denise.reichert@co
Mar 2017 07:44 2861 vance.com
PM
Closed Tuesday, 28 Mar CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2017 04:35 PM 2862 behalf of CVI TA
team)

Mar 2017 11:04 2863
AM
Closed Thursday, 30 CDISC- Mary Jo Brucker Merck & Co., Inc mj.brucker@merck.
Mar 2017 04:04 2864 com
PM
Mar 2017 04:07 2865 com
PM
Mar 2017 04:10 2866 com
PM
Closed Thursday, 30 CDISC- Barbara Lentz Bayer Pharma barbara.lentz1a@b

Mar 2017 04:14 2867 ayer.com
PM

Mar 2017 04:30 2868 behalf of Duchenne
PM Muscular Dystrophy
TA team)

Mar 2017 04:32 2869
PM
Mar 2017 04:35 2870 k.com
PM
Closed Friday, 7 Apr CDISC- Janessa Pierce Merck & Co., Inc. janessa.pierce@ya
2017 03:42 PM 2871 hoo.com
Closed Friday, 7 Apr CDISC- Catherine Roy Merck & Co., Inc. catherine.roy@mer
2017 04:07 PM 2872 ck.com
Closed Friday, 7 Apr CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 04:11 PM 2873 rg
Closed Friday, 7 Apr CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 04:14 PM 2874 rg
Closed Friday, 7 Apr CDISC- claire west GSK claire.m.west@gsk.

2017 04:21 PM 2875 com
2017 04:56 PM 2876 com

2017 05:00 PM 2877 com
2017 05:04 PM 2878 com

2017 05:08 PM 2879 com
2017 05:12 PM 2880 k.com

2017 05:17 PM 2881 k.com

2017 05:20 PM 2882 k.com
Closed Friday, 7 Apr CDISC- William Houser BMS william.houser@bm

2017 05:24 PM 2883 s.com

2017 11:20 AM 2884 nih.gov
Closed Friday, 14 Apr CDISC- Melissa Rowley GlaxoSmithKline melissa.c.rowley@
2017 11:22 AM 2885 gsk.com ;
Diane.E.Boram@g
sk.com

2017 11:22 AM 2886
Closed Friday, 14 Apr CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2017 11:23 AM 2887 behalf of INHAND) nih.gov
Closed Friday, 14 Apr CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2017 11:24 AM 2888 behalf of CrCa nih.gov
TAUG team)
Closed Friday, 21 Apr CDISC- Debbie Oneill Merck debra_oneill@merc

2017 01:08 PM 2889 k.com
Open Friday, 21 Apr CDISC- Debbie Oneill Merck debra_oneill@merc
2017 01:11 PM 2890 k.com
Closed Friday, 21 Apr CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2017 01:13 PM 2891 behalf of Duchenne
Muscular Dystrophy
TA team)
Closed Monday, 24 Apr CDISC- Roberta Rosenberg Pfizer roberta.e.rosenberg

2017 08:50 AM 2892 @pfizer.com
2017 11:41 AM 2893 com

2017 11:43 AM 2894
Open Friday, 28 Apr CDISC- Bess LeRoy CDISC bleroy@cdisc.org

2017 11:44 AM 2895
Closed Friday, 28 Apr CDISC- Joyce Hernandez JHC joyce.hernandez_0
2017 11:45 AM 2896 029@yahoo.com
Closed Friday, 28 Apr CDISC- Shaoyan Wang Covance Shaoyan.Wang@c

2017 11:46 AM 2897 ovance.com

2017 11:46 AM 2898 ovance.com
2017 11:47 AM 2899 ovance.com

2017 11:47 AM 2900 ovance.com

2017 11:48 AM 2901 ovance.com

2017 11:49 AM 2902 ovance.com

2017 11:49 AM 2903 ovance.com

2017 11:49 AM 2904 ovance.com

2017 11:50 AM 2905 ovance.com
2017 11:50 AM 2906 ovance.com

2017 11:51 AM 2907 ovance.com

2017 11:51 AM 2908 ovance.com

2017 11:51 AM 2909 ovance.com

2017 11:52 AM 2910 ovance.com

2017 11:52 AM 2911 ovance.com

2017 11:52 AM 2912 ovance.com

2017 11:53 AM 2913 ovance.com
2017 11:53 AM 2914 ovance.com

2017 11:53 AM 2915 ovance.com

2017 11:54 AM 2916 ovance.com

2017 11:54 AM 2917 ovance.com

2017 11:55 AM 2918 ovance.com
Closed Friday, 28 Apr CDISC- Catherine A Roy Merck & Co. catherine.roy@mer
2017 11:56 AM 2919 ck.com
Open Friday, 28 Apr CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Open Friday, 28 Apr CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.
Inc.

Inc.
Closed Friday, 28 Apr CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba

2017 12:00 PM 2925 yer.com
Closed Friday, 28 Apr CDISC- Roberta Rosenberg Pfizer roberta.e.rosenberg

2017 12:01 PM 2926 @pfizer.com
2017 05:57 PM 2927

May 2017 03:41 2928
PM
Closed Wednesday, 3 CDISC- Diane Corey C-Path dcorey@c-path.org

May 2017 03:41 2929
PM
Closed Friday, 5 May CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2017 10:53 AM 2930 behalf of INHAND nih.gov
CV OWG)

2017 10:54 AM 2931 k.com

2017 10:55 AM 2932 k.com
Closed Friday, 5 May CDISC- Latorre Sandra Business & sandra.latorre@bus

2017 10:57 AM 2933 Decision Life inessdecision.com
Sciences
Closed Friday, 5 May CDISC- Anna Kiely inVentiv Health eanna.kiely@invent
2017 10:58 AM 2934 Clinical ivhealth.com
Closed Friday, 5 May CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 10:59 AM 2935 rg
2017 11:01 AM 2936 rg

2017 11:02 AM 2937 rg
Closed Friday, 5 May CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2017 11:04 AM 2938 yer.com

2017 11:05 AM 2939 yer.com
Closed Friday, 5 May CDISC- Dana Booth CDISC dbooth@cdisc.org

2017 11:05 AM 2940

May 2017 03:26 2941
PM
Closed Friday, 12 May CDISC- Rohit Dhanjal Vertex rohit.dhanjal@vrtx.

Closed Friday, 12 May CDISC- Rohit Dhanjal Vertex rohit.dhanjal@vrtx.

Closed Friday, 12 May CDISC- Colleen Bonjo Merck colleen_bonjo@me

2017 12:52 PM 2944 rck.com
Closed Friday, 12 May CDISC- Joyce Hernandez JHC, Eliassen joyce.hernandez_0
2017 12:53 PM 2945 029@yahoo.com
Closed Friday, 12 May CDISC- Joyce Hernandez JHC, Eliassen joyce.hernandez_0
2017 12:54 PM 2946 029@yahoo.com

Inc.

Inc.
Closed Thursday, 18 CDISC- Gary Walker QuintilesIMS gary.walker@quintil
May 2017 04:39 2949 es.com
PM
Closed Thursday, 18 CDISC- Colleen Bonjo Merck colleen_bonjo@me
May 2017 04:40 2950 rck.com
PM
Open Thursday, 18 CDISC- Claire West GSK claire.m.west@gsk.
May 2017 04:41 2951 com
PM
Closed Thursday, 18 CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
May 2017 04:43 2952 behalf of SEND CT) nih.gov
PM

May 2017 04:44 2953 behalf of SEND CT) nih.gov
PM

May 2017 04:47 2954
PM
Closed Thursday, 18 CDISC- Theresa isaacs Covance Central theresa.isaacs@co

May 2017 04:49 2955 Lab vance.com
PM
Closed Thursday, 18 CDISC- Theresa isaacs Covance Central theresa.isaacs@co

May 2017 04:49 2956 Lab vance.com
PM

May 2017 04:51 2957 k.com
PM
2017 03:56 PM 2958

2017 03:57 PM 2959
Closed Friday, 26 May CDISC- Carrie Neeley Covance carrie.neeley@cov

2017 03:58 PM 2960 ance.com
Closed Friday, 26 May CDISC- Erin Muhblradt MSC muhlbradtee@mail.

2017 04:00 PM 2961 nih.gov
Open Friday, 2 Jun CDISC- Audrey Walker CRL audrey.walker@crl.

2017 12:15 PM 2962 com
Closed Friday, 2 Jun CDISC- Debbie Oneill Merck debra_oneill@merc

2017 12:16 PM 2963 k.com

2017 12:17 PM 2964 k.com

2017 12:17 PM 2965 k.com
2017 12:18 PM 2966 k.com
Closed Friday, 2 Jun CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2017 12:20 PM 2967 yer.com

2017 11:05 AM 2968 behalf of General
Team)

2017 11:07 AM 2969 behalf of General
Team)

2017 11:08 AM 2970 behalf of CV team)
Closed Friday, 9 Jun CDISC- Mary Jo Brucker Merck mj.brucker@merck.
2017 11:10 AM 2971 com
Closed Friday, 16 Jun CDISC- Mihaela Simion Biogen mihaela.simion@bi

2017 01:26 PM 2972 ogen.com
Closed Friday, 16 Jun CDISC- Colleen Bonjo Merck colleen_bonjo@me

2017 01:29 PM 2973 rck.com

2017 01:31 PM 2974 k.com
Closed Friday, 16 Jun CDISC- Catherine A Roy Merck catherine.roy@mer
2017 01:32 PM 2975 ck.com
Closed Friday, 16 Jun CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2017 01:34 PM 2976 om
Closed Friday, 16 Jun CDISC- Erin Muhlbradt NCI EVS NCI EVS
2017 01:35 PM 2977
Closed Friday, 16 Jun CDISC- Lou Florio Purdue Pharma lou.florio@pharma.

2017 01:36 PM 2978 com
Closed Friday, 16 Jun CDISC- Laura Song Critical Path lsong@c-path.org

2017 01:37 PM 2979 Institute
Closed Friday, 16 Jun CDISC- Dana Booth CDISC dbooth@cdisc.org

2017 01:39 PM 2980
Closed Friday, 16 Jun CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2017 01:40 PM 2981 behalf of SEND) nih.gov

2017 01:41 PM 2982 nih.gov

2017 01:42 PM 2983 nih.gov
2017 01:43 PM 2984 behalf of CrCa nih.gov
team)
Closed Friday, 23 Jun CDISC- Helen Owen LGC Ltd helen.owen@lgcgr
2017 01:25 PM 2985 oup.com
Closed Friday, 23 Jun CDISC- Lindsy Eickhoff BASi leickhoff@basinc.c

2017 01:26 PM 2986 om
Closed Friday, 23 Jun CDISC- Bob Dempsey CDISC rdempsey@cdisc.o

2017 02:05 PM 2987 rg
Closed Wednesday, 28 CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov
Jun 2017 11:57 2988 behalf of CVI TA
AM team)
Closed Wednesday, 28 CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
Jun 2017 12:33 2989 om
PM
Closed Wednesday, 28 CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

Jun 2017 12:35 2990 yer.com
PM
Closed Wednesday, 28 CDISC- Diane Wold CDISC diane.wold@cdisc.

Jun 2017 12:36 2991 org
PM
Closed Wednesday, 28 CDISC- Diane Wold CDISC diane.wold@cdisc.

Jun 2017 12:37 2992 org
PM
Open Wednesday, 28 CDISC- Donna Sattler Eli Lilly sattler_donna@lilly.
Jun 2017 12:38 2993 com
PM
Closed Wednesday, 28 CDISC- Roberta Rosenberg Pfizer roberta.e.rosenberg

Jun 2017 12:40 2994 @pfizer.com
PM
Open Friday, 7 Jul CDISC- Daniel Clark Parexel daniel.clark@parex
2017 10:24 AM 2995 el.com
Closed Friday, 7 Jul CDISC- Daniel Clark Parexel daniel.clark@parex

2017 10:26 AM 2996 el.com

2017 10:29 AM 2997 com

2017 10:31 AM 2998 nih.gov
Closed Friday, 7 Jul CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2017 10:33 AM 2999 yer.com
Closed Friday, 14 Jul CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2017 04:55 PM 3000 om

2017 04:56 PM 3001
Closed Friday, 14 Jul CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 04:58 PM 3002 org
Closed Friday, 21 Jul CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2017 11:03 AM 3003 behalf of Vaccines nih.gov
team)
2017 11:06 AM 3004 behalf of oncology nih.gov
TA program)
Closed Friday, 21 Jul CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba

2017 11:08 AM 3005 yer.com

2017 11:10 AM 3006 yer.com

2017 11:11 AM 3007 yer.com
Open Friday, 21 Jul CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba

2017 11:16 AM 3008 yer.com
Open Friday, 21 Jul CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba
2017 11:17 AM 3009 yer.com
Closed Friday, 21 Jul CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 11:18 AM 3010 org
Closed Thursday, 27 Jul CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.
Inc.

Inc.

Inc.

Inc.

Inc.
Inc.

Inc.

Inc.
Closed Thursday, 3 Aug CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2017 02:23 PM 3021 nih.gov
Closed Thursday, 3 Aug CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba

2017 02:26 PM 3022 yer.com
Closed Thursday, 3 Aug CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 02:28 PM 3023 org
Closed Thursday, 3 Aug CDISC- Maura Kush SCHARP mkush@scharp.org

2017 02:29 PM 3024
Open Thursday, 3 Aug CDISC- Maura Kush SCHARP mkush@scharp.org
2017 02:30 PM 3025
Open Thursday, 3 Aug CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Open Thursday, 3 Aug CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Closed Friday, 4 Aug CDISC- Jordan Li NCI EVS Jordan.li@nih.gov

2017 02:04 PM 3028

Aug 2017 12:49 3029 rck.com
PM
Aug 2017 12:50 3030 k.com
PM
Closed Thursday, 10 CDISC- Phil Pochon Covance phil.pochon@covan
Aug 2017 12:51 3031 ce.com
PM
Closed Thursday, 10 CDISC- Erin Muhlbradt MSC Inc (on behalf muhlbradtee@mail.
Aug 2017 12:51 3032 of SEND CT team) nih.gov
PM
Open Thursday, 10 CDISC- Steve Kopko CDISC (on behalf skopko@cdisc.org
Aug 2017 12:52 3033 of SDSelt)
PM
Closed Thursday, 10 CDISC- Dana Booth cdisc dbooth@cdisc.org

Aug 2017 12:54 3034
PM

Aug 2017 12:54 3035
PM

Aug 2017 12:54 3036
PM
Closed Friday, 11 Aug CDISC- Nicholas Pemble J&J (Janssen) npemble@its.jnj.co

2017 09:44 AM 3037 m
Aug 2017 10:19 3038
AM
Aug 2017 10:21 3039
AM
Aug 2017 10:21 3040
AM
Closed Friday, 18 Aug CDISC- Phil Pochon Covance phil.pochon@covan
2017 10:53 AM 3041 ce.com

2017 10:54 AM 3042 ce.com
Closed Friday, 18 Aug CDISC- Jordan Li (on NCI EVS Jordan.li@nih.gov
2017 10:56 AM 3043 behalf of TCM-
CAD-Angina TA
team))
Muscular Dystrophy
TA team)
Closed Friday, 18 Aug CDISC- Matt Bendekovits Merck and Co. Inc. matt.bendekovits@
2017 10:59 AM 3045 merck.com
Open Friday, 18 Aug CDISC- CHENNAREDDY ICON DOCS CHENNAREDDY.M

2017 11:00 AM 3046 MUKKU UKKU@DOCSGLO
BAL.COM
Closed Friday, 25 Aug CDISC- TAKASHI MISAWA JAPAN TOBACCO takashi.misawa@jt.
2017 08:58 PM 3047 INC. com
2017 09:00 PM 3048 behalf of TCM-
CAD-Angina TA
team)

2017 09:01 PM 3049 ce.com
Open Friday, 25 Aug CDISC- Angela Soriano The Emmes asoriano@emmes.

2017 09:02 PM 3050 Corporation com
Closed Friday, 25 Aug CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2017 09:02 PM 3051
Closed Friday, 25 Aug CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2017 09:03 PM 3052 om
Closed Friday, 1 Sep CDISC- Ryota Ogawa A2 Healthcare ogawa-

2017 03:04 PM 3053 Corporation ry@a2healthcare.c
om
2017 03:05 PM 3054 nih.gov

2017 03:09 PM 3055 k.com
Closed Thursday, 7 Sep CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2017 04:34 PM 3056 Pharma.com
Closed Thursday, 7 Sep CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4
2017 04:35 PM 3057 Pharma.com
Closed Thursday, 7 Sep CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 04:36 PM 3058 nih.gov
Closed Thursday, 7 Sep CDISC- Angela Soriano The Emmes asoriano@emmes.

Closed Monday, 11 Sep CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2017 05:05 PM 3060
Closed Monday, 11 Sep CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2017 05:06 PM 3061

Sep 2017 02:24 3062 nih.gov
PM
Sep 2017 02:25 3063 Ingelheim boehringer-
Inc.
Inc.
Inc.

Inc.
Sep 2017 02:28 3067 org
PM

Sep 2017 02:29 3068 nih.gov
PM
Closed Friday, 15 Sep CDISC- Cathy Bezek astellas cathy.bezek@astell

2017 12:58 PM 3069 as.com
Closed Friday, 22 Sep CDISC- Henrik Soeeborg Novo Nordisk A/S hkse@novonordisk.
2017 09:26 AM 3070 com
Closed Friday, 22 Sep CDISC- Henrik Soeeborg Novo Nordisk A/S hkse@novonordisk.
2017 09:26 AM 3071 com
Open Friday, 22 Sep CDISC- Debbie O'Neill Merck debra_oneill@merc

2017 09:27 AM 3072 k.com
Closed Friday, 22 Sep CDISC- Theresa J. Isaacs Covance theresa.isaacs@co

2017 09:28 AM 3073 vance.com
Open Friday, 22 Sep CDISC- Erin Muhlbradt MSC muhlbradtee@mail.

2017 09:29 AM 3074 nih.gov

2017 09:30 AM 3075 nih.gov
Closed Friday, 22 Sep CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 09:31 AM 3076 org
Closed Friday, 22 Sep CDISC- Audrey Walker Charles River Audrey.Walker@crl

2017 09:32 AM 3077 Laboratories .com
Open Friday, 22 Sep CDISC- Diane Wold (on CDISC diane.wold@cdisc.
2017 09:33 AM 3078 behalf of LuCa org
team)
Open Friday, 29 Sep CDISC- Lou Florio Purdue Pharma lou.florio@pharma.com

2017 09:33 AM 3079
Closed Friday, 29 Sep CDISC- Mihaela Simion Biogen mihaela.simion@biogen.com

2017 09:33 AM 3080
Closed Friday, 29 Sep CDISC- Mihaela Simion Biogen mihaela.simion@biogen.com

2017 09:33 AM 3081
Closed Friday, 29 Sep CDISC- Gary Walker QuintilesIMS gary.walker@quintiles.com

2017 09:33 AM 3082
Closed Friday, 29 Sep CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.nih.gov

2017 09:33 AM 3083
Closed Friday, 29 Sep CDISC- Ryota Ogawa A2 Healthcare ogawa-ry@a2healthcare.com

2017 09:33 AM 3084 Corporation

Closed Friday, 29 Sep CDISC- Christy Kubin MPi Research christy.kubin@mpiresearch.com

2017 09:33 AM 3087
Closed Friday, 29 Sep CDISC- Christy Kubin MPi Research christy.kubin@mpiresearch.com

2017 09:33 AM 3088
Closed Friday, 29 Sep CDISC- Todd IAPP tmarthaler@iapp.net

2017 09:33 AM 3089
Open Friday, 29 Sep CDISC- Todd IAPP tmarthaler@iapp.net

2017 09:33 AM 3090
Open Thursday, 5 Oct CDISC- Mihaela Simion Biogen mihaela.simion@bi
2017 05:56 PM 3091 ogen.com
Closed Thursday, 5 Oct CDISC- Mihaela Simion Biogen mihaela.simion@bi

2017 05:57 PM 3092 ogen.com
Closed Thursday, 5 Oct CDISC- Teresa Oberlander AbbVie teresa.k.oberlander

2017 05:59 PM 3093 @abbvie.com
Open Thursday, 5 Oct CDISC- Bess LeRoy CDISC bleroy@cdisc.org

2017 06:01 PM 3094
Open Thursday, 5 Oct CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2017 06:02 PM 3095
Open Thursday, 12 Oct CDISC- Mihaela Biogen mihaela.simion@bi

2017 01:22 PM 3096 ogen.com
Open Thursday, 12 Oct CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 01:23 PM 3097 nih.gov
Open Thursday, 12 Oct CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2017 01:23 PM 3098 nih.gov
Closed Thursday, 12 Oct CDISC- Jeroen Den Herder SGS Life Sciences jeroen.denherder@
2017 01:24 PM 3099 sgs.com
Closed Thursday, 12 Oct CDISC- Dana Booth CDISC dbooth@cdisc.org

2017 01:25 PM 3100
Closed Thursday, 12 Oct CDISC- Dana Booth CDISC dbooth@cdisc.org

2017 01:26 PM 3101
Closed Thursday, 12 Oct CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 01:26 PM 3102 org
Closed Friday, 13 Oct CDISC- Philip Pochon Covance phil.pochon@covan
2017 11:41 AM 3103 ce.com
Closed Thursday, 19 Oct CDISC- Cathy Bezek Astellas cathy.bezek@astell

2017 03:56 PM 3104 as.com
Open Thursday, 19 Oct CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2017 03:58 PM 3105 yer.com
Closed Thursday, 19 Oct CDISC- Claire West GSK claire.m.west@gsk.

2017 04:00 PM 3106 com
Open Thursday, 19 Oct CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Closed Thursday, 19 Oct CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Open Thursday, 19 Oct CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2017 04:04 PM 3109 yer.com
Closed Friday, 20 Oct CDISC- Dana Booth CDISC dbooth.external@c

2017 10:51 AM 3110 disc.org
Closed Wednesday, 25 CDISC- Steve Kopko CDISC skopko.external@c
Oct 2017 08:51 3111 disc.org
AM
Open Friday, 27 Oct CDISC- claire west GSK claire.m.west@gsk.
2017 05:10 PM 3112 com
Closed Friday, 27 Oct CDISC- Yasuhiro Masuzaki JAPAN TOBACCO yasuhiro.masuzaki

2017 05:12 PM 3113 INC. @jt.com
Closed Friday, 27 Oct CDISC- Yasuhiro Masuzaki JAPAN TOBACCO yasuhiro.masuzaki

2017 05:12 PM 3114 INC. @jt.com
Open Friday, 27 Oct CDISC- Ward Puttemans Johnson & Johnson wputtem@its.jnj.co
2017 05:14 PM 3115 m
Open Friday, 27 Oct CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2017 05:15 PM 3116 om
Closed Friday, 27 Oct CDISC- Catherine A. Roy Merck catherine.roy@mer

2017 05:17 PM 3117 ck.com
Open Friday, 27 Oct CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2017 05:20 PM 3118
Closed Friday, 3 Nov CDISC- Ryota Ogawa A2 Healthcare ogawa-

2017 10:11 AM 3119 Corporation ry@a2healthcare.c
om
Closed Friday, 3 Nov CDISC- Mihaela Simion Biogen mihaela.simion@bi
2017 10:12 AM 3120 ogen.com
Open Friday, 3 Nov CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 10:13 AM 3121 nih.gov

2017 10:14 AM 3122 nih.gov

2017 10:14 AM 3123 nih.gov

2017 10:15 AM 3124 nih.gov
Closed Friday, 3 Nov CDISC- Todd Bazin Biogen todd.bazin@biogen
2017 10:16 AM 3125 .com
Closed Friday, 3 Nov CDISC- Lorraine Spencer EMD Serono Lorraine.Spencer@
2017 10:17 AM 3126 emdserono.com
Closed Friday, 3 Nov CDISC- James Lyddane PPDI James.Lyddane@p

2017 10:19 AM 3127 pdi.com
Closed Friday, 3 Nov CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2017 10:19 AM 3128
Open Thursday, 9 Nov CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2017 04:25 PM 3129 nih.gov
Open Thursday, 16 CDISC- Dana Booth CDISC dbooth.external@c

Nov 2017 12:39 3130 disc.org
PM
Closed Thursday, 16 CDISC- Cathy Bezek Astellas cathy.bezek@astell

Nov 2017 12:43 3131 as.com
PM

Nov 2017 12:44 3132
PM

Nov 2017 12:45 3133 k.com
PM
Closed Thursday, 16 CDISC- jinfang li JL PharmPK. Inc jl.propharma@gmai
Nov 2017 12:46 3134 l.com
PM

Nov 2017 12:48 3135 com
PM

Nov 2017 12:49 3136
PM
Nov 2017 03:21 3137 k.com
PM
Closed Thursday, 16 CDISC- Yanmei Zhang Grifols yanmei.zhang@grif

Nov 2017 03:22 3138 ols.com
PM
Closed Friday, 17 Nov CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 12:09 PM 3139 org
Closed Tuesday, 21 Nov CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Closed Friday, 1 Dec CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2017 12:59 PM 3141 yer.com
Open Friday, 1 Dec CDISC- Ryota Ogawa A2 Healthcare ogawa-

2017 01:39 PM 3142 Corporation ry@a2healthcare.c
om
Closed Friday, 1 Dec CDISC- Mihaela Simion Biogen mihaela.simion@bi

2017 01:43 PM 3143 ogen.com
Open Friday, 1 Dec CDISC- Diane Wold CDISC diane.wold@cdisc.

2017 01:47 PM 3144 org
Closed Friday, 1 Dec CDISC- Michael Schmitz Bayer AG michael.schmitz4@

2017 01:48 PM 3145 bayer.com
Closed Friday, 1 Dec CDISC- Diane Wold CDISC diane.wold@cdisc.
2017 01:51 PM 3146 org
Open Friday, 1 Dec CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 01:52 PM 3147 nih.gov
Closed Friday, 1 Dec CDISC- Diane Corey C-Path dcorey@c-path.org

2017 01:54 PM 3148
2017 01:56 PM 3149 nih.gov
2017 01:57 PM 3150 nih.gov
Open Wednesday, 6 CDISC- Mihaela Simion Biogen mihaela.simion@bi

Dec 2017 12:43 3151 ogen.com
PM

Dec 2017 12:44 3152
PM
Closed Thursday, 7 Dec CDISC- Cathy Bezek Astellas cathy.bezek@astell

2017 05:40 PM 3153 as.com
Open Thursday, 7 Dec CDISC- Vanessa Sarrechia Janssen vsarrech@its.jnj.co
2017 05:41 PM 3154 Pharmaceutica m
Open Thursday, 7 Dec CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 05:42 PM 3155 nih.gov
Closed Thursday, 7 Dec CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 05:43 PM 3156 nih.gov

2017 05:49 PM 3157
Closed Thursday, 7 Dec CDISC- Dana Booth CDISC dbooth.external@c

2017 05:54 PM 3158 disc.org
Open Friday, 8 Dec CDISC- Monika Kawohl HMS Analytical monika.kawohl@an

2017 01:07 PM 3159 Software GmbH alytical-software.de
Closed Friday, 8 Dec CDISC- Monika Kawohl HMS Analytical monika.kawohl@an



Closed Friday, 15 Dec CDISC- Nicholas Pemble Janssen R&D (J&J) npemble@its.jnj.co
2017 10:49 AM 3164 m
Closed Friday, 15 Dec CDISC- Nicholas Pemble Janssen R&D (J&J) npemble@its.jnj.co
2017 10:51 AM 3165 m
Closed Friday, 15 Dec CDISC- Ryota Ogawa A2 Healthcare ogawa-

2017 10:52 AM 3166 Corporation ry@a2healthcare.c
om

2017 10:55 AM 3167 k.com
Closed Friday, 15 Dec CDISC- Julie Chason CDISC jchason@cdisc.org

2017 10:58 AM 3168
2017 11:04 AM 3169 k.com
Closed Sunday, 17 Dec CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2017 08:49 PM 3170 nih.gov

Dec 2017 12:05 3171
PM

Dec 2017 01:20 3172
PM

Dec 2017 01:21 3173
PM
Dec 2017 04:32 3174
PM

Dec 2017 04:32 3175
PM

Dec 2017 04:32 3176
PM

Dec 2017 04:33 3177
PM

Dec 2017 09:43 3178
PM

Dec 2017 09:43 3179
PM

Dec 2017 09:45 3180
PM
Closed Wednesday, 20 CDISC- Colleen Bonjo Merck colleen_bonjo@me

Dec 2017 09:46 3181 rck.com
PM
Closed Wednesday, 20 CDISC- Debbie O'Neill Merck debra_oneill@merc
Dec 2017 09:47 3182 k.com
PM
Closed Wednesday, 20 CDISC- Debbie O'Neill Merck debra_oneill@merc

Dec 2017 09:47 3183 k.com
PM

Dec 2017 11:08 3184
AM
Dec 2017 01:39 3185
PM
Dec 2017 01:39 3186
PM
Dec 2017 01:39 3187
PM
Open Friday, 29 Dec CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2017 12:30 PM 3188
Request Type
Create New SDTM- Multiple terms requested for

Term EGLEAD EGLEAD
Modify SDTM- Consistency with units between PC

Existing Term PKUNIT and PP
Create New SDTM- New term for SEMI-SUPINE

Term POSITION
Create New SEND- FRACTURE

Term NONNEO
Create New SEND- CALLUS

Term NONNEO
Create New SEND- IMMATURE GLOMERULI
Term NONNEO
Create New SEND- CENTRAL NUCLEATION

Term NONNEO
Create New SEND- DYSPLASIA

Term NONNEO
Create New SEND- MATRIX ALTERATION
Term NONNEO
Create New SEND- CELL LOSS

Term NONNEO
Create New SEND- ERYTHROPHAGOCYTOSIS

Term NONNEO
Create New SEND- GRANULATION TISSUE

Term NONNEO
Create New SEND- GROWTH PLATE OPEN and

Term NONNEO GROWTH PLATE CLOSED
Create New SEND- INCREASED NUMBER, CORPORA

Term NONNEO LUTEA
Create New SEND- INCREASED BONE and

Term NONNEO DECREASED BONE
Create New SEND- INCREASED OSTEOID
Term NONNEO
Create New SEND- INTRAHEPATOCLLUAR

Term NONNEO ERYHTROCYTES
Create New SEND- SQUAMOUS PLAQUE

Term NONNEO
Create New SEND- CORNEAL NEOVASCULARIZATION

Term NONNEO
Create New SEND- POLYCYSTIC CHANGE

Term NONNEO
Create New SEND- UMBILICAL ARTERY REMNANT

Term NONNEO
Modify SEND- modify CDISC DEFINITION
Existing Term NONNEO
Create New SDTM- QuantiFERON-TB Mitogen

Term LBTEST
Create New SDTM- QuantiFERON-TB Control

Term LBTEST
Create New SDTM- QuantiFERON-TB Sample
Term LBTEST
Create New SDTM- QMITOTBQNILCNTBQESAT6TB

Term LBTESTCD
Create New SDTM- FIBRINAGFIBRINAC

Term LBTESTCD
Create New SDTM- Fibrinogen AntigenFibrinogen Activity
Term LBTEST
Create New SDTM- New terms requested for EGSTESC

Term EGSTRESC
Create New SDTM- ASPERGILLUS OCHRACEUS
Term MICROORG
Modify SDTM- C71074 JUNCTIONAL

Existing Term EGSTRESC BRADYCARDIA
Modify SDTM-DIR Definitions for NASAL and

Existing Term TEMPORAL are not accurate as
descriptions of directionality
Modify SDTM- C112277 FACTXIII / Factor XIII
Existing Term LBTESTCD
Modify SDTM- C-terminal (cFGF-23) and intact
Existing Term LBTEST/CD (iFGF-23)
Create New SDTM- BORDETELLA HOLMESII

Term MICROORG
Modify SDTM- Synonym spelling mistake

Existing Term BEDECOD
Other SEND-SPEC Request to create four new terms

and add a synonym to an existing
published term.
Create New SDTM- MINIMAL RISK
Term RSKASMT
Create New SDTM- PHASE 0 TRIAL

Term TPHASE
Create New Multiple h*nmol/L/(mg/kg) ;

Term calcium/phosphorus
Create New SDTM-UNIT Consider to add new terms to the
Term UNIT codelist
Other Multiple Please note, this is a follow up to

REF #2592 and 2599 that was
originally submitted and in response
to email sent by Bernice Yost on
18th Nov 2016 requesting base cell
type, core cell type and receptor
pattern needs to be added.
Other None SDTM Publication Date Stamp 2013-

04-12
Create New SDTM- Grader 1
Term MEDEVAL
Create New SDTM- Senior grader

Term MEDEVAL
Create New Multiple New terms requested for LOC and

Term LBTESTCD/LBTEST
Create New SDTM-UNIT mmol/mmol

Term
Modify Multiple Changes to published QRS and Lab

Existing Term terminology
Modify Multiple QRS Typo/Capitalization changes
Existing Term
Create New SDTM-UNIT Events

Term
Create New SDTM- h*%

Term PKUNIT
Create New Multiple Please consider to create the new

Term RE, ECG and CVTEST-CD terms in
the attached file.
Create New SDTM- MULTIPLEXED

Term METHOD OPSONOPHAGOCYTIC KILLING
ASSAY
Create New SDTM- CELLSEARCH CTC TEST

Term METHOD
Create New SDTM- This is a request is coming from FDA

Term MSTEST/CD
Modify Multiple QRS-CSSRS codelists contain
Existing Term inconsistent abbreviations of the
words "number" and description.
Create New SDTM- Non-squamous Epithelial Cells

Term LBTEST
Create New SDTM- EPINSQCE

Term LBTESTCD
Create New Multiple This request is for the PTSD TA

Term team.
Create New SDTM-TTYPE Please add four new terms to the
Term TTYPE codelist; these are from
clinicaltrials.gov. The protocol entities
CT team would like to add these to
the codelist for completeness.
Definitions provided are from
clinicaltrials.
Create New SDTM- Please add two synonym to the

Term TSPARMCD existing term Trial Type (C49660).
These are what clinicaltrials.gov and
Eudract call this term respectively
and the protocol entities team
believes these synonyms will help
with mapping.
Modify SDTM- Please consider to change
Modify SDTM- See code request

Modify SDTM- DKFATS C129939

Existing Term DKFATS
Modify SDTM- C111278 msdRNA
Existing Term GENSMP
Modify Multiple Citation corrections/add digital object

Existing Term identifiers (doi)
Other SDTM- New terms added to SDTM
LBTEST/CD Terminology 2016-12-16 have their
c-code (from C130068 to C130153)
as the submission value. Are they set
intentionally or accidentally? I
suggest to correct them if this is a
bug.
Create New Multiple QSTESTCD, QSTEST and QSCAT

Term for the PODCI Adolescent Parent-
Reported
Create New Multiple QSTESTCD, QSTEST, QSCAT for

Term PODCI Adolescent Self-Reported
Create New PKPARM/CD CMAXSE (Max Conc Standard
Term Error); AUCINTSE (AUC from T1 to
T2 Standard Error)
Create New SDTM- FLUOROENZYMEIMMUNOASSAY

Term METHOD
Create New SDTM- Conisder to add terms
Term LBTEST/CD
Create New SDTM- Please add EC: Exposure as

Term DOMAIN Collected
Create New SDTM- TELLER ACUITY CARDS
Term METHOD
Create New SDTM- LANDOLT RING

Term METHOD
Create New SDTM- Multiple terms requested for

Term OETEST/CD OETEST
Create New Multiple Create new QSTEST-CD for MMSE
Term
Modify Multiple QRS - Please consider to use proper

Existing Term citation style in CAT CDISC
definitions
Create New Multiple QRS measure PRO-CTCAE

Codelist
Modify Multiple Citation corrections QRS

Existing Term
Create New SDTM- PKPARMCD = CONCZERO

Term PKPARM/CD PKPARM = Conc Zero
Create New SDTM- Please consider to add two new

Term CVTEST-CD terms, this is a TA request from the
Duchenne team
Modify SDTM-UNIT C71202 kUSP Error in synonym and

Existing Term definition
Create New SDTM- LBTESTCD=hs-cTnT LBTEST=High
Term LBTEST/CD Sensitivity Troponin T
Create New SDTM-UNIT Total Cells x 10^6

Term
Modify Multiple Codelist corrections & citations

Existing Term
Create New Multiple Add new terms to lab and microorg

Term
Create New SDTM- MOLECULAR

Term METHOD CHARACTERIZATION
Create New SDTM- New Microorg terms
Term MICROORG
Create New SDTM- Human Rhinovirus 16

Term ISTEST/CD
Create New SDTM- Please add Ebola Virus IgM Antibody

Term LBTEST/CD to LBTEST-CD codelists
Create New SDTM- Surgical site instillation

Term ROUTE
Create New Multiple New FT Request; This is a TA

Term request.
Modify Multiple Review Oncology codetable mapping

Existing Term update
Modify SDTM-UNIT Add C42549 Watt to VSRESU
Existing Term codelist - needed for VS Codetable
Mapping
Create New SDTM- CNEW kcal/day
Term VSRESU
Modify SDTM-LOC Recode C33794 in Anatomical
Existing Term Location codelist to C12506
Other Multiple Review TSPARM-ClinTrial-
Eudra_2017-03-07_rd for CT
mapping/alignment across codelists
Create New SDTM- SISH: Silver in Situ Hybridization

Term METHOD
Modify SDTM- Please modify existing MICROORG

Existing Term MICROORG terms
Multiple Two new units needed for LBTEST:

CLMYCELE/Myeloma
Cells/Leukocytes: /10^4 and /10^5.
This is already in Unit P30 working
Other Multiple Review ECG codelist mapping
Other Multiple New QSCAT PCL-5 and new Test

Code and Test Name codelists,
PCL01TC and PCL01TN, for the
PCL-5QRS REQUEST.
Create New Multiple Request to add a new QSTEST-CD
Term to SGRQ PAST 4 WEEKS VERSION
or advise
Create New SDTM- LBTESTCD = 'CMON' LBTEST =
Term LBTEST/CD 'Carbon Monoxide'
Create New SDTM-UNIT s*kPa

Term
Create New SDTM-UNIT L/sec/kPa

Term
Create New SDTM-UNIT Lab team requests to add cmH20
Term based off of request CDISC-2643.
Create New SEND-SPEC Term is BLOOD:WATER

Term
Create New SDTM- EPICNSCE

Term LBTEST/CD
Create New SDTM- Epithelial Cells/Non-Squamous Cells

Term LBTEST/CD
Create New Multiple New terms for LOC and FREQ

Term
Modify SDTM-LOC Please consider modifying LOC

Existing Term terms in the attached file. This is a
TA request from the CV-imaging
team
Create New SDTM- NON-COMPLIANCE WITH
Term NCOMPLT MEDICAL DEVICE
Create New SDTM- Need a change request number for 4

Term ONCRTS terms in oncology P30 public review
document.
Modify SDTM-FREQ Modify CDISC DEF for
Existing Term 'ONCE/C64576"; Just need a request
code
Modify SDTM- Add a SY to

Existing Term MICROORG ENTEROBACTERIACEAE/C85932.
Just need a request code
Other Multiple Need request codes for 3 new
CVTEST terms and 2 modification to
existing. Just need request codes.
Modify SDTM- Expand definition of TREATMENT

Existing Term EPOCH beyond therapeutic products. This is
being requested as part of Vaccines
TA. Just need a request number.
Modify QRS- Please remove the original CGI

Existing Term CGI01TC/ terminology, this includes C100763,
CGI01TN C100150, C100149, C100955,
C100956, C100957. Just need a
request code. This is already in the
P30 QRS Public Review Document
Create New SDTM- FREEZING POINT DEPRESSION

Term METHOD
Create New SDTM- ARAUCLST (Accumulation Ratio

Term PKPARM/CD AUC to Last Nonzero Conc)
Create New SDTM- MOTHER, CHILDREARING

Term RELSUB
Create New SDTM-LOC Add SPLENIC LYMPH NODE

Term
Create New SDTM- mL/kg/day
Term PKUNIT
Modify SDTM- Please remove term C130056 from

Existing Term CVTEST/CD codelist. This request is already in
the P31 CV working document, just
need a request code.
Create New Multiple FTTESTCD/FTTEST/FTCAT for

Term Performance of the Upper Limb
version 2.0
Modify SEND- Add the term ?Repro? in in the TP
Existing Term SDOMAIN domain name and CDISC Synonym,
"Trial Repro Paths". Update
Definition to "The Trial Repro Paths
domain is not subject oriented. This
domain provides the complete
planned sequence of Repro Stages
within each Repro Path".
Modify SEND- Add the term ?Repro? in the TT

Existing Term SDOMAIN domain name and CDISC Synonym
Modify SEND- SJ domain
Existing Term SDOMAIN
Create New SDTM-LOC Eye fields to use within the new OE

Term domain to precisely identify the
location of the test.
Create New Multiple Please consider adding new terms,

Term this is for Duchenne TA
Modify Multiple QRS request. Update DEFs for

Existing Term CCCAT, FTCAT, QSCAT
Create New SDTM- CITROBACTER WERKMANII

Term MICROORG
Create New SEND-SPEC SITE, SUBCUTANEOUS PORT

Term
Create New SEND- BASOPHILIC GRANULES
Term NONNEO
Other Multiple PK team - Please review highlighted

terms (P29 added) for UCUM
mapping
Other Multiple Unit team - Please review highlighted

terms (P29 added) for UCUM
mapping
Other SDTM- MCORGDET (Microbial Organism

MBTEST Detected)
Other Multiple CES01TN/TC EPDS01TC/TN
TSQM01TC/TN HAQ02TC/TN query
regarding codelist long name
Other SDTM- Terminology changes do not align

LBTEST/CD with IG
Other SDTM-MITS/ Link to IG?
CD
Other Multiple Need reference to IG/TAUG to

enable use of new codelists
Create New SDTM- HIV-1/2 Antibody + HIV-1 p24
Term LBTEST/CD Antigen
Create New SDTM- HIV-1 Viral Load

Term LBTEST/CD
Create New SDTM- Hepatitis C Virus Antibody

Term LBTEST/CD Signal/Cutoff
Create New Multiple Target (Generic) Target: Entrez

Term Gene ID Target: Entrez Gene
Symbol Target Action Target ec50
or ic50 value Target ec50 or ic50
unit Dosing Frequency Type of
Treatment NBE sub-class
Modify SDTM- Remove C132454 from ONCRSR

Existing Term ONCRSR codelist and put into ONCRSCAT
codelist. Was put in the wrong
codelist with P29. Erin to confirm with
Barrie that this should be fixed with
P30.
Create New SDTM- Required for chemistry specimens for
Term LBTEST/CD N-Terminal Pro-Atrial Natriuretic
Peptide Measurement.
Create New Multiple Request new QSCAT and

Term QLQ01TC/QLQ01TN codelists for
EORTC QLQ-C30
Create New SEND- Please add INHAND Skeletal terms
Term NONNEO to NONNEO codelist.
Create New Multiple This is batch 1 of the terminology to
Term support the colorectal cancer TAUG.
Create New SDTM-LOC SOFT TISSUE

Term
Create New SDTM- KUMAR IMWG 2016
Term ONCRSCAT
Create New SDTM- Request to add new terms to

Term MUSCTS-CD MUSCTS-CD codelists. This is a TA
request from the Duchenne Team.
Modify Multiple Please update QSTEST for FAC001

Existing Term and FAC023 current values of:
(C127432) FAC001-Satisfied Family
Comm of Illness (C127476)
FAC023-Satisfied Family Comm of
Illness
Create New SDTM- IMMUNOFLUORESCENT STAIN
Term METHOD
Create New Multiple New QSCAT RAND Social Support

Term Survey Instrument and test code/test
name codelists RSS01TC/RSS01TN
for the RAND Social Support Survey
Instrument
Other SDTM- Change synonym for the MB domain
DOMAIN from "Microbiology" to "Microbiology
Specimen" so that it is consistent
with the domain name
Create New SDTM- ctDNA
Term GENSMP
Create New SDTM- For Covance Test Code ORT8865,

Term LBTESTCD test name 'Toxoplasma
gondiiAb,IgG-315PNL'. The suggest
SDTM-LBTESTCD is GONIGGAB

Term LBTEST test name 'Toxoplasma
gondiiAb,IgG-315PNL'. The suggest
SDTM-LBTEST is 'Gondii IgG
Antibody'.
Term LBTESTCD test name ?Toxoplasma
gondiiAb,IgM-315PNL?. The suggest
SDTM-LBTESTCD is ?GONIGMAB?.
Create New SDTM- "For Covance Test Code ORT8866,

Term LBTEST test name ?Toxoplasma
gondiiAb,IgM-315PNL?. The suggest
SDTM-LBTEST is ?Gondii IgM
Antibody?."

Term LBTESTCD test name ?Alk Phos.Iso-Other-
315PNL?. The suggest SDTM-
LBTESTCD is ?ALPOT?.

Term LBTEST test name ?Alk Phos.Iso-Other-
315PNL?. The suggest SDTM-
LBTEST is ?Other Specific Alkaline
Phosphatase?.
Create New SDTM- For Covance Test Code SCT2550,

Term LBTESTCD test name ?Myeloma SPE-Beta1(%)-
CL?. The suggest SDTM-LBTESTCD
is ?MYESPB1P?.

Term LBTEST test name ?Myeloma SPE-Beta1(%)-
CL?. The suggest SDTM-LBTEST
is ?Myeloma SPE-Beta1
Percentage?.

Term LBTESTCD test name ?Myeloma SPE-Beta 1-
is ?MYESPB1A?.
Term LBTEST test name ?Myeloma SPE-Beta 1-
is ?Myeloma SPE-Beta1 Absolute?.
Create New SDTM- "For Covance Test Code SCT2555,

Term LBTESTCD test name ?Myeloma SPE-Beta 2-
is ?MYESPB2A?."

Term LBTEST test name ?Myeloma SPE-Beta 2-
is ?Myeloma SPE-Beta2 Absolute?.

Term LBTESTCD test name ?Myeloma UPE-Beta 1
glob-CL?. The suggest SDTM-
LBTESTCD is ?MYESPB2A?.

Term LBTEST test name ?Myeloma UPE-Beta 1
LBTEST is ?Myeloma UPE-Beta1
Absolute?.
Create New SDTM- "For Covance Test Code SCT3626,

Term LBTESTCD test name ?Myeloma UPE-Beta 2
LBTESTCD is ?MYEUPB2A?."

Term LBTEST test name Myeloma UPE-Beta 2
glob-CL. The suggest SDTM-
LBTEST is Myeloma UPE-Beta2
Absolute.

Term LBTESTCD test name Myeloma UPE-Beta1
glob(%)-CL. The suggest SDTM-
Percentage.
Term LBTEST test name Myeloma UPE-Beta1
LBTESTCD is MYEUPB1P.

Term LBTESTCD test name Myeloma UPE-Beta2
Percentage.

Term LBTEST test name Myeloma UPE-Beta2
LBTESTCD is MYEUPB2P.

Term LBTESTCD test name Myeloma SPE-Beta2(%)-
CL. The suggest SDTM-LBTEST is
Myeloma SPE-Beta2 Percentage.

Term LBTEST test name Myeloma SPE-Beta2(%)-
CL. The suggest SDTM-LBTESTCD
is MYESPB2P.
Create New SDTM- LBTEST and LBTESTCD; Please

Term LBTEST/CD add Interleukin-2 receptor subunit
beta, IL2Rb to the LBTEST and
LBTESTCD controlled terminology
type lists.
Create New SDTM- STUDENT
Term SCTESTCD
Create New SDTM- STUDENT STATUS

Term SCTEST
Create New SDTM- LIVARRNG
Term SCTESTCD
Create New SDTM- LIVING ARRANGEMENT
Term SCTEST
Create New SDTM-UNIT GLOBULE (C42937)

Term
Create New SDTM- PCWG SCHER PROSTATE

Term ONCRSCAT CANCER 2016 with CDISC
Synonym of PCWG3
Create New SDTM- Proposed new values (7) to

Term METHOD METHOD codelist
Modify SDTM- Add a new SY to DXA SCAN
Existing Term METHOD (C48789). Just need a request
number
Modify SDTM- Please retire the following concepts

Existing Term MSTEST-CD from the codelist C116250
C116249 C116248 C116247
C116254 C116253 C116252
C116251
Create New Multiple QSTESTCD/QSTEST/QSCAT for

Term PedsQL Young Adult Neuromuscular
Module
Create New SEND- Please add new SEND NONNEO
Term NONNEO terms to cover INHAND
Cardiovascular work group standard.
Modify SDTM-UNIT Add DRIP as a synonym to the

Existing Term existing Unit term of gtt
Create New SDTM- POTENTIOMETRY

Term METHOD
Modify SDTM- C127632: CDISC submission value

Existing Term LBTEST-CD "Proliferating Erythroid Cells/Total
Cells" is 41 characters, please
update to a maximum of 40
Create New NEW Disease Response and Clin
Codelist Classification: HAS-BLED
Modify Multiple QRS Type I changes

Existing Term
Modify SDTM- DKFATS Type I change
Existing Term DKFATS
Modify SDTM- MSTEST Type I Change

Existing Term MSTEST
Create New SDTM- READER 3

Term MEDEVAL

Term MEDEVAL
Create New Multiple Create BEBQ RETROSPECTIVE

Codelist and BEBQ CONCURRENT QSCATs
and BEBQ01TC, BEBQ01TN,
BEBQ02TC, and BEBQ02TN
codelists
Create New SDTM- Request to add IC50 and IC95
Term MSTEST terms. Terms already in the working
document, just need a request
number
Create New SDTM- LBTESTCD="CHIV", LBTEST = "HIV
Term LBTEST/CD Ag/Ab Combo"
Create New SDTM- File emailed separately, requesting

Term MBTEST/CD adding to "Microbiology Test Code"
codelist
Create New SDTM- RETEST = Fraction of Inspired
Term RETEST/CD Oxygen
Create New New PGx Mutation Type - Describes the
Codelist type of variation such as whether it is
inherited or not (Germline versus
Somatic) or the impact it has on the
individual.
Create New New CT for variable PFRESCAT
Term
Create New SDTM- BRAB1R

Term MITSCD
Create New SDTM-MITS Bradikinin B1 Receptor

Term
Create New SDTM- IL1RL1 (a.k.a. Interleukin-1 receptor-

Term LBTEST/CD like 1, or sST2 or Serum ST2)
Create New SDTM- RE-RANDOMIZATION

Term PROTMLST
Other Other Clarity required over language use
and impact in the SGRQ 3 MONTH
VERSION
Create New SEND- Please add 3 new term to SEND
Term NONNEO NONNEO Codelist. These rows are
already in the P31 working
document. Just need request
numbers.
Modify SEND- Two changes being requested as

Existing Term NONNEO part of 2017-05-15 SEND CT
meeting. These are already in P31
working document. Just need a
request number.
Modify SDTM- Please change Mycobacterium
Existing Term MBTEST/CD Tuberculosis to Mycobacterium
tuberculosis in C128982
Create New SDTM- Covance Central Lab test code

Term LBTESTCD ORT7644, test name Hep. E VirRNA-
Qual, IMMUNOLOGY, serum
sample with lab method of
POLYMERASE CHAIN REACTION.
Suggest LBTESTCD of HERNA
Create New SDTM- Covance Central Lab test code

Term LBTEST ORT7644, test name Hep. E VirRNA-
Qual, IMMUNOLOGY, serum
sample with lab method of
POLYMERASE CHAIN REACTION.
Suggest LBTEST of 'Hepatitis E
RNA'
Create New SDTM- KLEBSIELLA PNEUMONIAE, ESBL;

Term MICROORG KLEBSIELLA OXYTOCA, ESBL
Create New SDTM- Request to add three new terms.
Term MICROORG This request is already in the
Microbiology Working document, just
need request number
Modify SDTM- Request to update C132417 and

Existing Term MICROORG C122305. The changes are in the
Microbiology Working document, just
Create New SDTM- LBTESTCD= GLOBCRET LBTEST=
Term LBTESTCD Globulin/Creatinine
Create New Multiple Protocol P31 batch - just need a

Term request code.
Create New SEND- Amphophilic vacuolar tubular

Term NEOPLASM adenoma
Create New SDTM- ARTHROGRAPHIS

Term MICROORG
Create New SDTM- PATHOLOGIST

Term MEDEVAL
Create New SDTM-LOC SUBMENTAL LYMPH NODE

Term
Create New SDTM- Cocaine and Metabolites; 11-Nor-9-
Term LBTEST/CD Carboxy-Tetrahydrocannabinol

Term MEDEVAL
Create New SDTM-LOC Please add the new term LATERAL

Term VENTRICLE to LOC. Request is
already in the General File, just need
request code.
Create New SDTM- Please add the two new terms to
Term NCOMPLT NCOMPLT codelist: RANDOMIZED
BY MISTAKE WITH TREATMENT;
RANDOMIZED BY MISTAKE
WITHOUT TREATMENT. Request is
already in the General File, just need
a request code.
Modify SDTM- Request to update CDISC definitions

Existing Term CVTEST/CD for C127575, C127576, C127573,
C127574. The changes are already
in the CV working document, just
Modify SEND- FX domain (Fetal and Neonatal
Existing Term SDOMAIN Developmental Morphology): The
synonym, definition, and NCI PT
need to be updated. Name of the
domain in the SENDIG-DART is
"Fetal Pathology Findings".
Create New SDTM- New lab tests to be added to

Term LBTEST/CD LBTEST/LBTESTCD codelist
Create New SDTM-LOC URETERIC ORIFICE

Term
Create New SDTM- TONOMETRY; FLUORESCENCE

Term METHOD ANGIOGRAPHY
Create New SEND-SPEC NERVE, SAPHENOUS
Term
Create New Multiple New terms in the LBTESTCD,

Term LBTEST, and MICROORG codelists.
Other SDTM- Need request codes for P31

LBTEST/CD terminology for Lab - terms already in
P31 working document
Create New SDTM-FRM TABLET, IMMEDIATE RELEASE

Term
Create New SDTM- LBTESTCD: RPA1 LBTEST: Renal

Term LBTEST/CD Papillary Antigen 1
Create New Multiple Add new QSCAT value 'DRRI-2' and

Term create new DRR01TC/DRR01TN
codelists for the Deployment Risk
and Resilience Inventory-2 measure.
Create New SEND- CELLULARITY, INCREASED:

Term NONNEO Increased number of cells.
Modify SDTM-LOC Update CDISC definitions of C12739,

Existing Term C12740, ad C12353. We do not have
permission to publish MeSH cited
definitions.
Modify SEND-SPEC Re-code concept C77654 to C33659.

Existing Term
Create New Multiple These requests are already in
Term oncology P31 working document,
Just need a request number
Create New SDTM- SDTM LBTESTCD: TNFy SDTM
Term LBTEST/CD LBTEST: Tumour necrosis factor
gamma
Create New SEND- IN-EXTREMIS SACRIFICE

Term DSDECOD
Other Multiple P31_CDISC_Request_numbers

_pending_rd
Create New Multiple Pls consider adding new terms to
Term CVTEST and DOTEST codelists.
This is a TA request.
Create New SDTM- LBTESTCD and LBTEST - add
Term LBTEST/CD semen analysis codes and terms.
Create New SDTM- Please add term ENDOMETRIUM to

Term SPECTYPE the codelist
Create New SDTM- Spirometric Reference Equation

Term DUTEST
Create New SDTM- SPIREFEQ

Term DUTESTCD
Modify QRS- Changes needed QRS
Existing Term QIDSC1TC
Create New SDTM-LOC Subtalar Joint

Term
Create New SDTM- 1) BMDT (Bone Mineral Density T-
Term MUSCTSCD Score) 2) AREA 3) BMC (Bone
Mineral Content) 4) BMD (Bone
Mineral Density)
Modify SDTM- C120698 - OPHTHALMOSCOPYAdd

Existing Term METHOD synonyms FUNDUS
PHOTOGRAPHY and/or COLOR
FUNDUS PHOTOGRAPHY
Modify SDTM- TEST too long

Modify SDTM- C15320 - STYPE: Does this concept

Existing Term TSPARM need to be recoded? It is currently
mapped to 'Study Design'.
Create New SDTM- Request to add MIBG SCAN to the

Term METHOD METHOD codelist.
Create New SDTM- MOSQUITO FEED: Administration
Term ROUTE via the bite a female mosquito.
Modify SDTM- Please updated CDISC submission

Existing Term MBTEST/CD value, SY and NCI PT for C128983
Create New New codelist for reasons why arm and/or

Codelist armcode variables are null
Create New New Create four new terms for new

Term vaccines findings about codelist.
Create New SDTM- Create terminology for Gleason
Term MIFTSDTL Grade Groups based on Epstein JI,
Egevad L, Amin MB, Delahunt B,
Srigley JR, et al. paper from 2016.
See JIRA comments below for more
information.
Create New SDTM-LOC GUT-ASSOCIATED LYMPHOID

Term TISSUE (GALT)
Create New SDTM-MITS Fused PAX3 FKHR Genes

Term
Create New SDTM- PAX3FKHR

Term MITSCD
Create New SDTM- TRANSTHORACIC

Term METHOD ECHOCARDIOGRAPHY
CONTRAST
Create New SDTM- TRANSESOPHAGEAL
Term METHOD ECHODARDIOGRAPHY
CONTRAST
Create New New Codelist for abbreviations of SDTM

Term relationship datasets
Create New SDTM- TAUHL

Term PKPARMCD
Create New SDTM- Half-Life TAU

Term PKPARM
Create New SDTM- LAMZTAU

Term PKPARMCD
Create New SDTM- Lambda z TAU

Term PKPARM
Create New SDTM- LAMZLTAU

Term PKPARMCD
Create New SDTM- Lambda z Lower Limit TAU

Term PKPARM
Create New SDTM- LAMZUTAU

Term PKPARMCD
Create New SDTM- Lambda z Upper Limit TAU
Term PKPARM
Create New SDTM- LAMZNTAU

Term PKPARMCD
Create New SDTM- Number of Points for Lambda z TAU

Term PKPARM
Create New Multiple Multiple term request for

Term Huntington's Disease TAUG - Batch
1
Create New SDTM- LYMPH2Cx ASSAY
Term METHOD
Create New STUDY REFERENCE

Term
Create New SDTM- VAGINAL DISCHARGE

Term SPECTYPE
Create New SDTM- need two STI tests
Term LBTEST/CD
Create New SDTM- SRAUC

Term PKPARMCD
Create New SDTM- Stationarity Ratio AUC

Term PKPARM
Modify Multiple Please update submission values

Existing Term and CDISC definitions for terms in
ECG Result and Holter ECG Result
codelists
Create New SDTM-LOC SUPRACLAVICULAR FOSSA

Term
Create New SDTM-LOC BLADDER WALL, POSTERIOR;

Term BLADDER WALL, ANTERIOR;
BLADDER WALL, LATERAL
Create New SDTM- New terms and Synonyms for
Term LBTEST Chemistry Lab Data needed for
LOINC code project.
Create New SDTM- Reintatement of terms removed from

Term PKUNIT PKUNIT in P27 to ensure
compatibility with SEND 3.0 and 3.1.
Modify Multiple https://jira.cdisc.org/browse/SDS-
Existing Term 1180
Create New Multiple New test code /test name code lists
Term for the following FACT measures:
FKSI-15 (FAC039), FBRSI
(FAC029), FLSI (FAC043), FACT-C
V4 (FAC008)
FACT-BRM V4 (FAC062), FKSI-DRS
V4 (FAC041), NCCN-FACT FBRSI-
24 V2 (FAC030), FACT/GOG-NTX
V4 (FAC057), NCCN-FACT FHNSI-
22 V2 (FAC036)
FACT-L V4 (FAC016), FACIT-
DYSPNEA (FAC084)
Create New SDTM-UNIT Enzyme U/L

Term
Create New FTTESTCD/FTTEST/FTCAT for the
Term 10 meter walk/run for the Duchenne
TAUG
Create New FTTESTCD/FTTEST/FTCAT for 4
Term stair ascend/descend for Duchenne
TAUG
Create New FTTESTCD/FTTEST/FTCAT for
Term Rising from Floor for Duchenne
TAUG
Create New SDTM- New hematology terms and
Term LBTEST/CD synonyms from LOINC mapping
Create New SDTM- Add new LBTEST-CD terms, also

Term LBTEST/CD modify exsting lab terms
Create New Multiple Please considering adding these
Term terms. This request comes from the
TCM-CAD-Angina TA team.
Create New SDTM- Please consider adding new trial
Term TSPARM/CD summary terminology; this is a TA
request from the Duchenne team
Create New SEND- Oatp 1a/1b

Term STRAIN
Multiple FOR UDATED CODELIST
Modify SDTM-UNIT Proportion of 1.0

Existing Term
Create New SDTM- Please consider adding new
Term EGTEST/CD ECGTEST-CD terms. This is a TA
request from the TCM-CAD-Angina
Team.
Create New New Terms for Drug Screening from

Term LOINC matching
Create New SDTM- ELLA

Term METHOD
Modify SDTM- CDISC Description for C102356 has
Existing Term PKPARM/CD a small error. It reads ?The area
under the curve (AUCTAU) at steady
state divided by the area under the
curve (AUCTAU) over the initial
dosing interval.? and I think the term
in red and bold is wrong.
Create New Multiple Add new LBTEST terms; Add new

Term ROUTE term.
Create New SDTM- SDIAM / Shortest Diameter

Term TRTEST/CD
Modify SEND- Reconsider definition of
Existing Term NONNEO C2849/MALFORMATION
Create New SDTM-LOC PRETRACHEAL LYMPH NODE;

Term PRELARYNGEAL LYMPH NODE;
PARALARYNGEAL LYMPH NODE
Create New SDTM-UNIT cm[Hg]

Term
Other SDTM-UNIT Add the UCUM notation(s) for each
"UNIT" member as a "CDISC
synonym" and mark these as "UCUM
representation".
Create New Multiple Multiple term request for P31 terms

Term still needing request numbers.Just
need request number!
Create New SDTM- Add new term to Laboratory Test

Term LBTEST/CD Code and Laboratory Test Name
codelists: NMHN-methylhistamine
Create New SDTM- Need request code for P32 ECG
Term HESTRESC public review doc; DO NOT TRIAGE
this
Modify SDTM- Need request number for P32 Public

Existing Term MICROORG Review Doc for Microbiology;
PLEASE DO NOT TRIAGE
Create New SDTM- This request contains 13 proposed

Term CVTEST/CD new CVTEST-CD terms and 13
changes to existing codelist
Create New SDTM- BRAB1R
Term MITSCD
Create New SDTM-MITS Bradikinin B1 Receptor

Term
Create New SDTM- PTEN

Term MITSCD
Create New SDTM-MITS Phosphatase and Tensin Homolog

Term
None SDTM- Radiotherapy Definition should

PROCEDUR parallel those for more specific forms
of radiotherapy.
Create New Multiple Submitting a multiple term request

Term for P32 terminology going out for
public review that needs request
codes.
Create New SDTM- Add: ASPIRATION

Term METHOD
Create New SEND-SPEC LYMPH NODE, DRAINING
Term
Modify SEND-SPEC NCI code C32392:

Existing Term COSTOCHONDRAL JOINT Change
to - JOINT, COSTOCONDRAL
Create New SDTM- OXACILLIN RESISTANT

Term MICROORG STAPHYLOCOCCUS AUREUS
Create New Multiple Request to add LBTESTCD of

Term TPRO_CF and LBTEST of Total
Protein Cerebrospinal Fluid for
Covance test code ORT7053.
measurement of total protein using
SPECTROPHOTOMETRY on
specimen type LBSPEC of
CEREBROSPINAL FLUID
Modify SDTM- Codelist long name needs to be

Existing Term DTHDX; changed from 'Death Diagnosis' to
SDTM- 'Death Details' in support of
DTHDXCD SDTMIG3.3.
Modify SDTM- SEND-DDTEST; SEND-DDTESTCD
Existing Term DDTEST;
SDTM-
DDTESTCD
Create New Multiple QTEST codelist with terms "QT
Codelist Correction Method Description" and
"QT Correction Formula":
QTTESTDCD codelist with terms
"QTCDESC" and "QTCFORM"
Create New SEND-SPEC FLUID, KIDNEY

Term
Create New SDTM- "PATHOLOGICAL EXAMINATION"
Term METHOD
Modify Multiple Change Laboratory Test Name,

Existing Term code: C127632 to "Proliferating
Erythroid/Total Cells"
Change Tumor or Lesion Properties
Test Name code C132261 to "Sum
of Products: Perpendicular
Diameters"
Modify SDTM- Lab test name 'Proliferating Erythroid

Existing Term LBTEST Cells/Total Cells' (C127632) is
greater than 40 characters and
needs to be shortened.
Create New SDTM- Multiple terms requested to be added

Term LBTESTCD to LBTEST/CD codelist.
Create New SDTM-UNIT /uL

Term
None SDTM-VSRESU RATIO
Create New SDTM-VSRESU K

Term
Create New SDTM-VSRESU Pa
Term
Create New SDTM-VSRESU Hz

Term
Modify SDTM- BURR Cells (C74701 remove

Existing Term LBTEST/CD Keratocyte as a CDISC synonym
Create New SDTM- Add term keratocytes or fibroblasts

Term LBTEST/CD
Other Multiple Looking for the P32 CT Requests

Denied on the CDISC website??
Other SDTM-CVFARS CV codetable mapping updates on

CDISC website? Last 2015...
Create New SDTM-LOC Submandibular Gland
Term
Create New SDTM-LOC Sublingual Gland

Term
Create New SDTM- Blasts/Nucleated Cells

Term LBTEST/CD
Create New SDTM- Support for SDTMIG v3.3 MS

Term MSTEST/CD examples: Zone of Inhibition
Modify SDTM- Update C132416 and remove

Existing Term MBTEST/CD C132419 from codelist
Create New SDTM- WIFE

Term RELSUB
Modify SDTM- The CDISC Protocol Entities team

Existing Term TSPARM requests that the general team
consider a definition update to the
term C98746.
Modify SDTM- C15220/DIAGNOSIS: Protocol
Existing Term MHEDTTYP entities team suggests to add
synonym and slight update to
definition.
Other Multiple Terminology Question
Create New Multiple New QRS request

Codelist
Create New Multiple New QRS request

Codelist
Create New SDTM- Holter Monitoring

Term EGMETHOD
Create New SDTM- New Lab tests for LOINC Matching
Term LBTEST-CD

Term
Create New SDTM- New codes required due to the
Term ONCRSR publication and adoption of the
paper.
Create New Multiple New term requests for multiple

Term codelists
Create New SDTM- Request add following: MBTEST =

Term MBTEST/CD 'Haemophilus Influenzae' and
MBTESTCD = 'HAEMINF'
Create New SDTM-UNIT Request add following: UNIT = 'ug/g'

Term
Create New SDTM- Please add EVC as the RETESTCD

Term RETEST/CD and add Expiratory Vital Capacity as
the CDISC Synonym; and add
Expiratory Vital Capacity to the
RESTEST codelist, and the CDISC
Synonym.
Create New Multiple New cat for PASI02, new codelists

Codelist PASI02TC/PASI02TN
Modify SDTM- Change control to add the new PGI
Existing Term PGI01TC/TN test of "Overall Health"
Modify SDTM-LOC PANCREATIC DUCT
Existing Term
Create New SDTM- GU

Term LBTESTCD
Create New SDTM- Guanase

Term LBTEST
Create New SDTM- Hemoglobin A2/Hemoglobin

Term LBTEST/CD
Create New SDTM- New terms for MBTEST-CD
Term MBTEST/CD
Create New Multiple Add new terms and Modify existing

Term terms
Create New SDTM- Please add C41145 and C41255 to

Term RPTEST/CD the RPTEST/CD codelists
Create New SDTM- PIVKAII (Protein Induced by Vitamin

Term LBTEST-CD K Absence/Antagonist-II)
Create New SDTM- SIALOGRAPHY
Term METHOD
Modify SDTM- ADAPTIVE

Existing Term TSPARM/CD
Modify SDTM- Change defintion of FACTORIAL

Existing Term INTMODEL
Modify SDTM- Change definition of PARALLEL

Existing Term INTMODEL
Modify SDTM- Change definition of SINGLE

Existing Term INTMODEL GROUP. Requested by Protocol
Entities team.
Create New SDTM-CAN DOSE INTERRUPTED
Term
Create New Multiple Question about Glosary terms
Term
None Multiple Metabolite to parent ratios of

AUCINT, AUCTAU, AUCLST,
AUCIFO and CMAX
Create New New Create new codelist for

Codelist Immunogenicity Specimen
Assessments Test Details
(ISTSTDTL) and add three new
terms
Other Multiple Please have team review TS domain
codetable mapping file.
Create New New Create two new QSCATs plus test

Codelist code and test name codelists
TSCC01TC/TN and TSCYC1TC/TN
for the TSCC and TSCYC
questionnaires.
Create New Multiple multiple new term request for
Term MITESTCD and RSTESTCD
Modify SDTM- Please consider update CVTEST =

Existing Term CVTEST-CD Aortic Coarctation Indicator
(C139033) and Aortic Coarctation
Severity (C139037). This change is
for the CV-Imaging team
Create New SDTM-UNIT OI

Term
Create New SDTM- Ratio AUC from T1 to T2
Term PKPARM-CD
Modify SDTM- C123593 (MOLECULAR CR)

Existing Term ONCRSR
Create New SDTM- Please consider adding a new

Term METHOD method term: In Vitro Gene
Expression Assay
Other SDTM- Question regarding the formula,
LBTEST-CD specimens and units associated with
the Creatinine Clearance and
Glomerular Filtration Rate tests
Create New SDTM- ACN Infusion Rate Reduced

Term
Create New New Extensible codelist for reason arm or

Codelist actual arm not done. Values should
include "SCREEN FAILURE", "NOT
ASSIGNED" and "NOT TREATED".
Create New SDTM-UNIT RFU

Term
Create New SDTM- MCT. Add to RETEST Methacholine
Term RETEST-CD Challenge Test
Modify SDTM- Please modify the term of "Sum of

Existing Term TRTEST/CD Products of Perpendicular
Diameters" (C-code is C132261).
Create New New QRS request

Term
Create New SDTM- New terms needed for SDTM-

Codelist PROTMLST PROTMLST
Create New SDTM- OPEN LABEL TO TREATMENT

Term TBLIND
Create New New Needed to support explanations of
Term different ways that "dose" may be
represented in SDTM datasets.
Modify SDTM- Update definition of C16153 /

Existing Term TSPARM/CD Stratification Factor in TSPARM and
TSPARMCD codelists.
Create New Multiple RSCAT, RSTESTCD, RSTEST for

Term the ATLAS measure
Modify SDTM- Modify definitions of C49659 and
Existing Term TBLIND C28233: OPEN LABEL and SINGLE
BLIND
Create New SDTM- Add new term to codelist: from
Term TBLIND Protocol Entities team
Modify SDTM- For code C101020, please update

Existing Term MNSI1TN CDISC Synonym 'MNSI1-Left Dry
Skin, Callus' to 'MNSI1-Left Foot Dry
Skin, Callus'
Modify SDTM-QSCAT Need to retire C138337 and use
Existing Term C118498 due to NCI internal code
change
Create New SDTM- Add the term "SUBJECT AND

Term TBLIND INVESTIGATOR BLINDED"
Create New SDTM- TD
Term DOMAIN
Create New SDTM- From Protocol Entities Team: Please

Term OBSSMO add CROSS-SECTIONAL to
OBSSMO codelist. This term is in
clinicaltrials.gov codelist.
Create New SDTM- From Protocol Entities Team: Please

Term INTMODEL add ADAPTIVE and SEQUENTIAL to
INTMODEL codelist. This term is in
clinicaltrials.gov codelist.
Modify SDTM- Update CDISC submission value,

Existing Term CVTEST-CD definition and preferred term for
C139049
Modify Multiple Update CCCAT terminology

Existing Term
None Multiple Create a new Define-XML Controlled

Terminology file
Other ADaM- Please remove this CT from the
ANLPURP ADaM CT file and include it in the
new Define-XML CT file to be
created.
Other ADaM- Please remove this CT from the

ANLREAS ADaM CT file and include it in the
created.
Other SDTM- Please remove this CT from the

GNRLOBSC SDTM CT file and include it in the
created.
Create New Multiple Please add 2 new ADaM Dataset

Codelist Subclass CTs to the new Define-
XML CT file to be created
Other SDTM- CDISC supports C64818
LBTEST/CD Lymphocytes Atypical and C74629
Reactive Lymphocytes and
differentials thereof.
Other SDTM- C119272 Correct Calcium - Since

LBTEST/CD calcium can be correct for albumin or
total protein, please consider
changing the CDISC definition to
remove abumin.
Modify SDTM- Please modify "Neutrophils Band
Existing Term LBTEST/CD Form/ Neutrophils" (C-Code is
C120642) to "Neutrophils Band
Form/Neutrophils".
Create New SDTM- Helicobacter pylori Antigen

Term LBTEST/CD
Modify Multiple Change submission value for

Existing Term C10337 from "Special Purpose" to
"Special-Purpose".
Create New SDTM- Standard Base Excess
Term LBTEST/CD
Create New Multiple P33 Protocol Entities Content: 1

Term Entity, 16 attributes, and 36 terms
across 6 response codelists.
Create New SDTM- Duration of Response; RESPDUR.

Term ONCRTS-CD Need request number for P33
Oncology Denied Request file.
Create New Multiple Need request number for SEND P33

Term Public Review File
Modify Multiple Need request number for SEND P33

Existing Term Public Review File: Changes to
Existing.
Modify Multiple Need request codes for P33 General
Existing Term PR file: Changes to Existing.
Create New SDTM- Need request code for P33 Lab New
Term LBTEST-CD terms for LBTEST-CD
Modify Multiple Need request code for P33 Lab PR

Existing Term file: Changes to Existing.
Modify SDTM- Need request code for P33

Existing Term SPECTYPE SPECTYPE SPECCOND PR file:
Changes to Existing
Create New Multiple Need request code for P33 Oncology

Term PR file: New term requests
Modify Multiple Need request code for P33 Oncology

Existing Term PR file: Modify existing
Modify SDTM-LOC Please check the definition for

Existing Term C12291/SKIN OF THE LIP
Create New SDTM-LOC DISTANT LYMPH NODE

Term
Create New SDTM- Choriogonadotropin Beta, Free
Term LBTEST-CD (TESTCD = HCGFR)
Create New SDTM- Megakaryocytes/Leukocytes

Term LBTEST-CD (TESTCD: KRCYMGLE)
None VS codetable EM-See VS Codetable Mapping tab

mapping
update
Create New SDTM- Need request code for P33 Domain
Term Domain PR file: New terms
Create New Multiple Need request code for P33 Domain

Term PR file: New terms
Modify None Need request code for P33 Domain

Existing Term PR file: Changes to existing
Modify SDTM- Does this concept belong in the

Existing Term MBTEST-CD MBTEST-CD codelist or the MB
domain?
Final Outcome
Change
Type
File emailed separately. II SDTM, SEND-Published

Terms requested are LEAD Dorsal, LEAD in P30
Ventral, LEAD Axial, LEAD aVF-ventral, LEAD
aVL-axial, and LEAD aVR-dorsal. Proposed
definitions are in the emailed file.
I'm sure this will have been requested before but II

we have issues with PC and PP using different
'unit' codelist terminology.e.g.
In UNIT, ng/mL maps to ug/L.
In PKUNIT, ug/L maps to ng/mL.
Do we need to wait for 3.3 to be released to fix

this? Or can there be an interim change? Thanks
We would like to request a new POSITION term II SDTM, SEND-Published

of SEMI-SUPINE. We do not believe this is in P31
synonymous with SEMI-RECUMBENT since this
does not specify that the subject is lying on their
back facing upwards:
SEMI-RECUMBENT: A semi-sitting or semi-
reclined body position in which the head is
elevated above horizontal.
SUPINE: A posterior recumbent body position
whereby the person lies on its back and faces
upward.
If however you believe SEMI-SUPINE to be a
synonym of SEMI-RECUMBENT, please add it.
I do not see any corresponding or acceptable II SEND-Published in P31

term in CDISC list. This term can bez used for
any bone as well as for tooth
I do not see any corresponding or acceptable II Do not add (P30) -

term in CDIS list, CALLUS could be used for any Please follow INHAND
bone nomenclature and use
FRACTURE as the
MISTRESC and put
callus in as a modifier or
within comments.
IMMATURITY already present in CDISC list does II Do not add (P30) -
not fit (to my opinion), immature glomeruli are Being considered to be
present in dog kidney whatever the age of the added by INHAND as
animal part of the dog urinary
system at a future date.
The SEND CT team will
not add this term at this
time but will agree to
add when INHAND
publishes it.
this is skeletal muscle change which can be seen II SEND-Published in P30

isolated from any other muscle change. I do not Do not add (P32):
see any adequate term in CDISC list. In addition, CENTRAL NUCLEATION -
according to litterature, it is difficult to say Please use
whether is is REGENERATION or DEGENERATION/REGEN
DEGENERATION or DYSTROPHY ERATION or
REGENERATION.
INHAND publications
will be updated to
reflect this.
DYSPLASIA definition (proposal) : Dysplasia is II Do not add (P30) -

the abnormal development of an organ, tissue or INHAND does not agree
structure that causes alteration in size, shape, that DYSPLASIA is a
organisation of adult cells and/or defects. in MISTRESC in and of
CDISC list, there is only ADNEXAL DYSPLASIA itself. From INHAND's
(for skin), I'll propose DYSPLASIA e.g., for point of view, Dysplasia
adrenal gland (ex: DYSPLASIA, medulla), for is considered pre-
bone (ex: DYSPLASIA, growth plate) neoplastic in the clinical
realm but in the non-
clinical realm it is
generally not considered
pre-neoplastic but
instead considered a
developmental lesion.
INHAND suggests that
any MISTRESC values
with Dysplasia require
qualifiers as part of base
process. In general, it
would be the specimen
in adjectival form
followed by Dysplasia.
in CDISC list, I do not see an adequate term for II SEND-Published in P31
any matrix aleration or change, e.g. in bone or Do not add (P30):
tooth (dentin). ATROPHY does not always fit Please use DENTIN
MATRIX ALTERATION,
which is being added
with P31.
in CDISC list, I do not see an adequate term for II SEND-Published in P31

cell loss (e.g. neuronal cell loss). ATROPHY is
not adequate as we can see NEURONAL CELL
LOSS without ATROPHY. Other terms to propose
could be DEPLETION, which could be also
acceptable for secretion, sperm or matrix (ont
only cell) or DECREASED NUMBER
no corresponding term in CDISC list (To me II SEND-Published in P35

ACCUMULATION is not approporiate). Proposed
definition : macrophages with intracytoplasmic
red blood cells. Mainly seen in lymph nodes
no corresponding term in CDISC list. To me II SEND-Published in P35

INFLAMMATION is not fully appropriate as
granulation tissue is more repair than
INFLAMMATION. the proposed definition
(Thesaurus) : new connective tissue and tiny
blood vessels that form on the surfaces of a
wound during the healing process
no corresponding term in CDISC list. Both terms II SEND-Published in P31,

are usefull in defining sexual maturity in dog and P35
monkey (or other non rodent species). in rodent,
GROWTH PLATE CLOSED can be used as test
item related change
no corresponding term in CDISC list. II SEND-Published in P33

HYPERPLASIA is NOT acceptable :
HYPERPLASIA is an increased number of cells in
a tissue or organ, it does not correspond with an
increased number of histologic structures such as
corpora lutea
to me, no fully corresponding term in CDISC list. II SEND-Published in P31

would you consider ACCUMULATION for Do not add (P32):
INCREASED BONE and ATROPHY for INCREASED BONE and
DECREASED BONE DECREASED BONE -
Being added with P31.
to me, no fully corresponding term in CDISC list. II SEND-Published in P31
would you consider ACCUMULATION instead ? Do not add (P32):
INCREASED OSTEOID
- Being added with P31.
no corresponding term in CDISC List. This is a II SEND-Published in P33

specific mouse change : presence of red blood
cell within hepatocytes.

specific heart change in Monkey, Squamous
plaques are located on the surface of the heart or
directly under the cardiac surface. Single plaques
may have small central lumen (ref : Toxic Pathol
2003; 54: 301?303, URBAN & FISCHER
Spontaneous squamous cysts and squamous
epithelial plaques
in the heart of cynomolgus monkeys (Macaca
fascicularis)

specific corneal change with presence of small
blood vessels within the corneal stroma
non congenital or congenital different from cyst II Do not add (P35): Do

(single in CDISC Definition): progressive not add. Urinary OWG
distention of tubule lumens / glomerular capsules; does not recommend
radially arranged dilated tubules in both cortex using 'polycystic
and medulla, but casts are usualy absent; disease' and instead
interstitial fibrosis and atrophy of non cystic should be handled by
cortical tubules may be present capturing the diagnosis
of 'CYST,
MULTIFOCAL' (the base
process would be
CYST) and describing
the syndrome in the
pathology narrative.
embryonic remnant seen in dog or monkey II Do not add (P35): Do

urinary bladder, often with mineralization, not add. The dog and
hyalinosis. Today, there is no corresponding term non-human primate
in CDISC list, working groups consider
this a normal anatomic
variant and would not
diagnose it as an
abnormality. Therefore
CDISC will not control
the term but the codelist
is extensible if you feel
the need to submit it.
"Cell size enlargement due to the increase in the II Do not add (P30) - The
amount of cytoplasm and its constituent structure is bigger
organelles. the cells are larger but otherwise the because the individual
appaerence in unchanged". However in INHAND cells of the structure are
pulbications, HYPERTROPHY is also used for bigger. Therefore, since
structures e.g., for large corpora lutea we are defining
(HYPERTROPHY, CORPORA LUTEA, page 20S 'Hypertrophy' on its own,
of Dixon et al publication), or can also be used for without any contextual
enlarged physeal growth plate (PHYSEAL qualifiers, the granularity
HYPERTROPHY) of the existing definition
is correct and should not
be altered.
IMT1421, IMT1422, and IMT1423 are used to II Do not add (P30) - All of
report the numeric values for the components of these would map to a
IMT1442. IMT1421 is the Mitogen tube which lbtest of
acts as a built-in Positive control. IMT1422 is the IFNG/Interferon Gamma
Nil tube which acts as a built-in background and make use of a NSV
reading. IMT1423 is the Antigen tube which to capture what is in the
actually tests the sample for Interferon Gamma. tube (Mitogen, Nil, etc.).
All 3 tubes have to be ran in order to obtain Please see TB v2 TAUG
numeric values which then go through an to see how this should
algorithm for interpretation of the results. be modeled:
https://wiki.cdisc.org/x/
kxi8AQ.
kxi8AQ.
kxi8AQ.
kxi8AQ.
For II
Fibrinogen Antigen
Fibrinogen Activity
term Fibrinogen,
of measure is mg/dL
be done via clot
activity is then
concetration
measurement.
For proposed LBTESTCD II
FIBRINAG
FIBRINAC
term Fibrinogen,
of measure is mg/dL
be done via clot
activity is then
concetration
measurement.
Multiple terms requested:HEART RATE ONLY, II SDTM, SEND-Published
JUNCTIONAL ESCAPE in P30
RHYTHM,NONCONDUCTED P WAVE,NON- Do not add (P29) -
DETECTABLE P WAVE, SICK SINUS HEART RATE ONLY-This
SYNDROME,SUPRAVENTRICULAR ESCAPE is a measurement
COMPLEXES,SUPRAVENTRICULAR problem due to poor
PREMATURE COMPLEXES,WITHIN NORMAL ECG signal
LIMITS; quality/mechanical
File emailed separately issues. This is a type of
technical quality finding
that may negatively
impact an ECG
measurement, hence is
not considered an real
ECG finding.
NON-DETECTABLE P
WAVE - This is a
measurement problem
due to poor ECG signal
quality/mechanical
issues. This is a type of
technical quality finding
that may negatively
impact an ECG
measurement, hence is
not considered an real
ECG finding.
SICK SINUS SYNDROME-
This is a diagnosis, not
ECG finding, hence this
term does not belong in
the ECG Result codelist.
WITHIN NORMAL
LIMITS-Normally in
human trials, one would
expect an ECG result
such as sinus
Please add the term ASPERGILLUS II
OCHRACEUS to the Microorganism Codelist.
Proposed Definition: Any fungal organism that

can be assigned to the species Aspergillus
ochraceus.
Correct definition. Should read: An II SDTM, SEND-Published

electrocardiographic finding of a junctional rhythm in P30
with a heart rate which is abnormally low.
Add "r" to 'heart'.
Definitions for NASAL and TEMPORAL are not II SDTM, SEND-Published

accurate as descriptions of directionality in P31
File e-mailed separately
Error in Synonym - should read "Fibrin Stabilizing II SDTM, SEND-Published
Factor" in P30
C-terminal (cFGF-23) and intact (iFGF-23) is II SDTM, SEND-Published
used in assessing CKD-MBD status. in P30
FGF23[C96650] may be cFGF-23.
Missing from current code list (WIKI link: II SDTM-Published in P30

https://en.wikipedia.org/wiki/Bordetella_holmesii)
Synonym spelling mistake; Term C124326 - II

ALIQUOTING - has a synonym "Aliquotting" (with
double "t"). I believe the synonym should contain
just one "t" - same as the submission term.
SEND CT team agreed on 2017-01-09 to add the II SEND-Published in P30,

following four terms to the SEND-SPEC codelist: P31
NASAL TURBINATE, ETHMOIDAL CONCHA
NASAL TURBINATE, DORSAL CONCHA
NASAL TURBINATE, MEDIAL CONCHA
NASAL TURBINATE, VENTRAL CONCHA
SEND CT team also agreed to add the synonym

Nasal Concha to the existing published term
NASAL TURBINATE.
In terms of regulatory usefulness, it would be II SDTM-Published in P31
helpful to have an explicit MINIMAL RISK code,
as the other codes do not capture this nuance,
which is repeatedly used in the common rule and
the FDA regulations and becomes very important
in pediatric determinations, particularly for the
comparator arm of a study.
CDISC needs to align with CDISC glossary II SDTM-Published in P31

definition: Phase 0. First-in-human trials, in a
small number of subjects, that are conducted
before Phase 1 trials and are intended to assess
new candidate therapeutic and imaging agents.
The study agent is administered at a low dose for
a limited time, and there is no therapeutic or
diagnostic intent. NOTE: FDA Guidance for
Industry, Investigators, and Reviewers:
Exploratory IND Studies, January 2006 classifies
such studies as Phase 1. NOTE: A Phase 0 study
might not include any drug delivery but may be an
exploration of human material from a study (e.g.,
tissue samples or biomarker determinations).
[Improving the Quality of Cancer Clinical Trials:
Workshop summary?Proceedings of the National
Cancer Policy Forum Workshop, improving the
Quality of Cancer Clinical Trials (Washington, DC,
Oct 2007)] (CDISC glossary)
h*nmol/L/(mg/kg) used as unit to AUC dose II SDTM, SEND-Published

normalized PK parameter in P31
calcium/phosphorus it's a ratio of LBTEST
calcium over phosphorus
In reading the SDTM IG for the PC domain, the II Do not add (P30):
PCORRES and PCORRESU Variables are CDISC ascribes
defined as â€œResult of the measurement or mathetmatical
finding as originally received or collectedâ€, and synonymy as true
â€œOriginal units in which the data were synonymy to its unit of
collected.â€ measure. Therefore,
However, the Controlled terminology does not ug/mL is a true synonym
include adequate options within the â€œUnitâ€ of mg/L hence please
Codelist for the units in which Bioanalytical (BA) choose the correct
data is typically reported. BA data is almost submission value
always reported per mL, but the available units in corresponding to the
the controlled terminology are only available per Unit codelist you are
L. In order to maintain consistency and using. Additionally, the
traceability within a study, the actual units in SDTM leadership team
which BA data is collected should be available. has stated that
To help maintain data integrity and traceability ORRESU should use
with studies, please consider updating the the UNIT codelist, hence
controlled terminology for Units to include units of sponsors do need map
concentration per milliliter (ug/mL, ng/mL, pg/mL), their collected unit
so the units donâ€™t have to be reported as (however it was
mg/L, ug/L, and ng/L (which creates confusion). collected) to the
As a follow-up, an alternative solution to the appropriate CDISC
problem could be that the â€œPKUNITâ€ submission value as
Codelist could be referenced for the PCORRES published. Please note,
and PCORRESU variables in the PC domain collected units are often
(instead of the â€œUNITâ€ codelist), since it listed as synonyms in
does contain the new units requested. the synonym column of
the published
terminology. If you feel
that ORRESU should
not be controlled, please
contact the SDS
leadership team. The
CT team cannot make
this change by
themselves.
Please note, this is a follow up to REF #2592 and II SDTM-Published in P30,
2599 that was originally submitted and in P47
response to email sent by Bernice Yost on 18th
Nov 2016 requesting base cell type, core cell type
and receptor pattern needs to be added.
In the "SDTM Publication Date Stamp 2013-04- II Fixed

12.txt" file in the archive area, the Release Date
is incorrect - it is currently "2012-Apr-12" but it
should be "2013-Apr-12". Please can this be
corrected
The Release Date specified in Publication Date
Stamp files should be correct as these files may
be used to process historic releases of
terminology
An individual from that performs independent II Do not add (P30) -
assessments of imaging data Request removed by
requester.
An individual that performs over-read of the II Do not add (P30) -

assessments made by the initial imaging grader Request removed by
or provide their own assessments. The senior requester.
grader?s results will be considered final.
Provided by email on 26th Jan 2017 with an II SDTM-Published in P30,

additional attachment; File emailed separately P31, P32
Do not add (P30) -
LBTEST=DNA or RNA;
NHOID=Virus Name
Do not add (P30) -
MANDIBULAR LYMPH
NODE: Please use
existing published term
'SUBMANDIBULAR
LYMPH NODE'. We are
not aware that
Mandibular Lymph Node
is an actual anatomical
location. Please provide
evidence.
Do not add (P32) -
TARSUS BONES,
MIDFOOT: Please use
existing concept
TARSUS BONE C12796
Potassium-Creatinine Conventiion unit is mEq/mg II Do not add (P30): Do

SI unit is mmol/mmol not add. Already exists
as mol/mol C70455 in
UNIT codelist.
Changes to published QRS and Lab terminology; II QRS-Published in P29

File emailed separately Do not add (P30) -
When measuring
'phosphorus' in a body
fluid, it is always in the
phosphate form.
Therefore while we
agree that these are no
1:1 synonyms, the lab
team feels that the
addition of the synonym
of 'Phosphorus' will help
with mapping.
QRS Typo/Capitalization changes II QRS-Published in P29
Events for flow cytometry are simply the gated II Do not add (P30): Do
events captured during analysis for each not add. 'Gated Events'
parameter being described and is used as a is inherently part of the
quality assessment in the event there may be test and as such either
some variability observed in the % data. If there belongs in the test name
appears to be some variability observed one can or in some kind of test
reference the event counts and determine if that modifier non-standard
observation is simply due to a low frequency of variable.
gated events present, such as with Ki67+
populations which are normally present in low
frequency.
Hours times percent (area under the effect curve) II SDTM, SEND-Published
in P31
Please consider to create the new RE-, ECG- and II SDTM-Published in P30,
CVTEST-CD terms in the attached file. This is a P31, P32
TA Request; File emailed separately. Do not add (P29) -
Chamber Hypertrophy
or Enlargement
Indicator: Request
withdrawn by requester.
This assay MULTIPLEXED II

OPSONOPHAGOCYTIC KILLING ASSAY
(MOPA) is being used in Pneumococcal Vaccine
trials for to measure the protective capacity of
pneumococcal antibodies. The MOPA assay
simultaneously measures opsonophagocytosis
capacity of serum against the capsular serotypes
included in the pneumococcal conjugate vaccine
in a high-throughput fashion, requiring low
volumes of patient sera. Results reported as titer
values.
Definition: enumeration of circulating tumor cells II SDTM-Published in P32

(CTC) of epithelial origin in a biological specimen
<BLOOD>
Reference: https://www.cellsearchctc.com/
Virology TAUG - Please add EC50 terms similar II SDTM-Published in P31
what has been done for IC50
https://en.wikipedia.org/wiki/EC50
This is a request is coming from FDA

Would it be possible to make the use consistent II
throughout the CSSRS codelists, i.e. "num" used
in all instances rather than both "num" and
"number", and "desc" used for all instances
instead of "desc", "descr", and "description"?
Reason: current controlled terminology for II SDTM, SEND-Published

LBTEST does not include an analogous in P30
measurement
Definition: A measurement of the non-squamous
epithelial cells present in a biological specimen.
NCI preferred term: Non-squamous Epithelial
Cell Count
Associated unit: /HPF
Reason: current controlled terminology for II SDTM, SEND-Published

LBTESTCD does not include an analogous in P30
measurement
Definition: A measurement of the non-squamous
epithelial cells present in a biological specimen.
NCI preferred term: Non-squamous Epithelial
Cell Count
Associated unit: /HPF
Suggested LBTEST: Non-squamous Epithelial
Cells (request submitted 09-Feb-2017)
New QSCAT, test codes and test names for the II QRS-Published in P30
Life Events Checklist for DSM-5, Standard
Version; This request is for the PTSD TA team.
SUPPORTIVE CARE: A type of study protocol II SDTM-Published in P31
designed to evaluate one or more interventions
where the primary intent is to maximize comfort,
minimize side effects or mitigate against a decline
in the subject's health or function. In general,
supportive care interventions are not intended to
cure a disease. (clinical trials.gov)
SCREENING: A type of study protocol designed
to assess or examine methods of identifying a
condition (or risk factors for a condition) in people
who are not yet known to have the condition (or
risk factor). (clinicaltrials.gov)
BASIC SCIENCE: A type of study protocol
designed to examine the basic mechanism of
action (e.g., physiology, biomechanics) of an
intervention. (clinicaltrials.gov)
HEALTH SERVICES RESEARCH: A type of
study protocol designed to evaluate the delivery,
processes, management, organization or
financing of health care. (clinicaltrials.gov)
Two synonyms to add: Trial Scope (EudraCT) II SDTM-Published in P31

and Study Classification (Clinicaltrials.gov).
In CL.C65047.LBTESTCD, rephrase the II Do not add (P30) - The
descriptions of GFRBSCCC, GFRBSCRT and lab team feels that the
GFRBSCYC to clarify their meaning. proposed definition
For example the current description for update does not lend
GFRBSCRT is: enough clarity to the
GFRBSCRT : An estimation of the glomerular definition to agree to a
filtration rate adjusted for body surface area change, which can be
based on creatinine. onerous on the user
This could mean either: community.
GFRBSCRT : An estimation of (the glomerular
filtration rate adjusted for body surface area)
based on creatinine.
or
GFRBSCRT : An estimation of the glomerular
filtration rate, adjusted for body surface area
(based on creatinine).
If this code is intended to be used e.g. for
estimated GFR using the CKD-EPI creatinine
equation described in Pubmed id 19414839
(Levey et al. 2009, A new equation to estimate
glomerular filtration rate) then it has the former
meaning.
I suggest the following phrasing:
GFRBSCRT : An estimation of body-surface-
area-adjusted glomerular filtration rate based on
creatinine.
Existing term C103382 Clostridium tetani IgG II SDTM, SEND-Published

antibody recinded in LOINC and mapped to more in P30
appropriate term of Clostridium tetani toxoid IGG
antibody. Should we update to align to LOINC or
at least add Clostridium tetani toxoid IGG
antibody as a synonym?
See code request
Typo in CDISC Definition: change "namess" to II SDTM-Published in P30

'names'
Typo in CDISC Definition: change "stuctures" to II SDTM-Published in P30
'structures'.
Citation corrections/add digital object identifiers II SDTM-Published in P30

(doi) Do not add (P34): For
2017-02- CV terminology,
16_CDISC_Multi_Term_Request_Citations_Batc proposed update is not
h 1_Bob D correcting something
(File emailed separately) that is incorrect.
New terms added to SDTM Terminology 2016-12- II Question answered.
16 have their c-code (from C130068 to C130153) This was done
as the submission value. Are they set intentionally. Given the
intentionally or accidentally? I suggest to correct large numbers of
them if this is a bug. allergens and
immunophenotyping
terminology that will be
added to the LBTEST
codelist eventually, the
lab team decided that it
was not prudent to
attempt to come up with
meaningful 8 character
LBTESTCD values. The
LBTESTCD must be
unique, therefore the
NCI c-code was
determined to be
appropriate as a
LBTESTCD submission
value in the case of at
least Allergens and
Immunophenotyping.
QSTESTCD, QSTEST and QSCAT for the II QRS-Published in P30

PODCI Adolescent Parent-Reported; For
Duchenne TA
QSTESTCD, QSTEST, QSCAT for PODCI II QRS-Published in P30

Adolescent Self-Reported; For Duchenne TA
Terms are needed for standard error when data is II Do not add (P30): Our
pooled for PP domain. suggestion is to
represent this in
SUPPPP as a generic
standard error variable
that can be used for any
values of PPTEST.
Represent the CMAX
measurement in PP,
and represent CMAX
Standard Error in
SUPPPP. The reason
for this approach is to
prevent descriptive stats
being added as
PPTEST/CD values in
the PP domain. SEND
and SDTM use the
same PK Parameter-
Code codelists, it would
be ideal to harmonize
the modeling strategy
between clinical and
non-clinical studies -
having Standard Error
type measurements in
SUPPPP.
Method for Anti-Double Stranded DNA IgG II SDTM-Published in P32
Common benzodiazepines and/or specific II SDTM, SEND-Published

metabolites include Oxazepam (Serax), in P31
Nordiazepam, Temazepam (Restoril),
Flurazepam (Dalmane), Alprazolam (Xanax),
Lorazepam (Ativan), Chlordiazepoxide (Librium),
Clorazepate (Tranxene), Diazepam (Valium),
Halazepam (Paxipam), Medazepam (Nobrium),
Prazepam (Centrax), Flunitrazepam, Clonazepam
(Klonopin) and Midazolam (Versed), please
check if the corresponding LBTESTCD/LBTEST
should be added.
Right now, we have LBTEST=Benzodiazepine
only, and the lab may generate results for
multiple metabolites for LBTEST=Benzodiazepine
as separate records.
EC: Exposure as Collected is part of the SDTM II SDTM, SEND-Published

IG 3.2, but is not a CT yet. in P33
Definition: A visual acuity method which provides II SDTM-Published in P32
a quantitative measure of grating acuity in infants,
toddlers and nonverbal children because it does
not require a verbal response.
Definition: A method for measuring visual acuity II SDTM-Published in P32

consisting of an incomplete ring resembling the
letter C.
Multiple terms requested for OETEST; File II SDTM-Published in P31,
emailed separately P32
Create new QSTEST-CD for MMSE; Copyright II QRS-Published in P30
permission is been obtained.
There are 218 CAT concepts for FT, QS and CC, II

out of which 26 CDISC CAT definitions end with
".).", the rest all end with ")."
The proper citation style should be: period close
parenthesis period, .).
Please consider updating the definitions to
reflect this change.
This measure was requested by the FDA for II QRS-Published in P46

CDISC t develop. I have sent the draft QRS
terminology spreadsheet and annotated CRF via
separate EMAIL.
Citation corrections QRS; File emailed separately. II
The proposed definition is: Back-extrapolated II Do not add (P30) - This

concentration to time zero following a bolus is synonymous to C0
intravascular dose. (C85644), please use
C0 (C85644) instead.
With regard to the
requester's notes, back-
extrapolation is one of
many ways to calculate
C0, however, in general
for a CDISC definition
we do not include the
method with which a
parameter is
determined.
Please consider to add two new terms, this is a II SDTM-Published in P31

TA request from the Duchenne team; File
emailed separately
Pharmacopoeia to Pharmacopeia II SDTM, SEND-Published

in P31
Test to permits detection of very low levels of cTn II Do not add (P30) - The
in diagnosis of acute myocardial infarction (AMI). High Sensitivity
component of this assay
is about the method, not
the analyte. Please use
the existing published
term C74750.
Draft Definition: A unit of measure of quantity of II Do not add (P30): Do

total cells expressed in 10 to the sixth power of not add. This isn't a
cells. valid unit of measure.
This is a test and a
Refers to the total number of cells in the sample result value.
(sample example: body fluids)
Codelist corrections & citations; File emailed II SDTM-Published in P31

separately Do not add (P34): For
CV terminology,
proposed update is not
correcting something
that is incorrect.
SDTM-LBTESTCD: CHKVAB, Chikungunya Virus II SDTM, SEND-Published

Antibody in P30
SDTM-LBTEST: Chikungunya Virus Antibody
SDTM-MICROORG: CHIKUNGUNYA VIRUS;
This method is needed for further molecular II Do not add (P37): Do

characterization of certain isolates to not add. This data
determine/characterize the type of beta should be modeled in
lactamase that is being produced by the the PF domain and the
bacterium. requester could use an
This result is associated with an antibiotic. For existing PFTEST value
example, the molecular characterization is tied in of either GENVAR or
to imipenem (or any other carbapenem like GENOTYPE. The
meropenem). If an isolate is found to be METHOD would be
imipenem resistant, they will test for the presence some kind of
of an MBL (metallo beta lactamase). The result sequencing method.
would likely be (something like this): ?positive for The requester would
MBL? and then ?identified as IMP, VIM, SPM, need to pick the
GIM, NDM? appropriate sequencing
method that was used in
the assay to populate
the METHOD variable.
AEROCOCCACEAE; ALCALIGENACEAE; II SDTM-Published in P30
ENTEROBACTERIACEAE;
STREPTOCOCCACEAE
These are microorganism terms at the Family

Level. Requesting to add these terms for
classification of organisms at the Family level.
This test is capturing the presence of Human II

Rhinovirus 16 by PCR after the subject has been
inoculated with the virus via nasal administration.
The virology team had agreed to add Ebola Virus II SDTM, SEND-Published
IgM Antibody to the MBTEST-CD codelists, the in P30
Virology team would like to also add this term to
LBTEST-CD. LBTEST = Ebola Virus IgM
Antibody; LBTESTCD = EBOIGMAB; CDISC DEF
= A measurement of the Ebola virus IgM
antibodies in a biological specimen. The TEST-
CD values and CDISC DEF for this concept have
been reviewed and agreed upon by the virology
team, please use verbatim as suggested here.
Please notify Jordan if further changes are made
to this concept, thank you.
Administration at the surgery site drop by drop II SDTM-Published in P32
FTTESTCD/FTTEST/FTCAT for Performance of II QRS-Published in P31

the Upper Limb version 1.2 (PUL)
This is for the Duchenne TAUG
File emailed separately II Published in P31
VS Codetable Mapping II SDTM, SEND-Published

in P31
Needed for VS Codetable Mapping II SDTM, SEND-Published

in P31
C33794 is coded to 'Odontogenic Tissue'. Since II SDTM, SEND-Published
this is the anatomical location codelist, the in P31
concept of Tooth should be pointing to C12506
'Tooth'. C12506 is published in SEND-SPEC
codelist so please use the existing published
content.
Review TSPARM-ClinTrial-Eudra_2017-03-07_rd II Do not add (P34): This
for CT mapping/alignment across codelists will be updated with
File emailed separately CTR version 2 project.
SISH (Silver in situ hybridization) for determining II SDTM-Published in P32

of HER2 gene
Supporting doc:
https://www.ncbi.nlm.nih.gov/pubmed/20421783
"Silver-enhanced in situ hybridization (SISH) is a
rapid fully automated assay providing
permanently stained slides that are interpreted by
conventional bright field microscopy which
enables pathologists to evaluate slides within the
context of tissue morphology."
Please modify existing MICROORG terms; These II SDTM-Published in P30

changes are asked by the virology team; File
emailed separately.
Myeloma Cells/Leukocytes: /10^4 II SDTM, SEND-Published

Myeloma Cells/Leukocytes: /10^5 in P30
This is already in Unit P30 working document,
just need a request code. See rows 24 and 25 in
the UNIT tab.
Review ECG codelist mapping; File emailed II

separately
QRS REQUEST. This request is on behalf of the II QRS-Published in P30

TBI and PTSD TA teams.
Request to add a new TEST-CD to SGRQ PAST II

4 WEEKS VERSION or advise ; See attached
email
A measure of the carbon monoxide contained in a II SDTM, SEND-Published
sample. e.g. as measured in breath/expired air in in P31
ppm.
CMON suggested to avoid confusion with CO =
Comments domain.
A unit of resistance equal to the product of one II SDTM, SEND-Published
kilopascal and one second. in P31
Note: This unit is used with the sRaw
measuremnt in Body Plethsmography testing
A unit of conductance equal to the number of II SDTM, SEND-Published

liters per unit of time equal to one second per unit in P31
of pressure equal to one kilopascal.
Note: This unit is used with the Gaw

measurement in Body Plethsmography testing
Team agrees to add and will be publically II
reviewed with P29. Just need request number.
Required for PC data specimen type. II Do not add (P32): Do

Draft definition is "a specimen containing an not add. Please use
equal mixture of blood and water". existing SPECIMEN of
WHOLE BLOOD. If
water is important for
the submitted data,
please put specimen
preparation information
into a suppqual or non-
stand
A relative measurement (ratio or percentage) of II SDTM, SEND - Published

epithelial cells to non-squamous cells in a with P30
biological specimen
To be used with LBTEST : Epithelial Cells/Non-
Squamous Cells
A relative measurement (ratio or percentage) of II SDTM, SEND - Published
epithelial cells to non-squamous cells in a with P30
biological specimen
To be used with LBTESTCD : EPICNSCE
New terms for LOC and FREQ; File emailed II SDTM, SEND-Published
separately in P31, P32
Please consider modifying LOC terms in the II SDTM, SEND-Published

attached file. This is a TA request from the CV- in P31
imaging team; File emailed separately
An indication that a subject has not agreed with II SDTM-Published in P31

or followed the instructions related to the medical
device. (NCI)
(Taken from the definition for NON-

COMPLIANCE WITH STUDY DRUG and
adapted for the medical device.)
Need a change request number for 4 terms in II SDTM-Published in P30

oncology P30 public review document. File
emailed separately
Modify CDISC DEF for 'ONCE/C64576". This is II SDTM-Published in P30,
already in the P30 General working document, P31
team already approved the change, just need a
request code.
Add a SY to ENTEROBACTERIACEAE/C85932. II SDTM-Published in P30

This is in the P30 Virology Public Review
Document; Just need a request code
Need request codes for 3 new CVTEST terms II SDTM-Published in P30
and 2 modification to existing. All terms are
already in the P30 CV working document, just
need request codes.
Updated definition: A period in a clinical study II SDTM-Published in P30

during which subjects receive investigational
product.
This is going out with P30 public review - just
Please remove the original CGI terminology, this II QRS-Published in P30

includes C100763, C100150, C100149,
C100955, C100956, C100957. Just need a
request code. This is already in the P30 QRS
Public Review Document.
Serum Osmolality, 2hr II Do not add (P32):

Already published in
P30.
Accumulation Ratio AUC to Last Nonzero Conc : II SDTM, SEND-Published

The area under the curve (AUC) from the time of in P31
dosing to the last measurable concentration
divided by the area under the curve from the time
of dosing to the last measurable concentration
during the initial dosing interval.
A female figure, not necessarily of biological II Do not add (P30) = CT

connection to the child, who takes care of and team has not seen this
raises the child. term used in common
practice across other
companies and believes
the term as requested is
too vague/confusing to
be used correctly and
consistently across
multiple sponsors.
Therefore CDISC will not
Splenic lymph nodes are lymph nodes located II SDTM, SEND-Published
contro this term at this
along the splenic artery and vein. They receive in P32
time. The codelist is
lymphatic drainage from the anterior pancreatic
extensible so requester
body and tail and stomach. Used in pancreas can feel free to continue
cancer staging according to AJCC 7th edition. using it as appropriate.
This anatomical location is required.
Proposed definition: Milliliters per kilogram per II Do not add (P30):
day or milliliters per day (flow rate), divided by Request withdrawn by
kilograms (weight). requester.
A use case for this term would be that clearance

is a PK parameter that deals with a rate of
elimination and therefore needs a unit of time.
Please remove term C130056 from codelist. This II SDTM-Published in P31

request is already in the P31 CV working
We are publishing the CVTEST = "Mean Blood
Pressure, Estimated" in P30, there is no need for
the existing term. The common data element from
which the existing term was created is "Mean
Right Atrial Pressure, Estimated". This can be
modeled by using CVTEST = Mean Blood
Pressure, Estimated, and LOC = Right Atrium
the Duchenne Muscular Dystrophy TAUG II QRS-Published in P31

TP domain is new to SDTM v1.6. What was II SEND-Published in P32
approved by SDTM Governance slightly different
than originally requested.
Add the term ?Repro? in the TT domain name II SEND-Published in P32

and CDISC Synonym, ?Trial Repro Stages?.
Update Definition to ?The Trial Repro Stages
domain is not subject oriented. This domain
captures descriptions of, and rules for, the start
and end of planned blocks of time known as
Repro Stages, such as Gestation_TK,
Gestation_NonTK.?
TT domain is new to SDTM v1.6. What was

than original request.
Add the term ?Repro? in the SJ domain name II SEND-Published in P32
and CDISC Synonym, ?Subject Repro Stages?.
Update Definition to ?The Subject Repro Stages
domain captures subject-level periods of time
known as Repro Stages that a subject
experienced, such as F0_Premating, F0_Pairing,
F0_GestationTK.?
SJ domain is new to SDTM v1.6. What was

than original request.
Eye fields to use within the new OE domain to II Do not add (P32): Do
precisely identify the location of the test. File not add. Consider using
emailed separately ANTREG for this with
LOC=FUNDUS and
LAT=Left or Right.
ANTREG is an
approved variable in the
SDTM model.
Please consider adding new terms, this is II SDTM-Published in P31

for Duchenne TA; File emailed separately
Update DEFs for CCCAT, FTCAT, QSCAT II QRS-Published in P30

codelist descriptions; File emailed separately
This term is available on the NCBI website. II SDTM-Published in P31

Proposed definition: Any bacterial organism that
can be assigned to the species Citrobacter
werkmanii.
Definition: The anatomic site at which a device II SEND-Published in P33

implanted under the skin allows access to the
vascular system.
Driver: We have animal models with

subcutaneously implanted vascular access ports
(VAP) to allow the administration of test articles
and sampling of blood. At necropsy, the tissues
surrounding the subcutaneous port are sampled
and histologically evaluated. To allow greater
flexibility for the term, I did not define the port as
venous or arterial. Currently, no acceptable term
exists in the SEND Controlled Terminology
specimen lexicon.
Definition: Granules that have an affinity for basic II Do not add (P32):
dyes, such as hematoxylin. Already published in
NONNEO codelist as
Driver: In a study, we are observing and would C120868.
like to tabulate BASOPHILIC GRANULES.
A review of the scientific literature reveals

BASOPHLIC GRANULES in the renal tubular
epithelium of animals treated oligonucleotides;
and in the bone, cartilage and dentine of animals
with elevated fluoride levels.
o The occurrence of BASOPHILIC
GRANULES in renal tubular epithelium of animal
administered oligonucleotides is considered to be
the result of oligonucleotide uptake by
endosomes/lysosomes in the renal epithelial
cells1.
o The occurrence of BASOPHILIC
GRANULES in dentin, cartilage and dentine is
considered to be from the formation of calcium
fluoride crystals; ?Basophilic granules/bodies
noted in teeth (or bones) from fluoride-treated
rats are reported to represent decalcification-
related precipitation artifact (calcium fluoride
crystal formation) not pathology?2,3.
o BASOPHILIC GRANULES is accepted
nomenclature by the National Toxicology
Program (NTP); the NTP recommends
diagnosing and grading the change4.
File emailed separately (Unit-UCUM II Do not add (P30):

Codetable_2017-04-04_for PK team) Request withdrawn by
requester.
File emailed separately (Unit-UCUM II Do not add (P30):

Codetable_2017-04-04_for UNIT team) Request withdrawn by
requester.
Can the team please confirm if this test code is II Question Answered
synonymous with the one in the MB IG example (P30):
of ORGANISM (Organism Present)?
Although this pair of terms wasn't in the CT we

had used it as per the IG example. We want to
know if we should replace it with MCORGDET
Thanks
The codelist long name for CES01TN/TC doesn't II QRS-Published in P30
contain the 'Questionnaire' as per std convention.
e.g. Combat Exposure Scale Test Code vs
Combat Exposure Scale Questionnaire Test
Code
The same is true for EPDS01TC/TN:
Edinburgh Postnatal Depression Scale Test
Code VS Edinburgh Postnatal Depression Scale
Questionnaire Test Code
and TSQM01TC/TN:
Treatment Satisfaction Questionnaire for
Medication Version 1.4 Test Code VS Treatment
Satisfaction Questionnaire for Medication Version
1.4 Questionnaire Test Code
and HAQ02TC/TN:
Health Assessment Questionnaire Disability
Index Without Pain Visual Analog Scale Test
Code vs Health Assessment Questionnaire
Disability Index Without Pain Visual Analog Scale
Questionnaire Test Code. Its a bit of a mouthful -
but thats how it is for HAQ01.
The recent retirement of 'Viral Load' LBTESTCD II Question answer (P30):

codes causes considerable problems when used Noted. A company is
with the current IG structures. free to use whatever
The Virology TAUG v2.0 shows the variable as version of terminology
LBNSPCES and this is changed in 2.1 to NHOID. is most adequate for
However neither version is final. their needs. The
The 3.2 IG doesn't have either variable in the LB LBTEST-CD codelist is
Domain. So our only option if we are not to fall also extensible. The lab
foul of CDISC/Pinnacle checks is to add the non- terminology team
host organism identifier to SUPP as a key. This is acknowledges this is an
not ideal. It is most likely that GSK will not follow issue and is actively
this convention until we start to use 3.3. For now working to solve it. We
we will continue to add extensible terms to are also constrained by
LBTESTCD so that NHOID is not used. IG publication release
Releasing terminology now for future IGs is like schedule.
putting the cart before the horse!!!
The 3.2 IG lists the codelist for MITESTCD II Question answered
variable as MITESTCD. (P30): The IG is
What will be the impact on any checks if we published infrequently
change it to MITSCD? whereas CDISC CT is
published quarterly.
Because of this, the CT
may be out of sync with
the IG. This codelist
name change may throw
a warning/error in a
system that checks for
conformance but this
can be explained to an
FDA reviewer within the
SDRG since you are
technically using the
correct codelist for a
given version of
terminology used within
your study. This is a
perennial problem that
CDISC is actively
working to solve.
There are a few new codelists in P29 which I II Question Answered

can't find in any existing IG or TAUG. (P32): Good suggestion
Would it be possible to include some reference and something that
to this when new terms are published? Ideally the CDISC will consider in
domains and variables would be finalised before future public review files
the terminology to store in them is released. But if for new codelists. This
the TAUG is in a final version maybe this could particular codelist is
be documented in a new column of the 'change' used for the findings
table? I would want to know the domain and about test/testcd values
variable. in use in the Asthma TA
For example, ASFATSCD/ASFATS should be TAUG. Good suggestion
found in the Asthma TAUG, but the only version I and something that
can find on the website is version 1.0 from 2013 CDISC will consider in
which doesn't have any reference to these future public review files
codelists. If we know what they are we can create for new codelists. This
them as quasi-Custom domains until we start particular codelist may
using 3.3. be used for the
SUPPMI.CLMETH,
I'm assuming CLMETH is attached to a new SUPPMB.CLMETH,
variable in LB in 3.3. However I can't find a draft SUPPMS.CLMETH for
of 3.3 anywhere on the website. WOuld you be the TB V2 TAUG.
able to provide a copy please? If I have this we
can create a SUPP variable with the same name
to use until we move to version 3.3
Requested Test = HIV-1/2 Antibody + HIV-1 p24 II SDTM, SEND-Published
Antigen with Test Code = HIVAB_AG in P31
This is the 4th generation HIV Ag/Ab Combo
assay
This test is available in LOINC (LOINC Code:
83101-6 (Component - HIV 1+2 Ab & HIV1 p24
Ag panel)
Proposed definition: A measurement of the
antibody reaction of a biological specimen to
either the HIV-1 or HIV-2 virus and the HIV-1 p24
antigen in a biological specimen.
Requested Test = HIV-1 Viral Load with Test II Do not add (P30):
Code = HIV1VLD Removed by requester.
Proposed Definition: A measurement of the HIV-
1 viral load in a biological specimen.
Requested Test = Hepatitis C Virus Antibody II SDTM, SEND-Published

Signal/Cutoff and Test Code = HCABSC in P31
This test is available in LOINC. LOINC Code:
48159-8 Component: Hepatitis C virus Ab
Signal/Cutoffï¿½
Proposed Definition: A measurement of the
signal strength of the hepatitis C virus antibody in
a biological specimen and signal strength of an
internal cutoff.
File emailed separately II SEND-Published in P33,

P35
The BioCelerate Toxicology Data Sharing project Do not add (P32):
is beginning to exchange more information about Target ec50 or ic50
the category of the test article and its pharmalogic value, Target ec50 or
target(s). Please consider the mentioned 9 ic50 unit: Do not add.
additions to SEND-STSPRM and SEND- Request withdrawn by
STSPRMCD. The SEND Change Control Board requester.
agreed that conceptually these are okay to add NBE sub-class;
as PARMCDs. This is documented in JIRA TRTNBES: Do not add.
SEND-18 Instead this request will
be combined into the
PARM above: Test
Article Physical
Classification.
Remove C132454 from ONCRSR codelist and II SDTM-Published with

put into ONCRSCAT codelist. Was put in the P30
wrong codelist with P29. Erin to confirm with
Barrie that this should be fixed with P30.
Required for chemistry specimens for N-Terminal II SDTM, SEND-Published
Pro-Atrial Natriuretic Peptide Measurement. in P31
As the CDISC Code List for SEND-LBTEST and

SEND-LBTEST code were not available in the
drop down lists we selected the CDISC Code List
SDTM-LBTEST. Please make the additions so
that they are suitable for SEND-LBTEST and
SEND-LBTESTCD
For LBTESTCD please add the following:
CDISC Submission Value of NTPANP
CDISC Synonym of N-Terminal Pro-Atrial
Natriuretic Peptide, NT proANP
CDISC Definition of A measurement of the N-
terminal pro-atrial natriuretic peptide in a
NCI Preferred Term of N-Terminal Pro-Atrial
Natriuretic Peptide Measurement
For LBTEST please add the following:

CDISC Submission Value of N-Terminal Pro-
Atrial Natriuretic Peptide
CDISC Synonyms of N-Terminal Pro-Atrial
Natriuretic Peptide, NT proANP
CDISC Definition of A measurement of the N-
terminal pro-atrial natriuretic peptide in a
NCI Preferred Term of N-Terminal Pro-Atrial
Natriuretic Peptide Measurement
This request is on behalf of the colorectal, II QRS-Published in P38

prostate, and lung cancer TA teams.
File emailed separately. Bob this is already in the II SEND-Published in P31,

P30 SEND working documents in the NONNEO P33
tab starting on row 30 so all you'd need to do is
add the request number. Just need a request
number.
File Emailed Separately II SDTM-Published in P31,
P32, 34
Do not add (P34):
Number of
Mononucleotide
Markers, Number of
Pentaonucleotide
Markers: This can be
derived from the lists of
nucleotide markers,
which are being
developed as controlled
terminology with P34.
This was discussed at one of the Oncology SDS II SDTM-Published in P33

meetings. The location of SOFT TISSUE is
needed for MM studies.
Rationale: "Soft tissue? for plasmacytomas in
MM is meant to convey that these are not
plasmacytomas that occur in bone (the more
common location for plasmacytomas). They are
also called ?extramedullary plasmacytoma?. The
common locations for these are the throat, lungs,
and various places in the digestive tract. If the
eCRF lists the various individual locations where
the plasmacytoma can occur, that could be
enough, but if you don?t want to list the locations,
you could say ?soft tissue? as the basic location,
and add the specific location in an additional field,
the way we do it for lesions we describe as in ?
bone?.
Reference: International Myeloma Working Group II
consensus criteria for response and minimal
residual disease assessment in multiple
myeloma.
Lancet Oncol. 2016 Aug;17(8):e328-46. doi:
10.1016/S1470-2045(16)30206-6.
Authors:
Kumar S1, Paiva B2, Anderson KC3, Durie B4,
Landgren O5, Moreau P6, Munshi N3, Lonial S7,
Bladï¿½ J8, Mateos MV9, Dimopoulos M10,
Kastritis E10, Boccadoro M11, Orlowski R12,
Goldschmidt H13, Spencer A14, Hou J15, Chng
WJ16, Usmani SZ17, Zamagni E18, Shimizu
K19, Jagannath S20, Johnsen HE21, Terpos
E10, Reiman A22, Kyle RA23, Sonneveld P24,
Richardson PG3, McCarthy P25, Ludwig H26,
Chen W27, Cavo M18, Harousseau JL6,
Lentzsch S28, Hillengass J13, Palumbo A29,
Orfao A9, Rajkumar SV23, San Miguel J2, Avet-
Loiseau H30.
Request to add new terms to MUSCTS-CD II SDTM-Published in P31

codelists. This is a TA request from the
Duchenne Team. File emailed separately.
Please update QSTEST for FAC001 and FAC023 II QRS-Published in P30

current values of:
(C127432) FAC001-Satisfied Family Comm of
Illness
(C127476) FAC023-Satisfied Family Comm of
Illness
The recommended values found in the FACIT
Item Bank posted on the CDISC QRS CT web
page are:
FAC001-Satisfied Communication Illness
FAC023-Satisfied Communication Illness
An inconsistency has been noted across the
multiple FACIT Questionnaires published by
CDISC for the question, "I am satisfied with family
communication about my illness." Of the 7
versions published by CDISC that include this
question, 2 versions differ from the rest and do
not follow the recommended text shown in the
FACIT Item Bank (posted on the CDISC QRS CT
web page)
I'd like to request IMMUNOFLUORESCENT II SDTM-Published in P32
STAIN (Def: A microscopy staining method that
utilizes immunofluorescent markers for use with
histological applications of preserved cells).
The defintition for the existing method of
FLUORESCENT IMMUNOASSAY makes it clear
this is for live cellsm (A bioassay in which
fluorescent-coupled antibodies or antigens are
used to quantify or qualify a biological response
to a stimulus).
This was a suggestion from Erin.
This request is on behalf of the PTSD TA team. II QRS-Published in P30

Note that RAND does not appear to use an
abbreviation for this measure, hence the long
QSCAT.
This request was received as an SDTMIG Batch II

3 comment: https://jira.cdisc.org/browse/SDS-993
Scientists have discovered that dying tumor cells II SDTM-Published in P34
release small pieces of their DNA into the
bloodstream. These pieces are called cell-free
circulating tumor DNA (ctDNA).
A large number of cancer genome sequencing
studies have collectively identified the genetic
changes that make human tumors grow and
progress. Scientists have discovered that
virtually all cancers carry somatic DNA mutations.
These somatic mutations are only present in
tumor cell DNA, they provide an extremely
specific biomarker that can be detected and
tracked. Although a tumor itself is the major
source of tumor DNA, acquiring DNA through a
biopsy is invasive, risky and often not possible.
However since dying tumor cells release small
pieces of their DNA into the bloodstream, this
provides the potential of screening ctDNA for
somatic mutations as a way to detect and follow
the progression of a patient's tumor.
From these findings, they discovered that the
percentage of patients with detectable levels of
ctDNA in their blood correlated with the stage of
cancer. While only 47 percent of patients with
stage I cancers had detectable ctDNA, the
percentage of patients with stage II, III and IV
cancers was 55, 69 and 82 percent, respectively.
Moreover, the scientists found that the
concentration of ctDNA in blood increased as the
cancer stage increased.
Ref:
https://www.genome.gov/27556716/circulating-
tumor-dna-a-new-generation-of-cancer-
biomarkers/
This request is submitted for Covance Test Code II SDTM, SEND-Published

ORT8865, test name Toxoplasma gondiiAb,IgG- in P31
315PNL. Its result format is numeric.
Conventional Unit and SI Unit are both IU/mL.
Specimen Type is Serum. Testing Method is
IMMUNOCHEMILUMINOMETRIC ASSAY.

ORT8865, test name Toxoplasma gondiiAb,IgG- in P31
315PNL. Its result format is numeric.
Conventional Unit and SI Unit are both IU/mL.
ORT8866, test name ?Toxoplasma gondiiAb,IgM- in P31
315PNL?. Its result format is numeric.
Conventional Unit and SI Unit are both AU/mL.

ORT8866, test name ?Toxoplasma gondiiAb,IgM- in P31
Conventional Unit and SI Unit are both AU/mL.

ORT11734, test name ?Alk Phos.Iso-Other- in P31
Conventional Unit and SI Unit are both U/L.
Heat-inactivation/enzymatic. LBMETHOD is ?
ENZYMATIC COLORIMETRY?.

ORT11734, test name ?Alk Phos.Iso-Other- in P31
Conventional Unit and SI Unit are both U/L.
Heat-inactivation/enzymatic. LBMETHOD is ?
ENZYMATIC COLORIMETRY?.

SCT2550, test name ?Myeloma SPE-Beta1(%)- in P32
CL?. Its result format is numeric. Conventional
Unit and SI Unit are both %. Specimen Type is
Serum. LBMETHOD is ?ELECTROPHORESIS?.

SCT2550, test name ?Myeloma SPE-Beta1(%)- in P32
CL?. Its result format is numeric. Conventional
Unit and SI Unit are both %. Specimen Type is
Serum. LBMETHOD is ?ELECTROPHORESIS?.
This request is submitted for Covance Test Code II Do not add (P32): Do
SCT2554, test name ?Myeloma SPE-Beta 1-CL?. not add. Already
Its result format is numeric. Conventional Unit is published as
g/dL. SI Unit is g/L. Specimen Type is Serum. C119274/Beta-1
LBMETHOD is ?ELECTROPHORESIS?. Globulin.
SCT3625, test name ?Myeloma UPE-Beta 1 not add. Already
glob-CL?. Its result format is numeric. published as
Conventional Unit is mg/24hr. SI Unit is g/24hr. C119274/Beta-1
Specimen Type is unpreserved Urine. Globulin.
LBMETHOD is ?ELECTROPHORESIS?.
We submitted a request for this test, but the
suggest SDTM-LBTESTCD was provided as
'MYESPB2A' which is incorrect. Please ignore
that request and use this one.
SCT3625, test name ?Myeloma UPE-Beta 1 not add. Already
glob-CL?. Its result format is numeric. published as
Conventional Unit is mg/24hr. SI Unit is g/24hr. C119274/Beta-1
Specimen Type is unpreserved Urine. Globulin.
This request is submitted for Covance Test Code II Do not add (P32).
SCT3626, test name ?Myeloma UPE-Beta 2 Already published as
glob-CL?. Its result format is numeric. C119276/Beta-2
Conventional Unit is mg/24hr. SI Unit is g/24hr. Globulin.
Specimen Type is unpreserved Urine.
This request is submitted for Covance Test Code II Do not add (P32).
SCT3626, test name Myeloma UPE-Beta 2 glob- Already published as
CL. Its result format is numeric. Conventional Unit C119276/Beta-2
is mg/24hr. SI Unit is g/24hr. Specimen Type is Globulin.
unpreserved Urine. LBMETHOD is
ELECTROPHORESIS.

SCT3627, test name Myeloma UPE-Beta1 in P32
glob(%)-CL. Its result format is numeric.
Conventional Unit is %. SI Unit is %. Specimen
Type is unpreserved Urine. LBMETHOD is
ELECTROPHORESIS.
SCT3627, test name Myeloma UPE-Beta1 in P32
glob(%)-CL. Its result format is numeric.
ELECTROPHORESIS.
This request is submitted for Covance Test Code II Do not add (P32). Please
SCT3628, test name Myeloma UPE-Beta2 use existing term
glob(%)-CL. Its result format is numeric. C119277/GLOBB2PT
ELECTROPHORESIS.
SCT3628, test name Myeloma UPE-Beta2 use existing term
glob(%)-CL. Its result format is numeric. C119277/GLOBB2PT
ELECTROPHORESIS.
"This request is submitted for Covance Test Code II Do not add (P32). Please
SCT2551, test name Myeloma SPE-Beta2(%)- use existing term
CL. Its result format is numeric. Conventional Unit C119277/GLOBB2PT
is %. SI Unit is %. Specimen Type is Serum.
LBMETHOD is ELECTROPHORESIS.
"
SCT2551, test name Myeloma SPE-Beta2(%)- use existing term
CL. Its result format is numeric. Conventional Unit C119277/GLOBB2PT
is %. SI Unit is %. Specimen Type is Serum.
LBMETHOD is ELECTROPHORESIS.
Interleukin-2 receptor subunit beta is a protein II SDTM, SEND-Published

that in humans is encoded by the IL2RB gene.[4] in P32
Also known as CD122; IL15RB; P70-75.[4]
To be used with SCTEST : STUDENT STATUS II

An indication as to whether a person is enrolled in
a school.
To be used with SCTESTCD : STUDENT II

An indication as to whether a person is enrolled in
a school.
To be used with SCTEST : LIVING II Do not add (P33): Do
ARRANGEMENT not add. Given the
A code specifying the living arrangement of a vagueness of this
person. For example, Living with family, Living question (seems to be
with spouse/partner, Living on own in asking both about both
apartment/house, Living in a personal residence type
group/boarding/rooming house, etc. and the relationship
between the people
that live there) the team
feels that there is
enough ambiguity with
how this question
would be answered and
used in a clinical trial.
Since there does not
seem to be consistent
usage of this across
industry, CDISC chooses
to not control it at this
time. Thsi can be an
extensible term within
the sponsor dataset.
There may be some
existing values in
SCTEST that could be
used here, like 'Social
Risk Factor'.
To be used with SCTESTCD : LIVARRNG II Do not add (P33): Do
A code specifying the living arrangement of a not add. Given the
person. For example, Living with family, Living vagueness of this
with spouse/partner, Living on own in question (seems to be
apartment/house, Living in a asking both about both
group/boarding/rooming house, etc. personal residence type
and the relationship
between the people
that live there) the team
feels that there is
enough ambiguity with
how this question
would be answered and
used in a clinical trial.
Since there does not
seem to be consistent
usage of this across
industry, CDISC chooses
to not control it at this
time. Thsi can be an
the sponsor dataset.
There may be some
existing values in
SCTEST that could be
used here, like 'Social
Risk Factor'.
This request is to add the Pharmaceutial Dosage II SDTM, SEND-Published

Form of Globule (C42937) to the SDTM_UNIT in P31
codelist also. Concomitant Therapy for a specific
trial may need to record the units as Globule
The entries for PCWG BUBLEY PROSTATE II SDTM-Published with

CANCER 1999 (PCWG1) and PCWG SCHER P30
PROSTATE CANCER 2008 (PCWG2) are in the
ONCRSCAT codelist. The PCWG SCHER
PROSTATE CANCER 2016 (PCWG3) should
also be in the ONCRSCAT codelist.
Additionally, PCWG SCHER PROSTATE

CANCER 2016 (PCWG3) should be removed
from the ONCRSR codelist.
Proposed new values (7) to METHOD codelist; II SDTM-Published in P32

Add a new SY to DXA SCAN (C48789). This II SDTM-Published in P31
change is already in the P31 General Working
Document. Just need a request number.
Please retire the following concepts from the II SDTM-Published in P31

codelist
C116250
C116249
C116248
C116247
C116254
C116253
C116252
C116251
This request is already in the P31 Virology
Working Document, just need a request code.
This is for the Duchenne TAUG II QRS-Published in P31

file emailed separately. Rows already in II SEND-Published in P31

NONNEO tab in SEND working document. Do not add (P30):
Cardiomegaly - Do not
add. While this is valid
INHAND terminology,
team feels that it would
be used rarely or not at
all. Given the gross
implications of this term.
Team prefers to not add
and wait for a sponsor to
request it.
Please add DRIP as a synonym to the term gtt in II SDTM, SEND-Published

the Unit codelist. in P31, P32
Drip is defined as a small drop of a liquid.
POTENTIOMETRY is a method used in II SDTM-Published in P32

electroanalytical chemistry, usually to find the
concentration of a solute in solution. In
potentiometric measurements, the potential
between two electrodes is measured using a high
impedance voltmeter.
The laboratory tests that use this method
include: Bicarbonate, Chloride, Potassium, and
Sodium.
LBTEST submission value should not more more II SDTM, SEND-Published

than 40 characters in P31
Disease Response and Clin Classification: HAS- II QRS-Published in P31
BLED; File emailed separately
File emailed separately I QRS-Published in P30
C129939 CDISC Definition, change to (remove I SDTM-Published in P30

letter S in namess):
describe findings about a diabetic kidney disease
event or intervention.
C128687 MSTEST Definition (codes -> names) I SDTM-Published with
change to: P30
define microorganism responses to antimicrobial
agents.
A reader performing the assessment that is given II SDTM-Published in P31
the designation of three.
A reader performing the assessment that is given II Do not add (P30):

the designation of four. CDISC will control up to
3 of an individual and
the codelist is extensible
for four or more.
This request is on behalf of the Nutrition TA team. II QRS-Published in P30
Request to add IC50 and IC95 terms. Terms II SDTM-Published in P31

already in the P31 Virology working document,
just need a request number
Please see II Do not add (P34):

"http://www.fda.gov/downloads/BiologicsBloodVa Already published.
ccines/BloodBloodProducts/ApprovedProducts/ Please use
PremarketApprovalsPMAs/UCM450406.pdf". We C139085/HIV12P24
need this added to terminology since we would
be doing HIV Ag/Ab Combo testing in one of the
clinical studies.
File emailed separately, requesting adding to II SDTM-Published in P31

"Microbiology Test Code" codelist
Definition = The concentration of oxygen that a II SDTM-Published in P36

person inhales.
Values: II Do not add (P43): Do
GERMLINE - variation inherited from parent(s). not develop. PGx team
SOMATIC - variation occurring during the has decided to 'retire the
lifetime of the individual. MUTYP variable and
MISSENSE - This type of mutation is a change replace it with
in one DNA base pair that results in the GFINHERT.
substitution of one amino acid for another in the
protein made by a gene. (NIH)
NONSENSE - A nonsense mutation is also a
change in one DNA base pair. Instead of
substituting one amino acid for another, however,
the altered DNA sequence prematurely signals
the cell to stop building a protein. This type of
mutation results in a shortened protein that may
function improperly or not at all.
INSERTION - An insertion changes the number
of DNA bases in a gene by adding a piece of
DNA. As a result, the protein made by the gene
may not function properly.
DELETION - A deletion changes the number of
DNA bases by removing a piece of DNA. Small
deletions may remove one or a few base pairs
within a gene, while larger deletions can remove
an entire gene or several neighboring genes. The
deleted DNA may alter the function of the
resulting protein(s).
DUPLICATION - A duplication consists of a
piece of DNA that is abnormally copied one or
more times. This type of mutation may alter the
function of the resulting protein.
FRAMESHIFT - This type of mutation occurs
when the addition or loss of DNA bases changes
a gene's reading frame. A reading frame consists
of groups of 3 bases that each code for one
amino acid. A frameshift mutation shifts the
grouping of these bases and changes the code
for amino acids. The resulting protein is usually
Variable: PFRESCAT: II Do not add (P30): MRD-
POSITIVE, MRD-
FUSION - used when the result reports the NEGATIVE - Do not
actual gene fusion such as ACTB-MET. include. This belongs in
RS.
VARIANT - the differences in genes between Do not add (P34): MRD-
individual members of a population as compared POSITIVE, MRD-
with the frequency in which the various gene NEGATIVE for
types are expressed. GENRCAT - Do not
MRD-NEGATIVE - Evidence of Minimal include.
Residual Disease was not found. Do not add (P43):
MRD-POSITIVE - Evidence of Minimal Residual PFRESCAT codelist: Do
Disease was found. not develop. PGx team
WILDTYPE - is the most common genetic has decided not to
result found in the population. develop CT for
HETEROZYGOUS - having dissimilar pairs of PFRESCAT and instead
genes leave it sponsor defined.
COMMON HOMOZYGOUS - having identical
pairs of genes within the highest frequency of
occurrence in the population
MINOR HOMOZYGOUS - having identical
pairs of genes within the second highest
frequency of occurrence in the population
LOSS - A qualifier used when Copy Number is
equal to zero.
NON-FRAMESHIFT - This type of mutation
occurs when the addition or loss of DNA bases
does not change a gene's reading frame.
AMPLIFICATION - In oncology, it is used to
denote DNA Copy Number amplifications which
activate oncogenes which are usually present in
nearly all advanced tumors.
Ref:
http://www.nature.com/onc/journal/v25/n55/full/12
09717a.html
SPLICE-SITE - a genetic mutation that inserts,

To be used with MITS : Bradikinin B1 Receptor II SDTM-Published in P31
A measurement of the Bradikinin B1 Receptor in

To be used with MITSCD : BRAB1R II SDTM-Published in P31
A measurement of the Bradikinin B1 Receptor in

Needed for SDTM lab test reporting and not II SDTM, SEND-Published
found in current release. Need LBTEST and in P32
LBTESTCD added.
Definition: Participants are re-randomized during II
the life of a clinical trial based on protocol
requirements.
Do not add (P30) - lease
use RANDOMIZED BY
MISTAKE in the
NCOMPLT codelist (out
for public review with
P31).
Please see email sent 16th May 2017 for details II
CELLUARITY, INCREASED II SEND-Published in P31

STROMAL PROLIFERATION Do not add (P30):
STROMAL PROLIFERATION, VALVE Stromal Proliferation -
Request removed by
requester (team) Do not
add. We do not yet have
a context for this use in
anything other than
valves.
1. Remove synonym from C112430. II SEND-Published in P31

2. Update definition of C3113 to: Increase in the
number of resident cells, generally with an
increase in mitotic figures present, per unit area
in an organ or tissue.
Please change "Mycobacterium Tuberculosis" to II SDTM-Published in P31
"Mycobacterium tuberculosis" in C128982
(CDISC submission value, SY and NCI PT
change). The species level word should start with
a lowercase "t" in Tuberculosis. This request is
already in the P30 Virology Working Document,
just need a request number.
Covance Central Lab test code ORT7644, test II SDTM, SEND-Published

name Hep. E VirRNA-Qual, IMMUNOLOGY, in P32
serum sample with lab method of POLYMERASE
CHAIN REACTION. Suggest LBTESTCD of
HERNA
Covance Central Lab test code ORT7644, test II SDTM, SEND-Published

name Hep. E VirRNA-Qual, IMMUNOLOGY, in P32
serum sample with lab method of POLYMERASE
CHAIN REACTION. Suggest LBTEST of
'Hepatitis E RNA'
Proposed definitions: II SDTM-Published in P31

KLEBSIELLA PNEUMONIAE, ESBL - Any
bacterial organism that can be assigned to the
species Klebsiella pneumonia and produces
extended-spectrum beta-lactamases (ESBL).
KLEBSIELLA OXYTOCA, ESBL - Any bacterial

organism that can be assigned to the species
Klebsiella oxytoca and produces extended-
spectrum beta-lactamases (ESBL).
Request to add three new terms to Microorg II SDTM-Published in P31
codelist. This request is already in the
Microbiology Working document, just need
request number:
PSEUDOMONAS AERUGINOSA, NON-
MUCOID
PSEUDOMONAS AERUGINOSA, MUCOID
PSEUDOMONAS AERUGINOSA, SMALL-
COLONY VARIANT
Request to update C132417 and C122305. The II SDTM-Published in P31

changes are in the Microbiology Working
document, just need a request number.
Proposed definition: A relative measurement II SDTM, SEND-Published

(ratio or percentage) of the globulin to creatinine in P32
Proposed batch of Protocol entities P31 content. II Protocol-Published in
Erin will create the P31 public review draft so I P31
just need a review number.
A spontaneous tumor of rats composed of II
eosinophilic to amphophilic cells with granular to
vacuolar cytoplasm. Vacuoles are a required
component.
Proposed Definition: Any fungal organism that is II SDTM-Published in P31

not assigned to the species level but can be
assigned to the Arthrographis genus level.
Reference: NCBI Taxonomy
NCI Definition: Pathologist is a doctor specialized II SDTM-Published in P32

in medical diagnosis based on the macroscopic
and microscopic study of structural changes of
tissues and organs caused by the disease.
Term used in the collection of histologic data

being mapped to MI domain.
Proposed Definition: The group of lymph nodes II SDTM, SEND-Published

located beneath the chin. in P32
These are the small nodes that lie superficial to
the mylohyoid muscle; they receive afferents from
the lower lip, chin, and the tip of the tongue, and
send efferents to the deep lateral cervical nodes;
these nodes are part of the pericervical collar of
lymph nodes that initially receives drainage from
the head.
Cocaine and Metabolites - we are receiving this II SDTM, SEND-Published
test from the vendor Covance. From the vendor - in P32
The assay is designed to detect
Benzoylecgonine. However it will detect Cocaine
at concentrations greater than 25,000 ng/mL and
will also detect ecgonine at concentrations
greater than 5,000 ng/ml.
Proposed Test Code: COCANEMB
Proposed Definition: A measurement of cocaine
and metabolites present in a biological specimen.
11-Nor-9-Carboxy-Tetrahydrocannabinol - we
are receiving this test from the vendor Covance.
From the vendor - The assay is designed to
detect major urinary metabolites of 9-carboxy-
THC.
Proposed Test Code: THCCOOH
Proposed Synonym:9-Carboxy-THC
Proposed Definition:A measurement of 11-nor-
delta-9-tetrahydrocannabinol-9-carboxylic acid
present in a biological specimen.
For one of the readings evaluated, there are 5 II Do not add (P30):
readers, not just Reader, Reader 1 and Reader 2. CDISC will control up to
Request to add READER 5 to codelist. 3 of an individual and
the codelist is extensible
for four or more.
Please add the new term LATERAL VENTRICLE II SDTM, SEND-Published

to LOC. Request is already in the General File, in P31
just need request code.
Please add the two new terms to NCOMPLT II SDTM-Published in P31

codelist: RANDOMIZED BY MISTAKE WITH
TREATMENT; RANDOMIZED BY MISTAKE
WITHOUT TREATMENT. Request is already in
the General File,just need a request code.
Request to update CDISC definitions for II SDTM-Published in P31

C127575, C127576, C127573, C127574. The
changes are already in the CV working
Implementation updates were made since the II SEND-Published in P32
original creation of the domain code. Pups (live
born) are not included in this domain.
This domain captures observations for fetal
pathology examinations or fetal morphology
findings.....
This domain captures morphological changes of
fetuses for fetal pathology examinations....
Lab tests to be evaluated for standardization. II SDTM-Published in P32

Detailed request in email. Do not add (P32).
Smith Antibody -
Already published;
please use
C92281/SMTHAB. The
SmD peptide is given to
the subject to induce a
response so is part of
the assay method
perhaps.
Tetanus IgG antibodies -
Already published;
please use
C103382/CTTIGGAB or
C135406/CTXIGGAB.
Already available in the NCI Thesaurus (C12337) II SDTM, SEND-Published

with a definition of: The opening of the ureter in in P32
the bladder that is situated at the lateral angle of
the trigone.
Synonym = Ureteral Meatus
These 2 methods are being requested as they II SDTM-Published in P32

are being used for an Ophthalmic Examination
form. Both of these terms are available in NCI.
Tonometry - this request is for a more generic
term than the 2 terms currently available in the
Method codelist. NCI code is Code C120543 and
definition is A method in which pressure is
applied to the surface of the cornea in order to
flatten a prespecified area of the membrane,
which is used to calculate intraocular pressure.
Fluorescence Angiography - NCI code is Code
C116569 and definition is An examination
technique that uses fluorescent dye and a
specialized camera to inspect blood flow in the
retina and choroid.
This is a proper term identified in Nomina II SEND-Published in P33
Anatomica Veterinaria 4th ed. (p122) and in
Miller?s Anatomy of the Dog,
2nd ed
Definition: A cutaneous nerve in the

leg/Hindlimb; a branch of the femoral nerve.
The term would be used to describe this nerve.

in P32
For LBTEST/CD tab rows 36 and 37: RDWRSD II SDTM, SEND-Published

and RDWR in P31
For changes to existing codelists tab rows 62
and 63: Update definition for C64797
Modeled from: TABLET, DELAYED RELEASE. II SDTM, SEND-Published
Also consider CAPSULE, IMMEDIATE RELEASE in P32
etc
A measurement of renal papillary antigen 1 (RPA- II SDTM, SEND-Published
1) in a biological specimen. in P32
This is needed in SEND and SDTM controlled
terminology.
This request is on behalf of the PTSD TA team. II SDTM-Published in P32.
See row 18 of NONNEO tab in SEND P31 II SEND-Published in P31

working document. Term already there, just need
a request code.
Consider updated Definitions: II SDTM-Published in P32
C12739: The outer part of the renal parenchyma
beneath the renal capsule. It contains glomeruli
and tubules.
C12740: The inner part of the renal
parenchyma. It consists mostly of collecting
tubules and is organized in sections called
pyramids.
C12353: One of the cerebral lobes. It is located
inferior to the frontal and parietal lobes and
anterior to the occipital lobe.
This was incorrectly coded when initially II

published.
1. Changes to existing - please add synonym II SDTM-Published in P31
irRC to existing term C126051
2. Please add two new terms to TUIDRS
codelist - NEW NON-TARGET and NEW
TARGET
A measurement of tumor necrosis factor gamma II Do not add (P32):
in a biological specimen. Please use existing
published term of
Interferon Gamma.
Comment from
requester: On further
review, it appears that
the term I was given the
reference to was
incorrect and in fact a
typo as it should have
listed Interferon gamma.
For non-clinical our only options are sacrificed- II Do not add (P32): Do
scheduled, -moribund, or -non-moribund. There not add. Please use
are many instances where we sacrifice a study Moribund Sacrifice.
animal in-extremis at the study director's request,
as well as the attending veterinarian.
File emailed separately II SDTM-Published in P31
(P31_CDISC_Request_numbers _pending_rd)
Pls consider adding new terms to CVTEST and II SDTM-Published in P32,
DOTEST codelists. This is a TA request from the P33, P35
CV Imaging TA team. File emailed separately.
File emailed separately. II SDTM-Published in P32
Do not add (P32).
Sperm Concentration -
Already published;
please use
C74663/SPERM
Sperm Motility Grade -
Already published;
please use
C102281/SPERMMTL
Sperm Morphology
(Strict) - Please use new
tests being proposed:
Normal Sperm/Total
Sperm and Sperm
Morphology
Interpretation. Put the
criteria name and
version in the ANMETH
variable.
Sperm Morphology
(WHO) - Please use new
tests being proposed:
Normal Sperm/Total
Sperm and Sperm
Morphology
criteria name and
version in the ANMETH
variable.
Sperm Morphology -
Please use new tests
being proposed: Normal
Sperm/Total Sperm and
Sperm Morphology
criteria name and
Definition: The mucous membrane lining the II Do not add (P32):
uterus. The entry of ENDOMETRIUM is required Please use SPECTYPE
for women's health studies where the specimen is of TISSUE with LOC of
from the endometrium specifically. There is ENDOMETRIUM.
currently no other term that covers this area.
This term is used in the example here II SDTM-Published in P35

https://wiki.cdisc.org/display/SDD/RE+Example+1
This term is used in the example II SDTM-Published in P35

https://wiki.cdisc.org/display/SDD/RE+Example+1
QSTESTCD = QIDSR108, QIDSR109 II
CDISC Definition(s) use ..."for the past seven
days...", which is not correct. Only timing
information: "within the last two weeks", should be
included.
The two time frames in the CDISC Definition is

causing confusion for Lilly.
REQUEST RATIONALE II Do not add (P32).

For pediatric rheumatology clinical trials, Already published in
physician experts separate the subtalar joint from codelist; see C33653.
the intertarsal joints when identifying inflamed
joints to assess the Juvenile Idiopathic
Rheumatology (JIA) American College of
Rheumatology (ACR) response which is a very
sensitive measure and is the primary endpoint
measure in clinical trials of JIA. The number of
affected joints is counted and subtalar and
intertarsal are counted independently.
Given this we have the two as separate joints on

the CRF. The subtalar joint is not currently in the
CDISC list and we would like it added.
A question may arise regarding our request,

since the anatomical definition of the intertarsal
joint shows that it is actually seven individual
joints, one of which is the subtalar joint.
Specifically, the intertarsal joints are: the subtalar
joint, the calocalcaneonavicular joint, the
calcaneocuboid joint, the cuneonavicular joint, the
cuboideonavicular joint, and the intercuneiform
joints. The rationale for separating them in the
worksheet, and thereby in the CRF, is functional.
When the intertarsal joints are injected the
location is the same for all of them and, indeed, it
is not possible to clinically separate the exact
location of the inflammation or the fluid from the
injection, versus the subtalar injection, which can
be injected alone.
Given this functional difference and it?s direct

implications for the actual number of affected
joints for children with JIA, it is important to have
a separate and specific label for both intertarsal
BMDZ has been suggest for inclusion in the p31 II
CT release by the DMD team, but related and
underlying terms are currently not included. For
full DXA studies there terms would be required for
a full set of results. For example the T-Score is
often an endpoint rather than (or in addition to)
the Z-Score, and it is more transparent to include
the raw values as well as the 'Score' result.
For further consideration, DXA results for bone
densitometry are often required to be corrected
over the course of, or at the end of a study to
account for longitudinal drift in scanner output
over time, and for calibration across scanners on
a study, due to the non-uniform results across
DXA scanners. It is often required to deliver both
the raw results and the corrected results for
transparency, and for when data is not yet
available for correction but preliminary result
delivery is required. Would it be appropriate to
define distinct terms for these corrected results?
Currently there is no other METHOD term II SDTM-Published in P32

available for FP and CFP
The length of the LBTEST C127632 is 41 chars II SDTM-Published in P31

(Proliferating Erythroid Cells/Total Cells)
Can you please reduce this
From Protocol Entities team: Submit a request for II SDTM-Published in P32

the general to consider whether STYPE needs to
be recoded to another c-code in NCIt. Right now
it is coded to 'Study Design'. We are not
convinced this is a 1:1. Also please review the
existing definition, we don't think it is adequate for
the response values in the codelist C99077.
Definition: An imaging technique that uses small II Do not add (P33): Do

amount of a substance called radioactive MIBG not add. Please use
(metaiodobenzylguanidine) is injected into the existing term
vein and travels through the bloodstream. Cancer C127514/NUCLEAR
cells from tumors like neuroblastomas and RADIOLOGY. Please
pheochromocytomas take up the radioactive put the MIBG tracer
MIBG and are detected by a scanner. information in either the
AG domain or as a NSV
in the lab domain.
A Controlled Human Malaria Infection study is II Do not add (P33): Do
using female mosquito bites to deliver P. not add. This is a
falciparum, see ClinicalTrials.gov identifier modeling issue and out
NCT03014258. of scope for CT. This
clearly should be in one
of the intervention
domains, more suitable
for the AG domain,
where “bite” should be
represented by some
type of “route for
administration” but not in
the ROUTE variable we
use right now. Because
the current ROUTE
variable is used for
therapeutic
agents/treatments that
are actually beneficial to
the subject; biological
agents that are harmful
and hazardous to the
subject, its
administration will
require a different type
of “ROUTE”. Also the
Mosquito part needs to
be represented
elsewhere, it does not
belong in “ROUTE”.
lease updated CDISC submission value, SY and II SDTM-Published in P32

NCI PT for C128983. This request is already in
the Microbiology working document, just need a
change request code.
Codelist for reasons why arm and/or armcode II SDTM-Published in P32
variables are null; Codelist described here
https://wiki.cdisc.org/display/SDTMIG33/Draft+Co
ntrolled+Terminology+for+ARMNRS; File emailed
separately.
Create four new terms for new vaccines findings II SDTM-Published in P32
about codelist. File emailed separately
From Diane Wold: II SDTM-Published in P32
We had two comments from Japan about the
Gleason score, requesting that we cover a new
classification:
https://jira.cdisc.org/browse/PRCA-506
https://jira.cdisc.org/browse/PRCA-518
Our response was that these were not in the
original project scope and would be considered
for future.
Erin contributed some thoughts on developing
controlled terminology for the ?grade group?
classification in comments on PRCA-506. I
thought it might be a good idea to go ahead and
develop this terminology, even if it?s not in the
TAUG-PrCa. We could inform PMDA, and
through them the academic organization in
Japan, that we are acting on their suggestion, if
not including it in the TAUG. It might also help
them to understand that they can request
terminology independent on particular projects.
Gut-associated lymphoid tissue (GALT) consists II SDTM, SEND-Published

of isolated or aggregated lymphoid follicles in P32
forming Peyer?s patches (PPs). By their ability to
transport luminal antigens and bacteria, PPs can
be considered as the immune sensors of the
intestine. PPs functions like induction of immune
tolerance or defense against pathogens result
from the complex interplay between immune cells
located in the lymphoid follicles and the follicle-
associated epithelium. (Int J Inflam 2010;
2010:823710)
A measurement of the PAX3 FKHR Gene fusion II SDTM-Published in P32

protein in a biological specimen.
PAX3: paired box family transcription factor 3;
splotch; CDHS; HUP2; WS1; WS3; Pax3, paired
box 3
FKHR: Forkhead box protein 1; FOXO1; FKH1;
FOXO1A; forkhead box O1
A measurement of the PAX3 FKHR Gene fusion II SDTM-Published in P32

protein in a biological specimen.
PAX3: paired box family transcription factor 3;
splotch; CDHS; HUP2; WS1; WS3; Pax3, paired
box 3
FKHR: Forkhead box protein 1; FOXO1; FKH1;
FOXO1A; forkhead box O1 paired with term
Fused PAX3 FKHR Genes previously submitted
A technique used to selectively replicate nucleic II

acid sequences from RNA templates using
reverse transcriptase and RNA polymerase with
contrast.
A cardiac ultrasound performed by passing a II
specialized probe containing a transducer into the
patient's esophagus with contrast medium.
Background for creation of this codelist is in II SDTM-Published in P33

comments to JIRA issue SDDS-450 Do not add (P35):
https://jira.cdisc.org/browse/SDS-450 SUPP - do not add,
File mailed separately SEND can create their
own value; do not add.
MO not included in
SDTMIG v3.3; Specific
SUPP domains added
as part of P33.
Half-life determined in dosing interval TAU II SDTM, SEND-Published

in P33
To be used with PKPARM: Half-Life TAU
Half-life determined in dosing interval TAU II SDTM, SEND-Published

in P33
To be used with PKPARMCD: TAUHL
The first order rate constant associated with the II SDTM, SEND-Published
terminal (log-linear) portion of the curve in P33
determined in dosing interval TAU
To be used with PKPARM: Lambda z TAU

The first order rate constant associated with the II SDTM, SEND-Published
terminal (log-linear) portion of the curve in P33
determined in dosing interval TAU
To be used with PKPARMCD: LAMZTAU
The lower limit on time for values to be included II SDTM, SEND-Published

in the calculation of Lambda z determined in in P33
dosing interval TAU
To be used with PKPARM: Lambda z Lower Limit

TAU
The lower limit on time for values to be included II SDTM, SEND-Published

dosing interval TAU
To be used with PKPARMCD: LAMZLTAU

The upper limit on time for values to be included II SDTM, SEND-Published
dosing interval TAU.
To be used with PKPARM: Lambda z Upper

Limit TAU
The upper limit on time for values to be included II SDTM, SEND-Published
dosing interval TAU.
To be used with PKPARMCD: LAMZUTAU

The number of time points used in computing II SDTM, SEND-Published
Lambda z determined in dosing interval TAU in P33
To be used with PKPARM: Number of Points for

Lambda z TAU
The number of time points used in computing II SDTM, SEND-Published
Lambda z determined in dosing interval TAU in P33
To be used with PKPARMCD: LAMZNTAU

Multiple term request for Huntington's Disease II SDTM-Published in P32,
TAUG - Batch 1; File emailed Separately P33
The Lymph2Cx is a digital gene-expression assay II SDTM-Published in P37

for "Cell Of Origin" (COO) assignment in lysates
from formalin-fixed paraffin-embedded tissue
(FFPET) on the automated nCounter platform.
The technology is based on a direct multiplexed
hybridization of color-barcoded mRNA probes
with subsequent optical count on single-molecule
level.
In the Lymph2Cx assay expression of a 20-gene
panel is used to assign diffuse large B-cell
lymphoma (DLBCL) to either being germinal
center B-cell-like (GCB) or activated B-cell-like
(ABC) .
STUDY REFERENCE datasets establish study- II SDTM-Published in P33

specific terminology that will be used in subject
data.
See draft section is upcoming version of the
SDTM
https://wiki.cdisc.org/display/SDTM1DOT7/Study+
References?src=contextnavpagetreemode
We need to differentiate between STI test results II SDTM-Published in P32

and would like to use the --SPEC variable to do
so.
We need terminology for two STI tests: a whiff II
test and homogenous vaginal discharge. These
are not true lab tests but the results are
positive/negative and I could see them fitting into
a laboratory test code but I could also be open to
an alternative recommendation.
These are tests frequently used in our HIV
vaccine and prevention trials and it would be
good to have some controlled terminology or a
better idea of where to represent this information.
https://www.ncbi.nlm.nih.gov/books/NBK288/
The area under the curve (AUCTAU) at steady II

state divided by the area under the curve
extrapolated to infinity for the initial dosing
interval.
To be used with PKPARM : Stationarity Ratio
AUC
The area under the curve (AUCTAU) at steady II

state divided by the area under the curve
extrapolated to infinity for the initial dosing
interval.
To be used with PKPARMCD : SRAUC
For the following terms, this request is already in II SDTM, SEND-Published
the P32 ECG working Doc, just need request in P32
number:
C102597
C102639
C116129
C102652
C62257
C102603
C62256
C107100
C62259
C90483
Definition - The Supraclavicular fossa is an II SDTM, SEND-Published

indentation (fossa) immediately above the in P32
clavicle.
These Bladder Wall locations are being used in a II Do not add (P33):
Bladder Cancer study. Please use existing LOC
The NCI definitions and codes are: concept BLADDER
Bladder Wall, Posterior (Code C12335) - The WALL, with a DIR of
posterior aspect of the bladder wall. Posterior, Anterior, or
Bladder Wall, Anterior ( Code C12334) - The Lateral.
anterior aspect of the bladder wall.
Bladder Wall, Lateral (Code C12333) - The
aspect of the bladder wall that is located on the
side.
SDTM, SEND-Published
in P32, P33
Do not add (P33):
Troponin I, Cardiac - Do
not add. This is a
synonym to C135448.
T4INDEX; Thyroxine
Free Index: Do not add.
This has been removed
from the LOINC
mapping as the test has
become dated.
PSAFPSAT; Free
Prostate Spc Ag/Tot
Prostate Spc Ag: Do not
add. Already published
as C132384/PSAFPSAT
RTLPLMTT; Retinyl
Palmitate: Do not add.
C135442.

in P32
I reviewed the attached extract from the current II
CT released on 6/30 with the SDSeLT team on
Monday and I am actioned to follow-up with the
general terminology team for revision
considerations. Marcelina Hunguria initially had
the following JIRA issue
https://jira.cdisc.org/browse/SDS-1180.
I reviewed all of the body system based
domains when investigating this issue and noted
the attached inconsistencies across the domains
in ORANGE shaded cells. The body systems
with YELLOW shading are not officially released
in SDTM. I think it would be easier for searching
and understanding them if these were consistent
across all of these domains.
Some thoughts are:
â€¢ Should all code list names be â€œbody
systemâ€ test code or â€œbody systemâ€
findings test code?
â€¢ Should codelists for be consistently be
named â€œâ€”TESTCDâ€ with the
â€“indicating the body system domain?
â€¢ Should Ophthalmic Examinations be made
consistent in the TESTCD codelist?
Please let me know if you have any questions
and I would be happy to attend a general
terminology team meeting when this is review
Colorectal (FACT-C V4) is a TA request; the II QRS-Published in P31,

others are sponsor requests. P34
These are sponsor requests. II QRS-Published in P34
FACIT-DYSPNEA is a TA request for the lung II SDTM-Published in P33,

cancer team. The other is also being developed P34
for sponsors and testing of new SHARE QRS
Maker to help with QRS standards development.
Since U/L has been defined as an aribary unit per II SDTM, SEND-Published
liter and a distinction has been made specifically in P33.
for an Enzyme Unit as a standand alone unit, I
would like to ensure that we have the enzyme
unit concentation for use with common enzymes
such as ALT, AST etc....
FTTESTCD/FTTEST/FTCAT for the 10 meter II SDTM-Published in P32.
walk/run for the Duchenne TAUG
FTTESTCD/FTTEST/FTCAT for 4 stair II SDTM-Published in P32.

ascend/descend for Duchenne TAUG
FTTESTCD/FTTEST/FTCAT for Rising from Floor II SDTM-Published in P32.

for Duchenne TAUG
New hematology terms and synonyms from II

LOINC mapping; File E-mailed Separately
in P33
Do not add (P33):
LEUKLS; Left Shift
Leukocytes: Do not add.
Please use existing
published term 'Left
Shift Neutrophils'
C116202.
HRYCELE; Hairy
Cells/Leukocytes: Do
not add. Already
published; C135428
Add new LBTEST-CD terms, also modify exsting II
lab terms; File emailed separately
in P33
Do not add (P33):
ACTIGGAB; Actin IgG
Antibody: Do not add.
This has been added as
a synonym to
C122151/Smooth
Muscle IgG Antibody.
Please considering adding these terms. This II SDTM, SEND-Published
request comes from the TCM-CAD-Angina TA in P33
team. File emailed separately. Do not add (P33):
Type of Exercise Stress
Test
Protocol/TPESTPRO:
Do not add. This is
important information to
capture but using TS,
however, is an
intermediate solution
while a more permanent
solution for representing
this type of test-level
trial summary
information is being
discussed. Since this is
a temporary solution,
the terminology for
TSPARMCD/TSPARM
used in the example is
not being developed.
Highest Diastolic Blood
Pressure/HIDIABP: Do
not add. Based on MRC
decision here:
https://wiki.cdisc.org/x/h
oFAAg; please use
existing term Diastolic
Blood Pressure and use
a NSV to capture
'Highest'.
Highest Systolic Blood
Pressure/HISYSBP: Do
not add. Based on MRC
decision here:
https://wiki.cdisc.org/x/h
Please consider adding new trial summary II Do not add (P33): Do
terminology; this is a TA request from the not add. The starting
Duchenne team. File emailed separately positions for Range of
Motion tests are
important in order to
correctly interpret the
results. For Example 3
in Section 4.6,
Musculoskeletal
Assessments, the Trial
Summary (TS) domain
was used to represent
the starting position of
each Range of Motion
test. Using TS, however,
is an intermediate
solution while a more
permanent solution for
representing this
information is being
discussed. Since this is
a temporary solution,
the terminology for
TSPARMCD/TSPARM
used in the example is
not being developed.
Description: Oatp1a/1b homozygous Knockout II Do not add (P35): Do

rats not add. The SEND
team will not be adding
additional transgenic,
knockout, or other
genetically modified
strains to the list unless
the FDA requests the
term, based on usage.
The codelist is
extensible so sponsors
should feel free to
extend the codelist as
required.
FOR UDATED CODELIST II
"AMA: SI Conversion Calculator" and "globalrph: II SDTM, SEND-Published

SI Units for Clinical Data" use "Proportion of 1.0" in P33
instead of "fraction of 1".
I suggest that "Proportion of 1.0" is added on
CDISC Synonym of "fraction of 1".
Please consider adding new ECGTEST-CD II Do not add (P32):
terms. This is a TA request from the TCM-CAD- Highest Bruce Protocol
Angina Team. File emailed separately. This Stage Achieved;
request has already been added to the ECG Bruce Protocol Exercise
working document, just need a request code. No Stress Test Scr; ST
Triagging needed. Segment Depression
≥0.10 mV Indicator;
Time to ST Segment
Depression ≥0.10 mV;
Ind for Termin of
Exercise Stress Test ->
These are not true ECG
findings. An ECG finding
that can be represented
by the EG domain
needs to be a finding
produced by an ECG
recording. These are
findings about the
exercise stress test that
happens to use ECG.
New Terms for Drug Screening from LOINC II

matching; File emailed separately
in P33
Do not add (P32):
Clonazepam;
Oxazepam;
Nordiazepam - Already
published in P31.
Do not add (P33): APAP;
Acetaminophen: Do not
add. Published as
C135398.
enzyme-linked lectin assay II
Ella is an automated immunoassay system
using a combination of microfluidics and
immunofluorescence technologies. Compared
with ELISA, Ella has increased sensitivity, wider
dynamic range, minimum sample consumption,
lower cost, faster turnaround time, and multiplex
capability.
CDISC Description for C102356 has a small
error. It reads ?The area under the curve
(AUCTAU) at steady state divided by the area
under the curve (AUCTAU) over the initial dosing
interval.? and I think the term in red and bold is
wrong. Please check the definition. Peter
Schaefer
LBTESTCD: DNVAB - Dengue Virus Antibody II SDTM, SEND-Published

LBTESTCD: JEVAB - Japanese Encephalitis in P33
Virus Antibody Do not add (P33):
LBTESTCD: WNVAB - West Nile Virus Antibody ROUTE:
LBTESTCD: YFVAB - Yellow Fever Virus SCARIFICATION:
Antibody Please use
LBTESTCD: ZKVAB - Zika Virus Antibody INTRADERMAL as the
ROUTE: SCARIFICATION; File emailed ROUTE of
separately. administration. Creating
a procedure record may
be overkill, though not
forbidden, and instead
perhaps consider use of
METHOD (which will be
available for use in EX
domain with 3.3) for this
concept or a Method-
esque NSV for any other
interventions domain
that is not EX.
Please consider adding SDIAM / Shortest II Do not add (P33): Do

Diameter, because TRTESTCD/TRTEST include not add. The shortest
Longest Diameter but does not include Shortest diameter of any lesion is
Diameter. 0. What we think they
mean is the need for a
short axis measurement,
which the team strongly
suggest they use the
existing test value of
LPERP. Team will not
add SDIAM to the
codelist.
From Julie Chason: I?m a bit curious about the II SEND-Published in P33
CDISC definition for Congenital Abnormality
(Code C2849), ?Abnormal or anomalous
formation or structure.? It seems too general for
a congenital abnormality. The concept is
associated with the SEND CT CDISC submission
value MALFORMATION, which does seem to fit
the definition.
From Erin: suggest to either include the fact that
these occur during gestation and are present at
birth within the definition OR will need to consider
re-coding this concept.
These terms are used for an Head& Neck II SDTM, SEND-Published

Oncology trial in P33
Proposed definitions:
PRETRACHEAL LYMPH NODE - A lymph node
located anterior to the trachea.
PRELARYNGEAL LYMPH NODE - A lymph
node located anterior to the larynx.
PARALARYNGEAL LYMPH NODE - A lymph
node located adjacent to the larynx.
In Belgium (and some other countries), blood II SDTM, SEND-Published

pressure is always measured in centimeters of in P33
mercury column. The notation in electronic health
records is cm[Hg]. There is currently no synonym
for this in the "UNIT" codelist. Please add cm[Hg]
to the "UNIT" codelist and to the corresponding
sub-codelist for vital signs.
Adding the UCUM notation as a "CDISC II Question Answered
synonym" will finally allow to automate mapping (P33): CDISC currently
from units from electronic health records (all using produces a mapping
UCUM notation) to "CDISC units", and pave the between CDISC UNIT
way to a gradual transition to UCUM anyway. CT and valid UCUM
Without having the UCUM notation as a annotations and this file
"synonym", the mapping is currently a tedious, is available on the
manual and error-prone trask. CDISC.org terminology
In the XML representation, I propose to use page. It is produced
something like: programmatically with
<EnumeratedItem CodedValue="ohm" each quarterly
nciodm:ExtCodeID="C42554"> publication.
<nciodm:CDISCSynonym>Ohm</nciodm:CDISC
Synonym>
<nciodm:UCUMRepresentation>Ohm</
UCUMRepresentation>
<nciodm:CDISCDefinition>...</
nciodm:CDISCDefinition>
<nciodm:PreferredTerm>Ohm</
nciodm:PreferredTerm>
</EnumeratedItem>
with "ohm" (lowercase) being the "CDISC
submission value" and "Ohm" being the UCUM
representation
Multiple term request for P31 terms still needing II SDTM-Published in P31
request numbers. These have already been taken
care of and will be published with end of
September publication so NO NEED TO ADD TO
P32 or P33 CT WORKING ; File emailed
separately.
A measurement of N-methylhistamine in a II SDTM, SEND-Published

Need request code for P32 ECG public review II SDTM-Published in P32
doc; Chris, PLEASE DO NOT TRIAGE THIS
REQUEST, this is not for P33, these terms are in
the P32 public review doc.
Need request number for P32 Public Review Doc II SDTM-Published in P32
for Microbiology; Chris, PLEASE DO NOT
TRIAGE THIS REQUEST, this is not for P33,
these terms are in the P32 public review doc.
This request contains 13 proposed new CVTEST- II
CD terms and 13 changes to existing codelist
concepts. These changes are being requested in
order to create new test terminology to support
existing, published codelists, that do not yet have
published test terms to go with them. File Emailed
Separately
To be used with MITS : Bradikinin B1 Receptor II Do not add (P33): Do
not add. This term has
already been published
in MITS-CD codelist.
To be used with MITSCD : BRAB1R II Do not add (P33): Do
not add. This term has
already been published
in MITS-CD codelist.
A measurement of the PTEN protein in a II
To be used with MITS: Phosphatase and Tensin

Homolog
A measurement of the PTEN protein in a II
To be used with MITSCD: PTEN

Radiotherapy, a term used in Example 3 in the II SDTM-Published in P33
upcoming SDTMIG v3.3
https://wiki.cdisc.org/display/SDTMIG33/PR+Exa
mple+3
Definition should parallel those for more specific
forms of radiotherapy. needed to support
SDTMIG
Submitting a multiple term request for P32 II SDTM-Published in P32

terminology going out for public review that needs
request codes. Chris, do NOT triage this multi-
term request. The items are already in the
appropriate working documents for P32 and do
not need to be added again.
File emailed separately:
Contains requests for 24 new terms and 48
changes to existing that have been approved to
go for public review with P32.
4 new terms for PTSD project, 1 new term for
HIV project, and 6 new terms for Lung Cancer
project.
We would like METHOD=ASPIRATION added to II Do not add (P33): Do

controlled terminology because we have tests not add. This is a
where the specimen is BONE MARROW and the collection Method.
method is ASPIRATION. Bone marrow aspiration Please use NSV of
is the removal of a small amount of this tissue in CLMETH.
liquid form for examination. [Bone marrow
aspiration is not the same as bone marrow
biopsy. A biopsy removes actual marrow for
examination.]
The 'LYMPH NODE, DRAINING' code is needed II SEND-Published in P34
due to a decission by NN Pathologists to pool
findings in separate injection sites injected
multiple times with the same compound and by
doing so making the pooling of draining lymph
node a necessity.
Definition: A single lymph node or a
collection/pool of lymph nodes draining a specific
area(s)/organ(s) of interest
Even though COSTOCHONDRAL JOINT is II SEND-Published in P33

anatomically different from most other joints in the
SPEC code list we wonder if it could be changed
to 'JOINT, COSTOCHONDRAL' to enhance
consistency/searchability in the code list - if not
we wonder if we can apply for the term .'JOINT,
COSTOCHONDRAL' instead.
Requesting addition of organism OXACILLIN II

RESISTANT STAPHYLOCOCCUS AUREUS for
an Infectious Disease study. Also requesting the
addition of the synonym ORSA.
Proposed Definition: Any bacterial organism that
can be assigned to the species Staphylococcus
aureus and is resistant to oxacillin.
Request to add LBTESTCD of TPRO_CF and II Do not add (P32): Please

LBTEST of Total Protein Cerebrospinal Fluid for use C64858/Protein as
Covance test code ORT7053. measurement of the LBTEST and SPEC =
total protein using SPECTROPHOTOMETRY on Cerebrospinal Fluid
specimen type LBSPEC of CEREBROSPINAL
FLUID
Codelist long name needs to be changed from II

'Death Diagnosis' to 'Death Details' in support of
SDTMIG3.3.
Codelist long name needs to be changed from II Do not add (P32): Do

'Death Diagnosis' to 'Death Details' in support of not change. It is
SDTMIG3.3. currently consistent with
SEND IG 3.1.
To support new domain in the SDTMIG, II Do not add (P32):
described here Withdrawn by requester.
https://wiki.cdisc.org/pages/viewpage.action? An ad hoc QT
pageId=29923747&src=contextnavpagetreemode terminology team will be
formed to review the QT
domain terminology.
The fluid within the kidney. II Do not add (P34): Use

the existing SPEC of
ASPIRATE, with an
ANTREG of Kidney or
Kidney Cyst.
AJCC Staging can be clinical or pathological. II
"CLINICAL EXAMINATION" already exists in the
METHOD codelist, so we would like to have
"PATHOLOGICAL EXAMINATION" as a parallel
term.
This is being requested as part of the Lung
Cancer project.
The current values of the 2 TEST Names >40 II

characters
Test name does not meet length criteria II SDTM, SEND -

Published with P31.
File e-mailed separately II
in P33
Do not add (P33):
MIP1A; Macrophage
Inflammatory Protein 1
Alpha: Do not add.
C82023.
MIP1B; Macrophage
Inflammatory Protein 1
Beta: Do not add.
C82024.
When reporting count of RBC in urine we've II Do not add (P33): Do
received counts per microliter of urine and there not add. Please use
is not a simple "per microliter" unit available to existing term C67452
use in the current controlled terminology. I 10^6/L, which has a
suggest “/uL". synonym of 1/uL.
Add the unit RATIO to VSRESU codelist to II SDTM, SEND-Published

support the VSTEST of Waist to Hip Ratio. in P33
RATIO is currently published in UNIT and
PKUNIT codelists.
K (kelvin) is the SI unit for body temperature. For II SDTM, SEND-Published

new drug application of PMDA (regulatory agency in P33
in Japan), the use of the SI units is recommended
in standard units of Findings Class. Please
consider adding the SI unit to Units for Vital Signs
Results (C66770).
Pa (pascal) is the SI unit for blood pressure. For II SDTM, SEND-Published
new drug application of PMDA (regulatory agency in P33
in Japan), the use of the SI units is recommended
in standard units of Findings Class. Please
consider adding the SI unit to Units for Vital Signs
Results (C66770).
Hz (hertz) is the SI unit for pulse rate. For new II SDTM, SEND-Published
drug application of PMDA (regulatory agency in in P33
Japan), the use of the SI units is recommended in
standard units of Findings Class. Please consider
adding the SI unit to Units for Vital Signs Results
(C66770).
BURR Cells (C74701) is Keratocytes an II SDTM, SEND-Published

appropriate CDISC synonym? Burr Cells are one in P33
type of keratocyte so it doesn't seem like this is
correct.
A generic term should be available for those II SDTM, SEND-Published

companies that do not categorize specific types in P33
of keratocytes
Looking for the P32 CT Requests Denied on the II Question answered: HI

CDISC website? Todd,
In answer to your new
term request ‘Looking
for the P32 CT Requests
Denied on the CDISC
website??’ – please find
the file on this
webpage:
https://www.cdisc.org/s
tandards/semantics/ter
minology
On the right hand side
of the page in the box
labeled ‘Controlled
Terminology Related
Files’ – the file hyperlink
is called ‘CT Requests
Denied’.
CV codetable mapping updates on CDISC II

website? Last 2015...
This term exists in the SEND terminology, II
however the submission value is defined as
'GLAND, SALIVARY, SUBMANDIBULAR'. The
available definition is 'The salivary gland located
adjacent to the mandible.'
This term exists in the SEND terminology, II SDTM, SEND-Published

however the submission value is defined as in P33
'GLAND, SALIVARY, SUBLINGUAL'. The
available definition is 'The salivary gland located
under the tongue in the floor of the oral cavity or
adjacent to the submandibular salivary gland.'
New lab test requested to be collected - Blast II SDTM, SEND-Published

count reported as a percentage. Per internal MD, in P33
this lab test of Blast count 'is the % of the
nucleated cells which are blasts'. This result is
for a bone marrow biopsy or aspirate sample.
Please add an MSTESTCD/MSTEST for "Zone of II

Inhibition" as it is a result from an agar diffusion
test:
https://en.wikipedia.org/wiki/Agar_diffusion_test
SDTM example can be found:

https://wiki.cdisc.org/pages/viewpage.action?
pageId=48040514
Update CDISC submission value, synonym and II

NCI PT for C132416 and remove C132419 from
codelist. Chris, this request is already in the MB
working doc dated 2017-10-04, just need request
number and info, please fill in the yellow
highlighted cells with this change request info, in
the Changes to Existing Codelists tab.
Since term 'HUSBAND' already exists, we should II

also have term 'WIFE' present, with definition 'A
female partner in marriage.'
C98746 INTMODEL/Intervention Model: The trial II
design developed to compare treatment groups.
Proposed definition update: The general design
of the strategy for assigning interventions to
participants in a clinical study. (clinicaltrials.gov)
Team suggests that the clinicaltrials.gov
definition is more complete and follows an
existing standard, which makes harmonization
easier.
Add 'Diagnostic' as a synonym and slight update II
to definition thusly: The investigation, analysis
and recognition of the presence and nature of
disease, condition, or injury from expressed signs
and symptoms; also, the scientific determination
of any kind; the concise results or summary of
such an investigation. (NCI)
In multiple instances of the CDISC definition in II SDTM, SEND-Published

SDTM Terminology.xls, I see an incorrect use of in P33
scientific notation 'E' which seems to be used as
'.. to the power of ..' while it actually means 'x 10
to the power of ...'. Could this be corrected
throughout the SDTM terminology file?
For example, the definition of CDISC submission

value 'g' (Gram) mentions 'A unit of mass equal to
one thousandth (10E-3) of a kilogram, ...'. I
should be either 1E-3 or 10^-3 (with ^ meaning
the exponent as used for some CDISC
submission values).
Create new RSCAT VALG plus new test II SDTM-Published in P32.

code/test name lists VALG01TC/VALG01TN.
This is at the request of the Lung Cancer TA
team.
Create CATs and TESTCD/TESTNM codelists II SDTM-Published in P32.
for the following measures: IPAQ SF PHONE
VERSION, IPAQ LF PHONE VERSION, IPAQ SF
SELF-ADMINiSTERED VERSION, and IPAQ LF
SELF-ADMINISTERED VERSIONs.
These are for the Nutrition TA team.
We need a term for Holter monitoring method. It II SDTM, SEND-Published

may be that multiple terms would be approrpriate, in P33
if there are multiple types of Holter monitoring.
New Lab tests for LOINC Matching; File emailed II SDTM, SEND-Published
separately in P33
Do not add (P33):
TROPONI3; Troponin I
Type 3: Do not add.
C135448.
WBCINTP; WBC
Interpretation: Do not
add. The test is WBC
(C51948) which is
already published and
Interpretation goes into
test detail.
HGBINTP; Hemoglobin
add. The test is HGB
(C64848) which is
already published and
Interpretation goes into
test detail.

Do not add (P33):
MMGINTP/
Mammogram
add. Please consider the
following alternative
modeling approach:
METHOD =
MAMMOGRAPHY, and
TEST = Interpretation
(C41255).
"Interpretation" will be
added to RPTEST-CD
codelist.
ENDOTHCK/Endometrial
Thickness: Do not add.
Please consider the
following alternative
modeling approach: LOC
= ENDOMETRIUM, and
TEST = Thickness
(C41145). "Thickness"
will be added to
RPTEST-CD codelist.
New codes required due to the publication and II
adoption of the paper: IRECIST Modified
RECIST 1.1 for Immune-Based Therapeutics
(Seymour L, Bogaerts J, Perrone A, Ford R,
Schwartz LH, Mandrekars, Lin Nu, Litiere S,
Dancey J, Chen A, Hodi FS, Therasse P,
Hoekstra OS, Shankar, LK, Wolchok JD,
Ballinger M, Caramella C, De vries EGE.
iRECIST; Guidelines for Response Criteria for
Use in Trials Testing Immunotherapeutics.
LANCET ONCOL 2017, 18:E143-52.
Please find attached the multiple terms II SDTM, SEND-Published

spreadsheet containing 175 terms for the in P33, P34, P35, P37
following codelists: Do not add (P33):
CARDIAC
LBTESTCD/LBTEST CATHETERIZATION;
DIR TABLET, AMORPHOUS
EVAL FREE BASE; TABLET,
FRM BESYLATE SALT: See
LOC denied requests file for
MEDEVAL explanations.
METHOD Do not add (P34):
NCOMPLT FAMILY DOCTOR/GP;
POSITION DID NOT MEET
PROTMLST INCLUSION/EXCLUSIO
We do microbiology testing for Haemophilus
RELSUB II N CRITERIA;
Influenzae
ROUTE and hence this term is requested. It is EXACERBATION;
already
SPECTYPEpresent in MICROORGANISM codelist. INFORMED CONSENT
UNIT WITHDRAWN;
WITHDRAWAL
Calprotectin is generally reported in 'ug/g' units, II CRITERION MET;
Do not add (P34):
the existing term of mg/kg is not used in general INFORMED CONSENT
already published in
so it would be confusing for medical reviewers to NOT
UNIT OBTAINED;
codelist as
see those units for this test. BIOMARKER ug/g is
C67401/mg/kg.
INFORMED CONSENT
listed as a synonym.
OBTAINED;
Definition: The maximum volume of air an II PHARMACOGENETICS
individual can exhale from the point of maximal INFORMED CONSENT
exhalation. OBTAINED;
AMENDMENT
INFORMED CONSENT
OBTAINED;
EXTENSION PHASE
New cat for PASI02, new codelists II QRS-Published
CONSENT OBTAINED; in P46
PASI02TC/PASI02TN; sponsor request. RELATIVE, FIRST OR
This is a QRS Terminology change control II SDTM-Published
SECOND DEGREE; in P32,
request from the FDA Biostatisticians. E. Kiely P35
CHOLESCINTIGRAPHY
reviewed the sponsor CRF he was working on ; CKD-EPI FORMULA;
that had a Patient Global Impression test call ? COCKCROFT-GAULT;
Overall Health?. This was reviewed with the QRS MDRD 4 VARIABLE
Sub-Team with FDA Biostatisticians present and CALCULATION; MDRD
after thinking about it they requested this test be 6 VARIABLE
added to the PGI terminology that was originally CALCULATION; MDRD
released in package 30. ENZYMATIC; MDRD
ENZYMATIC JPN;
SCHWARTZ METHOD
FOR CHILDREN;
COLOR FUNDUS
PHOTOGRAPHY;
RAST
CLASSIFICATION;
FISCHER-SALLER
SCALE;
Can you please add these as synonyms of this II
term: Main Pancreatic Duct, Duct of Wirsung;
Major Pancreatic Duct
Reason: Current controlled terminology for II SDTM, SEND-Published

LBTESTCD dose not include guanase in P34
measurement.
Draft definition: A measurement of the guanase
To be used with LBTEST= Guanase.
Reason: Current controlled terminology for II SDTM, SEND-Published

LBTEST dose not include guanase in P34
measurement.
Draft definition: A measurement of the guanase
To be used with LBTESTCD= GU.
please add test Hemoglobin A2/Hemoglobin as a II

similar concept exist for Hemoglobin A1C
Add the following terms/codes to the II
MBTEST/MBTESTCD term lists
S. aureus <-> SAUREUS
Haemophilus <-> HAEMOPH
B. cepacia <-> BCEPACIA
Non-tuberculous mycobacteria <-> NTBMYCO
Add 2 new tests, 2 mew test codes and edit II SDTM, SEND-Published
synonym for existing term: in P35
LBTEST and LBTESTCD: <Antiglobulin Test IgG
Specific, Direct> <ANTIIGGD>
<Antiglobulin Test
C3d,C3b, Direct> <ANTIC3DR>
Add synonym: Antiglobulin Test Polyspecific,
Direct in LBTEST and LBTESTCD to C81974,
Antiglobulin Test, Direct.
Please add C41145 and C41255 to the II

RPTEST/CD codelists. Chris, this request is
already in the General document, please just add
the request number and details to rows 9-10 in
the RPTEST-CD tab.
PIVKAII (Protein Induced by Vitamin K II SDTM, SEND-Published

Absence/Antagonist-II) a.k.a. DCP (Des-gamma in P34
carboxyprothrombin) is one of the most common
biomarker for a hepatocellular carcinoma.
Although concept code is defined as C101804 in
the NCI Thesaurus, it is not defined as the
LBTEST/LBTESTCD in the SDTM terminology.
A type of radiography used to examine salivary II SDTM-Published in P35
glands. It usually involves the injection of a small
amount of contrast medium into the salivary duct
of a single gland, followed by routine X-ray
projections.
Also called radiosialography.
The TSPARM is a yes/no question, which means II

that this term is incorrectly coded in the TSPARM
codelist. Re-code this concept to 'Adaptive Study
Design Indicator' and keep definition as is.
Change definition to: Two or more interventions, II SDTM, Protocol-

each alone or in combination, are evaluated in Published in P33
parallel against a control group. This study design
allows for the comparison of active drug to
placebo, presence of drug-drug interactions, and
comparison of active drugs against each other.
Change 'and' to 'or' and add additional sentence
to help with clarity.
Change definition to: Participants are assigned to II SDTM, Protocol-

one of two or more treatment groups in parallel Published in P33
for the duration of the study.
Protocol entities team asks that this be changed:
Change 'arms' to 'treatment groups'.
Change defintion to: All trial participants are II SDTM, Protocol-
assigned to a single treatment group for the Published in P33
duration of the study.
There is a lack of granularity in the current List of II Do not add (P34): Action
Values to support drugs administered via IV Taken with Study
infusion. This new term would be distinctly Treatment was
different than the existing term 'DRUG intended to be for
INTERRUPTED'. describing an overall
change to the planned
Study teams at Biogen feel there is a need to dosing schedule in
differentiate between an AE that causes a single response to an adverse
IV infusion dose to be interrupted (i.e. 'DOSE event. What is being
INTERRUPTED') vs. an AE that causes the described by Biogen
subject to miss 1+ infusions entirely (i.e. 'DRUG here is a temporary,
INTERRUPTED'). single dose interruption
It is noted that previous requests to add terms to due to an adverse
this code list were rejected since the existing event. However, this
terms map directly to ICH E2B and it's non temporary single dose
extensible. However, the current term 'DRUG interruption is not in
INTERRUPTED' is not in ICH E2B. fact changing the
overall treatment plan.
This is more describing
reasons for why an
individual dosing event
wasn't completed,
which may be more
appropriate for EX. This
understanding of ACN is
in keeping with ICH E2B
guidelines.
SDTM-NCOMPLT list not found in drop down. II Do not add (P34):
(Can it be alphabetized or made more Question Answer: This is
"searchable"?) now in the drop down
Please: and the drop down is in
1) add "Subject Completion" (or Completed) to alphabetical order.
NCOMPLT Do not add: The use of
2) consider adding "Study Completion" (or C25250 has been in
Completed) to NCOMPLT place since the birth of
3) re-examine "Completed" as a member of this this codelist. Since the
list. codelist itself is context-
This is arises directly from definitions in the specific for subject
glossary. The current term COMPLETED is disposition events,
unnecessarily ambiguous. There is a difference people felt it was
between a subject exiting the study because the unnecessary to apply
subject completed all Elements and a subject 'subject' to every single
exiting the study because the subject reached a term in this codelist.
protocol defined ending before the subject could Therefore the generic
personally complete all elements. With two more term 'Completed' was
specific terms, sites will more easily identify chosen as the code for
status; sponsors can more easily classify subject this concept. The
dispositions, and then define analysis of subjects intended use of
classified as "Study Completed" as most COMPLETED is to signal
appropriate for the particular subject completion but
the codelist itself
In reviewing the glosary, I submitted the following defines the subject-
Jira item: specific context for the
Is there/What is the relationship between the use of the term
glossary term "subject completion" (defined as 'COMPLETED'. 'Subject
"The case where a subject ceases active Completion' was felt to
participation in a trial because the subject has, or be redundant for this
is presumed to have followed all appropriate codelist. The general CT
conditions of a protocol.") and the term team does not feel that
COMPLETED (defined as "To possess every the NCOMPLT codelist is
necessary or normal part or component or step; the correct place for a
having come or been brought to a conclusion. concept 'Study
(NCI)") in the CT NCOMPLT list. Completion'. DS is
The definition of subject completion feels like a subject level data and
RAUC&&&, RCMAX etc. II Do not add (P35):
Request considered;
new Metabolite to
parent ratio terms will
be added in the
upcoming packages.
Create new codelist for ISTSTDTL and add 3 new II Do not add (P38): This
terms to the codelist: value is deemed
inappropriate for
SCREENING TSTDTL, it has been
CONFIRMATORY represented in a
QUASI-QUANTIFICATION different non-standard
variable.
ISTSTDTL codelist description: Terminology
relevant to the additional descriptions of the test
being performed to produce the immunogenicity
specimen assessment result.
File emailed separately. II
Alana, Tabs have already been added to the
general CT file and the content within the file
submitted with this request has already been
incorporated into the general working document.
All I need you to do is to add a request code in
the changes to existing codelists tab, rows 21,
and 22 for this request.
This request is on behalf of the PTSD II

therapeutic area team. This request comes from
the PTSD TA team.

Do not add (P35):
ADENO; SQUAM - Do
not add. Request
removed by requester.
These can be results for
test of 'Histologic Type
of Cancer'.
Per SDS-867 comment, for CVTEST = Aortic II Do not add (P32):

Coarctation Indicator, pls consider changing this C139033, 139037 - Do
to something like "Blood Vessel Coarctation not change. Renal
Indicator" where LOC = Aorta. Coarctation refers artery Coarctation is
to the narrowing of something, and aortic actually renal artery
coarctation just means the narrowing of the aorta. stenosis, this is not
This term is also used to describe the narrowing Coarctation. Aortic
of renal artery therefore please consider post- Coarctation is a specific
coordinating 'coarctation' and 'aorta'. and unique clinical
phenomenon that only
happens at the aorta,
post-coordinating this
test would lose clinical
meaningfulness.
Request the addition of the term OI with the II Do not add (P35): Do
synonym Opsonization Index not add. Vendor
This unit is used for Pneumococcal confirms this is an OI50.
Polysaccharide antibody testing (i.e. Please use existing term
Pneumococcal Polysaccharide Antibody Serotype C130193
1) using the MULTIPLEXED
OPSONOPHAGOCYTIC KILLING ASSAY
method
For PP domain in SDTM and SEND, to handle II Do not add (P35):
AUCINT ratio at non-steady state. Request considered;
new Ratio AUC from T1
to T2 terms will be
added in the upcoming
packages.
C123593 (MOLECULAR CR) has a synonym of II Do not add (P33): Do

CMR. But CMRis a valid submission value within not change. Question
the same codelist which is an abbreviation for Answered: Having two
Complete Metabolic Response. identical submission
Should the synonym be removed to avoid values for two different
confusion? concepts goes against
basic terminology
principles. This would
‘break’ the terminology
in the sense that a
computer system would
end up equating two
different things, which is
inappropriate. However,
since synonyms are not
submitted and only exist
for mapping purposes,
the presence of a
synonym in one
concept, which is
identical to a submission
value in another concept
does not technically
break anything. It also
may be important to add
valid synonyms where
appropriate, especially
in instances where a
common acronym was
correctly assigned to
two distinct concepts
(e.g., ESR for Estrogen
Receptor or Erythrocyte
Sedimentation Rate).
Having an acronym in
both places would guard
against false positive
This method is used to detect neutralizing II SDTM-Published in P37
antidrug antibody (against a study product); this
term is proposed by the sponsor SME who
helped the MB team to develop the ADA concept
example sets:
https://wiki.cdisc.org/display/TER/Anti-Drug-
Antibodies+Modeling+Page
In Vitro Gene Expression Assay: A method that
detects gene transcription associated with an in
vitro cellular stimulus, through detection of the
resulting transcribed mRNA or translated protein.
Question regarding the formula, specimens and II SDTM-Published in P34
units associated with the Creatinine Clearance Do not add (P34):
and Glomerular Filtration Rate tests. File emailed Corrected Creatinine
separately Clearance - Please use
'Creatinine Clearance
Adjusted for BSA', which
will be published with
P33 in March 2018.
Glomerular Filtration
Rate Adj for BSA -
Question answered: Is
this eGFR? Or does
another test need to be
added to collected
eGFR Adj for BSA? Lab
Team: This was added
to use when a lab report
did not specify what
underlying material the
test was based upon.
Otherwise if you know
the material, you should
use that published term.
Glomerular Filtration
Rate - Question
answered: The
difference between GFR
and GFRE is the
difference in specimen
types. Units are the
same, otherwise.
GFR from Creatinine
Adjusted for BSA -
Question answered:
What formula is used for
this test? Lab team: Just
a more specific version
Our study is intravenous and subcutaneous II SDTM-Published in P34
injection. FDA is interested in the infusion rate.
But I cannot find it in the current CT. Could you
please add it?
This is codelist is for the new variable ARMNRS II Do not add (P34):
to be included in SDTMIG v3.3 and SDTM v1.7. Example CT will not be
See https://wiki.cdisc.org/pages/viewpage.action? included in SDTMIG.
pageId=32815150&src=contextnavpagetreemode Two published terms
can be used instead;
ASSIGNED, NOT
TREATED and NOT
ASSIGNED.
Relative Florescence Unit : Arithmetic mean of II SDTM-Published in P35

florescence detection measurement
A bronchial challenge test is a medical test used II Do not add (P36): Do
to assist in the diagnosis of asthma. The patient not add. Based on
breathes in nebulized methacholine or histamine. Asthma Therapeutic
Thus the test may also be called a methacholine User Guide the two
challenge test or histamine challenge test RETEST values for this
respectively type of assessment
would be FEV1 and
FEV1REV. Please see
page 41 of the
published Asthma
TAUG v1 for the full
modelin structure for this
test.
The length of the term of "Sum of Products of II

Perpendicular Diameters" (C-code is C132261) is
over 40 bytes. The length of a term stored in
TRTEST must be less than or equal to 40 bytes.
Please create controlled terminology (including II Do not add (P49): No

QSCAT) for quantified neurological examination response received from
and assessment of Kurtzke?s Functional requester for follow-up
Systems and the Expanded Disability Status inquires. Request
Scale in Multiple Sclerosis: denied.
https://www.neurostatus.net/index.php
New QRS Request: Terminology needed for

internal standards
BIOMARKER INFORMED CONSENT II

OBTAINED
PHARMACOGENETICS INFORMED
CONSENT OBTAINED
AMENDMENT INFORMED CONSENT
OBTAINED
EXTENSION PHASE CONSENT OBTAINED
SUB-STUDY CONSENT OBTAINED
The current value "INFORMED CONSENT
OBTAINED" does not provide the granularity
sponsors need. See
https://wiki.cdisc.org/display/CTC/Multiple+Protoc
ol+Milestone+Informed+Consents for additional
examples.
For a Trial using comparators as reference the II SDTM-Published in P36

Treatment Information (comparator A, comparator
B or IMP) was open "OPEN LABEL" the dose
Information of the IMP was "DOUBLE BLIND". So
none of the existing items would fit 100%.
Terms to be added to the CDISC Glossary. II Glossary-Published in
Active Ingredient dose -- the amount of active P40
ingredient in a dose of substance (usually a
medication) administered.
Product dose -- the amount of a product in a
dose of substance administered. Usually
expressed as a weight, volume, or a number of
items (e.g., dosage forms) administered. The
difference between the two is that a product
usually contains more than just active ingredients.
Please update definition to: An important II

prognostic factor measured at baseline that may
be taken into account during stratification or
analysis.
From the Protocol Entities team: The team is

concerned about the published TSPARM
definition for this term since stratification factors
can be determined post-randomization during
analysis. The definition as written now seems to
be specific for randomization purposes only. May
need to suggest a definition update to broaden
use of term. It is true that it is best practice to
specify stratification factors during study design
and randomization. Post-randomization
stratification factors are more of a 'whoops, we
forgot about that. We should look at that also !'
but does happen.
For the CDAD TAUG II SDTM-Published in P33

Update definition of C49659 to: A study in which II Do not add (P38): These
subjects and investigators know which treatment definition updates will
each subject is receiving; opposite of a blinded or not be considered at
double-blind study. (CDISC glossary) this time.
Update definition of C28233 to: A study in which

one party, either the investigator or the subject,
does not know which treatment is administered to
the subject; also called singlemasked study.
(CDISC glossary)
TRIPLE BLIND: A study in which knowledge of II Do not add (P35):
the treatment assignment(s) is concealed from TRIPLE BLIND - Do not
the people who organize and analyze the data of add. The blind is not
a study as well as from subjects and broken until database
investigators. (CDISC Glossary) lock so while the trial is
underway a double
blind study's data would
never be available for
analysis. So in real life a
'double blind' study is
always triple blinded as
per GCP.
Synonym and test name information for II

questionnaire codelist do not match.
Need to retire C138337 (Assessment of Cancer II SDTM-Published in P32.

Therapy-Kidney Symptom Index-15
Questionnaire) and use C118498 (FKSI-15
Questionnaire) due to NCI internal code change
Trials where the subject and investigator are II Do not add (P35): Do
blinded, and the sponsor is not blinded. not add. Please use
existing term DOUBLE
BLIND. Furthermore,
general team members
have not ever
experienced a double
blind study wherein the
sponsor was NOT
blinded due to database
locks while the study
was in progress. The
team does not believe
that this is able to
happen due to the fact
that the sponsor can't
be knowledgeable of
the treatments the
subject receives as that
can bias the data.
The Trial Design domain TD (Disease II
Assessments) is described in the SDTM-IG (as of
v3.2) however is not in the DOMAIN codelist; Can
this be added?
Definition: Studies in which observations or II

measurements made at a single point in time,
usually at subject enrollment. (clinicaltrials.gov)
Definitions: II SDTM, Protocol-

Adaptive: Studies in which observations or Published in P33
measurements made at a single point in time,
usually at subject enrollment. (clinicaltrials.gov)
Sequential: Groups of participants are assigned
to receive interventions based on prior milestones
being reached in the study. (clinicaltrials.gov)
Update CDISC submission value, definition and II SDTM-Published in P33

preferred term for C139049. Criag, this request is
already in the CV working doc, please just fill in
the requester info and request code in the yellow
highlighted rows. Thank you!
In the Category of Clinical Classification (IDS-C, II SDTM-Published in P33

QIDS-C) and Category of Questionnaire (IDS-SR,
QIDS-SR) codelists, we'd like to update the
CDISC definition to include copyright information.
Request on behalf of sponsor and QRS sub-
team
As discussed and agreed at an extended Define- II

XML Team meeting on 08-Dec-2017 with Erin
Muhlbrandt, a separate Define-XML CT file
should be created for the CTs that are relevant
for define.xml files. By having a separate Define-
XML CT file the users/implementers of Define-
XML can refer to that specific file instead of
searching for applicable CT included in either an
SDTM or ADaM CT file that will only be needed
when specifying metadata in define.xml.
This CT is used for a specific ADaM analysis II ADaM, Define-XML-
results metadata attribute within an ADaM Published in P40
define.xml file. Users implementing an ADaM
define.xml file will refer to the Define-XML CT file
for valid values rather than the ADaM CT file
which should focus on valid values for ADaM
dataset variables.
This CT is used for a specific ADaM analysis II ADaM, Define-XML-

results metadata attribute within an ADaM Published in P40
define.xml file. Users implementing an ADaM
define.xml file will refer to the Define-XML CT file
for valid values rather than the ADaM CT file
which should focus on valid values for ADaM
dataset variables.
This CT is used to specify the valid values for the II Define-XML, SDTM-
define.xml Class attribute which is included in Published in P40. This
SDTM, ADaM and SEND define.xml files. For codelist will stay in
users/implementers of define.xml it is preferable SDTM publication as
to look up the valid values in a CT file for Define- well.
XML rather than an SDTM CT file which should
primarily describe valid values for SDTM dataset
variables.
File emailed separately II Define-XML-Published

in P40.
The new CTs will be used within ADaM Do not add (P45):
define.xml files to denote if a specific ADaM OCCISC (new codelist) -
dataset belongs to a specific Subclass of a Do not add. The
standard ADaM Data Structure. integrated IG is ON
HOLD and has not been
published. Therefore
the team will not
develop these
observations classes
and subclasses further
until that IG is closer to
publication.
CDISC supports C64818 Lymphocytes Atypical II SDTM, SEND-Published
and C74629 Reactive Lymphocytes and in P38
differentials thereof. I believe these are
synonymous terms (see URL in additional
information)...also synonymous with Variant
Lymphocytes (not defined by CDISC). Also, when
typing both atypical and reactive lymphocytes into
the LOINC search both return Variant
Lymphocytes. Suggest one of these is removed
and added as a synonym of the other, along with
Variant Lymphocytes
https://books.google.be/books?
id=cHAjsUgegpQC&pg=PA221&lpg=PA221&dq=
variant+lymphocytes&source=bl&ots=qyKDnEDsI
_&sig=eFFut2yixDYiZOkDeRdi12rCzWE&hl=en&
sa=X&ved=0ahUKEwiy8fHG8YTYAhWSYVAKHV
d7DRQQ6AEImgEwFw#v=onepage&q=variant
%20lymphocytes&f=false
C119272 Correct Calcium - Since calcium can be II SDTM-Published in P35

correct for albumin or total protein, please
consider changing the CDISC definition to
remove abumin.
This term is typo. The space between slash and II Do not add (P36): Do
"Neutrophils" is not needed. not change. Team does
not agree to change the
submission value. While
the space is incorrect,
we do not think
removing it is enough
value-add for the user
community to warrant a
change to a submission
value.
Requesting addition of test Helicobacter pylori II SDTM-Published in P35

Antigen test done in a stool specimen with a
qualitative result.
The submission value for C103377 is written ? II Define-XML - Published
Special-Purpose? in the SDTM Implementation in P40
Guides but ?Special Purpose? in the General
Observation Class codelist (C103329). Can it be
changed to "Special-Purpose" for consistency?
Request the addition of Standard Base Excess - II SDTM, SEND-Published
which measures quantity of Acid or Alkali in P35
required to return the plasma in-vivo to a normal
pH under standard conditions (eg. Dose to return
E.C.F. to normal) . This differs from the existing
term of Base Excess which measures the
quantity of Acid or Alkali required to return the
plasma in-vitro to a normal pH under standard
conditions (eg. Dose to return plasma to normal).
LOINC has this information: Actual Base Excess
versus Standard Base Excess - In vivo, acid-base
homeostasis takes place throughout the
extracellular fluid (ECF), not just the blood
compartment that is in a patient specimen. The
concept of "standard" base excess attempts to
adjust for the base excess of the entire
extracellular compartment by calculating the base
excess for blood diluted as if the entire
extracellular compartment were sampled (approx
Hgb of 5g/l). So the ACTUAL base excess (ABE)
is the dose of acid to return PLASMA to normal
pH, whereas the STANDARD base excess (SBE)
is the dose to return ECF to normal pH.
File emailed separately II Protocol-Published in

Content is already on wiki and public review file P33, P34
has been created. Just need a request number
for the public review file.
RS prior response example from SDS oncology II Do not add (P33): Do
team - Discussed on 2017-10-13 not add. There is still
From SDTMIG 3.3: discussion as to whether
https://wiki.cdisc.org/x/ZRXdAg" this belongs in RS or
Need request number for P33 Oncology Denied MH and how it is
Request file. calculated. Melanie will
ask Diane to take the
example out of the IG.
Need request number for SEND P33 Public II SEND-Published in P33

Review File: new terms in NONNEO, SEV and
MITEST-CD.
Craig, I have already added the request
numbers into the P33 SEND PR file, so no
worries.
Need request number for SEND P33 Public II SEND-Published in P33

Review File: Changes to Existing.
Craig, I have already added the request numbers
into the P33 SEND PR file, so no worries.
Need request codes for P33 General PR file: II SDTM, SEND-Published
Changes to Existing. in P33
Craig, I have already updated the PR file with Do not change (P33):
request codes, no worries. Re-discuss the
synonymy of Abdominal
Cavity and Abdomen -
Synonymy will stand as
per EVS editors. Wait
for a new term request
from a user to re-open
this case.
Need request code for P33 Lab New terms for II SDTM, SEND-Published
LBTEST-CD. in P33
Craig, I have already updated the P33 LAB PR
file with request code, no worries.
Need request code for P33 Lab PR file: Changes II SDTM, SEND-Published
to Existing. in P33
Craig, I have already updated the P33 LAB PR
file with request code, no worries.
Need request code for P33 SPECTYPE II SDTM-Published in P33
SPECCOND PR file: Changes to Existing.
Craig, the request number has been added to
the PR file, so no worries.
Need request code for P33 Oncology PR file: II SDTM-Published in P33
New term requests.
Craig, the request number has been added to the
PR file, so no worries.
Need request code for P33 Oncology PR file: II SDTM-Published in P33
Modify existing
Craig, the request number has been added to the
PR file, so no worries.
Please check the definition for C12291/SKIN OF II SDTM-Published in P35
THE LIP: The skin portion of the lip that contains
hair. Is this correct? There is no hair on the lips.
Craig, this change request is already in the
General Working Doc, please just fill in the
requester info and request code number. Thank
you.
Within our study we need to report whether lymph II SDTM-Published in P35

node involvement is regional involvement or
distant involvement from the primary tumor site.
Currently, the NCI Thesaurus has: DISTANT

LYMPH NODE with the following definition: A
lymph node located distant to the anatomic site of
interest. The NCI Code = C106042
Proposed Definition: A measurement of the free II SDTM, SEND-Published
Choriogonadotropin Beta in a biological in P33
specimen. Do not add (P35): Being
This is measuring the free beta-subunit of HCG. added with P33.
C147360
Proposed Definition: A relative measurement II SDTM-Published in P35

(ratio or percentage) of the megakaryocytes to
leukocytes in a biological specimen.
This test is being performed on a whole blood
specimen.
Erin to update draft codetable once new VSTEST II Published
and VSRESU values are approved as draft.
Need request code for P33 Domain PR file: New II SDTM, SEND-Published
terms. Craig, the request number has been in P33
added to the PR file, so no worries.
Need request code for P33 Domain PR file: New II SDTM, SEND-Published
terms in P33
Need request code for P33 Domain PR file: II Published

Changes to existing
Does this concept belong in the MBTEST-CD II

codelist or the MB domain? C135410/Ebola Virus
IgM Antibody. This is measuring the host
antibody reaction toward ebola infection, should
this concept be in the IS domain? Similar
questions from users toward better defining the
IS domain, show emails from Dan Sinnett with
regard to whether study data should be
represented in the IS domain. (email sent by Dan
Sinnett on 12/21/2017, 2:13) File emailed
separately.
Date of Request
Submission Code
Closed Friday, 5 Jan CDISC- Barbara Lentz Bayer barbara.lentz1@ba

2018 11:20 AM 3189 yer.com

2018 11:21 AM 3190 yer.com

2018 11:25 AM 3191 yer.com
Closed Friday, 5 Jan CDISC- Craig Zwickl Independent/ czwickl@cdisc.org

2018 11:26 AM 3192 SEND CT Lead

2018 11:27 AM 3193 SEND CT Lead

2018 10:58 AM 3194 SEND CT Lead

2018 11:02 AM 3195 SEND CT Lead
2018 11:02 AM 3196 SEND CT Lead

2018 11:03 AM 3197 SEND CT Lead

2018 11:03 AM 3198 SEND CT Lead

2018 11:04 AM 3199 SEND CT Lead

2018 11:04 AM 3200 SEND CT Lead

2018 11:05 AM 3201 SEND CT Lead

2018 11:06 AM 3202 SEND CT Lead

2018 11:07 AM 3203 SEND CT Lead
2018 11:07 AM 3204 SEND CT Lead

2018 11:07 AM 3205 SEND CT Lead

2018 12:36 PM 3206 SEND CT Lead

2018 12:38 PM 3207 SEND CT Lead

2018 12:39 PM 3208 SEND CT Lead

2018 12:41 PM 3209 SEND CT Lead

2018 12:50 PM 3210 behalf of the CDAD
TA team)
2018 12:52 PM 3211 yer.com
Closed Friday, 12 Jan CDISC- Maura Kush SCHARP mkush@scharp.org

2018 12:54 PM 3212
Closed Friday, 12 Jan CDISC- Mihaela Simion Biogen mihaela.simion@bi
2018 12:57 PM 3213 ogen.com
Closed Friday, 12 Jan CDISC- rob wartenhorst GSK Vaccines rob.x.wartenhorst@

2018 01:03 PM 3214 gsk.com

2018 01:47 PM 3215 nih.gov
Open Friday, 19 Jan CDISC- Denise Adelman CDISC Glossary Dadelma1@its.jnj.c

2018 10:04 AM 3216 Team om
Closed Friday, 19 Jan CDISC- Christy Kubin MPI Research christy.kubin@mpir
2018 10:05 AM 3217 esearch.com
Open Friday, 19 Jan CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2018 10:05 AM 3218

2018 10:06 AM 3219

2018 10:07 AM 3220 .com
2018 10:07 AM 3221 .com
2018 10:07 AM 3222 .com
Closed Wednesday, 24 CDISC- Roberta Rosenberg Pfizer roberta.e.rosenberg

Jan 2018 10:12 3223 @pfizer.com
AM

Jan 2018 10:15 3224
AM
Jan 2018 10:16 3225
AM
Jan 2018 10:16 3226
AM
Open Thursday, 25 CDISC- Carrie Neeley Covance carrie.neeley@cov
Jan 2018 04:27 3227 ance.com
PM

Jan 2018 04:28 3228 k.com
PM

Jan 2018 04:29 3229 k.com
PM

Jan 2018 04:31 3230 k.com
PM
Jan 2018 04:31 3231 k.com
PM

Jan 2018 04:32 3232 k.com
PM
Jan 2018 04:33 3233 k.com
PM
Jan 2018 04:33 3234 k.com
PM

Jan 2018 04:33 3235 k.com
PM
Open Thursday, 25 CDISC- Erin Tibbs-Slone MPI Research erin.tibbs-
Jan 2018 04:34 3236 slone@mpiresearc
PM h.com
Closed Friday, 2 Feb CDISC- Chad Todisco Covance CLS chad.todisco@cova

2018 02:41 PM 3237 nce.com
Closed Friday, 2 Feb CDISC- Chad Todisco Covance CLS chad.todisco@cova
2018 02:42 PM 3238 nce.com
Closed Friday, 2 Feb CDISC- Sarah McLaughlin Syneos Health sarah.mclaughlin@

2018 02:44 PM 3239 syneosheath.com
Closed Friday, 2 Feb CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2018 02:44 PM 3240

2018 02:45 PM 3241

2018 02:46 PM 3242 k.com
Closed Friday, 2 Feb CDISC- Japie (Jacob John) Triclinium Clinical japie.vantonder@tc
2018 02:48 PM 3243 van Tonder Development d-global.com
Closed Friday, 2 Feb CDISC- Sarah McLaughlin Syneos Health sarah.mclaughlin@

2018 02:50 PM 3244 syneosheath.com
Closed Friday, 2 Feb CDISC- Mary Jo Brucker Merck mj.brucker@merck.

2018 02:52 PM 3245 com
Closed Friday, 2 Feb CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com
Closed Friday, 2 Feb CDISC- Debra O'Neill Merck debra_oneill@merc

2018 02:55 PM 3247 k.com
Closed Friday, 2 Feb CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2018 02:56 PM 3248 yer.com
Closed Thursday, 8 Feb CDISC- Mihaela Simion Biogen mihaela.simion@bi

2018 10:46 AM 3249 ogen.com
Closed Thursday, 8 Feb CDISC- Kimberley Holich AbbVie Inc. kimberley.holich@a

2018 10:47 AM 3250 bbvie.com
Closed Thursday, 8 Feb CDISC- David Radtke Eli Lilly and radtke_david_b@lill
2018 10:48 AM 3251 Company y.com
Closed Friday, 9 Feb CDISC- Chad Todisco Covance CLS Chad.Todisco@cov
2018 01:46 PM 3252 ance.com

2018 01:47 PM 3253 ance.com

Feb 2018 03:21 3254 nih.gov
PM

Feb 2018 03:23 3255 k.com
PM

Feb 2018 03:23 3256 k.com
PM
Open Thursday, 15 CDISC- Denise Adelman JNJ Dadelma1@its.jnj.c
Feb 2018 03:24 3257 om
PM
Closed Thursday, 15 CDISC- Denise Adelman JNJ Dadelma1@its.jnj.c
Feb 2018 03:25 3258 om
PM

Feb 2018 03:26 3259 k.com
PM
Closed Thursday, 15 CDISC- Mihaela Simion Biogen mihaela.simion@bi

Feb 2018 03:27 3260 ogen.com
PM

2018 11:57 AM 3261 ance.com
2018 11:57 AM 3262 ance.com

2018 11:57 AM 3263 ance.com

2018 11:58 AM 3264 ance.com
Closed Wednesday, 21 CDISC- Thomas G Pfizer thomas.g.tensfeldt
Feb 2018 12:35 3265 Tensfeldt @pfizer.com
PM

Feb 2018 11:26 3266
AM
Feb 2018 11:27 3267
AM

Feb 2018 11:48 3268 behalf of Claire
AM West)
Closed Thursday, 22 CDISC- Anne Cecilie Novo Nordisk acee@novonordisk
Feb 2018 04:49 3269 Engsig .com
PM
Closed Thursday, 22 CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba

Feb 2018 04:51 3270 yer.com
PM
Open Thursday, 22 CDISC- Lacey Wallace IQVIA Lacey.Wallace@IQ

Feb 2018 04:52 3271 VIA.com
PM
Open Thursday, 22 CDISC- Denise JNJ Dadelma1@its.jnj.c

Feb 2018 04:54 3272 om
PM
Open Thursday, 22 CDISC- Barbara Lentz Bayer LLC barbara.lentz1@ba
Feb 2018 04:55 3273 yer.com
PM
Closed Thursday, 22 CDISC- Thomas Forrester Frontier Science forrest@fstrf.org
Feb 2018 04:56 3274
PM

Feb 2018 04:58 3275 om
PM

2018 12:11 PM 3276 behalf of James
Kramer)
Closed Friday, 2 Mar CDISC- Barbara Lentz Bayer LLC barbara.lentz1@ba
2018 12:12 PM 3277 yer.com
2018 12:13 PM 3278 k.com

2018 12:14 PM 3279 k.com
Open Friday, 2 Mar CDISC- Jordan Li (on NCI EVS Jordan.li@nih.gov

2018 12:15 PM 3280 behalf of PK team)
Closed Friday, 2 Mar CDISC- Lou Florio Purdue Pharma lou.florio@pharma.

2018 12:16 PM 3281 L.P. com
Closed Friday, 2 Mar CDISC- Stephen Kopko CDISC skopko@cdisc.org

2018 12:17 PM 3282
Closed Friday, 9 Mar CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.

Inc.
Closed Friday, 9 Mar CDISC- claire west GSK claire.m.west@gsk.
2018 11:32 AM 3285 com
Closed Friday, 9 Mar CDISC- POINTCROSS karuna@pointcross

2018 11:33 AM 3286 lifesciences .com
Closed Friday, 9 Mar CDISC- Julia Talley LivaNova julia.talley@livanov

2018 11:34 AM 3287 a.com
Closed Friday, 9 Mar CDISC- Chad Todisco Covance CLS chad.todisco@cova

2018 11:35 AM 3288 nce.com
Closed Friday, 9 Mar CDISC- Chad Todisco Covance CLS chad.todisco@cova

2018 11:36 AM 3289 nce.com
Closed Friday, 9 Mar CDISC- Shaoyan Wang Covance Central Shaoyan.Wang@c
2018 11:37 AM 3290 Laboratory Service ovance.com
Open Friday, 9 Mar CDISC- James Kramer Janssen R&D jkramer2@its.jnj.co

2018 11:38 AM 3291 m
Closed Friday, 9 Mar CDISC- Lies Meirlaen Fern Valley lies.meirlaen@fern-

2018 11:40 AM 3292 valley.com

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.
Inc.

Inc.

Inc.
Inc.

Inc.
Inc.
Inc.
Inc.
Inc.
Inc.
Inc.

Inc.

Inc.
Inc.

Inc.

Inc.
Inc.

Inc.

Inc.
Inc.
Inc.
Inc.

Inc.

Inc.

Inc.
Inc.
Inc.
Inc.
Closed Friday, 16 Mar CDISC- Diane Corey C-Path dcorey@c-path.org
2018 11:29 AM 3329
Closed Friday, 16 Mar CDISC- Diane Corey C-Path dcorey@c-path.org

2018 11:30 AM 3330

2018 11:31 AM 3331 nih.gov

2018 11:32 AM 3332 nih.gov

2018 11:32 AM 3333 nih.gov
Closed Friday, 16 Mar CDISC- Diane Boram GlaxoSmithKline diane.e.boram@gs
2018 11:33 AM 3334 k.com
Open Monday, 19 Mar CDISC- Diane Corey C-Path dcorey@c-path.org

2018 12:07 PM 3335
Closed Monday, 19 Mar CDISC- Diane Corey C-Path dcorey@c-path.org

2018 12:08 PM 3336
Closed Thursday, 22 CDISC- Anthony Chow CDISC achow@cdisc.org

Mar 2018 06:39 3337
PM
Open Thursday, 22 CDISC- Anthony Chow CDISC achow@cdisc.org

Mar 2018 06:40 3338
PM
Closed Thursday, 22 CDISC- Susan Steen BMS Susan.Steen@bms
Mar 2018 06:41 3339 .com
PM
Closed Thursday, 22 CDISC- Nicholas Pemble Janssen (J&J) npemble@its.jnj.co

Mar 2018 06:43 3340 m
PM
Closed Thursday, 22 CDISC- Rohit Dhanjal Vertex rohit.dhanjal@vrtx.

Mar 2018 06:44 3341 Pharmaceuticals com
PM
Open Thursday, 22 CDISC- Rohit Dhanjal Vertex rohit.dhanjal@vrtx.

Mar 2018 06:45 3342 Pharmaceuticals com
PM
Mar 2018 06:46 3343 om
PM
Closed Thursday, 22 CDISC- Denise Adelman JNJ Dadelma1@its.jnj.c
Mar 2018 06:46 3344 om
PM
Open Friday, 30 Mar CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.
Closed Friday, 30 Mar CDISC- Colleen Bonjo Merck colleen_bonjo@me
2018 09:43 AM 3347 rck.com

2018 09:43 AM 3348 rck.com

2018 09:43 AM 3349 rck.com

2018 09:44 AM 3350 behalf of Nutrition
TA team)
Closed Friday, 30 Mar CDISC- Nik Pemble Janssen (J&J) npemble@its.jnj.co
2018 09:46 AM 3351 m
Closed Friday, 30 Mar CDISC- claire west GSK claire.m.west@gsk.
2018 09:47 AM 3352 com

2018 09:47 AM 3353
Closed Friday, 30 Mar CDISC- Rohit Dhanjal Vertex rohit.dhanjal@vrtx.

2018 09:49 AM 3354 Pharmaceuticals com
Closed Friday, 30 Mar CDISC- Philip Pochon Covance phil.pochon@covan

2018 09:49 AM 3355 ce.com
Closed Thursday, 5 Apr CDISC- Gary Walker IQVIA GARY.walker@iqvi

2018 11:24 AM 3356 a.com
Closed Friday, 6 Apr CDISC- Philip Pochon Covance phil.pochon@covan

2018 01:51 PM 3357 ce.com
Closed Friday, 6 Apr CDISC- Philip Pochon Covance phil.pochon@covan
2018 01:52 PM 3358 ce.com
Closed Friday, 6 Apr CDISC- Abhijeet Nagpure Novartis abhijeet.nagpure@

2018 01:54 PM 3359 novartis.com
Closed Wednesday, 11 CDISC- Roberta Rosenberg Pfizer Roberta.e.Rosenbe

Apr 2018 04:35 3360 rg@pfizer.com
PM
Closed Wednesday, 11 CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba
Apr 2018 04:36 3361 yer.com
PM
Closed Wednesday, 11 CDISC- Nicholas Pemble Janssen npemble@its.jnj.co

Apr 2018 04:37 3362 m
PM
Closed Wednesday, 11 CDISC- Elaine Hazzard Janssen ehazzard@its.jnj.co

Apr 2018 04:38 3363 m
PM

Apr 2018 04:39 3364 m
PM
Apr 2018 04:39 3365 nih.gov
PM
Closed Friday, 13 Apr CDISC- Diane Wold CDISC diane.wold@cdisc.

2018 12:08 PM 3366 org
Closed Thursday, 19 Apr CDISC- Kimberley Holich AbbVie Inc. kimberley.holich@a

2018 03:52 PM 3367 bbvie.com
Closed Thursday, 19 Apr CDISC- Diane Wold CDISC diane.wold@cdisc.

2018 03:53 PM 3368 org
Closed Thursday, 19 Apr CDISC- Barbara Lentz Bayer Pharma LLC barbara.lentz1@ba
2018 03:56 PM 3369 yer.com
Closed Thursday, 19 Apr CDISC- Mihaela Simion Biogen mihaela.simion@bi

2018 03:57 PM 3370 ogen.com
Closed Thursday, 19 Apr CDISC- Debbie Oneill Merck debra_oneill@merc

2018 03:58 PM 3371 k.com

2018 03:59 PM 3372 k.com
Closed Friday, 27 Apr CDISC- Jennifer Feldmann Epreda jennifer.feldmann@

2018 10:54 AM 3373 epreda.com

2018 10:55 AM 3374 nih.gov
2018 10:58 AM 3375 k.com
Closed Friday, 27 Apr CDISC- Phil Pochon Covance phil.pochon@covan

2018 11:19 AM 3376 ce.com
Closed Friday, 27 Apr CDISC- Nik Pemble Janssen (J&J) npemble@its.jnj.co

2018 11:30 AM 3377 m
Closed Friday, 27 Apr CDISC- Diane Wold CDISC diane.wold@cdisc.
2018 11:32 AM 3378 org
Closed Friday, 4 May CDISC- Elaine Hazzard Janssen ehazzard@its.jnj.co

2018 10:54 AM 3379 m
Open Friday, 4 May CDISC- claire west GSK claire.m.west@gsk.

2018 10:55 AM 3380 com
Closed Friday, 4 May CDISC- Sophie Arlix Syneoshealth sophiearlix@syneo
2018 10:56 AM 3381 shealth.com
Closed Friday, 4 May CDISC- Sophie Arlix Syneoshealth sophiearlix@syneo

Closed Friday, 4 May CDISC- Helle Gawrylewski Janssen R&D LLC hgawryl@its.jnj.co
2018 10:58 AM 3383 m
Closed Thursday, 10 CDISC- Barbara Lentz Bayer LLC barbara.lentz1@ba

May 2018 01:46 3384 yer.com
PM
Open Thursday, 10 CDISC- Barbara Lentz Bayer LLC barbara.lentz1@ba
May 2018 01:46 3385 yer.com
PM
May 2018 01:47 3386 yer.com
PM

May 2018 01:47 3387 yer.com
PM
Closed Thursday, 10 CDISC- Roberta Rosenberg Pfizer Roberta.e.rosenber
May 2018 01:48 3388 g@Pfizer.com
PM

May 2018 01:49 3389
PM
May 2018 01:50 3390
PM
Closed Thursday, 10 CDISC- Dana Booth CDISC dbooth@cdisc.org

May 2018 01:51 3391
PM

May 2018 01:52 3392 k.com
PM

May 2018 01:52 3393 k.com
PM
Closed Friday, 18 May CDISC- John Kremer Covance john.kremer@cova
2018 11:28 AM 3394 nce.com
Closed Friday, 18 May CDISC- John Kremer Covance john.kremer@cova

2018 11:28 AM 3395 nce.com
Open Friday, 18 May CDISC- John Kremer Covance john.kremer@cova

2018 11:29 AM 3396 nce.com

2018 11:29 AM 3397 nce.com

2018 11:29 AM 3398 nce.com
2018 11:29 AM 3399 nce.com
2018 11:30 AM 3400 behalf of PTSD nih.gov
TAUG)
2018 11:41 AM 3401 behalf of HIV nih.gov
TAUG)
Open Friday, 18 May CDISC- Barbara Lentz Barbara Lentz barbara.lentz1@ba
2018 11:42 AM 3402 Bayer LLC yer.com
Open Friday, 18 May CDISC- Barbara Lentz Barbara Lentz barbara.lentz1@ba

2018 11:42 AM 3403 Bayer LLC yer.com
Closed Friday, 18 May CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Closed Friday, 18 May CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Closed Friday, 18 May CDISC- Matt Bendekovits Merck matt.bendekovits@

2018 11:45 AM 3406 merck.com
Closed Friday, 18 May CDISC- Andrea Mulcahy Alnylam amulcahy@alnylam

2018 11:48 AM 3407 Pharmaceuticals .com
Open Friday, 18 May CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

Closed Friday, 18 May CDISC- Mihaela Simion Biogen mihaela.simion@bi

2018 11:50 AM 3409 ogen.com
Open Monday, 21 May CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2018 04:59 PM 3410

May 2018 01:36 3411 behalf of nih.gov
PM INHAND/SEND)

May 2018 01:37 3412 nih.gov
PM
Closed Thursday, 24 CDISC- Bettina Lawrenz Bayer AG bettina.lawrenz@b
May 2018 01:38 3413 ayer.com
PM
Closed Thursday, 24 CDISC- Bettina Lawrenz Bayer AG bettina.lawrenz@b
May 2018 01:39 3414 ayer.com
PM
Closed Thursday, 24 CDISC- ARLIX Syneoshealth sophie.arlix@syneo

May 2018 01:40 3415 shealth.com
PM
Closed Thursday, 24 CDISC- Nik Pemble Janssen (J&J) npemble@its.jnj.co

May 2018 01:41 3416 m
PM
Closed Thursday, 24 CDISC- claire barnard AstraZeneca claire.barnard@astr

May 2018 01:42 3417 azeneca.com
PM
Closed Thursday, 24 CDISC- claire barnard AstraZeneca claire.barnard@astr
May 2018 01:43 3418 azeneca.com
PM

May 2018 01:44 3419
PM
Closed Thursday, 24 CDISC- Dana Booth CDISC dbooth@cdisc.org
May 2018 02:15 3420
PM
Closed Tuesday, 29 May CDISC- Dana Booth CDISC dbooth@cdisc.org

2018 11:59 AM 3421
Closed Tuesday, 29 May CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.

2018 12:00 PM 3422 nih.gov
Closed Friday, 1 Jun CDISC- Anne Cecilie Novo Nordisk A/S acee@novonordisk
2018 11:19 AM 3423 Engsig .com

2018 11:20 AM 3424 com
Closed Friday, 1 Jun CDISC- Nicholas Pemble Janssen (J&J) npemble@its.jnj.co

2018 11:21 AM 3425 m
2018 11:22 AM 3426 m

2018 11:23 AM 3427 m

2018 11:24 AM 3428 nih.gov

2018 11:25 AM 3429 nih.gov
Open Friday, 1 Jun CDISC- Mihaela Simion Biogen mihaela.simion@bi

2018 11:26 AM 3430 ogen.com

2018 11:27 AM 3431 com
Closed Thursday, 7 Jun CDISC- Nik Pemble Janssen (J&J) npemble@its.jnj.co
2018 04:59 PM 3432 m
Closed Thursday, 7 Jun CDISC- Nik Pemble Janssen (J&J) npemble@its.jnj.co

2018 04:59 PM 3433 m
Closed Thursday, 7 Jun CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo
2018 05:00 PM 3434 shealth.com
Closed Thursday, 7 Jun CDISC- Steve Kopko CDISC skopko.external@c

2018 05:01 PM 3435 disc.org
2018 11:13 AM 3436 behalf of HIV nih.gov
TAUG)
Closed Friday, 15 Jun CDISC- Helle Gawrylewski Janssen hgawryl@its.jnj.co

2018 11:14 AM 3437 m
Closed Friday, 15 Jun CDISC- Carrie Neeley Covance carrie.neeley@cov

2018 11:15 AM 3438 ance.com
Closed Friday, 15 Jun CDISC- Maria Webster ICON Central Maria.Webster@ico
2018 11:16 AM 3439 Laboratory nplc.com
Closed Friday, 22 Jun CDISC- Nik Pemble Janssen (J&J) npemble@its.jnj.co
2018 11:47 AM 3440 m
Closed Friday, 22 Jun CDISC- Nik Pemble Janssen (J&J) npemble@its.jnj.co

2018 11:49 AM 3441 m
Closed Friday, 22 Jun CDISC- John Kremer Covance Labs john.kremer@cova

2018 11:53 AM 3442 nce.com

2018 11:54 AM 3443 nce.com

2018 11:54 AM 3444 nce.com
2018 11:59 AM 3445 nce.com
Open Friday, 22 Jun CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

Closed Friday, 22 Jun CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

Closed Friday, 22 Jun CDISC- Claire West GSK claire.m.west@gsk.
2018 12:02 PM 3448 com
Closed Friday, 22 Jun CDISC- James Kramer Janssen Research jkramer2@its.jnj.co

2018 12:03 PM 3449 and Development m
Open Friday, 22 Jun CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2018 12:11 PM 3450 yer.com
Closed Friday, 29 Jun CDISC- Mihaela Simion BIogen mihaela.simion@bi

2018 11:46 AM 3451 ogen.com
Closed Friday, 29 Jun CDISC- Gitte Frausing datastandardsdecis gfrausing@datasta
2018 11:47 AM 3452 ions ndardsdecisions.co
m

2018 11:49 AM 3453 k.com

2018 11:51 AM 3454 k.com
2018 11:54 AM 3455 nce.com
Closed Friday, 29 Jun CDISC- Steve Kopko CDISC skopko.external@c

2018 11:55 AM 3456 disc.org
Closed Tuesday, 3 Jul CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2018 04:42 PM 3457 yer.com

2018 04:46 PM 3458 yer.com
2018 04:47 PM 3459 yer.com
2018 04:50 PM 3460 yer.com

2018 04:51 PM 3461 yer.com
Open Tuesday, 3 Jul CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2018 04:52 PM 3462 yer.com
Closed Tuesday, 3 Jul CDISC- Gitte Frausing Data Standards gfrausing@datasta

m
Closed Friday, 6 Jul CDISC- Gitte Frausing Data Standards gfrausing@datasta
m
Closed Friday, 6 Jul CDISC- Erin Muhlbradt (on Data Standards muhlbradtee@mail.
2018 12:36 PM 3465 behalf of the CrCa DecisionsMSC Inc nih.gov
TAUG)

2018 12:37 PM 3466 yer.com
2018 12:37 PM 3467 yer.com
2018 11:34 AM 3468 behalf of CDASH) nih.gov
Open Friday, 13 Jul CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
Closed Friday, 13 Jul CDISC- Christine Connolly EMD Serono christine.connolly@
Closed Thursday, 19 Jul CDISC- Sharon Quek PMI Sharon.Quek@pmi.

2018 11:51 AM 3472 com
Closed Thursday, 19 Jul CDISC- Elaine Hazzard Janssen ehazzard@its.jnj.co

2018 11:52 AM 3473 m
Closed Thursday, 19 Jul CDISC- Elaine Hazzard Janssen ehazzard@its.jnj.co

2018 11:53 AM 3474 m
Closed Thursday, 19 Jul CDISC- Diane Cory C-Path dcorey@c-path.org

2018 11:54 AM 3475
Closed Thursday, 19 Jul CDISC- Diane Cory C-Path dcorey@c-path.org
2018 11:54 AM 3476
Open Thursday, 19 Jul CDISC- ACEE (Anne Novo Nordisk acee@novonordisk

2018 11:56 AM 3477 Cecilie Engsig) .com
Closed Thursday, 19 Jul CDISC- Claire West GSK claire.m.west@gsk.

2018 11:56 AM 3478 com
Open Friday, 27 Jul CDISC- Mihaela Simion Biogen mihaela.simion@bi

2018 01:32 PM 3479 ogen.com
Closed Friday, 27 Jul CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
2018 01:37 PM 3481 k.com
2018 02:05 PM 3482 com
Open Friday, 27 Jul CDISC- Helle Gawrylewski Janssen R&D LLC hgawryl@its.jnj.co
2018 02:08 PM 3483 m
2018 02:11 PM 3484 m
Closed Friday, 27 Jul CDISC- Amanda Johnson Syneos Health amanda.johnson2
2018 02:13 PM 3485 @syneoshealth.co
m
2018 02:51 PM 3486 m
Open Friday, 3 Aug CDISC- Colleen Bonjo Merck colleen_bonjo@me

2018 04:19 PM 3487 rck.com
2018 04:20 PM 3488 nih.gov
Closed Friday, 3 Aug CDISC- Jennifer Feldmann Epreda jennifer.feldmann@

2018 04:23 PM 3489 epreda.com
Closed Friday, 10 Aug CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2018 12:13 PM 3490 behalf of nih.gov
Huntington's
Disease TAUG)
Closed Friday, 10 Aug CDISC- HARDIK VASANI Cognizant hardik.vasani@cog
2018 12:14 PM 3491 Technology nizant.com
Solutions
Closed Friday, 10 Aug CDISC- Jennifer Feldmann Epreda jennifer.feldmann@

2018 12:15 PM 3492 epreda.com
Closed Friday, 10 Aug CDISC- Christine Connolly EMD Serono christine.connolly@

2018 12:18 PM 3493 emdserono.com
Closed Friday, 10 Aug CDISC- Deb Goodfellow Chiltern deborah.goodfellow

2018 12:18 PM 3494 @chiltern.com
Closed Friday, 17 Aug CDISC- Diane Corey C-Path dcorey@c-path.org
2018 12:29 PM 3495
Closed Friday, 17 Aug CDISC- Christy Kubin Charles River christy.kubin@crl.c

2018 12:31 PM 3496 Laboratories om
Closed Friday, 17 Aug CDISC- Erin Tibbs-Slone MPI erin.tibbs-

2018 12:33 PM 3497 Research/Charles slone@mpiresearc
River h.com
Closed Friday, 24 Aug CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo












Open Friday, 24 Aug CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo











































2018 12:37 PM 3566 nih.gov
Closed Friday, 24 Aug CDISC- Helena Sviglin FDA helena.sviglin@fda.

2018 12:38 PM 3567 hhs.gov
Open Friday, 24 Aug CDISC- Helle Gawrylewski Janssen hgawryl@its.jnj.co

2018 12:41 PM 3568 m
Closed Friday, 24 Aug CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
team)
Closed Friday, 24 Aug CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2018 12:43 PM 3570 yer.com
Closed Friday, 24 Aug CDISC- Daniel K Sinnett Emmes dsinnett@emmes.c
2018 12:47 PM 3571 om
Closed Friday, 24 Aug CDISC- Daniel K Sinnett Emmes dsinnett@emmes.c

2018 12:47 PM 3572 om

Closed Wednesday, 29 CDISC- Daniel K Sinnett Emmes dsinnett@emmes.c

Aug 2018 09:28 3574 om
AM
Closed Wednesday, 29 CDISC- Daniel K Sinnett Emmes dsinnett@emmes.c

Aug 2018 09:29 3575 om
AM
Closed Wednesday, 29 CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo
Aug 2018 09:30 3576 shealth.com
AM

Aug 2018 09:30 3577 nih.gov
AM
Aug 2018 11:28 3578 Ingelheim boehringer-
Inc.
Closed Friday, 7 Sep CDISC- Daniel K Sinnett Emmes dsinnett@emmes.c

2018 08:34 AM 3579 om
Closed Friday, 7 Sep CDISC- Diane Corey C-Path dcorey@c-path.org

2018 08:35 AM 3580
Closed Friday, 7 Sep CDISC- Deb Rittenhouse CSL Behring deborah.rittenhous
2018 08:36 AM 3581 e@cslbehring.com
2018 11:31 AM 3582 om

2018 11:31 AM 3583 om
Closed Friday, 21 Sep CDISC- Erin Muhlbradt (on NCI EVS erinmuhlbradt@gm
2018 03:59 PM 3584 behalf of ail.com
Huntington's
Disease TAUG)

2018 04:00 PM 3585 nih.gov
Inc.

Inc.

2018 09:19 AM 3588 om
Closed Friday, 28 Sep CDISC- Ryota Ogawa Translational ryota.ogawa@tri-

2018 09:20 AM 3589 Research Center kobe.org
for Medical
Innovation
Closed Friday, 28 Sep CDISC- Gary Cunningham The Griesser Group gcunningham@the
2018 09:21 AM 3590 griessergroup.com
Closed Friday, 5 Oct CDISC- Molly McClanahan Emmes mmcclanahan@em
2018 05:12 PM 3591 me.com
Closed Friday, 5 Oct CDISC- Helene Bertheux Servier helene.bertheux@s

2018 05:13 PM 3592 ervier.com
Closed Friday, 5 Oct CDISC- Clabaugh, Melissa Center for melissa.clabaugh@

2018 05:15 PM 3593 Biomedical nih.gov
Informatics &
Information
Technology/NIH
Informatics &
Information
Technology/NIH

Informatics &
Information
Technology/NIH

Informatics &
Information
Technology/NIH
Informatics &
Information
Technology/NIH

Informatics &
Information
Technology/NIH
Closed Friday, 5 Oct CDISC- Steve Kopko CDISC skopko@cdisc.org

2018 05:18 PM 3599
Closed Friday, 12 Oct CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Inc.
Closed Friday, 12 Oct CDISC- Mary Jo Brucker Merck & Co., Inc mj.brucker@merck.
2018 09:15 AM 3602 com
Closed Friday, 12 Oct CDISC- Mihaela Simion Biogen Mihaela.Simion@bi

2018 09:16 AM 3603 ogen.com
Closed Friday, 12 Oct CDISC- Mihaela Simion Biogen Mihaela.Simion@bi

2018 09:17 AM 3604 ogen.com
INHAND/SEND)
2018 04:47 PM 3606 behalf of HIV nih.gov
TAUG)
TAUG)
TAUG)
Closed Thursday, 18 Oct CDISC- Colleen Bonjo Merck colleen_bonjo@me
2018 05:02 PM 3609 rck.com
Closed Friday, 19 Oct CDISC- Claire West GSK claire.m.west@gsk.

2018 10:00 AM 3610 com

2018 10:01 AM 3611 com

2018 11:31 AM 3612 (P36) nih.gov
Closed Friday, 26 Oct CDISC- Sophie Arliex Syneoshealth sophie.arlix@syneo

Closed Friday, 26 Oct CDISC- Kit Howard CDISC khoward@cdisc.org
2018 11:33 AM 3614

2018 11:36 AM 3615 nih.gov
2018 11:51 AM 3616 nih.gov
Closed Monday, 29 Oct CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2018 09:22 AM 3617 behalf of the
Race/Ethn
Subteam)
Closed Friday, 2 Nov CDISC- Claire West GSK claire.m.west@gsk.

2018 02:24 PM 3618 com
Closed Friday, 2 Nov CDISC- Lacey Wallace IQVIA lacey.wallace@IQV
2018 02:25 PM 3619 IA.com
Closed Friday, 2 Nov CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2018 02:26 PM 3620 behalf of Anne
Cecilie Engsig)
Closed Friday, 9 Nov CDISC- Melanie Paules GSK melanie.a.paules@
2018 02:01 PM 3621 gsk.com
Open Friday, 9 Nov CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2018 02:02 PM 3622
Closed Friday, 16 Nov CDISC- Surjit GSK surjit.x.sondh@gsk.

2018 03:00 PM 3623 com
Closed Friday, 16 Nov CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2018 03:01 PM 3624 yer.com

2018 03:02 PM 3625 yer.com
Closed Friday, 16 Nov CDISC- Christine Connolly EMD Serono christine.connolly@
Closed Friday, 16 Nov CDISC- Erin M NCI EVS muhlbradtee@mail.

2018 03:05 PM 3627 nih.gov
Closed Friday, 16 Nov CDISC- Sharon Broderick boehringer- sharon.broderick@

2018 03:06 PM 3628 ingelheim boehringer-
ingelheim.com

ingelheim.com

ingelheim.com
ingelheim.com
Closed Wednesday, 21 CDISC- Sharon Broderick boehringer- sharon.broderick@

Nov 2018 04:28 3632 ingelheim boehringer-
PM ingelheim.com
Closed Friday, 30 Nov CDISC- Novonordisk ksdr@novonordisk.

2018 10:58 AM 3633 com

2018 10:58 AM 3634 com

2018 10:59 AM 3635 com

2018 10:59 AM 3636 com
2018 10:59 AM 3637 com

2018 11:00 AM 3638 com

2018 11:00 AM 3639 com

2018 11:00 AM 3640 com
Closed Friday, 30 Nov CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2018 11:01 AM 3641 behalf of Diane nih.gov
Wold)
Closed Friday, 30 Nov CDISC- Christine Connolly EMD Serono christine.connolly@

Closed Friday, 30 Nov CDISC- Claire West GSK claire.m.west@gsk.

2018 11:03 AM 3643 com
Closed Friday, 7 Dec CDISC- DANIEL L PDS dan.potenta@pdslif
2018 06:40 PM 3644 POTENTA esciences.com
Closed Friday, 7 Dec CDISC- Ying Li CRL Audrey.Walker@crl

2018 06:41 PM 3645 .com
Closed Friday, 7 Dec CDISC- Ying Li CRL Audrey.Walker@crl

2018 06:41 PM 3646 .com
Closed Friday, 7 Dec CDISC- Claire West GSK claire.m.west@gsk.
2018 06:47 PM 3647 com
Closed Friday, 7 Dec CDISC- Evangel Hager PPDI evangela.hager@p

2018 06:50 PM 3648 pdi.com
Closed Friday, 7 Dec CDISC- Claire West GSK claire.m.west@gsk.

2018 06:52 PM 3649 com
2018 06:53 PM 3650 behalf of CT nih.gov
Relationships
Team)
Open Friday, 7 Dec CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2018 06:54 PM 3651 behalf of CT nih.gov
Relationships
Team)
Closed Friday, 7 Dec CDISC- Steve Kopko CDISC skopko@cdisc.org

2018 06:55 PM 3652
Open Friday, 7 Dec CDISC- Steve Kopko CDISC skopko@cdisc.org
2018 06:56 PM 3653
Closed Friday, 7 Dec CDISC- Christy Kubin Charles River christy.kubin@crl.c

2018 06:57 PM 3654 Laboratories om
Dec 2018 04:17 3655 rck.com
PM

Dec 2018 04:18 3656 rck.com
PM
Dec 2018 04:18 3657 rck.com
PM

Dec 2018 04:18 3658 rck.com
PM

Dec 2018 04:21 3659 ogen.com
PM
Closed Thursday, 13 CDISC- Kathleen Hectors Janssen khectors@its.jnj.co

Dec 2018 04:21 3660 m
PM
Closed Thursday, 13 CDISC- PALATE Bernard "Citoxlab Group bernard.palate@fr.
Dec 2018 04:22 3661 (Pathologists from citoxlab.com
PM France, Canada,
Denmark, Hungary
& USA)
Closed Friday, 21 Dec CDISC- Carrie Neeley carrie.neeley@cov Covance

2018 12:17 PM 3662 ance.com
Closed Friday, 21 Dec CDISC- PALATE Bernard Bernard.Palate@fr. Citoxlab
2018 12:21 PM 3663 citoxlab.com
Closed Friday, 28 Dec CDISC- Daniel Sinnett dsinnett@emmes.c Emmes

2018 11:50 AM 3664 om
Request Type
Create New SDTM- ADJUDICATOR 1

Term MEDEVAL

Term MEDEVAL

Term MEDEVAL
Create New SEND- CUMULATIVE BODY WEIGHT GAIN

Term BGTEST
Create New SEND- CUMULATIVE FOOD

Term FWTEST CONSUMPTION
Create New NEW NULLFLAVOR

Codelist
Create New NEW NI or No information (CT team to

Term decide, as only one preferred term is
to be used) Include term in the new
NULLFLAVOR codelist.
Create New NEW INV or Invalid (CT team to decide, as
Term only one preferred term is to be
used) Include term in the new
Create New NEW OTH or Other (CT team to decide, as

Create New NEW PINF or Positive infinity (CT team to

Create New NEW NINF or Negative infinity (CT team to

Create New NEW UNC or Unencoded (CT team to
Create New NEW DER or Derived (CT team to decide,

Term as only one preferred term is to be
Create New NEW UNK or Unknown (CT team to

Create New NEW ASKU or Asked but unknown (CT

Term team to decide, as only one
preferred term is to be used) Include
term in the new NULLFLAVOR
codelist.
Create New NEW NAV or Temporarily unavailable (CT
Term team to decide, as only one
preferred term is to be used) Include
term in the new NULLFLAVOR
codelist.
Create New NEW NASK or Not asked (CT team to

Create New NEW QS or Sufficient quantity (CT team to

Create New NEW TRC or Trace (CT team to decide, as

Create New NEW MSK or Masked (CT team to decide,

Term as only one preferred term is to be
Create New NEW NA or Not applicable (CT team to

Create New NEW; SDTM- Create a new codelist and add new
Term MBTEST/CD terms to MBTEST-CD. This is a TA
request from the CDAD team
Create New SDTM- BONE SCINTIGRAPHY
Term METHOD
Modify SDTM-AESEV Update CDISC Controlled

Existing Term Terminology for AESEV to include
POTENTIALLY LIFE-
THREATENING and DEATH.
Create New SDTM-QSCAT Please add the following terms to
Term QSCAT
Create New ADaM-DTYPE ?OCCUROCF?. With as

Term description: ?Occurrence observation
carried forward: A data imputation
technique which populates an
occurrence value recorded for a time
interval for all planned time points?
Create New SDTM- Request from Vaccines TA Team:

Term VNFATS TOXGR/Toxicity Grade: A
standardized categorical
classification of the severity of an
event or finding.
Create New CDISC- Multiple New Term Request
Term Glossary
Create New SEND- Add the wild type for CB6F1-TgN
Term STRAIN (RasH2) (CDISC code C98711).

Existing Term MBTEST/CD C120678
Modify SDTM- Pls update CDISC definition for

Existing Term LBTEST/CD C120678.
Create New SDTM- PLATEIM

Term LBTESTCD
Create New SDTM- Immature Platelets
Term LBTEST
Create New SDTM- AUTOMATED CELL COUNT
Term METHOD
Create New Multiple Request development of Controlled

Codelist Terminology for the Pediatric
Functional Assessment of Chronic
Illness Therapy-Fatigue (PEDS
FACIT-F)
Create New Multiple term added to 10 meter walk/run
Term FTTESTCD/FTTEST
Create New Multiple add term to 4 stair ascend

Create New Multiple add term to 4 stair descend

Modify SEND- LEIOMYOMA, MESOVARIAL,
Existing Term NEOPLASM MALIGNANT
Create New SDTM-UNIT s/co

Term
Create New SDTM- ASPERGILLUS NIVEUS

Term MICROORG
Create New SDTM- Krebs von den Lungen-6 Antigen

Term LBTEST-CD
Create New SDTM- Islet Cell Antibody

Term LBTEST-CD
Create New SDTM- Oxyhemoglobin/Total Hemoglobin

Term LBTEST-CD
Create New SDTM- Methemoglobin/Total Hemoglobin

Term LBTEST-CD
Create New SDTM- Atherogenic Index

Term LBTEST-CD
Create New SDTM- Hepatitis A Virus IgG Antibody

Term LBTEST-CD
Create New SEND-SSTYP RANGE FINDING
Term
Create New SDTM- Chlamydia Trachomatic Urine

Term LBTEST
Create New SDTM- CTRUR
Term LBTESTCD
Create New SDTM- SS

Term DOMAIN
Create New SDTM- Request to add new value to Culture

Term CLTMDTYP Medium Type codelist; Craig, please
triage this to the MB team, thank you
:)
Create New SDTM- Request to add new value to Culture

Term CLTMDTYP Medium Type codelist; Craig, please
triage this to the MB team, thank you
:)
Create New SDTM- STAPHYLOCOCCUS CAPITIS

Term MICROORG SUBSP. UREALYTICUS
Create New SDTM- Cape Coloured or Khoisan
Term RACEC
Modify SDTM- The term 'Sum of Products of

Existing Term TRTEST-CD Perpendicular Diameters' is longer
than 40 characters
Create New SEND- CDISC published new version of the

Term SNDIGVER SENDIG-DART.
Create New SDTM-LOC Placenta

Term
Create New SDTM- CARBAPENEM RESISTANT

Term MICROORG ACINETOBACTER
Create New SDTM-LOC SDTM LOC - see attachment
Term
Modify SDTM-UNIT Please add the following synonyms

Existing Term to existing code C66962 with
submission value of 'mL/h': cm3/h;
cc/hr
Create New SDTM- Add submission value: Peripheral
Term LBTEST-CD Blood Morphology (test name), with
corresponding test code
(LBTESTCD): MORPHREV
Create New SDTM- multiple term file submitted

Term PKPARM-CD separately
Create New SDTM- Fibroblast Growth Factor 19
Term LBTEST
Create New SDTM- FGF19

Term LBTESTCD
Modify SDTM- Update definition of codelist

Existing Term NCOMPLT
Create New SDTM- Soluble CD163

Term LBTEST/CD
Create New SDTM- Retinol Binding Protein/Creatinine

Term LBTEST/CD
Create New CDISC- RMAT (regenerative medicine

Term Glossary advanced therapy)
Create New CDISC- regenerative medicine
Term Glossary
Create New SDTM- CELL PELLET

Term SPECTYPE
Create New Multiple Pls add new terms

Term
Create New SDTM- CYP2C19

Term LBTESTCD
Create New SDTM- CYP2C19 Genotype
Term LBTEST
Create New SDTM- CYP2C19INT

Term LBTESTCD
Create New SDTM- CYP2C19 Genotype Interpretation

Term LBTEST
Create New SDTM- New terms needed for PKPARM-CD
Term PKPARM/CD
Create New SDTM- add FTTESTCD='RISEF103' to Rise

Term RISEF1TC/TN from Floor for DMD TAUG
Create New SDTM- additional terms for T25FW1

Term T25FW1TC/ FTTESTCD/FTTEST code, for MS
TN TAUG
Create New NEW New QRS request for FACT-BMT

Codelist terminology
Create New Multiple Multiple term request
Term
Create New SDTM- Please add to the ONCRTS Codelist

Term ONCRSR Response of New Lesion with
ONCRTSCD NEWLRSP.
Other Other Please update the PC Unit CL to PK

Unit in the IG as it is pointing to the
wrong CL "UNIT" - these are not the
correct units needed for PK Conc
drug data.
Create New CDISC- Monitoring
Term Glossary
Create New SDTM- Please add OUTCOME EVENT to
Term NCOMPLT the NCOMPLT codelist.
Create New Multiple Pls add new terms and fix existing
Term term
Create New CDISC- Stem Cell

Term Glossary
Create New New Please create new CAT, TEST,

Codelist TESTCD terms for MMS
Create New SDTM- Add EC Exposure as Collected

Term DOMAIN
Create New SDTM- Protein Expression
Term PFTEST-CD
Create New SDTM- Lipids

Term LBTEST/CD
Modify Multiple Update CDISC definition for the five

Existing Term PK Unit codelist
Create New SDTM- Please add 'EC' for the EC domain.

Term DOMAIN Exposure as Collected.
Create New New MDD TA QRS instrument

Codelist terminology for Suicidal Ideation
Questionnaire (SIQ) and Suicidal
Ideation Questionnaire - JR (SIQ-JR)
Create New SDTM- VA

Term RETESTCD
Create New SDTM- Alveolar Volume

Term RETEST
Create New SDTM- Please add new term for Australian
Term RACEC Aborigines
Create New Aldrin Epoxidase

Term
Create New SDTM- NASOPHARYNGEAL

Term ROUTE
Create New SDTM- Nociceptin

Term LBTEST
Create New SDTM- NOCIPTIN

Term LBTESTCD
Create New SDTM- New LB terms
Term LBTEST-CD

Term
Create New SDTM- EC

Term DOMAIN

Term MITSCD
Create New SDTM-MITS CD3

Term
Term MITSCD

Term

Term MITSCD

Term
Create New SDTM- MBP

Term MITSCD
Create New SDTM-MITS Major Basic Protein

Term
Create New SDTM- ELACELL
Term MITSCD
Create New SDTM-MITS Neutrophil Elastase Expressing Cells

Term
Create New SDTM- TRYPCELL

Term MITSCD
Create New SDTM-MITS Tryptase Expressing Cells
Term

Term MITSCD

Term
Create New SDTM- SMUSCAB

Term MITSCD
Create New SDTM-MITS Smooth Muscle Antibody

Term
Create New SDTM- ENDOTH

Term MITSCD
Create New SDTM-MITS Endothelium

Term
Create New SDTM- MUC5AC
Term MITSCD
Create New SDTM-MITS MUC5AC

Term
Create New SDTM- INVLCRN

Term MITSCD
Create New SDTM-MITS Involucrin
Term
Create New SDTM- CY7

Term MITSCD
Create New SDTM-MITS Cytokeratin 7

Term
Create New SDTM- ECADHRN
Term MITSCD
Create New SDTM-MITS eCadherin

Term
Create New SDTM- BD1

Term MITSCD
Create New SDTM-MITS Beta-defensin 1

Term
Create New SDTM- S100A8

Term MITSCD
Create New SDTM-MITS S100 Calcium Binding Protein A8
Term
Create New SDTM- S100A9

Term MITSCD
Create New SDTM-MITS S100 Calcium Binding Protein A9

Term
Create New SDTM- EPICI

Term MITSCD
Create New SDTM-MITS Epithelium, Intact

Term
Create New SDTM- PAS
Term MITSCD
Create New SDTM-MITS PAS+ Count

Term
Create New NEW FTCAT/FTTESTCD/FTTEST for

Codelist Emotion Recognition for
Huntington's Disease TAUG
Create New NEW FTCAT/FTTESTCD/FTTEST for

Codelist Paced Tapping For Huntington's
Disease TAUG
Modify SDTM- Two terms in LBTEST/CD codelists

Existing Term LBTEST/CD may be synonymous - C100426 and
C103432. Check this.
Modify SDTM- Please explain the difference

Existing Term LBTEST/CD between 'Intact' and 'Whole' within
the CDISC definition. Confirm that
these are two different tests with
assays that can differentiate them.
Modify SDTM- Update CDISC definition to make

Existing Term LBTEST/CD clear distinctions between C112312
and C112291.
Create New SDTM-UNIT For NCI Code C71620 SEND-UNIT.
Term Selected "New" in CDISC Code List
above as SEND-UNIT is not listed.
Please consider addition of the term
"5 mins" for a unit of measurement of
5 minutes duration.
Modify Multiple Change CAT, TESTCD and TEST

Existing Term from Questionnaires to Funtional
Tests for MMSE version 1. Please
update CCODE values as well.
Create New Multiple FTCAT/FTTESTCD/FTTEST for

Term COWAT This is for the Huntington's
TAUG
Create New CDISC- Administration

Term Glossary
Create New CDISC- Exposure

Term Glossary
Create New SDTM- Pls add new terms to LBTEST-CD
Term LBTEST/CD codelists
Create New SDTM-UNIT Enzyme U/m2

Term
Create New SDTM- LBTEST = "Hepatitis C RNA";

Term LBTEST LBTESTCD = "HCRNA"
Create New SDTM- LBTEST ="HIV-1 RNA";

Term LBTESTCD LBTESTCD="HIV1RNA"
Create New Multiple Auxiliary medicinal product

Term
Create New Multiple Enrollment and or "enroll" containing
Term terms
Create New SDTM- DOSFRM

Term TSPARMCD
Create New SDTM- Dose Form

Term TSPARM
Create New SDTM- Test = Averag Vaginal Bleeding Flow

Term RPTEST/CD Description TESTCD = VBFDESCR
Create New SDTM- Test Name = Usual Duration of

Term RPTEST/CD Vaginal Bleeding TESTCD =
VAGBLDUR
Create New SDTM- Test Name = Menstrual Cycle

Term RPTEST/CD Pattern TESTCD = MENCYPAT
Create New Multiple Please add 1 new term to LBTEST-

Term CD codelist, and create new Findings
About TEST-CD codelists for the
Nutrition TAUG.
Create New SDTM-UNIT mgEq
Term
Modify SDTM- NITRITE - Amend definition
Create New Multiple Do not triage. Just need request

Term codes for the terms in P34 Public
Review.
Create New SDTM- LBTEST = "M2 Pyruvate Kinase";
Term LBTEST/CD LBTESTCD = "M2PK"
Create New SDTM- CDISC to LOINC mapping termjs

Term SPECTYPE
Create New QRS-QSCAT Rett Syndrome Clinical Severity

Term Scale (RCSS)
Create New SDTM-UNIT New Unit terms for LOINC matching

Term
Create New SDTM- New Method Terms for LOINC
Term METHOD Matching
Create New SDTM-RACE Not Reported'

Term
Create New SDTM- Please add the following 2 values to

Term RELSUB the RELSUB codelist MOTHER
FATHER
Create New SDTM- Please add PALM METHOD to the
Term METHOD METHOD codelist
Create New SDTM- CELLS

Term SPECTYPE
Create New SDTM- Blood Gas Analysis

Term METHOD
Create New SDTM-UNIT mg/L FEU and ug/L FEU

Term
Create New Multiple Batch 1 of Lung Cancer TA.
Term Contains 35 new terms.
Modify SDTM- Change CDISC Synonym for term

Existing Term DOMAIN C49578 from "Drug Accountability" to
"Product Accountability"
Create New SEND-SEV Add term: PRESENT to the Severity

Term codelist.
Modify SDTM- DA and DD have always been

Existing Term DOMAIN findings domains in the SDTMIG.
Create New SDTM- Please add VSTESTCD of NECKCIR
Term VSTEST/CD with VSTEST of Neck Circumference
to codelists.
Create New SDTM-LOC Please add new term: L5-S1 SPINAL

Term DISC
Create New SDTM-UNIT Index

Term
Create New SDTM- Drug Crystals (TESTCD: CYDRUG)

Term LBTEST/CD
Create New SEND-CLCAT A category to separate qualitative

Term food consumption findings from other
observations so that they can be
easily identified for comparison to
animal weight changes.
Modify SDTM- C51913; This is the incorrect code

Existing Term CLMETH based on the CDISC PT and
definition. Should be coded to
C38068.
Create New SDTM- Acylglycines (ACYGLYCN);
Term LBTEST/CD Acylcarnitine (ACYCRNTN); Amino
Acids (AMNOACID)
Create New SDTM- Pls add new terms to MBTEST-CD;

Term MBTEST/CD Needed for LOINC code mapping.
Pls modify existing terms
Create New SDTM- Fluoroscopy

Term METHOD
Create New SDTM- Need to add a term for the Trial Test
Term DOMAIN Lookup (TL) domain. This will also
need to be added to the SDOMAIN
codelist for SEND.
Create New SDTM- BONE MARROW MONONUCLEAR

Term SPECTYPE CELLS, BMMC
Modify SDTM- Querying the term HEMODIALYSIS

Existing Term ROUTE in ROUTE
Create New SDTM- Please add the NCI term "Ethinyl
Term LBTEST/CD Estradiol (Code C486)" as CDISC
LBTESTCD codelist.
Create New SDTM- Please add the NCI term

Term LBTEST/CD "Etonogestrel (Code C47528)" as
CDISC LBTESTCD codelist.
Modify CDISC- enrolled
Existing Term Glossary
Create New SDTM- INTRAVESICAL CHEMOTHERAPY

Term PROCEDUR
Create New SDTM- LOCAL IMMUNOTHERAPY

Term PROCEDUR
Create New SDTM- PATHOLOGIST 1

Term MEDEVAL
Create New SDTM- PATHOLOGIST 2

Term MEDEVAL
Create New SDTM- Please consider adding a new value
Term NCOMPLT to NCOMPLT: NO LONGER
CLINICALLY BENEFITTING
Modify SDTM- Target Cells - TRGTCE (CT-360)

Modify SDTM-UNIT Please look into terms in the UNIT
Existing Term codelist that pertain to "second(s)"
Modify Multiple Would like to revise the CDISC

Existing Term definition for the QSCAT for FAC070
and the FAC070TC/TN codelists to
reflect the update to the QSCAT and
definition.
Create New SDTM-UNIT nmol/mL
Term
Create New SDTM- Decanoylcarnitine

Term LBTEST/CD
Create New SDTM- To adapt the definition for
Term EGTEST/CD Continuous Ambulatory ECG to
account for animal models:
Create New SDTM- To adapt the definition for

Term EGTEST/CD Continuous Ambulatory ECG for
surgically-instrumented animal
models (a telemetry device is
implanted into the animal for
repeated recordings):
Create New SDTM- Contractility Index: An index of

Term CVTEST/CD cardiac contractility: Measured as left
ventricular dP/dt max divided the
systemic arterial systolic blood
pressure at that point.
Create New SDTM- Tau: Left ventricular isovolumic
Term CVTEST/CD relaxation time constant (time of
pressure decay)
Create New SDTM- DPDTMIN: Left Ventricular Maximum

Term CVTEST/CD Negative dP/dt; dPdt Minimum; -
dPdt: The maximum rate of negative
pressure change over time within the
left ventricle (diastole).
Create New SDTM- EMW: Electromechanical Window
Term CVTEST/CD
Create New Multiple Batch 1 request for PTSD

Term therapeutic area user guide. These
terms have already been added to
the General, Device, and Lab
working documents. The only action
is to add the new term request code
to the relevant working documents.
Create New Multiple Request for batch 1 of HIV TAUG

Term terminology
Create New SDTM- TSPARM of Pharmaceutical Dosage
Term TSPARM Form
Create New SDTM- TSPARMCD of DOSFRM with

Term TSPARMCD CDISC Synonym of Pharmaceutical
Dosage Form
Create New SDTM- Add new terms

Term MBTEST/cd
Create New SDTM- Additional Outcome Measure

Term TSPARM/CD (OUTMSADD)
Create New SDTM-UNIT Add new unit terms

Term
Create New SDTM- Request to add Delta Aminolevulinic

Term LBTEST/CD Acid, Porphobilinogen,
ALA/Creatinine, and PBG/Creatinine
to LBTEST codelist.
Create New SDTM- New LB term needed

Term LBTEST/CD
Create New SDTM- FLUOXTN/Fluoxetine

Term LBTESTCD
Modify SDTM-QSCAT Change C147584 to C121853
Existing Term
Create New SEND- Multiple term request to add new

Term NONNEO tumor types to the SEND
NEOPLASM codelist. These are from
the INHAND to send Mapping done
at the end of 2017. These tumors are
in INHAND publications but are not in
SEND CT.
Modify SDTM-LAT Incorrect NCI c-code used for

Existing Term UNILATERAL: Change C68598 to
C28012.
Create New SEND- Cytoplasmic Alteration (Liver)
Term NONNEO
Create New SEND- Depletion
Term NONNEO
Create New SDTM-FRM Please consider to add TABLET,

Term GASTRO-RESISTANT in the
Pharmaceutical Dosage Form
Codelist (FRM)
Create New SDTM- INTERFERON GAMMA RELEASE
Term METHOD ASSAY
Create New SDTM- umol/L/umol/kg

Term PKUNIT
Create New SDTM- h*umol/L/(umol/kg)
Term PKUNIT
Create New Multiple RSCAT/RSTESTCD/RSTEST for

Term UHDRS This is for the Huntington's
Disease TAUG
Create New Multiple New CCCAT=CAPS (CURRENT)
Term DSM-5 WITH DSM-IV SCORING
2016 VERSION, synonym CAP01,
and RSTESTCD/RSTESTNM of
CAP01TC/TN
Create New Create new QSCAT (FACIT-
Term DYSPNEA 33 ITEM BANK),
synonym FAC100 and new test
code/test name codelists
FAC100TC/TN
Modify SDTM- Pls remove terms
Existing Term DOMAIN
Create New SEND-SPEC For Codelist 'SPECIMEN' to add:
Term New term 'GLAND, BRUNNER'S'
Definition and use: 'Exocrine
compound tubular submucosal gland
present in the proximal part of the
Duodenum' Synonym(suggesting):
'Duodenal Gland'
Create New SDTM- 2 new LBTEST(CD) terms for your

Term LBTEST/CD consideration please
Modify SDTM-UNIT CCODE: C67377

Existing Term
Create New SDTM- IL2R - Interleukin 2 Receptor
Term LBTEST/CD
Create New SDTM-UNIT U as a representation of arbitrary unit

Term
Create New SDTM- Please add ARCHIVE RETRIEVING

Term BEDECOD to the BEDECOD codelist.
Create New SDTM- Please add: PREPAMT/Prepared

Term DATEST/CD Amount and UNUSDAMT/Unused
Amount to DATEST/CD codelist.
Modify SDTM-DTHDX DTHDX

Existing Term
Create New Multiple Pls add new terms

Term
Create New SDTM-LOC TIBIOTARSAL JOINT
Term
Create New SDTM- MYELOPEROXIDASE STAIN

Term METHOD
Create New SDTM- Please add the following NCI
Term LBTEST/CD Termonology in CDISC terminology :
CYP2C9 Gene (Code C21597)
Create New Multiple Create QRS terminology for the

Codelist Children's Depression Rating Scale
Revised (CDRS-R) instrument
Create New SDTM- Batch 2 HIV TAUG multiple term

Term MSTEST-CD request. 5 terms to be added to the
MSTEST/CD codelist.
Modify CDISC- Informed Consent definition

Create New SEND- Tricholemmoma, benign

Term NEOPLASM
Modify SDTM-UNIT Add a CDISC Synonym of mAU/mL
Existing Term for Code 122211; CDISC Submission
Value = mAnson U/mL
Create New SDTM- 7 codes in this request
Term VSTEST-CD
Create New SDTM- RATIO

Term VSRESU
Create New SDTM- Total Time: The amount of time

Term TRTEST-CD between one breath to the next
breath.
Create New SEND- Expiratory Flow (EF50): The

Term SRETST-CD expiratory flow at the point that tidal
volume is decreased by 50%
Create New SEND- Apnea Time: The length of time of

Term SRETST-CD breathing cessation, measured as
total time - (inspiration time +
expiration time).
Create New SEND- Add new term please
Term SRETST-CD
Create New SDTM- Please add the NCI value "Numeric

Term METHOD Rating Scale (Code C121548)" as
CDISC SDTM.METHOD Format.
Create New SDTM-FRM Nedded on Phase I trial with SDTM

Term submission
Create New SDTM-LOC ALVEOLUS
Term
Create New SDTM- Add new term to Hamilton Anxiety

Term HAMA1TC/TN Rating Scale Clinical Classification
Create New SDTM-LOC Please add the term UPPER ARM to

Term the LOC codelist.
Create New SDTM- New term to be created: SLOAN

Term METHOD LETTER EYE CHART 100%
Create New SDTM-UNIT U/kg/bid
Term
Create New SDTM-UNIT NT50; NT60

Term
Create New SDTM- FLUORESCENT NEUTRALIZATION

Term METHOD
Create New SDTM- Restrained: The subject (animal) is
Term POSITION placed in a chamber or other device
where movement is restricted.
Create New New ADaM PARM/PARMCD

Codelist
Create New SDTM-LOC Please add the term

Term INTERCEREBRAL to the LOC
(Anatomical Location) Codelist.
Create New SDTM-LOC SUBARACHNOID to the LOC

Term (Anatomical Location) Codelist.
Create New SDTM-LOC Please ad the term ABDOMEN to the
Term LOC (Anatomical Location) Codelist.
Create New SDTM- Please add the term CIRCULATING
Term SPECTYPE TUMOR DNA to the SPECTYPE
codelist.
Create New SDTM-LOC Please add term TRICEPS BRACHII

Term MUSCLE to the LOC (Anatomical
Location) Codelist
Create New SDTM-LOC Please add the new term

Term ILIOPSOAS MUSCLE to the LOC
codelist (Anatomical Location).
Create New SEND- Mean Tidal Volume

Term SRETST
Create New SDTM- RESTRAINING TUBE
Term POSITION
Create New SDTM- IMMUNOCYTOCHEMISTRY

Term METHOD
Create New SDTM- Please add the term FINE NEEDLE

Term METHOD ASPIRATION to the METHOD
codelist. The LB domain uses the
METHOD codelist and not CLMETH
which has the term FINE NEEDLE
BIOPSY.
Create New SDTM- Please add the term VENOUS
Term SPECTYPE MIXED BLOOD to the SPECTYPE
codelist.
Create New SDTM- Unknown; Not Reported

Term RACEC
Create New SDTM-RACE Unknown; Not Reported

Term
Create New Multiple New Term requests on for

Term Huntington's Disease TAUG.
Additions to DUTEST/CD and
DOTEST/CD
Create New SDTM- SURFACE PLASMON RESONANCE
Term METHOD
Create New SDTM- Please review new proposed terms

Term LBTEST/CD for LB Domain.
Create New SDTM- LBTESTCD= SDMA, LBTEST=

Term LBTEST/CD Symmetric Dimethylarginine,
Synonym= N,N'-dimethylarginine
Create New SDTM- LBTESTCD= ADMA LBTEST=
Term LBTEST/CD Asymmetric Dimethylarginine
Synonym= N,N-dimethylarginine
Create New Multiple QSCAT, QSTESTCD, QSTEST for
Term Symptoms of Major Depressive
Disorder Scale (SMDDS)
Term NSCLC-SAQ for the lung cancer
TAUG
Other Other SEND Question
Modify SDTM-QSCAT QSCAT of FACIT-FATIGUE 13-Item

Existing Term V4 - Incorrect case
Create New SDTM- UNMARRIED

Term MARISTAT
Create New SDTM- QUANTITATIVE COMPUTED

Term METHOD TOMOGRAPHY
Create New SDTM- Platelet Large Cell Ratio;

Term LBTEST-CD Hemoglobin H Inclusion Bodies
Modify SDTM- Addition of synonym to AMYLOIDP
Existing Term LBTEST-CD
Create New CDISC- participant cluster

Term Glossary
Modify CDISC- patient

Create New SDTM- Please add CDISC Submission
Term DOMAIN Value 'QT' and CDISC Synonym
'ECG QT Correction Model Data' to
NCI Code C66734 - SDTM Domain
Abbreviation Codelist.
Modify CDISC- study participant

Create New SDTM- New CVTEST and CVTESTCD

Term CVTEST/CD
Modify SDTM- Remove SUPPBW from the codelist
Existing Term DOMAIN (C147269). BW is still in discussion
as a draft domain.
Create New SDTM- TSACTVY - Test Site Activity
Term TSPARM/CD
Create New SDTM- 6 new requests for NVTEST-CD

Term NVTEST/CD codelist for the Huntington's TAUG.
MRS example.
Create New SDTM- Alternaria tenuis/alternata IgG4 Cat
Term LBTEST/CD Dander IgG4Mite Dermatophagoides
farinae IgG4Bermuda Grass
(Cynodon dactylon) IgG4Johnson
Grass (Sorghum halepense)
IgG4Timothy Grass (Phleum
pratense) IgG4Mite
Dermatophagoides pteronyssinus
IgG4
Create New SDTM- PURITY

Term TSPARM/CD
Create New SDTM- SINGLE-MOLECULE ARRAY

Term METHOD
Create New Multiple ADaM DTYPE ASSIGNED LLOQ

Term
Create New SDTM-UNIT millisecond squared 1/millisecond
Term
Create New SDTM- 7 LEAD STANDARD

Term EGMETHOD
Create New SEND-SSTYP MAXIMUM TOLERATED DOSE

Term
Create New SDTM- Please consider the addition of

Term DATEST-CD DATEST = "Vial Weight" in this
terminology.
Create New SDTM-DIR Please add MULTIPLE as a new

Term value considering this value is
already present in the codelist
"Portion/Totality".
Create New SDTM- Please add the value ABNORMA
Term EGTEST/CD and NORMAL considering these
values are already present in the
codelist "Normal Abnormal
Response" and since for ECG result,
we must used "ECG Result" codelist
and not "Normal Abnormal
Response" codelist.
Create New SDTM- Please consider adding the term

Term EGSTRESC "SUSPECT ELECTRODES
REVERSED, INTERPRETATION
ASSUMES REVERSAL"
Create New SDTM- Please add the value

Term EGSTRESC "INDETERMINED RHYTHM
IRREGULARITIES" considering that
an irregular rhythm cannot be always
determined.
Create New SDTM- Please add the value "NOT

Term EGSTRESC EVALUABLE" considering this value
is already present in the codelist
"Normal Abnormal Response" and
since for ECG result, we must used
"ECG Result" codelist and not
"Normal Abnormal Response"
codelist.
Create New SDTM- Please consider the value EARLY
Term EPOCH WITHDRAWAL
Create New SDTM- Please consider the value END OF

Term EPOCH STUDY or STUDY EXIT
Create New SDTM-EVAL PLease consider the value

Term "MEDICAL CODER"
Create New SDTM-FREQ Please add the term "HS"
Term considering medication can be given
once at the Bedtime. In this situation,
ONCE could be used but HS give
more information.
Create New SDTM-FREQ Please add the term "2-3 TIMES

Term PER WEEK" or "2 to 3 TIMES PER
WEEK" considering medication can
be given two to three Times weekly,
and this value is in the NCI
thesaurus.
Create New SDTM-FREQ Please add the term "3-4 TIMES

Term PER WEEK" or "3 to 4 TIMES PER
WEEK" considering medication can
be given three to four times weekly,
and this value is in the NCI
thesaurus.
Create New SDTM-FREQ Please add the value "THRICE"

Term
Create New SDTM-FREQ Please consider the value "QHS"

Term
Create New SDTM-FREQ ONCE PER 12 WEEKS

Term
Create New SDTM-FREQ "ONCE PER 3 YEARS" and "ONCE
Term PER 5 YEARS"
Create New SDTM-FRM AMPULE

Term
Create New SDTM-FRM CAPSULE, EXTENDED-RELEASE,

Term HARD
Create New SDTM-FRM CAPSULE, EXTENDED-RELEASE,
Term SOFT-GEL
Create New SDTM-FRM CAPSULE, NEAT FILLED

Term
Create New SDTM-FRM UNKNOWN

Term
Create New SDTM-LOC PALATE

Term
Create New SDTM- PHYSICAL STRENGTH
Term METHOD
Create New SDTM- VISUAL ANALOG SCALE or VISUAL

Term METHOD ANALOG SCALE 100mm
Create New SDTM- VISUAL INSPECTION

Term METHOD
Create New SDTM- CARDIAC TELEMETRY

Term PROCEDUR
Create New SDTM- VISUAL ESTIMATE

Term METHOD
Create New SDTM- INTRAMANDIBULAR

Term ROUTE
Create New SDTM- LACTESCENT

Term SPECCOND
Create New SDTM- NON-HEMOLYZED
Term SPECCOND
Create New SDTM- THAWED

Term SPECCOND
Create New SDTM- NASAL SWAB

Term SPECTYPE
Create New SDTM- m for meter

Term VSRESU
Create New SDTM-UNIT USP

Term
Create New SDTM-TTYPE Please consider these values

Term
Create New SDTM- PARTIALLY DOUBLE BLIND
Term TBLIND
Modify SDTM-LOC ORAL CAVITY (C12421)

Existing Term
Modify SDTM- CLOTTED

Existing Term SPECCOND
Create New SDTM- Anisochromia (ANISOCHR)

Term LBTEST/CD
Create New SDTM- Complement C5b-9 (C5B9)

Term LBTEST/CD
Create New SDTM- Chicken Erythrocytes (CRBC)
Term LBTEST/CD
Create New SDTM- Cytochrome P450 2C9 (CYP2C9)

Term LBTEST/CD
Create New SDTM- Drepanocytes (DREPA)

Term LBTEST/CD
Create New SDTM- Enterococcus faecalis (ENTCOFA)

Term MBTEST/CD
Create New SDTM- Complement C5, Free (C5FR)

Term LBTEST/CD
Create New SDTM- Large Lymphocytes (LYMLG or
Term LBTEST/CD LYMLRG)
Create New SDTM- Plasmocytes (PLASM)

Term LBTEST/CD
Create New SDTM- Pyridoxal Phosphate (PLP)

Term LBTEST/CD
Create New SDTM- Inorganic Pyrophosphate (PPI)

Term LBTEST/CD
Create New SDTM- Pus (PUS)

Term LBTEST/CD
Create New SDTM- Total Complement C5 (C5)

Term LBTEST/CD
Create New SDTM- AUC Over Dosing Interval at steady-

Term PKPARM/CD state (AUCTAUSS)
Create New SDTM- Average Concentration at steady-
Term PKPARM/CD state (CAVGSS)
Create New SDTM- Vol Dist Steady State Obs Norm by F

Term PKPARM/CD (VSSOF)
Create New SDTM- Cycle Day at First Dose

Term RPTEST/CD (CYCLEDAY)
Create New SDTM- Number of Deliveries (DLVRN)

Term RPTEST/CD
Create New SDTM- Estimated Next Menstrual Period
Term RPTEST/CD Date (ENMPDTC)
Create New SDTM- Menstrual Period Duration

Term RPTEST/CD (MENSPER)
Create New SDTM- UGT1A1 Gene (Code C20128)

Term LBTEST/CD
Create New SDTM- UGT1A9 Gene (Code C105862)

Term LBTEST/CD
Create New SDTM- "Fat Mass" (FATMASS) and "Lean

Term MUSCTS/CD Mass" (LEANMASS)
Create New SDTM- Absolute bioavaibility

Term PKPARM/CD
Create New SDTM- Max Effect
Term PKPARM/CD
Create New SDTM- Please consider the addition of these

Term PKPARM/CD terms
Create New SDTM- Percent of swing

Term PKPARM/CD
Create New SDTM- Time of CMAX Effect

Term PKPARM/CD
Create New SDTM- HOLTER CONTINUOUS ECG

Term PROCEDUR RECORDING
Create New SDTM- PAP SMEAR

Term PROCEDUR
Other Multiple Need new term request numbers
only for concepts in P35 publication.
The file contains 55 new term
requests and 16 changes to existing
terms.
Create New SDTM- New TSPARM/CD Terms

Term TSPARM/CD
Other New Medical Device Single Audit Program

[MDSAP]
Create New SDTM- Reinstate the MO domain back into

Term DOMAIN the SDTM domain abbreviations
codelist. MO will stay in SDTMIG3.3
with a note that it will be deprecated
in a future version. Therefore it will
need to stay in the CT codelist until a
new version of SDTMIG comes out.
Create New SDTM- Please add MIGET to the METHOD

Term METHOD codelist.
Create New SDTM-LOC HEPATOBILIARY SYSTEM
Term
Create New SDTM-LOC GENITOURINARY SYSTEM

Term
Create New New CDISC SEND Null Flavor Reason

Term Terminology (Code C150810) has
been added on Terminology version
208-06-29. Please consider to add
Null Flavor Reason Terminology for
CDISC SDTM.
Create New SDTM- CXCL11 - "Chemokine (C-X-C Motif)

Term LBTEST/CD Ligand 11"
Create New SDTM- chemokine (C-X3-C motif) ligand 1

Term LBTEST/CD Macrophage Inflammatory Protein-3
Modify SDTM-FRM Please add the following terms under
Existing Term CDISC Synonym(s) : - TABLET,
PROLONGED RELEASE -
PROLONGED-RELEASE TABLET -
PROLONGED RELEASE
TABLET
Modify SDTM- Check synonymy on

Existing Term LBTEST/CD Thyroperoxidase Antibody
Measurement C96638 and Thyroid
Antimicrosomal Antibody
Measurement C81991
Create New SDTM-EVAL GRAPPA CERTIFIED
Term
Create New SDTM-UNIT ECL

Term
Create New Multiple TESTCD/FTTEST/FTCAT for HD-

Term CAB For Huntington's TAUG
Create New CDASH- Submisson value: Maori Definition:
Term RACEC The indigenous Polynesian people of
New Zealand
Create New SDTM-UNIT genEq/mL
Term
Create New SDTM-UNIT genEq

Term
Create New SDTM-UNIT VOXEL

Term
Modify SEND- Change to NCI C-code: C7157 to

Existing Term NEOPLASM C94524. No change necessary to
CDISC definition unless team thinks
it is necessary.
Create New SDTM-UNIT mA
Term
Create New SDTM-UNIT kVp

Term
Create New SDTM- CONDUCTION DISTURBANCE,

Term EGSTRESC UNSPECIFIED
Create New SDTM-UNIT permil or per mil

Term
Modify Multiple Functional Assessment of Cancer

Existing Term Functional Assessment of Cancer
Therapy/Gynecologic Oncology
Group-Neurotoxicity Version 4
Questionnaire Test Code
Create New SDTM- REAL-TIME REVERSE
Term METHOD TRANSCRIPTASE POLYMERASE
CHAIN REACTION
Create New SEND- Plexiform vasculopathy (to be added

Term NONNEO in the NONNEO CT)
Create New SDTM- For the antibody against

Term ISTEST/CD Corynebacterium Diphtheriae Toxoid
(DTd): ISTESTCD = DTdAB,
ISTEST = Diphtheria Toxoid
Antibody
Create New SDTM- For the antibody against Clostridium
Term ISTEST/CD Tetani Toxin (TT): ISTESTCD =
TTAB, ISTEST = Tetanus Toxin
Antibody
Create New SDTM- For the antibody against Bordetella

Term ISTEST/CD pertussis Pertussis Toxin (PT):
ISTESTCD = BPPTAB, ISTEST =
Pertussis Toxin Antibody

Term ISTEST/CD Pertussis Filamentous
haemagglutinin (FHA): ISTESTCD =
BPFHAAB, ISTEST = Filamentous
Haemagglutinin Antibody
Term ISTEST/CD Pertussis Fimbria 2 or Fimbria 3
(FIM2/3): ISTESTCD = BPF23AB,
ISTEST = Fimbriae 2/3 Antibody

Term ISTEST/CD Pertussis Pertactin (Prn):
ISTESTCD = BPPrnAB, ISTEST =
Pertactin Antibody
Modify SDTM-CCCAT CCCAT Change

Existing Term
Create New SDTM- INTP

Term OETESTCD
Create New SDTM- Interpretation
Term OETEST
Create New Multiple FXFINDRS (Supernumerary Rib,

Term Cervical Rib, Lumbar Rib, Thoracic
Rib).
Create New SDTM-LOC Antecubital Fossa

Term
Create New SDTM-LOC Median Basilic Vein

Term
Create New SEND- File emailed separately. Terms
Term NONNEO already in SEND working document.
Just need to add the request code.
Modify SDTM- Updates to the submission values for

Existing Term MODTRN just-published terminology
Modify SDTM- C154909: Need to add the Test

Existing Term MUSCTSCD Name as a synonym
Create New Multiple New term requests for LBTEST,

Term METHOD, and SPECTYPE for
LOINC mapping.
Create New SDTM- Request term = IMMUNO-PET
Term METHOD SCAN
Modify SDTM-UNIT Clarification re RFU/RIU

Existing Term
Modify SDTM- C154736 - E-selectin

Create New Multiple Multiple term request containing all

Term P36 terminology that needs c-codes.
No need to add to any working
documents. Just need to get a
request code for these: 47 changes
and 93 new terms.
Create New SDTM- Please add TSPARMCD = DOSRGM

Term TSPARM/CD
Other none General Observation Class
Create New Multiple Multiple term request for LOINC

Term mapping clean up v2: 9 new terms
and 4 changes to existing
Create New SDTM- Gender Identity/GENIDENT. From
Term SCTEST/CD example here:
https://wiki.cdisc.org/display/TAHIV/R
epresentation+of+Gender+Identity+o
ver+Time
Create New SDTM- Please consider adding the values
Term ETHNICC relevant to Chines Ethnic Majority
and Minorities. This request comes
from the CDISC Race/Ethnicity Sub-
team.
Modify SDTM- UPDATE TO DEFINITION

Existing Term RETEST/CD
Create New Multiple For each domain the CT teams
Term should add the --TEST and --
TESTCD for the "not done" mapping
that goes on aCRF.
Modify SDTM- Pls modify CDISC DEF for Relative

Existing Term PKPARM/CD Bioavailability
Create New SDTM- A new term (DSDECOD) to describe
Term PROTMLST the protocol milestone of entering the
main part of the study.
Create New Multiple Per QRS team request, please

Term deprecate Tanner Scale terminology
from CC/RS and add to RPTEST-CD
Create New SDTM- Interleukin 6 treated with

Term LBTEST-CD lipopolysaccharide (LPS) Interleukin
6 untreated with LPS
Create New SDTM-FRM Please add to the FRM codelist the
Term term of TABLET, IMMEDIATE
RELEASE, SOLID DISPERSION
Create New CDISC- add ESS0109 to ESS01TC

Term ESS01TC_TN corresponding to ESS0109-Total
Score in ESS01TN to capture the
total score from the Epworth
Sleepiness Scale
Create New SDTM- Term: DROPLET DIGITAL PCR
Term METHOD
Create New Multiple Please add new animal rule CT

Term
Create New SDTM-DIR HOLOCEPHAL

Term
Create New SDTM-DIR FRONTAL

Term
Create New SDTM-DIR OCCIPITAL

Term
Create New SDTM-DIR FACIAL
Term
Create New SDTM-LOC ANAL VERGE

Term
Create New ADaM-DTYPE ULOQ1

Term
Create New ADaM-DTYPE ULOQ

Term
Create New ADaM-DTYPE LOQMISS

Term
Create New ADaM-DTYPE LOQHALF

Term
Create New ADaM-DTYPE LOQTHALF
Term
Create New ADaM-DTYPE LOQ

Term
Create New ADaM-DTYPE LOQ0

Term
Create New ADaM-DTYPE LOQHALFG

Term
Modify SDTM- Review definition of TSPARM
Existing Term TSPARMCD RFPENDTC
Other SDTM-UNIT Published term MFI (2018-09-28,

C96687, C71620) appears to
combine three different units
Create New Multiple Please add new terms to multiple

Term codelists
Create New SDTM- BLOOD SMEAR and BONE
Term SPECTYPE MARROW SMEAR. These are
typically specimens which are
collected and evaluated as BLOOD
SMEAR and BONE MARROW
SMEAR
Create New SDTM- LBTESTCD: NAGASECR; LBTEST:

Term LBTEST-CD N-acetyl-B-D-glucosaminidase/Creati
nine
Create New SEND-SPEC LOBAR BRONCHI

Term
Create New SDTM- 3 new Asian terms please
Term RACEC
Modify SDTM-UNIT SDTM Code: C92616, Codelist

Existing Term code:C71620 In the 'NCI Preferred
Term' column, there is an extra 'i' in
Millimole
Create New SDTM- New ANMETH term and change to

Term ANMETH previously requested ANMETH term
Modify SDTM- Retire Codelist

Existing Term TDIGRP
Create New New Create new codelist for TS variable:
Codelist TSVCDREF
Create New New A new QRSMTHOD codelist with

Codelist values to be represented in the --
METHOD variable in QRS domains
of FT, QS and RS.
Modify Multiple Remove the QRS "CGI GUY"
Existing Term terminology from the CCCAT
codelist,Clinical Global Impression
Questionnaire Test Code codelist -
CGGUY1TC and the Clinical Global
Impression Questionnaire Test Name
- CGGUY1TN
Create New SDTM-UNIT vg/kg

Term
Create New SDTM- Trypsin
Term LBTEST/CD
Create New SDTM- Add: Delta-9-Tetrahydrocannabinol

Term LBTEST/CD and THC as a synonym to CDISC
Submission Value of:
Tetrahydrocannabinol
Create New SDTM- LBTEST = Glycoholic Acid
Term LBTEST/CD LBTESTCD = GLYHLACD
Create New SDTM-LOC VAGINAL WALL

Term
Create New SDTM- New tests to be added to

Term LBTEST/CD LBTEST/CD codelist; details
provided via email.
Modify SDTM- Code list C85491 Term C117361

Existing Term MICROORG There appears to be a typo in the
submission value. Please correct to
PNEUMOCYSTIS JIROVECII
instead of PNEUMOCYSTIS
JIROVECI.
Create New Multiple Multiple terms submitted in the file
Term emailed separately
Create New SEND- Basophilic tubule

Term NONNEO
Create New SEND- MYOPATHY (submitted in a
Term NONNEO separate file on Thursday Dec 13th
2018)
Create New Multiple ISTESTCD, LBTESTCD, METHOD

Term
Change
Type
An individual that presides over and arbitrates II SDTM-Published in P34

between individuals or organizations who is a
given a designation of one.
given a designation of two.
given a designation of three.
At the SEND F2F in Oct 2017, there was general II Do not add (P36): Do
discussion involving FDA reviewer feedback for a not add. The underlying
need to include the cumulative body weight gain semantic concept is the
across all intervals in the SEND datasets. These same as the existing
data are currently being submitted by multiple published term 'Body
sponsors as an extension to the codelist. Weight Gain', with a
different interval. The
existing model can
accommodate this
without a new test/cd
variable.
At the SEND F2F in Oct 2017, there was general II Do not add (P36): Do
discussion involving FDA reviewer feedback for a not add. The underlying
need to include the cumulative food consumption semantic concept is the
across all intervals in the SEND datasets. These same as the existing
data are currently being submitted by multiple published term 'Food
sponsors as an extension to the codelist. Consumption', with a
different interval. The
existing model can
accommodate this
without a new test/cd
variable.
Codelist is identified for use in SENDIG v3.1, but II SEND-Published in P34

does not exist. SEND leadership decision to
develop this codelist and to populate it with the
controlled terminology from SENDIG v3.1 section
7.6.4, which are taken from ISO 21090. Each
term will be requested separately.
SENDIG v3.1 section 7.6.4, contains controlled II SEND-Published in P34

terminology taken from ISO 21090, for a new
ISO 21090 description: "The value is exceptional

(missing, omitted, incomplete, improper). No
information as to the reason for being an
exceptional value is provided. This is the most
general exceptional value. It is also the default
exceptional value."
NULLFLAVOR codelist. ISO 21090 description:
"The value as represented in the instance is not a
member of the set of permitted data values in the
constrained value domain of a variable. "

"The actual value is not a member of the set of
permitted data values in the constrained value
domain of a variable (e.g. concept not provided
by required code system). "

"Positive infinity of numbers. "

"Negative infinity of numbers. "
"No attempt has been made to encode the
information correctly but the raw source
information is represented (usually in
originalText). "

"An actual value may exist, but it must be derived
from the information provided (usually an
expression is provided directly). "

"A proper value is applicable, but not known. "

"Information was sought but not found (e.g.
patient was asked but didn?t know)."
"Information is not available at this time, but it is
expected that it will be available later."

"This information has not been sought (e.g.
patient was not asked)."

NULLFLAVOR codelist. ISO 21090 description: "
The specific quantity is not known, but is known
to be non-zero and is not specified because it
makes up the bulk of the material. 'Add 10 mg of
ingredient X, 50 mg of ingredient Y, and sufficient
quantity of water to 100 ml.' the null flavor would
be used to express the quantity of water."

"The content is greater than zero, but too small to
be quantified."

"There is information on this item available, but it
has not been provided by the sender due to
security, privacy or other reasons. There may be
an alternate mechanism for gaining access to this
information."

"No proper value is applicable in this context (e.g.
last menstrual period for a male). "
Create a new codelist and add new terms to II SDTM-Published in P34

MBTEST-CD. This is a TA request from the
CDAD team; File emailed separately.
A nuclear medicine imaging technique in which a II Do not add (P34):
radioactive compound?e.g., 99mTc IDA?is Please map this to
administered and its distribution in the body existing term of
analyzed by a scintillation camera for increased SCINTIGRAPHY and
or decreased uptake in bone. A bone scintigraphy put a LOC of BONE.
may be used to diagnose bone tumors or cancer
that has spread to the bone. It may also be used
to help diagnose fractures, bone infections, or
other bone problems. Also called bone scan.
CT Change Request: II Do not add (P35): Do

Comments and documentation from two DAIDS not add. If you must use
DMCs (SCHARP and FSTRF) AESEV, the team would
recommend, in the
DAIDS implementers of CDISC standards instance where there is
request an update to the CDISC Controlled a life-threatening or
Terminology for AESEV to include death AE, you would
POTENTIALLY LIFE-THREATENING and use 'SEVERE' as your
DEATH. AESEV value and then
Our studies use the DAIDS Table for Grading put Y in either the
the Severity of Adult and Pediatric Adverse AESLIFE or AESDTH
Events that includes five standard severity variables, which are
grading options Mild - Grade 1, Moderate - Grade separate variables in the
2, Severe - Grade 3, Potentially Life-Threatening dataset. These should
- Grade 4, Death - Grade 5. These are explicitly be used in conjunction
related to the severity grade of adverse events with the AESER variable
and not a toxicity grade. as per E2B and Argus
Safety. AETOXGR was
https://rsc.tech-res.com/docs/default-source/safet created with CTCAE in
y/daids-ae-grading-table-mar2017.pdf. mind but could also be
used for the DAIDS
Based on our review of other documentation severity scale as they
surrounding toxicity versus adverse event seem to be analogous.
severity grading we also suggest removing the The IG states that either
reference to CTCAE v3.0 for the AETOXGR data AESEV or AETOXGR
element in SDTM documentation. We believe that should be used and you
this reference is inconsistent with current ? must identify the name
CTCAE Version 4.0 ? and past guidance. and version of the scale
Specifically, in a NCI manual from 1999 about the - See AE assumption
use of common toxicity criteria, the below text is 6D. The word 'toxicity'
used to differentiate the concepts of toxicity and made its way into the
severity: TOXGR variable based
on the historical
https://www.fda.gov/ohrms/dockets/dailys/04/mar precedent set by
04/033104/78n-0036L-rc00002-04-Tab-C- CTCAE when it used to
vol137.pdf be called 'Common
Toxicity Criteria for....'
Scales for Outcomes in Parkinson?s Disease - II QRS, SDTM-Published
Autonomic (SCOPA-AUT) in P50
Parkinson's Disease Questionnaire (PDQ-39) Do not add (P50):
The Activities-specific Balance Confidence (ABC) CDISC is unable to
Scale. Terminology is needed for standard obtain copyright
questionnaires commonly used in the healthcare permission for this
industry. instrument at this time,
consequently, the
CDISC QRS CT team
had only created a CAT
value for this instrument
in Package 50. Because
of this, CDISC will NOT
develop TEST and
TESTCD terminology
associated with this
questionnaire.
For our CE analysis we need an ADaM dataset II Do not add (P40) - Do

with the following structure: not add. This is not a
PARAM ATPT AVAL common enough issue
PAIN DAY 1 NONE to develop CT. DTYPE
PAIN DAY 2 MILD is extensible, so the
PAIN DAY 3 MODERATE user can create their
PAIN DAY 4 NONE own term in this case.
PAIN DAY 5 NONE
PAIN DAY 6 NONE
PAIN DAY 7 NONE
In the source CE data we have 2 type of records

for each CETERM. One overall record with a time
interval of "day 1-7" and a COCCUR value of Y or
N. If the value is Y, then in CE we have 7 records,
one for each timepoint with CEOCCUR Y or N,
and if Y the variable CESEV has the severity. If in
the overall record for the time interval "day 1-7"
CEOCCUR is N, then we do not have the 7
records for each day. Hence we need to derive
those in our ADaM. To document this derivation
DTYPE we are suggesting to use the value
OCCUROCF, as we need to create 7 records with
value "NONE", as the overall occurrence value
being carried forward.
TOXGR/Toxicity Grade: A standardized II SDTM-Published in P34

categorical classification of the severity of an
event or finding.
https://wiki.cdisc.org/x/EEOWAg. Definition from
draft created by variable definitions team.
The wild type is often used on studies as control II Do not add (P36): Do
and TK animals. not add. Since the
It might be a good idea to consider automatically vendor provided the
adding the associated wild type when the name CB6F1-TgN
genetically modified strain is added to the (RasH2) for the wt
codelist. control strain then
please use the existing
published term and add
'wildtype' in substrain
details.
Update CDISC definition for C120678. Craig this II

request is already in the MB working doc, please
fill in the requester info and code in the yellow
highlighted cells. Thank you!
Pls update CDISC definition for C120678. Pls II

change definition to: A measurement of the
influenza A and/or B antigen in a biological
specimen. This term exists in both LBTEST-CD
and MBTEST-CD codelists, the MB team had
already agreed to change the CDISC definition so
we just need the LB team to agree on this change
as well so that we are consistent across codelists.
LBTESTCD for Immature Platelets II SEND, SDTM-Published

in P35
To match LBTESTCD PLATEIM II SEND, SDTM-Published
in P35
For CBC Platelet Count II SDTM-Published in P35
ARUP testing
Mehodology Automated Cell Count
Kit name Sysex CBC/Diff Reagents
Instrument Sysmex XN series
File emailed separately to Jordan Li with II SDTM-Published in P33

suggested CT for QSCAT, QSTESTCD and
QSTEST for the PEDS FACIT-F
term added to 10 meter walk/run II SDTM-Published in P33

FTTESTCD/FTTEST; File emailed separately;
DMD TA.
add term to 4 stair ascend FTTESTCD/FTTEST; II SDTM-Published in P33
file emailed separately; DMD TA.
add term to 4 stair descend FTTESTCD/FTTEST; II SDTM-Published in P33

file emailed separately; DMD TA.
CDISC code C124610 LEIOMYOMA, II
MESOVARIAL, MALIGNANT was a typo for
InHand terminology. Mesovarial leiomyoma is a
benign tumor, not malignant. Request to either
retire this existing CDISC code and create a new
code for LEIOMYOMA, MESOVARIAL, BENIGN
and definition of "A benign neoplasm of the
smooth muscle that arises from the
mesovarium.". Or edit the submission value and
definition for this existing Ccode, whichever
approach is more accurate.
This unit is for signal to cutoff ratio. Used with II Do not add (P35): Do
Hepatitis antibody testing. This unit is available in not add. The
UCUM as {s_co_ratio} TEST=C139086 (HCV
Antibody Signal/HCV
Antibody Cutoff) with
UNIT=RATIO, since s/co
is part of the test value.
Other virus testing (HIV,
HepA, HepB, etc.) would
need new CDISC test
codes to be requested
to the MB domain.
Proposed Definition: Any fungal organism that II SDTM-Published in P34

can be assigned to the species Aspergillus
niveus.
Request addition of test Krebs von den Lungen-6 II SDTM, SEND-Published

Antigen which is commonly abbreviated as KL-6 in P35
Currently terms exist for Islet Antigen 2 II SDTM, SEND-Published

Autoantibody, Islet Cell 512 Antibody and Islet in P35
Cell Cytoplasmic IgG Antibody. Requesting this
term to capture total Islet Cell Antibodies.
Requesting this test to capture Fractioned II SDTM, SEND-Published
Oxyhemoglobin (FO2 Hb) results. These results in P35
are expressed with the unit of %.
Requesting this test for Fractionated II SDTM, SEND-Published
Methemoglobin (FMET HB) expressed with the in P35
unit of %.
This test is defined as The base 10 logarithm of II SDTM, SEND-Published
the ratio of plasma triglyceride to high density in P35
lipoprotein cholesterol, has been employed as a
predictor of cardiovascular risk.|
Proposed Definition: A measurement of hepatitis II SDTM, SEND -
A virus IgG antibody in a biological specimen. Published with P39
There is currently not a term on this list for range- II
finding type studies where animals are dosed
repeatedly but at different dose levels each time.
We have discussed internally whether SINGLE
DOSE TOXICITY or REPEAT DOSE TOXICITY
fits, but would appreciate consideration from the
team on whether a new term should be created or
if one of the existing terms is more appropriate.
The specimen type is urine and the method is II SDTM, SEND-Published

POLYMERASE CHAIN REACTION in P38
Chlamydia trachomatis, urine PCR II SDTM, SEND-Published
Specimen type is urine the method is in P38
POLYMERASE CHAIN REACTION
SS is in the SDTM IG 3.2 but not in the DOMAIN II Do not add (P35):
codelist Published with P33
publication 2018-03-30
Submission Value = Cycloserine-Cefoxitin II SDTM-Published in P34
Fructose Agar
Synonym = CCFA
CDISC Def: A solid growth medium mainly

consisting of proteose peptone, fructose,
cycloserine, cefoxitin, fructose, and egg yolk,
which is developed primarily for the isolation and
cultivation of Clostridium difficile.
Example on how this term is used:

https://wiki.cdisc.org/display/TACDAD/C.
+difficile+Identification+Example+1
Submission Value = Chromogenic Selective II SDTM-Published in P34

Medium
CDISC Def: A solid growth medium mainly

consisting of various peptones, taurocholate and
a chromogenic substrate which is developed
primarily for the isolation and cultivation of
Clostridium difficile.
Example on how this term is used:

https://wiki.cdisc.org/display/TACDAD/C.
+difficile+Identification+Example+2
Reference; NCBI. II SDTM-Published in P34

Proposed Definition: Any bacterial organism that
can be assigned to the species Staphylococcus
capitis subspecies urealyticus.
Wikipedia: "In Southern Africa Cape Coloureds is II SDTM, CDASH-
the name given to an ethnic group composed Published in P35, P36
primarily of persons of mixed race. Although
Cape Coloureds form a minority group within
South Africa, they are the predominant population
group in the Western Cape". This is more of an
ETHNICITY than a RACE. Perhaps Khoisan
would be the correct term for RACE - it is not
clear-cut. Definitive differences are known
between the South African Black and Mixed
race/Cape coloured populations, specifically in
terms of pharmacogenetics, which justifies the
need for this distinction in SDTM. Currently there
is no terms for this RACE group.
TRTEST cannot be longer than 40 characters II Do not add (P35): This

will be fixed with P33
publication at end of
March 2018.
SEND IG DART Version 1.1. II SEND-Published in P34
The 1.1 version of the standard for exchange of
nonclinical data (SEND) developmental and
reproductive toxicology implementation guide.
CDISC published new version of the SENDIG-

DART.
Term "Placenta" needed in the Anatomical II SDTM-Published in P35

Locations codelist to assist users when collecting
tissue, as a specimen type, from placenta. CDISC
Lab Terminology Team agreed on 31-Jan-2018 to
add this LOC term.
NCI Definition: An organ present in some

vertebrates during embryonic gestation that
surrounds the fetus and provides it with nutrients
and oxygen, facilitates gas and waste exchange
between the fetus and mother, and provides
parasitic cloaking from the mother's immune
system by excretion of neurokinin B.
CDISC Definition: An organ present in true

mammals during embryonic developmen that
provides the fetus with nutrients and oxygen,
facilitates gas and waste exchange between the
fetus and mother.
Proposed Definition: Any bacterial organism that II SDTM-Published in P34

can be assigned to the genus Acinetobacter and
is resistant to the antibiotic carbapenem.
Do not add (P35):
EPIGASTRIC - Do not
add. Please use
C32525/EPIGASTRIC
REGION
PERIHILAR LYMPH
NODE - Do not add.
Already in anatomical
location codelist.
POST-CERVICAL
LYMPH NODE - Do not
add. Already in
anatomical location
codelist (C103428)
SOFT TISSUE - Do not
add. Soft Tissue occurs
all over the body and
isn't an anatomical
location as such. We
have put these tissue-
type terms in the
SPECTYPE codelist.
Please use soft tissue
as a SPEC and choose
the appropriate LOC
value from the existing
list.
Additional alternate units to be provided for this II SDTM, SEND-Published

concept. Thank you! in P37
Definition: An examination or assessment of the II SDTM, SEND-Published

form and structure of red blood cells, white blood in P36
cells and platelets.
Reason for suggestion: Available terminology
does not cover assessment of all cell lines
see separate file, I am a member of the standard II SDTM, SEND-Published
terminology team for PK (PP) and will explain any in P35, P36
issues during our weekly meeting. Do not add (P36):
Fraction Unbound-Do
not add. Already
published as C135490
Vz Obs-Do not add.
C85774
Amt Rec from T1 to T2-
Do not add. Already
published as C102359
Specimen type is Plasma the method is ENZYME II SDTM, SEND-Published
LINKED IMMUNOSORBENT ASSAY-TD in P35
Specimen type is Plasma the method is ENZYME II SDTM, SEND-Published

LINKED IMMUNOSORBENT ASSAY-TD in P35
I think the codelist can be used for all disposition II Do not add (P34): The
events with DSCAT = "DISPOSITION EVENT". NCOMPLT codelist can
Wording for the CDISC Note in SDTMIG v3.3 be used for both study
includes, " There are separate codelists used for drug discontinuation and
DSDECOD where the choice depends on the study discontinuation as
value of DSCAT. Codelist "NCOMPLT" is used for a whole. The phrase
disposition events and codelist "PROTMLST" is 'segment of the study' is
used for protocol milestones. The variable may supposed to include
be subject to controlled terminology for other treatment ending.
events." Normally when a subject
stops study drug but
From a question received from a user: The continues with the study,
definition of NCOMPLT codelist by CDISC is "The the Epoch changes from
status of the subject's completion of the study or Treatment to Washout,
a segment of the study, or the reason the subject or something else. The
discontinued the study or segment of the study." Epoch variable is
supposed to help clarify
Reason for study drug discontinuation gets whether the subject is
mapped to DS domain with completing/not
DSCAT=DISPOSITION EVENT. Can the CDISC completing the study or
codelist NCOMPLT be used for mapping Reason completing/not
for Study drug discontinuation or should it only be completing a course of
used for mapping completion/ reason for study treatment. The team
discontinuation? believes that the
inclusion of the phrase
'segment of the study'
within the existing
definition allows for
enough flexibility to
include completion/non
completion reason for
study drug.
Proposed Test Code: CD163SOL II SDTM, SEND-Published

Reference: in P35
Reference: http://www.iqproducts.nl/wp-
content/uploads/PI-IQP-383-ENG-10.pdf
Proposed Test Code: RBPCREAT II SDTM, SEND-Published

This test is done in a urine specimen. in P35
RMAT (regenerative medicine advanced therapy) II

is a new abbreviation to be evaluated for
inclusion within the CDISC Glossary.
regenerative medicine' is a new term to be II Glossary-Published with
evaluated for inclusion in the CDISC Glossary. P40
Capricor?s lead investigational cell therapy for
Duchenne muscular dystrophy, CAP-1002,
received the FDA?s regenerative medicine
advanced therapy designation.
Source:
https://www.fda.gov/downloads/biologicsbloodvac
cines/guidancecomplianceregulatoryinformation/
guidances/cellularandgenetherapy/
ucm585414.pdf
The agency expedites reviews for products with

the RMAT designation, which is granted to
regenerative medicine therapies that clinically
prove their potential to address unmet medical
needs in the treatment of serious conditions.
regenerative medicine therapies, which are
defined in section 506(g)(8) of the FD&C Act, as
including cell therapies, therapeutic tissue
engineering products, human cell and tissue
products, and combination products using any
such therapies or products, except for those
regulated solely under section 361 of the Public
Health Service Act (PHS Act) (42 U.S.C. 264)
and Title 21 of the Code of Federal Regulations
Part 1271 (21 CFR Part 1271).
http://uscode.house.gov/view.xhtml?
req=regenerative+medicine&f=treesort&fq=true&n
um=1&hl=true&edition=prelim&granuleId=USC-
prelim-title21-section356
As FDA interprets section 506(g), gene

therapies, including genetically modified cells,
that lead to a durable modification of cells or
tissues may meet the definition of a regenerative
This specimen type is used for PDL1 analysis. II SDTM-Published in P35
Need specimen type to differentiate between
tissue sample and cell pellet sample.
Proposed Definition (from NCI): A cell sample
collected and compacted by centrifugation of a
liquid suspension.
Please see attached the multiple requests file for II SDTM, SEND-Published
adding new terms to the following codelists: in P35, P36
LBTEST/CD
NVTEST/CD
LOC
UNIT
To investigate the relationship between CYP2C19 II Do not add (P37): Do

genetic polymorphs and not add. This is a gene
the PK and pharmacodynamics of MK-1942. name and not a
Specimen type is Blood and the method is PFTEST value. The
GenoSure PRIme/PCR/DNA sequencinq. gene name would go
into PFGENRI.
genetic polymorphs and not add. Please use the
the PK and pharmacodynamics of MK-1942. existing PFTEST of
Specimen type is Blood and the method is GENOTYPE and put
GenoSure PRIme/PCR/DNA sequencinq. CYP2C19 into
PFGENRI.

AutoGenomics Infiniti. CYP2C19 into
PFGENRI. Please use
PFRESCAT or TSTDTL
for 'Interpretation'.

AutoGenomics Infiniti. CYP2C19 into
PFGENRI. Please use
PFRESCAT or TSTDTL
for 'Interpretation'.
New terms needed for PKPARM-CD; File emailed II SDTM, SEND-Published
separately. in P35, P36, P37
Do not add (P38):
Steady State
Accumulation Ratio -
Please put the words
"Steady State" in a PP
supplemental qualifier
for now, where PPTEST
= Accumulation Ratio.
The PK CT team is
working on creating a
new PP domain
standard variable to
house values such as:
Single Dose, Multiple
Dose, and Steady State;
this variable will qualify
PPTEST. Pls note this
variable is currently
under development,
hopefully for inclusion of
SDTMIG 3.4 or later.
Do not add (P36):
Steady state volume of
distribution for unbound
drug-Do not add;
already defined as
VSSOUB and VSSPUB.
add FTTESTCD='RISEF103' to Rise from Floor II QRS-Published in P34.

for DMD TAUG; file emailed separately
Attached are additional terms for Timed 25 Foot II QRS-Published in P34.

Walk (T25FW1), this was originally developed for
the MS TAUG; file emailed separately
New QRS request for FACT-BMT terminology, II SDTM-Published in P33

this is a sponsor request; File emailed separately
Multiple term request II SEND-Published in P34,
P35
Do not add (P35):
BIOAVAILABILITY - Do
not add. Use "Absolute
Bioavailability", which
will be published with
P35. Please look out for
the term "Absolute
Bioavailability" in the
P35 CT public review
PK document.
SITE, INJECTION,
REPEAT DOSE; SITE,
INJECTION, SINGLE
DOSE - Do not add.
Please use the existing
published term SITE,
INJECTION for SPEC
and then use FOCID or
ANTREG to uniquely
identify injection sites
based on whether it was
a single or repeat dose.
Needed for iRecist. Definition is An assessment II Do not add (P35): Do

of the response of new target lesions and/or new not add. The two correct
non-target tumor()s) to the immunotherapy. values for iRECIST, as
Suggested CDISC Synonym is New Lesion published in the Lung
Response. Cancer TAUG, are 'Non-
Target Lesion
Worsening Indicator'
and 'New Lesion
Worsening Indicator'.
Please use these
existing published
values.
see team notes on this from past requests. II
A new term is requested for "monitoring" to be II

defined further based on research of sources by
the CDISC glossary team.
Definition for Outcome Event: II
?A medical occurrence in a patient or clinical
investigation subject administered a
pharmaceutical product which occurrence is
expected in the treated patient population. The
efficacy variable(s) of large outcome study can be
a composite of outcome events, e.g., death,
myocardial infarction and stroke. There has been
agreement with Health Authorities that such
events are not required to be reported as Serious
Adverse Events, but are rather reported on
dedicated outcome event forms and undergo
adjudication by an independent adjudication
committee. In addition, outcome events are (?
may be) reviewed by the independent drug
monitoring committee during the study conduct.?
For comparison reasons I add the definition for ?

Adverse Event? that CDISC provides:
?Any untoward medical occurrence in a patient
or clinical investigation subject administered a
pharmaceutical product and which does not
necessarily have a causal relationship with this
treatment. An adverse event (AE) can therefore
be any unintended sign (including an abnormal
laboratory finding), symptom, or disease
temporally associated with the use of a medicinal
(investigational) product, whether or not related to
the medicinal (investigational) product. NOTE:
For further information, see the ICH Guideline for
Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting. [Modified
from ICH E2A] Synonyms: side effect, adverse
experience. See also serious adverse event,
serious adverse experience. (CDISC glossary)?
Pls add new terms and fix existing term; File II SDTM-Published in P34,
emailed separately P35, P36
Do not add (P35):
HIV INFECTION
STATUS-Do not add.
Consider using MH or
MB domain for this
information.
INTERVENTION
TERMINATED BY
SPONSOR-Do not add.
Requester did not
supply the needed
information to resolve
the request. The
requester may re-submit
this request with
updated information.
Income Source;
INCSOUR - Do not add.
Requester did not
supply the needed
information to resolve
the request. The
requester may re-submit
this request with
updated information.
SATISFACTORY-Do not
add. SPCCND is used
for those instances
when the test was run
but there was something
to note about the
specimen condition that
may be important. There
is a variable to describe
why the test was not
Request to add Stem Cell at a new term- II
potentially related to regenerative medicine. As
technology changes so do the regulations and
the glossary.
Suggested source:
https://stemcells.nih.gov/info/basics/1.htm
Stem cells?Cells with the ability to divide for
indefinite periods in culture and to give rise to
specialized cells
Please create new CAT, TEST, TESTCD terms II QRS-Published in P34.

for MMSE2; File emailed separately
EC - Exposure as Collected. In SDTM IG 3.2, but II Do not add (P35):

not in the DOMAIN CT. Published with P33
We are using Protein Expression for the test II Do not add (P47): Do
when the Western bolt method is used to not add. The Genomics
determine OprD (Outer Membrane Protein (OprD) team has agreed that
Expression) loss for an organism. the PG domain should
be retired, therefore we
This test is available on the NCI website with the will not be adding any
following definition: The biosynthesis of new new TEST values to this
(often sets of distinct, functionally related) protein codelist. Additionally,
products, usually involving new mRNA protein expression type
transcripts, typically in response to an activating testing should be
stimulus. Refers to the amount of a protein made modeled in other lab-
in a cell. The study of protein expression in esque domains like LB
cancer cells may give information about a specific or MI, this is out of
type of cancer, the best treatment to use, and scope for the genomics
how well a treatment works. (NCI Code: C18966) domains.
Test to measure the total amount of lipids II SDTM, SEND-Published

(cholesterol, lipoproteins, and triglycerides) in P35
present in a sample. NCI code: C74949 and
LOINC code: 2569-2
Update CDISC definition for the five PK Unit II
codelist. For the following codelists
PK Units of Measure
PK Units of Measure - Dose mg
PK Units of Measure - Dose ug
PK Units of Measure - Weight g
PK Units of Measure - Weight kg
Pls remove the words "data and" from the
definitions.
Craig, this request has been added to the PK
working DOC, please fill in the request number.
Thank you.
EC was published in SDTM-IG 3.2 II Do not add (P35):

Published with P33
MDD TA QRS instrument terminology for Suicidal II QRS-Published in P34
Ideation Questionnaire (SIQ) and Suicidal
Ideation Questionnaire - JR (SIQ-JR)
WIll send spreadsheets and CRFs in separate

EMAIL
The aggregate volume of gas in the alveoli of the II SDTM-Published in P36

lungs.
To be used with RETEST : Alveolar Volume
The aggregate volume of gas in the alveoli of the II SDTM-Published in P36

lungs.
To be used with RETESTCD : VA

We are not sure which term is preferable: II SDTM, CDASH-
"Australian Aborigine", ?Aboriginal Australian?, ? Published in P35
Aboriginal? or ?Aboriginoid?
Please advise.
We also need advice regarding the correct RACE
term to use for this RACEC term.
Aldrin epoxidase, a cytochrome P-450-dependent II SDTM, SEND-Published

monooxygenase, was studied in the lung and in P35
kidney of male rats.The sensitivity of the liver
enzyme activity to different chemicals in vitro was
influenced by the treatment of the animals with
phenobarbital or methylcholanthrene. It will be
useful if this term can be added in SEND-
LBTEST codelist.
Nasopharyngeal is a route through which II Do not add (P35): Do

Temperature can be measured. not add. ROUTE
variable is for routes of
substance
administration. For the
requester's use case for
the body location from
which temperature is
taken, please use the
LOC variable.
Assess Changes in plasma levels of nociceptin, II SDTM, SEND-Published

and changes in serum levels of IL-1ï¿½, IL-2, IL- in P35
6,
IL-10, TNFa, IFNg, and CRP from baseline to
Week 8, correlated to treatment outcome
and exposure. Specimen type is Plasma.
Enzyme-linked immunosorbent assay
Assess Changes in plasma levels of nociceptin, II SDTM, SEND-Published

and changes in serum levels of IL-1ï¿½, IL-2, IL- in P35
6,
IL-10, TNFa, IFNg, and CRP from baseline to
Week 8, correlated to treatment outcome
and exposure. Specimen type is Plasma.
Enzyme-linked immunosorbent assay
Please create new term. II SDTM, SEND-Published
in P35, P36, P37, P38,
P39
Do not add (P35, P36):
Immunofixation
Impression-1/2/3 - Do
not add. Please use
existing term
C92291/MCPROT as
the test,
IMMUNOFIXATION
ELECTROPHORESIS is
the method, urine is the
specimen, and
Interpretation or
Impression is a test
detail. 1,2, or 3 is a
designation of multiple
peaks, which would not
be in the TEST value.
Protein M1/2/3 (M-
Spike) - Use the new
existing Monoclonal
Protein Spike/C117844,
the region could
currently go into
Suppqual. The Team is
pursuing the addition of
a new variable for region
of interest.
Urine Immunofixation
Impression-1/2/3 - Do
not add. Please use
existing term
C92291/MCPROT as
the test,
IMMUNOFIXATION
there are additional variables that belong to the II
PANSS. Some are rarely used, but we often see
Total Score collected in studies where it is used
in making a clinical decision.
The EC domain is described in the SDTM IG V3.2 II Do not add (P35):
but is not found back in the latest controlled Published with P33
terminology (20171222). publication 2018-03-30
Could the EC domain be added, or explained
why it is not present?
A count of the CD3 expressing cells per unit in a II SDTM-Published in P36

To be used with MITS : CD3

To be used with MITSCD : CD3



A count of the MBP expressing cells per unit in a II Do not add (P36): Do
biological specimen. not add. The
To be used with MITS : Major Basic Protein Immunophenotyping/IH
C team withiin CDISC is
working on an extension
of the MI domain as to
how to model these
'expressing-cell' count
type terms. Therefore
we will not control them
for now nor add them to
CDISC CT. The codelist
is extensible.
A count of the MBP expressing cells per unit in a II Do not add (P36): Do
biological specimen. not add. The
To be used with MITSCD : MBP Immunophenotyping/IH
how to model these
is extensible.
A count of the neutrophil elastase expressing II Do not add (P36): Do
cells in a biological specimen. not add. The
To be used with MITS : Neutrophil Elastase Immunophenotyping/IH
Expressing Cells C team withiin CDISC is
how to model these
is extensible.
A count of the neutrophil elastase expressing II Do not add (P36): Do

cells in a biological specimen. not add. The
To be used with MITSCD : ELACELL Immunophenotyping/IH
how to model these
is extensible.
A count of the mast cell tryptase expressing cells II Do not add (P36): Do
in a biological specimen. not add. The
To be used with MITS : Tryptase Expressing Immunophenotyping/IH
Cells C team withiin CDISC is
how to model these
is extensible.
A count of the mast cell tryptase expressing cells II Do not add (P36): Do
in a biological specimen. not add. The
To be used with MITSCD : TRYPCELL Immunophenotyping/IH
how to model these
is extensible.


A measurement of the total smooth muscle II SDTM-Published in P36

To be used with MITS : Smooth Muscle
Antibody
A measurement of the total smooth muscle II SDTM-Published in P36
To be used with MITSCD : SMUSCAB
A count of the blood vessels in a biological II SDTM-Published in P36

specimen
To be used with MITS : Endothelium
A count of the blood vessels in a biological II SDTM-Published in P36

specimen
To be used with MITSCD : ENDOTH
A count of the MUC5AC expressing cells in a II Do not add (P36): Do
biological specimen not add. The
To be used with MITS : MUC5AC Immunophenotyping/IH
how to model these
is extensible.
A count of the MUC5AC expressing cells in a II Do not add (P36): Do

To be used with MITSCD : MUC5AC Immunophenotyping/IH
how to model these
is extensible.
A measurement of the involucrin cells in a II Do not add (P36): Do

To be used with MITS : Involucrin Immunophenotyping/IH
how to model these
is extensible.
A measurement of the involucrin cells in a II Do not add (P36): Do
To be used with MITSCD : INVLCRN Immunophenotyping/IH
how to model these
is extensible.
A measurement of the cytokeratin 7 cells in a II Do not add (P36): Do

To be used with MITS : Cytokeratin 7 Immunophenotyping/IH
how to model these
is extensible.
A measurement of the cytokeratin 7 cells in a II Do not add (P36): Do

To be used with MITSCD : CY7 Immunophenotyping/IH
how to model these
is extensible.
A measurement of the eCadherin cells in a II Do not add (P36): Do
To be used with MITS : eCadherin Immunophenotyping/IH
how to model these
is extensible.
A measurement of the eCadherin cells in a II Do not add (P36): Do

To be used with MITSCD : ECADHRN Immunophenotyping/IH
how to model these
is extensible.
A measurement of the beta-defensin 1 in a II SDTM-Published in P36

To be used with MITS : Beta-defensin 1
A measurement of the beta-defensin 1 in a II SDTM-Published in P36

To be used with MITSCD : BD1
A count of the S100 calcium binding protein A8 II Do not add (P36): Do

expressing cells in a biological specimen. not add. The
To be used with MITS : S100 Calcium Binding Immunophenotyping/IH
Protein A8 C team withiin CDISC is
how to model these
is extensible.
To be used with MITSCD : S100A8 Immunophenotyping/IH
how to model these
is extensible.

To be used with MITS : S100 Calcium Binding Immunophenotyping/IH
Protein A9 C team withiin CDISC is
how to model these
is extensible.

To be used with MITSCD : S100A9 Immunophenotyping/IH
how to model these
is extensible.
A measurement of the intact epithelium in a II SDTM-Published in P36

biological specimen
To be used with MITS : Epithelium, Intact
A measurement of the intact epithelium in a II SDTM-Published in P36

biological specimen
To be used with MITSCD : EPICI
A count of the cells that have reacted to the II SDTM-Published in P36
periodic-acid Schiff stain
To be used with MITS : PAS+ Count
A count of the cells that have reacted to the II SDTM-Published in P36

periodic-acid Schiff stain
To be used with MITSCD : PAS
FTCAT/FTTESTCD/FTTEST for Emotion II QRS-Published in P34.

Recognition
for Huntington's Disease TAUG; file emailed
separately
FTCAT/FTTESTCD/FTTEST for Paced Tapping II QRS-Published in P34.
For Huntington's Disease TAUG; file emailed
separately
Beta-Trace Protein Measurement C100426 and II SDTM, SEND-Published

Prostaglandin D2 Synthase Measurement in P37
C103432 appear to be duplicates as there are
several references that state that beta-trace
protein and prostaglandin D2 synthase are the
same protein
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4
014775/,
http://clinchem.aaccjnls.org/content/48/6/939 and
https://www.uniprot.org/uniprot/P41222#names_a
nd_taxonomy).
Liz HD-Intact Parathyroid Hormone Measurement II

C74789 and Whole Parathyroid Hormone
Measurement C103451. I am not sure that there
is a difference between ?intact? and ?whole?.
These two words are the only differences in the
CDISC ALT_DEFs as well as the names. (Upon a
second look, I think ?Whole? is only pre-proPTH
and ?Intact? includes both pre-proPTH or a
proPTH. Still not sure why they are splitting hairs
here.)
Liz HD-Human Epidermal Growth Factor II SDTM, SEND-Published

Receptor 2 Measurement C112312 and HER2 in P40
Antigen Measurement C112291. There may be
some difference here but HER2 Antigen and
HER2 are usually used synonymously. The ?
Antigen? term implies immunohistochemistry but,
while the NCI DEF makes this distinction, the
CDISC ALT_DEF doesn?t. Obviously, they can
have their own ALT_DEF and these two may be
distinct but the may want to think about the use
cases and definitions for these terms.
New term to be used in EG domain for II Do not add (P36): Do
EGORRESU and EGSTRESU as ECG waveform not add. The use-case
analyses were performed for 5 minute intervals describes an ECG
on tracings collected over a 24 hour period. recording that took 5
minutes to perform
using probably 12-lead
continuous ECG. The "5
minutes" is the duration
of the recording and
should be represented
by an EG domain timing
variable. Please
consider using perhaps,
EGELTM.
Change CAT, TESTCD and TEST from II

Questionnaires to Funtional Tests for MMSE
version 1.
Please update CCODE values as well. file
emailed separately
II QRS-Published in P34.
FTCAT/FTTESTCD/FTTEST for COWAT

This is for the Huntington's TAUG. file emailed
separately
During recent CDISC Global Governance II Glossary-Published in

discussions, we came to realization that the term P40
"administration" for drug/agent/medicine/etc. is
frequently used in our standards. However, it is
not defined in the CDISC Glossary.
During recent CDISC Global Governance II

discussions, we came to realization that the term
"exposure" to drug/agent/medicine/etc. is
frequently used in our standards. However, it is
not defined in the CDISC Glossary.
Pls add new terms to LBTEST-CD codelists; file II SDTM, SEND-Published
emailed separately. in P36
Do not add (P36):
Acetone-Do not add.
Published as
C147288/ACETONE
Antithrombin III-Do not
add. Please use
C81977/Antithrombin
Antigen
Anti-Factor Xa Activity,
Apixaban-Do not add.
This assay is measuring
Apixaban (clotting drug)
via the Anti-Fact Xa
activity Assay. CDISC
CT does not control
LBTESTs for therapeutic
drug levels (see Lab
rules document) so the
team will not add
'Apixaban' to the
LBTEST codelist.
However Apixaban is
the appropriate LBTEST
value to use in the
dataset and the codelist
is extensible. In this
case the result value is
for the drug level so the
drug itself would be the
lab test since it is the
analyte (endpoint) of
interest.
Aspartate
Aminotransferase
Platelet Ratio Index-
Since U is being used to represent an arbitrary II SDTM, SEND-Published
unit (see definitions of U/U/L and U/m2) and in P36
Enzyme U is being used to report (differentiate)
Enzyme Units (see definition Enzyme U and
Enzyme U/L) we would like to request Enzyme
U/m2 as a diffentiated term for to U/m2. The
driver is the request of this unit is PEG-
Asparginase which is an anti-cancer therapy that
is actually an enzyme.
To measure HCV RNA in a biological specimen II Do not add (P38): This

concept is already
published, please use
C142330.
To measure HIV-1 RNA in a biological specimen II
Auxiliary medicinal product? means a medicinal II

product used for the needs of a clinical trial as
described in the
protocol, but not as an investigational medicinal
product; SOURCE EU-CTR
Enrollment II Glossary-Published in
The number of participants in a clinical study. P44
The "estimated" enrollment is the target number
of participants that the researchers need for the
study. SOurce Clinicaltrials.gov
https://www.clinicaltrials.gov/ct2/about-studies/glo
ssary
Only this is available as a source at
clinicaltrial.gov. See also a current Issue is
comparisons with Transcelerate definitions for the
Protocol template which seem to indicate any
subject that signs informed consent is "enrolled".
Contrast with screen failures, randomization, and
treatment criteria-drop out and withdrawals for
counts of enrolled.
The pharmaceutical dosage form of the drug II

administered to a patient or test subject.
To be used with TSPARM : Dose Form
The pharmaceutical dosage form of the drug II SDTM-Published in P35

administered to a patient or test subject.
To be used with TSPARM : Dose Form
Definition: A subject's description of the quantity II SDTM-Published in P36

of blood flow during her average menstrual cycle.
(Response expected: Scanty, Moderate or
Heavy)
Reason for Request: Menstrual History is
collected at Screening for baseline records as this
is part of the primary endpoint of the study.
Definition: The length of menstrual bleeding days. II SDTM-Published in P36

(Typically has an average between 4 to 8 days).
Definition: The pattern of menstrual cycles. A II SDTM-Published in P36

menstrual cycle of 24-38 days, measured from
the beginning of one menstrual period (bleeding)
to the beginning of the next menstrual bleeding, is
considered regular. (Response expected as
Regular or Irregular)
Please add 1 new term to LBTEST-CD; and II SDTM, SEND-Published

create new Findings About codelist for the in P35, P36
Nutrition TAUG.
This is a TA request; File emailed separately.
similar to already published term ugEq II SDTM-Published in P36
The definition currently says: A measurement of II SDTM, SEND-Published

the nitrite in a urine specimen. in P35
However our central lab is currently measuring
Nitrite in a plasma sample.
Can you please make the definition more
generic?
Just need request codes for the terms in P34 II SDTM-Published in P34
Public Review.
To measure M2 Pyruvate Kinase in a biological II SDTM, SEND-Published

specimen in P36
CDISC to LOINC mapping termjs; File Emailed II SDTM, SEND-Published

Separately in P35
Do not add (P35):
CONTROL - Do not add.
This is a qualifier on the
specimen specifying
whether the specimen is
from the subject or the
control. It is not a
specimen type. This will
need to be put into a
NSV for now.
Do not add (P38): No
longer needed for
LOINC mapping.
As published in Neul JL, Fang P, Barrish J, et al. II SDTM-Published in P43

Specific mutations in methyl-CpG-binding protein
2 confer different severity in Rett syndrome.
Neurology 2008;70:1313-1321
New Unit terms for LOINC matching II SDTM, SEND-Published
File Emailed Separately in P35
Do not add (P35):
MoM - Do not add. Put
this in an NSV of Result
Type, which we suspect
could be used to host
the LOINC Property
values. The result value
for these tests would
then be unitless.
New Method Terms for LOINC Matching; File II SDTM-Published in P35,
Emailed Separately P37
Do not add (P35, P36):
LATEX
AGGLUTINATION - Do
not add. This is a
synonym to MICRO-
LATEX PARTICLE-
MEDIATED
IMMUNOASSAY
(C142341)
VISUAL INSPECTION -
Do not add. "Inspection"
has been added to
Observation (C25598)
as a synonym.
FECAL
IMMUNOCHEMICAL
TEST-Do not add. Use
IMMUNOASSAY
(already published) in
the mapping,
Do not add (P37):
LACTATE TO
PYRUVATE REACTION
- Do not add. Please
use ENZYMATIC
COLORIMETRY with a
Method qualifier (NSV)
specifying the direction
of the reaction.
PYRUVATE TO
LACTATE REACTION -
ENZYMATIC
COLORIMETRY with a
Method qualifier (NSV)
There is request to add the race value as 'Not II SDTM-Published in P36
Reported' on demographics CRF. Some countries
from Europe are having the restriction for not to
disclose the RACE data of patients. This RACE
data will be captured at source. This rule is being
implemented across other trials. Can we add this
value on demographics CRF considering this law
from European countries?
Please let me know if you need more
information.
Current values are specific to Biological or Step II SDTM-Published in P35

parent. However, most circumstance (COA
Assessments) do not need this level of granularity
- making the options difficult to justify to subjects.
The palm is used as a reference (representing II SDTM-Published in P35
1% of the total BSA) and is used to repeatedly
cover the lesions on the body. The number of
total palms required estimates the percentage in
each of the four body regions. BSA values can be
entered with a precision of 0.5%.
Reference: Indian J Plast Surg. 2010 Jan-Jun;

43(1): 49?53.
doi: 10.4103/0970-0358.63962
PMCID: PMC2938623
PMID: 20924450
Determination of hand and palm area as a ratio
of body surface area in Indian population
Pawan Agarwal and Sashikant Sahu
I am requesting a generic term for cells rather II Do not add (P36): Do

than a specific cell type in support of nasal not add. Please use
swabbing. With swabbing, a number different 'SWABBED MATERIAL',
type of cells may be collected, so use of a generic which was added to the
term such as CELLS would seem warranted. codelist with P34.
Requesting this method to allow flexibility and II Do not add (P37): Do

differentiation of Oxygen saturation by Pulse not add. Please use
oximeter(VS) and Blood gasses (LB) on eCRF existing, published
collection. terms:
possible definition: A method that measures the POTENTIOMETRY and
amount of oxygen and/or carbon dioxide in the PH METER.
blood
Both units requested in support of D-DIMER II SDTM, SEND-Published

testing. in P37
Batch 1 of Lung Cancer TA. Contains 35 new II SDTM-Published in P35,
terms; File emailed separately. P38, P39
Do not add (P35):
EGFREA - Do not add.
Please use EGFR
Mutant
Protein/EGFRMP
HISTCLAS - Do not add.
Please use Histologic
Type of
Cancer/HISTTYPC.
Do not add (P37):
PRESENT- NO
ENLARGEMENT FROM
NADIR - Do not add.
This will be removed
from the example in the
TAUG. PRESENT will
be used as the
response intead.
CPYNUMRT - Do not
add. PGx team
recommends re-using
COPYNUM and putting
'Ratio' into test detail.
Do not add (P38):
Malignant Cells, NOS -
Request removed by
requestor. The dataset
is changing to LB so no
longer need a new test
code.
Do not add (P39):
GENREARR-The PGx
IG is currently
provisional. The PGx
team is doing major
The current value is too narrow for studies in II SDTM - Published in P47
which the investigational product is not a drug.
This topic arose in the context of the Nutrition
project, but is also applicable for biologic
products, such as vaccines.
Definition: Occurrence of an observation without II Do not add (P35): Do
a designated severity grade. not add. Present is not a
This term would be used for findings (e.g., severity by definition. In
microscopic observations) for which the 5-grade SEND, 'Present' may be
severity scale is not applicable. seen in orres or as part
of the original findings
string. However, in the
tabulated dataset, the
presence of the record
means the finding was
present in the animal.
Definitions for DA and DD incorrectly identify II SDTM-Published in P35

these as Events domains. Both are findings
domains. Definitions should change "events
domain" to "findings domain".
Needed for collection to determine effect on sleep II SDTM, SEND-Published
apnea: reference: OSA (Obstructive Sleep in P35
Apnea) ; Young T, Skatrud J, Peppard PE. Risk
factors for obstructive sleep apnea in adults.
JAMA 2004; 291:2013?2016
Term used on our CRF, along with L2-L3, L3-L4, II SDTM, SEND-Published
and L4-L5. in P35
Definition: The space between the L5 vertebra
and the first bony segment at the top of the
sacrum, which is sacral segment 1 (or S1).
Synonym: Lumbosacral Joint
Use this unit for antibody tests - such as CMV II Do not add (P37): Do
IgM Ab (LOINC code: 5126-8), Rubella IgM Ab not add. Please use
(LOINC Code: 8015-0). It is calculated by dividing RATIO as the Unit of
the OD value of the sample by the cutoff value. measure and Antibody
Index could be placed in
SCAT. The appropriate
test names for these
tests could be
something like CMV
Antibody Signal/CMV
Antibody Cutoff, etc.
The CMV and Rubella
tests are not yet
published so please
submit a new term
request.
Requesting addition of generic term for Drug II SDTM, SEND-Published

Crystals in urine. Question - if a study needs to in P35, P36
capture the name of the specific drug associated
with the crystal, what item should be used? Or
should this be captured in a SUPPQUAL?
It would be beneficial to have a separate category II Do not add (P35): Do

for the food consumption findings. Currently to not add. Already
get those, you must manually walk through all of published as
the findings to identify ones that are related to C129003/QUALITATIVE
food consumption (such as inappentance, FOOD CONSUMPTION
reduced appetite, etc). This makes correlation in the CLCAT codelist.
with weight difficult when trying to determine if
weight loss is due to lower food consumption or
other affect. This qualitative food is typically
collected instead of quantitative food values for
monkeys.
C51913; This is the incorrect code based on the II SDTM-Published in P35

CDISC PT and definition. Should be coded to
C38068.
Request to add the following test names (and test II SDTM, SEND-Published
codes): Acylglycines (ACYGLYCN), Acylcarnitine in P35
(ACYCRNTN), and Amino Acids (AMNOACID).
These tests are to capture the panel
interpretation of the individual components.
These tests are available on the ARUP test
directory with the associated LOINC codes:
Acylglycines, Urine Interpretation (LOINC Code:
53718-3), Acylcarnitine, Plasma Interpretation
(LOINC Code: 46252-3) and Amino Acids,
Plasma Interpretation (LOINC Code: 13500-4)
Pls add new terms to MBTEST-CD; Needed for II SDTM-Published in P35,

LOINC code mapping; ls modify existing terms. P42
File emailed separately Do not add (P35):
Add synonym to
CDFTXN (Clostridium
difficile Toxin):
Clostridium difficile
Toxins A+B -Do not
change. This term will
be moving into the MB
codelist and they have
created a separate term
to encompass A+B.
https://www.fda.gov/Radiation- II SDTM-Published in P36

EmittingProducts/
RadiationEmittingProductsandProcedures/
MedicalImaging/MedicalX-Rays/ucm115354.htm
What has been developed so far by the SEND II Do not add (P45): Do
Dermal Ocular team: not add. This was
The TL domain is included to the Trial Design submitted in 2018 and
domain category as it includes information that is has not been integrated
known before the study commences, i.e. protocol into a planned version of
or pre-defined procedural details. The structure of SDTMIG. SDS team is
this domain allows for relating procedural details taking a fresh look at the
to most any level within the dataset package. problem in 2021 so they
Currently, it is applicable to relate further can re-submit after they
information about a method or test to the Findings come to consensus on
Observation Class domains. This domain should what a new domain
not duplicate protocol information found in other would look like.
Trial Design domains such as TS or TX.
TL Definition: Provides descriptive

characteristics, attributes or methodology of the
measurements, tests or examinations that are
performed in the findings general observation
class datasets as defined by a unique
combination of up to three variables, such as --
CAT, --TEST and --METHOD. The TL domain
scope, as outlined by examples in this IG,
contains pivotal metadata necessary to interpret
study data correctly and completely. Until such a
time where a SEND metadata guidance
document is published and the CDISC define
standard can accommodate this information, the
trial test metadata (as outlined by examples and
assumptions in this IG) should be included in the
TL dataset.
A bone marrow cell with a single nucleus, for II SDTM-Published in P36

example lymphocytes, monocytes and
hematopoietic stem and progenitor cells.
We have been asked to create a new term of II

'Intradialytic' to route. But I can see that the
definition of HEMODIALYSIS (Administration
through hemodialysate fluid) means that you
would expect us to use HEMODIALYSIS. Is that
correct?
The requestor pointed out that this term is
actually a procedure ( to remove fluid and waste
products from the blood and to correct electrolyte
imbalances.)
Woudl you consider changing the submission
value to be more inline with other 'INTRAxxxx'
route terms?
If not, can you please add INTRADIALYTIC' as a
synonym?
The NCI term "Ethinyl Estradiol (Code C486)" II Do not add (P36): Do
may be used in SDTM. not add. Do not add.
CDISC CT does not
control LBTESTs for
therapeutic drug levels
(see Lab rules
document) so the team
will not add 'Ethinyl
Estradiol' to the LBTEST
codelist. However
Ethinyl Estradiol is the
appropriate LBTEST
value to use in the
interest.
The NCI term "Etonogestrel (Code C47528)" II Do not add (P36): Do

may be used in SDTM.LB. not add. CDISC CT
does not control
LBTESTs for therapeutic
drug levels (see Lab
rules document) so the
team will not add
'Etonogestrel' to the
LBTEST codelist.
However Etonogestrel is
the appropriate LBTEST
value to use in the
interest.
Enrolled definition does not include the most II Glossary-Published in
frequently used concept for enrolled, only a P36
narrow one.
Enrolled: Status assigned to a subject who
agrees to participate in a study, following
completion of the informed consent process and
meeting inclusion criteria. NOTE:
Enrollment routinely requires verification of
eligibility and inclusion in the analysis database.
[after Clinicaltrials.gov]; less common is the point
of enrollment from the signing of an informed
consent form and this can be defined in some
protocols. (See also informed consent)
Definition: Administration of chemotherapy inside II SDTM-Published in P36

the bladder.
Differentiate from IMMUNOTHERAPY. Definition: II

Local administration of immunotherapy.
There is a precedent for having the medical II SDTM-Published in P35

evaluator, along with a designation of one and
two. Request to add PATHOLOGIST 1. The
proposed definition is A physician who
specializes in the science of pathology that is
given the designation of one.
There is a precedent for having the medical II SDTM-Published in P35

evaluator, and then for the same discipline, a
designation of one and two. Request to add the
CDISC Submission value of PATHOLOGIST 2.
The proposed definition is A physician who
specializes in the science of pathology that is
given the designation of two.
Time to No Longer Clinically Benefitting is a new II SDTM-Published in P36
FDA-accepted endpoint from the Prostate Cancer
Working Group 3 Guidelines. New
recommendations for trial outcome measures
include the time to event end point of
symptomatic skeletal events, as well as time to
first metastasis and time to progression for trials
in the nonmetastatic CRPC state. PCWG3
introduces the concept of no longer clinically
benefiting to underscore the distinction between
first evidence of progression and the clinical need
to terminate or change treatment, and the
importance of documenting progression in
existing lesions as distinct from the development
of new lesions.
There was a jira comment submitted for P34 CT II SDTM, SEND-Published

public review pertaining to the term Target Cells - in P36, P37
TRGTCE (C96636), which is NOT part of the p34
new terms to be released. However the lab team
had reviewed this comment and think this needs
further discussion. This ticket is submitted to carry
this discussion further, and possibly make
changes to existing terminology. Please see the
following JIRA comment for details.
https://jira.cdisc.org/browse/CT-360
This inquiry came in as a P34 CT PR comment, a II SDTM, SEND-Published
reviewer found inconsistent naming for UNIT in P36
submission values that contain "second". For the Do not add (P37):
newer terms in the UNIT codelist, the letter "s" is Please look into terms in
used to indicate "second(s)" which is consistent the UNIT codelist that
with UCUM and SI units, but for some of the older pertain to "second(s)":
terms, there are a mixture of "sec", "second(s)" Do not change. The
and "s" used to indicate "second". Please look team agreed awhile ago
into this matter and discuss whether the older that we would use 's' for
terms should be updated. Here is the JIRA the 'second' terminal
comment: https://jira.cdisc.org/browse/CT-362. unit going forward for
new additions to the
Also, Erin please add to the Unit Naming Rule codelist. However,
doc to use "s" for "second(s)" in the future, if the existing submission
team agrees to this rule. value changes are
expensive for CT users
to implement. We feel
that the cost of the
change does not yet
outweigh the benefit of
consistency in this case.
If a compelling use case
was presented (such as
a regulatory guidance)
to convert all units to
being SI compliant, then
we would reconsider this
position.
Currently the CDISC definitions for FAC070 and II QRS-Published in P36.

FAC071 only differ by the word 'Scale'. Would
like to add '13-item' to the QSCAT and CDISC
definitions for clarity.
This unit is associated with the test II Do not add (P36): Do

Decanoylcarnitine. Refer to LOINC Code 30327-1 not add. Please use
exsting term
C48508/umol/L
Decanoylcarnitine is part of the acylcarnitine II
analysis used for the diagnosis of fatty acid beta-
oxidation disorders. Has the synonym of C10.
One of the LOINC codes associated with this test
is 30327-1.
Suggested TESTCD is DCCARNIT.
A continuous electrocardiographic (ECG) II SDTM-Published in P35
recording utilizing 1 or more leads that uses Do not add (P35):
radiotelemetry to transmit physiological data. The Scoring Method - Do not
subject need not be restricted. modify the existing term.
Since these devices are typical used in animal The ECG team decides
models (e.g. dogs, non-human primates), the 2nd that the current
sentence is modified to better reflect living definition for Continuous
conditions. Ambulatory ECG is
The first term request covers ECG data collected correct and should only
using a jacketed telemetry system. Briefly, be used with human
external electrodes are attached to the animal, subjects, a new
and then a jacket is placed on the animal to EGMETHOD term will
protect the equipment. The ECG signals are be created for this
transmitted using radio waves to an external request: Continuous
computer. These 2 types of studies are distinct Surface ECG Recording
since the surgical instrumentation may have for Non-human Species
impacts on other endpoints (e.g. anatomic
pathology).
A continuous electrocardiographic (ECG) II SDTM-Published in P35

recording utilizing 1 or more leads from a Do not add (P35): Do
surgically-instrumented device that uses not modify the existing
radiotelemetry to transmit physiological signals. term. The ECG team
The subject need not be restricted. decides that the current
Since these devices are typical used in animal definition for Continuous
models (e.g. dogs, non-human primates), the 2nd Ambulatory ECG is
sentence is modified to better reflect living correct and should only
conditions. be used with human
The second term covers ECG data collected subjects, a new
using an internal transmitter device. Each animal EGMETHOD term will
is surgically-instrumented and the ECG leads are be created for this
placed internally (placed subcutaneously on the request: Continuous
muscle or directly on the heart, among other ECG Recording for Non-
configurations). ECG signals are transmitted human Species Using
using radio waves. These 2 types of studies are Implanted Leads
distinct since the surgical instrumentation may
have impacts on other endpoints (e.g. anatomic
pathology).
This is a term calculated in nonclinical studies in II

animals implanted with a telemetry device
equipped with a catheter implanted into the left
ventricle. We would also need a corresponding
CV Test Name. Thank you.
EMW: Electromechanical Window: Temporal II
difference between the end of electrical systole
(i.e., the QT interval) and the completion of
ventricular relaxation: Measured as the time
difference between the return of the left
ventricular pressure to its resting level and the
electrocardiogram?s end of T-wave.
This is a term calculated in nonclinical studies in

Batch 1 request for PTSD therapeutic area user II SDTM-Published in P35

guide. These terms have already been added to Do not add (P35):
the General, Device, and Lab working Scoring Method - Do not
documents. The only action is to add the new add. Please put this
term request code to the relevant working information into the --
documents. File emailed separately ANMETH variable in the
nv.xpt dataset.
Request for batch 1 of HIV TAUG terminology. II SDTM-Published in P35,

File emailed separately P37, P39
not add. Please use
BLOOD TRANSFUSION
(out with P35 public
review).
DXA SCAN -There is no
PRDECOD value in the
example, hence it was
probably not necessary
to control at this time.
Usual Number of
Bleeding Days, Min;
NUMBLMIN - Do not
add. RPTEST=Menses
Duration. Min/Max/
Typical/Usual go into
COLSRT NSV.
Usual Number of
Bleeding Days, Max;
NUMBLMAX - Do not
add. RPTEST=Menses
Duration. Min/Max/
Typical/Usual go into
COLSRT NSV.
Do not add (P39):
HIV12AB; HIV-1/2
Antibody -Please use
C74714
Alternaria
tenuis/alternata IgG4-
Use C130153
II
Definition: The pharmaceutical dosage form for

the drug administered per a specific interval.
Definition: The pharmaceutical dosage form for II

the drug administered per a specific interval.
TSPARMCD = DOSFRM; TSPARM =

Pharmaceutical Dosage Form
Add new MBTEST terms; file emailed separately. II SDTM-Published in P42

Do not add (P42):
Gram-negative bacteria-
Do not add. Map to
C154812 in MBTEST-
CD codelist.
Our protocol has Additional Outcome Measures, II SDTM-Published in P36

and we would like TS to reflect the protocol and
hence we don't want to use "Exploratory
Outcome Measure"
add new unit terms; file emailed separately. II SDTM-Published in P38
Do not add (P38): BID is
a frequency and as such
belongs in the DOSFRQ
variable. So the
appropriate unit of
measure would be
mg/kg which is already
published in the UNIT
codelist. (C64496).
Request to add Delta Aminolevulinic Acid, II SDTM, SEND-Published

Porphobilinogen, ALA/Creatinine, and in P36
PBG/Creatinine to LBTEST codelist; File emailed
separately
For the following NCI Term "HIV-1 and HIV-2 II

Antibodies and HIV p24 Antigen Measurement
(Code C142278)", a CDISC LBTESTCD/LBTEST
should be created. Thanks.
Term does not currently exist in standard codelist; II SDTM, SEND-Published

we use it as 'Fluoxetine and/or Metabolite' and, in P37
according to LOINC, can map to Fluoxetine
(3644-2) and also Norfluoxetine (3868-7), but I
am unsure what the standard submission value
should be. Thank you!
Merge C147584 into C121853, concept already II
exists in NCIt for caDSR, need to reuse the older
C-code
Multiple term request to add new tumor types to II SDTM-Published in P36,
the SEND NEOPLASM codelist. These are from P37
the INHAND to send Mapping done at the end of Do not add (P36):
2017. These tumors are in INHAND publications Mesothelioma,
but are not in SEND CT. File emailed separately epicardium or
pericardium-Do not add.
This maps to the generic
C4456/MESOTHELIOM
A, MALIGNANT
Thecoma, malignant-Do
not add. Wait for OWG
female repro to weigh in
on granularity.
Adenoma, sebaceous
cell-Do not add. Maps to
C40310
ADENOCARCINOMA,
SEBACEOUS,
MALIGNANT. Add
InHAND term as a
synonym
Carcinoma, sebaceous
cell-Do not add. Maps to
C4174/ADENOMA,
SEBACEOUS, BENIGN.
Add synonym instead.
Do not add (P37):
Carcinoma, Leydig cell -
Do not add. This is a
synonym of C4213.
Move to changes to
existing.
Fibrosarcoma,
pleomorphic - Do not
add. Synonymous with
C4247. Move to
changes to existing tab.
C68598 is the generic concept while C28012 is II SDTM, SEND-Published
the anatomical concept. Use C28012. in P35
INHAND term frequently used in our guideline II SEND-Published in P35

studies
Synonym(s): Cytoplasmic alteration;
Cytoplasmic change; Granular change; Granular
degeneration; Hyaline degeneration; Glycogen
accumulation; Ground glass change.
Pathogenesis: Often xenobiotic-induced and
may be associated with other forms of liver
damage.
Diagnostic Features: Affected cells may show
increased cytoplasmic granularity, cell swelling,
and eosinophilia.
INHAND term frequently used in our guideline II Do not add (P35): Do
studies not add. Please use
Depletion, germ cell (testis) in: Creasy D, Bube C120885/GERM CELL
A, de Rijk E, Kandori H, Kuwahara M, Masson R, DEPLETION. INHAND
Nolte T, Reams R, Regan K, Rehm S, Rogerson does not recommend
P, Whitney K (2012) Proliferative and splitting apart this term.
nonproliferative lesions of the rat and mouse As such most all uses of
male reproductive system. Toxicol Pathol 40 (6): 'Depletion' in SEND CT
40S?86S would contain some
doi:10.1177/0192623312454337 type of modifier. It is not
Depletion, secretory (salivary glands, stomach recommended that
and pancreas) in: Nolte T, Brander-Weber P, Depletion be used on its
Dangler C, Deschl U, Elwell MR, Greaves P, own.
Hailey R, Leach MW, Pandiri AR, Rogers A,
Shackelford CC, Spencer A, Tanaka T, Ward JM
(2016) Nonproliferative and proliferative lesions of
the gastrointestinal tract, pancreas and salivary
glands of the rat and mouse. J Toxicol Pathol 29:
1S?124S
doi:10.1293/tox.29.1S
This value can be need for Phase 1 study. II SDTM-Published in P36
Needed for T-Spot and Quantiferon tests II Do not add (P37): Do

not add. Based on the
Tuberculosis V2 TAUG,
the METHOD should be
ELISA and the assay
name go into DIVAL as
the Device Type.
micromoles per litre (concentration) divided by II Do not add (P37): Do

micromoles per kilogram not add. This seems to
be an one-off use-case
of a unit and the PK
UNIT codelist is
extensible, please add
as a sponsor controlled
term for now. The PK
team will revisit this type
of terms when the team
perform a more
extensive review of the
PKUNIT codelist.
Hours times micromoles per liter (area under the II Do not add (P37): Do
curve), divided by micromoles per kilogram (dose not add. This seems to
normalized by body weight). be an one-off use-case
of a unit and the PK
UNIT codelist is
extensible, please add
as a sponsor controlled
term for now. The PK
team will revisit this type
of terms when the team
perform a more
extensive review of the
PKUNIT codelist.
RSCAT/RSTESTCD/RSTEST for UHDRS II QRS-Published in P35

This is for the Huntington's Disease TAUG
New CCCAT=CAPS (CURRENT) DSM-5 WITH II QRS, SDTM-Published
DSM-IV SCORING 2016 VERSION, synonym in P50
CAP01, and RSTESTCD/RSTESTNM of
CAP01TC/TN
This request is for the PTSD TA.
This request is on behalf of the Lung Cancer TA II QRS-Published in P35
team.
Please remove the following terms from the II SDTM-Published in P35

codelist:
SUPPCO
SUPPSV
SUPPSE
SUPPTS
SUPPTV
SUPPTX
SUPPTA
SUPPTD
SUPPTE
SUPPTI
SUPPTM
SUPPTP
SUPPTT
SUPPDI
SUPPDR
SUPPOI
These domains are special purpose domains,
which do not get supplemental datasets per
SDTMIG.
Dear Team, II SEND-Published in P35
We are requesting this new term as, Novo need
this as a separate organ as we sometimes report
changes herein and would like SEND data to
reflect data from the data collection system.
Hope this could be added in review for package
35 or 36.
Thank you very much
We need 2 new tests for the following which are II SDTM, SEND-Published
measured in EXPIRED AIR: in P37
Mean Fractional Nitric Oxide Do not add (P37):
Fractional Nitric Oxide Mean Fractional Nitric
Oxide - Do not add.
In addition, we can see that there is an existing Please use the existing
code for NITRICOX (Nitric Oxide) but we aren't lab test of Nitric Oxide
sure if this is purely for measurement in blood or with a SPECTYPE of
could be used for expired air too? EXPIRED AIR, and use
If these tests are measured as part of other the NSV --COLSRT (will
respiratory tests we wonder if they would be be published in the
better in the RETESTCD/RETEST codelists? nutrition TAUG) to
Please advise. capture the 'mean'
component of the
requested test value.
Fractional Nitric Oxide -
the existing lab test of
Nitric Oxide with a
SPECTYPE of
EXPIRED AIR.
CCODE: C67377 Submission value is IU/mL. Can II Do not add (P37): Do

we consider changing the submission value to not change. Existing
either kIU/L or 10^3 IU/L. In most cases, unit is submission value
represented in an SI compliant (having a whole changes are expensive
denominator) and this is a commonly used unit for CT users to
that is an exception. You will also need to change implement. We feel that
the definition the cost of the change
does not yet outweigh
the benefit of
consistency in this case.
If a compelling use case
was presented (such as
a regulatory guidance)
to convert all units to
being SI compliant, then
we would reconsider this
position.
There is currently a test for the alpha and beta II SDTM, SEND-Published
subunit, not no test for the overall receptor value. in P37
The test is supported by LOINC: 24458-2. The
receptor is actually formed by a combination of
three non-covanently bound protein chains
(alpha, beta and gamma)
Some tests such as the Complement Activation II Do not add (P38): The
EIA (which differs from CH50) use assay specific sponsor can choose to
units such as CAE units. Rather than request use the existing term
CAE units, we are proposing to map all such units 'Arbitrary U' or could
to a general "arbirary unit". This assay uses request a more specific
control samples and the result are not expressed Arbitrary Unit such as
by volume or weight.....just CAE units.....so we CAE Unit, if they
would like a generic "aribrary unit" to map this choose. CAE U would
too. be an acceptable term
to develop as CT by
CDISC given the
existing precedent of
adding specific kinds of
arbitrary units to the
codelist.
From CrCa TAUG example here: II SDTM-Published in P35

https://wiki.cdisc.org/display/TAUGCrCa/Cancer+
Genetic+Variation+Data
Based on the Nutrition TAUG example here: II Do not add (P36): Do
https://wiki.cdisc.org/display/TANUTRI/SDTM+Inf not add. Removed from
ant+Nutrition+- example in Nutrition
+Amount+Dispensed+and+Returned TAUG.
Please update codelist definition from II
'Terminology relevant to the test codes that
describe the death diagnosis and related details.'
to 'Terminology relevant to the test names that
describe the death diagnosis and related details.'.
53 new TESTCD/TESTS in existing codelists II SDTM, SEND-Published

23 new terms in existing codelists in P36, P38, P39, P40
1 Change to existing term Do not add (P37):
1 New Codelist with 7 new terms Urine Output - Do not
File Emailed seperately add. Please use the
LBTESTCD=VOLUME,
with Urine as the SPEC,
EVLINT=P24H, and
ORRESU/STRESU=mL/
day.
Digoxin - Do not add.
The lab rules state: Lab
terminology does not
include lab tests to
perform therapeutic drug
level monitoring, e.g.,
Digoxin.
Pancreatic Isoenzyme -
existing term
AMYLASEP.
Salivary Isoenzyme - Do
not add. Please use
existing term
AMYLASES.
ANTERIOR SEGMENT
OPTICAL COHERENCE
Need as part of joint assessment in RA trials. II SDTM, SEND-Published
Tarsal joint is an available term (join formed by in P36
union of the tarsal bones), but Tibiotarsal joint
(joint between the tibia and the tarsus) is not
present in the current CT
I want to use this for my MPO test code. Can it be II SDTM-Published in P37
added?
Needed for Phase 1 trial II Do not add (P39):
Please put the Gene
name into PFGENRI
and then pick an
appropriate PFTEST
value that captures what
about the gene you are
measuring or assessing.
The TA's for Bi-Polar and GAD requested this II QRS-Published in P35
interment be implemented in CDISC data
standards. Copyright approval was obtained form
the publisher, WPS. Thuis is also on the FDA
priority list as a "Yes" priority that they will
perform an internal review when developed..
Batch 2 HIV TAUG multiple term request. 5 terms II SDTM-Published in P36,

to be added to the MSTEST/CD codelist; file P37
emailed separately Do not add (P36):
Stanford HIV Resistance
Calculator Score -
Withdrawn by requester.
Modeling has changed
so this term is no longer
needed.
Stanford HIV Resistance
Calculator Level -
Withdrawn by requester.
Modeling has changed
so this term is no longer
needed.
Informed Consent definition - add Note:In some II Glossary-Published in

cases, when the prospective participant is unable P36
to legally consent, permission to participate may
be obtained from a legally-authorized
representative.
Note was placed in the term enrolled but is more
pertinent in the ICF
A term does not currently exist. II SEND-Published in P36

Proposed definition: A benign hair follicle
neoplasm with differentiation toward cells of the
outer root sheath.
The unit of mAU/mL was reported under PIVKA II II Do not add (P37): Do
test not add. This synonym
could be confused with
other units of measure
in the list including
Anson Unit, Allergy Unit,
Arbitrary Unit, and
Antibody Unit. We are
not seeing evidence that
AU is a common
abbreviation for 'Anson
Unit' specifically.
Indeed, UCUM uses
'AU' as an abbreviation
for 'Allergy Unit'.
Covance also
abbreviates Allergy Unit
to AU. Additionally
CDISC CT has chosen
AU in a submission
value to mean Allergy
Unit.
VSTESTCD/VSTEST requests for the following II SDTM, SEND-Published
tests in P35, P36, P39
APGAR - APGAR Score Do not add (P36):
CHESTCIR - Chest Circumference APGAR Score; APGAR
CONCLVL - Level of Consciousness - Do not add. This is a
GROWTH - Growth Percentile clinical classification and
INTP - Interpretation (to be used to report VS should be modeled in
overall interpretation similar to EGINTP) the RS domain. CDISC
NECKCIR - Neck Circumference is working on getting
PO2 - Partial Pressure of Oxgyen (to be used copyright permission to
when measure transcutaneously) publish this CT.
Partial Pressure of
Oxgyen; PO2 - Do not
add. This is already
published as a lab test
and the requester has
not provided enough
additional information to
justify its addition to VS.
Do not add (P38):
Level of Consciousness-
The APVU scale was
determined to be a
clinical classification by
the QRS team and
should be modeled in
the RS domain. The
QRS team is developing
terminology and a
supplement for this
scale as part of the
Ebola TAUG (though
can be used for many
other therapeutic areas).
Please add RATIO unit concept for the use with II Do not add (P36): Do
"Waist to Hip" ratio. RATIO is a unit in the UNIT not add. Use existing
code list used in other findings domains. published term
RATIO/C44256
Total Time: The amount of time between one II SDTM-Published in P37
breath to the next breath.
This term is needed for data and subsequent
calculations done with plethysmography
equipment in nonclinical species
Expiratory Flow (EF50): The expiratory flow at the II SEND-Published in P37
point that tidal volume is decreased by 50%.
Apnea Time: The length of time of breathing II SEND-Published in P37

cessation, measured as total time - (inspiration
time + expiration time).
Enhanced Pause (PenH): The proportion of the II Do not add (P36): Do
pressure signal from inspiration and expiration not add. Please use
and the timing of expiration, measured using the existing term C120937
following equation: PenH = (ExpirationTime +
ApneaTime)/(RelaxationTime-1) *
(PeakExpiratoryFlow/PeakInsipiratoryFlow).

Please add the NCI value "Numeric Rating Scale II

(Code C121548)" as CDISC SDTM.METHOD
Format.
Moreover as per CDISC SDTM Pain Intensity
Questionnaire Supplement (Version 1.1),
"NUMERIC RATING SCALE 11-POINT",
"NUMERIC RATING SCALE NN-POINT" where
NN is numeric could be also used.
It will be used for Questionnaires and Relating
Score.
Could you please consider to add "Chewable Gel II SDTM, SEND-Published

Dosage Form (Code C134876)" to CDSIC FRM in P36
codelist ?
If Yes, "gummie" should be added as CDISC
synonym.
Nedded on Phase I trial with SDTM submission
When I requested a new SPECTYPE of II SDTM, SEND-Published
'BRONCHOALVEOLAR LAVAGE FLUID ' I was in P36
told in the rejection reason: "Do not add. Please
use published specimen type of LAVAGE FLUID
with LOC of BRONCHUS and ALVEOLI"
ALVEOLI or ALVEOLUS do not exist in LOC. I'm
assuming I should use ALVEOLUS since you
seem to use LOC in the singular rather than
plural. Please advise.
I just wondered if this should be updated to be

PULMONARY ALVEOLUS?
It seems the definition of ALVEOLUS is a word
used in anatomy for hollow cavities - which can
include the bony socket for the root of a tooth.
As per my request I'm assuming you prefer the

singular ALVEOLUS to ALVEOLI?
I would appreciate your thoughts as I have 30
mappings to update to remove the SPECTYPE of
BRONCHOALVEOLAR LAVAGE FLUID, so I'd
really like to get it right first time :-)
Many thanks
HAMA1TC please add new item HAMA115 II QRS-Published in P35

(synonym HAMA1-Total Score)
HAMA1TN please add new item HAMA1-Total
Score (synonym HAMA1-Total Score)
used to record total score on Hamilton Anxiety
Scale
The definition for is: Upper Arm is: (Lat. II

bracchium):Tthe part of the arm between the
shoulder and the elbow.
FOREARM is in the codelist, but not the

precoordinated choice of UPPER ARM.
We perform Visual Acuity testing at low contrast II SDTM-Published in P37

(method = SLOAN LETTER EYE CHART 2.5% or
method = SLOAN LETTER EYE CHART 1.25%)
and also at high contrast (method = SLOAN
LETTER EYE CHART 100%). Low contrast
methods already exist in the standard terminology
and a new value of 'SLOAN LETTER EYE
CHART 100%' is needed for the high contrast
testing.
New term reflecting a dosing of international units II Do not add (P38): BID
per kg body weigh given twice daily is a frequency and as
such belongs in the
DOSFRQ variable. So
the appropriate unit of
measure would be U/kg
which is already
published in the UNIT
codelist. (C67465).
Requesting the addition of the units NT50 and II Do not add (P38): NT50
NT60. and NT60 will be
NT50 (Neutralizing Titer 50%) is The titer at housed under
which infection was inhibited by 50%. ISTSTDTL (test detail)
NT50 (Neutralizing Titer 60%) is The titer at variable where ISTEST
which infection was inhibited by 60%. is either "Binding
Both of these units are used in vaccine trials with Microbial-induced
viral reduction neutralization assays, such as Antibody" or
PRNT (Plaque reduction neutralization test). "Neutralizing Binding
Study Vaccine-induced
AB", therefore they will
not be treated as units.
For more information on
how NEUTRALIZING
TITER 50% and 60%
are modeled in the IS
domain, please refer to
the upcoming IS
domain.
This is a method used in vaccine trials to capture II SDTM-Published in P37

viral reduction neutralization results. This method
is defined as A high-throughput image-based
fluorescent neutralization assay for the
serological detection of virus infection. It is
associated with the unit of NT60 (Neutralization
Titer 60%).
In nonclinical rodent respiratory assays, the II Do not add (P37): Do
animal is placed inside of a chamber where its not add. 'Restrained' is
movement may be restricted. Asking for a term to not a body position in
reflect this type of experiment. We are open to an that one can be
alternate definition that may be more helpful to restrained in any body
other groups (e.g. metabolism cages) that may position (standing, lying
use a similar configuration. down, etc.). This piece
of information would
need to be modeled as
a suppqual for now
however the Animal
Rule TAUG will be
introducing some new
variables around
restraints that can be
used when that is
published. If you'd like to
align with this TAUG
now, the suppqual could
be 'Restraint
Indicator/RSTIND' with
valid values of Y or N.
The ADQRS team would lie to have a codelist for II ADaM-Published in P37
ADaM PARM/PARMCD created in order to
control terminology for these variables in ADaM
QRS Supplements. Nancy Brucken and Karin
LaPann lead the ADQRS team and would like to
have a call with the QRS terminology team to
determine how best to do this. Their 1st ADQRS
supplement for the GDSSF instrument is
wrapping up public review comment resolution
and they would like the codelist in place around
the time of publication of this supplement. The
CDSSF PARM/PARMCDs would be the first use
case for this codelist, with others to follow.
L, intra + cerebrum, brain. pertaining to the area II Do not add (P36): Do

or substance within the cerebrum. not add. Please use
C12351/CEREBRUM as
the LOC.
Definition: SUBARACHNOID: between the II SDTM, SEND-Published
arachnoid and the pia mater. in P36
Definition: The part of the body of a mammal II SDTM, SEND-Published
between the thorax and the pelvis (belly). in P36
Definition: In a biological sample is the antipode II Do not add (P37): Do
of the analyte, e.g. the complementary part of a not add. The CRF
sample which has not been analyzed. provided by the
CIRCULATING TUMOR DNA is tumor-derived requester is assessing
fragmented DNA in the bloodstream. Microsatellite Instability
Note that CIRCULATING TUMOR CELL is and Tumor Mutation
already in the codelis. Burden. Any
assessments that are
using ctDNA as a
specimen type would be
modeled in PF domain
(not MI). the PF domain
uses the GENSMP
codelist for the SPEC
variable, hence the
requester has not
provided the appropriate
context for us to add
ctDNA to the SPECYPE
codelist. The
SPECTYPE codelist is
extensible so this term
can be an extensible
term for the purposes of
the Sponsor's use case.
We need this term in order to map to LOC for the II Do not add (P36); Do
Colorado Adult Joint Assessment Worksheets. not add. Please use
The term BICEPS BRACHII MUSCLE is already either 'ABDOMINAL
present in the codelist. CAVITY' C12664 or
The definition for TRICEPS BRACHII MUSCLE is 'ABDOMINAL REGION'
the large muscle on the back of the upper arm. It C139186 which is
is the muscle principally responsible for extension already published in the
of the elbow joint. LOC codelist.
We need this term in order to map to LOC for the II

Colorado Adult Joint Assessment Worksheets.
The definition for ILIOPSOAS MUSCLE is the
composite muscle formed from the psoas major
muscle, and the iliacus muscle. It acts as the
strongest flexor of the hip.
This is a mean value over time of the volume of II Do not add (P38): The
air moved into and out of the lungs during intent of the term “Tidal
breathing at rest. As opposed to 'Tidal Volume' Volume” in SENDIG 3.1
which is on the codelist, this could refer to a examples was as the
single breath. aggregate mean over
In general, the codelist should be reviewed for the evaluation interval.
terms that apply only for single breaths and terms Therefore please use
that apply over a period of time and definitions the exiting term Tidal
should be updated accordingly. Volume/TV, which is
already published in the
codelist.
Animal restrained in a tube that allows for limited II Do not add (P37): Do
movement preventing the animal to turn around. not add. 'Restrained' is
not a position, nor is the
mechanism you use to
physically restrain an
animal. The SEND
Animal Rule TAUG
(draft) contains two new
variables 'Restraint
Indicator' (Yes/No
response) and 'Restraint
Mode' (which contains
only two responses
CHEMICAL, PHYSICAL;
the codelist will be non-
extensible). The TAUG
will indicate that the
Restraint Type will go
into a device domain
(DI). So for this request
for the near future one
would need to put this
information into some
kind of supplemental
qualifier until SDTM1.8
(which will contain the
new variables in the
SENDIG AR) is
published.
During some final updates to the CRCA Concept II SDTM-Published in P37

Maps, Jon N. noticed that immunocytochemistry
was not in CT.
This is related to concept map >>
https://wiki.cdisc.org/display/TAUGCrCa/Concept
+Map.+Molecular+Work-up%3A+Overview (right
hand purple box)
Jon has used ICC for this based on IHC.
Definition of FINE NEEDLE ASPIRATION is The II Do not add (P37): This

removal of tissue specimens or fluid from the is a Collection Method,
living body with a thin needle. (Same as definition not analysis method,
in CLMETH.) hence it does not belong
Barbara email after submission of new term in the METHOD
request: The term should be FINE NEEDLE codelist.
ASPIRATION rather than FINE NEEDLE Also FINE NEEDLE
BIOPSY. ASPIRATION is the
submission value in the
Specimen Collection
Method codelist. There
is no FINE NEEDLE
BIOPSY.
Definition of VENOUS MIXED BLOOD: Blood II SDTM-Published in P37
that is composed of the venous blood from the
heart and all systemic tissues in proportion to
their venous returns, present in the main
pulmonary artery.
Please add these two values to the RACE II SDTM-Published in P36
codelist. Request from the CDASH team: Do not add (P36):
This question was discussed at the CDASHIG Already published in the
V2.1 meeting. We came to an agreement that it codelist.
would be best to update the Race codelist to be
similar to the ?Ethnic Group? codelist. In the ?
Ethnic Group? codelist, the options ?Not
Reported? and ?Unknown? are both present. Our
preference is to add both options ?Unknown? and
?Not Reported? to the Race codelist. We
reviewed the FDA guidance on Race collection
and considering that FDA is recommending the ?
minimum? choices, we could add those two
additional essential choices to accurately collect
and submit this data.
Craig-These are already in the general working

document. Please just add the request codes.
Please add these two values to the RACE II SDTM-Published in P36

codelist. Request from the CDASH team:
This question was discussed at the CDASHIG
V2.1 meeting. We came to an agreement that it
would be best to update the Race codelist to be
similar to the ?Ethnic Group? codelist. In the ?
Ethnic Group? codelist, the options ?Not
Reported? and ?Unknown? are both present. Our
preference is to add both options ?Unknown? and
?Not Reported? to the Race codelist. We
reviewed the FDA guidance on Race collection
and considering that FDA is recommending the ?
minimum? choices, we could add those two
additional essential choices to accurately collect
and submit this data.
Craig-These are already in the general working

document. Please just add the request codes.
New Term requests on for Huntington's Disease II

TAUG. Additions to DUTEST/CD and
DOTEST/CD; File emailed separately
Definition: A method used to detect binding II SDTM-Published in P38
interaction using optical biosensing technology.
This would be a term and definition to describe

methodology used in Biacore assays (which is a
proprietary company name). This methodology is
used to generate results for both anti-drug
antibodies and neutralizing anti-drug antibodies.
Please review new proposed terms for LB II Do not add (P37):

Domain; File emailed separately CD45R, CD45R - Do not
add. There is an effort
within CDISC to create a
separate domain for
immunophenotyping
type tests. Therefore we
will not control these
values at this time. The
codelist is extensible
and these can go into
the LB domain while the
new domain is still under
construction.
CD45RLY,
CD45R/Lymphocytes -
Do not add. There is an
effort within CDISC to
create a separate
domain for
immunophenotyping
will not control these
values at this time. The
and these can go into
the LB domain while the
new domain is still under
construction.
CD45RLE,
CD45R/Leukocytes - Do
not add. There is an
effort within CDISC to
create a separate
domain for
immunophenotyping
A measurement of the Symmetric II SDTM, SEND-Published
Dimethylarginine in a biological specimen. in P37
A measurement of Asymmetric Dimethylarginine II SDTM, SEND-Published

in a biological specimen. in P37
QSCAT, QSTESTCD, QSTEST for Symptoms of II QRS-Published in P35

Major Depressive Disorder Scale (SMDDS); file
emailed separately
QSCAT, QSTESTCD, QSTEST for NSCLC-SAQ II QRS-Published in P35
for the lung cancer; TAUG file emailed separately
To whom it may concern, II

I am not sure were to give this comment for the
SENDIG 3.1 and it is a minor comment, but never
the less.
One of my colleagues in Novo have this
observation TS domain for TSPARMCD=
SPREFID.
The corresponding TSPARM should, according to
the code list STSPRM, should be â€ Sponsor's
Study Reference IDâ€, but in the SENDIG 3.1 it
is stated as â€Sponsorâ€™s Reference IDâ€
(page 211).
So It should be corrected to â€œSponsor's Study
Reference IDâ€ for alignment with CDISC
terminology (or CDISC terminology should be
changed?).
FACIT-FATIGUE 13-Item V4 has Item in Title II QRS-Published in P35

case. As per other QSCAT 'xx-ITEM' terms it
should be in uppercase. Can this please be
updated?
Please add term 'UNMARRIED' that already II
exists in Marital Status codelist in HL7:
https://www.hl7.org/fhir/valueset-marital-
status.html; definition for this term is: Currently
not in a marriage contract.
A type of CT scan used to measure density of II SDTM-Published in P38
bone in the vertebrae or in the extremities
(peripheral QCT), usually the wrist.
Platelet Large Cell Ratio (PLCR) - the II SDTM, SEND-Published

percentage of platelets that exceed the normal in P37, P38
value of platelet volume of 12 fL in the total
platelet count. This is one of the platelet indices
with MPV and PDW.
Hemoglobin H Inclusion Bodies - Hemoglobin H,
consisting of beta chain tetramers, is an unstable
hemoglobin which forms precipitates just below
the red blood cell membrane. This precipitated
hemoglobin inclusion can be observed when red
blood cells are stained with Brilliant Cresyl Blue
(BCB).
For AMYLOIDA (C125940), there is a synonym of II SDTM-Published in P36
'Serum Amyloid A'. Do not add (P36): Do
Can you please add a synonym of Serum not add synonym.
Amyloid P to AMYLOIDP (C81998). Or if SAP is Amyloid P can be
not a synonym of AMYLOIDP please create as a measured in many
new term. biological specimens.
Specifying one in the
synonym column will set
a precedent that is
incorrect for the lab
model, which specifies
separating the analyte
from the specimen type.
We will however remove
the synonym from
Amyloid A, since this
has created confusion.
Participant cluster - A ?participant? is a person or II

entity with a role in healthcare or a clinical study.
"Study participant? (new term and NCI code)
refers to a member of the study population who is
either a healthy subject or one with the indication
under study or is a patient under a physician?s
care. Note: This new term is used with growing
frequency in some clinical documents and
patient-facing ones like the informed consent
form, Plain Language Summaries of study
results, and publications.
Subject or patient are terms used in regulatory
guidelines, databases, other clinical research
documents, or systems to refer to study
participants. See also human subject and patient.
Patient ? a person under physician?s care for a II

particular disease or condition.
NOTE: A subject in a clinical trial is not
necessarily a patient, but a patient in a clinical
trial is a subject. See also subject, trial subject,
healthy volunteer. Although often used
interchangeably as a synonym for subject, a
healthy volunteer is not a patient.
Revise NOTE: A subject in a clinical trial is not
necessarily a patient, but a patient in a clinical
trial is a subject. See also human subject, healthy
volunteer. Although patient is often used
interchangeably as a synonym for subject, a
healthy volunteer is not a patient.
CDISC SDTMIG3.3 Draft shows the domain 'QT' II Do not add (P36): Do
as 'ECG QT Correction Model Data' which will be not add. This domain
a 'FIndings' domain. will not be included in
the final version of
SDTMIG3.3. It is still
considered a draft
domain. If a user wants,
they can use “QT” as
the domain code for a
custom domain, but this
domain code should not
be added to the
terminology.
Study participant - a member of the study II

population who is either a healthy subject or one
with the indication under study or is a patient
under a physician?s care. Note: This new term is
used with growing frequency in some clinical
documents and patient-facing ones like the
informed consent form, Plain Language
Summaries of study results, and publications
Subject or patient are terms used in regulatory
guidelines, databases, other clinical research
documents, or systems to refer to study
participants. See also human subject and patient.
New CVTEST and CVTESTCD; File emailed II

separately
Remove SUPPBW from the codelist (C147269). II SDTM-Published in P36
BW is still in discussion as a draft domain.
Need a TSPARMCD/TSPARM that allows the II SEND-Published in P44

study activity performed by a test site to be
documented with each test site. It is not sufficient
to just have a list of test sites/locations used for a
study, it is also important to say what each is
doing on the study. This is consistent with the
study protocol document.
6 new requests for NVTEST-CD codelist for the II SDTM-Published in P36,

Huntington's TAUG. MRS example. file emailed P37
separately
These Allergen specific antibody measurement is II Do not add (P40) -
required in Asthma & atopic dermatitis studies Bermuda Grass
and difficult for mapping. (Cynodon dactylon)
IgG4 - Do not add.
Please use C130071
Timothy Grass (Phleum
pratense) IgG4 - Do not
add. Please use
C130091
Cat Dander IgG4 - Do
not add. Please use
C130127.
The FDA reviewer template must have % purity of II SEND-Published in P40

the test article entered, but that information is
nowhere in SEND. It should be a new
TSPARMCD/TSPARM so it is easily accessible
by FDA reviewers.
Rationale: We are generating laboratory test II SDTM, SEND-Published
results using this methodology; analogous to an in P38, P40
ELISA readout but using a different wet lab
technique. Please find additional information
here:
https://s3.amazonaws.com/myriadrbm/docs/Simo
a-WhitePaper.pdf).
Synonyms: single molecule array immunoassay;
Single Molecule Array (SiMoA)
Proposed definition: A technique which uses an
array of femtoliter-sized reaction chambers to
isolate and detect individual immunocomplexes of
a specified analyte on paramagnetic
microspheres.
ADaM DTYPE II ADaM-Published in P41

ASSIGNED Do not add (P40) - Do
LLOQ; File emailed separately not add. There must be
a reason in the SAP as
to why that specific
constant value is being
assigned. For example,
is it assigned to the
worst possible value?
This reason should be
what is used for DTYPE,
not "ASSIGNED".
Attached please find a request to add 2 terms to II SDTM, SEND-Published
the Unit codelist. This came about when creating in P38, P40
terminology/supplement for the Paced Tapping
QRS measure. Attached in the spreadsheet are
portions of the data dictionary for Paced Tapping
to explain the variables that these units are used
for in the measure. file emailed separately
Draft definition: An electrocardiogram lead II SDTM, SEND-Published

placement on the subject using a five electrode in P37
lead set to monitor 7 lead electrocardiograph data
(I, II, III, aVR, aVL, aVF, and V2)
Reason for suggestion: none of the existing
terms in the EGMETHOD codelist describe the
method used by our facility to collect ECG
readings on large animals. Upon consultation
with our cardiologist, the suggested term and
definition are considered to accurately reflect the
methodology routinely used on study.
An MTD is a common type of non-clinical study II SDTM-Published in P40

used to identify the dose below that which
produces significant toxicity that can include
unexpected mortality.
Draft Defintion of Vial Weight : A measurement of II Do not add (P37): Do
the weight of a dispensing vial. not add. Additional
information needed from
requester and not
received. Please re-
submit request if
information is gotten.
CDISC synonym : Many; Several II Do not add (P36): Do

CDISC definition : More than one. (NCI) not add. 'Multiple' is not
a directionality so does
not belong in this
codelist. The instance of
Multiple you cite in the
PORTOT codelist is for
a literal meaning of
multiple, not the fact that
there are multiple values
that can be put into that
data field. The use of
MULTIPLE in a dataset
to convey more than
one value is a
convention in SDTM and
as such 'Multiple' will not
be added to CT
codelists.
II Do not add (P37):
SDTMIG 3.3 allows
multiple codelists to
ABNORMAL, CDISC Defintion : Deviating in any support a single
way from the state, position, structure, condition, varaible. This is also a
behavior, or rule which is considered a norm. "result value" not TEST,
(NCI) therefore please use the
NORMAL CDISC Definition : Being Normal Abnormal
approximately average or within certain limits; Response codelis
conforming with or constituting a norm or (C101834) for the
standard or level or type or social norm. (NCI) EGSTRESC varaible.

Please use C114160
(PRECORDIAL
Term "SUSPECT LIMB ELECTRODES ELECTRODE(S)
REVERSED, INTERPRETATION ASSUMES POSITIONED
REVERSAL" C114174 exist in the SDTM INCORRECTLY) or
codelist, but electrodes can also be reversed on C114152
thorax site, or any other site. Please consider this (PRECORDIAL
value for none specific site. ELECTRODES
CDISC Definition : An electrocardiographic INTERCHANGED).
recording in which an interchange of one or more
none specific site lead electrodes is suspected,
and for which an interpretation is performed as
though the leads have in fact been interchanged.

Please use C116131
(UNDETERMINED
CDISC definition : An electrocardiographic finding RHYTHM) or C120607
in which the irregular rhythm cannot be (UNDETERMINED
determined. SUPRAVENTRICULAR
RHYTHM).

SDTMIG 3.3 allows
multiple codelists to
CDISC Synonym(s) : Not Assessable; Not support a single
Evaluable varaible. Please use the
CDISC Definition : Unable to be evaluated. Normal Abnormal
(NCI) Response codelis
(C101834) for the
EGSTRESC varaible.
II Do not add (P36): Do
epoch but rather a point
CDISC Definition : A period in a clinical study in time event or
during which information about the health status disposition event. The
of an individual is obtained after withdrawal requester could use DS
decision. Or A period in a clinical study during domain and the
which information about an individual is obtained NCOMPLT codelist for
at the time of withdrawal decision. DSDECOD making use
of either existing term:
WITHDRAWAL BY
PARENT/GUARDIAN or
WITHDRAWAL BY
SUBJECT. 'Early
Withdrawal' is
redundant, 'Withdrawal'
would suffice.
Please add this value. II SDTM-Published in P36

Explanation : FOLLOW-UP definition is "A period Do not add (P36): Do
in a clinical study during which information about not add. Please use the
the health status of an individual is obtained after existing term FOLLOW-
study procedures and treatments have UP. We will update the
concluded." This term cannot be used since definition to clarify that
during END OF STUDY or STUDY EXIT period the phrase 'study
safety procedures (Vital Signs, ECG, Lab ...) are procedures and
performed to collect health status of the subject. treatments' was meant
Sponsors used this terminology in their clinical to convey only
trial protocol. interventional
CDISC Definition : A period in a clinical study procedures/treatments,
during which study procedures are performed to not additional study
collect health status of an individual after activities like vital signs
treatments have concluded. measurements, etc.

Explanation : When SUPPCM is used to present not add. This is not an
additional data (e.g other ATC code level) QEVAL appropriate use of the
variable should be populated (since CDISC EVAL variable; an
definition for QEVAL: Used only for results that evaluator is someone
are subjective (e.g., assigned by a person or a who is interpreting the
group). data that is collected
CDISC Definition : A person who is employed by while an encoder is
a study sponsor or by a contract research trying to find a match of
organization (CRO), responsible for the medical what was collected to a
coding data within a particular trial or institution term that exists in a
dictionary or a
standardized term. We
do not think this is the
same. The codelist is
extensible but CDISC
CT will not
publish/control this term
at this time.
CDISC Definition : Beginning hour of sleep (NCI). II SDTM, SEND-Published
CDISC synonyms : At Bedtime;Bedtime;Hour Of in P38
Sleep Do not add (P36): Do
not add. This is not a
frequency; a frequency
would be QHS.

CDISC Defintion : Scheduled or occurring at a not add. This has been
frequency of two or three times per week (NCI). previously denied (see
CDISC Synonym : Two to Three Times Weekly; CDISC-1393).The list is
Two to Three Times a Week extensible. Users should
add new terms using the
convention of existing
terms but the possible
combinations are
endless.

not add. This has been
previously denied (see
CDISC Definition : Scheduled or occurring at a CDISC-1393).The list is
frequency of three or four times per week. extensible. Users should
CDISC synonym : Three to Four Times Weekly; add new terms using the
Three to Four Times a Week convention of existing
terms but the possible
combinations are
endless.
II SDTM, SEND-Published
in P36
For the same reason it was decided to add

"TWICE" value.
CDISC Definition : Three times.
in P38
For the same reason it was decided to add

"QAM" (Every morning) value.
CDISC Definition : Every bedtime.
CDISC Synonym : Every bedtime.
in P38
Explanation : For Tuberculosis or Hepatits C,

medication can be given once a week, for 12
weeks. In this case, we could used the value
ONCE PER 12 WEEKS.
CDISC Definition : Scheduled or occurring at a
frequency of once per twelve week.
CDISC Synonym : Once per Twelve Weeks
in P38
Explanation : Medication can be given once for 3

or 5 years. In this case, when medication is
indicated as ongoing, we could used the value
ONCE PER 3 YEARS or ONCE PER 5 YEARS
CDISC Definition : Scheduled or occurring at a
frequency of once per three year or Scheduled or
occurring at a frequency of once per five year.
DISC Synonym : Once per Three Years or Once
per Five Years
II
Please add this term considering medication form

can be an AMPULE.
CDISC Definition : A container capable of being
hermetically sealed, intended to hold sterile
materials. (NCI)
in P37
Explanation : CAPSULE, EXTENDED RELEASE

CDISC definition is "A solid dosage form in which
the drug is enclosed within either a hard or soft
soluble container made from a suitable form of
gelatin, and which releases a drug (or drugs) in
such a manner to allow a reduction in dosing
frequency as compared to that drug (or drugs)
presented as a conventional dosage form. (NCI)".
When for a study, the objective is to compare the
rate and extent of absorption of formulations of
extended-release capsules (extended-release
soft-gel capsules and extended-release hard
capsules), we need to get the precision.
CDSIC Definition : A solid dosage form in which
the drug is enclosed within an hard soluble
container made from a suitable form of gelatin,
and which releases a drug (or drugs) in such a
manner to allow a reduction in dosing frequency
as compared to that drug (or drugs) presented as
a conventional dosage form. (NCI)
in P37
Explanation : CAPSULE, EXTENDED RELEASE

CDISC definition is "A solid dosage form in which
the drug is enclosed within either a hard or soft
soluble container made from a suitable form of
gelatin, and which releases a drug (or drugs) in
such a manner to allow a reduction in dosing
frequency as compared to that drug (or drugs)
presented as a conventional dosage form. (NCI)".
When for a study, the objective is to compare the
rate and extent of absorption of formulations of
extended-release capsules (extended-release
soft-gel capsules and extended-release hard
capsules), we need to get the precision.
CDISC Definition : A solid dosage form in which
the drug is enclosed within a soft soluble
container made from a suitable form of gelatin,
and which releases a drug (or drugs) in such a
manner to allow a reduction in dosing frequency
as compared to that drug (or drugs) presented as
a conventional dosage form.

not add. Please use
CAPSULE as the
CAPSULE, LIQUID FILLED is present in the dosage form. We
codelist so please consider this value. believe 'Neat Filled' is
out of scope for this
codelist because it is not
a state of matter but
rather is describing
treatment itself.
in P37
Please consider this value.

CDISC Definition : Not known, not observed, not
recorded, or refused. (NCI)
CDISC Synonym : U; Unknown;UNK
in P36
HARD PALATE and SOFT PALATE are included

in Terminology. But in case where we do not
have more information about HARD and SOFT,
"PALATE" value should be considered.
CDISC Definition : The roof of the oral cavity. It
separates the oral cavity from the nasal cavity.
(NCI)
Please consider this value for Muskuloskeletal

Domain.
CDISC Definition : Degree of intensity or force in
regard to a physical activity. (NCI)
II
Please consider this value for Pain Intensity VAS

100 mm Form.
Do not add (P38):
Please use
Please consider this value for visual check. For 'OBSERVATION'
example, a visual check could be performed at (C25598) which is
study drug application (TONGUE, FLOOR OF already published. We
MOUTH ?) to check mucosal irritation. will add 'Visual
Inspection as a
synonym.

Request closed out by
requester. This is
Please consider this value. covered in existing
EGMETHOD values.
II Do not add (P38): The
published lab test that
goes with this is
Please consider this value since we can receive 'Platelets, Estimated'
Visual estimate Platelet result. (C135440). Since the
'estimated' is part of the
test, it is not necessary
for the Method value.
The team instead would
suggest the use of
existing methods like
LIGHT MICROSCOPY,
MANUAL COUNT, etc.
in P36


CDISC Definition : A specimen that has become
milky.

CDISC Definition : A specimen that has not
undergone the destruction of red blood cells
followed by the release of the hemoglobin.

CDSIC Definition : A specimen that has change
from a frozen to a liquid or semiliquid state

not add. Please use
existing concept of
Please consider this value. C150895/SWABBED
CDSIC Definition : A method used to collect MATERIAL. Use LOC to
biological material from within the nasal indicate the nasal cavity
passages. A cotton swab is inserted into the as the location of the
nasal opening and rotated against the anterior biospecimen.
nasal mucosa and them withdrawn.
in P36
Please consider this value
in P38

CDISC Synonym : United States Pharmacopeia
II SDTM, Protocol-
Published in P37, P38
ADHESION PERFORMANCE
ALCOHOL EFFECT
BIO-SIMILARITY
DEVICE-DRUG INTERACTION
DOSE FINDING
DOSE PROPORTIONALITY
DRUG-DRUG INTERACTION
POSITION EFFECT
SWALLOWING FUNCTION
THOROUGH QT
not add. The proposed
term is generic enough
Please consider this value. that it is unclear who is
unblinded and who is
blinded. We also think
this could change from
study to study, which
makes creating a term
and definition very
II difficult.SEND-Published
SDTM, Based on the
existing
in P37 definition of
SINGLE BLIND in the
Buccal cavity was retired from NCI thesaurus. So codelist, we believe that
please add "Buccal;Buccal cavity" as synonym for this use case fits the use
ORAL CAVITY. of SINGLE BLIND and
CDISC Synonym : Mouth;Buccal;Buccal cavity we would recommend
that term be used
instead. Alternatively
II you could submit this
term as an extensible
term, however you
CDSIC Definition is A specimen that has become would probably still need
coagulated. (NCI) so please add "Coagulated" as to explain in the Data
CDSIC Synonym. Reviewers Guide who
exactly is blinded and
II unblinded.
in P38

CDSIC Definition : Anisochromia is a marked
variation in the chromaticity, the color density of
erythrocytes (red blood cells), which is particularly
relevant to the description of certain blood
diseases, such as the megaloblastic anemias
in P37
PLease consider this value.

CDSIC Definition : A measurement of the
complement C5b9 in a biological specimen.
II Do not add (P38): If you
are measuring
erythrocytes in a
Please consider this value chicken, then the lab
CDISC Definition : Cells derived from the chicken test would be
used as a biological model for research 'Erythrocytes/RBC'
CDSIC Synonym : Chicken Red Blood Cells (C51946) which is
already published. If
Chicken Erythrocytes
are the test system or as
a control, then LBTEST
is not the appropriate
variable to put that
information. If you are
injecting a subject with
chicken erythrocytes to
test the immune
response, the TEST
value would be an
antibody measurement.
in P38

Definition : A measurement of the cytochrome
P450 2C9 in a biological specimen.
in P37

Definition : A measurement of the drepanocytes
in P38
Please consider this value included in NCI

thesaurus.
Definition : Any bacterial organism that can be
assigned to the species Enterococcus faecalis.
(NCI)
Synonym : Streptococcus faecalis
in P38

Definition : A measurement of the free
complement C5b in a biological specimen.
in P37

Definition : A measurement of the large
in P37

Definition : A measurement of the plasmocytes in
in P37

thesaurus.
in P38

in P38

thesaurus.
in P38
PLease consider this value

Definition : A measurement of the total
complement C5 in a biological specimen.

Please consider this value supplemental qualifier
Definition : The area under the curve (AUC) at for now, where PPTEST
steady state for the defined interval between = AUC Over Dosing
doses (TAU). Interval. The PK CT
team is working on
creating a new PP
domain standard
variable to house values
such as: Single Dose,
Multiple Dose, and
Steady State; this
variable will qualify
under development,
Please consider this value supplemental qualifier
Defintion : AUCTAU divided by TAU at steady for now, where PPTEST
state. = Average
Concentration. The PK
CT team is working on
creating a new PP
domain standard
variable to house values
such as: Single Dose,
Multiple Dose, and
Steady State; this
variable will qualify
under development,
II

Definition : The volume of distribution at steady
state based on the observed CLST for a
substance administered by intravascular dosing
divided by absolute bioavaibility.
Please consider this value II Do not add (P37): Do

Definition : The cycle day corresponding to first not add. This is not a
dosing body system
physiology/morphology
test; this information
could be appropriate for
any general observation
class. This is more like a
timing variable, in this
requester's case a
qualifier on a dosing
event. We suggest that
'cycle day' should be
treated as a non-
standard variable in an
exposure domain. The
first record
chronologically could be
looked up.
Please consider this value II SDTM-Published in P37

Definition : A measurement of the total number of
deliveries events experienced by a female.
Please consider this value II SDTM-Published in P37
Definition : The estimated first day of the next
menstrual cycle.
Please consider this value. II Do not add (P37): Do
Definition : The length of time of the menses not add. This is already
cycle, measured from the beginning of one published in the codelist
menstrual period to the end of this. as
MENSDUR/Menstrual
Cycle Duration
(C119549)
Please add this NCI value for CDISC. II Do not add (P39):
Please put the Gene
name into PFGENRI
and then pick an
appropriate PFTEST
Please add this NCI value for CDISC. II Do not add (P39):
Please put the Gene
name into PFGENRI
and then pick an
appropriate PFTEST
For WHOLE BODY AND LUMBAR SPINE DXA II SDTM-Published in P37

ASSESSMENT, Fat Mass and Lean Mass
measurements are done.
These measurements are performed on specific
body parts as Left Arm, Right Arm, Left Leg,
Right Leg, Lumbar Spine....
So we need the addition of these terms.
I would like to warn you that in the Vital Sign
codelist, the following terms exist : BODYFATM
(Body Fat Measurement)/LBM (Lean Body Mass)
but it concerns the whole body and not a part of
the body.
Please consider the addition of this term, usually II Do not add (P37):
mentionned in protocol by F Already Published. Do
not add. Please use
C154838.
II Do not add (P38): This
is a PD parameter, not
PK. CDISC PP/PC
Please consider the addition of this term domains are PK-centric,
and therefore should not
be used for PD analysis
data. Please consider
creating
custom/sponsor-defined
domain for PD data.
in P38
Natural Log of AUC Infinity Obs,

Natural Log of AUC to Last Nonzero Conc,
Natural Log of Max Conc
in P38
Please consider the addition of this term

is a PD parameter, not
PK. CDISC PP/PC
Please consider the addition of this term domains are PK-centric,
and therefore should not
be used for PD analysis
data. Please consider
creating
custom/sponsor-defined
domain for PD data.

not add. Additional
information needed from
Please consider this value requester and not
received. Please re-
submit request if
information is gotten.

File emailed separately; please don't add this II SDTM, SEND-Published
content to team working documents. This is just in P35
for P35 terms that have already gone through
public review but don't yet have new term request
numbers.
Just need request numbers.
Five novel values for TSPARM with companion

values for TSVAL (or examples) are being
submitted with this request. This table was also
provided to Erin by email and is available to
submit outside of this online form. Just let me
know if you want it
II
new audit process and abbreviation should be in

the Glossary
Source is at this link
https://www.fda.gov/downloads/medicaldevices/in
ternationalprograms/mdsappilot/ucm390382.pdf
It was removed because the information given to

the team at the time was that it would be removed
from SDTMIG 3.3. This has changed so we will
need to reinstate the domain.
The Multiple Inert Gas Elimination Technique is

mainly used in pulmonology measuring the
concentrations of various inert gases in mixed
venous blood, arterial blood and expired gas of
the subject. The technique quantifies true shunt
physiological dead space ventilation, ventilation
versus blood flow(VA/Q) ratio, and diffusion
limitation.
Rationale: No term exists (that I could find) for II SDTM, SEND-Published
this particular system. Individual terms exist for in P36
the BILIARY TRACT (whose definition specifies
the duct system), GALLBLADDER, LIVER, and
PANCREAS as well as for the
GASTROINTESTINAL SYSTEM in general. This
system of organs is specified as a potential
infection site in a transplant study.
Proposed definition: The system that includes
the gallbladder, biliary tract, pancreas, and liver
that contribute to digestive functions.
in P36
Rationale: Terms exist for both the URINARY

SYSTEM and the MALE/FEMALE
REPRODUCTIVE SYSTEMs, but no term exists
for the more general genitourinary system.
Genitourinary system is a commonly understood
term and is being used to indicate a general site
of infection.
Proposed definition: The system composed of
organs of both the urinary system and male or
female reproductive systems.

not add. The SDS team
has chosen to point to
Null Flavor Reason Terminology could be used the ISO standard
as CDISC SDTM.Terminology instead of separate instead of re-publishing
terminology. the values in SDTM
terminology.
in P38
LBTESTCD: CXCL11, LBTEST: Chemokine (C-

X-C Motif) Ligand 11
Synonyms: ITAC, I-TAC, IFN-inducible T cell
alpha chemoattractant
Definition: A measurement of the CXCL10,
chemokine (C-X-C motif) ligand 11, in a biological
specimen.
in P38
chemokine (C-X3-C motif) ligand 1

Macrophage Inflammatory Protein-3
file emailed separately.
II SDTM-Published in P37,
P38
According to the NCI Thesaurus, for the term

"Extended Release Tablet Dosage Form (Code
C42927)", "Prolonged-release tablet" is indicated
as Synonym. So, please add the term under
CDISC Synonym(s).
in P36
There are two separate concepts in NCIt:

Thyroperoxidase Antibody Measurement C96638
Thyroid Antimicrosomal Antibody Measurement
C81991
From a caDSR colleague: Doing a general
search, using Google, and found that the majority
of the returns, including one from Mayo Clinic and
Arup, that lists these synonyms:
Thyroid Peroxidase Antibody
Thyroperoxidase Antibody, Serum
TPO (Thyroperoxidase) Antibodies
Thyroid Microsomal Antibodies
Antithyroid Antibodies
I also searched BTRIS RED and found Anti-
Thyroid Peroxidase (TPO) Autoantibody Serum
Test, which looks like a good match (by name) for
the LOINC test name, Thyroperoxidase Ab
[Units/volume] in Serum or Plasma, LOINC Code
8099-4, which matches C96638.
EVAL codelist contains
'roles' for people
Site medical personnel who have completed the associated with the trial,
respective GRAPPA (Group for Research and whereas this request is
Assessment of Psoriasis and Psoriatic Arthritis) a qualification that a
training person with a role in the
trial may have. This type
of operational data may
be better suited for other
trial documents (such as
protocol, site
documentation, etc.)
and does not seems
appropriate to add to a
dataset. If the requester
feels that it is important
to put this in the dataset,
we suggest to use a
suppqual for EVAL to
specify the GRAPPA, or
any other, certification.
Term: ECL II SDTM, SEND-Published

Synonym: Electrochemiluminescence Unit in P38
Definition: Arbitrary unit(s) of
electrochemiluminescence.
Rationale: Used for
ELECTROCHEMILUMINESCENCE
IMMUNOASSAY results; AFU (Arbitrary
Fluorescence Unit) does not accurately describe
the results of this assay as luminescence is
generated electrochemically and not by
absorption-re-emission of EM radiation as in
fluorescence.
file emailed separately II SDTM-Published in P40
Clinical studies done in New Zealand identify this II SDTM-Published in P37

population
Term: genEq/mL II SDTM, SEND-Published
Synonym: Genomic equivalents per milliliter in P38
Definition: A unit of concentration quantifying the
number of whole organism genomes per milliliter
of a sample derived by comparing the number of
organism-specific DNA copies to an organism-
specific genomic reference.
Rationale: Units of genomic equivalents per mL
are being reported for qtPCR data of bacterial
shedding in a BCG study; no similar unit exists in
CT.
Term: genEq II SDTM, SEND-Published

Synonym: Genomic equivalents in P38
Definition: A unit of measure quantifying the
number of whole organism genomes in a sample
derived by comparing the number of organism-
specific DNA copies to an organism-specific
genomic reference.
Rationale: qtPCR data of bacterial shedding are
being reported using these units in a BCG study.
Unit also exists in the literature, but I've found no
good equivalent in CT.
in P37
This is a unit of measure in the Huntington's

TAUG MRS example in the du.xpt dataset:
https://wiki.cdisc.org/display/TAHUNT/MRS+Hunti
ngton%27s+Example+1
C7157/Posterior Pituitary Gland Neoplasm/NCI

Def: A low-grade neoplasm that arises from the
neurohypophysis. It includes the granular cell
tumor of the neurohypophysis and pituicytoma.
to
C94524/Pituicytoma/NCI Def: An extremely rare,
WHO grade I, circumscribed and slow-growing
tumor that arises from the neurohypophysis or
infundibulum and described in adults. It is
characterized by the presence of elongated,
spindle-shaped neoplastic glial cells that form
storiform patterns or interlacing fascicular
arrangements. Signs and symptoms include
visual disturbances, headache, amenorrhea, and
decreased libido.
in P38
A unit of electric current that is one thousandth of

an ampere.
in P41
The highest voltage occurring during an electrical

cycle.
Term: CONDUCTION DISTURBANCE, II Do not add (P37): This

UNSPECIFIED seems more of a
Definition: An electrocardiographic finding of an sponsor-specific
atrioventricular or intraventricular-intraatrial endpoint/outcome, it is
conduction disturbance where the specific not considered as a
disturbance(s) is not specified. standard terminology by
Rationale: When used for screening or general the ECG CT Team. The
safety purposes, ECG data collection forms may EGSTESC codelist is
not require a specific finding (e.g., 2ND DEGREE extensible, please feel
AV BLOCK) be specified, but may instead ask a free to add this term for
yes/no question of "Conduction disturbance your need, but the ECG
(complete left or complete right bundle branch CT team will not create
block or nonspecific intraventricular conduction controlled terminology
disturbance or second- or third-degree for this concept.
atrioventricular block or... )" In these cases a
specific finding fitting the AVCOND or IVTIACD
test codes is not currently available.
Please refer to Wikipedia II SDTM-Published in P38.

(https://en.wikipedia.org/wiki/Per_mille) Please use C69112
ppth, which is already
published. We will add
your request terms as
synonyms to this
existing term.
Text "Functional Assessment of Cancer" in Test II QRS-Published in P36.

Code codelist name is duplicated and does not
match corresponding text in Test Name codelist.
II SDTM-Published in P38.
Synonyms: rRT-PCR
Definition: A modified reverse transcriptase

polymerase chain reaction (PCR) technique to
recreate and amplify complementary DNA (cDNA)
from total RNA or messenger RNA (mRNA) and
quantified as the PCR reaction progresses,
through the use of fluorescent DNA probes in the
reaction mixture.
Rationale: This term does not fit existing

definitions for qRT-PCR, qPCR, or RT-PCR. This
technique is being used in a flu study.

Please use Published
term ANGIECTASIS
draft definition : = plexiform vasculopathy (C132484) with modifier
corresponds with an increased size and number 'vasovasorum'.
of vasa vasorum around/close to blood vessel
(vein or artery)
II SDTM - Published with

P39
we from CMBI are working on a project called

Periscope, where we want to convert immunology
lab data to the CDISC SDTM format.
For the first format we're trying to convert, we
have a series of Multiplex Immunoassay (MIA)
values measured per antibody per patient.
Unfortunately, the current SDTM terminology
does not seem to include the series of antibodies
that were used in these measurements. That's
why we decided to suggest additional terminology
to be added to the format.
P39


P39


P39

P39


P39

Need too change the Category of Clinical II QRS-Published in P36.

Classification submission value CDRS-R
Synonym from CDRS01 ro CDRS1 in order to
accommodate the 8 character QSTESTCDs in
the instrument. The codelistes of CDRS01TC and
CDRS01TN need to be revised to CDRS1TC
and CDRS1TN also to be consistent. All of the
QSTESTCDs are correct
To be used with OETEST: Interpretation II SDTM-Published in P37
An act or process of elucidation; explication, or

explanation of the meaning of the event or thing
via the assignment of objects from the domain to
the constants of a formal language, truth-values
to the proposition symbols, truth-functions to the
connectives, other functions to the function
symbols, and extensions to the predicates, if any.
The assignments are result of human logic
application and are not native to the symbols of
the formal language.
To be used with OETESTCD: INTP II SDTM-Published in P37
An act or process of elucidation; explication, or

explanation of the meaning of the event or thing
via the assignment of objects from the domain to
the constants of a formal language, truth-values
to the proposition symbols, truth-functions to the
connectives, other functions to the function
symbols, and extensions to the predicates, if any.
The assignments are result of human logic
application and are not native to the symbols of
the formal language.
FXFINDRS (Supernumerary Rib, Cervical Rib, II SEND-Published in P37

Lumbar Rib, Thoracic Rib). Do not add (P37):
LOC (Placental, Caudal Vertebra) THORACIC RIB - Do
See Additional Information not add. Not am
File emailed separately. abnormal finding in and
of itself.
New term needed; already exists in NCI II SDTM, SEND-Published

Thesaurus with definition: 'A triangular space on in P37
the anterior side of the elbow joint. Three main
veins of the arm, the brachial artery, the medial
nerve and the tendon of the biceps pass through
this space.' and synonyms: Cubital Fossa, Elbow
Pit. Thank you!
Please create new term; exists in NCI Thesaurus II SDTM, SEND-Published

with definition: 'A vein between the biceps and in P37
pronator radii teres muscles that unites with the
common ulnar vein to form the basilic vein within
the forearm.' Also, please add synonym: Median
Cubital Vein. Thank you!
Multiple term request to add NONNEO terms II SEND-Published in P37,
based on INHAND mapping across all published P38, P39
OWG publications. Contains both new terms and Do not add (P37):
3 proposed changes to existing. SEPTAL
File emailed separately. Terms already in SEND PERFORATION - Do
working document. Just need to add the request not add. Please use
code. PERFORATION.
Do not add (P38):
KERATINIZATION,
INCREASED - Please
use existing term
HYPERKERATOSIS.
CRYPTORCHIDISM -
This is a Gross
diagnosis and as such is
not subject to being
included in this codelist.
MESENCHYMAL
PROLIFERATIVE
LESION - Being added
with P37
not add. Use existing
term 'CELLULARITY,
DECREASED' with
Neuron or neuronal as a
modifier.
Based on the Public Review for the HIV TAUG II SDTM-Published in P37
we have been asked by FDA to replace the terms
?HETEROSEXUAL CONTACT? and ?
HOMOSEXUAL CONTACT?, with ?OPPOSITE-
SEX SEXUAL CONTACT? and ?SAME-SEX
SEXUAL CONTACT?.
This is a type 1 request and will need to be II SDTM-Published in P36

published ASAP. This will go into P36.
File emailed separately II SDTM-Published in P37,

P38
Do not add (P37):
VAGINAL FLUID -
Please use SPEC =
C13236/FLUID and LOC
= VAGINA/C12407
Do not add (P38):
IMMUNODIFFUSION -
Being published with
P37. No need to add.
Reference = II SDTM - Published with
http://theoncologist.alphamedpress.org/content/1 P39
2/12/1379.full
Use - Oncology study needs to bring in external
vendor data which needs to differentiate between
the use of a PET SCAN and an IMMUNO-PET
SCAN.
Normalized Fluorescence Intensity Unit; II SDTM, SEND -

Normalized Intensity Unit; Relative Fluorescence Published with P39
Intensity Unit; Relative Intensity Unit. As per P35
it was split into 2 - keeping NIU and creating a
new RFU.
RFU has the following synonyms: Relative
Fluorescence Intensity Unit; Relative
Fluorescence Unit. RIU was removed. Can you
please confirm that Relative Intensity Unit would
also be another synonym? If so can I please ask
you to add it back in as I have a unit of RIU which
I'd like to map to RFU if appropriate.
The other 3 'selectin' LBTEST codes have II SDTM-Published in P37

Selectin with an uppercase S i.e. P-Selectin,
Soluble P-Selectin, Soluble E-Selectin. Should E-
selectin be changed to follow this convention?
Multiple term request containing all P36 II SDTM, SEND, QRS,

terminology that needs c-codes. No need to add CDASH, ADaM-
to any working documents. Just need to get a Published in P36
request code for these: 47 changes and 93 new
terms. File Emailed Separately
in the same way that DOSFRQ has been added, II SDTM-Published in P37
it would be good to add DOSRGM
This term is used in all data-related CDISC II Glossary-Published with
standards, yet we don't seem to have defined it P40
anywhere.
Multiple term request for LOINC mapping clean II SDTM, SEND-Published
up v2: 9 new terms and 4 changes to existing, file in P37, P38
emailed separately Do not add (P38): Lupus
Anticoagulant - Please
use existing term
'DRVVT' (C96696) with
'Interpretation in
TSTDTL.
The row has already been added to the general II SDTM-Published in P38
team working document. Just needs a request Do not add (P38): Being
code. published with P37.
Please refer to the "CDISC White Paper: FDA II SDTM-Published in P37,

Race & Ethnicity Guidance", section 3.1.1.2 P38
(example 2) for details. Do not add (P37):
https://wiki.cdisc.org/x/VAfbAw Undistinguished - Do not
add. Not officially
The Race/Ethn sub-team requests to add: HAN recognized by chinese
CHINESE and the 55 ethnic minority terms listed government.
in the following WIKI page: Naturalized Citizen - Do
https://en.wikipedia.org/wiki/List_of_ethnic_group not add. Not officially
s_in_China_and_Taiwan recognized by chinese
government.
If this request is denied, please inform the
Race/Ethn ASAP and why.
II SDTM-Published in P37,
P38
For RETEST(CD) pairs C111359 and C123565

(FEV1FVC and FEV1FVC6 respectively) please
update the definition to remove the initial wording
'The ratio' and replace with 'A relative
measurement (ratio or percentage) of the..........'
We are measuring this relative test in percent.
For each domain the CT teams should add the -- II Question answered
TEST and --TESTCD for the "not done" mapping (P38): Do not change.
that goes on aCRF. So many different sponsors - This is a published
so many different versions: The format suggested convention in SDTMIG.
in the IG seems to be lost in the process (also We think it more prudent
P21 errors) for both components. The --TEST that Pinnacle 21 update
seems to be done incorrectly 1/2 the time (the -- their software.
TESTCD XXALL is very consistent). Just this
week I saw LBTEST= "LB", "Labs", "LAB TEST",
and "Lab Test" and the actual correct version (in
my opinion) would have been "Laboratory Test
Results" to match the domain name in the CT and
this was rejected by the internal team because it
is not in the CT as such and the Sponsor had
"LBTEST=LB, LBTESTCD=LBALL" in the
Metadata. Adding these will not only cut back on
a misinterpretation of a fairly common concept,
but it will also cut down on the P21 errors we all
get for these not done records and the
explanations in the SDRG across the industry.
See IG 3.2 Page 51:
If a group of tests were not done:

? --TESTCD should be --ALL
? --TEST should be <Name of the Module>
? --CAT should be <Name of Group of Tests>
? --ORRES should be null
? --STAT should be ?NOT DONE?
? --REASND, if collected, might be ?Specimen
lost?
For example, if urinalysis is not done then:
? LBTESTCD should be ?LBALL?
? LBTEST should be ?Labs Data?
? LBCAT should be "URINALYSIS"
? LBORRES should be NULL
? LBSTAT should be ?NOT DONE?
? LBREASND, if collected, might be ?Subject
This request is associated with CT-410, II SDTM, SEND-Published
in P37, P38
A new term (DSDECOD) to describe the protocol II SDTM-Published in P38
milestone of entering the main part of the study.
The subject was screened, passed/completed
screening, and put into the study (not screened,
passed/completed screening, and waiting to see
if subject needed and never put into the study).
These subject may or may not be randomized.
Note: this could be a NCOMPLT codelist if you
consider disposition event rather than protocol
milestone.
We are struggling to find the right words/term. In

a study, we want to describe/identify subjects that
completed/passing screening and went into the
main study. We have considered the word ?
ENROLLED? but everyone who is screened is
enrolled per the CDISC glossary. We are looking
to describe those subjects who went into the
study. C150884=MET ELIGIBILITY CRITERIA
BUT NOT NEEDED is used for those that
completed/passed screening but didn?t go into
the main part of the study. When a study is
designed, there is a target sample size which is
for the number of subjects who completed/passed
screening and went into the main study to be
analyzed. For analysis purposes, we need to use
this population for certain summaries for
disclosure purposes. Here is an example for
some text that we use to define this population for
the analysis.
The Enrolled population (used for some tables

required by EudraCT) comprises participants who
passed screening and entered the study.
Included are:
? Run-in Failures
? Randomized Participants in a randomized
Per QRS team request, please deprecate Tanner II
Scale terminology from CC/RS and move to
RPTEST-CD. Please see attached file for details.
II Do not add (P39): LPS

is the stimulating agent
and is a part of the
2 new terms required to differentiate between method, hence should
interleukin 6 treated with lipopolysaccharide not be pre-coordinated
(LPS) and interleukin 6 untreated with LPS. into the LBTEST
submission value. You
These are 2 distinct measurements with 2 may put this information
different results. into a lab supplemental
qualifier for now.
Solid dispersions, defined as the dispersion of II SDTM, SEND-Published
one or more active pharmaceutical ingredient in a in P38
carrier at solid state and an efficient technique to
improve dissolution of poorly water-soluble drugs
to enhance their bioavailability.
Use the links for further information to support

addition of this term:
http://ijpsr.com/bft-article/solid-dispersions-a-
review-on-drug-delivery-system-and-solubility-
enhancement/?view=fulltext
https://www.sciencedirect.com/science/article/
pii/S2211383513000968
add ESS0109 to ESS01TC corresponding to II QRS-Published in P37

ESS0109-Total Score in ESS01TN to capture the
total score from the Epworth Sleepiness Scale
Requested to add ESS0109 to ESS01TC

corresponding to ESS0109-Total Score in
ESS01TN to capture the total score from the
Epworth Sleepiness Scale, which is not on the
questionnaire directly, but the website :
http://epworthsleepinessscale.com/about-the-ess/
goes into detail explaining the total score.
Therefore, it is requested to be added.
Discussed with the QRS CT team on 15Nov2018
and it was agreed to be added to the supplement.
Submitted twice as still haven't received
confirmation from NCI that they received it.
Term: DROPLET DIGITAL PCR; Synonyms: II SDTM-Published in P40
Digital Droplet PCR; ddPCR; Definition: Droplet
Digital PCR (ddPCR) is a method for performing
digital PCR that is based on water-oil emulsion
droplet technology. A sample is fractionated into
multiple droplets, and PCR amplification of the
template molecules occurs in each individual
droplet. Counting positive droplets represents a
precise/ absolute quantification of target. ddPCR
technology uses reagents and workflows similar
to those used for most standard TaqMan probe-
based assays. The massive sample partitioning is
a key aspect of the ddPCR technique.
Merck / EMD Serono uses this assay

methodology and it is not currently represented in
SDTM CT (i.e., current P35 controlled terms were
reviewed and did not feel applicable/appropriate).
Please add new animal rule CT. File emailed

seperately.
II Do not add (P38): In
the medical literature,
Holocephalic is used as
Pertaining the complete brain. an adjective to describe
a migraine and a fetus
(it is also a genus of
fish). It is not however
used to as an adjective
to describe a body part,
which is what the DIR
codelist is meant to do.
You could use a LOC of
BRAIN with a PORTOT
value of ENTIRE.
in P37, P38
Pertaining the front side of the brain.

in P38
Pertaining the back of one's head.

in P38
Pertaining to ones part of the face.
in P37
The distal end of the anal canal, forming a

transitional zone between the epithelium of the
anal canal and the perianal skin.

ADaM Leadership team
believes this is not
Result at or above Limit of Quantification: An common enough to
imputation technique populating AVAL for LAB need CDISC CT. The
values with Upper Limit of Quantification + 1 codelist is extensible
and so this value could
be used as an
extensible, sponsor-
defined term.
II ADaM-Published in P41
Upper limit of quantification: Result at/above Limit

of Quantification: An imputation technique
populating AVAL with Upper Limit of
Quantification
II Do not add (P41): If --

STRESN is missing, no
DTYPE is needed. If
Missing for result below limit of quantification: creating a record to hold
Result at/below Limit of Quantification: An missing data, use new
imputation technique setting AVAL to missing term PHANTOM
instead.
II ADaM-Published in P41
Lower limit of quantification*0.5

Result at/below Limit of Quantification: An
imputation technique populating AVAL with
0.5*Lower Limit of Quantification
Limit of quantification based on T1/2 common enough to
Result at/below Limit of Quantification: An need CDISC CT. The
imputation technique populating AVAL using the codelist is extensible
expected exponential decline based on the and so this value could
subject-specific t_half of the parameter. be used as an
defined term.

Please use new terms
LLOQ and ULOQ.
Limit of Quantification
Result at/below Limit of Quantification: An
imputation technique populating AVAL with the
value of LOQ.

ADaM Leadership Team
believes that much of
Limit of quantifaction result set to zero the time another DTYPE
Result at/below LOQ: AVAL set to zero for would be more
results at/below Limit of Quantification appropriate. Many other
derivation methods
could result in a value of
0 (zero) on a given
record. A standard
DTYPE of ZERO could
introduce confusion and
inconsistency among
implementers. In cases
where another DTYPE
is not appropriate, the
user can extend the CT.

Generalised lower limit of quantification common enough to
AVAL imputed to generalised limit of need CDISC CT. The
quantification taking a hard floor for the analytical codelist is extensible
method into consideration: AVAL = (LLOQ + and so this value could
HARD FLOOR)/2 be used as an
defined term.
At the SDS meeting today, there was a

discussion about clarifying the definition of
RFPENDTC in light of feedback from a query to
the FDA about what ?end of participation? means
for a subject that died. Their feedback was that
for a subject who died, participation ends at
death, even if data was collected after death
(e.g., that a subject died was discovered at a
follow-up call, in which case the date of collection
(the date of the call) is after the date of death).
Elina pointed out that the definition of the trial
summary parameter ?Study End Date? is ?Final
date on which data was collected for any subject
(Date/Time of End of Participation, RFPENDTC)
based on the protocol.? This ties the parameter
to RFPENDTC but also to the end of data
collection, so there?s a possible conflict.
II SDTM, SEND -
Published with P39
Published term MFI (2018-09-28, C96687,

C71620) appears to combine three different units:
mean fluorescence intensity, geometric mean
fluorescence intensity, and median fluorescence
intensity. Suggest updating current term MFI to
represent mean fluorescence intensity and add
new terms for geometic mean fluorescence
intensity and median fluorescence intensity. File
emailed separately.
Please add new terms to multiple codelists; File II SDTM, SEND-Published

emailed separately. in P38, P39, P40, P41,
P47
Do not add (P39):
NORMALIZED EVENT-
Request removed by
requester.
SONICATION LINKER
MEDICATED
POLYMERASE CHAIN
REACTION-Request
removed by requester.
The Blood Smear and Bone Marrow Smear are II Do not add (P38):
typically collected and when evaluated, findings BLOOD SMEAR:
are recorded under these designations, as Currently, this should be
opposed to BLOOD or BONEMARROW modeled as
histopathologically, or if the Blood smears or SPEC=BLOOD and
bonemarrow smears are evaluated during clinical METHOD=SMEAR
pathology. and/or LIGHT
BLOOD SMEAR a sample of blood which is MICROSCOPY (can use
collected on a glass slide typically during the multiple convention).
necropsy, stained and retained for possible future Smear may in fact be a
evaluation specimen preparation
BONEMARROW SMEAR a sample of method in some cases
bonemarrow which is collected on a glass slide (especially if there is
typically during necropsy, stained and retained for staining involved after
possible future evaluation the smear); if that is the
case you may want to
consider putting 'Smear'
into suppqual.
BONE MARROW
SMEAR: Currently, this
should be modeled as
SPEC=BONE
MARROW and
METHOD=SMEAR
and/or LIGHT
MICROSCOPY (can use
the multiple convention).
Smear may in fact be a
specimen preparation
method in some cases
(especially if there is
staining involved after
the smear); if that is the
case you may want to
consider putting 'Smear'
into suppqual.
II SDTM, SEND -
Published with P39
A relative measurement (ratio or percentage) of

the N-acetyl-beta-D-glucosaminidase (enzyme) to
creatinine in a biological specimen.

specimen would be
Lung or Bronchus and
The secondary section of the tubular structures in the ANTREG would be
continuation with the trachea, serving as an air Lobar Bronchus.
passage.
CENTRAL/SOUTH ASIAN - A person having II SDTM, CDASH -
origins in Central Asia (Afghanistan, Kazakhstan, Published in P38
Kyrgyzstan, Tajikistan, Turkmenistan and
Uzbekistan) or in South Asia in the Indian
Subcontinent (Bangladesh, Bhutan, India, Nepal,
Pakistan, Sri Lanka).
EAST ASIAN - A person having origins in China,
Korea, Mongolia. Note: Participants of Chinese
ancestry resident in Taiwan, Hong Kong will also
be assigned to this category. Although
geographically located in South East Asia, the
population of Singapore comprises >70% people
of Chinese ancestry. Singapore residents of
Chinese ancestry will be assigned East Asian
Heritage, those of Malay ancestry will be
assigned South East Asian Heritage, those of
Indian ancestry will be assigned South Asian
Heritage.
SOUTH EAST ASIAN - A person having origins in
Cambodia, Indonesia, Laos, Malaysia, Myanmar
(Burma), Philippines, Thailand, Vietnam.
These collected Races are captured on our
Demography CRF. Others can be mapped to
existing CDISC terms.
in P38
SDTM Code: C92616, Codelist code:C71620 In

the 'NCI Preferred Term' column, there is an extra
'i' in Millimole
Please see email submitted separately.
In SDTMIG 3.2 and 3.3, SNOMED-CT is listed as II SDTM-Published in P38

the preferred terminology for responses to the
TDIGRP TSPARM. The TDIGRP codelist has one
value 'HEALTHY SUBJECT' which appendix C of
hte SDTMIG expressly prohibits being used as a
response to TDIGRP. This needs discussion and
explanation with the general team.
Additionally it is listed as the preferred
terminology in the FDA TCG. It is not listed in the
FDA data standards catalog however Diane Wold
has emailed the FDA/CDISC technical group
leads to let them know about this inconsistency
so that the data standards catalog can be
updated.
Codelist Values (From SDTMIG TS domain II
examples and Appendix C):
SNOMED-CT
FDA Substance Registration System - Unique
Ingredient Identifier (UNII) DUNS
ClinicalTrials.gov Identifier EudraCT Number
MED-RT ISO 3166-1 alpha-3 CDISC
The concept of representing the QRS scale of II QRS-Published in P37

responses was initially requested by the PAIN TA
team based on the numerous discrepancies seen
in PAIN studies. The FINDINGS permissible
variable ??METHOD? is used in QRS FT, QS
and RS domains to represent this concept. This
concept was generalized as the QRS sub-team
noticed the same type of VAS and NRS scales
used in other QRS instruments at the overall
instrument level and at the individual question
level in other QRS instruments. This request is
being made to handle this concept.
The QRSMTHOD multiple term request

spreadsheet was sent separately.
II
This version of the CGI instrument based on the

GUY standard Case Report Form (CRF) from the
ECDEU Assessment Manual for
Psychopharmacology, is being reviewed by the
SDS team to not be released based on internal
review comments form the FDA Biostatistiians.
The thought is having two CGI supplements with
highly redundant information may cause
confusion in the public. For this reason, we
believe that the general CGI supplement alone is
sufficient. This reasoning is consistent with the
explanation in the current draft of the general CGI
and PGI supplements for not developing CDISC
standards for the PGA and CGA instruments: ?
CDISC standards will not be developed for
synonymous instruments (e.g., for the Patient
Global Assessment or Physician/Clinician Global
Assessment instruments) since these instruments
do not substantially differ from the analogous PGI
and CGI instruments.? Furthermore, we propose
adding the following language to the current draft
of the general CGI supplement: ?Note that the
general CGI supplement can be used for the CGI
GUY CRF, as the CGI GUY instrument is a
separate but synonymous version of the general
CGI instrument.?
The SDeLT team agreed with not publishing this

supplement and removing the CGI GUY
terminology at the 7/9/18 SDSeLT meeting.
A unit for cloning vector amount expressed as the II SDTM, SEND -

number of vector genomes per kilogram. Published with P39
II SDTM, SEND -
Published with P39
Definition = A measurement of the trypsin in a

NCI C Code = C84232
II SDTM, SEND -
Published with P39
To aid the users as both of the synonyms are

common names for Tetrahydrocannabinol
II SDTM, SEND -
Published with P39
Referenced in Clinical Guide to Laboratory Tests

by Norbert Tietz
Collected units = mol/L (for serum) and M (for

blood)
in P38
Definition: The wall of the vagina is muscle

covered in a mucus membrane. The wall
contains layers of tissue with many elastic fibers.
The surface of the wall also contains rugae,
which are pleats of extra tissue that allow the
vagina to expand during sex or childbirth.
II SDTM, SEND -
Published with P39, P40

Code list C85491

Term C117361
There appears to be a typo in the submission
value. Please correct to PNEUMOCYSTIS
JIROVECII instead of PNEUMOCYSTIS
JIROVECI.
II SEND-Published in P38,
File emailed separately P39, P40, P47, P50
Do not add (P38):
INHAND does not agree
that DYSPLASIA is a
MISTRESC in and of
itself. From INHAND's
point of view, Dysplasia
is considered pre-
neoplastic in the clinical
pre-neoplastic but
any MISTRESC values
in adjectival form
Cytoplasmic alteration -
Already published (P36)
C154895
Mesenchymal
proliferative lesion -
being added with P37
Atretic follicle, increased
number - being added
with P37
Basophilic Granules -
No change for P38. We
are updating the
definition for this term in
Proposed definition: A basophilic tinctorial change

in renal tubular epithelium; often associated with
enlarged cells. May occur as a component of
chronic nephropathy.
Reason: Basophilic tubule is a common finding.

Update of the Requested definition sent on Dec II SEND-Published in P50
13 2018 for the new submitted term MYOPATHY:
Specific changes of skeletal myofibers seen in
minipigs, including both acute (dominated by
necrosis, hemorrhage, edema, and mixed
inflammatory cell infiltrates) and more chronic
lesions (characterized by basophilic regenerating
myofibers, mineralization, and occasionally
fibrosis). An inflammatory component is not
always a prominent feature.
The updated file will be emailed separately.
ISTESTCD, LBTESTCD, METHOD II SDTM, SEND -

File emailed separately Published with P39, P47
Do not add (P40) -
Viable
T-Lymphocytes/T-
Lymphocytes - Do not
add. This belongs in the
Cell Phenotyping
domain (draft) and as
such we will not add it to
LB as controlled
terminology but instead
develop this request in a
future CPTEST/CD
codelist. The
LBTEST/CD codelist is
extensible, therefore this
can be submitted as an
extensible term in LB
until such a time as the
CP domain is published.
Date of Request
Submission Code
Closed Friday, 4 Jan CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2019 11:56 AM 3665 om
Closed Friday, 4 Jan CDISC- claire west GSK claire.m.west@gsk.

2019 11:57 AM 3666 com
Closed Friday, 4 Jan CDISC- Soumya Rajesh Syneos Health soumya.rajesh@sy

2019 11:58 AM 3667 neoshealth.com

2019 12:00 PM 3668 nih.gov
Closed Friday, 11 Jan CDISC- Joyce Hernandez JHC joyce.hernandez_0

2019 01:17 PM 3669 029@yahoo.com
Closed Friday, 11 Jan CDISC- Angela Soriano The EMMES asoriano@emmes.

2019 01:21 PM 3670 Cooperation com

Closed Friday, 11 Jan CDISC- Dana Booth CDISC dbooth.external@c
2019 01:33 PM 3677 disc.org
Closed Friday, 18 Jan CDISC- Joyce Hernandez JHC joyce.hernandez_0

2019 10:55 AM 3678 029@yahoo.com
Open Friday, 18 Jan CDISC- Colleen Bonjo Merck colleen_bonjo@me
2019 10:57 AM 3679 rck.com
Closed Friday, 18 Jan CDISC- Colleen Bonjo Merck colleen_bonjo@me

2019 10:58 AM 3680 rck.com

2019 10:58 AM 3681 rck.com

2019 10:59 AM 3682 rck.com

2019 10:59 AM 3683 rck.com
Closed Friday, 18 Jan CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2019 11:00 AM 3684 om
Closed Friday, 18 Jan CDISC- Natalia Khelmer Janssen nkhelmer@its.jnj.co
2019 11:01 AM 3685 Pharmaceutical m
Closed Friday, 25 Jan CDISC- ARLIX Sophie Syneoshealth sophie.arlix@syneo


Closed Friday, 25 Jan CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2019 12:36 PM 3689 yer.com

2019 12:37 PM 3690 nih.gov
2019 12:38 PM 3691
Closed Friday, 1 Feb CDISC- Roberta Rosenberg Pfizer roberta.e.rosenberg

2019 11:44 AM 3692 @pfizer.com

Inc.
Closed Friday, 1 Feb CDISC- Mihaela Simion Biogen mihaela.simion@bi

2019 11:49 AM 3694 ogen.com
Closed Friday, 1 Feb CDISC- Diane Wold CDISC diane.wold@cdisc.
2019 11:51 AM 3695 org
Closed Friday, 1 Feb CDISC- Sharon Weller Eli Lilly and weller_sharon_m@
2019 11:54 AM 3696 Company lilly.com

2019 11:55 AM 3697 yer.com

2019 11:56 AM 3698 yer.com
Closed Friday, 8 Feb CDISC- Chandra Thames Technical Research cthames@tech-

2019 12:19 PM 3699 International res.com
2019 12:20 PM 3700 yer.com
Closed Friday, 8 Feb CDISC- Charlotte Keenan CM Keenan charlotte.keenan@

2019 01:08 PM 3701 ToxPath msn.com
Consulting/INHAND

2019 01:17 PM 3702 behalf of T1D TA
Team)
Closed Friday, 8 Feb CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
INHAND/SEND) -
special senses
Closed Friday, 8 Feb CDISC- Catherine Roy Merck & Co. catherine.roy@mer
2019 01:19 PM 3704 ck.com
Closed Friday, 8 Feb CDISC- Natalia Khelmer Janssen nkhelmer@its.jnj.co
2019 01:22 PM 3705 Pharmaceutical m

2019 01:23 PM 3706 yer.com
Open Friday, 8 Feb CDISC- Stephen Raymond ERT Stephen.raymond
2019 01:24 PM 3707 @ERT.com
Open Friday, 8 Feb CDISC- Stephen Raymond ERT Stephen.raymond

2019 01:24 PM 3708 @ERT.com

2019 01:25 PM 3709 yer.com

Feb 2019 10:15 3710 behalf of Dana
AM Booth)

2019 11:51 AM 3711 yer.com
Closed Friday, 15 Feb CDISC- Anja Metzger Bayer AG anja.metzger@hot
2019 11:53 AM 3712 mail.de
Closed Friday, 15 Feb CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com
Closed Friday, 15 Feb CDISC- Claire West GSK claire.m.west@gsk.
2019 11:55 AM 3714 com

2019 11:56 AM 3715 com
2019 11:58 AM 3716 nih.gov

2019 11:59 AM 3717 nih.gov
Open Friday, 15 Feb CDISC- Colleen Bonjo Merck colleen_bonjo@me

2019 12:00 PM 3718 rck.com
Closed Friday, 15 Feb CDISC- Julianne D. Halley Envigo julianne.halley@en
2019 12:01 PM 3719 vigo.com
Closed Friday, 15 Feb CDISC- Julianne D. Halley Envigo julianne.halley@en
2019 12:02 PM 3720 vigo.com
2019 12:06 PM 3721
Closed Tuesday, 19 Feb CDISC- Swarupa Sudini Pfizer swarupa.sudini@pfi
2019 12:20 PM 3722 zer.com
Closed Tuesday, 19 Feb CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2019 03:11 PM 3723
Open Thursday, 21 CDISC- Ryota Ogawa Translational ryota.ogawa@tri-

Feb 2019 07:16 3724 Research Center kobe.org
PM for Medical
Innovation

PM for Medical
Innovation

PM for Medical
Innovation

Feb 2019 07:19 3727
PM
Closed Thursday, 21 CDISC- GOINEAU- Porsolt sgoineau@porsolt.
Feb 2019 07:22 3728 BRISSIEUX com
PM

PM

PM
Closed Thursday, 21 CDISC- Diane Corey CPATH dcorey@c-path.org

Feb 2019 07:23 3731
PM

Feb 2019 07:24 3732
PM

Feb 2019 07:24 3733
PM

Feb 2019 07:24 3734
PM
Closed Thursday, 21 CDISC- Helle Gawrylewski Hawkwood hmgawrylewski@g

Feb 2019 07:25 3735 Consulting mail.com
PM
Closed Thursday, 21 CDISC- Gary Walker IQVIA gary.walker@iqvia.

Feb 2019 07:26 3736 com
PM
Closed Friday, 22 Feb CDISC- Mihaela Simion Biogen mihaela.simion@bi

2019 11:22 AM 3737 ogen.com
Closed Friday, 22 Feb CDISC- Diane Boram GlaxoSmithKline diane.e.boram@gs
2019 11:36 AM 3738 k.com
Closed Wednesday, 27 CDISC- Smitha Karra Gilead Sciencecs, smitha.karra@gilea

Feb 2019 10:20 3739 Inc d.com
AM
Open Friday, 1 Mar CDISC- Steve Kopko CDISC skopko@cdisc.org
2019 03:04 PM 3740
Closed Friday, 1 Mar CDISC- Dhruv Bansal PAREXEL dhruv.bansal@pare

2019 03:14 PM 3741 International xel.com
2019 03:36 PM 3742 yer.com

2019 03:37 PM 3743 yer.com
Closed Friday, 1 Mar CDISC- Gary Walker IQVIA GARY.WALKER@I

2019 03:38 PM 3744 QVIA.COM
Closed Friday, 1 Mar CDISC- Art Gertel MedSciCom, LLC medscicom@rcn.co
2019 03:39 PM 3745 m

2019 03:40 PM 3746

2019 03:41 PM 3747 nih.gov

2019 03:42 PM 3748 nih.gov

2019 03:42 PM 3749 nih.gov
Closed Friday, 8 Mar CDISC- Mhaela Simion Biogen mihaela.simion@bi

2019 12:11 PM 3750 ogen.com
Closed Friday, 8 Mar CDISC- Melissa Rowley GSK melissa.c.rowley@
2019 12:13 PM 3751 gsk.com
Closed Friday, 8 Mar CDISC- Claire West GSK claire.m.west@gsk.

2019 12:15 PM 3752 com

2019 12:17 PM 3753 com
Closed Friday, 8 Mar CDISC- Virginie Ory IPSEN virginie.ory@ipsen.

2019 12:18 PM 3754 com
2019 12:21 PM 3755 com

2019 12:22 PM 3756 com

2019 12:23 PM 3757

2019 01:43 PM 3758 rck.com
2019 01:44 PM 3759 yer.com
Closed Friday, 15 Mar CDISC- Mihaela Simion Biogen mihaela.simion@bi

2019 01:45 PM 3760 ogen.com
2019 01:46 PM 3761 ogen.com

2019 01:48 PM 3762 ogen.com
Open Friday, 15 Mar CDISC- Lucile Le Labourier Sanofi lucile.le-

2019 01:49 PM 3763 labourier@sanofi.c
om

2019 04:04 PM 3764 ogen.com
Open Friday, 22 Mar CDISC- Proma Mukherjee PAREXEL proma.mukherjee@

2019 04:07 PM 3765 PAREXEL.com

2019 04:09 PM 3766 ogen.com
2019 04:11 PM 3767 ogen.com

2019 04:18 PM 3768 com
Closed Friday, 22 Mar CDISC- Erin Tibbs-Slone Charles River Labs erin.tibbs-
2019 04:19 PM 3769 slone@crl.com

2019 04:21 PM 3770 com
2019 04:22 PM 3771 yer.com

2019 04:23 PM 3772 yer.com

2019 04:24 PM 3773 yer.com
2019 04:25 PM 3774 yer.com

2019 04:25 PM 3775 nih.gov
Closed Friday, 22 Mar CDISC- Dana Booth CDISC dbooth.external@c

2019 04:26 PM 3776 disc.org
Closed Friday, 22 Mar CDISC- Swarupa Sudini Pfizer swarupa.sudini@pfi
2019 04:27 PM 3777 zer.com
2019 04:30 PM 3778 zer.com
Closed Friday, 22 Mar CDISC- ARLIX Sophie Syneoshealth sophie.arlix@syneo


Closed Friday, 22 Mar CDISC- Nicholas Pemble Janssen (J&J) npemble@its.jnj.co

2019 04:36 PM 3782 m
Closed Friday, 22 Mar CDISC- Nicole Lyons Janssen Reseach nvaccaro@its.jnj.co
Closed Friday, 22 Mar CDISC- Nicole Lyons Janssen Reseach nvaccaro@its.jnj.co

Closed Friday, 29 Mar CDISC- Paula Falck Pfizer Paula.L.Falck@pfiz
2019 11:33 AM 3785 er.com

2019 11:34 AM 3786 zer.com
Closed Friday, 29 Mar CDISC- Monitha Mohan Merck KGaA monitha-
2019 11:35 AM 3787 Harilkumar mohan.haril-
kumar@merckgrou
p.com

2019 11:36 AM 3788 rck.com
2019 01:35 PM 3789 rck.com

2019 01:36 PM 3790 rck.com

2019 01:37 PM 3791 rck.com

2019 01:40 PM 3792 rck.com
Closed Thursday, 4 Apr CDISC- Janessa Pierce Merck & Co., Inc. janessa_pierce@m
2019 04:04 PM 3793 erck.com
Closed Thursday, 4 Apr CDISC- Claire West GSK claire.m.west@gsk.
2019 04:05 PM 3794 com
Closed Thursday, 4 Apr CDISC- Steve Kopko CDISC skopko@cdisc.org

2019 04:06 PM 3795
Open Friday, 5 Apr CDISC- Ryota Ogawa Translational ryota.ogawa@tri-

for Medical
Innovation
for Medical
Innovation
for Medical
Innovation
2019 01:34 PM 3799
Closed Friday, 12 Apr CDISC- Nicholas Pemble Janssen (J&J) npemble@its.jnj.co
2019 01:35 PM 3800 m
2019 01:36 PM 3801 nih.gov
Closed Friday, 12 Apr CDISC- Ellina Babouchkina Quality Data ebabouchkina@qd

2019 01:39 PM 3802 Services, Inc. services.com
Closed Friday, 12 Apr CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2019 01:41 PM 3803 yer.com

2019 01:42 PM 3804 nih.gov

2019 01:42 PM 3805 nih.gov
Closed Friday, 12 Apr CDISC- Mihaela Simion Biogen mihaela.simion@bi

2019 01:45 PM 3806 ogen.com
Open Friday, 12 Apr CDISC- Vidya Muthukumar IQVIA Biotech vidya.muthukumar
2019 01:46 PM 3807 @novellaclinical.co
m
Closed Friday, 12 Apr CDISC- Denise Adelman JNJ Dadelma1@its.jnj.c

2019 01:48 PM 3808 om
2019 01:49 PM 3809
Open Friday, 12 Apr CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2019 01:49 PM 3810
2019 01:53 PM 3811

2019 04:08 PM 3812 k.com

2019 04:09 PM 3813 k.com

2019 04:10 PM 3814 k.com

2019 04:11 PM 3815 nih.gov

2019 04:12 PM 3816 nih.gov

2019 04:13 PM 3817 nih.gov
Closed Friday, 19 Apr CDISC- Sophie ARLIX Syneoshealth sophie.arlix@syneo

Open Friday, 19 Apr CDISC- Denise Adelman JNJ Dadelma1@its.jnj.c
2019 04:17 PM 3819 om
Open Thursday, 25 Apr CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2019 02:07 PM 3820
Open Thursday, 25 Apr CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2019 02:08 PM 3821
Closed Thursday, 25 Apr CDISC- Diane Cory C-Path dcorey@c-path.org

2019 02:08 PM 3822

2019 12:24 PM 3823 zwick@astrazenec
a.com
Closed Friday, 26 Apr CDISC- Colleen Bonjo Merck colleen_bonjo@me

2019 12:25 PM 3824 rck.com
2019 12:26 PM 3825
Closed Friday, 26 Apr CDISC- Magdalena Litwin- Roche litwinwm@roche.co

2019 12:47 PM 3827 nih.gov
Closed Friday, 3 May CDISC- Debbie Oneill Merck debra_oneill@merc

2019 11:48 AM 3828 k.com

2019 11:49 AM 3829 nih.gov
Closed Friday, 3 May CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov
2019 11:50 AM 3830 behalf of the T1D
TA team)
Open Friday, 3 May CDISC- Helle Gawrylewski Hawkwood hmgawrylewski@g
2019 11:50 AM 3831 Consulting mail.com
Closed Friday, 3 May CDISC- Steve Kopko CDISC skopko@cdisc.org

2019 11:51 AM 3832
Closed Thursday, 9 May CDISC- Diane Cory C-Path dcorey@c-path.org

2019 03:01 PM 3833
Closed Friday, 10 May CDISC- Ryota Ogawa Translational ryota.ogawa@tri-

for Medical
Innovation
Closed Friday, 10 May CDISC- Susan DeHaven Sanofi susan.dehaven@s
2019 11:44 AM 3835 anofi.com
Closed Sunday, 12 May CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov
2019 06:24 PM 3836 behalf of PK CT
team)
Closed Friday, 17 May CDISC- Nghi LaTran Genentech, INC. LA.NGHI@GENE.

2019 12:33 PM 3837 COM
Closed Friday, 17 May CDISC- Claire West GSK claire.m.west@gsk.

2019 12:35 PM 3838 com
2019 12:36 PM 3839 nih.gov

2019 12:37 PM 3840 nih.gov

2019 12:37 PM 3841 nih.gov
Closed Friday, 17 May CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com
Closed Friday, 17 May CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com
Closed Friday, 24 May CDISC- Sophie ARLIX Syneoshealth sophie.arlix@syneo





Closed Friday, 24 May CDISC- Claire West GSK claire.m.west@gsk.

2019 11:07 AM 3851 com
Closed Friday, 24 May CDISC- Christine Connolly Merck / EMD christine.connolly@

2019 11:07 AM 3852 Serono emdserono.com

2019 11:08 AM 3853 yer.com
Closed Friday, 24 May CDISC- Melanie Paules GSK melanie.a.paules@
2019 11:09 AM 3854 gsk.com

2019 01:14 PM 3855 yer.com
Closed Friday, 31 May CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

2019 01:26 PM 3857
Closed Friday, 31 May CDISC- Diane Corey C-path dcorey@c-path.org

2019 01:27 PM 3858

2019 01:28 PM 3859

2019 01:28 PM 3860
Closed Friday, 31 May CDISC- Jenny Jones Covance jenny.jones@covan

2019 01:34 PM 3861 ce.com

2019 01:34 PM 3862 ce.com

2019 01:35 PM 3863 ce.com
Closed Friday, 31 May CDISC- Catherine A. Roy Merck & Co., Inc. catherine.roy@mer
2019 04:34 PM 3864 ck.com
Closed Friday, 31 May CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2019 04:35 PM 3865 behalf of PK team)
Closed Friday, 7 Jun CDISC- Jenny Jones Covance jenny.jones@covan
2019 11:35 AM 3866 ce.com

2019 11:38 AM 3867 nih.gov

2019 11:39 AM 3868 rck.com

2019 11:40 AM 3869 rck.com

2019 11:40 AM 3870 ce.com
2019 11:42 AM 3871 ce.com

2019 11:43 AM 3872
Open Friday, 7 Jun CDISC- Colleen Bonjo Merck colleen_bonjo@me
2019 11:45 AM 3873 rck.com
2019 11:46 AM 3874 yer.com
Closed Friday, 7 Jun CDISC- DANIEL POTENTA PDS dan.potenta@pdslif

2019 11:47 AM 3875 esciences.com
Closed Friday, 7 Jun CDISC- Dana Booth C-Path dbooth.external@c

2019 11:49 AM 3876 disc.org
Closed Friday, 7 Jun CDISC- Kit A Howard CDISC khoward@cdisc.org

2019 11:50 AM 3877
Closed Friday, 7 Jun CDISC- Lucile Le Labourier Sanofi lucile.le-

2019 11:51 AM 3878 labourier@sanofi.c
om
om

om

om
Open Friday, 14 Jun CDISC- Jenny Jones Covance jenny.jones@covan

2019 05:26 PM 3882 ce.com
Closed Friday, 14 Jun CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.
Open Friday, 14 Jun CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2019 05:28 PM 3884
Closed Friday, 14 Jun CDISC- Sharon Broderick Boehringer sharon.broderick@

2019 05:29 PM 3885 Ingelhiem boehringer-
Inc.
Open Friday, 14 Jun CDISC- Claire West GSK claire.m.west@gsk.
2019 05:30 PM 3886 com

2019 05:31 PM 3887 com
Closed Friday, 14 Jun CDISC- Anh Nguyen AbbVie anh.n.nguyen@abb

2019 05:32 PM 3888 vie.com
Open Friday, 14 Jun CDISC- Colleen Bonjo Merck colleen_bonjo@me

2019 05:34 PM 3889 rck.com
Closed Friday, 14 Jun CDISC- Dana Booth CDISC dbooth.external@c

2019 05:35 PM 3890 disc.org
Closed Friday, 14 Jun CDISC- Gary Walker Gary G Walker LLC gary.walker.ggw@g
2019 05:37 PM 3891 / CDISC mail.com
Open Friday, 21 Jun CDISC- Lucile LE Sanofi lucile.le-

2019 11:18 AM 3892 LABOURIER labourier@sanofi.c
om
om

om
Closed Friday, 21 Jun CDISC- Gitte Frausing gfrausing@datasta

2019 11:20 AM 3895 ndardsdecisions.co
m
Open Friday, 21 Jun CDISC- Debbie Oneill Merck debra_oneill@merc

2019 11:20 AM 3896 k.com
Open Friday, 21 Jun CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2019 11:21 AM 3897 om
Open Friday, 21 Jun CDISC- Claire West GSK claire.m.west@gsk.
2019 11:23 AM 3898 com
Closed Friday, 21 Jun CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell

2019 11:23 AM 3899 as.com
Closed Friday, 28 Jun CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2019 01:15 PM 3900 ng LLC mail.com
2019 01:16 PM 3901 com

2019 01:18 PM 3902 om

2019 01:19 PM 3903 om
Open Wednesday, 3 CDISC- lesley workman WWARN lesley.workman@u
Jul 2019 07:45 3904 ct.ac.za
PM

Jul 2019 07:47 3905 Ingelhiem boehringer-
Inc.
Closed Wednesday, 3 CDISC- Igor Rubets n/a igor.rubets@certar
Jul 2019 07:49 3906 a.com
PM
Closed Jul 2019 07:49
Wednesday, 3 3907
CDISC- Gitte Frausing n/a shealth.com
gfrausing@datasta
PM
Jul 2019 07:50 3908 ndardsdecisions.co
PM m

Inc.

Inc.
Jul 2019 07:56 3911 shealth.com
PM
Closed Wednesday, 3 CDISC- Melissa Rowley GSK melissa.c.rowley@
Jul 2019 07:57 3912 gsk.com
PM
Closed Friday, 12 Jul CDISC- Deborah Bauer Sanofi Deborah.Bauer@s

2019 12:35 PM 3913 anofi.com
Closed Friday, 12 Jul CDISC- Lucile LE SANOFI lucile.le-

2019 12:36 PM 3914 LABOURIER labourier@sanofi.c
om

om
om

om

om

om
Closed Friday, 12 Jul CDISC- Ryota Ogawa Translational ryota.ogawa@tri-
2019 12:40 PM 3920 Research Center kobe.org
for Medical
Innovation
2019 12:41 PM 3921 com

for Medical
Innovation
for Medical
Innovation

2019 12:47 PM 3924 yer.com

2019 12:48 PM 3925 yer.com

for Medical
Innovation
Closed Friday, 12 Jul CDISC- Gabriel Kaufman Certara Strategic gabriel.kaufman@c
2019 12:59 PM 3927 Consulting ertara.com

2019 01:00 PM 3928 com

2019 01:04 PM 3929 com

2019 01:07 PM 3930 com

2019 01:08 PM 3931

2019 01:10 PM 3932 as.com
Closed Wednesday, 17 CDISC- Dana Booth CDISC dbooth.external@c
Jul 2019 06:05 3933 disc.org
PM
Closed Wednesday, 17 CDISC- Dana Booth CDISC dbooth.external@c

Jul 2019 06:06 3934 disc.org
PM

Jul 2019 06:07 3935 behalf of T1D TA
PM Team)

2019 04:17 PM 3936 com
Closed Friday, 19 Jul CDISC- Craig Zwickl on Transendix craig.zwickl@cdisc.

2019 04:19 PM 3937 behalf of SEND org
CCB
Open Friday, 19 Jul CDISC- Gabriel Kaufman Certara Strategic gabriel.kaufman@c
2019 04:20 PM 3938 Consulting ertara.com

2019 04:21 PM 3939 yer.com
Closed Friday, 19 Jul CDISC- Shannon Labout Data Science Shannon.Labout@

2019 04:21 PM 3940 Solutions LLC DataScienceSolutio
nsLLC.com
2019 04:07 PM 3941 behalf of T1D
team)

2019 04:08 PM 3942 yer.com
Closed Friday, 26 Jul CDISC- Elaine Hazzard Janssen ehazzard@its.jnj.co

2019 04:09 PM 3943 m

for Medical
Innovation

2019 04:28 PM 3945 rck.com

2019 04:28 PM 3946 rck.com
2019 04:29 PM 3947 rck.com

2019 04:30 PM 3948 rck.com

2019 04:31 PM 3949 rck.com
Open Friday, 2 Aug CDISC- Jenny jones Covance Jenny.Jones@Cov

2019 04:33 PM 3950 ance.com
2019 04:34 PM 3951 ance.com
Closed Friday, 2 Aug CDISC- Jenny jones Covance Jenny.Jones@Cov

2019 04:36 PM 3952 ance.com

2019 04:36 PM 3953 ance.com

2019 04:36 PM 3954 ance.com
2019 04:37 PM 3955 ance.com
2019 04:38 PM 3956

2019 04:38 PM 3957
Closed Friday, 2 Aug CDISC- Gary Walker Gary G Walker LLC gary.walker.ggw@g
2019 04:40 PM 3958 / CDISC mail.com
Open Friday, 2 Aug CDISC- Claire West GSK claire.m.west@gsk.

2019 04:41 PM 3959 com
Closed Friday, 2 Aug CDISC- Mihaela Simion Biogen mihaela.simion@bi

2019 04:43 PM 3960 ogen.com
Closed Friday, 2 Aug CDISC- Jordan Li NCI EVS Jordan.li@nih.gov

2019 04:44 PM 3961
Open Friday, 2 Aug CDISC- Jordan Li (on NCI EVS Jordan.li@nih.gov

2019 04:58 PM 3962 behalf of Dana
Booth and
Psoriasis TA)
Closed Friday, 2 Aug CDISC- Aileen St Marie Bristol Myers aileen.stmarie@bm
2019 05:00 PM 3963 Squibb s.com
Closed Thursday, 8 Aug CDISC- Nicholas Pemble J&J npemble@its.jnj.co

2019 03:59 PM 3964 m
Closed Thursday, 8 Aug CDISC- Colleen Bonjo Merck colleen_bonjo@me
2019 04:00 PM 3965 rck.com
Closed Thursday, 8 Aug CDISC- Colleen Bonjo Merck colleen_bonjo@me

2019 04:01 PM 3966 rck.com
Closed Thursday, 8 Aug CDISC- Claire West GSK claire.m.west@gsk.

2019 04:05 PM 3967 com
Closed Thursday, 8 Aug CDISC- Jenny Jones Covance Jenny.Jones@Cov

2019 04:06 PM 3968 ance.com

2019 04:06 PM 3969 ance.com

2019 04:06 PM 3970 ance.com

2019 04:07 PM 3971 ance.com
2019 04:07 PM 3972 ance.com

2019 04:07 PM 3973 ance.com
Closed Thursday, 8 Aug CDISC- Claire West GSK claire.m.west@gsk.

2019 04:08 PM 3974 com
Closed Thursday, 8 Aug CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2019 04:09 PM 3975 om
Closed Thursday, 8 Aug CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2019 04:11 PM 3976 om
Open Thursday, 8 Aug CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

Closed Thursday, 8 Aug CDISC- Debbie Oneill Merck debra_oneill@merc
2019 04:14 PM 3978 k.com
Closed Thursday, 8 Aug CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.

Inc.
Closed Friday, 9 Aug CDISC- Tineke Callant SGS Belgium NV tineke.callant@sgs.
2019 02:57 PM 3981 com
Closed Friday, 9 Aug CDISC- Tineke Callant SGS Belgium NV tineke.callant@sgs.

2019 02:57 PM 3982 com
Closed Friday, 9 Aug CDISC- Carrie Neeley Covance carrie.neeley@cov

2019 03:00 PM 3983 ance.com
2019 03:00 PM 3984 ance.com
2019 03:00 PM 3985 ance.com

2019 03:01 PM 3986 ance.com
2019 03:01 PM 3987 ance.com

2019 03:01 PM 3988 ance.com

2019 03:01 PM 3989 ance.com
Closed Wednesday, 14 CDISC- Paula Falck Pfizer Paula.L.Falck@pfiz

Aug 2019 04:38 3990 er.com
PM
Closed Wednesday, 14 CDISC- Anna Pron-Zwick AstraZeneca anna.pron-
Aug 2019 04:39 3991 Pharmaceuticals zwick@astrazenec
PM a.com
Closed Friday, 16 Aug CDISC- Jenny Jones Covance Jenny.Jones@Cov

2019 06:34 PM 3992 ance.com
Closed Friday, 23 Aug CDISC- Debbie Oneill Merck debra_oneill@merc
2019 12:15 PM 3993 k.com


2019 12:27 PM 3996 behalf of Nutrition
TA Team)
2019 12:29 PM 3997 ance.com
Closed Friday, 23 Aug CDISC- Mihaela Simion Biogen mihaela.simion@bi

2019 12:31 PM 3998 ogen.com

Aug 2019 05:46 3999 ogen.com
PM

2019 10:49 AM 4000 k.com

2019 10:49 AM 4001 k.com

2019 10:50 AM 4002 k.com
2019 10:50 AM 4003 k.com

2019 10:50 AM 4004 k.com
Open Friday, 30 Aug CDISC- Debbie Oneill Merck debra_oneill@merc

2019 10:52 AM 4005 k.com

2019 10:52 AM 4006 k.com

2019 10:53 AM 4007 k.com

2019 10:54 AM 4008 k.com

2019 10:54 AM 4009 k.com
2019 10:55 AM 4010 k.com

2019 10:55 AM 4011 k.com

2019 10:56 AM 4012 k.com
Closed Friday, 30 Aug CDISC- Florence Halbert Novartis florence.halbert@n

2019 10:56 AM 4013 Pharmaceuticals ovartis.com
Open Friday, 30 Aug CDISC- Lee Jung Hyun Asan Image junghyunlee@aim-
2019 10:58 AM 4014 Metrics, Asan aicro.com
Medical Center
Closed Friday, 30 Aug CDISC- Adam Batchelor AbbVie Inc. adam.batchelor@a

2019 10:59 AM 4015 bbvie.com

2019 11:00 AM 4016 Ingelhiem boehringer-
Inc.
Inc.
Inc.

Inc.
Inc.

Inc.

Inc.

Inc.

Inc.

Inc.
Closed Friday, 30 Aug CDISC- Jenny Jones Covance Jenny.Jones@Cov
2019 11:13 AM 4026 ance.com
Closed Tuesday, 3 Sep CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2019 11:23 AM 4027 nih.gov
Closed Friday, 6 Sep CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

Closed Friday, 6 Sep CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2019 11:58 AM 4029 yer.com

2019 11:58 AM 4030 yer.com
Closed Friday, 6 Sep CDISC- Claire West GSK claire.m.west@gsk.
2019 11:59 AM 4031 com

2019 11:59 AM 4032 com
Closed Friday, 6 Sep CDISC- Diane Wold CDISC diane.wold@cdisc.

2019 12:00 PM 4033 org

2019 12:01 PM 4034 nih.gov
Closed Friday, 13 Sep CDISC- Susan DeHaven Sanofi susan.dehaven@s

2019 11:29 AM 4035 anofi.com
Closed Friday, 13 Sep CDISC- Mihaela Simion Biogen mihaela.simion@bi

2019 11:31 AM 4036 ogen.com
2019 11:31 AM 4037 ogen.com

2019 11:43 AM 4038 ogen.com
2019 11:44 AM 4039 ogen.com

2019 11:44 AM 4040 ogen.com

2019 11:45 AM 4041 ogen.com
Closed Friday, 13 Sep CDISC- Paula Falck Pfizer paula.l.falck@pfizer

2019 11:46 AM 4042 .com
Closed Friday, 13 Sep CDISC- Steve Kopko CDISC skopko@cdisc.org

2019 11:46 AM 4043
Sep 2019 08:40 4044 org
PM

Sep 2019 08:43 4045 behalf of Dana
PM Booth)
Open Thursday, 19 CDISC- Erin Tibbs-Slone CRL erin.tibbs-
Sep 2019 08:45 4046 slone@crl.com
PM

Sep 2019 08:47 4047 nih.gov
PM
Closed Thursday, 19 CDISC- Yan Yuan CDC glu5@cdc.gov

Sep 2019 08:51 4048
PM
Closed Thursday, 19 CDISC- Shannon Labout Data Science shannon.labout@d
Sep 2019 08:54 4049 Solutions LLC atasciencesolutions
PM llc.com
Closed Friday, 20 Sep CDISC- Smitha Karra Gilead Sciences smitha.karra@gilea

2019 12:06 PM 4050 d.com
Sep 2019 04:42 4051 yer.com
PM
Open Wednesday, 25 CDISC- Dana Booth CDISC dbooth.external@c

Sep 2019 04:44 4052 disc.org
PM
Closed Friday, 27 Sep CDISC- Igor Rubets Certara igor.rubets@certar

2019 12:01 PM 4053 a.com
Closed Friday, 27 Sep CDISC- Rune Kaasen ALK-Abello A/S rune.kaasen@alk.n

2019 12:02 PM 4054 et
Closed Friday, 4 Oct CDISC- Anna Pron-Zwick Astra Zeneca anna.pron-

a.com
a.com

a.com

a.com
Open Friday, 4 Oct CDISC- Anna Pron-Zwick Astra Zeneca anna.pron-

a.com
a.com

a.com

a.com

a.com

a.com

a.com
Closed Friday, 4 Oct CDISC- Kevin Galinsky Takeda kevin.galinsky@tak

2019 12:06 PM 4066 eda.com
Closed Friday, 4 Oct CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

Closed Friday, 4 Oct CDISC- Colleen Bonjo Merck colleen_bonjo@me
2019 12:08 PM 4070 rck.com
Closed Friday, 11 Oct CDISC- Afsana Sayyed Cognizant afsana.sayyed@co

2019 04:51 PM 4071 Technology gnizant.com
Solution
Closed Friday, 11 Oct CDISC- Jenny Jones Covance Jenny.Jones@Cov
2019 04:53 PM 4072 ance.com

2019 04:54 PM 4073 ance.com

2019 04:55 PM 4074 ance.com

2019 04:55 PM 4075 ance.com

2019 04:56 PM 4076 ance.com

2019 04:58 PM 4077 com
Closed Friday, 11 Oct CDISC- Debbie Oneill Merck debra_oneill@merc

2019 04:58 PM 4078 k.com
Open Friday, 11 Oct CDISC- Jacques Thuet Servier jacques.thuet@ser

2019 04:59 PM 4079 vier.com
Closed Friday, 18 Oct CDISC- William Houser Bristol-Myers william.houser@bm
2019 02:08 PM 4080 Squibb s.com

Pharmaceuticals ingelheim.com
Inc

Inc
Inc
2019 02:18 PM 4084 rck.com
Closed Friday, 18 Oct CDISC- Nicholas Pemble npemble@its.jnj.co Janssen Pharma
2019 02:21 PM 4085 m

Closed Friday, 25 Oct CDISC- Anna Pron-Zwick AstraZeneca anna.pron-
a.com
Closed Friday, 25 Oct CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell

2019 12:15 PM 4088 as.com

2019 12:16 PM 4089 nih.gov
Closed Friday, 25 Oct CDISC- Alla Ostrovsky Biogen alla.ostrovsky@bio

2019 12:16 PM 4090 gen.com
Closed Friday, 25 Oct CDISC- Alla Ostrovsky Biogen alla.ostrovsky@bio

2019 12:17 PM 4091 gen.com
Open Friday, 25 Oct CDISC- Dana Booth CDISC dbooth.external@c

2019 12:18 PM 4092 disc.org
Closed Thursday, 31 Oct CDISC- Alla Ostrovsky Biogen alla.ostrovsky@bio
2019 03:33 PM 4093 gen.com
Open Thursday, 31 Oct CDISC- Colleen Bonjo Merck colleen_bonjo@me

2019 03:37 PM 4094 rck.com

2019 03:39 PM 4095 rck.com

2019 03:40 PM 4096 rck.com

2019 03:42 PM 4097 rck.com
2019 03:43 PM 4098 rck.com
Open Thursday, 31 Oct CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Open Thursday, 31 Oct CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Closed Friday, 8 Nov CDISC- Diane Wold CDISC diane.wold@cdisc.

2019 10:37 AM 4101 org

2019 10:38 AM 4102 nih.gov
Open Friday, 8 Nov CDISC- Colleen Bonjo Merck bonjocol@gmail.co

2019 10:39 AM 4103 m
Closed Thursday, 14 CDISC- Diane Corey C-path dcorey@c-path.org
Nov 2019 06:04 4104
PM
Closed Thursday, 14 CDISC- Steve Kopko CDISC skopko@cdisc.org

Nov 2019 06:06 4105
PM
Closed Thursday, 14 CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

Nov 2019 06:06 4106 om
PM

Nov 2019 06:07 4107 om
PM

Nov 2019 06:07 4108
PM
Nov 2019 06:09 4109 nih.gov
PM
Closed Thursday, 14 CDISC- Steve Kopko CDISC skopko@cdisc.org

Nov 2019 06:11 4110
PM

Nov 2019 06:12 4111
PM
Closed Thursday, 14 CDISC- Nathalie Picard Robarts Clinical nathalie.picard@ro
Nov 2019 06:12 4112 Trials Inc. bartsinc.com
PM
Closed Friday, 22 Nov CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo


2019 05:23 PM 4114

2019 05:25 PM 4115
2019 05:26 PM 4116
Closed Friday, 22 Nov CDISC- Steve Kopko CDISC skopko.external@c

2019 05:28 PM 4117 disc.org
Closed Friday, 22 Nov CDISC- Colleen Bonjo Merck colleen_bonjo@me

2019 05:38 PM 4118 rck.com
Closed Friday, 22 Nov CDISC- Ryota Ogawa Translational ryota.ogawa@tri-

for Medical
Innovation
Closed Friday, 22 Nov CDISC- Ryota Ogawa Translational ryota.ogawa@tri-
for Medical
Innovation
Open Friday, 22 Nov CDISC- Ryota Ogawa Translational ryota.ogawa@tri-
for Medical
Innovation
Closed Friday, 22 Nov CDISC- Alla Ostrovsky Biogen alla.ostrovsky@bio
2019 05:43 PM 4122 gen.com
2019 05:44 PM 4123 gen.com

2019 05:45 PM 4124 gen.com
Closed Tuesday, 26 Nov CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2019 03:47 PM 4125 yer.com
Closed Tuesday, 26 Nov CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2019 03:48 PM 4126 nih.gov

2019 03:48 PM 4127 nih.gov

2019 03:49 PM 4128 nih.gov
Closed Tuesday, 26 Nov CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell
2019 03:50 PM 4129 as.com
Closed Tuesday, 26 Nov CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com

a.com

a.com
a.com

a.com
Closed Friday, 6 Dec CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

Closed Friday, 6 Dec CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo


Inc

Inc

Inc
Closed Friday, 6 Dec CDISC- Magdalena Litwin- Roche magdalena.litwin-
2019 12:03 PM 4140 Wojciechowska wojciechowska@ro
che.com
Closed Friday, 6 Dec CDISC- Diane Corey C-Path dcorey@c-path.org

2019 12:04 PM 4141

2019 12:05 PM 4142 nih.gov

2019 12:05 PM 4143 nih.gov
Closed Friday, 6 Dec CDISC- Steve Kopko CDISC skopko@cdisc.org
2019 12:06 PM 4144
Closed Friday, 13 Dec CDISC- Anje Van Mileghem anje.van-

2019 11:57 AM 4145 mileghem@idorsia.
com

com
Open Friday, 13 Dec CDISC- Claire West GSK claire.m.west@gsk.

2019 11:58 AM 4147 com
2019 11:59 AM 4148 nih.gov
Closed Friday, 20 Dec CDISC- Assia Bouhadouza Sanofi assia.bouhadouza

2019 12:09 PM 4149 @sanofi.com
Closed Friday, 20 Dec CDISC- Baole Fan Regeneron baole.fan@regener

2019 12:10 PM 4150 on.com
Closed Friday, 20 Dec CDISC- Lacey Wallace Audentes lwallace@audentes

2019 12:11 PM 4151 tx.com
Request Type
Create New Multiple New Term Requests

Term
Modify SDTM- Addition of synonyms

Create New SDTM- NCOMPLT (Reason for Non-

Term NCOMPLT Completion) codelist - add the
following codes: 1. Sponsor
Request 2. Non-compliance with
Study Schedule
Create New Multiple Just need request codes for these

Term terms in P37 public review. There are
142 in total, including changes to
existing. Craig does not need to add
these to P38 team working
documents.
Create New SDTM-UNIT pg/mL - picograms per milliliter

Term ng/mL - Nanograms per milliliter
Create New SDTM-UNIT FFU

Term
Create New SDTM-LOC SKIN OF THE ELBOW JOINT

Term
Create New SDTM-LOC FOREARM SKIN
Term
Create New SDTM-LOC SKIN OF THE CHEST
Term
Create New SDTM-LOC SKIN OF THE INGUINAL REGION
Term
Create New SDTM-LOC SKIN OF THE FOOT
Term
Create New SDTM-LOC SKIN OF THE KNEE JOINT
Term
Create New New New APVU Terminology
Term
Create New SDTM- New LBTEST-CD terms please

Term LBTEST-CD
Create New SDTM- Test Name = Spontaneous
Term CVTEST/CD Baroreceptor Sensitivity TESTCD =
SBRS
Create New SDTM-UNIT Submission Value = msec/mmHg

Term
Create New SDTM- Test Name = Standard Deviation Of

Term CVTEST/CD NN Intervals TESTCD = SDNN
Create New SDTM- Test Name = Root Mean Square Of

Term CVTEST/CD Successive Differenc TESTCD =
RMSSD
Create New SDTM-LOC HEEL

Term
Create New SDTM- NEUTRALIZATION ASSAY
Term METHOD
Create New SDTM- SCREEN FAILURE
Term NCOMPLT
Create New SDTM- Please consider add the value

Term ISTEST-CD Human Anti-Human Antibody
(ISTESTCD = HAHA) which
corresponds to the Code C103990 in
NCI thesaurus
Create New SDTM-TTYPE Please consider USABILITY as new
Term value
Create New SDTM-TTYPE Please consider WATER EFFECT as
Term new value
Create New SDTM-LOC Please consider adding 8 LOC

Term terms.
Modify CDISC- Change c-code from C142702 to

Existing Term Glossary C90462. These will be merged in
NCIt.
Modify SDTM- Is the FATEST = Number of Events
Existing Term DKFATS-CD (C130057), the same as, the
FATEST = Number of Episodes
(C124281)?
Create New SDTM-LOC Please add: SKIN OF THE

Term INFRASCAPULAR REGION
Create New SDTM- SWAB

Term METHOD
Modify SDTM- Please add synonym 'Creatine

Existing Term LBTEST/CD Phosphokinase' to existing term
'Creatine Kinase'.
Create New New ARMNRS is a new variable in
Codelist SDTMIG v3.3. Requesting a codelist
for values for this variable.
Create New New Pls add TSVAL entries

Codelist
Create New SDTM-FREQ Please add the term Q12W for Every
Term 12 Weeks into the FREQ codelist.
Create New SDTM-FREQ Please add Q16W to the FREQ

Term codelist to reflect Every 16 Weeks.
None Multiple Naming of survey variable names.

Create New SDTM-FRM Please add 2 new terms to the FRM
Term codelist.
Create New SEND- RODENT PROGRESSIVE

Term NONNEO CARDIOMYOPATHY
Create New Multiple Please consider adding new terms to

Term VSTEST-CD and Relationship to
Subject codelists
Create New SEND- INHAND Special Senses publication
Term NONNEO new terminology
Create New NONNEO/ Multiple terms for SEND-NONNEO
Term Non-
Neoplastic
Finding Type
Modify SDTM- Please consider replacing ?SCREEN
Existing Term NCOMPLT FAILURE? with ?FAILURE TO
MEET ELIGIBILITY CRITERIA?.
Create New SDTM- Please add a choice of OBSERVER

Term TBLIND BLIND to the TBLIND codelist.
Create New CDISC- Real World Evidence, Real World
Term Glossary Data. Gottlieb FDA presentation
shows a wider use in clinical
research, but narrower interpretation
than for the AI applications peering
into facebook....
Create New CDISC- development

Term Glossary
Create New SDTM-LAT Please add to the LAT codelist the

Term term MIDLINE.
Create New New Please create new TEST-CD

Codelist codelists for PHQ-2
Create New SDTM-LOC Please add the term RIGHT, HEART

Term to the LOC codelist.
Create New Multiple Pls consider adding new terms to
Term multiple codelists.
Modify SDTM- Albumin Index (C154734)

Existing Term LBTEST-CD
Create New SDTM- FFPE or FORMALIN-FIXED
Term SPECCOND PARAFFIN-EMBEDDED
Other SDTM-UNIT? Query regarding UNIT related to

Excretion rates collected over
various durations.
Modify SDTM- Please review terms C139046,
Existing Term CVTEST/CD C139047, and C139048. In some of
these cases, 'Pericardial' may not be
necessary to include in the TEST
value.
Modify SDTM- C20989/PHYSICAL EXAMINATION:

Existing Term METHOD Modify definition
Create New SDTM- Cytomegalovirus DNA

Term MBTEST/CD
Create New Multiple Please add ECG terms
Term
Create New SDTM-POS Pls add new EGPOS terms
Term
Modify SDTM- Please consider harmonizing
Existing Term LBTEST/CD Endomysium IgA Antibody
(C147334) into Tissue
Transglutaminase IgA Antibody
(C147441).
Modify SDTM- See Additional Information box for
Existing Term AIMS01TC/TN more details.
Modify SDTM- Remove C135409 from the codelist

Existing Term MBTEST/CD
Create New SDTM- LVID; left ventricular internal

Term CVTEST/CD dimension
Create New SDTM- IVS; Interventricular septum

Term CVTEST/CD thickness
Create New SDTM- PWD; left ventricular posterior wall

Term CVTEST/CD thickness
Modify SDTM- Please retire Number of Occurrences

Existing Term CDFATS/CD (C150827) from the CDAD Findings
About Test Name/Code codelists.
This is a TA request from CDAD.
Create New SDTM- PINSFLOW
Term RETEST/CD
Create New SDTM- PEXPFLOW

Term RETEST/CD
Create New SDTM- RELTIME

Term RETEST/CD
Modify SDTM-FTCAT 4 Stair Ascend FTCAT, citation

Existing Term changed, see file send via email
Modify SDTM-FTCAT 4 Stair Descend FTCAT, citation

Existing Term changed, see file in email
Modify SDTM-FTCAT Rise From Floor FTCAT, citation

Existing Term changed, file emailed separately
Modify SDTM-FTCAT 10 Meter Walk/Run FTCAT, citation

Existing Term changed, file emailed separately
Create New CDISC- regenerative medicine advanced

Term Glossary therapy (RMAT) designation
Create New SDTM- ASSENT OBTAINED

Term PROTMLST
Create New SDTM- Tramadol

Term LBTEST/CD
Create New SDTM-UNIT Please reconsider addition of the
Term term "/5 mins" for a rate of
occurrence within a period of time
equal to 5 minutes
Modify SDTM- See additional information box for

Existing Term DS01TC/TN more details
Create New NEW Body System domain level codetable
Codelist for --TESTCD/--TEST responses
similar to other Body System FA
codetables
Create New Multiple Please create new terms for SDTM-

Term AESEV SDTM-OUT
Modify SDTM- Suggest modifying the definition of
Existing Term METHOD the submission value of
APPALANATION TIONOMETRY to
make it broader, or alternatively add
a new term of ARTERIAL
APPLANATION TONOMETRY.
Modify SDTM- NON-INVASIVE DIELECTRIC

Existing Term METHOD SENSING
Modify SDTM- Modify "CTAUG" to "TAUG", modify

Existing Term TSPARM/CD "SDTIGVER" to "SDTMIG", modify
"SDTMVER" to "SDTM" and add
"TECHSP" (Technical Specification)
Create New SDTM- Master Protocol
Term Glossary
Modify SDTM- update cdisc definitions for

Existing Term ISTEST/CD C147272C147273C147274C147275
Create New SDTM- OI Domain

Term DOMAIN
Modify SDTM-TTYPE Update definition of C49666 to

Existing Term support use in Animal Rule studies
for SEND.
Modify SEND-SSTYP Modify definition of the codelist.

Existing Term
Create New SDTM-DIR ANTEROLATERAL

Term
Create New Multiple New LBTEST, LBTESTCD and UNIT
Term terms requested. File emailed
separately.
Create New SDTM- DROPLET DIGITAL PCR

Term METHOD
Create New SDTM- MSPIKEXR (Monoclonal Protein

Term LBTEST/CD Spike Excretion Rate)
Create New Multiple SDTM codelists (LOC, BEDECOD,

Term DICTNAM, DIR, EGSTRESC,
MEDEVAL, METHOD, FRM,
SPECCND)
Create New SDTM- TEST-OF-CURE
Term EPOCH
Create New SDTM- New terms required for GFR

Term LBTEST/CD adjusted for BSA using different
components
Modify SDTM- Please merge the labtest C135429

Existing Term LBTEST/CD into C81985, they are synonymous.
Create New SDTM-LOC PARASPINAL REGION

Term
Create New SDTM-FREQ Please add the submission value of
Term 3 TIMES PER WEEK to the SDTM
CT codelist FREQ.
Create New SDTM-UNIT steps/min

Term
Create New SDTM-UNIT deg/s
Term
Create New SDTM-UNIT deg2

Term
Create New SDTM- Prophylaxis

Term TRTINTNT
Create New SDTM- ELECTRICAL IMPEDANCE

Term METHOD MYOGRAPHY
Create New CDASH- INJECTION

Term EXDOSFRM
Create New Multiple New terms for LOC and METHOD

Term codelists.
Create New SDTM- TAU PROTEIN, FREE
Term LBTEST/CD
Create New SDTM- New LBTESTCD/LBTEST pair for

Term LBTEST/CD C3a-desArg
Modify SDTM- Crenated Cells; Echinocytes
Create New SDTM- 3 new methods please: WHOLE

Term METHOD EXOME SEQUENCING, GENE-
TARGET SEQUENCING,
FLUOROMETRY
Create New SDTM-MITS/ Please add new MITSCD of ALK_O
Term CD for the Submission Value and ALK
Fusion (Oncogene) as the synonym.
Please add new MITS of ALK Fusion
(Oncogene) as the Submission
Value.
Create New SDTM-MITS/ Please add the MITSCD of ROS1_O

Term CD as the submission value and ROS1
Fusion (Oncogene) as the synonym.
Also add MITS of ROS1 Fusion
(Oncogene).
Create New SDTM-MITS/ Please add the MITSCD of EGFR as

Term CD the submission value and Epidermal
Growth Factor Receptor as the
synonym. Also add MITS of
Epidermal Growth Factor Receptor
as the submission value.
Create New SDTM-MITS/ Please add the MITSCD of HPV_P16
Term CD as the submission value and Human
Papilloma Virus Associated Cancer
as the synonym. Also add MITS of
Human Papilloma Virus Associated
Cancer as the submission value.
Create New CDISC- Data Standards' is not defined

Term Glossary anywhere in the CDISC lexicon. It
would be a good addition to the
glossary.
Create New Multiple NEW CC/RS Codelist

Codelist
Modify SDTM-Domain Please refer to additional information
Existing Term box for more details
Create New SEND- Please refer to additional information
Term SDOMAIN box for more details
Modify SDTM- OLD OR AGE UNDETERMINED

Existing Term EGSTRESC RIGHT VENTRICULAR
MYOCARDIAL INFARCTION NCI =
Old or Age Indeterminate Right
Ventricular Myocardial Infarction by
ECG Finding
Modify SDTM- Term COMPLEX or COMPLEXES
Existing Term EGSTRESC are used. Is it possible to be
consistent ? NCI terminology use
"COMPLEX" term for all mentionned
CDISC values
Create New SDTM- Please consider the mentionned NCI

Term EGSTRESC terms in order to include them in
EGSTRESC CDISC codelist
Create New SDTM-UNIT Please add uV2 (microvolt squared)

Term to the UNIT codelist.
Create New SDTM- New PK term requests for
Term PKPARM/CD PKPARM/CD.
Modify SDTM- Changes to existing PKPARM/CD

Existing Term PKPARM/CD terms
Create New SDTM-LOC Please consider adding New terms to
Term the LOC codelist
Modify Multiple See additional information box for

Existing Term more details
Create New Multiple Requesting additional SDTM terms
Term to support collection of Laboratory
assay results.
Create New SDTM- Date of Delivery or Termination

Term RPTEST/CD TESTCD = DDTDTC
Create New SDTM- Test Name = Type of Delivery or
Term RPTEST/CD Termination TESTCD = TEDYTN
Create New SDTM- Test Name = Mode of Delivery

Term RPTEST/CD TESTCD = MEDYTN
Create New SDTM- Test Name = Products of Conception

Term RPTEST/CD Examined TESTCD = PROCOEX
Create New SDTM- Test Name = Exposed Through

Term RPTEST/CD Lactation TESTCD = EXPLACT

Term Pharmacology
Create New SDTM- New term: FLAP ENDONUCLEASE
Term METHOD MEDIATED STRUCTURE SPECIFIC
CLEAVAGE ASSAY
Create New Multiple Create Clinical Classifications CT for

Codelist the Brief Psychiatric Rating Scale
(BPRS) instrument
Create New SDTM- LVDD; Left Ventricular Dimension at
Term CVTEST/CD Diastole
Create New SDTM- IVSD; Interventricular Septum

Term CVTEST/CD Thickness at Diastole
Create New SDTM- PWD; Posterior Wall Thickness at

Term CVTEST/CD Diastole
Modify SDTM- Change C119174 submission value

Existing Term DLQI1TN = DLQI-Score to DLQI1-Score
Create New SDTM- Soluble B Cells Mature Antigen
Term LBTEST/CD
Create New New For SDTM-LBANMET codelist (new
Term with P38), please add FIBROSURE
FORMULA, HEPATOSCORE
FORMULA, and FIBROMETER
FORMULA. This is to support the
LOINC mapping.
Create New SDTM-UNIT mL/s/m2

Term
Create New SDTM- Please add to the PROCEDUR

Term PROCEDUR codelist the CDISC Submission
Value of POLYGRAPHY.
Modify CDISC- C94236/good clinical practice (GCP)

Create New NEW Create a new codelist, containing

Codelist valid values for the CSTATE findings
variable. This can be handled by the
general terminology team.
Create New SDTM- JCVDNA/JC Virus DNA

Term MBTEST
Other SDTM- Request to have one CDSIC CT file
LBTEST/CD for LAB with all possible values for
LBTESTCD, LBTEST and
LBSTRESU (standard units).
Create New CDISC- Multiple terms File emailed

Term Glossary separately
Modify SDTM- Please remove Penicillium
Existing Term LBTEST/CD chrysogenum IgE Antibody/C147287
from the LBTEST-CD codelists, it is
synonymous to P. notatum Antigen
IgE Antibody/C130146.
Modify SDTM- Please add synonyms to LB Terms

Create New MULTIPLE Multiple new term requests from the
Term Type 1 Diabetes TA project.
Create New SDTM-UNIT log10 PFU; log10 PFU/mL

Term
Create New SDTM-UNIT umol/mmol

Term
Create New SDTM- 5-Hydroxyindoleacetic

Term LBTEST/CD Acid/Creatinine
Create New SDTM- new term requests for four new

Term LBTEST/CD LBTEST values to support draft
LOINC mapping
Modify SDTM- Review published lab tests C142275
Existing Term LBTEST/CD and C147350: I think these are
synonymous. At the very least the
synonyms infer synonymy.
Create New Multiple 1 new term request for LBTEST/CD

Term and 3 new terms for METHOD
Modify SDTM-LOC For the submission value "AXILLA",

Existing Term is it possible to add "ARMPIT" as
synonym ?
Modify CDISC- C156629 anticipated adverse event
Modify SDTM- Modify two terms: C106519 and

Existing Term MBTEST/CD C117849
Modify SDTM- Add a new CDISC SY to C74716

Existing Term MBTEST/CD
Create New NEW QSCAT/QSTESTCD/QSTEST for

Codelist T1DDS (Diabetes Distress Scale for
Adults with Type 1 Diabetes) This is
for T1D TAUG
Create New SDTM- Soluble Complement C5b-9
Term LBTEST/CD
Create New SDTM-LOC EXTRANODAL

Term
Modify SDTM- Pls add SY to C81976/Anti-
Existing Term LBTEST/CD Saccharomyces cerevisiae Antibody
Create New SDTM-EVAL Submission value: DEVICE Preferred

Codelist term: Medical Device
Create New SDTM- See section 3.1 example 1 (is.xpt) of
Term ISTEST/CD the HIV TAUG. There is an ISTEST-
CD value in the example that is not
published in the codelist. Could the
team review the example and figure
out what the published ISTEST and
ISTESTCD should be and develop
it?
Create New SDTM- PSEUDOVIRION-BASED

Term METHOD NEUTRALIZATION ASSAY
Modify SEND- C120931 - TESTCD is 9 characters.

Existing Term SRETSTCD
Create New Multiple Please add new TEST/CD and
Term PARM/CD terms
Modify CDISC- data subject - An individual who is
Existing Term Glossary the subject of personal data, persons
to whom data refers. [ISO/TS
25237:2008]
Create New Multiple Add the following scores to the BDI

Term and TDI instrument CT BDI0104
BDI01-Baseline Focal Score
TDI0104 TDI01-Transition Focal
Score "
Create New NEW NEW QRS REQUEST

Codelist
Create New SDTM- ATC, CTCAE, UNII, MED-RT, NDF-

Term DICTNAM RT
Modify SEND- Please return Microscopic

Existing Term MITEST Examination.
Modify SDTM-UNIT Add CDISC SYs and update
Existing Term definitions for 3 existing UNI terms
Create New SDTM- IMMATURE PLATELET FRACTION,

Term LBTEST/CD %IPF
Modify SDTM- Querying synonym for C75350

Modify SDTM- Homocitrulline is listed as a synonym
Existing Term LBTEST/CD for both C154759 and C154758. We
need to check this and either remove
from one or merge these concepts.
Create New NEW Create response codelist for

Codelist TSPARM: BLNDSTAT. Requested
by the CT relationships Team.
Create New NEW Request from CT Relationships

Codelist team: Please create response
codelist for TSPARM: ECG Read
Method
Create New SDTM- Mumps rubulavirus
Term MICROORG
Create New SDTM- Flocculation, Charcoal Enhanced

Term METHOD
Modify SDTM- Please delete "Homocitrulline" as

Existing Term LBTESTCD synonym of submission value Alpha-
Aminobutyric Acid/AAMBTAC
Modify SDTM- Please delete "Basophilic

Existing Term LBTESTCD Erythroblast" as synonym of
Prorubricyte
Modify SDTM- Please delete "Basophilic
Existing Term LBTESTCD Normoblast " as synonym of
Prorubricyte
Modify SDTM- Please delete "Polychromatophilic

Existing Term LBTESTCD Erythroblast" as synonym of
Rubricyte
Modify SDTM- Please delete "Polychromatophilic

Existing Term LBTESTCD Normoblast " as synonom of
Rubricyte
Modify Multiple For Laboratory Test Name/Code

Existing Term LBTESTCD/LBTEST and SDTM
Microscopic Finding Test
Name/Code MITSCD/MITS codelists
Modify Multiple CMR is reported as synonym of
Existing Term MOLECULAR CR but the value CMR
already exists and means Complete
Metabolic Response
Create New SDTM-UNIT DNA copies/ug

Term
Create New Multiple We are requesting terms for

Term pharmacokinetic parameters
generated from noncompartmental
analysis (file emailed separately).
Create New SDTM- Please add DIGITAL WIDE FIELD
Term PROCEDUR IMAGING to the PROCEDUR
codelist.
Create New SDTM- COMPLETED FOLLOW-UP
Term NCOMPLT
Create New SDTM- Please add DISH to the METHOD

Term METHOD codelist.
Create New SDTM- CHLAM/Chlamydia

Term LBTEST/CD
Modify SDTM- Update definition for MMSE-2
Existing Term MMS2TC/TN STANDARD VERSION CAT CDISC
definition
Create New Multiple QSCAT/QSTESTCD/QSTEST for

Codelist DDS Partner measure

Codelist GMSS

Codelist HCS - Hypoglycemic confidence
scale
Create New SDTM- Methylphenidate

Term LBTEST/CD
Create New SDTM- Ritalinic Acid

Term LBTEST/CD
Create New SDTM- Ethyl Glucuronide and Ethyl Sulfate

Term LBTEST/CD
Create New SEND-CLCAT Pan/Cage Signs

Term
Modify SDTM-UNIT Add SY to C122230 and update

Existing Term definition. This is a TYPE 1 change
Erin.
Create New SDTM- 8 Hydroxydeoxyguanosine
Term LBTEST/CD
Create New Multiple Please find attached a multiple term

Term request file that contains all content
from P38 without a new term request
number. It includes 135 new term
requests and 22 changes to existing.
Create New SDTM-UNIT 10^7 PFU

Term
Create New SDTM-UNIT 10^8 PFU

Term
Create New SDTM- Galectin-3

Term LBTEST/CD
Create New SDTM- Soluble L-Selectin
Term LBTEST/CD
Modify SDTM- Please remove 155 terms from

Existing Term LBTEST/CD LBTEST-CD
Create New SDTM- Mean Pulmonary Artery Wedge
Term CVTEST Pressure
Create New SDTM-UNIT Please add to the UNIT codelist:
Term days/week days/month hours/week
Create New SEND? For Non-Neoplastic codelist.

Term AUTOLYSIS
Create New Multiple Create new GAD02TC/TN and

Term QSCAT="GAD-7 V2" for a 2nd
version of the Generalized Anxiety
Disorder-7.
Create New CDISC- Traceability
Term Glossary
Create New SDTM- CLONAL PLASMA CELL

Term LBTEST/CD
Create New SDTM- CORNEAL TOPOGRAPHY
Term METHOD
Create New SDTM- ORTHOSTATIC

Term POSITION
Create New SDTM- Gene Mutation Indicator

Term PFTEST/CD
Create New SDTM- Chlamydia pneumoniae IgG Antibody

Term MBTEST/CD
Create New SDTM- Please refer to file
Term LBTEST/CD CDISC_Multi_Term_Request_RohitD
hanjal_2019-06-10.xls emailed to
NciEvsCdiscHelp@mail.nih.gov.
Please see 'Exist Codelist - New Test
PARM' worksheet
Modify SDTM-FTCAT Pls update FTCAT C123667

Existing Term
Create New SDTM- RESTING FUNCTIONAL MRI

Term METHOD
Modify SDTM-UNIT "Please add the following synonym
Existing Term to the C69112 (ppth) term: - '%O'
and Promille "
Modify SDTM-LOC Please add synonyms to the

Existing Term following LOC terms: ELBOW JOINT
and WRIST JOINT
Modify SDTM- Progesterone Receptor

Create New SDTM-UNIT TCID 50/L

Term
Create New Multiple Create QSTESTCD = "GDS0131"

Term and QSTEST = "GDS01-Total Score"
for GDS01TC/TN codelists and
create QSTESTCD = "GDS0216"
and QSTEST = "GDS02-Total Score"
for GDS02TC/TN codelists.
Create New SDTM- "PATERNAL PARTNER" and

Term RELSUB "MATERNAL PARTNER"
Create New SDTM- Gene Alteration Type

Term PFTEST
Create New SDTM- GENALTP
Term PFTESTCD
Create New SDTM- GENEMIND

Term PFTEST/CD
Create New SEND- IHC Histopathologic Exam, Qual

Term MITEST/CD (TESTCD: IHCHSXQL)
Create New SDTM- Respiratory Tests - Multiple Request

Term RETEST/CD
Modify SDTM- Add the following synonyms to the
Existing Term LBTEST/CD current list for LBTESTCD=CD40L
and LBTEST=CD40 Ligand: CD154,
TRAP, T-BAM, gp39.
Create New SDTM- 2 new LBTESTCD/LBTEST pairs
Term LBTEST/CD please
Create New SDTM- Add "DNA copies/ug"

Term PKUNIT
Create New SDTM- new concept in development at FDA

Term glossary
Create New SDTM- Two new QRS METHOD terms
Term QRSMTHOD
Create New Multiple New terms

Term
Create New SDTM- PLAQUE REDUCTION

Term METHOD NEUTRALIZATION TEST
Other SDTM-Domain Domain
Create New SDTM- RECRUITMENT CLOSED

Term NCOMPLT
Create New SDTM- ARAUCIFO, ARAUCIFD :

Term PKPARM/CD Accumulation Ratio AUCIFO
Create New SDTM-Domain MO is already present

Term
Create New SEND- INTERIM RECOVERY SACRIFICE
Term DSDECOD
Create New SDTM- OBSERVATION

Term EPOCH
Create New SDTM- ug/dL

Term PKUNIT
Create New SDTM- Please add "Study Data Technical
Term FDATSRS Conformance Guide v4.3"

Term
Create New Multiple POOLINT

Term
Create New SDTM- SUPPORTIVE CARE

Term TRTSET
Create New SDTM- INDUCTION OF

Term TRTSET RADIOSENSITIZATION
Create New SDTM- TRANSPLANT CONDITIONING
Term TRTSET
Create New SDTM- REMISSION INDUCTION THERAPY

Term TRTSET
Create New SDTM-EVAL NEUROLOGIST

Term
Create New SDTM- CODELIST_DEFINITION contains

Term SKINCLAS more than one space between two
words, please update
Create New SDTM- Urothelial Cell
Term LBTEST
Modify SDTM- Changes required to C158230?

Create New SDTM- VEGFD; Vascular Endothelial

Term LBTEST/CD Growth Factor D
Create New SDTM- CXCL12; Stromal Cell-Derived

Term LBTEST/CD Factor-1 Alpha
Create New SDTM-LOC Please add the term SAGGITAL

Term SINUS to the LOC codelist.
Create New SDTM-LOC Please add SIGMOIDAL SINUS to

Term the LOC codelist.
Create New SDTM- Otolaryngologic Examination

Term DOMAIN Findings domain
Create New SEND- similar to ARAUCLST or ARCMAX.
Term PYTESTCD
Other SDTM- Request for new Codetable mapping

PKUNIT file for PK
Create New SDTM- 4 NEW TEST PAIRS PLEASE

Term LBTEST/CD
Modify SDTM- Typo for the word Paliative. Should

Existing Term EOR02TC be Palliative.
Modify SDTM-QRS Remove and add new SY to the 6

Existing Term METHOD values in the QRS Method codelist
Create New SDTM- OT (Otolaryngologic Findings)

Term DOMAIN
Create New SDTM- FAC070TC/TN (FAC07014, FAC070-
Term FAC070TC/TN Subscale Score)
Create New SDTM- FAC008TC/TN for subscale and total

Term FAC008TC/TN scores
Create New SDTM- Add new term to DUTEST-CD. This

Term DUTEST/CD is from the T1D TAUG
Create New SDTM-DIR Please create 4 new DIR terms

Term related to the LOC of
SUPRATENTORIAL BRAIN
Create New SEND- Date of Final QA Sign off (QADTC)

Term STSPRM
Create New SEND- SE of Cmax for a sparse-sampling
Term PPTMDARS profile for a given POOOLID be
reported as SECMAX. SE of
AUC(last) would be reported as
SEAUCLST, and so on.
Create New SDTM-LOC Please add the term EARLOBE to

Term the LOC codelist. The definition is:
The soft, fleshy lower part of the
external ear.
Create New SDTM-OUT Consider adding the term

Term "WORSENED" as a new, unique
value to this non-extensible codelist.
Create New NEW Please create a new generic SEV
Codelist codelist to support the SEV variable
across domains.
Create New SDTM- Please add BIOIMPEDANCE

Term METHOD SPECTROSCOPY (BIS) to the
METHOD codelist.
Create New SDTM- LBTEST/CD REquest

Term LBTESTCD
Create New SDTM- REMISSION

Term NCOMPLT
Create New SDTM- Test Name = Peak Tricuspid

Term CVTEST/CD Regurgitation Velocity TESTCD =
PTVRGVEL
Create New SDTM- Test Name = Peak Tricuspid Inflow

Term CVTEST/CD Velocity TESTCD = PTVIFVEL
Create New SDTM- Test Name = Left Ventricle
Term CVTEST/CD Longitudinal Shortening TESTCD =
LVLNGSTR
Create New SDTM- Test Name = Left Ventricle

Term CVTEST/CD Circumference Shortening TESTCD
= LVCIRSTR
Create New SDTM- Test Name = Mean Left Ventricle

Term CVTEST/CD Longitudinal Strain TESTCD =
MLVLGSTR
Create New SDTM- Mumps Virus IgM Antibody

Term MBTEST/CD
Create New SDTM- Chlamydia pneumoniae IgG Antibody
Term MBTEST/CD
Create New SDTM- Mycoplasma pneumophila IgM

Term MBTEST/CD Antibody
Create New SDTM- Mycoplasma pneumophila IgG

Term MBTEST/CD antibody
Create New SDTM- Mycoplasma genitalium

Term MBTEST/CD
Create New SDTM- Rubella IgM Antibody
Term MBTEST/CD
Term Asthma Daytime Symptom Diary

Term Asthma Nighttime Symptom Diary
Modify SDTM- Modify CDISC Synonym for the Vital
Existing Term VSTESTCD Signs test code/test of
BODLNGTH/"Body Length" by
adding the synonyms " crown-heel
length" and "CHL" as these are
common terms used in pediatrics for
this measurement.
Modify SDTM-UNIT Synonym additions please

Existing Term
Create New SDTM- PNFH/Phosphorylated Neurofilament

Term LBTESTCD Heavy Chain
Modify SDTM- MEASLES VIRUS/C14237 Update

Existing Term MICROORG CDISC submission value and add SY
Create New SDTM- Please add the exisiting 6 values

Term METHOD; from the QRS METHOD into the
QRSMTHOD METHOD codelist. Please also add
the brand new QRS METHOD values
into METHOD as well
Create New Multiple Please add new terms to LBTEST
Term and METHOD
Create New SDTM- Make changes to lab terms

Term LBTEST/CD
Create New SDTM- MULTIFOCAL
Term PORTOT
Create New SDTM- MULTICENTRIC

Term PORTOT
Create New SDTM- AGAR PROPORTION

Term METHOD
Create New SDTM- S-adenosylmethionine

Term LBTEST/CD
Create New SDTM- S-adenosylhomocysteine

Term LBTEST/CD
Create New SDTM- Betaine

Term LBTEST/CD
Create New SDTM- Cysteine

Term LBTEST/CD
Create New SDTM- Dimethylglycine
Term LBTEST/CD
Create New SDTM- Cystathionine Beta-synthase

Term LBTEST/CD
Create New NEW New PFANMET codelist -

Term Pharmacogenomics Analytical
Method Calculation Formula
Attached to PFANMETH
Create New SDTM- LBTESTCD: FTH1 LBTEST: Ferritin

Term LBTESTCD Heavy Chain
Create New SDTM- LBTESTCD: FTL LBTEST: Ferritin

Term LBTESTCD Light Chain
Modify CDISC- control, control group, controlled trial

Create New SDTM- WASH FLUID
Term SPECTYPE
Create New SDTM- ANPPROMR

Term LBTESTCD
Create New SDTM- Mid-Reg Pro-Atrial Natriuretic

Term LBTEST Peptide
Create New ADaM-DTYPE LOQ

Term
Create New ADaM-DTYPE LOD

Term
Create New SEND- CONGESTION/HEMORRHAGE

Term NONNEO
Create New SEND- HYPERPLASIA/HYPERKERATOSIS
Term NONNEO
Create New SEND- LIPID GLOMERULUS
Term NONNEO
Create New SEND- PHYSEAL DYSPLASIA

Term NONNEO
Create New SEND- MENINGIOANGIOMATOSIS
Term NONNEO
Create New SEND- ENDOMETRIOSIS

Term NONNEO
Create New SEND- FIBRIN

Term NONNEO
Create New SDTM-FRM Please consider adding New terms to

Term the FRM codelist
Create New SDTM- Nucleic Acid-Based Tests
Term METHOD
Create New SDTM- 7-alpha-hydroxy-4-cholesten-3-one

Term LBTEST
Create New SDTM- CELL CYTOTOXICITY
Term METHOD NEUTRALIZATION ASSAY
Create New SDTM- Thrombin Antithrombin Complex
Term LBTEST/CD (Code C161371)
Modify SDTM- Oncology Response Assessment

Existing Term ONCRSR Result = MR (C123598) meaning
Minor Response
Create New Multiple Add 2 new terms to DATEST-CD;

Term remove a term from Nutrition
Findings About Test Name/Code
Create New SDTM- New LBTEST
Term LBTEST/CD
Create New SDTM-LOC Abductor Pollicis Brevis Muscle

Term
Create New SDTM-LOC Abductor Digiti Minimi of the Hand

Term
Create New SDTM- Aspergillus Antibody

Term MBTEST/CD
Create New SDTM- Cancer Antigen 242

Term LBTEST/CD
Create New SDTM- CD20/Lymphocytes

Term LBTEST/CD
Create New SDTM- CD38/Lymphocytes
Term LBTEST/CD
Create New SDTM- Choriogonadotropin Tumor Marker

Term LBTEST/CD
Create New SDTM- Circulating Plasma Cells

Term LBTEST/CD
Create New SDTM- Epstein-Barr Virus DNA

Term MBTEST/CD
Create New SDTM- Hepatitis B Virus Core Antigen

Term MBTEST/CD
Create New SDTM- Hepatitis E Virus Antigen

Term MBTEST/CD
Create New SDTM- Lipoprotein Lipase

Term LBTEST/CD
Create New SDTM- Renal Epithelial Cells Casts
Term LBTEST/CD
Create New SDTM- Cytomegalovirus pp65 Antigen

Term MBTEST/CD
Create New SDTM-UNIT /5x10^4 WBC

Term
Create New Multiple Multiple Test, Test Code, and Terms.

Term See spreadsheet named below in
Additional Information.
Create New Multiple RECIST 1.1, iRECIST, Anatomical
Term Location
Create New Multiple New LBTEST and LBTESTCD for

Term Reactive Lymphocytes (LYMRCT)
Remove Reactive Lymphocytes
synonym from Lymphocytes Atypical
(LYMAT)
Create New SDTM- ERAW

Term RETEST/CD
Create New SDTM- Effective Airway Resistance
Term RETEST/CD
Create New SDTM- ESRAW

Term RETEST/CD
Create New SDTM- Effective Specific Airway Resistance

Term RETEST/CD
Create New SDTM- FEV3FVC

Term RETEST/CD
Create New SDTM- FEV3/FVC

Term RETEST/CD
Create New SDTM- FEV1SVC

Term RETEST/CD
Create New SDTM- FEV1/SVC

Term RETEST/CD
Create New SDTM- FEV3PP

Term RETEST/CD
Create New SDTM- Percent Predicted FEV3

Term RETEST/CD
Create New SDTM- Human rhinovirus/enterovirus

Term MBTEST/CD (HRV/ENT)
Create New Multiple P39 terms need request code
Term
Create New SDTM- Leptocytes

Term LBTEST/CD
Create New SDTM- Please add ENDOCRINOLOGIST to

Term MEDEVAL the MEDEVAL codelist.
Create New SDTM- Please add the term INTERNIST to

Term MEDEVAL the SDTM MEDEVAL codelist.
Create New SDTM-UNIT Request for 3 new terms related to
Term ophthalmic therapy
Create New SDTM- New term for cfDNA please

Term GENSMP
Create New NEW "STUDY PARTICIPATION" or

Codelist "STUDY TREATMENT"
Modify Multiple Many and Multiple are not

Existing Term synonymous.
Modify SEND- Mean Arterial Pressure

Existing Term SCVTST
Create New SDTM- 3,4-methylenedioxyamphetamine

Term LBTEST/CD (MDA)
Create New SDTM- 3,4-methylenedioxy-N-
Term LBTEST/CD ethylamphetamine ("Eve"); MDEA
Create New SDTM- Ephedrine ; EPHD

Term LBTEST/CD
Create New SDTM- Phenylpropanolamine
Term LBTEST/CD
Create New SDTM- Norpseudoephedrine

Term LBTEST/CD
Create New SDTM- Phentermine

Term LBTEST/CD
Create New SDTM- Please consider adding two new

Term SPECCOND terms to the SPECCOND codelist
Modify Multiple Draft spreadsheet of the suggested

Existing Term change was discussed at the QRS
CT meeting on 9/12 and sent
separately.
Modify SDTM- Change definition to broaden to
Existing Term DOMAIN "study product", not just "study drug".
This is to allow use in studies that
investigates products other than
drugs.
Create New Multiple New QS codelists, QSCAT,
Codelist QSTEST-CD terminology request for
FACT-COG
Create New SEND-SSTYP Please consider adding three
Term additional SSTYPs (DERMAL,
OCULAR, OTOTOXICITY)
Create New SDTM- Needed for LOINC

Term LBTEST/CD mapping...identified during internal
review.
Create New SDTM-UNIT add "BOWL"

Term
Create New SDTM- WITHDRAWAL OF CONSENT

Term NCOMPLT
Create New Multiple Add new CT terms for scoring

Term variables in (FACIT-F V4) and
(WPAI-SHP) by extending codelists
for
Create New New Please model and define the CT for
Codelist the Short Physical Performance
Battery Protocol and Score Sheet. I
believe it belongs in the FT domain.
Modify Multiple This request is to modify the

Existing Term GDS02PC and GDS02PN codelists.
Create New SDTM- CDISC submission value =

Term PKPARM/CD MRAUCINT, CDISC Synonym(s) =
Metabolite Ratio AUCINT from T1 to
T2
Create New SDTM- DISEASE MODIFYING.
Term TINDTP
Create New SDTM- Artificial heart implant; Synonym -

Term PROCEDUR Total artificial heart
Create New SDTM- Intra-Aortic Balloon Pumping
Term PROCEDUR
Create New SDTM- EXTRACORPOREAL MEMBRANE

Term PROCEDUR OXYGENATION
Create New SDTM- Extracorporeal Membrane

Term PROCEDUR Oxygenation
Create New SDTM- Intra-Aortic Balloon Pumping

Term PROCEDUR
Create New SDTM- PERCUTANEOUS VENTRICULAR
Term PROCEDUR ASSIST DEVICE PLACEMENT;
Synonym - Insertion of percutaneous
external pVAD
Create New SDTM- ULTRAFILTRATION, MECHANICAL

Term PROCEDUR FLUID REMOVAL PROCEDURE
Create New SDTM- HEMODIALYSIS

Term PROCEDUR
Create New SDTM- HEMOFILTRATION

Term PROCEDUR
Create New SDTM- IMPLANTATION OF

Term PROCEDUR BIVENTRICULAR DEFIBRILLATING
CARDIAC PACEMAKER
Create New SDTM- BIVENTRICULAR CARDIAC

Term PROCEDUR PACEMAKER PROCEDURE;
SYNONYM: PACEMAKER
PROCEDURE, BIVENTRICULAR
NON-DEFIBRILLATING
Create New SDTM- IELSE
Term MITSCD
Create New SDTM- QTCIAG1, QTcI Interval, Aggregate
Term EGTESTCD 1
Create New SDTM- Please consider adding "STATIC

Term METHOD PERIMETRY"
Create New SDTM- Please consider adding OEEXAM
Term OETESTCD (Ophthalmic Examination)
Create New SDTM-LOC PERIFACIAL LYMPH NODE
Term
Other SDTM- streptococcal group A antigen testing

MBTEST-CD or Rapid Strep A test
Create New SDTM- coulometric titration
Term METHOD
Create New SDTM- Type I Interferon Gene Expression

Term LBTEST/CD
Create New SDTM- Hepcidin

Term LBTEST/CD
Create New SDTM- VLDL/Chylomicron triglyceride total

Term LBTEST/CD (included in a NMR LipoProfile-III
Subclass Particle Analysis)
Create New SDTM- In Situ Hybridization (ISH)

Term LBTEST/CD
Create New SDTM- LIKERT SCALE 5-POINT

Term QRSMTHOD
Create New SDTM- PLAQUE ASSAY

Term METHOD
Create New SDTM-CAN DOSE POSTPONED

Term
Modify SDTM- Code C38312 and Code C38271 on
Existing Term ROUTE the List C66729 as published in the
SEND Terminology 2019-09-27 have
the same submission value
"URETERAL".
Create New SDTM-EVAL PARENT/CAREGIVER

Term
Create New SDTM- CPREDOSE

Term PKPARMCD
Create New SDTM- Conc Predose

Term PKPARM
Create New SDTM- Test Name = ECG Findings, Not

Term EGTEST/CD Otherwise Specified TESTCD =
ECGFNOS
Modify SDTM-LOC Can you please add a synonym of
Existing Term "MID-TARSAL JOINT" to the term
C102354 - TRANSVERSE TARSAL
JOINT
Create New SDTM- Study Data Technical Conformance
Term FDATSRS Guide v4.4
Create New SDTM-UNIT kU/L
Term
Create New SDTM- Add PLAQUE ASSAY. If it is

Term METHOD equivalent to CELL BASED
BIOASSAY, then add it as a
synonym for CELL BASED
BIOASSAY
Create New Multiple Batch 1 terminology for Heart Failure

Term TAUG - 7 new terms and 12 changes
to existing.
Create New SDTM- CYURTUSP - Urate Crystals,

Term LBTEST/CD Unspecified
Create New SDTM- CYPHOUSP - Phosphate Crystals,

Term LBTEST/CD Unspecified
Create New Multiple Create new test codes and test

Term names for FAC008TC/TN for TOI
(FAC00843) and FACT-G subtotal
scores (FAC00844) on the FACT-C.
Create New SDTM- CSHYAGRA - Hyalogranular Casts
Term LBTESTCD
Create New Other These results are being mapped to

Term the TRTEST of Tumor State as a
result for the questions of we are
asking for: Non-Target Lesion Status
and New Non-Target Lesion Status
Create New SDTM- NEW NON-TARGET EXTRA NODAL

Term TUIDRS
Create New SDTM- NEW NON-TARGET NODAL

Term TUIDRS
Create New SDTM- NEW TARGET EXTRA NODAL

Term TUIDRS
Create New SDTM- NEW TARGET NODAL
Term TUIDRS
Create New SDTM- NUMERICAL RATING SCALE 11-

Term METHOD POINT
Create New SDTM- VISUAL ANALOG SCALE (100 MM)

Term METHOD
Create New SDTM- Support an existing SDTMIG

Term PROCEDUR example.
Create New Multiple 3 new term requests for the LOINC

Term mapping
Create New Codetable Oncology_Codetable spreadsheet -

Term Mapping request to add: NON-
PATHOLOGICAL to the
TR_Codetable_Mapping tab for the
TRTEST of: Tumor State
Create New Multiple FTTESTCD/FTTEST/FTCAT for
Codelist Rockport One Mile Walk Test For
T1D Exercise and Prevention TAUG
Modify QRS- "Please remove the PGI instrument

Existing Term PGI01TC/TN test PGI0104/PGI01-Overall Health
QSTESTCD/QSTEST from the
codelists PGI01TC and PGI01TN. "
Create New SDTM- LBTESTCD: FLT3L LBTEST: FMS-

Term LBTEST/CD like Tyrosine Kinase 3 Ligand
Create New SDTM- LBTESTCD: TNF5S LBTEST:

Term LBTEST/CD Soluble TNF Superfamily Member 5
Create New SDTM-QSCAT Pls create QSCAT for Bristol Stool

Term Form Scale, C125393
Create New Multiple This file contains 3 new term
Term requests for the LBTEST/CD
codelists and 5 changes to existing
terms to the LBTEST/TESTCD and
UNIT codelists. All to support the
LOINC mapping
Modify QRS- Convert the QRS instrument CT for

Existing Term EDSS01TC/ the Kurtzke Expanded Disability
TN Status Scale (EDSS) form a
questionnaire to a clinical
classification
Modify SDTM- Update CDISC definition for 5

Existing Term PKPARM/CD PKPARM-CD terms
Create New SDTM-LOC ILEUM, DISTAL
Term
Create New SDTM- t1/2 distribution, kdist

Term PKPARM/CD
Create New Multiple Request to create GAD02PC/PN,

Term GAD02TS/GAD02-Total Score -
Analysis for GAD-7 V2 ADaM CT
Create New This request is for the PTSD TA and
Codelist the SDS QRS Subteam.
Modify Multiple Functional Activities Questionnaire
Existing Term NACC Version (FAQ-NACC)
Modify Multiple Functional Assessment Scale-NACC

Existing Term UDS v3.0 (FAS-NACC UDS V3.0)
Create New SDTM- FINGERSTICK

Term CLMETH
Create New SDTM- L-FABP, L-type fatty acid-binding

Term LBTEST/CD protein
Create New SDTM- 8-Hydroxy-2'-Deoxyguanosine (aka

Term LBTEST/CD 8-OHdG)
Create New SDTM- LAVOLIDX; Left Atrial Volume Index

Term CVTEST/CD
Create New SDTM- Please add "FLUORESCENT FLOW

Term METHOD CYTOMETRY" from the SDTM-
METHOD Codelist
Create New SDTM- Please add "DC SHEALTH FLOW"
Term METHOD tp the SDTM-METHOD Codelist
Create New SDTM- Please add "CYANIDE-FREE SLS"

Term METHOD to the SDTM-METHOD Codelist.
Create New SDTM- Please add PHARYNGEAL to the

Term ROUTE ROUTE codelist.
Create New Multiple Batch 1 Psoriasis TAUG terminology
Term
Other Multiple P40 publication terminology additions

and changes needing new term
request numbers. 115 terms total =
92 new terms + 23 changes to
existing
Other Multiple "CDISC Glossary P40 publication

terminology additions and changes
needing new term request numbers.
xx Terms total = 22 new terms + 33
changes to existing "
Create New SDTM- New lab terms to be added
Term LBTEST/CD
Create New SDTM- Factor XIII Activity

Term LBTEST/CD
Create New SDTM- Whole Blood Equivalent Glucose

Term LBTEST/CD
Create New SDTM- B-Lymphocytes

Term LBTEST/CD
Create New SDTM- B-Lymphocytes/Lymphocytes
Term LBTEST/CD
Create New SDTM- B-Lymphocytes/Leukocytes

Term LBTEST/CD
Modify SDTM-UNIT Submission value : g/g

Existing Term
Modify Multiple For all UNIT codelists, (PKUNIT,

Existing Term UNIT, VSRESU), it is possible to add
in synonym the value when u
(micro) is used.
Create New SDTM- HIGH PROTEIN

Term SPECCOND
Create New SDTM- TASK FUNCTIONAL MRI

Term METHOD
Create New SDTM- PERFUSION MRI

Term METHOD
Create New SDTM-DIR Delete C161325 - FRONTAL
Term
Create New NEW CCTESTCD/CCTEST/CCCAT for

Codelist KDIGO Staging for AKI For AKI
TAUG
Create New CDISC- Add XML (eXtensible Markup
Term Glossary Language) to the CDISC glossary
Create New CDISC- Update the citation in definition for

Term Glossary C142548/XML Data Element
Create New The EXACT instrument needs 3
Term respiratory scores and a total score
added, based on the user manual
description of these items. These
may be provided as part of
Electronic Data Transfer (eDT) by
vendors using PRO devices to
capture the data.
Create New SDTM-LOC ANTERIOR INFERIOR

Term CEREBELLAR ARTERY
Create New SDTM-LOC POSTERIOR INFERIOR

Term CEREBELLAR ARTERY
Create New SDTM- "I would like to request that the

Term CVTEST/CD following terms in the VSTEST(CD)
codelist be included in CVTEST(CD)
too: PULSEPR (Pulse Pressure)
MAP (Mean Arterial Pressure) HR
(Heart Rate) "
Create New CDISC- Glossary terms
Term Glossary
Create New NEW ROUTEC for "Route as Collected"

Codelist with term "INTRAMUSCULAR OR
SUBCUTANEOUS"
Create New Multiple NEW QS requests

Codelist
Create New SDTM-LOC "SUPRASPINATUS should be added

Term "
Change
Type
MBTESTCD N. gonorrhoeae NGO II SDTM-Published in P38,

MBTESTCD Beta-Lactamase Positive N. P39
gonorrhoeae BLPNGO
MBTESTCD Beta-Lactamase Negative N.
gonorrhoeae BLNNGO
MBTESTCD Beta-Lacatamase Positive
Bacteria BLPBAC
MBTESTCD Beta-Lactamase Negative
Bacteria BLNBAC
MBTESTCD Beta-Lactamase BLACT
METHOD OUCHTERLONY DOUBLE
IMMUNODIFFUSION
II SDTM, SEND -
As per advice given in P37 Denied file, please Published with P39
add:
Pancreatic Isoenzyme as a synonym to
AMYLASEP
Salivary Isoenzyme as a synonym to
AMYLASES
One of our studies has the above terms that do II SDTM-Published in P38
not match with the existing values NCOMPLT
(Reason for Non-Completion) codelist. So we
request that they please be added to the
NCOMPLT codelist
Just need request codes for these terms in P37 II SDTM-Published in P37
public review. There are 142 in total, including
changes to existing. Craig does not need to add
these to P38 team working documents.
Needed to support units being collected for II Do not add (P39):

Interleukin and Adhession Module laboratory pg/mL-Synonymous with
tests. ng/L (C67327), which is
already published.
ng/mL-Synonymous with
ug/L (C67306), which is
already published.
Focus-forming units (FFU). Similar to plaque- II SDTM, SEND -

forming units (PFU). Areas (foci) of cytopathic Published with P39
effect that indicate replication of the virus on a
lawn of cells may be counted, instead of actual
plaques.
The integument that covers the elbow joint. II SDTM, SEND-Published
in P38
The integument that covers the forearm. II SDTM, SEND-Published
in P38
The integument that covers the chest. II SDTM, SEND-Published
in P38
The integument that covers the inguinal region II SDTM, SEND-Published
in P38
The integument that covers the foot. II SDTM, SEND-Published
in P38
The integument that covers the knee joint. II SDTM, SEND-Published
in P38
Create a new CCCAT ( , RSTESTCD II QRS-Published in P38
AVPU01TC/TN: AVPU0101, AVPU01-Assess
Patient's Mental Status for the Alert Verbal
Painful Unresponsive QRS scale. This is for the
Ebola and Zika Tas
Supersedes previous request. II SDTM, SEND -
Published with P39, P40
LBTESTCD = PECAM LBTEST = Do not add (P39):
Platelet Endothelial Adhesion Molecule VCAM1-Do not add.
Description = A measurement of total Please map to C82042.
Platelet/Endothelial Cell Adhesion Molecule in a Do not add (P40):
biological specimen PAGA_P; PGA_P;
GM327C - Do not add.
LBTESTCD = ICAM3 LBTEST = Additional information
Intercellular Adhes Mol 3 (ICAM-3) requested from
Description = A measurement of total requestor was not
Intercellular Adhesion Molecule 3 in a biological received.
specimen
LBTESTCD = VCAM1 LBTEST =

Vascular Cell Adhesion Mmolecule 1
Description = A measurement of total Vascular
cell adhesion molecule 1 in a biological specimen
LBTESTCD = MAC1 LBTEST =

Macrophage Inflammatory Protein 1
Description = A measurement of total
Macrophage inflammatory protein-1 in a
biological specimen
LBTESTCD = PGA LBTEST = Platelet

Granulocyte Aggregates
Description = A measurement of total Platelet
Granulocyte Aggregates in a biological specimen
LBTESTCD = PAGA_P LBTEST = Plt

Activated Granalocyte Aggregates %
Description = A measurement of Platelet
Activated Granulocyte Aggregates percent in a
biological specimen
LBTESTCD = PGA_P LBTEST =

II
Definition: Is a measurement to quantify how

much control the baroreflex has on the heart rate.
II SDTM, SEND -
Published with P39
This is the unit for the new requested CV Test of:

Spontaneous Baroreceptor Sensitivity
II
Definition = Is calculated by simply taking the

standard deviation of the IBI series. It is typically
used as a representation of total variability of a
segment.
II
Definition = Is the root mean square of

successive differences. It is calculated by taking
the RMS of differences between successive N-N
intervals.
in P38
Definition: The portion of the human body that lies

at the bottom-rear part of each foot. Its exterior
shape is formed by the calcaneus, also known as
the heel bone.
Submitted on behalf of NIAID/Vaccine Research II SDTM - Published with
Center Chief Medical Officer, Dr. Julie P39
Ledgerwood; Scientific Advisors to Clinical Trials Do not add (P39): In the
Program - Dr. Katherine Houser and Dr. Emily context of viruses and
Coates vaccines,
Microneutralization and
The NIAID Vaccine Research Center requests Neutralization Assays
the addition of NEUTRALIZATION ASSAY to the are synonymous. In
METHOD Codelist , since the prefix of ?micro? in order to avoid future
the term MICRONEUTRALIZATION ASSAY, confusion, we will
which is currently listed in the METHOD Codelist, instead add 'Virus
implies a specific type of neutralization assay. Neutralization Assay' as
However, the definition given for a synonym to the
MICRONEUTRALIZATION ASSAY, ?an in vitro existing term C120695.
assay that is used to determine whether Given that there are
antibodies that can block viral infection are other types of
present in a biological specimen,? is non-specific. 'Neutralization Assays'
An internet search of published research shows not associated with
that the terms neutralization and viruses (e.g., Enzymes,
microneutralization can be used interchangeably, Cytokines, non-viral
but that the term ?microneutralization assays? is mABs, etc.) it is not an
most commonly used in influenza studies (e.g., appropriate 1:1
https://journals.plos.org/plosone/article? synonym.
id=10.1371/journal.pone.0056023 - where the
term ?Neutralization Assay? is used in the title
but the first sentence of the abstract uses ?
microneutralization?).
Since the generic term of NEUTRALIZATION

ASSAY fits the current generic definition of
MICRONEUTRALIZATION ASSAY, we request
that either MICRONEUTRALIZATION ASSAY is
replaced with NEUTRALIZATION ASSAY, or that
NEUTRALIZATION ASSAY is added to the
Codelist and an appropriate definition be provided
for MICRONEUTRALIZATION ASSAY.
The standards team at Janssen Pharmaceutical II Question answered: We
has a question on how to interpret the ?SCREEN agree that subjects
FAILURE? option below. could discontinue during
CDISC Definition: The potential subject who the screen Epoch for
does not meet one or more criteria required for things others than
participation in a trial. screen failures. The
Based on the description, the understanding requester's
was that this option should be applied to subjects interpretation is correct
who failed to meet one or more as long as the subject
Inclusion/Exclusion criteria. Therefore, meets both conditions 1
DSDECOD=SCREEN FAILURE will be assigned and 2 (as described by
as such only if this subject failed to meet eligibility the requester).
criteria. The subjects with ARMCD=SCRNFAIL
will be subjects with DSDECOD=SCREEN
FAILURE as well as subjects who discontinued
during the Screening epoch for any possible
reason (e.g. Death, Withdrawal of Consent, Lost
to Follow Up, etc.).
We could identify subjects who failed screening
by the following conditions:
1. all subjects who discontinued trial during
Screening epoch
2. ARMCD assigned as SCRNFAIL
Could you please confirm whether our
understanding is accurate?
Needed for Phase 1 trial for IS dataset
II SDTM, Protocol-
Primary Objective: Published in P38
To evaluate the effect of food on the
pharmacokinetics of [STUDY DRUG] 10 mg oral
soluble film, administered as 1 x 10 mg oral
soluble film under fasting and fed conditions.
Secondary Objectives:
? To evaluate the usability of a new [STUDY
DRUG]10 mg oral soluble film formulation.
? To evaluate the safety and tolerability of
[STUDY DRUG] 10 mg oral soluble film.
Study Design:
This will be a single centre, open-label,
randomized, single-dose, 2-period, 2-sequence,
crossover, food-effect bioavailability study.
Primary Objective: II Protocol, SDTM-
To compare the rate and extent of absorption of Published with P38
[STUDY DRUG] 10 mg oral soluble film (Test)
administered as 1 x 10 mg oral soluble film with
and without water, versus [STUDY DRUG 2] 10
mg tablet (Reference) administered as 1 x 10 mg
tablet, under fasting conditions.
Secondary Objectives:
? To compare the rate and extent of
absorption of [STUDY DRUG] 10 mg oral soluble
film administered as 1 x 10 mg oral soluble film
with water, versus without water, under fasting
conditions.
? To evaluate the usability of a [STUDY
DRUG] 10 mg oral soluble film formulation.
? To evaluate the safety and tolerability of
[STUDY DRUG] 10 mg oral soluble film.
Study Design
This will be a single centre, bioavailability, open-
label, randomized, single-dose, 3-period, 6
sequence, crossover study under fasting
conditions. Each volunteer will be given a single
dose of the Test formulation in two study periods
(with and without water), and a single dose of the
Reference formulation (with water) in the other
study period.
with P38
Please consider adding 8 LOC terms. File

emailed separately
II
Change c-code from C142702 to C90462. These

will be merged in NCIt.
II
Bess Leroy raised a question about the difference

between these two terms. "Number of Events" is
only used and published for the DKD TAUG. In
retrospect I think this term, at least in the context
of the DKD TAUG, was meant to be used to
convey the same meaning as "Number of
Episode". Should we consider retiring this term
from the DKD FATEST-CD codelists, and
perhaps add "Number of Episodes" to the DKD
FATEST-CD codelists instead?
Here is the DKD WIKI Example for "Number of

Events" https://wiki.cdisc.org/x/NB_8AQ.
Here are some examples for "Number of

Episodes": https://wiki.cdisc.org/x/vj7zAw
In the COPD TAUG, FATEST="Number of
Episodes" is used with a FAOBJ = COPD
Exacerbation.
Proposed value will be used in a dermatology II SDTM, SEND-Published

study where study drug is applied topically to skin with P38
lesions located at multiple body locations
Proposed Definition:
The integument that covers the region of the back
lateral to the vertebral region and below the
scapula.
II Do not add (P40) - Do

not add. Swab is a
specimen collection
A technique in which a tufted material on the end method for which we
of a stick is rubbed against a surface. already have a
published codelist
CLMETH, within which
SWAB is already
published, which
supports the CLMETH
NSV. Please do not put
this into the METHOD
variable.
II SDTM, SEND -
Published with P39
New synonym needed to account for how this test

is being reported by the lab.
codelist is already
published. (C142179)
CDISC Note for ARMNRS: "A coded reason that
Arm variables (ARM and ARMCD) and/or actual
Arm variables (ACTARM and ACTARMCD) are
null. Examples: "SCREEN FAILURE", "NOT
ASSIGNED", "ASSIGNED, NOT TREATED",
"UNPLANNED TREATMENT". It is assumed that
if the Arm and actual Arm variables are null, the
same reason applies to both Arm and actual
Arm."
II SDTM-Published with
P38
Please create codelists for TSVAL entries. These

will be dependent on TSPARMCD values.
We need TSVAL codelists for the CTAUG,
FDATCHSP, SDTIGVER, and SDTMVER
TSPARM codes.
in P38
This is a frequency that we have encountered,

and need to have it represented.
in P38
Every 16 weeks is a frequency that has been

used in a study, and so we need it to be
represented in the codelist.
Need updated control terminology for creating

standard variable names.
File emailed separately. II Do not add (P38):
TABLET, ROUND and
TABLET, OBLONG -
The dosage form here is
still TABLET,
IMMEDIATE RELEASE.
The information about
the shape of the tablet
(which acts as a
surrogate/blind for high
or low dose load) should
be put into another
variable.
Rodent progressive cardiomyopathy (RPCM) is a
spontaneous, chronic and progressive myocardial
disease of laboratory rats and mice. It is often
associated with older animals where it is most
prominent and a greater spectrum of
morphologies are present. Definition: A
spontaneous, age-related cardiac disease of rats
and mice, characterized by myocardial changes
presenting a continuum that begins as focal to
multifocal individual cardiomyocyte necrosis
attended by a few inflammatory cells progressing
at different rates in different animals to include
multifocal mononuclear cell inflammation and
even fibrosis for larger lesions.
This is a TA request from Type 1 Diabetes. File in P38, P39
emailed separately
II SEND-Published in P38,
file emailed separately: Craig, no need to add P39
rows into working document. They are already Do not add (P39):
there. Just add the request number. Acinar alteration-
INHAND Special
Senses group will
change this term to
CYTOPLASMIC
ALTERATION (which is
already published) with
modifier 'Acinar'.
File emailed separately. II SEND-Published in P38,
P39, P40, P43, P48
Do not add (P38):
DYSLASIA - INHAND
does not agree that
DYSPLASIA is a
MISTRESC in and of
itself. From INHAND's
point of view, Dysplasia
is considered pre-
neoplastic in the clinical
pre-neoplastic but
any MISTRESC values
in adjectival form
ANEURYSM - Being
published with P37.
Do not add (P39):
ACANTHOSIS: Do not
add. The INHAND OWG
recommends using
HYPERPLASIA, which
is already published.
CONCRETION: Do not
add. This is
synonymous with
Corpora Amylacea. We
not replace Screen
The rationale: We used the option ?Screen Failure with Failure to
Failure? for many years. This item caused Meet Eligibility Criteria.
confusion and incorrect data entry on study site Conflating Screen
level since the site personal considers all subjects Failures this to "all
who discontinued during Screening Period as subjects who
Screen Failures. discontinue during
screening period are
screen failures" is
incorrect. Individuals
could meet eligibility
criteria but still
discontinue during the
screening period for
other reasons. These
individuals would not be
screen failures. Screen
Failure is the failure to
meet eligibility criteria
during the screening
period. Once the subject
begins participation,
they may still need to
meet eligibility criteria
throughout the study.
However there can be
other reasons for
discontinuing during the
screening period that
are NOT Failure to Meet
Eligibility Criteria. You
could use SUBJECT
WITHDRAWAL,
PHYSICIAN DECISION,
etc. By definition, these
II Do not add (P38): We
suspect that this blinding
schema is very rarely
The proposed definition for the new code used and feel
OBSERVER BLIND in the TBLIND codelist is: A uncomfortable assigning
study in which neither the subject nor the a controlled value to
investigator BUT the research team interacting something that may be
with the subject or data during the trial knows defined differently
what treatment a subject is receiving. across different
sponsors. The codelist
is extensible and so the
sponsor should feel free
to submit their proposed
term in the dataset.
the value at this time.
II
What is the relevance of RWE to

"drug/device/vaccine/biologic/intervention/dianosti
c" clinical research.
II
Another case where we all know what we mean

by development, but have strongly different
contexts. I hear the term in the context of pre-
approval clinical research. Post market research
on value/ economics, and even safety monitoring
would not seem to be development. What does
CDISC think?

MIDLINE is present in
the DIR codelist (to
Please add to the LAT codelist the term support the DIR
MIDLINE. MIDLINE is an anatomical definition of variable) so should be
the brain. It is a line that crosses the brain and used in that context
divides it in two portions - right and left. instead.
Please create new TEST-CD codelists for PHQ-2,

For the new term RIGHT, HEART, the proposed II Do not add (P38): This
definition is: The right side of the heart, which should be modeled as
receives deoxygenated blood from the body, LOC=HEART and
pumps it through the right atrioventricular valve LAT=Right. The heart is
into the right ventricle and pumps it further subdivided into 4 parts
through the pulmonic valve into the pulmonary (the ventricles and
arteries. atria); there is not a
higher level subdivision
commonly noted in
anatomy pertaining to
LEFT and RIGHT. We
think this is very much
an appropriate use of
the LAT variable since
the requester is
describing the right 'side'
of the heart in the notes.
in P38, P39, P40, P45
Do not add (P38):
Pls consider adding new terms to multiple Do not add. PQ interval
codelists. File emailed separately is a synonym to PR
interval, please use
PRAG and PRSB for
aggregate and single
beat measurements.
PQ Interval, Aggregate
has been added as a
synonym to PR Interval,
Aggregate (C117773) in
P38.
PQ Interval, Single Beat
has been added as a
synonym to PR Interval,
Single Beat (C117774)
in P38.
UTERINE BODY - This
is already published as
CORPUS UTERI
C12316.
Do not add (P39):
LIPASE-Do not add.
This will be added as a
CDISC synonym to
LIPASE/C117748.
SD_NAD-Do not add.
Please map to LBTEST
= Sediment
Examination/C105744
and use Normal
Abnormal Response
codelist for result.
PK Evaluation Interval-
The PK team considers
II SDTM, SEND -
Published with P39
Please consider updating the definition to: A

relative measurement (ratio) of the albumin in
cerebrospinal fluid to albumin in serum and/or
plasma in a biological specimen. Also add a
synonym for CSF/Plasma Albumin Index
Reference: http://arh.adam.com/content.aspx?
productId=49&pid=49&gid=150212
not add as a new term.
We regularly collect a specimen condition as PARAFFIN-
FFPE (FORMALIN-FIXED PARAFFIN- EMBEDDED. If it is
EMBEDDED). I can see that there is a important to note that
PARAFFIN-EMBEDDED CDISC term, but I'm the tissue was Formalin-
unsure whether it's acceptable to create FFPE as Fixed, this would need
an extensible term (and request it from you), or to go into a suppqual.
whether the use of Formalin to fix the specimen
needs to be stored elsewhere e.g. SUPP (and
what would the QNAM/Label be). It's just that
FFPE is an industry term where I have seen
compared to FROZEN sample conditions so it
seems wrong to split it out.
See https://www.biocompare.com/Editorial-
Articles/168948-FFPE-or-Frozen-Working-with-
Human-Clinical-Samples
I'd appreciate your thoughts.
When we collect "excretion rate" tests, these can II Question answered:

be determined as being over differing time Decision a: The nominal
frames: 24hrs, 8hrs, sometime just "not 24hrs". or planned/proposed
Up until now we have been creating extensible duration would be
LBTESTCD codes so that they are each defined present in EVLINT or
specifically. However, in our new tool we are EVINTX (in cases where
going back to using the CDISC term and storing you can't do an
the start and end date/times. So we have 2 ISO8601
issues: representation).
a. where and how we should store the proposed Decision b: Given the
duration, not just the actual duration. variability of how units of
b. With these specific duration tests, the units measure are reported by
being provided to us by the labs reflect the labs for excretion rates,
duration e.g. MMOL/24HR, MMOL/6HR, we don't think we can
MMOL/COLLECT (used for the "not-24hr" specify a single way of
durations.) This means that we are unable to representing the units of
have a standard unit for the generic excretion rate measure (ie all X/h or
test (as required by P21). Do you propose that something like that), and
this is explained away in the SDRG? Or do you since the timing
have any other suggestions? variables can be used
for test durations that
are either for excretions
or excretion rate type
tests (hence we can't
use EVLINT solely for
excretion rate type
terms), we think we'll
need to extend the UNIT
codelist (when
requested) with units of
measure with a variety
of timing components in
the denominator to
support excretion rate
type lab tests. We would
like to create a rule in
which we will only
See modeling in LuCa TAUG for how Pleural II
Effusions are handled. 'Effusion Indicator' may be
a better test with a LOC value of 'Pericardal
Cavity'. Not sure if other Effusion type questions
could be split but it is worth thinking about.

P39
Remove second sentence. CDISC tends not to

put this type of information into definitions. This
term is going to be re-used for the SEND Animal
Rule TAUG project in their 'Age Estimation
Method' codelist and it was felt that the second
sentence did not apply to that context.
II
Definition: A measurement of the

Cytomegalovirus virus DNA in a biological
specimen.
The CMV study is collecting either Qualitative

(Negative or Positivie) or Quantitative (Not
Detected, Indeterminated, Detected) results for
this test.
II Do not add (P38): As
part of the SEND Animal
Rule implementation
Please add EGMETHOD = "9 LEAD guide, two new variables
STANDARD", EGLEAD = "MV1", EGLEAD = have been added to the
"MV2" and EGLEAD = "MV3". Findings and
"9 LEAD STANDARD" = "An electrocardiogram Interventions classes to
(ECG) recorded using 7 electrodes to generate 9 better model this type of
ECG leads (ECG wave forms). The 7 electrode data. There is the
configuration includes 4 limb electrodes in an variable
Einthoven configuration and three chest --RSTIND/Restraint
electrodes. The 9 ECG leads recorded consist of Indicator (with y/n
three standard limb leads (leads I, II, and III), answers) and --
three augmented leads (leads aVR, aVF, and RSTMOD/Restraint
aVL), and three chest leads (which are generated Mode (with codelist of
using two unipolar chest leads (typically CV5RL PHYSICAL, CHEMICAL,
[rV2], CV6LL [V2], and [V10] for canines or MV1, PHYSICAL AND
MV2, and MV3 for non-human primates). This CHEMICAL). For
lead configuration is routinely used to record Physical restraints it is
ECGs in canines and non-human primates." appropriate to use the
File emailed separately Device domains to
further describe the
restraints used and for
chemical restraints it is
appropriate to use the
AG domain to further
describe the chemical
agents used to restrain
the subject. See the
concept map in the
SENDIG-AR:
https://wiki.cdisc.org/dis
play/ANIMALRULE/Phy
sical+and+Chemical+Re
straints.
Do not add (P42):
9 LEAD STANDARD-Do
II Do not add (38): As part
of the SEND Animal
Rule implementation
EGPOS = "RESTRAINT IN PRIMATE CHAIR"; guide, two new variables
EGPOS = "RESTRAINED" have been added to the
Currently there are no adequate alternatives for Findings and
these ECG positions. Interventions classes to
"RESTRAINT IN PRIMATE CHAIR" = "Limbs, better model this type of
body and head are secured in a purpose built data. There is the
restraint chair" variable
"RESTRAINED" = "The animal's limbs and/or --RSTIND/Restraint
body parts are held secure by technicians while Indicator (with y/n
they undergo ECG" answers) and --
File emailed separately RSTMOD/Restraint
Mode (with codelist of
PHYSICAL, CHEMICAL,
PHYSICAL AND
CHEMICAL). For
Physical restraints it is
Device domains to
further describe the
restraints used and for
chemical restraints it is
AG domain to further
describe the chemical
agents used to restrain
the subject. See the
concept map in the
SENDIG-AR:
play/ANIMALRULE/Phy
sical+and+Chemical+Re
straints.
Please consider harmonizing Endomysium IgA II Do not merge (P39):
Antibody (C147334) into Tissue These are separate
Transglutaminase IgA Antibody (C147441). tests in LOINC, ARUP,
However the MB team would like the LB team to LabCorp. AZ also has
hold the merge until LOINC gets back with our them as separate
questions. Since there are separate LOINC codes entities. Upon further
for these tests, we'd like LOINC's comment on discussion we think
whether they are synonymous. there is a parent/child
relationship here but not
The MB team thinks these two tests are actually necessarily a 1:1.
synonymous - the target to the IgA antibody is Tissue
simply Tissue Transglutaminase (tTG), which is Transglutaminase may
formerly known as Endomysial Antigen. However be a type of Endomysial
LOINC sees them differently and provides antigen but we are not
different LOINC codes for them. sure that it is the only
one, especially in other
Additional INFO: TAs besides celiac
-The endomysial antigen has been identified as disease. The team
the protein cross-linking enzyme known as tissue agrees to not merge
transglutaminase. these for now.
-The endomysium is a layer of connective tissue
that ensheaths a muscle fiber. The endomysium
contains a form of transglutaminase called "tissue
transglutaminase" or "tTG" for short, and
antibodies that bind to this form of
transglutaminase are called endomysial
autoantibodies (EmA).
From Labcorp: https://www.labcorp.com/test-
menu/24646/endomysial-antibody-iga
Even though Labcorp calls the antibody test:
Endomysial IgA Antibody, in its ?Use? section it
is says: Tissue transglutaminase is the
autoantigen recognized by endomysial antibody
in celiac disease.
The QRS sub-team team approved the move of II QRS-Published in P38
AIMS (CAT, TESTCD/TESTs) from the QS to RS
domain as a clinical classification based on the
instrument definition. This involves moving the
following:
- The questionnaires category codelist
QSCAT value of ?AIMS? to the clinical
classifications CCCAT codelist
- Renaming the questionnaires TESTCD
codelist of ?Abnormal Involuntary Movement
Scale Questionnaire Test Code? to the clinical
classifications TESTCD codelist ?Abnormal
Involuntary Movement Scale Clinical
Classification Test Code ?
- Renaming the questionnaires TEST codelist
of ?Abnormal Involuntary Movement Scale
Questionnaire Test Name? to the clinical
classifications codelist of
-Abnormal Involuntary Movement Scale Clinical
Classification Test Name?.
Please proceed with updating the NCI/EVS
CDISC controlled terminology for this instrument
as a clinical classification.
Remove C135409-Deoxyribonucleic Acid/DNA

from the MBTEST-CD codelists.
II
Please add new terms to CVTEST/CVTESTCD

LVID; left ventricular internal dimension
II

IVS; Interventricular septum thickness
II

PWD; left ventricular posterior wall thickness
This term was originally requested for the CDAD II SDTM-Published in P38
TAUG, which has been removed from the TAUG.
It is been decided by the TA team that this term is
no longer needed - it has the same usage as
"Number of Episodes" which is also in the same
Findings About Codelist.
PINSFLOW will be the short name of Peak II Do not add (P38):
Inspiratory Flow (parameter measured in the Already published
whole body plethysmography study). C120939/PIF
RE domain
PEXPFLOW would be the short name of Peak II Do not add (P38):
Expiratory Flow (parameter measured in the Already published
whole body plethysmography study). C41372/PEF
RE domain
RELTIME would be the short name of Relaxation II SEND - Published with
Time (parameter measured in the whole body P39
plethysmography study).
RE domain




II Glossary-Published with
P40
https://www.fda.gov/BiologicsBloodVaccines/
CellularGeneTherapyProducts/ucm537670.htm
verify that this term and designation is included in

Glossary
For studies including minors or subjects who II SDTM-Published in P38

cannot legally provide consent, assent may be
collected. It would be nice to have a standard
CDISC value for this as a standards protocol
milestone DSDECOD value.
Please add Tramadol to Laboratory Test II SDTM, SEND-Published
Name/Code codelist; it is listed as a substance of in P38
use (https://drugabuse.com/addiction/drugs-a-z/).
Thank you!
For NCI Code C71620 SEND-UNIT. Selected II Do not add (P50): Do
"New" in CDISC Code List above as SEND-UNIT not add. Response not
is not listed. received from requester
Please reconsider addition of the term "/5 mins" for more information.
for a rate of occurrence within a period of time Requester may re-
equal to 5 minutes. Please note this was submit the request as
requested before; however, the final outcome appropriate.
response did not correctly describe how GSK
performs ECGs (see detailed description).
New term of "/5 mins" for unit to be used in the

EG domain. At GSK, ECG tracings are collected
over a 24 hour period with qualitative analysis of
waveforms performed for a 5-minute interval at
each selected timepoint postdose. The
timepoints are included under EGELTM (i.e.,
PT5H). The unit "/5 mins" would be used under
EGORRESU and EGSTRESU in a similar fashion
to the use of the existing unit "/h" (for when
waveforms are reviewed for a one hour interval
over a 24 hour period). I am unable to find a unit
in the current codelist which can be used in this
case. Thanks for reconsidering.
The QRS sub-team team approved the move of

DISESASE STEPS (CAT, TESTCD/TESTs) from
the QS to RS domain as a clinical classification
based on the instrument definition. This involves
moving the following:
? The questionnaires category codelist QSCAT
value of ?DISEASE STEPS? to the clinical
classifications CCCAT codelist
? Renaming the questionnaires TESTCD codelist
of ?Disease Steps Questionnaire Test Code? to
the clinical classifications TESTCD codelist ?
Disease Steps Questionnaire Test Code?
? Renaming the questionnaires TEST codelist
of ?Disease Steps Questionnaire Test Name? to
the clinical classifications codelist of ?Disease
Steps Questionnaire Test Name?.
There is a need to develop new body system II
level codetables based on the new QRS clinical
classification rule that allows for QRS instruments
based on a single body system to be mapped to
that body systems findings domain. The rule is
currently documented here:
https://www.cdisc.org/foundational/qrs#gbm6g0ny
8k
The first use case for a body system codetable

was reviewed and requested to move forward at
the 2/22 GGG meeting in review of the Tanner
Scale being included in the T1 Diabetes TAUG.
A draft RP domain codetable is being sent in a

separate EMAIL fir review with the General CT
team. Please let me know if you have any
questions on this?

list is non-extensible
because it was set up to
File emailed separately follow-E2B terminology.
The team considered
the validity of this choice
and agreed to continue
following it by keeping
the codelist non-
extensible and only
containing those values
in E2B.
not add. ICH E2A
makes a distinction
between seriousness
and severity. As per ICH
E2A, Severity values
should be scoped to
include MILD,
MODERATE, and
SEVERE only. If you
must use AESEV, in the
instance where there is
a life-threatening AE,
you would use
'SEVERE' as theAESEV
value and then put Y in
the AESLIFE variable. If
the context of this
request is for a toxicity
grading scale, the
recommendation would
be to use TOX and
TOXGR variables
instead of AESEV.
Suggest that the definition of applanation II SDTM - Published with
tonometry sbe widened by CDISC, even if the P39
term is used in > 95 % of cases in context of
cornea / eye. Suggested definition of existing
submission value of APPLANATION
TONOMETRY be modified to: A method in which
a constant pressure is applied (e.g., to the
surface of the cornea or an artery), in order to
flatten a prespecified area of the membrane,
which is used to calculate the pressure (e.g.,
intraocular or arterial).
If definition will not be updated, request to add

new submission value of ATERIAL
APPALANATION TONOMETRY Here the central
blood pressure (aorta) is measured. The method
in the description of the device was only ?
applanation tonometry? but this does not fit to the
definition of CDISC.
Proposed definition: A method in which the II SDMT-Published in P40

dielectric tissue properties are measured based
on the emission and reflection of low-power
electromagnetic signals in between two sensors
attached to the body.
See publication: International Journal of

Cardiology, Vol 221, 15 October 2016, Pages
841-846. The device is called ReDS TM
Per the FDA Study Data Technical Conformance II Do not add (P38): Do
Guide (v 4.2 October 2018 and v4.2.1 January not change. The FDA
2019) the FDA recommends use of these will be using published
TSPARMC values. The FDA suggested values CDISC CT values in the
do not match the CT equivalent values, and one next version of the TCG.
is not in the current CT (TECHSP). I did not see
this inconsistency nor the request for TECHSP in
the terminology tracker.
Suggested definition: II Glossary-Published with
Trial designs that test multiple drugs and/or P40
multiple subpopulations in parallel under a single
protocol, without a need to develop new protocols
for every trial. NOTE: The term "master protocol"
is often used to describe the design of such trials,
with variable terms such as "umbrella", "basket",
or "platform" describing specific designs.
REF: modified from FDA DRAFT Guidance:

Master Protocols: Efficient Clinical Trial Design
Strategies to Expedite Development of Oncology
Drugs and Biologics. September 2018.
update definitions for II SDTM-Published in P38

C147272
C147273
C147274
C147275
Craig, these changes are already in the MB
working doc, just need a request number. pls fill
in the request number.
To support SDTM3.3
Please update definition to: A study that assesses II Do not add (P38): The
the efficacy of treatment given after a protocol- animal rule term is a
defined manifestation of the challenge agent(s)- different concept and
induced disease or condition. should get a different c-
code. Erin to update the
c-code before P37
publication.
The SEND AR team was reviewing terminology II SEND-Published in P38

and came up the codelist description and thought
it was generally not great. At the very least the
examples need to be removed.
Directionality term needed to capture the location II SDTM, SEND -
of dose administration, specified on the CRF as Published with P39
Anterolateral Thigh.
New LBTEST, LBTESTCD and UNIT terms II SDTM, SEND -
requested. File emailed separately. Published with P39, P40
Do not add (P40):
NAGASEXR - Do not
add. For an excretion
wherein one is
calculating an amount,
please use the existing
published concept
C103419. If this is truly
an excretion rate, then
NAGASEXR will be
added with P40.
Synonym: DDPCR II SDTM-Published in P40

Def: A technique used to deliver high-throughput
digital PCR. Droplets partition a sample premixed
with PCR reagents into hundreds of individual
PCR reactions, which allows the absolute
quantification of target sequences and rare allele
detection, as compared to conventional real-time
quantitative PCR.
Used: in PF to measure Mutation in Genetic
Variation
Def: A measurement of the amount of Monoclonal II SDTM, SEND -

Protein being excreted in a biological specimen Published with P39
over a defined amount of time (e.g. one hour).
This is part of the suite of M-SPIKE tests. This is

used for urine specimens and is measured in
g/24hrs. I believe it follows theformatting of the
CREATEXR term
SDTM codelists (LOC, BEDECOD, DICTNAM, II SDTM, SEND-Published

DIR, EGSTRESC, MEDEVAL, METHOD, FRM, in P38, P39, P40, P42,
SPECCND); File emailed separately P44
Do not add (P38):Please
use C132416-Microbial
Organism
Identification/MCORGID
N.
This MBTEST is used
for non-targeted
assessment with the
intent of the following
query: “what
microorganism(s) are
there in the subject’s
sample?" Responses to
this test could be:
(names of) bacteria,
virus, fungi, etc.
Do not add (P39):
AORTA, ANNULUS: Do
not add, Please use
C130167/AORTIC
VALVE ANNULUS
AORTA,
SINOTUBULAR
Definition: A period post-end of therapy when a II Do not add (P40) - Do
subject is reassessed, either by re-culturing from not add. This was
the site of initial infection and/or assessing clinical originally in P39 public
signs and symptoms, to determine whether the review but after further
subject is cured consideration the team
decided that this was
more like a purpose for
the epoch and so are
not prepared to make
this a controlled term at
this time. The codelist is
extensible.
GFRBSCU (GFR from Creat and UreaN Adj for II SDTM, SEND -
BSA). Published with P39
Def: An estimation of the glomerular filtration rate
adjusted for body surface area based on
creatinine and urea nitrogen.
Rationale: Needed to associate with the newly
proposed ANMETH of MDRD 5 VARIABLE
FORMULA
GFRBSCUA (GFR from Creat, UreaN & Alb Adj

for BSA) Def:An estimation of the glomerular
filtration rate adjusted for body surface area
based on creatinine, urea nitrogen and albumin
Rationale: Needed to associate with the newly
proposed ANMETH of MDRD 6 VARIABLE
FORMULA
LOINC has Islet Cell 512 Antibody/C81985 as II SDTM, SEND -

their preferred term, hence please keep C81985 Published with P39
as the CDISC submission value, merge the
newer c-code into the older C-code. Islet Antigen
2 = Islet Cell 512 = ICA512. The MB team found
this issue during one of our discussions and
agree that they are synonymous.
Definition: The region adjacent to the spine. II SDTM, SEND-Published

in P40
Some drugs are given 3 times per week, so we II Do not add (P39):
need to capture this frequency in the database. Already exists in the
Also note that there are already existing codes for codelist as C64528.
x times per week in the codelist.
Please add value 'steps/min' to the unit codelist, II SDTM, SEND-Published

used to measure cadence in mobility testing. in P40
Please add term 'deg/s' (degrees/second, II SDTM, SEND-Published
deg/sec), used to measure turn angular velocity, in P40
arm swing velocity in mobility testing.
Please add term 'deg2' (square degree) to the II SDTM, SEND-Published

UNIT codelist, used to measure postural sway in P40
area in mobility testing. Please see reference:
https://www.apdm.com/mobility/. Thank you!
Request to add Prpphylaxis as synonym for term II

PREVENTATIVE :
Synonym in missing in CDISC SDTM

Terminology. Prophylaxis as per NCI Thesaurus
is a synonym of PREVENTATIVE and also a child
concept of Intent of Use (Intent for Prophylaxis).
This synonym is used to collect in what context
the medication has been given.
Please add term ELECTRICAL IMPEDANCE II SDTM-Published in P40

MYOGRAPHY to the METHOD codelist; this is
different from existing term of Electromyography
that is needle-based. Definition from Wikipedia:
Electrical impedance myography, or EIM, is a
non-invasive technique for the assessment of
muscle health that is based on the measurement
of the electrical impedance characteristics of
individual muscles or groups of muscles.
In the latest 'CDISC CDASH Controlled II

Terminology, 2018-12-21' , a CDISC Submission
Value for 'INJECTION' is not currently present in
'Exposure Dose Form' (EXDOSFRM - NCI Code:
C78426). It should be added there.
Please add new value 'Tau Protein, Free' to II SDTM, SEND -

LBTEST/CD codelist; suggested definition: A Published with P39
measurement of the free, unbound Tau protein in
a biological specimen.. Thank you!
We have been informed by our lab that C3a and II SDTM, SEND -
C3a-desArg are now distinguishable (I will send Published with P39, P40
test sheets separately) so we need new
LBTESTCD/LBTEST codes and 'Complement C3
DesArg' needs to be removed as a Synonym for
C3a.
LBTESTCD=C3ADARG
LBTEST=Complement C3a DesArg
Suggest that the term and synonym be re- II SDTM, SEND -
examined. Our internal clinical pathology group Published with P39, P40
has indicated that crenated cells and echinocytes
are not the same thing as echinocytes represent
a pathophysiologic change while crenated cells
are an artifact often associated with slow smear
drying or prolonged storage in EDTA.
WHOLE EXOME SEQUENCING. II SDTM-Published in P40

Synonyms: WES; EXOM SEQUENCING Do not add (P40) -
Definition: A genomic technique for sequencing WHOLE EXOME
all of the protein-coding region of genes in a SEQUENCING -
genome. It consists of two steps: the first step is Already published in
to select only the subset of DNA that encodes METHOD codelist as
proteins. The second step is to sequence the C101295
exonic DNA using any high-throughput DNA FLUOROMETRY - Do
sequencing technology not add. Please use
Rationale/Use: Used in PF to measure Tumor existing term
Mutation Burden FLUORIMETRY.
GENE-TARGET
GENE-TARGET SEQUENCING SEQUENCING-Do not
Synonyms: TARGET ANALYSIS SEQUENCING; add. Please use either
TARGET AMPLICON SEQUENCING TARGETED GENOME
Definition: A next generation sequencing SEQUENCING/C15825
technique focusing on all of the protein-coding 3 or WHOLE EXOME
region of genes in a genome SEQUENCING/C10129
Rationale/Use: Used in PF to measure Tumor 5, depending upon the
Mutation Burden level of granularity of
METHOD information
FLUOROMETRY given to you by the lab
Definition: A measurement of fluorescence vendor.
intensity at a particular wavelengthwith the help of
a filter fluorimeter or spectrofluorimeter
Uses: Used in the faecal HemoQuant test
Please add the new MITSCD of ALK_O for the II Do not add (P46):
submission value and ALK Fusion (Oncogene) as Response withdrawn
the synonym. from requester. The MI
Please add the new MITS of ALK Fusion domain is currently
(Oncogene) as the Submission Value. structured to support
The proposed definition is Anaplastic lymphoma protein analysis only.
kinase oncogene fusion present in a biological Any genetic type
specimen. assessments on genes
the provisional PF
domain or the GF
domain to be published
in SDTMIGv3.4. Specific
ALK or ROS1 fusion
proteins should be
requested as new terms
to the MITEST codelist,
as long as it is the fusion
protein being
measured/assessed.
Please add the MITSCD of ROS1_O as the II Do not add (P46):

submission value and ROS1 Fusion (Oncogene) Response withdrawn
as the synonym. Also add MITS of ROS1 Fusion from requester. The MI
(Oncogene). Proposed definition is c-ROS domain is currently
oncogene 1 fusion present in a biological structured to support
specimen. protein analysis only.
Any genetic type
assessments on genes
the provisional PF
domain or the GF
domain to be published
in SDTMIGv3.4. Specific
ALK or ROS1 fusion
proteins should be
requested as new terms
to the MITEST codelist,
as long as it is the fusion
protein being
measured/assessed.
Please add the MITSCD of EGFR as the II Do not add (P46):

submission value and Epidermal Growth Factor Response withdrawn
Receptor as the synonym. Also add MITS of from requester. Already
Epidermal Growth Factor Receptor as the in the list.
submission value. Proposed definition is
Evaluation of mutations in the Epidermal Growth
Factor Receptor in tumor tissue.
Please add the MITSCD of HPV_P16 as the II SDTM-Published in P46
submission value and Human Papilloma Virus
Associated Cancer as the synonym. Also add
MITS of Human Papilloma Virus Associated
Cancer as the submission value. The proposed
definition is Evaluation of HPV genome presence
or as a surrogate p16 protein overexpression in
tumor tissue.
NCI Definition : A statement that defines II

conventions, guidelines, characteristics or
methods for consistent data handling to facilitate
exchange or processing of the data. This set of
criteria are reviewed by and agreed upon by the
user community or a governing body before they
are released and adopted for use.
Here?s also a description from USGS: Data

standards are the rules by which data are
described and recorded. In order to share,
exchange, and understand data, we must
standardize the format as well as the meaning.
From EPA: Data standards are documented

agreements on representation, format, definition,
structuring, tagging, transmission, manipulation,
use, and management of data. EPA data
standards are a means to promote the efficient
sharing of environmental information among US
EPA, states, tribes, local governments, the
private sector, and other information trading
partners.
From HealthIT (ONC): Data standards define the

approach and practices for developing,
approving, and instituting compliance for data
representation, data access, and data distribution
standards.
Requesting permission to develop a new --CAT II QRS-Published in P38

(E-TRIP) and ETRP01TC/TN codelists for the
Emory Treatment Resistance Interview for PTSD
(E-TRIP). The --CAT would either be in CCCAT
or a new XXCAT specifically for non-oncology
disease response. This is at the request of the
PTSD TA team.
In the current SDTM CT 2018-12-21 SDTM II SDTM - Published with
Domain Abbreviation codelist has the following P39
SEND-only domains. Please remove them. Do not change (P41):
SUPPBG Supplemental Qualifiers for Body SUPPER - This is not a
Weight Gain SEND domain but is
SUPPCL Supplemental Qualifiers for Clinical published in the Ebola
Observations and Malaria TAUGs.
SUPPER Supplemental Qualifiers for SUPPQT-This is not be
Environmental and Social Factors a SEND domain. This is
SUPPFM Supplemental Qualifiers for Fetal in the QT studies TAUG.
Measurements SUPPWB-This is not be
SUPPFW Supplemental Qualifiers for Food and a SEND domain. This is
Water Consumption a draft TCM domain in
SUPPFX Supplemental Qualifiers for Fetal the TCM-CAD UG.
Pathology Findings
SUPPIC Supplemental Qualifiers for Implantation
Classification
SUPPMA Supplemental Qualifiers for
Macroscopic Findings
SUPPOM Supplemental Qualifiers for Organ
Measurements
SUPPPM Supplemental Qualifiers for Palpable
Masses
SUPPQT Supplemental Qualifiers for ECG QT
Correction Model Data
SUPPSJ Supplemental Qualifiers for Subject
Stages
SUPPTF Supplemental Qualifiers for Tumor
Findings
SUPPWB Supplemental Qualifiers for Whole
Body Findings
Please check if you need to create the following II Do not add (P39): These
supplementary qualifier domains: don't belong in the
SUPPBG Supplemental Qualifiers for Body DOMAIN codelist as
Weight Gain they are really file
SUPPCL Supplemental Qualifiers for Clinical naming conventions.
Observations
SUPPER Supplemental Qualifiers for
Environmental and Social Factors
SUPPFM Supplemental Qualifiers for Fetal
Measurements
SUPPFW Supplemental Qualifiers for Food and
Water Consumption
SUPPFX Supplemental Qualifiers for Fetal
Pathology Findings
SUPPIC Supplemental Qualifiers for Implantation
Classification
SUPPMA Supplemental Qualifiers for
Macroscopic Findings
SUPPOM Supplemental Qualifiers for Organ
Measurements
SUPPPM Supplemental Qualifiers for Palpable
Masses
SUPPQT Supplemental Qualifiers for ECG QT
Correction Model Data
SUPPSJ Supplemental Qualifiers for Subject
Stages
SUPPTF Supplemental Qualifiers for Tumor
Findings
SUPPWB Supplemental Qualifiers for Whole
Body Findings
PLease update by "OLD OR AGE INDETERMINE II Do not change (P39):

RIGHT VENTRICULAR MYOCARDIAL While the ECG team
INFARCTION" (INDETERMINE instead of recognizes the
UNDERTERMINED) to be consistent with others inconsistency,
CDISC values starting with "OLD OR AGE..." technically the current
submission value is not
wrong. Given that a
submission value
change has a large
impact on
implementation and this
term is been in use for a
long time, the ECG team
decides to not make this
change.
PREMATURE ATRIAL COMPLEXES BLOCKED II SDTM, SEND -
JUNCTIONAL PREMATURE COMPLEX Published with P39
PREMATURE ATRIAL COMPLEXES
MULTIFOCAL
PREMATURE VENTRICULAR COMPLEXES
MULTIFOCAL
PREMATURE ATRIAL COMPLEXES UNIFOCAL
PREMATURE VENTRICULAR COMPLEXES
UNIFOCAL
PREMATURE VENTRICULAR COMPLEX
INTERPOLATED
SUPRAVENTRICULAR PREMATURE
COMPLEX, ORIGIN UNKNOWN
PREMATURE VENTRICULAR COMPLEX
PREMATURE ATRIAL COMPLEXES
Bundle Branch Re-Entrant Ventricular II SDTM, SEND -

Tachycardia by ECG Finding Published with P39
Ectopic Supraventricular Rhythm by ECG Do not add (P39):
Finding Bundle Branch Re-
Fascicular Tachycardia by ECG Finding Entrant Ventricular
Inappropriate Sinus Tachycardia by ECG Finding Tachycardia by ECG
Incomplete Bundle Branch Block by ECG Finding Finding: This term was
Myocardial Ischemia by ECG Finding previously deprecated
Right Ventricular Outflow Tract Tachycardia by from the EGSTRESC
ECG Finding codelist because this is
Prolonged PR Interval by ECG Finding not a diagnosis that can
QRS Complex Absent by ECG Finding be made solely by ECG.
QTcB Prolongation Greater Than 500 msec Other methods can lead
QTcF Prolongation Greater Than 500 msec to this diagnosis hence
R Wave Abnormality by ECG Finding this term is too hyper-
Respiratory Sinus Arrhythmia by ECG Finding specific by method.
S Wave Abnormality by ECG Finding Ectopic Supraventricular
Sick Sinus Syndrome Rhythm by ECG
ST Segment Abnormality by ECG Finding Finding: This term is a
T Wave Abnormality by ECG Finding synonym to
Brugada Syndrome Ventricular Arrhythmia by C62245/ECTOPIC
ECG Finding ATRIAL RHYTHM,
Long QT Syndrome please use C62245
Short QT Syndrome instead. Also "Ectopic
Ventricular Hypertrophy by ECG Finding Supraventricular
Ventricular Tachycardia Storm by ECG Finding Rhythm" has been
Verapamil-Sensitive Ventricular Tachycardia by added as a synonym to
ECG Finding ECTOPIC ATRIAL
RHYTHM to assist
future mapping.
Fascicular Tachycardia
by ECG Finding: This
term was previously
deprecated from the
EGSTRESC codelist
because this is not a
diagnosis that can be
It is needed in support of absolute power II SDTM, SEND-Published
measure for ELECTROENCEPHALOGRAPHY in in P40
the NV domain
New PK term requests for PKPARM/CD. File II SDTM, SEND-Published
Emailed Separately in P43, P44, P47, P48
Do not add (P43):
AUCCBER; AUCLST
Divided by AUCIFO - Do
not add. Use
PPTEST/CD = Ratio
AUC (C156471), and
map the two actual
ratios in PKANMETH,
see this example in
SDTMIG v3.4 for detail:
https://wiki.cdisc.org/x/iN
OHBQ
AUCIFUTR; AUC Infinity
Obs Unchng/TR Ratio -
Do not add. Use
PPTEST/CD = Ratio
AUC (C156471), and
map the two actual
ratios in PKANMETH,
see this example in
SDTMIG v3.4 for detail:
https://wiki.cdisc.org/x/iN
OHBQ
AUCLSTDW; AUC to
Last Nonzero Conc
Norm by Dose/Wt - Do
not add. Map to the new
PKPARM = AUCLST
Norm by Dose/WT in
P43. See P43 PK Public
Review Document.
AUCLUTR; AUC to Last
Nonzero Conc
Unchng/TR Ratio - Do
not add. Use
Changes to existing PKPARM/CD terms File II SDTM, SEND-Published
Emailed Separately in P42
The following values are used to assess lesion II SDTM, SEND-Published
sites in an Atopic Dermatitis study. in P40, P41
-Skin around the eye - The integument that

covers the area surrounding the eye, excluding
the eye lid.
-Skin around the mouth - The integument that
covers the area around the mouth, excluding the
skin of the lips.
-Antecubital Fossa - The triangular region in the
forearm on the anterior (flexor) surface of the
elbow. Bounded laterally by the brachioradialis
muscle and medially by the pronator teres
muscle.
-Popliteal Fossa - The diamond-shaped space
posterior to the knee joint bounded superficially
by the diverging biceps femoris and
semimembranosus muscles above and inferiorly
by the two heads of the gastrocnemius muscle.

ECOG (CAT, TESTCD/TESTs) from the QS to
RS domain as a clinical classification based on
the instrument definition. This involves moving
the following:
value of ?ECOG? to the clinical classifications
CCCAT codelist
of ?Eastern Cooperative Oncology Group
Performance Status Questionnaire Test Code? to
the clinical classifications TESTCD codelist ?
Eastern Cooperative Oncology Group
Performance Status Clinical Classification Test
Code ?
of ?Eastern Cooperative Oncology Group
Performance Status Questionnaire Test Name?
to the clinical classifications codelist of ?Eastern
Cooperative Oncology Group Performance Status
Clinical Classification Test Name?.
Lot of new terms; File Emailed Separately. II SDTM, SEND -
Published with P39,
P40, P43, P47
Do not add (P39):
/mL - Do not add. /mL is
going to be added as a
synonym to C105519
/mm3: Do not add.
/mm3 is being added as
a synonym to the
C67452/10^6/L. Please
use that concept as the
submission value
instead.
/uL: Do not add. /uL is
being added as a
synonym to the existing
published term
C67452/10^6/L. Please
use that concept as the
submission value
instead.
ng/mL: Do not add.
Synonymous with ug/L
(C67306) which is
already published.
pg/mL: Do not add.
Synonymous with ng/L
(C67327) which is
already published.
ug/mL: Do not add.
Synonymous with mg/L
(C64572) which is
already published.
Do not add (P40) -
CD3 - Do not add.
Definition = The date of delivery or termination. II SDTM - Published with
P39
Information is being collected as part of standard
worksheets that all studies must utilize in case of
a pregnancy while on study or for a subject's
spouse or partner that maybe pregnant.
Definition = A description of the type of delivery or II Do not add (P39):
termination for a pregnancy. Based on the given
response values, this
Sample of the Type of deliveries/termination that seems to be asking
are asked are: Vaginal Live Birth; C-section Live many questions, within a
Birth, check all that apply (Breech, single test. The codelist
Malpresentation, or Transverse Lie, is extensible but we
Cephalopelvic Disproportion, Cord Prolapse, would welcome the
Placenta Previa, Failure to Progress or Dystocia, submitter to consider re-
Fetal Distress, etc); Fetal Loss, select only one submitting multiple,
(Ectopic Pregnancy, Elective Abortion due to fetal individual test values to
abnormality, Elective Abortion due to maternal be controlled.
condition or disease, Elective Abortion Due to
Perceived Risk from Study Medication, etc).
Definition = The mode of delivery. II SDTM - Published with

P39
Select from: Emergency Cesarean Section,
Forceps, Induced Vaginal Delivery, Planned
Cesarean Section, Spontaneous Vaginal
Delivery, Vacuum Extraction, Unknown
Definition - Description of the products of II SDTM - Published with

conception. P39
Question asks: YES, Describe and NO

Definition = Describe any anomalies of the II Do no add (P39): The
infant/child if exposed to medication through team does not think this
lactation. belong in the RP domain
at all given that it is a
Choices = No and Yes, describe qualifier on an event or
intervention. This might
be modeled in either the
AE domain, as a non-
standard variable on the
adverse event record
itself OR in an
interventions domain,
possibly associated with
the route of exposure.
REASON: Study type needed to support a II Do not add (P39):

combination Pharmacology study (i.e. CARDIOVASCULAR
Cardiovascular and Respiratory Telemetry PHARMACOLOGY and
Study). RESPIRATORY
PHARMACOLOGY are
DESCRIPTION: The study of the effects of drugs both published as
upon the heart or circulatory system along with separate response
the branch of pharmacology that deals with the values in the SSTYP
respiratory system. codelist already. In the
TS domain, if there is
more than one response
for a single TSPARM
question, the
appropriate thing to do
is to create two rows of
data with the same parm
code and put the
individual response in
each row. One can have
This is the term we propose to use with a request II Do not add (P48): Do
I asked for earlier of INVADER DNA ASSAY and not add. The team
which was denied in P38 review. agrees that this
I believe this is the underlying method for this sequencing
assay based on expert advice from GSK. There is methodology is no
also information in this link under the heading longer in use
'Flap Endonuclease' consistently across the
https://en.wikipedia.org/wiki/SNP_genotyping industry so maintenance
by CDISC is not ideal.
The requester can
choose to submit this
terms as extensible
terminology.
Alternatively the value in
METHOD could be
something more generic
like POLYMERASE
CHAIN
REACTION/C17003 or
SEQUENCE-SPECIFIC
OLIGONUCLEOTIDE
PROBE POLYMERASE
CHAIN
REACTION/C130181
and the specific assay
name can go into a
suppqual.
Reference document, annotated CRf and CT II QRS-Published in P38

spreadsheet sent via EMAIL; File emailed
separately.
Please add new terms of "LVDD; Left Ventricular II
Dimension at Diastole" to CVTEST/CVTESTCD
Please add new terms of "IVSD; Interventricular II

Septum Thickness at Diastole" to
CVTEST/CVTESTCD
Please add new terms of "PWD; Posterior Wall II

Thickness at Diastole" to CVTEST/CVTESTCD
Change C119174 submission value = DLQI- II QRS-Published in P38

Score to DLQI1-Score
in P41
Can be either soluble BCMA or Soluble TNF

Receptor Superfamily Member 17 (synonym).
See CCODE C156526 for an precedent (?) for
the latter
1. Fibrosure Formula: A formula that measures II SDTM-Published in P42
liver pathology through the assessment of a six-
parameter blood test (for Alpha-2-macroglobulin,
Haptoglobin, Apolipoprotein A1, Gamma-glutamyl
transpeptidase (GGT), Total bilirubin, and Alanine
aminotransferase (ALT)), taking into account the
age and gender of the patient. z=4.467 x log10
[1.9(g/L)] - 1.356 x log10 [0.652 (g/L)] + 1.017 x
log10 [60(IU/L)] + 0.0281 x 36 + 1.737 x log10
[18.126(umol/L)] - 1.184 x [1.45(g/L)] + 0/301 x 1
- 5.54. (US Patent 6631330) 2. Hepatoscore
Formula: need more info 3. Fibrometer Formula:
A formula that measures liver pathology through
the assessment of 7 blood markers plus age and
gender. (needs more info)
Here?s the source where this unit is mentioned: II SDTM, SEND-Published

https://accessmedicine.mhmedical.com/content.a in P40
spx?bookid=1069&sectionid=60775149.
Please add to the PROCEDUR codelist the II SDTM-Published in P40

CDISC Submission Value of POLYGRAPHY.
Polygrapy is very similar to the
POLYSOMNOGRAPHY, but does not record the
"neurological" channels for emg, eog, or eeg.
However, the other parameterS, especially AHI,
are the same. Polygraphy can be performed on
the normal ward and its use allows the site to
treat more patients per time than
POLYSOMNOGRAPHY, which requires a
specialized lab space.
Is this a proper noun and if so, should the CDISC II Glossary-Published with
submission value be capitalized to Good Clinical P40
Practice (GCP)?

P39
Valid values specified in the SDTM models 1.4-

1.7 are:
CONSCIOUS, SEMI-CONSCIOUS,
UNCONSCIOUS
Please add term JCVDNA/JC Virus DNA to II SDTM - Published with

MBTESTCD/MBTEST codelists. P39
In one of your earlier Controlled Terminology II
webinars, it was mentioned that the CDISC team
was going to publish a LAB CT version with all
the Controlled Terminology LBTESTCD, LBTEST
along side instead of having to scroll up and
down in the Controlled Terminology CT.
Also, would you have a listing of all LBTESTCD,
LBTEST with Standard Units and/or factor
multiplier to get Standard Units (LBSTRESU)?
it would be very helpful to have one such

standard Lab Controlled Terminology with all the
possible LBTESTCD, LBTEST and LBSTRESU in
one file.
Please let me know if there is any move towards

request?
Multiple terms requests; File emailed separately II Glossary-Published with

P40
Please remove Penicillium chrysogenum IgE II SDTM, SEND -
Antibody/C147287 from the LBTEST-CD Published with P39
codelists. Penicillium chrysogenum is
synonymous to Penicillium notatum
(https://www.ncbi.nlm.nih.gov/Taxonomy/Browser
/wwwtax.cgi?
mode=Info&id=5076&lvl=3&lin=f&keep=1&srchm
ode=1&unlock), and there already is a LBTEST
for P. notatum Antigen IgE Antibody/C130146.
II
Please add synonyms to the following concepts:

-C130147 P. notatum Antigen IgA Antibody,
add SY = Penicillium chrysogenum Antigen IgA
Antibody
-C130146 P. notatum Antigen IgE Antibody,
add SY = Penicillium chrysogenum Antigen IgE
Antibody
-C130148 P. notatum Antigen IgG Antibody,
add SY = Penicillium chrysogenum Antigen IgG
Antibody
-C130149 P. notatum Antigen IgG4
Antibody, add SY = Penicillium chrysogenum
Antigen IgG4 Antibody
Multiple new term requests from the Type 1 II SDTM, SEND -
Diabetes team. Craig, I am still in the process of Published with P39,
getting these terms ready for Erin to review next P40, P42
Friday. I am putting this request here as a place Do not add (P40) -
holder and getting a request code. Please do not Continuous
worry about triaging this request, once I have the Subcutaneous Infusion -
terms ready I will add them into the General Do not add. Example
Working Document for review. Thank you. updated in TAUG to use
FREQ and ROUTE. No
new terminology
needed.
These units are used for the agent administered II SDTM, SEND -
in a respiratory challenge study involving the Published with P41
administration of a virus
The unit umol/mmol is used for the test 5- II SDTM, SEND -

Hydroxyindoleacetic Acid/Creatinine in a urine Published with P39
specimen. It is measuring umol/mmol (creatinine). Do not add (P39): Add
as a synonym to
C111253 instead.
Requesting test 5-Hydroxyindoleacetic II SDTM, SEND -
Acid/Creatinine done in urine associated with unit Published with P41
request umol/mmol.
percentage) of the 5-hydroxyindoleacetic acid to
creatinine in a biological specimen.
new term requests for four new LBTEST values II SDTM, SEND -
to support draft LOINC mapping; File emailed Published with P39
separately.
Review published lab tests C142275 and II SDTM, SEND -
C147350: I think these are synonymous. At the Published with P40
very least the synonyms infer synonymy.
II SDTM, SEND -
Published with P39,
P40, P42
II SDTM, SEND -
Published with P39
ARMPIT correspond to the CDISC definition

CORRECT the that that: Other adverse events II
that are not study endpoints and are not
"expected" (i.e., because they are not in the
investigator's brochure) that that can be
anticipated to occur with some frequency during
the course of the trial, regardless of drug
exposure, depending on the patient population
and disease under study. NOTE: Examples of
such "anticipated" events include known
consequences of the underlying disease or
condition under investigation, events anticipated
from any background regimen, or re-emergence
or worsening of a condition relative to
pretreatment baseline. [after FDA, Guidance for
Industry and Investigators: Safety Reporting
Requirements for INDs and BA/BE Studies]
Modify two terms. Terms are already in the MB II

working Doc, just need a request code
Add a new CDISC SY to C74716 II
QSCAT/QSTESTCD/QSTEST for T1DDS II QRS-Published in P38

(Diabetes Distress Scale for Adults with Type 1
Diabetes) This is for T1D TAUG
Please consider adding a CDISC LBTEST for II SDTM, SEND-Published
Soluble Complement C5b-9; Suggested in P41
LBTESTCD: SC5B9; Suggested Definition: A
measurement of the soluble complement C5b-9
in a biological specimen. Link to information:
https://www.ncbi.nlm.nih.gov/pubmed/3584995.
Thank you.
Definition - An area or organ outside of the lymph II Do not add (P43): Do

nodes. not add. Requester
withdraws request.
This is term is used quite often in oncology trials
where an exact location is not available. Please
note - this term is available in the NCI Thesaurus
using Code C25504
Pls add SY to C81976/Anti-Saccharomyces II Request withdrawn by
cerevisiae Antibody. NEW SY = Baker's Yeast requester.
Antibody (this is LOINC preferred term)
LOINC treats this test as an allergy lab test.

6713-2, Baker's yeast IgG Ab. LOINC has the
following description for this test: A food, which
may result in allergy symptoms in sensitized
individuals. Common names include yeast,
baker's yeast, and brewer?s yeast. S. cerevisiae
may induce symptoms of allergy, including
allergic rhinitis, asthma, and atopic dermatitis, in
sensitised individuals. Hypersensitivity
pneumonitis has been reported.
Hence this test should remain in LB. Pls consider

adding the SY.
Definition: An instrument, apparatus, implement, II Do not add (P39): Team

machine, contrivance, implant, in vitro reagent, or considers that the EVAL
other similar or related article, including any variable itself is defined
component, part, or accessory, which is thusly: Role of the
recognized in the official National Formulary, or person who provided the
the United States Pharmacopeia, or any evaluation. Used only
supplement to them, intended for use in the for results that are
diagnosis of disease or other conditions, or in the subjective (e.g.,
cure, mitigation, treatment, or prevention of assigned by a person or
disease, in man or other animals, or intended to a group). Examples:
affect the structure or any function of the body of ADJUDICATION
man or other animals, and which does not COMMITTEE,
achieve its primary intended purposes through INDEPENDENT
chemical action within or on the body of man or ASSESSOR,
other animals and which is not dependent upon RADIOLOGIST.
being metabolized for the achievement of its Therefore we cannot
primary intended purposes. (FDA) change the definition of
Copy of C99078.C16830 the codelist NOR add
this term to the codelist
We have a couple times now received data from unless/until the variable
both a machine and a qualified person where a itself is changed in a
distinction needs to be made. So it would be future version of the
helpful if CDISC can add a solution to the EVAL SDTM.
codelist for this.
We've considered using the devices domains but
they are more appropriate when describing the
devices used in procedures/tests rather then
specifying that the particular measurements were
evaluated by a device.
A definition of the EVAL codelist may need to be
updated to accommodate this as it refers to an
individual nor an entity so it does not cover a
device. Also, the description of the --EVAL
variable reads "Role of the person who provided
the evaluation.". Nowadays, we get more and
more data evaluated by all sorts of machines.
Could CDISC consider updating this description?
New ISTEST = Binding Microbial-Induced II
Antibody: Could the team review the example and
develop a concept for this? Otherwise write-up a
reason for why the terminology is not appropriate
and and put this as a denied request.
Used in vaccine immunogenicity study to II SDTM-Published in P42

measure neutralizing antibodies.
Proposed Definition: A pseudovirion-based
neutralization assay (PBNA) detects all
neutralizing antibodies that can arrest the
infection of pseudovirus and thus have the
potential for providing protection against the virus.
Consider EXPRLTIM instead of EXPRELTIM. II SEND-Published with

P39
Please add new terms. This request is from the II SDTM-Published in P41
T1D TA team. File emailed separately. Do not add (P41):
GLUCALHI; Plasma
Equiv Glucose Alarm
Setting, High-This is
incorrect terminology
and team agrees that
T1D team should either
remove this example all
together, or the
modeling of this
example needs to
change to be consistent
with this:
https://wiki.cdisc.org/x/fz
1cB
GLUCALLO; Plasma
Equiv Glucose Alarm
Setting, Low-This is
incorrect terminology
and team agrees that
T1D team should either
remove this example all
together, or the
modeling of this
example needs to
change to be consistent
with this:
https://wiki.cdisc.org/x/fz
1cB
GLUCTRNG,
GLUVLRNG,
GLULRNG, GLUHRNG,
GLUVHRNG: Withdrawn
by requester. Dataset
has been remodeled
and this term is no
New definition: In the context of privacy II
guidelines, ... refers, and from whom data are
collected, processed, and stored. [after ISO/TS
2537:2008; and EU GDPR] See also study
participant and participant
The reference article describes these scores and II QRS-Published in P38

the new QRS rule is to include scores if
documented in the reference article. The updated
draft CT spreadsheet was sent separately.
QSCAT/QSTESTCD/QSTEST for DDS Parent II QRS - Published with

version For T1D TAUG P39
Please add new dictionary name of ATC, CTCAE, II SDTM - Published with
UNII, MED-RT and NDF-RT. These dictionaries P39
are used in SDTMIG.
The new term (March 2018) is surprising. where II Do not add (P39): Do
does this come from? It is not a common industry not change. When the
term, it is over complex, must be mapped from team began considering
every source (no one uses the new term additional tests that
operationally) and the change is impacting were needed for the MI
databases which have used the original term for domain (e.g., sexual
YEARS worth of data. maturity, skeletal
maturity, etc.), it was
determined that the
existing term of
'Microscopic
Examination' prevented
the inclusion of
additional tests into the
domain, i.e., the test of
'Microscopic
Examination' was a re-
statement of the domain
name, which the team
deemed an
inappropriate level of
granularity for a TEST
value. The team
considered what was
actually meant/intended
when the term
'Microscopic
Examination' was first
published and came up
with the more specific
term 'General
Histopathologic
Examination,
Qualitative'. Removal
and replacement of this
term was approved by
SEND Core Team at the
Add CDISC SYs and update definitions for 3 II SDTM, SEND -
existing UNI terms: C71169, C70523, C70525. Published with P39
Request already in the UNIT working doc, just
need request code.
"full link: II SDTM, SEND-Published

http://www.sysmex.co.uk/education/knowledge- in P41
centre/sysmex-parameters/immature-platelet-
fraction-ipf.html
What is Immature Platelet Fraction counting?

The immature platelet fraction (%IPF) is a modern
parameter that measures young and thereby
reticulated platelets in peripheral blood. The
reference range is approximately 1 to 5% of the
total platelet count.
IPF levels rise as bone marrow production of
platelets increases. Therefore its measurement
provides an assessment of bone marrow platelet
production from a peripheral blood sample, in a
similar way to how a reticulocyte count could
provide a measure of red cell production.
There is a high clinical utility of the %IPF in the
laboratory diagnosis and treatment of
thrombocytopenia due to the ability to relate
raised %IPF levels with increased peripheral
platelet destruction. It is particularly useful for
supporting the diagnosis of autoimmune
thrombocytopenic purpura, thrombotic
thrombocytopenic purpura and for distinguishing
these from bone marrow suppression or failure. In
the case of the latter, the %IPF value would be
low.
The %IPF can also be a sensitive measure for
evaluating thrombopoietic recovery during
aplastic chemotherapy. In some specialist
haematology and cancer centres, for instance,
%IPF is taken into consideration in platelet
transfusions. Transfusions may only be
considered when the %IPF values are not rising
as this would indicate poor intrinsic
thrombopoietic activity. "
C75350 is BNZLCGN (Benzoylecgonine). It has II SDTM, SEND-Published
the following synonyms: Benzoylecgonine; in P42
Cocaine Metabolite.
However there are a number of cocaine
metabolites; Benzoylecgonine is not the only one.
I need a CDISC term for the generic 'Cocaine
Metabolites', but I think this should be a new term
- I can't use 75350.
Can you please remove the synonym and create

a new term?
Homocitrulline is listed as a synonym for both II SDTM, SEND-Published
C154759 and C154758. We need to check this in P41
and either remove from one or merge these
concepts.
From DianeW: The intent here was to create a II Do not add (P41): Do
flag that describes whether the data submission not create response
contains blinded or unblinded data. The values codelist. Instead the
would be: 'CONTAINS BLINDED DATA' and TSPARM/CD is being
'CONTAINS UNBLINDED DATA'. retired.
This TSPARM came from the QT studies TAUG. II SDTM-Published in P42

Response values would be MANUAL,
AUTOMATIC, SEMI-AUTOMATIC.
Please consider adding new viral microorganism II SDTM-Published in P40

"Mumps rubulavirus" with synonym of "Mumps
virus". Reference:
https://www.ncbi.nlm.nih.gov/Taxonomy/Browser/
wwwtax.cgi?
mode=Info&id=1979165&lvl=3&p=mapview&p=ha
s_linkout&p=blast_url&p=genome_blast&lin=f&ke
ep=1&srchmode=1&unlock; Suggested definition:
Any viral organism that can be assigned to the
species Mumps rubulavirus. Thank you.
Rapid Plasma Reagin testing measures II SDTM-Published in P42

macroscopic agglutination (flocculation) of
cardiolipin-coated charcoal particles, useful for
Syphilis screening and assessing adequacy of
therapy. It seems to be an enhanced form of
flocculation as a test method. This was discussed
at the MB team meeting, we realized that VDRL
uses the traditional Flocculation method and RPR
uses the Charcoal-enhanced version of
Flocculation method, hence please consider
adding as a child concept of Flocculation (which
is published).
Homocitrulline/HOMOCOT is already present as II SDTM, SEND-Published

submission value in P41
Basophilic Erythroblast already exists II Do not remove (P41): In

humans, these are
synonymous terms.
C147311/Basophilic
Erythroblast exists as a
standalone term for non-
human lab usage.
Please see definition.
Basophilic Normoblast already exists II Do not remove (P41): In
humans, these are
synonymous terms.
C147405/Basophilic
Normoblast exists as a
standalone term for non-
human lab usage.
Polychromatophilic Erythroblast already exists II Do not remove (P41): In

humans, these are
synonymous terms.
C147418/Polychromato
philic Erythroblast exists
as a standalone term for
non-human lab usage.
Polychromatophilic Normoblast already exists II Do not remove(P41): In

humans, these are
synonymous terms.
C147419/Polychromato
philic Normoblast exists
as a standalone term for
non-human lab usage.
"ERS" is present as synonym value of Estrogen II Do not remove synonym

Receptor but "ESR" is also present in LBTESTCD (P41): ESR is an
codelist for Erythrocyte Sedimentation Rate. That abbreviation that is used
lead some confusion. I think ESR should not be for more than one lab
present as synonym of Estrogen Receptor test. The presence of
ESR as a synonym here
will force people to
check with the lab
vendor as to whether
the test was for
Estrogen Receptor or
Erythrocyte
Sedimentation Rate.
The rule we do follow is
that we cannot have two
identical CDISC
submission values for
different concepts in the
same codelist but
otherwise we can add
appropriate synonyms if
the abbreviation is used
for more than one lab
test.
CMR shoud be deleted as synonym of II Do not add (P40) - Do
MOLECULAR CR not remove synonym.
Published CT rules
indicate that the use of
common acronyms as
synonyms is okay as
long as two distinct
terms in a codelist do
not have the same
CDISC submission
value. The presence of
acronyms ensures that
the appropriate value is
chosen.
DNA copies/ug - The unit of concentration of II SDTM, SEND-Published

deoxyribonucleic acid (DNA) copies expressed as in P41
a number of copies per unit volume equal to one
microgram.
in P40, P42
The definition for DIGITAL WIDE FIELD II SDTM-Published in P40

IMAGING is: a wide-angle retinal imaging system
and the most common system for fundus
photography in premature born children. The
obtained high-quality photographs can be
evaluated by a remote expert. It has been shown
to have high reliability and accuracy in detecting
referral-warranted ROP. Additionally, the method
is generally well received by parents and is highly
cost-effective.
In oncology studies with progression free survival II Do not add (P40) - Do
and overall survival endpoints with defined follow- not add. In this instance,
up periods, i.e. follow the subject for 5 years or the EPOCH would be
until death), subjects can complete the study FOLLOW-UP, so this
because they died or because they completed the requested term still does
follow-up. In analysis displays of the data for not differentiate
analysis, it is necessary to summarize/count the between those that
number of the deaths separately from the number complete the follow-up
that completed the follow-up. The existing CT due to survival versus
value of COMPLETED is too vague in these those that complete the
situations where it is necessary to differentiate follow-up due to death.
between completions due to death and Because as the
completions due to completion of the follow-up. requester states, Death
or Survival both mean
completion. The
requested term still does
not make this clear.
Additionally, this codelist
was only meant to
capture either the fact
that the subject
completed OR the
reason for non-
completion. The
requester seems to be
stating a reason for
completion (Death or
Survival) which this
codelist was not meant
to convey as defined.
The team recommends
capturing this
information elsewhere. It
may be possible to put
something like 'Survived
Follow-up' and 'Death
during Follow-up' in
DISH is "DISH" = Dual In Situ Hybridization and is II Do not add (P42): Do
a well-documented method. not add. Please use
existing concepts CISH,
FISH, SISH, or IN SITU
HYBRIDIZATION and
the information that two
probes were used could
go into suppqual or in
device domain dataset.
The METHOD codelist
is also extensible so the
requester can choose to
use this proposed term
as an extensible value in
the METHOD codelist.
Please consider the addition of "Chlamydia" as II SDTM, SEND-Published

Lab parameter. in P42
Update definition for MMSE-2 STANDARD II QRS-Published in P38
VERSION CAT CDISC definition; File emailed
separately
QSCAT/QSTESTCD/QSTEST for DDS Partner II QRS-Published in P39

measure; File emailed separately
T1D TA
QSCAT/QSTESTCD/QSTEST for GMSS; file II QRS-Published in P39

emailed separately
T1D TA.
QSCAT/QSTESTCD/QSTEST for HCS - II QRS-Published in P39

Hypoglycemic confidence scale; file emailed
separately
T1D TA.
A measurement of the Methylphenidate present II SDTM, SEND-Published

in a Urine sample by LC-MS/MS method. in P41
A measurement of the Ritalinic Acid present in a II SDTM, SEND-Published

Urine sample by LC-MS/MS method in P41
A measurement of the Ethyl Glucuronide and/or II SDTM, SEND-Published

Ethyl Sulfate present in a URINE sample by in P41
LC/MS/MS method
This would better distinguish an actual animal II SEND-Published in P40

Clinical Sign from Pan/Cage signs; Often Pan
Signs and animal Clinical Signs are done as a
'first session' leading to 2 different CLTPT values
for the same TPTNUM value which breaks a FDA
business rule.
Add SY to C122230 and update definition. II SDTM, SEND -

New SY = ugEq/L Published with P39
New DEF = A concentration unit measured as the
number of microgram equivalents of solute per
liter of solution, or as the number of nanogram
equivalents of solute per mililiter of solution.
The PK team has added this term to the PKUNIT
codelist with a different submission value of
ngEq/mL, therefore we request the lab team to
consider updating the definition to so it defines
both ugEq/L and ngEq/mL, which will appear in
both UNIT and PKUNIT. Thank you
A measurement of the 8 Hydroxydeoxyguanosine II SDTM, SEND-Published
in a URINE sample by ELISA method. with P42
Please find attached a multiple term request file II SDTM, SEND, Protocol
that contains all content from P38 without a new - Published with P38
term request number. It includes 135 new term
requests and 22 changes to existing. File emailed
separately.
Study Medication within a vaccine trial is using II SDTM, SEND-Published

10^7 PFU as the unit. in P41
Definition: A unit of measurement of infectious

entities with numbers equal to 10 to the seventh
power plaque forming units.
Synonyms: Ten Million Plaque Forming Units,
Ten Million PFU
Currently in NCI with the following C Code:

C67265
Study Medication within a vaccine trial is using II SDTM, SEND-Published

10^8 PFU as the unit. in P41
Definition: A unit of measurement of infectious

entities with numbers equal to 10 to the eighth
power of plaque forming units.
Synonyms: Hundred Million PFU, Hundred Million
Plaque Forming Units
Currently in the NCI Thesaurus using the

following C Code: C67266
A measurement of the Galectin-3 in a PLASMA II SDTM, SEND-Published

sample by ELISA method. in P42
A measurement of the Soluble L-Selectin activity II SDTM, SEND-Published
in a SERUM specimen by ELISA method in P42
Please remove 155 terms from LBTEST-CD; File II SDTM, SEND -

emailed separately. Published with P39
Rationale: Cardiovascular study which created a II
form to collect very specific Cardiac
Catheterization Measurements
TESTCD = MPAWP
Definition: A measurement of mean blood
pressure within the pulmonary artery branch by
wedging a balloon catheter into the branch.
The Multiple spreadsheet has protected cells, so I II SDTM, SEND-Published
cannot enter the required information, therefore I in P41
am providing the 3 new terms within this request.
I will send the document of the example CRFs
sections where these codes are needed to the
email address above.
days/week - a rate of occurrence within a period

of time equal to one day over another period of
time of a week days/month - a rate of occurrence
within a period of time equal to the number of
days over another period of time of a month
hours/week - a rate of occurrence within a period
of time equal to the number of hours over another
period of time of a week
Starting to see SENDIGv3.1 data. Autolysis is II SEND-Published in P42

used as a diagnostic term histopathologically, and
graded. It is also used, when Autolysis precludes
reading the tissue, as a specimen condition,
when the tissue is not read as a result. Sponsors
have been putting as non-standard terminology,
but I think it is clear this is standard terminology,
for microscopy, and is usually stand alone,
meaning no UNREMARKABLE will appear with
autolysis in a specimen condition. Most every
dataset I have seen to date has grading of
autolysis microscopically.
This request is for the ADQRS subteam and is an II QRS-Published in P39

update to the MDD TA team's original request.
Traceability is a key concept underlying most of II Glossary-Published with

what we do as a standards organization. It is P40
referenced in much of our public-facing
documentation and appears in several standards.
Yet there doesn't appear to be a definition in any
of the sources I checked. it would be good.
proposal definition : clonal Plasma cells are a II SDTM, SEND-Published

bone marrow-based malignant disorder of in P42
postgerminal center B-cells that is characterized
by a clonal proliferation of plasma cells. For test
code, we wait proposal from CDISC if the test
name is approved.
This test is used in oncology studies.

Proposal definition : corneal topography is a II SDTM-Published in P42
method of computer-assisted examination of the
cornea, the clear front portion of the eye that
transmits and focuses light into the eye.
Proposal definition : The act of assuming or II CDASH, SDTM, SEND -

maintaining an erect upright position. (NCI) Synonym published with
P40
For every studies, this is required by statistician Do not add (P40) - Do
to have orthostatis has the difference between not add. This is a
standing and supine position in bps. synonym of STANDING,
which is already in the
codelist. We will add a
synonym instead.
proposal definition: An indication as the result of II Do not add (P44): Do

any gain, loss or alteration of the sequences not add. The Genomics
comprising a gene, including all sequences team has agreed that
transcribed into RNA the PF domain will be
retired and replaced with
the GF domain,
therefore we will not be
adding any new values
to the PFTEST-CD
codelist. The team will
however review these
requests as to whether
they will add them to
GFTEST-CD.
A measurement of the Chlamydia pneumoniae II

IgG Antibody in a SERUM specimen by
FLUORESCENT MICROSCOPY Method
in P40
Do not add (P40):
HCRNA/Hepatitis C
RNA - Do not add, map
to C142330
HIV-1 RNA - Do not
add, map to C158238
Do not add (P42):
AATAGLVL-Do not add.
C80167.
AATFUNC-Do not add.
The requester reports
that the unit of measure
for this functional assay
is umol/L. Given that
that is a mass
concentration
measurement, we don't
think it appropriate to
create a new 'Alpha-1
Antitrypsin Activity' term
because we suspect the
functional assay is using
activity measurements
as a surrogate for
amount measured.
Therefore, they should
still use the existing
published term C80167.
CD16; CD1656LY;
CD16CD56; CD16LY;
CD56LY-Do not add.
CDISC is developing a
new domain to support
CD marker
MOCA to MOCA VERSION 7.1, with the following II
definition change:
Montreal Cognitive Assessment Version 7.1

(MOCA VERSION 7.1) (Copyright Z. Nasreddine
MD. Ziad S. Nasreddine, Natalie A. Phillips,
ValÃ©rie BÃ©dirian, Simon Charbonneau, Victor
Whitehead, Isabelle Collin, Jeffrey L. Cummings
and Howard Chertkow. The Montreal Cognitive
Assessment, MoCA: A Brief Screening Tool For
Mild Cognitive Impairment. J Am Geriatr Soc.
2005 Apr;53(4):695-9).
A type of MRI that takes a series of images of an II SDTM-Published in P45

organ in quick succession in completely resting
state and statistically analyzes the similarity
between different locations in the image.
"%O is used by some local labs as a collected II
unit for reticulocytes to represent promille (ppth)
of RBC.
Pls also add Promille as a SY to C69112 (ppth)
"
As per KNEE=KNEE JOINT, please add ELBOW II SDTM-Published in P40

as a synonym of ELBOW JOINT and WRIST as a
synonym of WRIST JOINT.
I understand that these are synonyms in NCI as
well after discussion with Erin.
PGR (PgR) should be added as synonym for II SDTM, SEND-Published

Progesterone Receptor test code in P41
Unit is needed for a vaccine trial as this is the unit II

written into the protocol
Synonym: 50 Percent Tissue Culture Infective

Dose per Liter
Definition: A potency unit equal to the potency at
which one liter of infectious material contains one
50 percent tissue culture infective dose.
This was originally for the Alzheimer's Disease II QRS-Published in P39

TA team in 2013. The terminology is being
updated to include total score.
A term used when the subject of the trial is 1) the II SDTM-Published in P40
mother (for "Paternal partner") or 2) is the father
(for "Maternal partner") reflecting data for 1) "the
father of my child" or 2) "the mother of my child".
proposal of definition : the result of any gain, loss II

or alteration of the sequences comprising a gene,
including all sequences transcribed into RNA
distinguishable as an identifiable class based on
common qualities.
This is used in Onclogies studies. I send by mail
the case report form page.
Definition Proposal : The code of the result of any II
gain, loss or alteration of the sequences
comprising a gene, including all sequences
transcribed into RNA distinguishable as an
identifiable class based on common qualities.
associated Test name is Gene Alteration Type
for Test name : Gene Alteration Indicator. II

Proposal definition : the code of an indication as
the result of any gain, loss or alteration of the
sequences comprising a gene, including all
sequences transcribed into RNA
Very often we have to include histopathological II Do not add (P40): Do

evaluation of special stained tissues. The data is not add. The SEND
very similar to 'normal' MI data and can easily be MAMI team has not yet
adapted into the MI domain. Following the determined (it is part of
general test name of 'General Histopathologic that team's charter) how
Exam, Qual', special staining such as IHC should to model targeted
be included with a similar general test name, as examinations for the MI
proposed. The type of staining, such as 'IHC - domain and so the CT
CD20 stain' is included in MIMETHOD in line with team feels it is
the SENDIG recommendation of 'H&E' staining. premature to be adding
Any more information is not offered in the study a new MITEST-CD at
report, but recides in SOPs and is therefore this time. Additionally,
considered operational. It can be included in the team is concerned
SUPP QUALs if deemed necessary. We have about the inclusion of
found the need only for one other variable: methodological
Marker String, but only in very specific instances, information in the
not for all IHC data. proposed TEST-CD
value. The codelist is
extensible so the
sponsor should feel free
submit any sponsor-
defined MITEST-CD
terms in their dataset,
prior to a defined
solution by the MAMI
team.
A lab is sending data for CD154 expressing cells. II

Appendix II of Janeway's Immunobiology, 9th
Edition (Murphy and Weaver) lists CD40L, TRAP,
T-BAM, and gp39 as other names for CD154.
Since CD40L already exists in CT, I suggest
adding the suggested synonyms.
CANAMET - Cannabis Metabolites. II
Synonym: Marijuana Metabolites.
Definition: A measurement of any Cannabis
metabolites in a biological specimen Request
reason: Used for drug screening in Urine
BTLBARTL - Butabarbital
Synonym: Butisol
Definition: A measurement of Butabarbital in a
biological specimen Request reason: Used for
drug screening in Urine
Draft definition: ""The unit of concentration of II SDTM, SEND-Published

deoxyribonucleic acid (DNA) copies expressed as in P42
a number of copies in unit volume equal to one Do not add (P43):
microgram."" h*DNA copies/ug/pfu:
This is for an oncology study where subjects will Do not add. No final
receive an IV infusion of cells transfected with an response received from
encoding target antigen. PK is monitored via requester for follow-up
determination of genomic DNA in the cell by inquiries.
quantitative PCR.
Software as a medical device International II Glossary-Published with

Medical Device Regulators Forum (IMDRF) P40
software intended to be used for one or more
medical purposes that perform these purposes
without being part of a hardware medical device.1
FDA, under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) considers medical
purpose as those purposes that are intended to
treat, diagnose, cure, mitigate, or prevent disease
or other conditions.
Key definitions reference: Software as a Medical
Device (SaMD):
http://www.imdrf.org/docs/imdrf/final/technical/imd
rf-tech-131209-samd-keydefinitions-140901.pdf.
Please add QRSMTHOD to the dropdown list of II SDTM-Published in P40
codelists. Could they also be ordered
alphabetically?
Please add the following new terms:
NUMERICAL RATING SCALE 6-POINT
LIKERT SCALE 7-POINT
NUMERICAL RATING SCALE 6-POINT - A

questionnaire, rating and scale (QRS) data type
using a 6-point numeric rating scale (NRS).
LIKERT SCALE 7-POINT - A questionnaire,
rating and scale (QRS) data type using a 7-point
Likert Scale.
Used in QRS data. The first was approved by

Steve, Dana and Jordon. The second was found
in a UG.
New term requests for MBTESTCD/MBTEST, II SDTM-Published in P40

UNIT, and MICROORG codelists. Additional Do not add (P45): Do
suggested update in the MICROOR codelist. not add. This test 'Cycle
of Quantitation (often
File emailed separately. called Cycle Threshold
or "Ct"' is modeled as a
MBTSTDTL, which was
published with P44, and
has been determined to
be unitless. Therefore
no unit is required for
this value.
PLAQUE REDUCTION NEUTRALIZATION TEST II SDTM-Published in P42

Definition: A type of neutralization assay used to
determine whether antibodies that can block
infection are present in a biospecimen by
counting the number of plaque forming units
(PFU) in cultured media compared to the number
of PFU in a control media.
Synonyms: PRNT
Multiple labs submitting data use the PRNT,
which is considered the gold standard assay for
some viral infections (see e.g.,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC37
52766/)
We are interested in neglected diseases such as II
visceral leischmaniasis which includes
audiometry checks. As far as I can determine
there is a domain for opthalmology but not for
audiometry. I sueegst using AU or similar for this.
Patient still in screening or had not yet been II SDTM-Published in P40

randomised when recruitment was closed
Exactly as other accumilation ratios, but based on II SDTM, SEND-Published

AUCIFO in P41
Please consider adding SUPPMO II SDTM-Published in P40

In a recent study, there was a 4 week and a 52 II Do not add (P40): Do
week recovery period for the same dose groups not add. Please use the
(several cohorts or trial sets of animals in the published term
treatment groups). The definition of INTERIM RECOVERY
SACRIFICE indicate that it can be used only if SACRIFICE and timing
animals are sacrificed prior to terminal sacrifice, variables, since there is
which is not the case for the 4 week recovery sac. no difference in
The definition of RECOVERY SACRIFICE also treatment exposure
precludes that use, since it is defined as the end other than days of being
of a post-dose observation period, which is treatment-free, which is
clearly not the case for the 4 week sac either. reflected in the DSDTC.
Therefore a term such as INTERIM RECOVERY
SACRIFICE with a definition such as "An
indication that the study subject is part of a
protocol-defined set of animals that are sacrificed
during a protocol-defined treatment-free period" is
needed.
A period in a methodolocal clinical study after II SDTM-Published in P40

eligibility has been met and subjects are under
observation during which no treatment is
administered.
To be used when TS.Study Type

Response=OBSERVATIONAL, and when no
treatment is administered.
Microgram per Deciliter: A unit of mass II SDTM, SEND-Published

concentration defined as the concentration of one in P40
microgram of a substance per unit volume of the
mixture equal to one deciliter. The concept also
refers to the unit of mass density (volumic mass)
defined as the density of substance which mass
equal to one microgram occupies the volume one
deciliter.
Version 4.3 is available since March 2019 II SDTM-Published in P40
Multiple Term requests for LBTEST (Tear Test), II SDTM, SEND-Published

LBTESTCD (TEAR), Unit (mm/2min) and in P41, P42
MISPEC (GLAND, ZEIS Do not add (P45):
mm/2min -> Do not add.
Please use existing
UNIT of mm and place
'2min' (in ISO8601
format) into --EVLINT
variable.
File emailed separately. Includes request to II ADaM-Published in P40

modify existing terms and create new term. This
request is being submitted on behalf of the ADaM
Integration subteam to address the public
comments received on the document and ensure
the CT is consistent with the latest Integration
document.
Term definition : Supportive care is that which II SDTM-Published in P42

helps the patient and their family to cope with Do not add (P42): Do
cancer and treatment of it from pre-diagnosis, not add to TRTSET.
through the process of diagnosis and treatment, This is a Treatment
to cure, continuing illness or death and into Intent. Team will
bereavement. It helps the patient to maximize the develop term to add into
benefits of treatment and to live as well as TRTINTNT codelist
possible with the effects of the disease.
Supportive therapy may provide a patient with
friendship, encouragement, practical advice such
as access to community resources or how to
develop a more active social life, vocational
counseling, suggestions for minimizing friction
with family members, and, above all, hope that
the life of the patient may be improved. In all
situations, supportive therapy involves the
teaching of such life skills as managing
medication, learning to socialize, handling
finances, and getting a job.
This term is used in the medical form.
Definition proposal : An agent that makes tumor II SDTM-Published in P42

cells more sensitive to radiation therapy. Do not add (P42): Do
This term is present in medical form. not add to TRTSET.
This is a Treatment
Intent. Team will
develop term to add into
TRTINTNT codelist
definition proposal : Term Definition NCI : (Code II Do not add (P42): Do
C64468) Administration of high doses of not add. Please use the
chemotherapy or radiation therapy, as well as existing term
immunosuppressive therapy, to a transplant CONDITIONING in the
recipient prior to a bone marrow or hematopoietic TRTSET codelist.
stem cell transplant. Conditioning destroys the
patient's abnormal blood cells or cancer, as well
as slows the patient's immune response against
the donor bone marrow (graft rejection).
This term is used in medical form.
NCI-GLOSS Definition: Initial treatment with II Do not add (P42): Do

anticancer drugs to decrease the signs or not add. Please use the
symptoms of cancer or make them disappear. existing term
This term is used in medical form INDUCTION in the
TRTSET codelist.
A physician who specializes in diagnosing and II Do not add (P40) - Do
treating diseases and disorders of the nervous not add. The SDTMIG
system. indicates that EVALID
Used in questionnaires mapping in order to put should make use of
initials in ?EVALID (Example: questionnaire is MEDEVAL CT. The
assessed by independant neurologist) SDS oncology team
recommends putting an
evaluator's initials into a
suppqual/nsv instead of
EVALID because the
EVALID variable was
not created to support
person initials and for
privacy concerns.
Additionally, when the
EVAL codelist was
created, it was meant to
be at a generic level of
granularity and not
meant to hold medical
specialty roles. EVALID
was meant to hold more
specific information (but
not person initials).
Changing this precedent
in CT without further
explanation in an IG
would be detrimental to
the model. Therefore the
team would not add
NEUROLOGIST to the
EVAL codelist at this
time; NEUROLOGIST is
more appropriate for the
EVALID variable (and is
published in that
codelist). A request has
To generate automatic rules, please keep only II SDTM-Published in P40
one space between words.
Urothelial cell is a component detected from urine II Do not add (P42): Dot
in urinary sediment examination. not add. Map to
Urothelial
Cells/C163500.
In P38, C74629 - LYMRCT (Rective II SDTM, SEND-Published
Lymphocytes) was retired and merged with in P40
Atypical Lymphocytes.
However there is also C158230 - LYMRCTLE
(Reactive Lymphocytes/Leukocytes) which I
assume should also be merged into C64819
LYMATLE (Lymphocytes Atypical/Leukocytes)?
C-fos-induced growth factor (FIGF) (or vascular II SDTM, SEND-Published

endothelial growth factor D, VEGF-D) is a in P42
vascular endothelial growth factor that in humans
is encoded by the FIGF gene.
The stromal cell-derived factor 1 (SDF1), also II SDTM, SEND-Published
known as C-X-C motif chemokine 12 (CXCL12), in P42
is a chemokine protein that in humans is encoded Do not add (P42):
by the CXCL12 gene on chromosome 10. CXCL12-Do not add.
HUGO and Genecards
indicate that this is
synonymous with
Please add the term SAGGITAL SINUS to the II SDTM,
CXCL12. SEND-Published
We will add it
LOC codelist. The sagittal sinus is a large vein in
asP40
a synonym with P42
found in the human head. This vein travels over instead.
the top portion of the skull, beginning at the top of
the skull and moving to the back part of the skull.
This is needed as we are receiving 3rd party MRI
data with this value.
Please add SIGMOIDAL SINUS to the LOC II SDTM, SEND-Published

codelist. The sigmoidal sinus is a venous sinus in P40
of the dura mater on either side, continuous with
the straight sinus and draining into the internal
jugular vein of the same side. We are getting this
specification in 3rd party data transfer for MRI.
For a domain represented the data of sensory II Do not add (P40): Do

organ examinations, the specific domain about not add. New body
mouth, nose and eyes already have been system domains will
prepared (e.g., RE, OE). However the domain of only be added to the
examination about ears have not been assigned. DOMAIN abbreviation
Therefore we request that Otolaryngologic list when they are
Examination Findings domain are added. published in a version of
Otolaryngologic Examination Findings often the SDTMIG.
includes assessments using otoscope and
measuments about auditory using audiometer
etc..
No SEND PK parameters code exists for II SDTM, SEND-Published
accumulation ratios based on AUC Infinity Obs. in P41
Perhaps a code like ARAUCIFO would be more
specific that RAAUCIFO, which encompasses
_any_ AUC Infonity Obs ratio?
Accumulation ratio (e..g. Day 28 / Day 1) fo AUC
Infinity Obs (AUCIFO) would be reported as a PK
parameter for Day 28, similar to ARAUCLST or
ARCMAX.
With PKPARM having the posibility of being II

associated with 5 different PKUNIT codelists it
would be very helpful to have a VLM mapping
table to identify which PK unit codelist is
associated with each parameter.
"BGTCPHRL (Beta-Gamma Tocopherol) Def: A II SDTM, SEND-Published
measurement of the beta and gamma tocopherol in P42
in a biological specimen. Rationale: This is a
combined test performed by Q2:
http://www.specialtylabs.com/clients/gbmc/details.
asp?id=QC.931&spt=false
CDOXYCA (Chenodeoxycholic Acid) Synonym:
Chenodiol Def: A measurement of
Chenodeoxycholic Acid in a biological specimen.
CHOLA (Cholic Acid) Synonyms: 3?,7?,12?-
trihydroxy-5?-cholan-24-oic Acid. Def: A
measurement of Cholic Acid in a biological
specimen.
DOXYCA (Deoxycholic Acid) Synonyms:
Cholanoic Acid, Kybella, Celluform Plus, Belkyra,
3?,12?-dihydroxy-5?-cholan-24-oic Acid. Def: A
measurement of Deoxycholic Acid in a biological
specimen.
C161616 & C161617 - The codelist name and II QRS-Published in P39

CDISC definition have a typo. It has 'Paliative'.
But I believe this should be Palliative.
Remove and add new SY to the 6 values in the II SDTM-Published in P40
QRS Method codelist
A findings domain that contains physiological and II Do not add (P40): Do

morphological findings related to the ear, nose, not add. New body
and throat. system domains will
only be added to the
DOMAIN abbreviation
list when they are
published in a version of
the SDTMIG.
Requesting creation of a new term for II QRS-Published in P39
FAC070TC/TN (FAC07014, FAC070-Subscale
Score) to represent the subscale score for the
FACIT-FATIGUE 13-Item V4 instrument.
Request on behalf of QRS Subteam all TAs
interested in this instrument.
Request to create new test codes and test names II QRS-Published in P39,
in FAC008TC/TN for subscale and total scores P40
for the FACT-C V4 QRS instrument.
This request is on behalf of sponsors, the
Colorectal Cancer TA team, and the CDISC SDS
QRS Subteam.
DUTESTCD = BOLREMD II SDTM-Published in P42

DUTEST = Bolus Reminder Off
DEF: A setting on an insulin pump make alerts if
a bolus is not delivered during a specified time
period; this setting can typically be switched
between "On" and "Off".
"ANTEROTEMPORAL; PERIVENTRICULAR; II SDTM-Published in P40,

SUBCORTICAL; PARIETO-OCCIPITAL. These P41
are related to LOC terms requested in Jan 2017
(CDISC-2782) specific to SUPRATENTORIAL
BRAIN (C12512)
"
FDA reviewer request reported by Gitte Frausing II Do not add (P47): Do

and approved by SEND CCB. not add. The original
request was based on a
reported request from
an agency reviewer. On
following up by the
SEND CCB, a response
from FDA CDER eData
stated "CDER does not
consider a new Trial
Summary parameter
code for the date of final
QA sign off (QADCT) to
be needed at this time."
SEND CCB agreed not
to approve the addition
and closed the request.
No SEND PK parameters code exists for the II
standard errors (SE) of Cmax or AUC as
determined from a sparse-sampling non-
compartmental analysis. Perhaps a code like
SECMAX and SEAUCLST (and permutations for
other AUC calculations) would help depict the
true spread of the data which make up the
composite PK parameter?
SE of Cmax for a sparse-sampling profile for a

given POOOLID be reported as SECMAX. SE of
AUC(last) would be reported as SEAUCLST, and
so on.
Please add the term EARLOBE to the LOC II SDTM, SEND-Published

codelist. While EARLOBE is part of the EAR, in P40
OUTER, it is a distinct part and has a name to
reference it. EARLOBE is not a synonym for the
EAR, OUTER term that already exists in the LOC
codelist. This anatomical location of EARLOBE is
being used in the Vital Signs.
It is common for organizations to close out an II Do not add (P40) - Do

existing AE when it worsens (i.e., when severity not add. This request
worsens, or when a non-serious AE becomes has been denied before.
serious) and create a new AE record. This allows This codelist is based on
them to show the true history of the AE in the the E2B standard, which
standard AE structure (i.e., one record where the is why it is non-
non-serious AE has AESER=N and another extensible. Based on
record for the SAE with AESER=Y, both showing the requester's use
the start dates, etc.). None of the existing terms in case, it appears they are
the OUT codelist work well for that concept, so trying to identify the
the implementer would have to use the value of reason for why the
UNKNOWN and put the value of WORSENED in adverse event record
a SUPPAE record. terminated and a new
one was started. This
information could be
inferred within the SEV
variable and is not
appropriate to store in
the OUT variable. The
OUT variable would still
use the existing
published term 'NOT
RECOVERED/NOT
RESOLVED' in this
instance.
Please create a new generic SEV codelist to II SDTM-Published in P40
support the SEV variable across domains. File
emailed separately
Craig, please send this to the General team,

thank you!
The definition for BIOIMPEDANCE II SDTM-Published in P42

SPECTROSCOPY (BIS) is a method that by
measuring body water volumes (Total Body
Water (TBW), Intracellular Fluid (ICF), and
Extracellular Fluid (ECF and Body Cell MASS
(BCM)) provides an impedance measurement
over the entire spectrum of frequencies, rather
than being limited to only 1 (BIA) or only a few
(MFBIA) frequencies. BIS differs from BIA and
MFBIA in that it does not rely on statistically
derived, population-specific, regression equations
to predict body water volumes. We are using this
method in a CRF to assess Body Composition
Measurement. We are collecting the values of
overhydration, Lean Tissue Mass, Adipose
Tissue Mass, Lean Tissue Index, Fat Tissue
Index, Total Body Water, Extracellular Water,
Intracellular Water, Fat Mass, and Body Cell
Mass.
LBTEST= Gamma hydroxybutyrate, LBTESTCD II SDTM, SEND-Published

= GHB, Definition "A measurement of the total in P42
Gamma-hydroxybutyrate in a biological
specimen." Possible synonym 4-hydroxybutanoic
acid
https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC2257868/
The definition of remission is "An abatement in II Do not add (P41):

intensity or degree (as in the manifestations of a Request removed by
disease)" in NCI Thesaurus. requester. Remission is
a reason for completion
but in this case
NCOMPLT should still
be COMPLETED.
This test was provided by a central vendor with II

the following definition: Doppler derived peak
pressure difference between the right ventricle
and the right atrium in systole.
Unit for the result = mmHg

the following definition: Doppler derived peak
velocity across the tricuspid valve in systole.
Unit for the result = m/sec

the following definition: LV longitudinal systolic
(shortening) strain (deformation) in all segments
of the LV. The Formula is: Strain = length in end-
diastol minus length in end-systol divided by
length in end-systol.
Unit for the result = %
Additional information ? we are capturing

separate results using: 2-chamber, 3-chamber
and 4-chamber views by using 2D
echocardiography as separate results.

the following definition: LV circumferential systolic
of the LV.

the following definition: LV longitudinal systolic
of the LV derived from the average of LV strain in
4, 2, and 3-chamber view
A measurement of the mumps virus IgM antibody II

A measurement of the Chlamydia pneumoniae II
IgG antibody in a biological specimen.
A measurement of the mycoplasma pneumophila II SDTM-Published in P40

IgM antibody in a biological specimen.
A measurement of the mycoplasma pneumophila II SDTM-Published in P40

A measurement of the mycoplasma genitalium in II SDTM-Published in P40

A measurement of the rubella IgM antibody in a II
QSCAT/QSTESTCD/QSTEST for Asthma II QRS-Published in P39
Daytime Symptom Diary; file emailed separately
QSCAT/QSTESTCD/QSTEST for Asthma II QRS-Published in P39

Nighttime Symptom Diary; file emailed separately
It might be good to add another vital signs test for II SDTM, SEND-Published
Crown-Rump Length as this is another measure, in P41
which is used, when measured during a Do not add (P41): Do
sonogram, as an input for calculating the not add as synonym.
estimated gestational age. Instead create new
term.
Can I please ask you to add the following II

synonyms:
mL/mmHg/min to C67417 mL/min/mmHg
mL/min/mmHg/L to C67418 mL/mmHg/min/L
I realise you may not want to add all permutations

of these units but these would help to identify
those where the ordering of the unit fragments is
acceptable. Thanks
Please add term PNFH/Phosphorylated II SDTM, SEND-Published

Neurofilament Heavy Chain to LBTEST/CD in P42
codelist; reference:
Pls change the submission value of II SDTM-Published in P40

C14237/MEASLES VIRUS to MEASLES
MORBILLIVIRUS as per NCBI and ICTV naming
convention. Add Measles Virus as a new SY.
Please add 6 existing QRS METHOD terms into II

the METHOD codelist; please add 2 brand new
terms into BOTH QRS METHOD and METHOD
codelists. Please also modify existing terms. This
is a TA request to support the Psoriasis TAUG,
example FACE: https://wiki.cdisc.org/x/Ey7sB
Please add new terms to LBTEST and METHOD; II SDTM-Published in P42
File emailed separately. Do not add (P42):
INT17A-Do not add. We
believe this is
synonymous with
INTLK17. We will add
IL17A as a synonym to
the existing term
instead.
IL2SR-Do not add.
Added to the codelist as
C158220/IL2SR/Soluble
Interleukin 2 Receptor.
PECAM1-Do not add.
C135472. We will add
synonyms with P42 to
help with mapping.
QFPCR-> Do not add.
Requester withdraws
request. They will use
REAL-TIME
POLYMERASE CHAIN
REACTION ASSAY
instead.
LYMRCT (Reactive Lymphocytes) was II SDTM, SEND-Published

retired/deleted and added as a synonym of in P41
Atypical Lymphocytes (LYMAT), however,
C74654 LYMRCTLY and C158230 LYMRCTLE
are still present. Please retire C158230 and make
Reactive Lymphocytes/Leukocytes a synonym of
C64819. Please also make a new test LYMATLY
with synonyms Atypical
Lymphocytes/Lymphocytes; Variant
Lymphocytes/Lymphocytes; Reactive
Lymphocytes/Lymphocytes
Definition: Arising from, pertaining to, or having II Do not add (P41): The
many locations. portion/totality codelist is
meant to qualify the
Term already in CDISC with a the following code: test/specimen. Whereas
C25253 the Distribution codelist
within SEND (which
contains MULTIFOCAL)
is meant to qualify the
result. We can't imagine
a use for the concept of
'Multifocal' in the context
of a test/question. This
information would most
likely be conveyed in a
result. The team will not
add this term into the
PORTOT codelist.
Definition: Having many centers. A multicentric II Do not add (P41): Team

cancer consists of a primary tumor with satellites agrees that this does
of cancerous growth in surrounding tissues. not belong in PORTOT.
The PORTOT codelist is
Already in NCI Thesaurus with the following code: meant to qualify the
C25303 test/specimen. This
looks to be a finding, or
qualifing a result.
Draft Def: Agar proportion determines MIC by II SDTM-Published in P42

comparing to the proportion of growth on the
drug-containing plate against the growth on the
control plate.
Used in MB/MS Domain
A measurement of the S-adenosylmethionine in II SDTM, SEND-Published

a biological specimen. in P42
A measurement of the S-adenosylhomocysteine II SDTM, SEND-Published

in a biological specimen (PLASMA) using in P42
LC/MS/MS method.
A measurement of the Betaine in a biological II SDTM, SEND-Published

specimen (PLASMA) using LC/MS/MS method. in P42
A measurement of the Cysteine in a biological II SDTM, SEND-Published

specimen (PLASMA) using LC/MS/MS method. in P42
A measurement of the Dimethylglycine in a II SDTM, SEND-Published
biological specimen (PLASMA) using LC/MS/MS in P42
method.
A measurement of the Cystathionine Beta- II SDTM, SEND-Published

synthase in a biological specimen (PLASMA) in P42
using LC/MS/MS method.
"As per the Domain specific LBANMET codelist II Do not add (P45): Do
we also require a new codelist for PF with the not add for now. This is
following codes: for compartmental
GINI INDEX (A measure of dispersion in a analysis (CA). The PP
population, e.g. income inequality, species domain was originally
dominance and existence of dominant clones in a created for the
transplant.) Used in the PF Domain for PFCAT of representation of NCA
VECTOR INSERTION'. PFTESTCD is Site data, while this domain
Abundance. And method is CALCULATION. allows CA data
SHANNON INDEX (A diversity index that mapping, it lacks the
accounts for both abundance and evenness of appropriate structure
the species present, e.g. diversity of clones in and variables to
subjects samples that contribute to sufficiently support CA
hematopoiesis.) Used in the PF Domain for data. Therefore CA -
PFCAT of VECTOR INSERTION'. PFTESTCD is related terms will not be
Site Abundance. And method is CALCULATION controlled at this time
CHAO1 INDEX (A diversity index that estimates until CDISC updates the
the number of taxa observed within a sample by modeling of PP domain,
adding pseudo-counts for rare Operational and creates new PP
Taxonomic Units (OTUs) which may be missing variables to better
due to insufficient sequencing depth.) INVERSE support CA data (this
SIMPSON INDEX (A diversity index describing may happen in 2021-
evenness of the species that accounts for both 2022). This codelist is
the number and abundance of the species extensible, you may add
present (this index gives more weight to taxa of this value as an
higher relative abundance compared to the extensible term to the
Shannon Index).) PRINCIPAL COMPONENT codelist.
ANALYSIS (A statistical procedure that uses an
orthogonal transformation to convert a set of
observations of possibly correlated variables into
a set of values of linearly uncorrelated variables)
"
An influenza vaccine study is using an H. pylori II SDTM, SEND-Published

based ferritin molecule as a platform for in P42
hemagglutinin presentation to immune cells.
Serum levels of the human ferritin heavy chain
subunit are measured as part of the study.
An influenza vaccine study is using an H. pylori II SDTM, SEND-Published
based ferritin molecule as a platform for in P42
hemagglutinin presentation to immune cells.
Serum levels of the human ferritin light chain
subunit are measured as part of the study.
Update 3 terms. II
We are collecting results for Bronchial Wash. It II SDTM-Published in P41
looks like a Wash Fluid differs from Lavage Fluid
based upon the difference in which the sample is
collected. The Wash Fluid is obtained by washing
the collected cells with salt solution.
Bronchoalveolar lavage: is a medical procedure
in which a bronchoscope is passed through the
mouth or nose into the lungs and fluid is squirted
into a small part of the lung and then collected for
examination.
Bronchial Wash: A bronchoscope is inserted
through the nose or mouth into the lungs. A mild
salt solution is washed over the surface of the
airways to collect cells, which are then looked at
under a microscope. Bronchial washing is used to
find infections.
A measurement of the Mid-Regional Pro-Atrial II SDTM, SEND-Published

Natriuretic Peptide in a biological specimen. in P42
To be used with LBTEST=Mid-Reg Pro-Atrial
Natriuretic Peptide
A measurement of the Mid-Regional Pro-Atrial II SDTM, SEND-Published

Natriuretic Peptide in a biological specimen. in P42
To be used with LBTESTCD=ANPPROMR
Limit of Quantification: laboratory and PK results II Do not add (P41):

sometimes require imputation when below or Please use new terms
above a limit of quantification (e.g., '<10'). Doing LLOQ and ULOQ.
so requires the completion of the variable DTYPE
as the derivation of AVAL in this case differs from
the other records (where AVAL is mostly a direct
copy of LB.LBSTRESN or PC.PCSTRESN).
Limit of Detection: in some analysis, for example II ADaM-Published in P43

HIV, distinction is made between detectable, not
quantifiable results and not detectable results.
Their imputation method might differ. For
detectable not quantifiable results we can use the
value 'LOQ' (see other request). For the non
detectable results the imputation method per SAP
can then be set to 'LOD'.
proposed definition: A finding that generally has II SEND-Published in P41

features of congestion and hemorrhage
Proposed definition: A finding that generally has II SEND-Published in P41
features of hyperplasia and hyperkeratosis.
Proposed definition: Accumulation of lipid in the II Do not add (P41):
mesangial cells of glomeruli. Requester asks to
withdraw this request.
Wait for INHAND
publication before
developing term.
Disorganization of the physeal chondrocytes with II SEND-Published in P41

or without increased thickness of physis
Proposed definition: A malformation II Do not add (P41):
characterized by a proliferation of vessels and Requester asks to
meningothelial cells in the leptomeninges withdraw this request.
Wait for INHAND
publication before
developing term.
Proposed defintion: A nonneoplastic finding of II Do not add (P41):

endometrial tissue in an abnormal location in the Requester asks to
abdomen or pelvis withdraw this request.
Wait for INHAND
publication before
developing term.
Proposed definition: A finding characterized by an II SEND-Published in P43

eosinophilic beaded to fibrillary proteinaceous
material; normally associated with edema or
inflammation
The following values are used to distinguish II SDTM, SEND-Published
modified release tablets. in P41
-Tablet, Modified Release: Long Duration - A
solid dosage form which delay delivery with 80%
of the dose delivered between 11 and 14 hours.
-Tablet, Modified Release: Short Duration - A
solid dosage form which delay delivery with 80%
of the dose delivered between 6 and 8 hours
Please consider adding a method codelist term II SDTM-Published in P44
as a broader concept to capture nucleic acid-
based tests. A bucket term per se. Nucleic-acid
based tests analyze variations in the sequence,
structure, or expression of deoxyribonucleic acid
(DNA) and ribonucleic acid (RNA) in order to
diagnose disease or medical conditions, infection
with an identifiable pathogen, or determine
genetic carrier status. The FDA has posted a list
of various nucleic acid-based tests at
https://www.fda.gov/medical-devices/vitro-
diagnostics/nucleic-acid-based-tests. Our
company has case report forms capturing this
method of testing, but is not necessarily capturing
the specific type of test performed, e.g., Nucleic
Acid Amplification Test. Some of our clinical trials
just want to know, on a broader level, if a nucleic
acid-based test method was used.
A measurement of the 7-alpha-hydroxy-4- II SDTM, SEND-Published

cholesten-3-one in a biological specimen. in P42
CELL CYTOTOXICITY NEUTRALIZATION II SDTM, SEND-Published
ASSAY (CCNA) is a method to detect the in P42
presence of C. difficile toxin in fecal samples. In
this assay, a filtrate of stool sample is prepared
and inoculated onto sensitive tissue culture cells.
Typically human fibroblast cells are utilized; if
toxin is present in the filtrate, it causes the
fibroblasts to round up in a characteristic
cytopathic effect. To verify that the cytopathic
effect is in fact caused by C. difficile toxin (and
not by some other toxic component or viral agent)
the filtrate is also inoculated in parallel onto a
second set of tissue culture cells, to which C.
difficile specific anti-toxin has been added.
Absence of the cytopathic effect in the second set
of cell cultures provides evidence that the cellular
changes in the first set were caused by C. difficile
toxin.
For this term, CDISC synonyms are => TAT; II Do not remove synonym
Thrombin Antithrombin Complex; Thrombin (P41): TAT is an
Antithrombin Complex Antigen. abbreviation that may be
Please delelte ""TAT"" as synonym since used for more than one
C106574 parameter LBTESTCD = TAT, LBTEST lab test. Additionally we
= Thrombin/Antithrombin already exist and do not want to change
causes confusion. existing published
submission values
simply because they
could mean something
else. The rule we do
follow is that we cannot
have two identical
CDISC submission
values for different
concepts in the same
codelist but otherwise
we can add appropriate
synonyms if the
abbreviation is used for
more than one lab test.
Users should read the
TEST long names,
synonyms, and
definitions to ensure that
they are using the
correct submission
value for a test.
MR is reported as synonym of MINIMAL II Do not add (P40): Do

RESPONSE but the value MR already exists and not remove synonym.
means Minor Response. Published CT rules
indicate that the use of
common acronyms as
synonyms is okay as
long as two distinct
terms in a codelist do
not have the same
CDISC submission
value. The presence of
acronyms ensures that
the appropriate value is
chosen.
Add 2 new terms to DATEST-CD; remove a term II SDTM-Published in P40,

from Nutrition Findings About Test Name/Code; P41
pls see attachement. This is a TA request from
the Nutrition Team.
Acetaminophen-Cysteine Adducts or II SDTM, SEND-Published
Acetaminophen Protein Adduct, APAPAD is in P42
suggested for the LBTESTCD for this test also.
A measurement of the Acetaminophen-Cysteine
Adducts or Acetaminophen Protein Adduct in a
Please add term 'Abductor Pollicis Brevis Muscle'; II SDTM, SEND-Published

draft definition: The abductor pollicis brevis in P40
muscle is a thin subcutaneous muscle located
laterally in the thenar eminence of the hand, and
is one of the intrinsic muscles of the hand.
Please create term: Abductor Digiti Minimi of the II SDTM, SEND-Published

Hand; draft definition: a muscle of the hand that in P40
abducts the little finger and flexes the phalanx
nearest the hand.
Request addition of Aspergillus Antibody test that II SDTM-Published in P40

is not specific to a particular species of
Aspergillus
CA 242 is a tumor marker for detection of colon, II SDTM, SEND-Published

pancreatic and lung cancer. in P42
A relative measurement (ratio or percentage) of II Do not add (P42): Do

CD20 expressing cells to all lymphocytes in a not add. CDISC is
biological specimen. developing a new
domain to support CD
marker measurement
types of
immunophenotyping
tests. Therefore please
use this term as an
extensible term in LB,
but the team will not
control these values
since they'll need to be
moved eventually.
A relative measurement (ratio or percentage) of II Do not add (P42): Do
CD38 expressing cells to all lymphocytes in a not add. CDISC is
biological specimen. developing a new
domain to support CD
marker measurement
types of
immunophenotyping
tests. Therefore please
use this term as an
extensible term in LB,
but the team will not
control these values
since they'll need to be
moved eventually.
Some abnormal tissues, tumors, and cancers II Do not add (P46): Do

may also produce hCG, making the hCG test not add. The tumor
useful as a tumor marker. This test measures the marker
amount of intact hCG, and sometimes the beta Choriogonadotropin is
subunit of hCG, in the blood. I found conflicting identical to the analyte
articles that list beta HCG, total HCG or intact and of Choriogonadotropin.
beta HCG as HCG measured as a tumor marker. Please use existing
LOINC has it as a separate LOINC code (53959- terms C147128,
3). Should this be a separate test or a synonym to C147360, or C147361
an existing test? depending upon what
specifically is being
assessed.
Plasma cells are normally not detected in II

peripheral blood, the ability to isolate circulating
plasma cells (CPCs) is highly relevant to Multiple
Myeloma.
A measurement of the Epstein-Barr virus DNA in II SDTM-Published in P40
A measurement of the hepatitis B core antigen in II SDTM-Published in P40

Synonym: HBcAg
Link to an assay from Creative Diagnostics that II SDTM-Published in P40

measures Hepatitis E virus Antigen:
https://www.creative-diagnostics.com/HEV-Ag-
EIA-Kit-3617-466.htm
LOINC Code: 2572-6 Blood tests can reveal II SDTM, SEND-Published

reduced activity of the lipoprotein lipase enzyme in P43
in the plasma, following intravenous
administration of heparin. Heparin is a substance
normally found in the liver that stimulates the
release of lipoprotein lipase in the body.
A measurement of the renal epithelial cell casts II SDTM, SEND-Published
present in a biological specimen. in P43
Test done on a whole blood specimen with unit of II SDTM-Published in P40,

/5x10^4 WBC; 2 different methods C7-HRP and P41
C10/C11
Unit used with the test Cytomegalovirus pp65 II SDTM, SEND-Published

Antigen - methods include C7/HRP and C10/C11 in P40, P41
Multiple Test, Test Code, and Terms. See II SDTM-Published in P41,

spreadsheet named below in Additional P44, P49
Information. SDTM, SEND-Published
File has been emailed separately. Name of file is in P40
CDISC Multi Term Request Spreadsheet Do not add (P40): Do
Florence Halbert Aug212019 not add. This is not a
record that comes off of
a single ECG reading
directly (not collected
data), rather this is
statistical computation
and analysis data that
should be handled by
ADaM. Therefore this
should not be added to
SDTM and will not be
added as CT.
Do not add (P41):
ng/g - This term is a SY
to C67396 (pg/mg)
which is already
published in the PKUNIT
codelist. The PK team
added the requested
term "ng/g" into the
PKUNIT sub-codelist:
PK Units of Measure -
Weight g. Please use
the appropriative
codelist. However for
SEND users who do not
use the sub-PKUNIT
codelists, please map to
C67396 (pg/mg) in the
PKUNIT codelist.
pg/mL-Please use
existing term C67327
Since I would like to request to create multiple II
terminology for RECIST, iRECIST and
Anatomical location as radiologist perspective in
the clinical trial(oncology), I am writing this email
to send the separated excel file for multiple term
request. Furthermore, in case of error to open the
supplemental files and link from the excel, I also
attached those files in this email. Please refer to
attachments; one for multiple term request
spreadsheet_junghyunlee_20190828 and five for
supplemental files. Reference link for the
anatomical location is below;
http://www.radiologyassistant.nl/en/p4375bb8dc2
41d/anatomy-of-the-liver-segments.html
New LBTEST and LBTESTCD for Reactive II Do not change (P41):

Lymphocytes (LYMRCT) Remove Reactive From the lab/practical
Lymphocytes synonym from Lymphocytes perspective, it is difficult
Atypical (LYMAT); File Emailed Separately to make unequivocal
morphological
judgement/distinction on
whether the atypical
lymphocyte is neoplastic
or reactive. While
medically speaking they
are different and we
recognize that they are
subtypes of atypical
lymphocyte but large
labs will not be able to
distinguish neoplastic
from reactive. Also,
reactive is a functional
description not
morphological/pathologi
cal description of the
lymphocytes. The lab
team considers
Reactive, Atypical and
Variant lymphocytes
synonymous.
The average slope of the airway resistance II Do not add (P43):

measures. Request withdrawn by
To be used with RETEST : Effective Airway requester.
Resistance
The average slope of the airway resistance II Do not add (P43):
measures. Request withdrawn by
To be used with RETESTCD : ERAW requester.
The average slope within the loop measure of II Do not add (P43):
specific airway resistance. Request withdrawn by
To be used with RETEST : Effective Specific requester.
Airway Resistance
The average slope within the loop measure of II Do not add (P43):
specific airway resistance. Request withdrawn by
To be used with RETESTCD : ESRAW requester.
A relative measurement (ratio or percentage) of II SDTM-Published in P41

the forced expiratory volume during the first three
seconds of exhalation to the largest observed
expired volume.
To be used with RETEST : FEV3/FVC

the forced expiratory volume during the first three
seconds of exhalation to the largest observed
expired volume.
To be used with RETESTCD : FEV3FVC

the forced expiratory volume during the first
second of exhalation to the largest observed slow
vital capacity.
To be used with RETEST : FEV1/SVC

the forced expiratory volume during the first
second of exhalation to the largest observed slow
vital capacity.
To be used with RETESTCD : FEV1SVC
Forced expiratory volume in three seconds as a II SDTM-Published in P41

To be used with RETEST : Percent Predicted
FEV3
Forced expiratory volume in three seconds as a II SDTM-Published in P41

To be used with RETESTCD : FEV3PP
Any viral organism that can be assigned to the II SDTM-Published in P41

species Human rhinovirus/enterovirus
(HRV/ENT).
245 new terms and 39 changes to existing terms II SDTM, SEND, Protocol
in P39 publication file that require CDISC term - Published with P39
request number. 284 terms total.
File Attached - No need to add these into team
working documents. They are already in there
from P39. Just submitting this to get a request
number.
Please consider adding this parameter. II SDTM, SEND-Published

Previously this term was a synonym of Target in P43
Cells but it was removed and now we need this
parameter.
LB team notes about the history of this term: we
made the update in P37 to remove two of the
synonyms (Leptocytes; Mexican Hat Cells). Here
are the notes I have from our discussion that day:
2018-11-14: Target cells as per LOINC is the
same as codocytes. leptocyte is actually a
different concept hence leptocyte should be
removed from the list of SYs. Looks like no one is
really using leptocytes so the LB team will not
create it as a new term until it is requested. I
imagine we removed â€˜Mexican Hatâ€™ for the
same reason, in that it is probably antiquated
terminology.
Please add ENDOCRINOLOGIST to the II SDTM-Published in P41

MEDEVAL codelist. The proposed definition is:
A doctor who has special training in diagnosing
and treating disorders of the endocrine system
(the glands and organs that make hormones).
These disorders include diabetes, infertility, and
thyroid, adrenal, and pituitary gland problems.
(NCI)
Please add the term INTERNIST to the SDTM II SDTM-Published in P41

MEDEVAL codelist.Please add the term
INTERNIST to the MEDEVAL codelist. The
proposed definition is: A doctor who has special
training in internal medicine. An internist works
with adult patients to prevent, diagnose, and treat
diseases without using surgery. (NCI)
MASK (A dosing measurement based on the II SDTM, SEND-Published
mask unit.) LENS (A dosing measurement based in P41
on the lens unit.) PLUG (A dosing measurement
based on the plug unit.)
These relate to the use of cooling eye masks,

bandage contact lenses and lacrimal plugs.
cfDNA II SDTM-Published in P44

Synonym: Cell Free Circulating DNA
Def: cfDNA are degraded DNA fragments
released to the blood plasma
This is a request for a single new codelist that II SDTM-Published in P41

would be extensible but start with the two values
mentioned: Subcategory for Disposition Event
with values "STUDY PARTICIPATION" or
"STUDY TREATMENT"
See DS Examples in SDTMIG v3.3. Codelist
would be extensible, since sometimes a specific
study treatment (rather than "STUDY
TREATMENT") would be needed. Subcategory
for Disposition Event with values "STUDY
PARTICIPATION" or "STUDY TREATMENT".
Many and Multiple are not synonymous. CDISC II SDTM, SEND-Published

has accidentally mis-named their submission in P40, P41
values such that they are inconsistent with the
NCI preferred terms. Additionally the two distinct
C-codes have the same CDISC definition.
Changes proposed in separate file.
"File emailed separately containing proposed
changes to existing terms in 3 SEND codelists
and 2 SDTM codelists. The codelists are shared
so final decision will need to be approved by
SEND and SDTM CT teams.
The definition of this term is limited to II SDTM, SEND-Published

measurement by 2 methods: direct measurement in P42
(i.e. telemetry) or approximation by a forumula.
However, there is another method for
measurement of Mean Arterial Pressure by High
Definition Oscillometry (medVET HDO Monitor).
The definition should either exclude method
(which can be provided by another variable) or
include all available methods.
Please create new term: 3,4- II SDTM, SEND-Published

methylenedioxyamphetamine (MDA), needed for in P43
our trials.
Please create term 3,4-methylenedioxy-N- II SDTM, SEND-Published
ethylamphetamine ("Eve") with TESTCD = in P43
MDEA, needed for our trials.
Please add term Ephedrine with TESTCD = II SDTM, SEND-Published

EPHD, needed in our trials. in P43
Please add term Phenylpropanolamine with II SDTM, SEND-Published
synonyms: Beta-Hydroxyamphetamine, in P43
Norephedrine, Norpseudoephedrine, needed in
our trials.
Please add term Norpseudoephedrine with II SDTM, SEND-Published

synonym Cathine and TESTCD = NPSDEPHD, in P43
needed for our trials.
Please add term Phentermine with TESTCD = II SDTM, SEND-Published

PHTRMN, needed for our trials. Thank you! in P43
The following values are needed to explain the II Do not add (P45):
condition of the tissue being examined. NOT INFLAMED -> Do
NOT INFLAMED : A specimen that is collected not add. Based on
from normal body part (tissue) requester feedback, this
INFLAMED : A specimen that is collected from data is being mapped to
diseased body part (tissue) a findings domain and
appears to be more of a
focus of the
examination, rather than
the physical
state/description of the
specimen. Team
recommends using --
FOCID variable if using
SDTMIG3.3 or a
suppqual if using
SDTMIG3.2.
INFLAMED -> Do not
add. Based on
requester feedback, this
seems to be more of a
focus of an examination,
rather than the physical
state/description of the
specimen. Team
recommends using --
FOCID variable.
QRS CT request to change synonyms for the II SDTM-Published in P40

BPRS and BPRS-A instruments since they are
different CRFs with different references.
Draft spreadsheet of the suggested change was
discussed at the QRS CT meeting on 9/12 and
sent separately.
See https://wiki.cdisc.org/pages/viewpage.action? II SDTM-Published in P47
pageId=37781820&src=contextnavpagetreemode
New QS codelists, QSCAT, QSTEST-CD II SDTM-Published in P40

terminology request for FACT-COG
Please consider adding three additional SSTYPs II

(DERMAL, OCULAR, OTOTOXICITY). File e-
mailed separately
Please add the following new LBTEST values: II SDTM, SEND-Published

Factor X Activity Actual/Control in P40, P41
Factor V Activity Actual/Control
Factor IX Activity Actual/Control
Factor VII Activity Actual/Control
Factor X Activity Actual/Control
Prothrombin Activity Actual/Control
Antithrombin Actual/Control
In the meal (ML) domain, could be use to II SDTM, SEND-Published

measure the food taken in P40, P41
Requesting a new term that is defined to explicitly II SDTM-Published in P41

distinguish the available terms of "WITHDRAWAL
BY SUBJECT" and "WITHDRAWAL BY
PARENT/GUARDIAN" from the concept that
subject or parent/guardian withdrew consent.
This has been an ongoing conversation related to
GDPR because withdrawing consent can trigger
a unique set of activities vs. general withdrawal
from the study without withdrawing consent.
1. Functional Assessment of Chronic Illness II SDTM-Published in P40

Therapy-Fatigue Version 4 Questionnaire Test
Code 2. Functional Assessment of Chronic Illness
Therapy-Fatigue Version 4 Questionnaire Test
Name 3.Work Productivity and Activity
Impairment Questionnaire - Specific Health
Problem V2.0 Questionnaire Test Code 4. Work
Productivity and Activity Impairment
Questionnaire - Specific Health Problem V2.0
Questionnaire Test Name
Sponsor request and part of the QRS update to

add FACT/FACIT score terminology and WPAI-
SHP terminology.
Questionnaire emailed separately. II SDTM-Published in P41
Short Physical Performance Batter Protocol &
Score Sheet. Please model and define the CT for
the attached functional test.
This request is to modify the GDS02PC and II

GDS02PN codelists. If approved, the test name
corresponding to "GDS02T2" will have " -
Analysis" added to it and the synonyms for both
will have " - Analysis" added to them.
This request is on behalf of the ADQRS Subteam.
There is already MRAUCLST. However, II SDTM, SEND-Published

sometime there is a need to create the in P41
metabolite/parent ratio based on the AUCINT
In some cases, the effect of treatment might far II SDTM-Published in P41

outlast the actual treatment, even if the condition
or disease is not cured. I believe this will happen
more frequently in the future as some genetic
modifications are studied, but currently we at ALK
have at least one study showing that the effect of
treatment with allergy immune therapy outlasts
the treatment by several years, even if the
condition is not actually cured.
It is different from TREATMENT in that it aims to
modify the underlying causes, where
TREATMENT in general has a more symptomatic
approach.
NCI Concept Unique Identifier (CUI): C3267026; II SDTM-Published in P42

A total artificial heart (TAH) is a pump that is
surgically installed to provide circulation and
replace heart ventricles that are diseased or
damaged. The ventricles pump blood out of the
heart to the lungs and other parts of the body.
Machines outside the body control the implanted
pumps, helping blood flow to and from the heart.
A doctor may recommend a TAH if you have
heart failure caused by ventricles that no longer
pump blood well enough, and you need long-term
support. TAH surgery may be an alternative
treatment in certain patients who are unable to
receive a heart transplant.
MSH Definition: Counterpulsation in which a II SDTM-Published in P42
pumping unit= synchronized with the patient's
electrocardiogram rapidly fills a balloon = in the
aorta with helium or carbon dioxide in early
diastole and evacuates = the balloon at the onset
of systole. As the balloon inflates, it raises aor=
tic diastolic pressure, and as it deflates, it lowers
aortic systolic press= ure. The result is a
decrease in left ventricular work and increased
myocar= dial and peripheral perfusion. NCI
Concept Unique Identifier (CUI): C002186=
0
MSH Definition: Application of a life support II SDTM-Published in

system that circulates the blood through an P41a
oxygenating system, which may consist of a
pump, a membrane oxygenator, and a heat
exchanger. Examples of its use are to assist
victims of SMOKE INHALATION INJURY;
RESPIRATORY FAILURE; and CARDIAC
FAILURE; NCI Concept Unique Identifier (CUI) is
C0015357
MSH Definition: Application of a life support II SDTM-Published in

system that circulates the blood through an P41a
oxygenating system, which may consist of a
pump, a membrane oxygenator, and a heat
exchanger. Examples of its use are to assist
victims of SMOKE INHALATION INJURY;
RESPIRATORY FAILURE; and CARDIAC
FAILURE. NCI Concept Unique Identifier (CUI):
C0015357
MSH Definition: Counterpulsation in which a II

pumping unit synchronized with the patient's
electrocardiogram rapidly fills a balloon in the
aorta with helium or carbon dioxide in early
diastole and evacuates the balloon at the onset of
systole. As the balloon inflates, it raises aortic
diastolic pressure, and as it deflates, it lowers
aortic systolic pressure. The result is a decrease
in left ventricular work and increased myocardial
and peripheral perfusion. NCI Concept Unique
Identifier (CUI): C0021860
Percutaneous ventricular assist devices (PVAD) II SDTM-Published in P42
are not implanted into the body, but rather are
connected to the circulatory system by inserting
tubes into the femoral artery. A PVAD remains
outside your body, as the pump rests on your
abdominal wall. It connects to a driver that
operates the pump and to a controller that
provides feedback when it is time to adjust or
repair your system. PVADs are most often used
to treat a weak heart or heart failure, and are
often used as a temporary support in preparation
for LVAD implantation. They can help increase
heart function and increase blood circulation until
long-term therapy can be implemented to help
with advanced disease. NCI Concept Unique
Identifier (CUI): C1456084
Ultrafiltration is a mechanical fluid removal II SDTM-Published in P42

procedure designed to treat patients who have an
excess of fluid in their bodies and have difficulty
removing fluid with diuretics. The goal of
treatment is to restore fluid balance in the body.
NCI Concept Unique Identifier (CUI): C0041612
NCIt Definition: A therapeutic procedure used in II SDTM-Published in P42

patients with kidney failure. It involves the
extracorporeal removal of harmful wastes and
fluids from the blood using a dialysis machine.
Following the dialysis, the blood is returned to the
body. NCI Concept Unique Identifier (CUI):
C0019004
MSH Definition: Extracorporeal II SDTM-Published in P42

ULTRAFILTRATION technique without
HEMODIALYSIS for treatment of fluid overload
and electrolyte disturbances affecting renal,
cardiac, or pulmonary function. NCI Concept
Unique Identifier (CUI): C0019014
A procedure involving the placement of an II SDTM-Published in P42

implantable cardiac pacemaker with an additional
third lead placed in the left ventricle that is
designed to keep the contractions of the
ventricles synchronized with each other, and acts
as a defibrillator as well.
A procedure involving the placement of an II Do not add (P42): Do

implantable cardiac pacemaker with an additional not add. Please use
third lead placed in the left ventricle that is existing C80436. We will
designed to keep the contractions of the add your term as a
ventricles synchronized with each other. synonym.
Corresponds to MITEST "Intraepithelial II SDTM-Published in P45
Lymphocytes / 100 Enterocytes". Intraepithelial
lymphocyte counts are used in the diagnosis of
celiac disease and are elevated during a gluten
challenge.
Please consider adding QTCIAG1 (QTcI Interval, II Do not add (P41): QtCI
Aggregate 1) for QT studies. by definition is subject-
Please refer to the TAUG-QT v1.0. specific heart rate
correction of QT interval
where the heart rate
correction formula does
not apply to the general
population like
commonly used generic
heart rate corrections
(e.g., Bazett, Fridericia,
or Framingham
formulae) - this means,
the correction formula
for QTcI is different from
subject to subject, and
correction value is
different between
subjects. Therefore
QTCI measurements will
not be controlled and
the CDISC ECG
controlled terminology
team will not create
QTCI-related
EGTEST/CD terms.
The EGTEST/CD
and users may choose
to create QTCI-related
terms as extended
values for EGTEST/CD
and represent QTCI
measurements as a part
of the SDTM dataset.
However, since
Used for ophthalmic examination II SDTM-Published in P43
Terms used on SDTMIG 3.3, section 6.3.10.5, II SDTM-Published in P41

example 1
Currently there is no existing concept in the II SDTM, SEND-Published
anatomical location codelist that covers this in P41
concept.
Definition: The nodal pads that lie anterior or
posterior to the anterior facial vein on top of the
facial artery in the submandibular triangle
Please let us know in which code does below test II Question not answered:
is included; if not then could you please consider Team follow-up inquires
to add it. sent to requester but no
Definition : Group A Streptococcus (GA Strep) reponses were received.
also referred to as Group A beta-hemolytic
Streptococcus, or Streptococcus pyogenes is a
gram positive bacteria which causes a variety of
disease conditions and complications Synonym :
streptococcal group A antigen testing or Rapid
Strep A test
Definition of coulometric titration; a method of II SDTM-Published in P43
titration in which the titrating agent is produced in
a solution by electrolysis and the required amount
of the agent is determined by measuring the
number of coulombs used in preparing it. Used to
determine a Chloride level from a perspiration
specimen for diagnosis of cystic fribrosis.
A measurement of the Type I Interferon Gene II Do not add (P42): Do

Expression in a biological (BLOOD) specimen via not add. This should be
CAPILLARY ELECTROPHORESIS Method. modeled in the PF
domain. Please see the
PGx user guide for
guidance.
A measurement of the Hepcidin in a biological II SDTM, SEND-Published

(SERUM) specimen via LC/MS/MS method in P43
A measurement of the VLDL/Chylomicron II SDTM, SEND-Published

triglyceride total in a biological (PLASMA) in P43
specimen via NMR or Magnetic Resonance
Spectroscopy Method.
ISH is used to map and order genes and other II Do not add (P43): Do
DNA and RNA sequences to their location on not add. Map to
chromosomes and within nuclei. The technique is C17562/IN SITU
based on the principle that double-stranded DNA HYBRIDIZATION.
denatures on heating to single-stranded DNA.
Def: A questionnaire, rating and scale (QRS) data II SDTM-Published in P42

type using a 5-point Likert Scale.
This method is used to measure viral load, but II SDTM-Published in P43

measuring viral infectivity as opposed to virus
particles with a unit of log PFU/mL.
For oncology studies, it is possible that the II

administration planned during a day is postponed
to a different day of the same cycle as an action
taken due to Adverse Event.
Dose is not really Reduced nor Interrupted as
only the timing changes.
Was this intentional? The definitions are II Question answered
different; so, I would have expected different (P41): The submission
submission values, but this is not an area of my values are different
expertise. URETERAL vs
URETHRAL. Ureter and
Urethra are two different
anatomical structures.
The former is the tube
from the kidneys to the
bladder or cloaca and
the latter is the tube
from the bladder to the
outside of the body.
This is a combination of the already approved II Do not add (P41): There

PARENT and CAREGIVER entries, and is to be is a general principle
used/selected when a differentiation between that we do not
PARENT/CAREGIVER is not needed. The create/control combined
differentiation needed is between the STUDY terms within codelists.
SUBJECT and the PARENT/CAREGIVER The requester can
choose to use this in
their dataset as an
extensible term. The
multiple convention
would not be
appropriate to use here.
Predose concentration immediately before next II Do not add (P41): Map

dose administration To be used with PKPARM : to CTROUGH/Conc
Conc Predose Trough/C102394.
Predose concentration immediately before next II Do not add (P41): Map

dose administration To be used with to CTROUGH/Conc
PKPARMCD : CPREDOSE Trough/C102394.
This was requested back in 2016 and at that time II Do not add (P41): This
you sent questions to the requestor that were term is too high-level
never answered. I would like you to reconsider and non-specific hence
the above requested terms with the following this will not be
explanation to your questions from 2016: controlled. The
We collect local ECG results where our form is EGTEST-CD codelists
built using CDISC tests and results. However, are extensible please
there are times when information is provided that add this term as a
does not fit into a specific result category. We sponsor-defined,
have a text field to capture this data which is an extended value in this
EGORRES/EGSTRESC item. Currently we are codelist.
using the TESTCD/Test Name of: ECGNOS/ECG
Findings, Not Otherwise Specified to map this
data.
https://en.wikipedia.org/wiki/ II SDTM, SEND-Published
Transverse_tarsal_joint in P41
v4.4 is available since October 2019. II SDTM-Published in P41
Please consider either making kU/L (kiloUnit per II Do not add (P41): This
liter) a CDISC Submission Value and demoting is mathematically
U/mL to a synonym, or alternatively add kU/L as synonymous with U/mL,
a synonym to existing preferred term U/mL which is already
(C77607). Thank you. Anna Pron-Zwick published in the UNIT
codelist. We will add a
synonym to C77607 to
help with mapping.
Plaque-based assays are used to determine virus II SDTM-Published in P43

concentration in terms of infectious dose. Viral
plaque assays determine the number of plaque
forming units (pfu) in a virus sample, which is one
measure of virus quantity. This assay is based on
a microbiological method conducted in petri
dishes or multi-well plates.

Do not add (P42): HIGH
SENSITIVITY ASSAY-
Do not develop further.
TAUG has chosen to
use a Method of
'ELECTROCHEMILUMI
NESCENCE
IMMUNOASSAY'. The
information about
whether the method
sensitivity is high, low,
or something else will go
into NSV or MTHSEN.
Please add test: "CYURTUSP - Urate Crystals, II Do not add (P43): Do

Unspecified". It is used in our trial not add. Please use
existing code
C74684/CYURIAC/Uric
Acid Crystals.
Please add test: ""CYPHOUSP - Phosphate II SDTM, SEND-Published
Crystals, Unspecified"". It is used in our trial. in P43
Request for Colorectal Cancer TA team. II

Please add "CSHYAGRA - Hyalogranular II SDTM, SEND-Published
Casts". We have this test in our trial. in P43
Oncology_Codetable spreadsheet - request to II

add: ENLARGEMENT FROM NADIR and
FURTHER ENLARGEMENT FROM NADIR to the
TR_Codetable_Mapping tab for the TRTEST of:
Tumor State
These results are being mapped to the TRTEST

of Tumor State as a result for the questions of we
are asking for: Non-Target Lesion Status and
New Non-Target Lesion Status
Request the new term be added to the TUIDRS II Do not add (P42): Do
codelist and to the TU_Codetable Mapping not add. Requester
Spreadsheet for the TUTEST Tumor Identification withdraws request.
Definition: The identification of a tumor or lesion

located outside of or independent of any lymph
nodes which is not present at baseline and not
considered a target, but may be part of the
assessment of the response to the therapeutic
intervention.

located at or near the lymph node that is not
present at baseline and not considered a target,
but may be part of the assessment of the

that is not present at baseline, located outside of
or independent of any lymph nodes, and is the
target of the therapeutic intervention.

located at or near the lymph node that is not
present at baseline.
Request to include this item from QSMTHOD into II

the METHOD codelist, until such a time as
QSMTHOD is published in a Implementation
Guide. Current IG publications indicate the
METHOD codelist to be used with the
QSMETHOD variable.
Request to include this item from QSMTHOD into II

the METHOD codelist, until such a time as
QSMTHOD is published in a Implementation
Guide. Current IG publications indicate the
METHOD codelist to be used with the
QSMETHOD variable.
"HOLTER MONITORING" or something similar. II SDTM-Published in P42

SDTMIG Procedure Example 2 uses the term
"24-HOUR HOLTER MONITOR". That may be
the best choice for the value, but I think we need
a term or terms to use for procedures such as
this. Note that the ECG Test Method codelist
includes the term "HOLTER CONTINUOUS ECG
RECORDING" but also includes other terms for
continuous eCG monitoring.
1. For the SPECTYPE codelist: Add SERUM OR II SDTM, SEND-Published

PLASMA OR BLOOD 2. For the UNIT codelist: in P41
Add INDEX 3. For the LBTEST-CD codelist: Add Do not add (P41): The
'Alpha-methylphenethylamine' with SY of LOINC mapping was
'Amphetamine' update to not include
All for LOINC mapping INDEX as a unit of
measure (an
explanatory note was
added to the mapping
file). We will wait for
someone to request this
with a valid use case.
This result is being mapped to the TRTEST of II

Tumor State as a result for the questions we are
asking for: Non-Target Lesion Status and New
Lesion Status
FTTESTCD/FTTEST/FTCAT for Rockport One II SDTM-Published in P40
Mile Walk Test For T1D Exercise and Prevention
TAUG; File emailed separately
Please remove the PGI test PGI0104/PGI01- II SDTM-Published in P40

Overall Health QSTESTCD/QSTEST. This was
originally requested by a sponsor for the PGI
instrument in 2017, but in the FDA review of the
supplement, they requested it to be removed at
that time. The FDA only wanted the SEVERITY,
CHANGE and IMPROVEMENT tests to be
represented in the PGI instrument. That is why it
is not mentioned in the published supplement.
The PGI CT was published before the
supplement was approved and the request to
remove it from CT must have been overlooked at
that time.
FLT3L/FMS-like Tyrosine Kinase 3 Ligand is II SDTM, SEND-Published

being measured as a marker of cell mediated in P43
immunity via a Lumanix assay (see microparticle
region 19); it functions as a cytokine and/or
growth factor. The term does not exist in CT (nor
synonyms that I could find). Proposed definition:
""A measurement of the FMS-like tyrosine kinase
3 ligand in a biological specimen.
A Luminex based assay is measuring the amount II SDTM, SEND-Published

of soluble CD40L (CD40 Ligand) (Note - the in P43
assay is not measuring CD40L cells, which is a
term that already exists). Based on Table 1 in
65196/ and existing terminology values (e.g.,
TNF12S, C-code C156526), I suggest
LBTESTCD of TNF5S. As synonyms, I'd suggest
including: soluble TNFSF5, soluble CD40L,
soluble CD154, and gp39.
Definition: A measurement of soluble tumor

necrosis factor superfamily member 5 in a
Pls create QSCAT for Bristol Stool Form Scale, II SDTM-Published in P41
C125393; File emailed separately
This file contains 3 new term requests for the II SDTM, SEND-Published
LBTEST/CD codelists and 5 changes to existing in P41
terms to the LBTEST/TESTCD and UNIT Do not change (P46):
codelists. All to support the LOINC mapping; File Remove RATIO - Do not
emailed separate remove from codelist. It
was originally
considered to remove
‘RATIO’ from the unit
codelist because it is
being added into the
RESTYPRS codelist to
support the Result Type
(RESTYP) variable.
Team agrees that
RATIO should be
retained in the UNIT
codelist but should only
be used when the units
in the numerator and
denominator cancel
each other. More
specific ratio-related
units of measure should
be considered for use as
the unit of measure
when the numerator and
denominator do not
cancel each other out,
e.g., g/kg, etc.
This involves converting the QSCAT to CCCAT, II SDTM-Published in P40

and renaming the test code and test name codes
list to a clinical classification. I have also sent the
CT change control spreadsheet.
Update CDISC Definition for 5 CDISC terms: II SDTM, SEND-Published

C156567 in P41
C156568
C156565
C156566
C156569
"As part of the Crohn's disease working group to II Do not add (P45): Do
develop a TAUG, I discussed that we lack a not add. This is not yet
segment for radiology imaging modalities (MR, standard nomenclature
CT). The MaRIA and London scoring indices in anatomy nor is there
allow to evaluate the CD disease in the small consistent
bowel. ILEUM represents the whole ileum and understanding of the
ILEUM, TERMINAL represents the last 15 cm of definition of what this
the ileum. We need a term to cover the part of the would be. The requester
ileum that is not within the last 15 cm. company can submit
this as extensible
Refer to these publications for more details on terminology by CDISC
segments: will not control this term
a. MaRIA: Rimola J, Rodriguez S, Garcia-Bosch as part of the LOC
O, et al. Magnetic resonance for assessment of codelist. Additionally,
disease activity and severity in ileocolonic 'Distal Ileum' may be a
Crohn's disease. Gut 2009;58:1113-20. + Jairath confusing submission
V, Ordas I, Zou G, et al. Reliability of Measuring value/preferred term
Ileo-Colonic Disease Activity in Crohn's Disease since the CDISC
by Magnetic Resonance Enterography. Inflamm definition of the
Bowel Dis 2018;24:440-449. 'Terminal Ileum' is 'The
b. London Index: Steward MJ, Punwani S, most distal section of
Proctor I, et al. Non-perforating small bowel the ileum that is
Crohn's disease assessed by MRI enterography: continuous with the
derivation and histopathological validation of an cecum. (NCI)'.
MR-based activity index. Eur J Radiol
2012;81:2080-8.
c. London Extended Index: Jairath V, Ordas I,
Zou G, et al. Reliability of Measuring Ileo-Colonic
Disease Activity in Crohn's Disease by Magnetic
Resonance Enterography. Inflamm Bowel Dis
2018;24:440-449.
"
Please consider adding these 2 parameters for II SDTM, SEND-Published

PP analysis. in P42
t1/2 distribution : the distributive half-live
calculated by the equation t1/2=In(2)/kdist
This is for the ADQRS Subteam. II ADaM-Published in P41,

P42
Request to create new codelists CES01R1- II QRS-Published in P46

CES01R5 for original response controlled
terminology for the Combat Exposure Scale
(CES) and CES01S1-CES01S5 for standardized
character controlled response terminology for the
CES. CES01R1 and CES01S1 are for item 1.
Similarly, CES01R2-CES01R4 and CES01S1-
CES01S4 are for items 2 through 4. CES01R5
and CES01S5 are for the 5th item group which
represents items 5 through 7 as these items have
the same response sets.
After discussions on permissions with the II QRS-Published in P45
University of Washington, it was necessary to
rename the Functional Activities Questionnaire
NACC Version (FAQ-NACC) to Functional
Assessment Questionnaire (FAQ-NACC UDS
V2.0).
A CT change control is needed for the following

changes:
? QSCAT submission value, CDISC Synonym,
CDISC Definition and NCI PT
? FAQ-NACC UDS V2.0 Questionnaire Test
Code Codelist Name, submission value, CDISC
Synonym, CDISC Definition and NCI PT + same
for all test codes
? FAQ-NACC UDS V2.0 Questionnaire Test
Name Codelist Name, submission value, CDISC
Synonym, CDISC Definition and NCI PT + same
for all test names
The draft revised annotated CRF and CT
spreadsheet was sent via email.
Permission was obtained from the University of II SDTM-Published in P41

Washington for the Functional Assessment
Scale-NACC UDS v3.0. The draft agreement,
draft annotated CRF, and CT spreadsheet was
sent via email.
A technique in which a finger is pricked with a II SDTM-Published in P44

lancet to obtain a small quantity of capillary blood
for testing.
Please add L-FABP and L-type fatty acid-binding II SDTM, SEND-Published

protein to the synonym of FABP1 (C82012). in P44
Please add new terms, 8-Hydroxy-2'- II SDTM, SEND-Published

Deoxyguanosine to LBTEST. in P43
Please add new terms to CVTEST/CVTESTCD II

LAVOLIDX; Left Atrial Volume Index
This method was provided by a local laboratory II Do not add (P44): Do

on one of our studies. not add. Please use
existing term
C16585/FLOW
CYTOMETRY
This method was reported by a local lab in out II SDTM-Published in P44
study. I found a reference here:
https://www.sysmex-europe.com/academy/knowl
edge-centre/measurement-technologies/dc-
sheath-flow-detection-method.html
This method was reported by a local lab on our II SDTM-Published in P44

study. I found a reference here:
https://www.sysmex-europe.com/academy/knowl
edge-centre/measurement-technologies/sls-
detection-method.html
Please add PHARYNGEAL to the ROUTE II SDTM, SEND-Published

codelist. The definition provided is: Pharyngeal in P42
is the adj. form of pharynx(nasal vs. nose). The
pharynx is the part of the throat behind the mouth
and nasal cavity, and above the esophagus and
larynx. It is divided into three sections:
Nasopharynx is the top section; Oropharynx is
the middle section; Hypopharynx is the lowest
section.
This is a TA request. File Emailed Separately. II SDTM-Published in P41,
P42, P43, P45
Do not add (P41):
SKIN OF THE LEG-
Already exists as 'LEG
SKIN' in published CT.
Update submission
value in UG.
SKIN OF THE NECK -
SKIN OF THE NECK
SKIN OF THE
MUCOUS
MEMBRANES - Please
use 'MUCOSA'. 'Skin of
the' doesn't make
sense.
SKIN OF THE
ANTERIOR TRUNK -
SKIN OF THE TRUNK
and put 'ANTERIOR'
into DIR variable.
SKIN OF THE ARM-Do
not add please use ARM
SKIN, which is already
published.
Do not add (P42):
SKIN OF THE ARM
EXCLUDING ELBOW-
Do not add. Requester
withdraws the request.
No longer in TAUG.
SKIN OF THE LEG
EXCLUDING KNEE-Do
not add. Requester
withdraws the request.
File Emailed Separately. Do not add to working II Define-XML, SDTM,
documents. Craig, these do not need triaging, SEND, Protocol -
they are being publsihed this quarter so just to Published in P40
get new term request numbers for P40
publication.
File Emailed Separately. Do not add to working II Glossary-Published with

documents. These are being submitted just to get P40
new term request numbers for P40 publication.
Craig, these do not need triaging, they are being

publsihed this quarter so just to get new term
request numbers for P40 publication.
in P43
Do not add (P43):
AXL Receptor Tyrosine
Kinase: Do not add.
Map to C165943/AXL
Receptor Tyrosine
Kinase. Please be sure
to check the latest
version of the controlled
terminology.
Chemokine (C-C Motif)
Ligand 16: Do not add.
Map to
C165948/Chemokine
(C-C Motif) Ligand 16
TNF Receptor
Superfamily Member 6:
Do not add. Map to
C165960/Fas Cell
Surface Death
Receptor. TNFRSF6 is a
synonym. We will
instead add this as a
synonym to the existing
term.
Please consider adding Factor XIII Activity as a II SDTM, SEND-Published

new LBTEST term with the following definition: A in P43
measurement of the factor XIII activity in a
Please consider adding a term and code to II SDTM, SEND-Published

capture the measurement of whole blood in P44
equivalent glucose similar to the concept of
plasma equivalent glucose with the following
definition: A measurement of the whole blood
equivalent glucose in a biological specimen.
Reference:
71466/
Please consider adding this concept to the SDTM II SDTM, SEND-Published

LB codelists similar to T-Lymphocytes. Proposed in P43
definition: A measurement of the total bone
marrow-derived lymphocytes in a biological
specimen. Reference:
https://www.rndsystems.com/research-area/b-
cells
LB codelists. Proposed definition: A relative in P43
measurement (ratio or percentage) of the bone
marrow-derived lymphocytes to all lymphocytes in
a biological specimen. Reference:
https://www.britannica.com/science/lymphocyte

LB codelists. Proposed definition: A relative in P43
measurement (ratio or percentage) of the bone
marrow-derived lymphocytes to all leukocytes in a
biological specimen. Reference:
https://www.britannica.com/science/lymphocyte
only "mg/mg" is reported as Synonym. II SDTM, SEND-Published

According to the NCI thesaurus, the following in P43
values are also synonyms : kg/kg, mcg/mcg,
ug/ug
Could you please add them ?
Some examples For "ug" it is possible to add "g" II Do not add (P43): No
as synonym ? changes. The proposed
For "Bq/ug", it is possible to add "Bq/ g" as examples given via the
synonym ? requester are incorrect
For "10^12/L" is it possible to add 10^6/ L as mathematical
synonym since 10^6/uL is already reported ? synonyms. Bq/ug =
MBq/g, not Bq/g.
10^12/L=10^6/uL , not
10^6/L. You need to
convert on both sides of
A specimen that consists of or contains excessive II Do
the not add (P47):
fraction. In the Do
case
amounts of proteins. not add.ofRequester
of units measure,will
true
need to re-submit
synonyms with
would have
information requested
identical numerical
by the lab team.
values associated with
A type of MRI that takes a series of images of an II them. The team isinopen
SDTM-Published P45
organ in quick succession and statistically to adding new
analyzes the differences between the images. synonyms to any
During the MRI, the patient performs certain tasks published terms but
to test the brain activation these would need to be
specifically requested by
a requester. We would
Perfusion scanning by the use of a particular MRI II prefer to receive in P44
SDTM-Published
sequence. The acquired data are then requests to add
postprocessed to obtain perfusion maps with synonyms based on
different parameters, such as BV (blood volume), actual usage.
BF (blood flow), MTT (mean transit time) and TTP
(time to peak).
We already have ANTERIOR (C25231) defined II Do not change (P42):
as "Denoting the front surface of the body; often Do not change. Anterior
used to indicate the position of one structure and frontal, although
relative to another." FRONTAL looks like a they are related terms,
synonym. they are not exactly the
same with regard to
anatomy. Anterior (like
posterior) refers to an
anatomical position in
relation to the body,
meaning in the front or
towards the front of the
body. For example,
when you examine
breast lumpectomy
specimens, it is of
paramount importance
to define the surgical
margins right away
(anterior vs. posterior
vs. superior vs. inferior).
If there is tumor
involving the anterior
aspect of the specimen
(meaning the part of the
breast tissue that was
towards the front of the
body) , you state: ductal
(or lobular or whatever)
breast carcinoma
involving the anterior
(not frontal) surgical
margin. So, anterior
means tissue that is in
the front or towards the
front of the body. The
same applies to many
The glossary has XML-related terms and many II

references to XML in definitions but not
standalone term.
Team not sure what FDA - GL/IEEE is II Glossary-Published with

referencing. Find new citation and add reference P44
to reference list.
"The EXACT instrument CRF does not include 3 II QRS-Published in P45
respiratory symptom scores or a total score on
the CRF. The E-RS (EXACT-Respiratory
Symptoms)* USER MANUAL (Version 4.0) May
2015 that is provided upon user's receiving
copyright permission provides information to
calculate these items. This may be provided as
Electronic Data Transfer (eDT) by vendors using
PRO devices to capture the data. Thus, these
items would be viewed as captured data in the
data transfers to the sponsor. Based on this the
following QSTESTCD/QSTEST CT is requested
to be added.
EXACT115 EXACT1-Breathlessness Score

EXACT116 EXACT1-Cough & Sputum Score
EXACT117 EXACT1-Chest Symptoms Score
EXACT118 EXACT1-EXACT Total Score
The CT change control spreadsheet was

EMAILED.
"

Anterior_inferior_cerebellar_artery in P42
synonym: AICA

Posterior_inferior_cerebellar_artery in P42
synonym: PICA
These parameters are being captured as part of II

Pulse Wave Analysis CV testing using a high-
fidelity micromanometer. There are a number of
other parameters, some of which are already in
CVTEST(CD) and others which are not and which
will need to be requested. However, its clear that
these 3 tests belong with the suite of tests using
this device. I do not feel that trying to split the
parameters in VS and CV is appropriate or
logical.
VS has always felt to me to be more of a 'high
level' domain capturing generally 'one-off' results
which for the most part are captured manually.
SDTMIG v3.3 Section 7.1.2 has some terms and II
definitions/descriptions related to trial design. I
mapped this content to published CDISC glossary
and identified 2 new terms for possible addition
as well as a number of existing terms that could
benefit from citation updates. File Emailed
Separately
This would be used to collect injection site as II Do not add (P42): Do

reported by patient. not create codelist.The
team will not create a
new codelist as there
isn't a variable or NSV in
any of the published or
draft IGs and UGs that
warrant the creation of a
new supportive codelist.
This term is appropriate
as a value for the
existing --ROUTE
variable. The ROUTE
and so this combination
term could be added
into a submission by the
sponsor as an
extensible term. The
CDISC CT team will not
add combination terms
to the ROUTE codelist.
Request QSCAT, QSTESTCD and QSTEST to II SDTM-Published in P42

be added for EORTC Quality of Life
Questionnaire LC13 (EORTC QLQ-LC13) which
is still open request back in 2014.
Back to 2014, Colleen Bonjo from Merck made
the request but there is no final outcome. Please
check "Change Request Tracker".

Supraspinatus_muscle in P42
Date of Request
Submission Code

2020 11:02 AM 4152 yer.com
Closed Friday, 3 Jan CDISC- Henrik Soeborg Merck Healthcare henrik.soeborg@ex

2020 11:03 AM 4153 KGaA ternal.merckgroup.c
om

2020 11:40 AM 4154 nih.gov
Closed Friday, 10 Jan CDISC- Magdalena Litwin- Roche Magdalena Litwin-

2020 11:51 AM 4155 Wojciechowska Wojciechowska
Closed Friday, 10 Jan CDISC- Magdalena Litwin- Roche Magdalena Litwin-

2020 11:52 AM 4156 Wojciechowska Wojciechowska

2020 11:54 AM 4157 nih.gov
Closed Friday, 10 Jan CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Closed Friday, 10 Jan CDISC- Diane Corey C-Path dcorey@c-path.org

2020 12:01 PM 4161

Jan 2020 01:38 4162 behalf of PK team)
PM
Closed Friday, 17 Jan CDISC- Christine A. Q2 Solutions christine.huselton@
2020 12:01 PM 4163 Huselton q2labsolutions.com
2020 12:02 PM 4164 behalf of the T1D
team)
Closed Friday, 17 Jan CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo
Open Friday, 17 Jan CDISC- Janessa Pierce Merck JANESSA_PIERCE

2020 12:04 PM 4166 @MERCK.COM

2020 12:05 PM 4167 nih.gov
Closed Friday, 17 Jan CDISC- Ellina Babouchkina Quality Data ebabouchkina@qd
2020 12:06 PM 4168 Services, Inc. services.com

Jan 2020 04:30 4169 behalf of T1D
PM team)
Closed Friday, 24 Jan CDISC- Nicholas Pemble Janssen npemble@its.jnj.co

2020 12:48 PM 4170 m

2020 12:49 PM 4171 behalf of T1D
team)
Closed Friday, 24 Jan CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

Open Friday, 24 Jan CDISC- Claire West GSK claire.m.west@gsk.
2020 01:14 PM 4173 com

2020 01:15 PM 4174
Closed Friday, 24 Jan CDISC- Melissa Cook NCI/CBIIT melissa.cook@nih.

2020 01:16 PM 4175 gov
2020 02:18 PM 4176
Closed Friday, 24 Jan CDISC- sophie arlix Syneoshealth sophie.arlix@syneo
Open Friday, 24 Jan CDISC- sophie arlix Syneoshealth sophie.arlix@syneo

Closed Friday, 24 Jan CDISC- saritha.mannam Syneoshealth saritha.mannam@s

2020 02:24 PM 4179 yneoshealth.com
Closed Friday, 31 Jan CDISC- Claire West GSK claire.m.west@gsk.

2020 11:26 AM 4180 com

2020 11:27 AM 4181 rck.com
Closed Friday, 31 Jan CDISC- Denise Reichert Covance denise.reichert@co
2020 11:41 AM 4182 vance.com
Closed Friday, 31 Jan CDISC- Dave Scocca Rho, Inc. dave_scocca@rho

2020 11:42 AM 4183 world.com
Closed Friday, 31 Jan CDISC- Dave Scocca Rho, Inc. dave_scocca@rho

2020 11:45 AM 4184 world.com
Closed Friday, 31 Jan CDISC- Jenny Jones Covance Jenny.Jones@cova

2020 11:46 AM 4185 nce.com

2020 11:46 AM 4186 nce.com

2020 11:47 AM 4187 nce.com

2020 11:47 AM 4188 nce.com

2020 11:48 AM 4189 nce.com
Closed Friday, 31 Jan CDISC- Ann Croft ARC Statistical annrcroft@gmail.co
2020 11:49 AM 4190 Services Limited m

2020 11:50 AM 4191 yer.com
Closed Friday, 31 Jan CDISC- Mary Jo Brucker Merck mj.brucker@merck.

2020 12:21 PM 4192 com

2020 12:00 PM 4193 com
Open Friday, 7 Feb CDISC- Gitte Ullmann Novo Nordisk gku@novonordisk.c
2020 12:01 PM 4194 om
Closed Friday, 7 Feb CDISC- Gitte Ullmann Novo Nordisk gku@novonordisk.c

2020 12:01 PM 4195 om

2020 12:02 PM 4196 behalf of T1D
team)

2020 04:11 PM 4197 yer.com
Closed Friday, 14 Feb CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2020 04:12 PM 4198 behalf of Heart nih.gov
Failure Team)
Closed Friday, 14 Feb CDISC- Jeb Adams Amgen, Inc jeba@amgen.com
2020 04:13 PM 4199

2020 10:12 AM 4200 yer.com

2020 10:13 AM 4201 nih.gov
Closed Friday, 21 Feb CDISC- Jenny Jones Covance Jenny.Jones@cova

2020 10:14 AM 4202 nce.com

2020 10:15 AM 4203 nce.com
Open Friday, 21 Feb CDISC- Jenny Jones Covance Jenny.Jones@cova

2020 10:15 AM 4204 nce.com
2020 10:16 AM 4205 nce.com

2020 10:17 AM 4206 nih.gov

2020 10:28 AM 4207 com
Closed Friday, 21 Feb CDISC- Debbie Oneill Merck debra_oneill@merc

2020 10:36 AM 4208 k.com

2020 10:37 AM 4209 k.com
2020 10:40 AM 4210 k.com
Open Friday, 21 Feb CDISC- Diane Corey C-Path dcorey@c-path.org

2020 10:41 AM 4211
Closed Friday, 21 Feb CDISC- Jordan Li (for Dana NCI EVS jordan.li@nih.gov
2020 10:42 AM 4212 Booth)
Closed Friday, 28 Feb CDISC- Kevin Viel Omeros kviel@omeros.com
2020 11:54 AM 4213
Open Friday, 28 Feb CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2020 11:57 AM 4214 ng LLC mail.com

2020 11:58 AM 4215 behalf of T1D
team)
2020 12:09 PM 4216 nce.com

2020 12:09 PM 4217 nce.com

2020 12:10 PM 4218 nce.com
Open Friday, 28 Feb CDISC- Anna Pron-Zwick AstraZeneca anna.pron-
a.com

Inc.

2020 12:15 PM 4221

2020 12:15 PM 4222

2020 12:16 PM 4223 yer.com
Closed Friday, 6 Mar CDISC- Mihaela Simion Biogen Mihaela.Simion@bi

2020 11:45 AM 4224 ogen.com
Open Friday, 6 Mar CDISC- Mihaela Simion Biogen Mihaela.Simion@bi

2020 11:46 AM 4225 ogen.com
Closed Friday, 6 Mar CDISC- Mihaela Simion Biogen Mihaela.Simion@bi

2020 11:46 AM 4226 ogen.com
2020 11:47 AM 4227

2020 11:47 AM 4228

2020 11:49 AM 4229 k.com
Closed Friday, 6 Mar CDISC- Ying Li CRL Audrey.Walker@crl

2020 11:49 AM 4230 .com
2020 11:50 AM 4231 .com
2020 11:51 AM 4232 .com
Closed Friday, 6 Mar CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell

2020 11:51 AM 4233 as.com
Closed Friday, 6 Mar CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell

2020 11:52 AM 4234 as.com
Closed Friday, 6 Mar CDISC- Tina Talyor TINA.M.TAYLOR@

2020 11:53 AM 4235 saic.com

Mar 2020 08:00 4236 behalf of T1D
PM team)

Mar 2020 08:03 4237
PM
Open Thursday, 12 CDISC- Diane Corey C-Path dcorey@c-path.org
Mar 2020 08:04 4238
PM
Closed Thursday, 12 CDISC- Alla Ostrovsky Biogen alla.ostrovsky@bio

Mar 2020 08:04 4239 gen.com
PM

2020 01:10 PM 4240 rck.com

2020 01:11 PM 4241 rck.com
Closed Friday, 20 Mar CDISC- Anna Pron-Zwick AstraZeneca anna.pron-
a.com
Closed Friday, 20 Mar CDISC- Jozef Aerts XML4Pharma jozef.aerts@xml4p

2020 01:22 PM 4243 harma.com
Closed Friday, 20 Mar CDISC- Jordan Li (on MSC Inc. jordan.li@nih.gov

2020 01:23 PM 4244 behalf of Crohn's
Disease)
Inc
Disease TA team)
Closed Friday, 27 Mar CDISC- Jozef Aerts XML 4 Pharma jozef.aerts@xml4p
2020 03:38 PM 4247 harma.com

2020 03:38 PM 4248 harma.com
2020 03:39 PM 4249 harma.com

2020 03:39 PM 4250 harma.com

2020 03:39 PM 4251 harma.com
2020 03:40 PM 4252 harma.com
2020 03:40 PM 4253 harma.com

2020 03:40 PM 4254 harma.com

2020 03:41 PM 4255 harma.com

2020 03:41 PM 4256 harma.com
2020 03:41 PM 4257 harma.com

2020 03:42 PM 4258 harma.com

2020 03:42 PM 4259 harma.com

2020 03:42 PM 4260 harma.com
Open Friday, 27 Mar CDISC- Jozef Aerts XML 4 Pharma jozef.aerts@xml4p

2020 03:42 PM 4261 harma.com
2020 03:43 PM 4262 harma.com
2020 03:43 PM 4263 harma.com

2020 03:44 PM 4264 harma.com

2020 03:44 PM 4265 harma.com

2020 03:45 PM 4266 harma.com
2020 03:45 PM 4267 harma.com
2020 03:45 PM 4268 harma.com

2020 03:46 PM 4269 harma.com

2020 03:47 PM 4270 harma.com

2020 03:47 PM 4271 harma.com

2020 03:48 PM 4272 harma.com

2020 03:48 PM 4273 harma.com

2020 03:48 PM 4274 harma.com

2020 03:49 PM 4275 harma.com
Closed Friday, 27 Mar CDISC- Anna Pron-Zwick AstraZeneca anna.pron-
a.com
Open Friday, 27 Mar CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2020 04:07 PM 4278 nih.gov
Closed Friday, 27 Mar CDISC- Magdalena Litwin- Roche litwinwm@roche.co

Open Friday, 27 Mar CDISC- Guido Claes CDISC Glossary guidoclaes@outloo
2020 04:10 PM 4280 team member k.com




Closed Friday, 27 Mar CDISC- Guido Claes CDISC Glossary guidoclaes@outloo
Closed Friday, 27 Mar CDISC- Sophie Arlix sophie.arlix@syneo


2020 05:04 PM 4288 nih.gov
Open Thursday, 9 Apr CDISC- Gary Walker Gary G Walker LLC gary.walker.ggw@g
2020 03:36 PM 4289 mail.com

2020 03:37 PM 4290 nih.gov
Closed Thursday, 9 Apr CDISC- Colleen Bonjo Merck colleen_bonjo@me

2020 03:37 PM 4291 rck.com

2020 03:38 PM 4292 rck.com
Open Thursday, 9 Apr CDISC- Melissa Rowley GSK melissa.c.rowley@
2020 03:39 PM 4293 gsk.com
Closed Thursday, 9 Apr CDISC- Melissa Rowley GSK melissa.c.rowley@

2020 03:39 PM 4294 gsk.com
2020 03:40 PM 4295 com
Closed Thursday, 9 Apr CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2020 03:41 PM 4296 yer.com
Open Thursday, 9 Apr CDISC- Jozef Aerts XML 4 Pharma jozef.aerts@xml4p

2020 03:42 PM 4297 harma.com
Closed Thursday, 9 Apr CDISC- Guido Claes CDISC Glossary guidoclaes@outloo


2020 03:44 PM 4301 nih.gov
Closed Thursday, 16 Apr CDISC- Jozef Aerts XML 4 Pharma jozef.aerts@xml4p

2020 09:18 PM 4302 harma.com

2020 09:19 PM 4303 harma.com

2020 09:19 PM 4304 harma.com

2020 09:19 PM 4305 harma.com
Closed Thursday, 16 Apr CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov

2020 09:20 PM 4306 behalf of
Aparna.Kulkarni)
Closed Thursday, 16 Apr CDISC- The Emmes asoriano@emmes.


2020 09:22 PM 4308 yer.com
2020 09:22 PM 4309 yer.com
Closed Thursday, 16 Apr CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2020 09:23 PM 4310 com
Closed Thursday, 16 Apr CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.
2020 09:23 PM 4311 com
Closed Thursday, 16 Apr CDISC- Steve Kopko CDISC skopko@cdisc.org

2020 09:24 PM 4312
Closed Friday, 17 Apr CDISC- Jozef Aerts XML 4 Pharma jozef.aerts@xml4p
2020 01:16 PM 4313 harma.com

2020 01:17 PM 4314 harma.com

2020 01:18 PM 4315 harma.com

Inc
Closed Sunday, 19 Apr CDISC- Dana Booth CDISC dbooth@cdisc.org

2020 05:10 PM 4317
2020 10:09 AM 4318 yer.com

2020 10:10 AM 4319 yer.com

2020 10:12 AM 4320 rck.com

2020 10:12 AM 4321 rck.com
Closed Friday, 24 Apr CDISC- Ivan Jiang Roche/ Genentech jiangi@gene.com
2020 10:13 AM 4322
Closed Friday, 24 Apr CDISC- Mihaela Simion Biogen mihaela.simion@bi

2020 10:14 AM 4323 ogen.com
Closed Friday, 24 Apr CDISC- Claire West GSK claire.m.west@gsk.

2020 10:15 AM 4324 com
Closed Friday, 24 Apr CDISC- Steve Kpoko CDISC skopko@cdisc.org

2020 10:15 AM 4325
Closed Friday, 24 Apr CDISC- Jung Hyun Lee Asan medical junghyun.lee@aim-
2020 10:16 AM 4326 Center aicro.com

2020 10:17 AM 4327 k.com
Closed Friday, 24 Apr CDISC- Claire West GSK claire.m.west@gsk.

2020 10:18 AM 4328 com
Closed Friday, 24 Apr CDISC- Nik Pemble Janssen npemble@its.jnj.co
2020 10:19 AM 4329 m

2020 10:19 AM 4330 nih.gov

2020 10:20 AM 4331 nih.gov

Inc.
Closed Monday, 27 Apr CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2020 03:57 PM 4333 nih.gov
2020 04:40 PM 4334 rck.com
Open Thursday, 30 Apr CDISC- Colleen Bonjo Merck colleen_bonjo@me

2020 04:42 PM 4335 rck.com
Open Thursday, 30 Apr CDISC- Colleen Bonjo Merck colleen_bonjo@me

2020 04:42 PM 4336 rck.com

2020 04:44 PM 4337 k.com
Closed Thursday, 30 Apr CDISC- Erin Tibbs-Slone CRL erin.tibbs-
Closed Thursday, 30 Apr CDISC- Erin Tibbs-Slone CRL erin.tibbs-


2020 04:46 PM 4340 nih.gov
Closed Thursday, 30 Apr CDISC- Ivan Jiang Roche/Genentech jiangi@gene.com
2020 04:47 PM 4341

2020 04:48 PM 4342 com
Closed Thursday, 30 Apr CDISC- Sigrid Fouchier SMS-oncology s.fouchier@sms-

2020 04:49 PM 4343 oncology.com
Closed Thursday, 30 Apr CDISC- Sigrid Fouchier SMS-oncology s.fouchier@sms-
2020 04:49 PM 4344 oncology.com
Closed Friday, 1 May CDISC- Christine A. Q2 Solutions Christine.Huselton

2020 10:59 AM 4345 Huselton @q2labsolutions.co
m
Closed Wednesday, 6 CDISC- Jozef Aerts XML 4 Pharma XML 4 Pharma

May 2020 09:24 4346
AM
Closed Friday, 8 May CDISC- Colleen Bonjo Merck Merck

2020 12:20 PM 4347
Open Friday, 8 May CDISC- Colleen Bonjo Merck Merck

2020 12:21 PM 4348
Closed Friday, 8 May CDISC- Anna Pron-Zwick GSK GSK

2020 12:21 PM 4349
Closed Friday, 8 May CDISC- Jozef Aerts XML4Pharma XML4Pharma
2020 12:22 PM 4350
Closed Friday, 8 May CDISC- Melissa Rowley GSK GSK

2020 12:23 PM 4351
Open Friday, 8 May CDISC- Melissa Rowley GSK GSK

2020 12:23 PM 4352
Closed Friday, 8 May CDISC- Jordan Li (on NCI EVS NCI EVS
2020 12:24 PM 4353 behalf of T1D
team)
Closed Friday, 8 May CDISC- Claire West GSK GSK
2020 12:25 PM 4354
Closed Friday, 8 May CDISC- Mihaela Simion Biogen Biogen

2020 01:06 PM 4355

2020 01:07 PM 4356

2020 01:08 PM 4357

2020 01:08 PM 4358
Closed Friday, 8 May CDISC- Karina Rostgaard Novo Nordisk A/S Novo Nordisk A/S
2020 01:12 PM 4359 Stender
2020 01:15 PM 4360 Stender
2020 01:16 PM 4361 Stender
2020 01:16 PM 4362 Stender
2020 01:17 PM 4363 Stender
2020 01:18 PM 4364 Stender

2020 01:19 PM 4365

2020 01:22 PM 4366
Open Friday, 8 May CDISC- Guido Claes CDISC Glossary CDISC Glossary
2020 01:23 PM 4367 team team
Open Friday, 8 May CDISC- Guido Claes CDISC Glossary CDISC Glossary
2020 01:24 PM 4368 team team
Closed Friday, 8 May CDISC- DANIEL POTENTA PDS PDS

2020 01:25 PM 4369
Closed Friday, 15 May CDISC- Mary Jo Brucker Merck Merck

2020 08:44 AM 4370

2020 08:44 AM 4371
Closed Friday, 15 May CDISC- Ivan Jiang Roche/ Genentech Roche/ Genentech
2020 08:45 AM 4372
Closed Friday, 15 May CDISC- Carrie Neeley Covance Covance
2020 08:46 AM 4373
Closed Friday, 15 May CDISC- Sharon Broderick Boehringer Boehringer

2020 08:47 AM 4374 Ingelheim Ingelheim
Pharmaceuticals Pharmaceuticals
Inc Inc
Closed Friday, 15 May CDISC- Sharon Broderick Boehringer Boehringer

2020 08:47 AM 4375 Ingelheim Ingelheim
Pharmaceuticals Pharmaceuticals
Inc Inc
Closed Friday, 15 May CDISC- Barbara Lentz Bayer Pharma Bayer Pharma
2020 08:48 AM 4376
Closed Friday, 15 May CDISC- Barbara Lentz Bayer Pharma Bayer Pharma
2020 08:49 AM 4377
Closed Friday, 15 May CDISC- Adam Batchelor AbbVie Inc. AbbVie Inc.
2020 08:50 AM 4378
Closed Friday, 15 May CDISC- Charlotte M CM Keenan CM Keenan

2020 08:52 AM 4379 Keenan ToxPath Consulting ToxPath Consulting
Closed Friday, 15 May CDISC- Charlotte M CM Keenan CM Keenan

2020 08:53 AM 4380 Keenan ToxPath Consulting ToxPath Consulting
2020 08:54 AM 4381
Open Friday, 15 May CDISC- Colleen Bonjo Merck Merck

2020 08:54 AM 4382

2020 08:55 AM 4383

2020 08:56 AM 4384

2020 08:56 AM 4385
Closed Friday, 22 May CDISC- Richard Marshall CDISC CDISC

2020 10:43 AM 4386

2020 10:45 AM 4387

2020 10:45 AM 4388
2020 10:46 AM 4389
Closed Friday, 22 May CDISC- Rohit Dhanjal Vertex Vertex

2020 10:47 AM 4390
Closed Friday, 22 May CDISC- Jordan Li NCI EVS NCI EVS

2020 10:47 AM 4391
Open Friday, 22 May CDISC- Sharon Broderick Boehringer Boehringer

2020 10:48 AM 4392 Ingelhiem Ingelhiem
Pharmaceuticals, Pharmaceuticals,
Inc. Inc.
Open Friday, 22 May CDISC- Sharon Broderick Boehringer Boehringer

2020 10:48 AM 4393 Ingelhiem Ingelhiem
Pharmaceuticals, Pharmaceuticals,
Inc. Inc.
Closed Friday, 22 May CDISC- Nicholas Pemble Janssen Janssen

2020 10:51 AM 4394

2020 10:52 AM 4395
2020 10:52 AM 4396
Closed Friday, 22 May CDISC- Phil Pochon Covance Covance

2020 10:55 AM 4397
2020 10:55 AM 4398

2020 10:56 AM 4399
Closed Tuesday, 26 May CDISC- Jozef Aerts XML4Pharma XML4Pharma

2020 11:05 AM 4400
Closed Tuesday, 26 May CDISC- Jozef Aerts XML4Pharma XML4Pharma

2020 11:05 AM 4401
Closed Thursday, 28 CDISC- Jordan Li (on NCI EVS NCI EVS

May 2020 12:59 4402 behalf of MB team)
PM
Closed Thursday, 28 CDISC- Erin Muhlbradt NCI EVS NCI EVS

May 2020 02:48 4403
PM
Closed Thursday, 28 CDISC- Sharon Broderick Boehringer Boehringer
May 2020 02:52 4404 Ingelheim Ingelheim
PM Pharmaceuticals Pharmaceuticals
Inc Inc

May 2020 02:52 4405 Ingelheim Ingelheim
Inc Inc
Closed Thursday, 28 CDISC- Mihaela Simion Biogen Biogen

May 2020 02:53 4406
PM
Closed Thursday, 28 CDISC- Mihaela Simion Biogen Biogen

May 2020 02:54 4407
PM
Closed Thursday, 4 Jun CDISC- Gary Walker Gary G Walker,LLC Gary G Walker,LLC
2020 05:00 PM 4408
Closed Thursday, 4 Jun CDISC- Anna Pron-Zwick AstraZeneca AstraZeneca
2020 05:01 PM 4409
Closed Thursday, 4 Jun CDISC- Anna Pron-Zwick AstraZeneca AstraZeneca

2020 05:01 PM 4410
Closed Thursday, 4 Jun CDISC- Rahul Thandavan Roche Roche

2020 05:02 PM 4411 Pharmaceuticals Pharmaceuticals
Closed Thursday, 4 Jun CDISC- Assia Bouhadouza Sanofi Sanofi

2020 05:12 PM 4412
Closed Monday, 8 Jun CDISC- Jozef Aerts XML 4 Pharma XML 4 Pharma
2020 10:27 AM 4413
Closed Wednesday, 10 CDISC- LE LABOURIER Sanofi Sanofi
Jun 2020 04:24 4414 Lucile
PM
Open Wednesday, 10 CDISC- LE LABOURIER Sanofi Sanofi

Jun 2020 04:25 4415 Lucile
PM
Closed Wednesday, 10 CDISC- LE LABOURIER Sanofi Sanofi

Jun 2020 04:26 4416 Lucile
PM
Closed Wednesday, 10 CDISC- Gary Walker Gary G Walker LLC Gary G Walker LLC
Jun 2020 04:27 4417
PM
Closed Wednesday, 10 CDISC- oleg shchelochkov NIH NIH

Jun 2020 04:28 4418
PM
Closed Wednesday, 10 CDISC- Diane Cory C-Path C-Path
Jun 2020 04:28 4419
PM
Closed Wednesday, 10 CDISC- Charlotte Miller C.M. Keenan C.M. Keenan

Jun 2020 04:29 4420 Keenan ToxPath Consulting ToxPath Consulting
PM
Closed Wednesday, 10 CDISC- Charlotte Miller C.M. Keenan C.M. Keenan

PM
Closed Friday, 12 Jun CDISC- Manolya Ezgimen AbbVie AbbVie

2020 11:47 AM 4422
Closed Friday, 12 Jun CDISC- Fariba Alipour EMD Serono EMD Serono
2020 11:48 AM 4423
Closed Friday, 12 Jun CDISC- Jordan Li NCI EVS NCI EVS

2020 11:50 AM 4424
Open Friday, 12 Jun CDISC- Steve Kopko CDISC CDISC
2020 11:53 AM 4425
Closed Friday, 12 Jun CDISC- Steve Kopko CDISC CDISC

2020 11:54 AM 4426
Closed Monday, 15 Jun CDISC- Diane Corey C-path C-path

2020 04:42 PM 4427
Closed Thursday, 18 CDISC- Charlotte M. C.M. Keenan C.M. Keenan
PM
Closed Thursday, 18 CDISC- Charlotte M. C.M. Keenan C.M. Keenan

PM
Closed Thursday, 18 CDISC- LE LABOURIER Sanofi Sanofi

Jun 2020 02:18 4430
PM
Closed Thursday, 18 CDISC- Mary Jo Brucker Merck & Co., Inc Merck & Co., Inc
Jun 2020 02:19 4431
PM
Closed Thursday, 18 CDISC- Dave Scocca Rho, Inc. Rho, Inc.

Jun 2020 02:20 4432
PM
Closed Thursday, 18 CDISC- Claire West GSK GSK
Jun 2020 02:21 4433
PM

Jun 2020 02:21 4434
PM

Jun 2020 02:21 4435
PM
Jun 2020 02:22 4436
PM

Jun 2020 02:23 4437 Ingelheim Ingelheim
Inc Inc
Closed Thursday, 18 CDISC- Rohit Dhanjal Vertex Vertex
Jun 2020 02:23 4438
PM
Closed Friday, 19 Jun CDISC- LE LABOURIER Sanofi Sanofi

2020 11:52 AM 4439

2020 11:52 AM 4440

2020 11:54 AM 4441
Closed Friday, 26 Jun CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2020 01:29 PM 4442 nih.gov
2020 01:30 PM 4443 yer.com

2020 01:31 PM 4444 com
Closed Friday, 26 Jun CDISC- Jenny Jones Covance Jenny.Jones@cova

2020 01:31 PM 4445 nce.com

2020 01:32 PM 4446 nce.com

2020 01:32 PM 4447 nce.com

2020 01:32 PM 4448 nce.com
2020 01:32 PM 4449 nce.com
2020 01:33 PM 4450 nce.com
2020 01:33 PM 4451 nce.com
2020 01:33 PM 4452 nce.com

2020 01:33 PM 4453 nce.com
2020 01:33 PM 4454 nce.com
2020 01:34 PM 4455 nce.com

2020 01:34 PM 4456 nce.com

2020 01:34 PM 4457 nce.com
2020 01:34 PM 4458 nce.com
2020 01:34 PM 4459 nce.com
2020 01:35 PM 4460 nce.com

2020 01:35 PM 4461 nce.com
2020 01:35 PM 4462 nce.com
2020 01:35 PM 4463 nce.com
2020 01:35 PM 4464 nce.com
2020 01:36 PM 4465 nce.com
2020 01:36 PM 4466 nce.com
2020 01:37 PM 4467 nce.com
2020 01:37 PM 4468 nce.com
2020 01:37 PM 4469 nce.com

2020 01:37 PM 4470 nce.com
2020 01:37 PM 4471 nce.com
2020 01:37 PM 4472 nce.com
2020 01:38 PM 4473 nce.com
2020 01:38 PM 4474 nce.com
2020 01:38 PM 4475 nce.com
Closed Friday, 26 Jun CDISC- Ben Sefing Merck benjamin_sefing@
2020 01:39 PM 4476 merck.com
Closed Friday, 26 Jun CDISC- Denise Reichert Covance denise.reichert@co
2020 01:39 PM 4477 vance.com

2020 01:40 PM 4478 nih.gov

2020 01:40 PM 4479 nih.gov

2020 01:41 PM 4480 yer.com
Closed Wednesday, 1 CDISC- Mihaela Simion Biogen mihaela.simion@bi

Jul 2020 06:44 4481 ogen.com
PM

Jul 2020 06:45 4482 ogen.com
PM
Jul 2020 06:45 4483 ogen.com
PM
Closed Wednesday, 1 CDISC- Ivan Jiang Roche/ Genentech jiangi@gene.com

Jul 2020 06:46 4484
PM

Jul 2020 06:47 4485 yer.com
PM

Jul 2020 06:47 4486 yer.com
PM
Closed Wednesday, 1 CDISC- Nik Pemble Janssen npemble@its.jnj.co

Jul 2020 06:48 4487 m
PM
Closed Thursday, 2 Jul CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4
2020 04:54 PM 4488 Pharma.com
Closed Thursday, 2 Jul CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4
2020 04:54 PM 4489 Pharma.com
Open Friday, 10 Jul CDISC- assia bouhadouza Sanofi assia.bouhadouza

2020 10:23 AM 4490 @sanofi.com
Closed Friday, 10 Jul CDISC- Rahul Thandavan Roche rahul.thandavan@r

2020 10:24 AM 4491 Pharmaceuticals oche.com
Closed Friday, 10 Jul CDISC- Richard Marshall CDISC richard@accurates

2020 10:25 AM 4492 ystems.co.uk
Closed Friday, 10 Jul CDISC- Ivan Jiang Roche/ Genentech jiangi@gene.com
2020 10:26 AM 4493

2020 10:27 AM 4494

2020 10:27 AM 4495 com
2020 10:28 AM 4496 com
Closed Friday, 10 Jul CDISC- Swarupa Sudini Pfizer swarupa.sudini@pfi

2020 10:29 AM 4497 zer.com

2020 04:08 PM 4498 com
2020 04:08 PM 4499 com

2020 04:09 PM 4500 com

2020 04:10 PM 4501 com
Open Friday, 17 Jul CDISC- Steve Kopko CDISC skopko@cdisc.org
2020 04:11 PM 4502
2020 04:11 PM 4503 behalf of Charlotte nih.gov
Keenan, INHAND)
Closed Friday, 17 Jul CDISC- Diane Corey C-Path dcorey@c-path.org

2020 04:13 PM 4504
Closed Friday, 17 Jul CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p
2020 04:14 PM 4505 fizer.com
Open Friday, 17 Jul CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

2020 04:14 PM 4506 fizer.com
Closed Friday, 17 Jul CDISC- Brenda Baldwin FDA brenda.baldwin@fd

2020 04:16 PM 4507 a.hhs.gov
Closed Friday, 17 Jul CDISC- Mihaela Simion Biogen mihaela.simion@bi

2020 04:16 PM 4508 ogen.com
2020 04:17 PM 4509 ogen.com

2020 04:17 PM 4510 ogen.com
TA team)
Closed Thursday, 23 Jul CDISC- Jordan Li (on NCI EVS jordan.li@nih.gov
TA team)
Closed Thursday, 23 Jul CDISC- Mihaela Simion Biogen mihaela.simion@bi

2020 04:17 PM 4513 ogen.com

2020 04:18 PM 4514 ogen.com

2020 04:18 PM 4515 ogen.com
Open Friday, 24 Jul CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g
2020 05:06 PM 4516 ng mail.com

2020 05:06 PM 4517 ng mail.com
Closed Friday, 24 Jul CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2020 10:40 AM 4519 ng mail.com
Closed Friday, 31 Jul CDISC- Colleen Bonjo Merck colleen_bonjo@me

2020 10:41 AM 4520 rck.com

2020 10:42 AM 4521 rck.com

2020 10:42 AM 4522 rck.com

2020 10:42 AM 4523 rck.com

2020 10:43 AM 4524 rck.com

2020 10:43 AM 4525 yer.com
2020 10:44 AM 4526 yer.com
Closed Friday, 7 Aug CDISC- Colleen Bonjo Merck colleen_bonjo@me

2020 11:30 AM 4527 rck.com
Closed Friday, 7 Aug CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2020 11:31 AM 4528
Closed Friday, 7 Aug CDISC- Barbara Lentz Bayer barbara.lentz1@ba

2020 11:32 AM 4529 yer.com

2020 03:12 PM 4530 ance.com
Closed Friday, 14 Aug CDISC- Jenny Jones Covance jenny.jones@covan
2020 03:13 PM 4531 ce.com
Closed Friday, 14 Aug CDISC- David Neubauer Elevar david.neubauer@el

2020 03:14 PM 4532 Therapeutics evartherapeutics.co
m

2020 03:16 PM 4533 yer.com
Closed Friday, 14 Aug CDISC- Charlotte Miller C.M. Keenan charlotte.keenan@

2020 03:17 PM 4534 Keenan ToxPath Consulting msn.com
Closed Friday, 14 Aug CDISC- ARLIX Sophie Syneoshealth sophie.arlix@syneo

Closed Friday, 14 Aug CDISC- Charlotte Miller C.M. Keenan charlotte.keenan@
2020 03:21 PM 4536 Keenan ToxPath Consulting msn.com

2020 03:23 PM 4537

2020 03:24 PM 4538 behalf of the MB
CT Team)
Closed Friday, 14 Aug CDISC- Stephen Raymond ERT Stephen.raymond

2020 03:25 PM 4539 @ERT.com
Open Friday, 14 Aug CDISC- Stephen Raymond ERT Stephen.raymond

2020 03:26 PM 4540 @ERT.com
Open Friday, 14 Aug CDISC- Stephen Raymond ERT Stephen.raymond
2020 03:26 PM 4541 @ERT.com
Closed Friday, 14 Aug CDISC- Sophie ARLIX Syneoshealth sophie.arlix@syneo


2020 03:30 PM 4543 rck.com

2020 03:31 PM 4544 rck.com

2020 03:31 PM 4545 rck.com
Closed Friday, 21 Aug CDISC- Rahul Thandavan Roche rahul.thandavan@r
2020 05:33 PM 4546 Pharmaceuticals oche.com
Open Friday, 21 Aug CDISC- Jennifer Feldmann Epreda LLC jennifer.feldmann@

2020 05:34 PM 4547 epreda.com
2020 05:35 PM 4548 yer.com

2020 11:27 AM 4549 yer.com
Closed Tuesday, 1 Sep CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2020 10:32 AM 4550 yer.com
Closed Friday, 4 Sep CDISC- Colleen Bonjo Merck colleen_bonjo@me
2020 11:25 AM 4551 rck.com
Closed Friday, 4 Sep CDISC- Mihaela Simion Biogen Mihaela.Simion@bi

2020 11:26 AM 4552 ogen.com

2020 11:27 AM 4553 yer.com

2020 11:27 AM 4554 yer.com

2020 11:28 AM 4555 yer.com
Closed Friday, 4 Sep CDISC- Jung Hyun Lee Asan Image junghyun.lee@aim-
2020 11:31 AM 4556 Metrics, Seoul aicro.com
Asan Medical
Center
Open Friday, 4 Sep CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2020 11:32 AM 4557 ng mail.com

2020 11:33 AM 4558 nih.gov
2020 11:34 AM 4559 rck.com
Closed Friday, 4 Sep CDISC- Jenny Jones Covance Jenny.Jones@Cov

2020 11:34 AM 4560 ance.com

2020 11:35 AM 4561
2020 11:36 AM 4562
2020 03:11 PM 4563 com
Closed Friday, 11 Sep CDISC- Dana Booth CDISC dbooth@cdisc.org

2020 03:12 PM 4564
Closed Friday, 11 Sep CDISC- Rahul Thandavan Roche rahul.thandavan@r
2020 03:12 PM 4565 Pharmaceuticals oche.com
Open Friday, 11 Sep CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Closed Friday, 11 Sep CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.
2020 03:14 PM 4567 nih.gov
Closed Friday, 18 Sep CDISC- Nicholas Pemble J&J npemble@its.jnj.co

2020 09:18 AM 4568 m
Closed Friday, 18 Sep CDISC- Sophie ARLIX Syneoshealth sophie.arlix@syneo

Closed Friday, 18 Sep CDISC- Magdalena Litwin- Roche magdalena.litwin-

2020 09:19 AM 4570 Wojciechowska wojciechowska@ro
che.com
2020 09:21 AM 4571 rck.com
Closed Friday, 18 Sep CDISC- Mhaela Simion Biogen mihaela.simion@bi

2020 09:22 AM 4572 ogen.com

2020 09:23 AM 4573 rck.com
Closed Friday, 18 Sep CDISC- DIANE E WOLD CDISC diane.wold@cdisc.

2020 09:24 AM 4574 org
Closed Friday, 18 Sep CDISC- Fariba Alipour EMD Serono fariba.alipour@emd
2020 09:25 AM 4575 serono.com
Closed Friday, 18 Sep CDISC- Erin Muhlbradt (on NCI EVS muhlbradtee@mail.
2020 09:26 AM 4576 behalf of T1D nih.gov
Pediatrics and
Devices TAUG)
Closed Friday, 18 Sep CDISC- Erin Muhlbradt (on MSC Inc. muhlbradtee@mail.
2020 11:30 AM 4577 behalf of T1D nih.gov
Pediatrics and
Devices TAUG)
Closed Tuesday, 22 Sep CDISC- Julia Yang Medtronic plc julia.yang@medtro

2020 02:02 PM 4578 nic.com
Closed Tuesday, 22 Sep CDISC- claire west GSK claire.m.west@gsk.

2020 02:03 PM 4579 com

Sep 2020 12:50 4580 yer.com
PM
Sep 2020 12:50 4581 yer.com
PM

Sep 2020 12:50 4582 yer.com
PM

Sep 2020 12:50 4583 yer.com
PM

Sep 2020 12:51 4584 yer.com
PM
Sep 2020 12:51 4585 yer.com
PM

Sep 2020 12:51 4586 yer.com
PM

Sep 2020 12:52 4587 yer.com
PM
Sep 2020 12:52 4588 yer.com
PM

Sep 2020 12:52 4589 yer.com
PM

Sep 2020 12:53 4590 rck.com
PM
Sep 2020 12:53 4591 rck.com
PM
Sep 2020 12:53 4592 rck.com
PM
Closed Thursday, 24 CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.
Sep 2020 12:54 4593 nih.gov
PM
Closed Thursday, 24 CDISC- Erin Tibbs-Slone CRL erin.tibbs-
Sep 2020 12:54 4594 slone@crl.com
PM
Closed Thursday, 24 CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

Sep 2020 03:28 4595 nih.gov
PM
Closed Friday, 25 Sep CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2020 12:01 PM 4596 om
Closed Friday, 2 Oct CDISC- Yanli Chang Novartis yanli.chang@novar

2020 11:11 AM 4597 tis.com
Closed Friday, 2 Oct CDISC- Kevin Horan Nordic Bioscience keh@nordicbio.co
2020 11:11 AM 4598 m

2020 11:12 AM 4599 rck.com
Closed Friday, 2 Oct CDISC- Debbie ONeill Merck debra_oneill@merc

2020 11:13 AM 4600 k.com

2020 11:13 AM 4601 ance.com
2020 11:14 AM 4602 ance.com

2020 11:23 AM 4603 com
2020 11:24 AM 4604 com
Closed Friday, 9 Oct CDISC- Rihab Kordane Certara rihab.kordane@cert

2020 11:24 AM 4605 ara.com

Inc
Closed Friday, 9 Oct CDISC- Patricia Gleason Merck patricia.gleason@

2020 11:25 AM 4607 merck.com
Closed Friday, 9 Oct CDISC- Dr William Stevens Nuffield will.stevens@ndph.
2020 11:26 AM 4608 Department of ox.ac.uk
Population Health,
Closed Friday, 9 Oct CDISC- Mihaela Simion Biogen mihaela.simion@bi

2020 11:27 AM 4609 ogen.com

2020 11:27 AM 4610 ogen.com
Closed Friday, 9 Oct CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.
2020 11:28 AM 4611 nih.gov
Closed Friday, 9 Oct CDISC- Assia Bouhadouza Sanofi assia.bouhadouza

2020 11:28 AM 4612 @sanofi.com
2020 11:29 AM 4613 rck.com

2020 11:29 AM 4614 rck.com

2020 11:30 AM 4615 rck.com
Closed Friday, 9 Oct CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2020 11:30 AM 4616 yer.com
Closed Friday, 16 Oct CDISC- DIANE E WOLD CDISC diane.wold@cdisc.
2020 12:42 PM 4617 org
Open Friday, 16 Oct CDISC- DIANE E WOLD CDISC diane.wold@cdisc.

2020 12:43 PM 4618 org

Inc
Inc
2020 12:44 PM 4621 nih.gov
Closed Friday, 23 Oct CDISC- Melissa Rowley GSK melissa.c.rowley@

2020 03:13 PM 4622 gsk.com
Closed Friday, 23 Oct CDISC- Rajinder Randhawa GSK Rajinder.Randhawa
2020 03:14 PM 4623 @gsk.com

2020 03:15 PM 4624 nih.gov
Closed Friday, 23 Oct CDISC- Dicky To Abbvie dicky.to@abbvie.co
2020 03:15 PM 4625 m
Open Friday, 23 Oct CDISC- Diane Corey C-Path dcorey@c-path.org

2020 03:16 PM 4626
2020 03:16 PM 4627
Closed Friday, 30 Oct CDISC- Debra ONeill Merck debra_oneill@merc

2020 12:07 PM 4628 k.com

2020 12:07 PM 4629 k.com
Closed Friday, 30 Oct CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2020 12:08 PM 4630 yer.com
Closed Friday, 30 Oct CDISC- Assia Bouhadouza Sanofi assia.bouhadouza

2020 12:08 PM 4631 @sanofi.com
Open Friday, 30 Oct CDISC- Assia Bouhadouza Sanofi assia.bouhadouza
2020 12:09 PM 4632 @sanofi.com

2020 12:09 PM 4633 ogen.com
Closed Friday, 30 Oct CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4
2020 12:10 PM 4634 Pharma.com
2020 12:10 PM 4635 Pharma.com

2020 12:11 PM 4636 Pharma.com
Closed Friday, 30 Oct CDISC- Ying Li CRL Audrey.Walker@crl

2020 12:11 PM 4637 .com
2020 12:12 PM 4638 nih.gov

2020 12:12 PM 4639 nih.gov

2020 12:13 PM 4640 k.com
Closed Friday, 30 Oct CDISC- Ying Li CRL Audrey.Walker@crl

2020 12:14 PM 4641 .com
Closed Friday, 30 Oct CDISC- Mohan Pokharel Odonate mpokharel@odonat

2020 12:15 PM 4642 Therapeutics e.com
2020 12:16 PM 4643 Pharma.com
Closed Friday, 30 Oct CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2020 12:17 PM 4644 com
Closed Friday, 6 Nov CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2020 04:38 PM 4645 Pharma.com
Closed Friday, 6 Nov CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2020 04:38 PM 4646 Pharma.com

2020 04:39 PM 4647 yer.com
2020 04:39 PM 4648 yer.com

2020 04:39 PM 4649 yer.com

2020 04:40 PM 4650 yer.com
2020 04:40 PM 4651 yer.com

2020 04:40 PM 4652 yer.com

2020 04:40 PM 4653 yer.com

2020 04:41 PM 4654 yer.com
Closed Friday, 6 Nov CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.
2020 04:42 PM 4655 nih.gov

2020 04:42 PM 4656 nih.gov
Closed Friday, 6 Nov CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Closed Friday, 6 Nov CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2020 04:43 PM 4658 om
Closed Friday, 6 Nov CDISC- Julia Yang Medtronic PLC julila.yang@medtro

2020 04:44 PM 4659 nic.com

2020 04:44 PM 4660 nic.com

2020 04:44 PM 4661 nic.com
Closed Friday, 6 Nov CDISC- Ivan Jiang Roche/Genentech jiangi@gene.com

2020 04:45 PM 4662

2020 04:46 PM 4663 yer.com

2020 04:46 PM 4664 yer.com
2020 04:46 PM 4665 yer.com

2020 04:47 PM 4666 yer.com
Closed Friday, 6 Nov CDISC- Michael Bayer michael.rosentreter

2020 04:47 PM 4667 Rosentreter @bayer.com
Closed Friday, 6 Nov CDISC- Jenny Jones Covance Jenny.Jones@Cov

2020 04:58 PM 4668 ance.com
2020 12:45 PM 4669 ogen.com
Closed Friday, 13 Nov CDISC- Jenny Jones Covance Jenny.Jones@cova

2020 12:46 PM 4670 nce.com
2020 12:47 PM 4671 nih.gov
Closed Friday, 20 Nov CDISC- Diane Wold CDISC

2020 01:26 PM 4672

2020 01:27 PM 4673 ogen.com
Open Friday, 20 Nov CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2020 01:27 PM 4674
Closed Friday, 27 Nov CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo


2020 04:49 PM 4676 ogen.com
Closed Friday, 27 Nov CDISC- Anja Loewitz Covance anja.loewitz@cova

2020 04:50 PM 4677 nce.com
Closed Monday, 30 Nov CDISC- Erin Muhlbradt NCI EVS muhlbradtee@mail.
2020 01:53 PM 4678 nih.gov
Open Thursday, 3 Dec CDISC- Shannon Labout Data Science shannon.labout@d

2020 05:04 PM 4679 Solutions LLC atasciencesolutions
llc.com
Closed Thursday, 3 Dec CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2020 06:23 PM 4680 anofi.com
Closed Thursday, 3 Dec CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2020 06:24 PM 4681 anofi.com
2020 06:25 PM 4682
Open Thursday, 3 Dec CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2020 06:25 PM 4683 com
Closed Thursday, 3 Dec CDISC- Colleen Bonjo Merck colleen_bonjo@me

2020 06:26 PM 4684 rck.com
Closed Thursday, 3 Dec CDISC- Anita Umesh anita.umesh@gmai

2020 06:28 PM 4685 l.com
Closed Friday, 4 Dec CDISC- Michael Bayer AG michael.rosentreter
2020 11:39 AM 4686 Rosentreter @bayer.com

2020 11:42 AM 4687 rck.com
Closed Friday, 11 Dec CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2020 11:43 AM 4688 anofi.com

2020 11:43 AM 4689 anofi.com
2020 11:44 AM 4690 anofi.com

2020 11:44 AM 4691 anofi.com

2020 11:44 AM 4692 anofi.com
2020 11:44 AM 4693 anofi.com

2020 11:44 AM 4694 anofi.com

2020 11:45 AM 4695 anofi.com

2020 11:45 AM 4696 anofi.com

2020 11:45 AM 4697 anofi.com
2020 11:45 AM 4698 anofi.com

2020 11:45 AM 4699 anofi.com

2020 11:46 AM 4700 anofi.com
2020 11:46 AM 4701 anofi.com

2020 11:46 AM 4702 anofi.com

2020 11:46 AM 4703 anofi.com

2020 11:46 AM 4704 anofi.com

2020 11:47 AM 4705 anofi.com

2020 11:47 AM 4706 anofi.com
2020 11:47 AM 4707 anofi.com

2020 11:47 AM 4708 anofi.com

2020 11:47 AM 4709 anofi.com

2020 11:48 AM 4710 anofi.com
2020 11:48 AM 4711 anofi.com

2020 11:48 AM 4712 anofi.com

2020 11:48 AM 4713 anofi.com

2020 11:49 AM 4714 anofi.com
2020 11:49 AM 4715 anofi.com

2020 11:50 AM 4716 anofi.com

2020 11:50 AM 4717 anofi.com

2020 11:50 AM 4718 anofi.com
2020 11:50 AM 4719 anofi.com
Closed Friday, 11 Dec CDISC- Ivan Jiang Roche/ Genentech jiangi@gene.com

2020 11:52 AM 4720
Closed Friday, 11 Dec CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2020 11:54 AM 4721

2020 01:13 PM 4722 anofi.com
Closed Friday, 18 Dec CDISC- Gitte Frausing data standards gfrausing@datasta

2020 01:50 PM 4723 decisions ndardsdecisions.co
m
Closed Friday, 18 Dec CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2020 01:51 PM 4724 yer.com

2020 01:52 PM 4725 nih.gov
Closed Friday, 18 Dec CDISC- Jenny Jones Covance jenny.Jones@Cova

2020 01:52 PM 4726 nce.com
Dec 2020 04:03 4727 yer.com
PM
Request Type
Create New SDTM- Please add LEA CHART to the

Term METHOD METHOD codelist.
Create New SDTM-UNIT mm3

Term
Modify SEND- Change CDISC submission value

Existing Term CHAGNAMR and definition for C80605. It should
be 'Phoxim', not 'Phoxin'.
Modify SDTM-UNIT C166100 - mL/s/m2 - A metric unit of

Existing Term volumetric flow rate defined as the
rate at which one milliliter of matter
travels during the period of time
equal to one second per meter
squared.
Modify Multiple C85492 - RULER C81184 -

Existing Term CALIPER C17648 - MULTIPLE
Create New SDTM- C135009 - Add this SEND TSPARM

Term TSPARMCD to the SDTM TSPARM/CD
Create New SDTM- New method terms please
Term METHOD
Create New SDTM- New terms please
Term NCOMPLT
Create New SDTM- Requesting new terms for respiratory

Term RETESTCD tests
Modify Multiple For CAT IPAQ-LF PHONE VERSION

Existing Term QSTESTCD needs to change
Create New NEW Create New Codelist for PPANMETH

Codelist
Create New PKUNIT ng/mL/(mg/cm2) and

Term h*ng/mL/(mg/cm2)
Create New Multiple 26 New terms from the T1D TA team
Term
Create New SDTM- Please consider the addition of

Term LBTESTCD ASTALT/Aspartate;
Aminotransferase to Alanine
Aminotransferase Ratio
Measurement
Create New SEND-SPEC NERVE, CAUDAL PLEXUS

Term
Create New SEND- 6 new terms and 1 change to

Term NONNEO existing for the SEND NONNEO
codelist. This is to support updates
made by the CNS publication by
INHAND.
Create New NEW AJCCGRD8, AJCC8TC, AJCC8TN;
Codelist 'AJCC V8' CDISC Submission Value
to the CCCAT and ONCRSCAT.
Create New SDTM- Pls add Enterovirus and Rotavirus to

Term MBTEST/CD MBTEST
Create New SDTM- HALLUC / Hallucinogen

Term LBTEST/CD
Create New Multiple Pls add new term from the T1D TA
Term
Create New SDTM- Side Effect

Term glossary
Create New SDTM- Please add the following tests
Term CVTEST/CD related to Pulse Wave Velocity
Analysis (PWA) and Velocity (PWV)
Modify Multiple Changes with regard to "w/"

Existing Term
Create New SEND- Will send spreadsheet separately.

Term STRAIN
Create New SDTM- Need request codes for the approved
Term MICROORG MICROORG terms
Modify SDTM- Duplicate value for C112326
Existing Term MBTESTCD (JCVAB) and C163540 (JCVDNA)
Modify SDTM- Error for synonym value

Create New SDTM-UNIT CAPSULE; DROP

Term
Create New Multiple Request to create new DVCAT and

Codelist DVDECOD terminology.
Create New SDTM- SURGICAL RESECTION

Term CLMETH
Create New SDTM-UNIT mg/mL/day
Term
Create New SDTM-LOC SPHENOID SINUS

Term
Create New SDTM-LOC OSTIOMEATAL COMPLEX

Term
Create New SDTM- Total Cholic Acid

Term LBTEST/CD
Create New SDTM- Total Chenodeoxycholic Acid

Term LBTEST/CD
Create New SDTM- Total Deoxycholic Acid

Term LBTEST/CD
Create New SDTM- Total Ursodeoxycholic Acid

Term LBTEST/CD
Create New SDTM- Neutrophil Gelatinase - associated

Term LBTEST/CD Lipocalin (NGAL)
Create New CDISC- "Standard of Care" for a new list
Codelist Glossary TSCURTRT
Create New SDTM-LAT Please add to the LAT codelist the

Term submission value of MIDLINE.
Create New SEND- Multiple for FXFINDRS.

Term FXFINDRS
Create New SDTM- Please create a new term for

Term POSITION 'STANDING LEANING OVER' or
similar
Modify SDTM-UNIT Code C85754 is implemented having
Existing Term the submission value = pmol/g for
codelists C71620 (UNIT) whereas it
is implemented as nmol/kg for code
lists C84494 and C128683.
Create New SDTM-UNIT Please add new term to codelist

Term UNIT (C71620): nmol/kg/day
Create New SDTM- Add new term to MOOD codelist.

Term BRDGMOOD SCHEDULED, NOT PERFORMED
Create New SDTM- Please add the term CATARACT

Term PROCEDUR SURGERY to the PROCEDUR
codelist.
Create New Multiple This is a TA request.

Term
Create New SDTM- Recommend code CSS be added to
Term PKPARM/CD SDTM:PKPARMCD and
SEND:PKPARMCD with equivalent
"Steady State Conc" added to
SDTM:PKPARM and
SEND:PKPARM.
Create New SDTM- Please add the code SPECT/CT to

Term PROCEDUR the PROCEDUR codelist.
Create New CDISC- Disease Milestone

Term Glossary
Create New SDTM- TITRATION or Van De Kamer

Term METHOD method
Create New SDTM- Coefficient Nitrogen Absorption

Term LBTEST/CD (CAN)
Create New SDTM- Coefficient Fat Absorption (CFA)

Term LBTEST/CD
Create New SDTM- Durvalumab or Durvalumab
Term LBTEST/CD Antibody (high-affinity human
immunoglobulin G1 kappa
monoclonal antibody)
Create New Multiple 116 total changes => 48 new terms

Term and 68 changes to existing
Create New SDTM- IDMS-MDRD ENZYMATIC

Term LBANMET JAPANESE CKDI FORMULA
Create New SDTM- INTRACELLULAR CYTOKINE

Term METHOD STAIN
Create New SDTM- INDIRECT BINDING

Term METHOD ELECTROCHEMILUMINESCENCE
Create New SDTM- COMPETITIVE ELISA
Term METHOD
Create New Multiple All consensus cardiac classification

Term system test codes/test names are
moving from CV to CC
Create New Multiple EORTC-QLQ C-29

Term
Modify SDTM-UNIT Perusing, i.e. very informally, several
Existing Term PubMed articles use "Osm".
Create New CDISC- New term

Term Glossary
Create New SDTM- "Pls add the term ""SELF

Term METHOD ASSESSMENT"" to the METHOD
codelist. This is a TA request. "
Create New SDTM- CRTH2 cells - chemoattractant
Term LBTEST/CD receptor-homologous molecule
expressed on Th2 cells
Create New SDTM- 17 helper T cells (Th17 cells)

Term LBTEST/CD
Create New SDTM- GATA3 cells- GATA-binding protein

Term LBTEST/CD 3 (GATA3)
Create New SDTM- SARS Coronavirus 2
Term MICROORG
Create New SDTM- h*ngEq/L

Term PKUNIT
Create New SDTM- add "fraction of 1" to PKUNIT

Term PKUNIT
Modify Multiple Update NCI PT for E-TRIP for P41

Existing Term QRS publication, also need request
code
Create New SDTM- Please add the submission value of
Term ROUTE TRANSVESICAL to the ROUTE
codelist.
Modify SDTM- Definition and synonym for term

Existing Term MBTESTCD C163540 (JCVDNA) seem to be
incorrect.

Existing Term CVPRCIND
Create New SDTM- COMPUTED TOMOGRAPHY

Term METHOD PERFUSION
Modify Multiple QSTESTCD/QSTEST changes for
Existing Term IPA03 and IPA04 (IPAQ SF and LF
SELF-ADMINISTERED measures
Create New SDTM-UNIT 3 new unit terms
Term
Create New SDTM- CURETTAGE; DEFINITIVE

Term CLMETH THERAPY
Create New SEND- Segmental

Term DSTRBN
Create New SEND- Strain short name: L.G6PC -/-
Term STRAIN
Create New SDTM-UNIT breaths/30s
Term
Create New SDTM- Amt Rec to Last Nonzero Conc

Term PKPARM/CD
Create New SDTM- RCAMLST

Term PKPARM/CD
Create New SDTM- Can 'BONE SCAN' be added as a

Term METHOD value to this code list? CDISC SDTM
Method Terminology (Code C85492)
Create New D1FATS-CD Create new Findings About TEST-

Term CD terms for T1D TAUG
Create New SDTM-EVAL Add the term "NON-HEALTH CARE

Term PROFESSIONAL" to the EVAL
codelist This is for the T1D
Prevention TAUG
Create New SDTM- Add "NUMERICAL RATING SCALE
Term QRSMTHED 5-POINT" to the QRS-METHOD
codelist For the Psoriasis TAUG
Create New SDTM- Please add a new LBTESTCD

Term LBTEST/CD "PTAUAB42" with the LBTEST of
"Phosphorylatd Tau Prot/Amyloid
Beta 1-42"
Create New SDTM-LOC EXTRAHEPATIC PERIHILAR
Term REGION
Create New SDTM-LOC DISTAL EXTRAHEPATIC REGION

Term
Modify SDTM- Neutrophil-Activating Peptide 2
Existing Term LBTEST/CD (C165976)
Create New Multiple New term request for 12 new TESTs

Term and 2 METHOD values. For
Coronavirus research related to
LOINC codes
Create New NEW Batch 1 new term request for Crohn's

Codelist Disease TA
Create New SDTM- LIGAND BINDING ASSAY

Term METHOD
Create New Multiple 6 new terms for Crohn's Disease TA

Term
Create New SDTM-LOC "Celiac artery" or "Celiac trunk artery"

Term
Create New SDTM-LOC Ductus arteriosus

Term
Create New SDTM-LOC Dorsal pedal artery
Term
Create New SDTM-LOC Ulnar artery

Term
Create New SDTM-LOC Dental arch

Term
Create New SDTM-LOC Palpebral fissure
Term
Create New SDTM-LOC Arterial blood
Term
Create New SDTM-LOC Capillary blood

Term
Create New SDTM-LOC Venous blood

Term
Create New SDTM-LOC cord blood

Term
Create New SDTM-LOC Venous cord blood
Term
Create New SDTM-LOC Preductal blood

Term
Create New SDTM-LOC postductal blood

Term
Create New SDTM-LOC Mixed venous blood

Term
Create New SDTM- Intravascular end systolic blood

Term VSTEST/CD pressure
Create New SDTM- Intravascular peak systolic blood
Term VSTEST/CD pressure
Create New SDTM- Intracrranial systolic pressure
Term VSTEST/CD
Create New SDTM-LOC Digital artery

Term
Create New SDTM-LOC penile artery

Term
Create New SDTM-LOC index arteries

Term
Create New SDTM-LOC little finger arteries
Term
Create New SDTM-LOC middle finger arteries
Term
Create New SDTM-LOC Ring finger arteries

Term
Create New SDTM-LOC Thumb arteries

Term
Create New SDTM-LOC Semen

Term
Create New SDTM-LOC arterial blood

Term
Create New SDTM-LOC venous blood

Term
Create New SDTM- body core temperature

Term VSTEST/CD
Create New SDTM- Mutiple code request

Term VSTEST/CD
Create New SDTM-UNIT kUA/L
Term
Create New CDISC- Plain language Health literacy
Term Glossary
Create New Multiple File contains 6 new SCTEST values

Term to publish to support EBOLA TAUG
and 1 change to a published
LBTEST definition for a COVID-19
trial
Create New SDTM- C137943 - PATIENT DECISION
Term NCOMPLT Definition: A position, opinion or
judgment reached after consideration
by a patient. (NCI)
Create New CDISC- Cell therapy is an important and
Term Glossary commonly used term, globally valid.
We need to ensure being clear on
the coherence with existing term
regenerative medicine therapy but
also be aware of the differences
(regenerative medicine is a broader
concept)
Create New CDISC- "Gene therapy is an important

Term Glossary common term in medicine. We need
to ensure that the term is defined
and fitting properly in the
regenerative medicine cluster "
Create New CDISC- Regenerative medicine therapy

Term Glossary
Create New CDISC- Observational study
Term Glossary
Create New CDISC- subcategory of observational clinical

Term Glossary study
Create New CDISC- subcategory of observational clinical

Term Glossary study
Create New CDISC- Subcategory of observational study.
Term Glossary Existing term to be revisited.
Create New SDTM- version 4.5 is available since March

Term FDATSRS 2020
Create New Add to codelist

Term
Create New SDTM- Maximum Blood Flow Velocity
Term CVTEST/CD
Modify SDTM-MITS C156548: Team to re-discuss

Existing Term whether this is the appropriate TEST
or whether this belongs in TSTDTL
Create New SDTM- CONTINUING INTO SURVIVAL

Term PROTMLST FOLLOW-UP
Create New SDTM- NOT CONTINUING INTO SURVIVAL

Term PROTMLST FOLLOW-UP
Create New SDTM- RPPAG/Rate-Pressure Product,
Term CVTEST/CD Aggregate
Create New SDTM- QTCP/QTcP Interval, Aggregate

Term EGTEST/CD
Modify SDTM- Revise label ordering for Atypical
Existing Term LBTEST Lymphocytes/Lymphocytes (C74654)
to match other terms
Create New SDTM- PKPARM and PKPARMCD. 11 new

Term PKPARM/CD codes requested to be added to the
PKPARM/CD codelists to reflect
dose per kg body weight, as they are
currently not represented.
Create New PGx SARS coronavirus 2 S gene

Term
Create New CDISC- PANDEMIC: An epidemic occurring
Term Glossary worldwide, or over a very wide area,
crossing international boundaries,
and usually affecting a large number
of people
Create New CDISC- EPIDEMIC

Term Glossary
Create New CDISC- ENDEMIC DISEASE: The constant
Term Glossary presence of a disease or infectious
agent within a given geographic area
or population group; may also refer
to the usual prevalence of a given
disease within such area or group
Modify Multiple Definition for C20080 Angiography

Existing Term omits the aspect of X-ray, which
seems to be an important component
of the definition. Consider definition
update: The X-ray examination of the
blood vessels or chambers of the
heart.
Create New SDTM- "STATED", or "STATEMENT" as a

Term METHOD method.
Create New SDTM- Requesting

Term VSTEST/CD VSTESTCD=FWTAPCTL and
VSTEST=Fetal Weight-for-Age
Percentile
Create New SDTM- Mandibular Length (or Mandible
Term VSTEST/CD Length)
Create New SDTM- Fetal Mandibular Length (or Fetal

Term VSTEST/CD Mandible Length)
Modify SDTM-LOC Pls fix typo in C102286

Existing Term
Create New SDTM-TTYPE REACTOGENICITY

Term
Create New SDTM-FREQ Please add Q72H to the FREQ

Term codelist.
Create New SDTM-FREQ Please add 3 OR 4 TIMES PER
Term WEEK to the FREQ codelist.
Modify SDTM- To make the codelist consistent

Create New SDTM-UNIT Erythrocytes/uL Leukocytes/uL
Term nkat/gHb
Create New Multiple Revise the Tanner Scale from the RP

Codelist to the RS Domain
Create New SDTM- SARS-related coronavirus+MERS
Term MBTEST/CD coronavirus RNA
Create New SDTM- SARS-related coronavirus RNA

Term MBTEST/CD
Create New SDTM- RAPID IMMUNOASSAY

Term METHOD
Create New NEWSDTM- Add to codelist PKANMET (codelist

Term PKANMET to be added in P42) Submission
Value = OBSERVATION
Create New Multiple These requests are for the COVID-

Codelist 19 TA team.
Create New SDTM- Add to MEDEVAL Codelist the term
Term MEDEVAL ENT SPECIALIST.
Create New SDTM-DTYPE Please add new codes for the

Term DTYPE codelist. Each entry is a
type of derivation used for analysis;
used to report the DTYPE in the
submission.
Create New SDTM-DTHDX Test Name: Source of Notification

Term TESTCD: SRCNOTF
Create New SDTM-DTHDX Death Sudden Indicator TESTCD:

Term DTHSDIND
Other SDTM- Looking at LOINC, it looks like these
LBTEST/CD additional actual/control parameters
would always refer to the activity
measurements. Thus, I do not see
the need to have these new terms
introduced.
Create New SDTM- Ulnar Length - ULNLNGTH

Term VSTEST/CD
Create New SDTM- New term required related to TEARS

Term SPECTYPE
Create New Multiple Patient-Reported Outcomes Version

Codelist of the Common Terminology Criteria
for Adverse Events Version 1.0
(PRO-CTCAE v1.0) revised CT
based on NCI & FDA review
Create New SDTM- "TUSENUM/Tumor Series Number,
Term ONCRTS/CD the Series number of images(CT,
MR) to represent tumor lesion
TUIMNUM/Tumor Image Number,
the Image Number of image(CT, MR)
to represent tumor lesion "
Create New SDTM-LOC CERVICOVAGINAL REGION

Term
Create New SDTM- ANEUTAB (Anti-Neutrophil Antibody)

Term LBTEST/CD
Other SDTM- CCODE: C38082 TESTCD FIO2 I
LBTEST/CD am wondering is this is something
measure on a subject and whether it
should indeed be a Lab Test.
Create New SDTM-UNIT Teaspoon

Term
Create New SDTM- Fibronectin

Term LBTEST/CD
Create New SDTM- h*pmol/L/(mg/kg)

Term PKUNIT
Create New Multiple COVID 19 Terminology

Term
Create New SDTM-UNIT Term = 10^7 TCID 50
Term
Create New SDTM- Test Name = Mean Annular e'

Term CVTEST/CD Velocity TESTCD = MANNEVEL
Create New SDTM- Test Name = Mean Mitral E/e Ratio

Term CVTEST/CD TESTCD = MMITRLEE
Create New SDTM-LOC PERIVESICAL REGION

Term
Create New Multiple Multiple term requests for SPEC and
Term NONNEO codelists
Create New SDTM- 3 New Terms Pls

Term EGTEST/CD
Modify SDTM- Please add synonym of 'BHB' to

Existing Term LBTEST/CD C96568/Beta-Hydroxybutyrate
Modify SDTM- This request pertains to C38082,
Existing Term LBTEST/CD LBTESTCD=FIO2. However, the
same C-code also exists on LBTEST
codelist.
Create New SDTM- 4 new ALP Activity tests please

Term LBTEST/CD
Create New SDTM-UNIT Add EP U

Term
Create New SDTM-FRM Add PUMP
Term
Create New SDTM- PK unit of h*ng/mL/(mg/cm2/day)

Term PKUNIT
Create New SDTM- SARS-CoV-2 IgG/IgM/IgA Antibody

Term MBTEST/CD
Create New SDTM- Test Name = Greater Than 14 Cont

Term RPTEST/CD Days Bleed/Spot Test Code =
CTBLDIND
Create New SDTM- Test Name = Vaginal Bleeding or

Term RPTEST/CD Spotting Test Code = VGBLDSPT
Modify SDTM- CDISC Code C135472 for Platelet

Existing Term LBTEST/CD Endothelial Adhesion Molecule 1
Create New SDTM- DRIED BLOOD SPOT COVID-19
Term SPECTYPE Request
Create New SEND- For nonclinical SEND Controlled

Term EGCATSND Terminology, please add the
following CDISC Submission Value:
ABSOLUTE VALUES to the Codelist
Name: EGCATSND
Create New SEND- For nonclinical SEND Controlled

Term EGCATSND Terminology, please add the
following CDISC Submission Value:
CHANGE FROM PRETREATMENT
to the Codelist Name:EGCATSND
Create New SDTM- Pls add LBTEST = Glucose

Term LBTEST/CD Management Indicator; LBTESTCD
= GMI This is T1D TA request.
Create New SDTM- This is a request to add a new term
Term QRSMETHOD to C158113 QSMETHOD, which isn't
new but isn't in the drop down list.
Create New SDTM- NRHDRCDN/Norhydrocodone

Term LBTEST/CD
Create New SDTM- NORXYCDN/Noroxycodone

Term LBTEST/CD
Create New SDTM- HALPRZLA/Alpha

Term LBTEST/CD Hydroxyalprazolam
Create New NEW LESION NON-LESION

Codelist
Create New ADaM-DTYPE Submission value: BASECORR
Term Pref. term: Baseline corrected value
Create New ADaM-DTYPE Submission value: LITV Preferred

Term term: Last in-trial value
Create New ADaM-DTYPE Submission value: LOTV Preferred

Term term: Last on-treatment value
Create New ADaM-DTYPE Submission value: LOQ0 Preferred

Term term: Limit of quantification result set
to zero
Create New ADaM-DTYPE Submission value: MMRM Preferred

Term term: Mixed model repeated
measures
Create New ADaM-DTYPE Submission value: ZEROIMPUTED
Term Preferred term: Zero for missing
result
Create New SDTM- Test Name: Oxygen

Term LBTEST/CD Saturation/Fraction Inspired O2 Test
Code: O2SFIO2 COVID-19 Request
Create New SDTM-FREQ Please add 3 new terms

Term
Create New CDISC- VACCINE

Term Glossary
Create New CDISC- Prevention
Term Glossary
Create New SEND- benign deciduoma

Term NEOPLASM
Modify SDTM-LOC For SKULL in the LOC codelist, add

Existing Term synonyms 'Skull Bone' and/or 'Bone,
Skull'.
Modify SDTM-LOC For BLADDER in the LOC codelist,
Existing Term add synonym 'Urinary Bladder'.
Create New SDTM- Please consider to add "Tracheal

Term SPECTYPE Aspirate" as a synonym of the term,
Endotracheal Fluid (C171504).
Create New SEND- Add new term for AUTOPHAGY,
Term NONNEO NEURON
Create New SDTM- CALFCIR

Term VSTESTCD
Create New SDTM- Calf Circumference

Term VSTEST
Create New SDTM- Multiple terms for SPECTYPE

Term SPECTYPE codelist.
Create New SDTM-UNIT Please add 6 new terms to the
Term PKUNIT codelist. The multiple term
request form was attached to an
email sent a couple of minutes ago.
Create New SEND- Add terms to the SEND NONNEO

Term NONNEO codelist (file emailed separately)
Create New SEND- GLAND, PARATHYROID C12765

Term NEOPLASM Adenoma GLAND, PARATHYROID
C12765 Carcinoma
Modify SEND- SARCOMA, UNDIFFERENTIATED,

Existing Term NONNEO MALIGNANT (C27096)
Create New SDTM-DTHDX Test Name: Source of Notification
Term Test Code: SRCNOTF
Create New SDTM-DTHDX Test Name: Death Sudden Indicator

Term Test Code: DTHSUD
Create New SDTM- Test Name = Hosp due to Preg

Term RPTEST/CD Complication Indicator Test Code =
HSPPGIND
Create New SDTM- Test Name = Infant Term Test Code
Term RPTEST/CD = INFTERM
Create New SDTM- Test Name = Number of Weeks Pre-

Term RPTEST/CD term Test Code = NMPRTWK
Modify SDTM-UNIT Deprecate "U" (C44278) and change

Existing Term the Submission Value for C75765
from "Arbitrary U" to "U"
Modify SDTM- Add synonym

Create New SDTM-UNIT Please create the following new

Term terms: UG/MMOL & NG/MMOL
Create New SDTM- Please create the following new
Term LBTEST/CD LBTEST(CD) codes: KIM1CREA
(Kidney Injury Molecule-1/Creatinine)
Create New SDTM- WITHDRAWL OF CONSENT

Term NCOMPLT
Modify QRS-PASI Changes to PASI terminology, QRS,

Existing Term needs request code.
Create New SDTM- VENTTHRE

Term RETESTCD
Create New SDTM- Ventilatory Threshold

Term RETEST
Create New SDTM- Please add a generic MDRD code for

Term LBANMET when local labs are used but they do
not specify the exact forumla details
Create New SDTM- "Test Name = Oxygen

Term VSTEST/CD Saturation/Fraction Inspired O2
TESTCD = O2SFIO2 This is a
COVID-19 related term, pls give
priority."
Create New SDTM- Test Name = Fraction of Inspired
Term VSTEST/CD Oxygen TESTCD = FIO2 This is a
COVID-19 related term, pls give
priority.
Create New SDTM- Multiple new microorganism terms

Term MICROORG being requested
Modify SDTM-LOC Submission Value: TRICUSPID
Existing Term VALVE. Add synonym, "Right
Atrioventricular Valve"
Modify SDTM-LOC Submission Value: MITRAL VALVE.
Existing Term Add synonym, "Left Atrioventricular
Valve"
Create New SDTM- MBTESTCD=SAR2IGAM
Term MBTEST/CD MBTEST=SARS-CoV-2 IgA/IgM
Antibody
Create New SDTM- New Term

Term MBTEST/CD
Create New Multiple MB team added multiple new terms

Term and made changes to existing terms
during 2020-05-28 meeting, need
request codes.
Create New Multiple 25 new terms and 15 changes to
Term existing terms that need new term
request numbers for P42 publication
Create New SDTM- STEYE
Term OETESTCD
Create New SDTM- Study Eye

Term OETEST
Create New SDTM-LOC MACULA

Term
Create New SDTM- IReST (International Reading Speed

Term METHOD Texts) Test
Create New SDTM- New term of Gravida for

Term RPTEST/CD "Reproductive System Findings Test
Code" and "Reproductive System
Findings Test Name" CDISC
codelists
Create New SDTM- PP Arterial O2/Fraction Inspired O2
Term RETEST/CD (C119293)
Create New SDTM- Partial Thromboplastin Time

Term LBTEST/CD
Modify SDTM-LOC Add 'Couinaud Segment I' as a

Existing Term CDISC Synonym for C33000 -
'LIVER, CAUDATE LOBE'
Create New SDTM-FREQ Q2D

Term
Create New SDTM- MBTESTCD=SAR2NAB
Term MBTEST/CD MBTEST=SARS-CoV-2 (COVID19)
neutralizing antibody
Modify SDTM- MR MINIMAL RESPONSE
Existing Term ONCRSR
Modify SDTM-PGTST Pharmacogenomics/Genetics

Existing Term Methods and Supporting Information
Test Name
Create New SDTM- HIV-1/2 Antigen

Term MBTEST-CD
Modify SDTM- Cell Density - CELLDENS - C120538

Existing Term OETEST/CD definition for OETEST and
OETESTCD.
Create New SDTM- total 2-methylcitrate. Synonyms: 2-

Term LBTEST/CD methylcitrate, 2-methylcitric acid
Modify Multiple QSTESTCD and QSTEST for all 4
Existing Term IPAQ questionnaires with synonyms
of IPA01, IPA02, IPA03 and IPA04
Modify SEND These are currently in the SEND

Existing Term Neoplasm neoplasm list and wanted to have a
review to see if they might be
redundant.
Modify SEND AMPHOPHILIC VACUOLAR

Existing Term Neoplasm ADENOMA This is currently in the
SEND neoplasm list and wanted to
have a review to see if it might be
redundant.
Modify SDTM- Could "Desmethyldiazepam" be

Existing Term LBTEST/CD added as Synonym for Nordazepam?
Modify Multiple Move of KFSS (CAT,
Existing Term TESTCD/TESTs) from the QS to RS
domain as a clinical classification
Create New NEW Create new MB Test Detail codelist

Codelist with 5 valid values
Modify SDTM-CCCAT Replace the existing reference in the
Existing Term HAMD 17 CCCAT from the 1967 to
1960 version
Create New SDTM-QSCAT Suggest QSCAT values were

Modify Multiple FTTESTCD and FTTEST and

Existing Term FTCAT for 10 meter walk test
Create New SEND- SARCOMA, ENDOMETRIAL
Term NEOPLASM STROMAL
Create New SEND- LEIOMYOMA, MESOVARIAL,

Term NEOPLASM BENIGN
Create New SDTM- RELAPSE

Term MHEDTTYP
Create New SDTM-LOC LOC codelist, add multiple new terms

Term for SEND use in FX domain
(FXLOC).
Create New SDTM- Adding some additional more specific

Term LBTEST/CD IgE test names/codes and some bile
acid panel test names/codes to
LBTEST/LBTESTCD.
Create New SDTM- PENICILLIN ZONE EDGE TEST
Term METHOD
Create New SDTM- PULSED-FIELD GEL

Term METHOD ELECTROPHORESIS
Create New SDTM-EVAL STAFF SUPERVISOR/LEADER

Term
Create New SDTM- "ENDOSCOPIC RETROGRADE
Term METHOD CHOLANGIOPANCREATOGRAPHY
ENDOSCOPIC ULTRASOUND
TRANSABDOMINAL
ULTRASOUND"
Create New SDTM- mg/dL

Term PKUNIT
Create New SDTM- Quick PT Activities (QKPT)
Term LBTEST/CD
Create New SDTM-UNIT Thou/mcL

Term
Create New SDTM-UNIT K/cu

Term
Create New SDTM-UNIT Mill/mcL

Term
Create New SDTM-LOC 2 new terms for Psoriasis TAUG and

Term 1 change to existing
Create New SDTM- Please add to the PROCEDUR
Term PROCEDUR codelist the term: Secondary
Electrospray Ionization High-
resolution Mass Spectrometry (SESI-
HRMS)
Create New SDTM-UNIT min*mg/mL

Term

Term LBTEST Lipo

Term LBTEST Lipocalin (NGAL)/Creatinine Ratio
Create New SDTM- Osteopontin /Creatinine Ratio

Term LBTEST
Create New SDTM- Lurasidone

Term LBTEST
Create New SDTM- Haloperidol
Term LBTEST
Create New SDTM- Quetiapine
Term LBTEST
Create New SDTM- Olanzapine
Term LBTEST
Create New SDTM- Ndesmethylolanz
Term LBTEST
Create New SDTM- Chlorpromazine

Term LBTEST
Create New SDTM- Risperidone
Term LBTEST
Create New SDTM- 9-hydroxyrisperidone
Term LBTEST
Create New SDTM- Risperidone and 9-

Term LBTEST Hydroxyrisperidone - Total
Create New SDTM- Paliperidone

Term LBTEST
Create New SDTM- Brexpiprazole
Term LBTEST
Create New SDTM- Aripiprazole
Term LBTEST
Create New SDTM- Cariprazine(CSA)
Term LBTEST
Create New SDTM- Thiothixene

Term LBTEST
Create New SDTM- Loxapine
Term LBTEST
Create New SDTM- Thioridazine
Term LBTEST
Create New SDTM- Mesoridazine
Term LBTEST
Create New SDTM- Fluphenazine
Term LBTEST
Create New SDTM- Molindone
Term LBTEST
Create New SDTM- Mesoridazine
Term LBTEST
Create New SDTM- Trifluoperazine
Term LBTEST
Create New SDTM- Prochlorperazine
Term LBTEST
Create New SDTM- Iloperidone

Term LBTEST
Create New SDTM- Asenapine
Term LBTEST
Create New SDTM- Ziprasidone
Term LBTEST
Create New SDTM- Pimozide
Term LBTEST
Create New SDTM- Perphenazine
Term LBTEST
Create New SDTM- Sonic Hedgehog
Term LBTEST
Create New Multiple Requesting multiple additions to
Term SEND MI domain including new
codes list and updates to existing
code lists related to sexual maturity
data.
Create New SDTM- h*ug/g
Term PKUNIT
Create New SDTM- Create a TSPARM value to support

Term TSPARM CONROL response codelist
Create New SDTM- Create 2 new terms for LOINC

Term TSPARM Mapping: Metanephrines and
Metanephrines Excretion Rate
Create New SDTM- Please consider adding to the

Term NCOMPLT NCOMPLT codelist a new term of
LOGISTICAL REASONS.
Create New SDTM-LOC Superior Temporal Gyrus

Term
Create New SDTM-LOC Middle Temporal Gyrus

Term
Create New SDTM-LOC Inferior Temporal Gyrus
Term
Modify SDTM- For NCI Code C81951, instead of

Existing Term LBTEST/CD "Starch Crystals Measurement",
could we rename this to "Starch
Granules Measurement"? Per
literature searches and LOINC, the
microscopic finding is always
granules instead of crystals.
Create New SDTM- Please add to the METHOD codelist

Term METHOD the new submission_value of
QUANTITATIVE METYLATION
SPECIFIC-PCR.
Create New SDTM- Please add to the METHOD codelist

Term METHOD the submission_value of:
METHYLATION SENSITIVE-
QUANTITATIVE LOCKED NUCLEIC
ACID PCR.
Modify SDTM- C154759 please consider adding

Existing Term LBTEST/CD Homoalanine as a synonym of
Alpha-Aminobutyric Aicd
Create New SDTM- "MBTESTCD=SAR2AB
Term MBTEST/CD MBTEST=SARS-CoV-2 Antibody
COVID-19 Request, give priority "
Create New SDTM- MBTESTCD=SAR2AG,
Term MBTEST/CD MBTEST=SARS-CoV-2 Antigen
COVID-19 Request, give priority
Modify SDTM- Please rename codelist to C19FATS,

Existing Term C19FAT I believe "S" is missing at the end.
Modify SDTM- Add 'Resection' as a CDISC

Existing Term PROCEDUR Synonym for 'C15232-Excision'
Modify Multiple Please correct the misspelling of

Existing Term "principal" in the CDISC Definition for
the term INVESTIGATOR (C25936),
which is found in both the CONROL
(C127257) and EVAL (C78735)
codelists.
Modify SDTM- For term C81998, Amyloid P
Existing Term LBTEST/CD Measurement, is this not also known
as serum amyloid p component?
Could we update the term to "Serum
Amyloid P Component
Measurement", or add "Serum
Amyloid P Component" as a
synonym?
Modify SDTM-LOC Modify CDISC def for C32974/Leg

Existing Term
Create New SDTM- PCNSV (Percent Change Nadir in

Term TRTESTCD Sum of Volume)
Modify Multiple C116111 (SPCIES) submission
Existing Term value update for term SARS
CORONAVIRUS (C112432)
Modify Multiple See Additional information box for

Existing Term more details
Create New SDTM-LOC PYLORUS OF THE STOMACH;

Term LESSER CURVATURE OF THE
STOMACH
Create New SDTM- PCBVML (%Change Baseline
Term TRTEST/CD Volume Measured Lesion) PCNVML
(%Change Nadir Volume Measured
Lesion)
Other Multiple Clarification regarding DENIED file

comments
Modify Multiple Please move the KPS SCALE from

Existing Term QS and move to CC
Modify Multiple Replace the QRS HAMD 17 CDISC
Existing Term definition with the original 1960
reference
Modify SEND- Possible redundancies in SEND
Existing Term NEOPLASM NEOPLASM codelist
Create New NEW QSTESTCD/QSTEST/QSCAT for

Codelist IBDQ (Quality of Life in Inflammatory
Bowel Disease Questionnaire) for
Crohn's TAUG
Create New SDTM- Multi term request spreadsheet
Term NVTEST/CD emailed
Create New Multiple Request for new CVTEST, DIR

Create New SDTM- Primary Doctor Visit; Specialty

Term HODECOD Doctor Visit; Emergency Room Visit
Create New SDTM- ROTH 28 HUE TEST

Term METHOD
Create New SDTM- FLUORESCENCE ANGIOGRAPHY
Term METHOD
Create New SDTM- Indocyanine Green Angiography

Term METHOD
Create New Multiple New terms for Crohn's TA WP1 and
Term 2
Create New Multiple New terms for Crohn's TA WP2
Term Batch 2 new terms
Create New SDTM- ARPPRZL/Aripiprazole

Term LBTEST/CD
Create New SDTM- BRXPPZL/Brexipiprazole

Term LBTEST/CD
Create New SDTM- Pls add LBTEST new terms

Term LBTEST/CD
Create New CDISC- important new term that needs to be
Term Glossary understood and well defined
Create New CDISC- frequently used in definitions but not

Term Glossary in the present Glossary
Create New SDTM- Alpha-1 Antitrypsin, Functional

Term LBTEST/CD (A1ANTRPF)
Create New CDISC- New term that is being used more
Term Glossary frequently in AI
Create New SDTM- MOST RECENT EPISODE

Term MHEDTTYP
Create New SDTM- HOME, NURSING CARE

Term DISCHDX
Create New SDTM- LONG TERM NURSING CARE

Term DISCHDX FACILITY
Create New SDTM- NON-HOSPITAL INTERMEDIATE

Term DISCHDX CARE FACILITY
Create New SDTM- REHABILITATION FACILITY

Term DISCHDX
Create New SDTM-LOC Please add the term UPPER BACK

Term to the LOC (Anatomical Location)
codelist.
Create New SDTM- Please add a new term SKIN
Term PROCEDUR SUCTION BLISTER to the
PROCEDUR codelist.
Other SDTM- Question regarding CDISC

ONCRSR Submission Values of: MINIMAL
RESPONSE (C158264) compared to
MR (C123598)
Modify SDTM- Deprecate the SDTM Species

Existing Term SPCIES codelist and it 118 values.
Create New SDTM- PKMARMCD: QRCPCLSTI

Term PKPARM/CD PKPARM: Pct Rec to Last Measured
Interval
Create New SEND-SPEC MUSCLE, ZYGOMATICUS

Term
Create New SDTM- Phospholipase A2
Term LBTEST/CD
Modify SDTM- SS domain abbreviation (C117655)

Existing Term DOMAIN be updated
Create New ADaM-DTYPE Please add a new code for DTYPE

Term of LVWI
Create New SEND- PITUICYTOMA, MALIGNANT

Term NEOPLASM
Create New SDTM-LOC FAUCES

Term
Modify SEND- "C81854 C88025 Neoplasm Type
Existing Term NEOPLASM LEIOMYOBLASTOMA, BENIGN
C81855 C88025 Neoplasm Type
LEIOMYOBLASTOMA,
MALIGNANT"
Modify Multiple FTTESTCD/FTTEST for 4-Stair

Existing Term Ascend and 4-Stair Descend and
Rise From Floor
Modify SDTM- Pls deprecate C161328/Threshold

Existing Term DOTEST/CD Cycle
Modify CDISC- remote clinical trial

Create New CDISC- Virtual (as an aspect of a clinical trial

Term Glossary or study)
Create New CDISC- decentralized clinical trial (DCT)
Term Glossary
Modify SDTM-TTYPE THOROUGH QT

Existing Term
Create New SDTM- Date of Last Sexual Intercourse Test

Term RPTEST/CD Code: LSXICDTC
Create New SDTM- Test Name: Total Number of Sexual

Term RPTEST/CD Partners Test Code: TOTPART
Create New SDTM- Test Name: Condom Use Indicator

Term RPTEST/CD Test Code: CNDMIND
Create New Multiple Request to add new terms to LOC,
Term METHOD and PROCEDUR Codelist.
Create New SEND-STCAT There are no categories that align

Term with the SSTYP values that were
added for Animal Rule studies
Create New SDTM-UNIT Please add m% to the UNIT codelist.
Term
Create New SDTM-LOC Please add to the Anatomical

Term Location (LOC) the new term of
PANCREAS, NECK.
Create New MSTEST/CD MSTESTCD/MSTEST request for

Term new MSTESTCDs and MSTERMs.
Create New SDTM-LOC FACIAL MUSCLE
Term
Create New SDTM-UNIT rad/s

Term
Create New SDTM-LOC Please add the term SKIN OF THE

Term UPPER BACK to the LOC
(Anatomical Location) Codelist.
Create New SDTM-LOC Please add SKIN OF THE INNER

Term FOREARM to the LOC (Anatomical
Location) codelist.
Create New SDTM-LOC Please add the new term INNER

Term FOREARM or FOREARM, INNER to
the LOC (Anatomical Location)
codelist.
Create New SDTM- As Variables for supplemental
Term TRTSET qualifiers: TRSENUM/Tumor Series
Number: Series number of
images(CT, MR) to represent tumor
lesion TRIMNUM/Tumor Image
Number: Image Number of
image(CT, MR) to represent tumor
lesion
Create New CDISC- necessary terms references.

Term Glossary wikipedia deep learning machine
learning
Create New Multiple Multiple term request to get request

Term codes for P43 terminology prior to
publication.
Create New SDTM- RETROGRADE PYELOGRAM
Term METHOD
Create New SDTM- Cytogenetic result

Term LBTEST/CD
Create New Multiple CCTESTCD/CCTEST/CCCAT for

Codelist SES-CD
Create New Multiple CCTESTCD/CCTEST/CCCAT for
Codelist CDAI instrument
Create New SDTM- Please add IMPRESSION
Term CLMETH CYTOLOGY & SUPERFICIAL
KERATECTOMY to CLMETH
Create New SDTM- New submission value of

Term DOMAIN "RELSPEC" in the SDTM Domain
Abbreviation codelist with a CDISC
Synonym = "Related Specimens"
and definition "A dataset used to
represent relationships between
specimens."
Create New Multiple Request to add new terms to LOC,
Term GENRTYP,METHOD,RACEC,UNIT,
SPECTYPE
Create New SDTM- ng/mg ug/mg

Term PKUDMG
Create New SDTM- Pleural Fluid mapping from EVS
Term SPECTYPE editors
Create New SDTM- HGFR / Hepatocyte Growth Factor

Term MITEST Receptor
Create New SDTM- Please consider to add "Study Data

Term FDATSRS Technical Conformance Guide
v4.5.1"
Other SDTM- MEASIND
TUTESTCD
Create New SDTM- ONCRSCAT = IWC HALLEK CLL
Term ONCRSCAT 2018
Create New SDTM- IOPI testing used in our trials and

Term MUSCTSCD therefore terminology is needed for
mapping this data to SDTM.
Create New SDTM- ONCRSCAT = DIMOPOULOS

Term ONCRSCAT WALDENSTROMS
MACROGLOBULINEMIA 2018
Create New SDTM- SS domain

Term DOMAIN
Modify Multiple Move of DRS (CAT,
Existing Term TESTCD/TESTs) from the QS to RS
domain as a clinical classification
Create New New From NSV registry team: Create a

Codelist codelist to support the COLSRT and
COLSDT NSVs published in the
T1D: Pediatrics and Devices.
COLSDT: Collected Summary Dose
Type COLSRT: Collected Summary
Response Type
Create New Multiple New MITS-CD and MIFTSDTL
Term terminolgoy to support Crohn's
Disase WP2 Histopathology test for
GHAS and RHI.
Create New DefineXML- Dataset name: ADDL. Dataset

Term GNRLOBSC Description: Device-Level Analysis
Dataset.it is one record per device
(optional: per subject). Class of
Dataset: DEVICE LEVEL ANALYSIS
DATASET
Create New SDTM-UNIT Please create the following units:

Term 10^9 cells 10^5 CFU/mL 10^7
CFU/mL
Create New SDTM-FRM Please add VAGINAL RING to the

Term FRM (Formulation) codelist.
Create New SDTM-FRM Please add CAPSULE FOR
Term INHALATION to the FRM
(Formulation) codelist.
Create New SDTM-FRM Please add add DRY POWDER

Term SUSPENSION to the FRM
Create New SDTM-FRM Please add READY TO USE

Term SUSPENSION to the FRM
(Formulation) codelist
Create New SDTM-FRM Please add TABLET, ROLLER

Term COMPACTION to the FRM
Create New SDTM-FRM Please add TABLET, HIGH SHEAR
Term GRANULATION to the FRM
Create New SDTM- Please add SUBDURAL to the

Term ROUTE ROUTE codelist.
Create New SDTM-TTYPE Please add BASELINE

Term INVESTIGATION to the TTYPE (Trial
Type Response) codelist
Create New SDTM-TTYPE Please add DEVICE FEASIBILITY to
Term the TTYPE (Trial Type Response)
codelist
Create New SDTM- Please add GARGLE to the ROUTE

Term ROUTE codelist.
Create New SDTM- HODECOD = HEALTHCARE VISIT

Term HODECOD
Create New SDTM- HODECOD = DIETARY

Term HODECOD SPECIALIST VISIT
Create New SDTM- HODECOD = MENTAL HEALTH

Term HODECOD SPECIALIST VISIT
Create New SDTM- Employment Status

Term SCTEST/CD
Create New New Requesting the creation of a new
Codelist codelist for the TCNTRL Parameter
Code. This request links to JIRA:
SEND-408
Create New Multiple CDASH SAE terminology
Term
Modify SDTM- "Interleukin 12 Beta; Interleukin 12

Existing Term LBTESTCD p40; Interleukin 23 p40" and for
definition, "A measurement of the
interleukin 12 beta and/or interleukin
23 p40 in a biological specimen."
Create New SDTM-RACE RACE value ?MULTIPLE?, ?

Term OTHER? described in CDISC IG to
support multiple RACEs, but are not
available in CT yet
Modify SDTM- PROC6 C165979
Create New None NE as a valid Oncology Response

Term Assessment Result for ONCRTSCD
= METBRESP
Create New SDTM- HOME, NURSING CARE; LONG
Term DISCHDX TERM NURSING CARE FACILITY;
NON-HOSPITAL INTERMEDIATE
CARE FACILITY; REHABILITATION
FACILITY
Create New SDTM- Growth Differentiation Factor 15

Term LBTEST
Create New SDTM- Supression of Tumorigenicity 2
Term LBTEST
Create New SDTM- MACROFLOCCULATION

Term METHOD MICROFLOCCULATION
Create New SDTM- MMARG (Monomethylarginine )
Term METHOD
Create New PKUNIT SEND and SDTM PK Unit for Urine

Term Percent Recovered when the dose
administered is normalized (by body
weight).
Modify SDTM- Please correct Submission Value for

Existing Term METHOD C154790 (SECONDARY ION MASS
SPECTOMETRY) to SECONDARY
ION MASS SPECTROMETRY
Create New SDTM- 2 new METHOD terms for

Term METHOD consideration
Create New SDTM- BEFORE OR COINCIDENT or
Term STENRF COINCIDENT OR AFTER should be
added
Create New SDTM- Muscle Strength, Abduction

Term MUSCTS
Create New SDTM- Muscle Strength, Dorsiflexion

Term MUSCTS
Create New SDTM- Add additional values to CTAUGRS;
Term CTAUGRS based on recent publications.
Create New SDTM- Add "Interim User Guide for COVID-

Term CTAUGRS 19 v1.0"
Create New SDTM- OETEST = Corrective Lens for
Term OETEST Distance OETESCD = CRRLNDST
Create New SDTM- PINHOLE OCCLUDER

Term METHOD
Create New SDTM- OETESCD = INTP

Term OETEST
Create New SDTM- Please add WALLACE RULE OF

Term METHOD NINES to the METHOD codelist.
Modify SDTM- SV in SDTM Domain Abbreviations
Existing Term DOMAIN codelist. The domain is changing,
and proposed new definition is "An
events domain that contains
information for each subject's actual
and planned visits and contact
events."
Other SDTM-RACE Change the codelist from non-

extensible to extensible
Create New SDTM- LEGLNGTH

Term VSTESTCD
Create New SDTM- Leg Length

Term VSTESTCD
Create New Multiple 38 new terms to support

Term SDMTIGv3.4
Create New SEND-SPEC Please add the following Specimen

Term to the SEND Specimen Codelist:
ILEOCOLOCAECAL AREA
Create New SDTM- 1. NOT SUSCEPTIBLE 2.
Term MSRESCAT SUSCEPTIBLE, INCREASED
EXPOSURE 3. AREA OF
TECHNICAL UNCERTAINTY
Create New CDISC- Phase IIB C49688

Term Glossary
Create New SDTM- MBTEST=SARS-CoV-2 Antigen
Term MBTEST/CD MBTESTCD=SAR2AG Definition=A
measurement of the SARS-CoV-2
Antigen in a biological specimen.
Create New Multiple Add 1 TESTCD and TEST to AJCC

Term V7 for Residual Tumor
Create New Multiple RSCAT, RSTESTCD, RSTEST for
Term Crohn's Disease Activity Index
(CDAI)
Create New SDTM- MRECIST ARMATO
Term ONCRSCAT MESOTHELIOMA 2018
Create New SDTM- itRECIST

Term ONCRSCAT
Create New SDTM-LOC Please add to the Anatomical

Term Location (LOC) codelist the new term
PROXIMAL INTERPHALANGEAL
JOINT 1 OF THE HAND. There are
already entries for 2 - 5, but 1 is
missing.
Create New SDTM- SUVMAX

Term TRTESTCD
Create New New PET Score X / PET Score 1 / PET
Term Score 2 / PET Score 3 / PET Score 4
/ PET Score5.
Create New SDTM- Endurance

Term MUSCTS
Create New SDTM- SARS coronavirus 2 stimulated
Term MBTESTCD gamma interferon
Create New SDTM- SARS coronavirus 2 stimulated
Term MBTESTCD gamma interferon release by T-cells
Create New SDTM- SARS coronavirus 2 specific TCRB

Term MBTESTCD gene rearrangements
Create New SEND-SPEC SMALL INTESTINE, JEJUNOILEUM

Term
Create New CDISC- Early Termination of Trial; Premature
Term Glossary Termination of Trial
Modify CDISC- termination (of trial)

Create New SDTM-LOC OBTURATOR LYMPH NODE;

Term CARDIOPHRENIC LYMPH NODE
Create New SEND- NTac:SD-Bdkrb2em5717(Y143S)Tac

Term STRAIN P301S heterozygous hTau mice
Create New SDTM-UNIT Please add 10^3/uL to Unit codelist.

Term
Create New SDTM- File with name
Term EGTEST ECG_Jozef_Aerts_CDISC_Multi_Ter
m_Request_2020-10-30.xls mailed
separately
Modify SDTM- We are requesting changing of

Existing Term PKUNIT C85624 from 'h*ng/mL' to 'ng*h/mL'
since our proposal reflects the
common way of presenting the AUC
instead of existing term. We will
email references in a separate file
Create New SDTM- hyperchromic Erythrocytes /

Term LBTESTCD Erythrocytes
Create New SDTM- Hypochromic Erythrocytes /

Term LBTESTCD Erythrocytes
Create New SDTM- AJCC V8 is the new term requested

Term ONCRSCAT to add to the ONCRSCAT codelist.
Create New SDTM- Please add new term MRECIST
Term ONCRSCAT TSAO MESOTHELIOMA 2011 to the
ONCRSCAT codelist.
Create New SDTM- Please add the new term SIOPEN

Term ONCRSCAT MIBG SCORE FOR
NEUROBLASTOMA - LEWINGTON
2017 to the ONCRSCAT codelist
Create New SDTM- Please add the new term CURIE

Term ONCRSCAT MIBG SCORE FOR
NEUROBLASTOMA - ADY 1995 to
the ONCRSCAT codelist.
Create New SDTM- Please add the new term OWEN
Term ONCRSCAT WALDESTROM
MACROGLOBULINEMIA 2013 to the
ONCRSCAT codelist.
Create New SDTM- Please add the new term CANCER

Term ONCRSCAT RECURRENCE to the ONCRSCAT
codelist.
Create New SDTM- Please add the new term

Term ONCRSCAT INTERNATIONAL THYMIC
MALIGNANCY INTEREST GROUP
to the ONCRSCAT codelist.
Create New SDTM- Please add the new term DOHNER

Term ONCRSCAT ELN AML 2017 to the ONCRSCAT
codelist.
Modify SEND-SPEC Change c-code of NERVE ROOT
Existing Term from C54024 to C12791.
Modify SEND-SPEC Forestomach (Code C77956) and

Existing Term Nonglandular Stomach (Code
C77662)
Modify SDTM- Change EPIDEMIC to EPDEMIC

Existing Term TSPARMCD
Modify SDTM- RPTESTCD: PREGOUT RPTEST:
Existing Term RPTEST Pregnancy Outcome
Create New Define-XML At ADaM Structure Group, we

Term request adding BDS(MEDICAL
DEVICE) for Medical Device
analysis. Abbreviation BDSMD.
Term request adding OCCDS(MEDICAL
DEVICE) for Medical Device
analysis. Abbreviation OCCDSMD.
Term request adding BDS(MEDICAL
DEVICE, TIME-TO-EVENT) for
Medical Device analysis.
Abbreviation BDSTTEMD.
Modify SDTM- C171439 - Severe Acute Respiratory
Existing Term MBTEST Syndrome Coronavirus 2 Antibody
Measurement
Create New SDTM- Request to add a new term of

Term TUIDRS ABSENT to the TUIDRS codelist
Create New SDTM- Request to add new term of

Term TUIDRS PRESENT to TUIDRS codelist
Create New SDTM- Request to add a new term of
Term TUIDRS EXTRAMEDULLARY DISEASE to
the TUIDRS codelist .
Create New SDTM-UNIT Request to add a new term of

Term %min/h to the UNIT codelist
Create New SDTM- SEND-PKPARM / SEND-

Term PKPARM PKPARMCD
Create New SDTM- Valproic Acid

Term LBTEST
Create New SDTM- Arm Span
Term VSTEST
Create New SDTM- Multiple

Term MBTEST
Create New Multiple PanCan TAUG Batch 1 Terminology
Term
Create New NEW Revive the FATEST/FATESTCD

Codelist codelists and include all terms from
TA-specific FA codelists
Create New SDTM- Cast Type (CSTYPE) and Crystal
Term LBTEST/CD Type (CYTYPE)
Create New SDTM- Add new terms to MICROORG and

Term MICROORG add SYs to existing MICROORG
terms
Create New SDTM-UNIT Cells per Microliter (Code C67242)
Term
Create New SDTM- Magnetoencephalography

Term METHOD
Create New SDTM- Hexosaminidase A

Term LBTEST/CD
Create New Multiple Here is the multiple term request file
Term for all approved P44 terminology that
does not have a request code
associated with this. It contains 76
new terms and 93 changes to
existing. No need for Craig to add
these into the team working docs.
Create New NEW New Codelist for Standardized Term

Codelist for Protocol Deviations to populate
DVDECOD
Create New SDTM- Reactogenicity Event Type

Term VNFATS
Create New SDTM- REACTYP

Term VNFATSCD
Create New Multiple Need request code for QRS
Term instruments: NSCLC-SAQ and
SMDDS V1 which will be published
in P44
Create New SDTM- ZNT8AB (Zinc Transporter 8
Term LBTEST/CD Antibody)
Create New SDTM-LOC VESICOURETERIC JUNCTION

Term
Create New SDTM- NAFLD Activity Score (and

Term MITEST-CD components thereof) from Kleiner et
al 2005 Hepatology (PMID15915461)
Create New Multiple SEND PKPARM/PKPARMCD SEND
Term PKUNIT
Create New SDTM-LOC CDISC Submission Value = TIBIAL

Term GROWTH PLATE
Create New SDTM- Gauge Size

Term VNFATS/CD
Create New SDTM- NGAUGESZ

Term VNFATS/CD
Create New SDTM- Physical Examination
Term VNFATS/CD
Create New SDTM- PHYSEXAM

Term VNFATS/CD
Create New SDTM- Finding

Term VNFATS/CD
Create New SDTM- FINDING
Term VNFATS/CD
Create New SDTM- Observation Result

Term VNFATS/CD
Create New SDTM- OBSR

Term VNFATS/CD
Create New SDTM- Sign and Symptom

Term VNFATS/CD
Create New SDTM- SIGNSYMP

Term VNFATS/CD
Create New SDTM- Swelling Description
Term VNFATS/CD
Create New SDTM- SWELDESC

Term VNFATS/CD
Create New SDTM- Joint Location

Term VNFATS/CD
Create New SDTM- JOINTLOC
Term VNFATS/CD
Create New SDTM- Prevents Daily Activities

Term VNFATS/CD
Create New SDTM- DAILYACT

Term VNFATS/CD
Create New SDTM- Specify

Term VNFATS/CD
Create New SDTM- SPECIFY

Term VNFATS/CD
Create New SDTM- Dengue Serotype

Term VNFATS/CD
Create New SDTM- DENSEROT
Term VNFATS/CD
Create New SDTM- Dengue Severity Indicator

Term VNFATS/CD
Create New SDTM- DESEVIND

Term VNFATS/CD
Create New SDTM- Dengue Severity Grade

Term VNFATS/CD
Create New SDTM- DENSEVGR
Term VNFATS/CD
Create New SDTM- Bleeding Spontaneous Indicator

Term VNFATS/CD
Create New SDTM- FABLSYN

Term VNFATS/CD
Create New SDTM- Other Severe Visceral Manifestation

Term VNFATS/CD
Create New SDTM- OTHSVM
Term VNFATS/CD
Create New SDTM- Circumference

Term VNFATS/CD
Create New SDTM- CIRCUMF

Term VNFATS/CD
Create New SDTM- Pregnancy Week of Vaccination

Term VNFATS/CD
Create New SDTM- PREGWEEK
Term VNFATS/CD
Modify SDTM- fluorescein angiography is the

Existing Term METHOD recognized term by our ophthalmic
imaging vendors.
Create New SDTM- New FATEST request from Crohn's
Term CRFATS-CD Disease TA
Create New Multiple New terms needed for codelist

Term MUSCTS/MUSCTSCD.
Create New SEND- BIFOCAL

Term DSTRBN
Create New NEW Please create controlled terminology
Codelist for Cumulative Illness Rating Scale -
Geriatrics (CCCAT and new CIRSG
C and CIRSG N codelists) and
FACT-BP V4 (QSCAT and new
FAC074 C and T codelists). for QRS.
Modify Multiple See MIFTSDTL: AJCC GRADE and

Existing Term AJCCGRD codelist responses.
Create New SDTM- NEW lab terms

Term LBTEST
Create New SDTM- Please add the new term of
Term PROCEDUR EXTRACORPOREAL CYTOKINE
ADSORBER to the PROCEDUR
codelist.
Change
Type
Please add LEA CHART to the METHOD II Do not add (P45):

codelist. The definition is: The non-translucent Request withdrawn by
Lea Symbols Chart #250250 is the original folding requester.
distance chart for preschool and kindergarten
children and for assessment of vision of persons
with difficulties in testing based on letters or
numbers.
A unit of volume measurement of a cubic II Do not add (P44): Do

structure measured in millimeters on all three not add. Please use
dimensions C48153 with submission
value 'uL' (mm3 is listed
as a synonym).
Change CDISC submission value and definition II SEND-Published in P42

for C80605. It should be 'Phoxim', not 'Phoxin'.
CDISC submission value should read: II Do not add (P43): Do

mL/sec/m2 to be consistent with other similar not add. There are use
units. cases in which this unit
Also I suggest updating the definition to include of measure may be
""body surface area"" (similar to C105505): used for things other
A metric unit of volumetric flow rate defined as than body surface
the rate at which one milliliter of matter travels areas, (measuring on a
during the period of time equal to one second per tissue sample in the lab)
meter squared of body surface area. therefore we'd like to
keep the definition
generic enough to be
C85492 - RULER II SDTM-Published in P41,
used for all purposes.
C81184 - CALIPER P44
We also instantiated a
C17648 - MULTIPLE rule in which we will use
File emailed separately 's' going forward for all
This non-clinical TSPARM is in the FDA sdTCG II new units
SDTM, of measure
SEND-Published
for clinical studies so needs to be added to the containing
in P42 'seconds'.
clinical TSPARM-CD codelist. Review existing We will not go back and
definition, may need to be expanded for clinical change older
usage. submission values that
use 'sec' because we
know this affects
backward compatibility.
We will however add a
synonym of 'mL/sec/m2'
to help with mapping.
AUTO-REFRACTION, II SDTM-Published in P42,
CT SCAN SPIRAL WITH CONTRAST, P44
CT SCAN SPIRAL WITHOUT CONTRAST, Do not add (P42):
CT SCAN WITH CONTRAST, CT SCAN WITH
CT SCAN WITH IV CONTRAST, CONTRAST-Do not
CT SCAN WITH ORAL AND IV CONTRAST, add. Please use existing
CT SCAN WITH ORAL CONTRAST, term CONTRAST
FDG-PET, ENHANCED CT
FIBROSCAN, SCAN/C137805. We will
FIBROTEST, add this request as a
FLT-PET, synonym to existing
GENETIC SEQUENCING term.
CT SCAN WITH IV
CONTRAST-Do not
term CONTRAST
ENHANCED CT
SCAN/C137805. The
method of administration
of the contrast agent
would be capture in
AGROUTE variable.
CT SCAN WITH ORAL
AND IV CONTRAST-Do
not add. Please use
existing term
CONTRAST
ENHANCED CT
SCAN/C137805. The
method of administration
of the contrast agent
would be capture in
AGROUTE variable.
CT SCAN WITH ORAL
CONTRAST-Do not
term CONTRAST
NEVER DOSED, II SDTM-Published in P42
REQUIRES PROHIBITED MEDICATION, Do not add (P42):
SUBJECT REFUSED FURTHER DOSING (NOT REQUIRES
DUE TO AE), PROHIBITED
COMMERCIAL DRUG IS AVAILABLE FOR MEDICATION-Do not
SUBJECT add. This value should
go into DSTERM only
and requester should
use either published
term SCREEN
FAILURE, PROTOCOL
DEVIATION, or
PROTOCOL
VIOLATION as the
DSDECOD (dependent
upon when within the
trial the prohibited
medication was taken).
SUBJECT REFUSED
FURTHER DOSING
(NOT DUE TO AE)-Do
not add. Team
recommends using
existing term 'NON-
COMPLIANCE WITH
STUDY DRUG' as the
DSDECOD value and
putting the requested
term into DSTERM.
FET Forced Expiratory Time II SDTM-Published in P43

FEV075 Forced Expiratory Volume in 0.75
Seconds
FRCMN Mean Functional Residual Capacity
LCI25 LCI to 1/20th Initial Concentration
LCI25MN Mean LCI to 1/40th Initial
Concentration
LCI5 LCI to 1/40th Initial Concentration
LCI5MN Mean LCI to 1/20th Initial Concentration
synonym is incorrect file emailed separately II SDTM-Published in P41
Add four new PK Analysis Method terms II SDTM-Published in P42
Need to have for dose normalized PK variables, II SDTM, SEND-Published

units using the surface area of cm2 for non- in P42
clinical studies.
26 New terms from the T1D TA team; File II SDTM-Published in P42,
emailed separately P43
LBTESTCD = ALTAST, LBTEST = Alanine II SDTM, SEND-Published

Aminotransferase to Aspartate Aminotransferase in P44
Ratio Measurement (Code C106498) already
exists. We need also ASTALT since this type of
data is also calculated.
Problem: A study will be conducted to evaluate II

the nerves of the tail in rat. In the scientific
literature, the anatomic detail and nomenclature
for the nerves of the tail is often lacking and/or
confusing, but recent publications, including the
Nomina Anatomical Veterinaria have defined the
nomenclature as Dorsal Caudal Nerve Plexus
and Ventral Caudal Nerve Plexus.
Recommendation:
CDISC Submission Value: NERVE, CAUDAL
PLEXUS CDISC Definition: A nerve network
originating from the spinal nerves in the sacral
and caudal vertebrae and giving rise to multiple
nerves that innervate the tail.
Additional information for justification emailed
separately.
6 new terms and 1 change to existing for the II SEND-Published in P43,

SEND NONNEO codelist. This is to support P44
updates made by the CNS publication by Do not add (P42): Do
INHAND. File emailed separately not change. While
SEND rules do dictate
that noun forms of PTs
are preferrable, we don't
think that the change in
submission value is
worth it. We also agree
not to change
submission values of
C161569 and C161539.
January 1, 2018 is the new implementation date II SDTM-Published in P42,
of the AJCC 8th Edition for cancer data collection. P43
However, the codelists for this edition are not
present in the CDISC SDTM CT 20191220. It is
only referenced in the CDISC Definition column
for 'MID-JUGULAR LYMPH NODE' (C132511)
and 'LOWER JUGULAR LYMPH NODE'
(C132512) in Anatomical Location (C74456). Will
codelists/values for this AJCC Edition be added
to the CDISC SDTM CT?
Pls add Enterovirus and Rotavirus to MBTEST. II SDTM-Published in P42

This is a TA request from T1D.
This is a request for a generic hallucinogen test. II SDTM, SEND-Published

Propose LBTESTCD=HALLUC in P44
LBTEST=Hallucinogen
Definition: A measurement of any hallucinogenic
class drug present in a biological specimen.
Pls add new term. File emailed separately II SDTM-Published in P42,

P43
not add. Morphologically
an instrument or human
cannot tell these apart.
Instead the difference in
terminology is based on
the therapeutic
indication of the trial,
being that oncology
trials tend to use
Terms was included in 2011 Glossary version II Glossary-Published in
'Atypical' whereas other
with no source. P44
trials tend to use
Any actions or effects of a drug or treatment other
than the intended effect. In FDA sources a side 'Reactive'. This
effect is considered synonymous with an distinction in terminology
is not based on a
unwanted effect, adverse event or adverse drug
morphological distinction
reaction https://www.fda.gov/drugs/drug-
that can be made by
information-consumers/finding-and-learning-
man or instrument, it is
about-side-effects-adverse-reactions
based solely on the
https://www.nhs.uk/common-health-questions/
clinical indication in the
medicines/what-are-side-effects/
protocol itself. Therefore
Side effects are unwanted symptoms caused by
CDISC will not split
medical treatment.
these values apart. The
But side effects can be positive, theoretically
sponsor is welcome to
submit 'Reactive' or
'Variant' type terms as
additional, extensible
sponsor defined
terminology if the
sponsor chooses to
make the distinction.
CSYSBP Central Systolic Blood Pressure II
(mmHg)
CDIABP Central Diastolic Blood Pressure
(mmHg)
CPULSEPR Central Pulse Pressure (mmHg)
CAUGPR Central Augmentation Pressure
(mmHg)
CAUGIX Central Augmentation Index (%)
PPULSEPR Peripheral Pulse Pressure (mmHg)
CRFMDIST Carotid to Femoral Distance (mm)
NTCRDIST Notch to Carotid Distance (mm)
NTFMDIST Notch to Femoral Distance (mm)
ARTMREF Aortic Time to Reflection (ms)
Units just FYI.
Pulse wave analysis (PWA) is a reproducible,

noninvasive method for assessing central blood
pressure and augmentation index (AIx, a
measure of the contribution that wave reflection
makes to the arterial pressure waveform). The
amplitude and timing of the reflected wave
ultimately depends on the stiffness of the small
(pre-resistance) vessels and large arteries, and
thus, AIx provides a measure of systemic arterial
stiffness.
Screenshots of the measurements were sent to

Erin and Jordan on 3rd Dec 2019.
This request is also associated with the request
on 11th Dec 2019 to add MAP, HR & PULSEPR
to CVTEST(CD) as part of this analysis.
1. C127403 EPIC2-Problem Pain/Burning W/ II SDTM-Published in P41

Urination, change W/ to w/
2. remove the spaces after "w/ " in C161724,
C161712 and C127403.
Please add this list of dog Breed terms to the II Do not add (P46): Do
STRAIN codelist (or create a new codelist if you not add. The context
think that is warranted). presented by the
requester is for clinical
Also, please create a code table mapping file studies in dogs, which
between the SPECIES value for dog and these SEND nor SDTM is
dog breed terms. scoped to support right
now. Additionally, the
This set of dog breeds was created by Lyuba for STRAIN variable is not
the CRDC canine node (ICDC). for use in SDTM and
this codelist is only for
SEND use. The team
would re-consider this
request in future if
modeling and scope
changes.
Need request codes for the approved II SDTM-Published in P42
MICROORG terms.
CDISC Synonym(s) are same for these 2 codes. II SDTM-Published in P42
Please check and correct.
Please delete the synonym "Homocitrulline" for II

C154759 = AAMBTAC since a separate value for
Homocitrulline already exisit with code C154758
CAPSULE; DROP II Do not add (P44):

CAPSULE/C48480,
which is already in the
codelist.
DROP/C69441, which is
already in the codelist.
File emailed separately. II Do not add (P45): Do

We would like you to consider our proposal to not add. List is
create SDTM controlled terminology for the extensible. Team will not
DVCAT and DVDECOD data. control non-specific
Due to the lack of CDISC codelists , our SDTM values such as OTHER.
partners and CROs are not standardising the
DVCAT and DVDECOD terms. This causes us
problems when we assimilate studies across
providers for submission purposes.
We feel it is a good time to try to standardize
these terminology and the GSK team has taken
existing sponsor terms and the experience of
SMEs to draft a list we would like you to review.
I have added a new tab to store codelist 2 and in
that tab Iâ€™ve also added a new column which
gives our suggestions for the DVDECOD -
DVCAT relationship.
Iâ€™m sure there will be questions! So can I

please ask you to include Bruce Chambers on
any emails as he is facilitating this team.
Definition: The removal of tissue specimens from II SDTM-Published in P44

the living body using a surgical technique.
Dosing unit needed for EXDOSU and TRTDOSU II SDTM, SEND-Published
to match presented in the protocol. in P44
Proposed definition: A unit expressed in
milligrams per milliliter per period of time equal to
twenty-four hours.
This already exists in NCI CT, with code C12278, II SDTM, SEND-Published
but is not in the CDISC CT list. Will be using in in P43
an SDTM RE domain for the location associated
with results of nasal endoscopy.
I am unsure as to the full definition of this II SDTM, SEND-Published

anatomical location; I have found the description: in P43
The ostiomeatal complex (OMC) or ostiomeatal
unit (OMU), sometimes less correctly spelled as
osteomeatal complex, is a common channel that
links the frontal sinus, anterior ethmoid air cells
and the maxillary sinus to the middle meatus,
allowing airflow and mucociliary drainage.
at https://radiopaedia.org/articles/ostiomeatal-
complex?lang=us
Will be using in an SDTM RE domain for the
location associated with results of nasal
endoscopy.
Total Cholic Acid is a measurement of a specific II Do not add (P44): Do

type of bile acid in a biological specimen. not add. Please use
CHOLATE/C172499,
which was published in
P42.
Total Chenodeoxycholic Acid is a measurement II Do not add (P44): Do
of a specific type of bile acid in a biological not add. Please use
specimen. CDCA/C172498, which
was published in P42.
Total Chenodeoxycholic Acid is a measurement II Do not add (P44): Do
of a specific type of bile acid in a biological not add. Please use
specimen. DCA/C172500, which
was published in P42.
Total Ursodeoxycholic Acid is a measurement of II SDTM, SEND-Published
a specific type of bile acid in a biological in P44.
specimen.
Neutrophil Gelatinase - associated Lipocalin II SDTM, SEND-Published

(NGAL) is a measurement in a biological in P44.
specimen; new marker of kidney disease. Do not add (P44): Do
not add. This is a
synonym of Lipocalin-2.
We will add as a
synonym instead.
A codelist for Trial Design CURTRT which allows II Do not add (P43): Do
"Standard of care" when the protocol is not not add. As per the FDA
specific on a shortlist of allowable treatment data standards catalog,
regimes or that the subject should continue their the FDA requires UNIIs
existing (protocol unspecified) treatment. for response values for
Under the TS Model Current Treatment has to be this TSPARM. Therefore
specified for a therapy that is in addition to a we don't think that this
subjects existing treatment (ADDON=Y) yet not term would be
all protocols need to have a prescriptive shortlist appropriate to put out as
of allowable existing treatments. In this instance a standard term for
the existing regime which a subject follows or that people to use. It could
which is suitable for the subject should be be considered a
maintained throughout the study. sponsor-defined term
with explanation for why
its been used, instead of
a UNII, logged in the
SDRG.
Please add to the LAT codelist the submission II Do not add (P43): Do
value of MIDLINE. The definition is: A medial not add. This value is
line, especially the medial line or plane of the present in the DIR
body. midline (?m?d?la?n) n a line situated in the codelist which supports
middle of something, esp an imaginary line that the --DIR variable.
divides an organism or organ into symmetrical Please use the --DIR
parts mid?line (?m?d?la?n) n. a median plane, variable instead of --LAT
esp. of the body or a body part. for this value.
File emailed separately. II SEND-Published in P43

On behalf of Repro Team to include localization Do not ad (P43):
of finding for descriptive findings. ABSENT ANUS- Do not
This list covers fetal pathology external and add. Synonymous with
maternal-fetal gross observation findings. existing term C84784.
See change the
existing.
ABSENT DIGIT- Do not
This is required to store the position used to II SDTM,
conceptSEND-Published
of ABSENT with
administer Gluteal IM injections. This would be in P43
RESLOC filled in.
used if the injection was given to a subject who is ABSENT HEAD- Do not
leaning over a chair or desk. add. Please use existing
concept of ABSENT with
Other codes used are: RESLOC filled in.
Lying face down (PRONE) ABSENT JAW,
Lying on side (LATERAL DECUBITUS) MANDIBLE- Do not add.
Standing (STANDING) Please use existing
RESLOC filled in.
ABSENT LIMB- Do not
RESLOC filled in.
ABSENT MOUTH- Do
not add. Please use
existing concept of
ABSENT with RESLOC
filled in.
ABSENT PAW- Do not
RESLOC filled in.
ABSENT PINNA- Do not
Code C85754 is implemented having the II
submission value = pmol/g for codelists C71620
(UNIT) whereas it is implemented as nmol/kg for
code lists C84494 and C128683.
NCI preferred term in all three cases = Nanomole
per Kilogram.
It is confusing that different submission values
are used for the same code. We see no reason
for this difference.
Please update UNIT codelist C71620, term
C85754, submission value to align with the other
code lists: nmol/kg which is the most common
use of the code.
We usually dose our animals mg/kg/day or II SDTM, SEND-Published

nmol/kg/day, but the last unit does not yet exist in in P44
UNIT code list.Please add.
DEF: To order a planned list of activities or II Do not add (P42):

events but does not execute and carry through to Request withdrawn from
completion. requester. The example
https://wiki.cdisc.org/x/o_iHBQ, example 1: modeling has changed
MLMOOD .This is T1D TA request. to disclude the use of
the MOOD variable.
Do not add (P43): Code
C85754 - Do not
change. This
Please add to the PROCEDUR codelist the term II submission value in
SDTM-Published has
P43
CATARACT SURGERY with the definition:the been around for a long
procedure whereby the lens of the eye is time and we don't think
removed and replaced with an artificial one. This changing it for the sake
procedure is necessary if the lens of the eye gets of consistency across
so cloudy that it impairs vision. multiple codelists adds
much value. The
requester also did not
provide a T1D-specific
Batch 2 for Heart Failure TAUG: II use case for why this
SDTM-Published in P43,
3 new PROCEDUR terms submission
P46 value must
1 new CVTEST-CD term change.
Do not addGiven thatDo
(P45): units
1 new codelist with 4 new terms haveadd.
not mathematical
This is a high
File Emailed Separatly. synonymy method
sensitivity with other
and
units and
should begiven
mappedthatas
we
could
such. never choose a
single submission value
that could support all
use cases, it doesn't
make sense to change
this submission value
now.
The steady state concentration, found by dividing II Do not add (P42): Do
the infusion rate by the clearance, is used in not add. Use PPTEST =
continuous IV-dosed studies where there is no CONC/Concentration
terminal phase. (C41185), and put
Steady State in the non-
standard variable
"QLABEL=Condition of
PK
Analysis/QNA=PKCON
D" in SuppPP. See
example here:
play/SDTMIG/PK+Para
meters+2
Please add SPECT/CT to the PROCEDUR II SDTM-Published in P43

codelist with the definition: A nuclear medicine
tomographic imaging technique for examining
structures within the body by scanning them with
gamma rays and using a computer to construct a
series of cross-sectional scans along a single
axis.
This language is used in the SDTMIG in the trial II

design section. It is also used in some variable
names so CDISC would like to have it published
in the CDISC Glossary.
"A disease milestone is something that cannot be
scheduled, but which, when it occurs, triggers
data collection. A disease milestone may be
something would be anticipated to have
happened pre-study in the study population, or
something that is anticipated to occur during the
study."
TITRATION or Van De Kamer method ,standard II SDTM-Published in P45

titrimetric method to a colorimetric endpoint with
Thymol Blue indicator. Used in measuring fat
malabsorption like the coefficient of fat absorption
(CFA), which is the percentage of absorbed fat in
the diet.
Coefficient Nitrogen Absorption (CNA) is a marker II SDTM, SEND-Published

of protein absorption in a biological sample often in P44
a stool sample by ENZYMATIC COLORIMETRY
method.
Coefficient of fat absorption (CFA), which is the II
percentage of absorbed fat in the diet used for
measuring fat malabsorption
A measurement of the Durvalumab or high- II SDTM, SEND-Published
affinity human immunoglobulin G1 kappa in P44
monoclonal antibody in a biological specimen like Do not add (P44):
SERUM using Should be modeled as a
ELECTROCHEMILUMINESCENCE TEST in IS domain.
IMMUNOASSAY as the method. Do not add (P46):
https://en.wikipedia.org/wiki/Durvalumab Durvalumab or
Durvalumab Antibody
(high-affinity human
immunoglobulin G1
kappa monoclonal
antibody) - Do not add,
follow-up inquires sent,
no response from
requester.
P41 terminology needing new term request II ADaM, Define-XML,

numbers. Do not add into working documents! SDTM-Published in P41
116 total changes => 48 new terms and 68
changes to existing
Isotope Dilution Mass Spectrometry (IDMS) II SDTM-Published in P47

Japanese CKDI Co-efficient MDRD equation
eGFR: (mL/min/1.73 m2) = 175 x (serum Cr
[mg/dL])-1.154 x (Age) -0.203 x (0.742 if female)
x 0.741 if Japanese.
This is similar to the MDRD ENZYMATIC

FORMULA term, but includes the x 0.741 for
Japanese subjects.
I found this article which I thought was helpful:
https://www.sciencedirect.com/science/article/pii/
S0272638609003898
A flow cytometry?based assay that can detect II SDTM-Published in P45

cytokine production by immune cells in
combination with cell surface markers. It detects
the production and accumulation of cytokines
within the endoplasmic reticulum after cell
stimulation.
The test associated with this method is a count of

mock stimulated CD4 T lymphocytes that produce
cytokines such as IFN ad IL-2
This method is used to measure RSV PreFusion II SDTM-Published in P45

and PostFusion F Protein IgG antibodies
Also known as inhibition ELISA or competitive II SDTM-Published in P45
immunoassay, this assay measures the
concentration of an antigen by detection of signal
interference.
Used for tests measuring competitive antibodies
binding to RSV PreFusion or PostFusion F
Proteins
All consensus cardiac classification system test II

codes/test names are moving from CV to CC. file
emailed separately
EORTC-QLQ C-29 terminology for P41. II SDTM-Published in P41
The CDISC submission values for codes C67318, II SDTM, SEND-Published

C67427, C67330, and C73736 are mOsm, in P43
mOsm/kg, osm, and uOsM, respectively. This
represents three versions of the base "Osm"
when comparing case-sensitively: "osm", "Osm",
and "OsM".
Perusing, i.e. very informally, several PubMed
articles use "Osm".
"biological product" is defined as a virus, II

therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic
product, protein, or analogous product, or
arsphenamine or derivative of arsphenamine (or
any other trivalent organic arsenic compound),
applicable to the prevention, treatment, or cure of
a disease or condition of human beings? "):
www.regulations.gov/Docket No. FDA-2018-N-
273
Pls add the term "SELF ASSESSMENT" to the II SDTM-Published in P45

METHOD codelist.
https://wiki.cdisc.org/x/sOiHBQ
The General team reviewed the FAPR example
and suggested to the T1D team to change the
method from PERCEIVED to SELF
ASSESSMENT. Relevant comment from the
General team can be found here:
https://jira.cdisc.org/browse/TADIAB-783
DEF: A measurement, evaluation, or judgment
made by and about oneself.
A measurement of the chemoattractant receptor- II Do not add (P48): Do
homologous molecule expressed on Th2 cells not add. These are
(CRTH2) - CRTH2 cells per unit in a biological biodistribution tests that
specimen. are measuring a test
article of genetically
modified cells so really
belong in PC/PP
domains. Please consult
the SDTMIG for how to
model these types of
tests in the
pharmacokinetics
domains.
A measurement of the 17 helper T cells (Th17 II Do not add (P48): Do

cells) per unit in a biological specimen. not add. These are
biodistribution tests that
are measuring a test
belong in PC/PP
tests in the
pharmacokinetics
domains.
A measurement of the GATA3 cells- GATA- II Do not add (P48): Do

binding protein 3 cells per unit in a biological not add. These are
specimen. biodistribution tests that
are measuring a test
belong in PC/PP
tests in the
pharmacokinetics
domains.
A species of CORONAVIRUS causing atypical II
respiratory disease (SEVERE ACUTE
RESPIRATORY SYNDROME) in humans. The
organism is believed to have first emerged in
Wuhan Province, China, in 2019. The most likely
ecological reservoirs for SARS-CoV-2 are bats,
but it is believed that the virus jumped the species
barrier to humans from another intermediate
animal host. References: NCBI Taxonomy and
ICTV. Suggested synonyms to be added as well:
SEVERE ACUTE RESPIRATORY SYNDROME
VIRUS 2; SARS-CoV-2; 2019-nCoV; COVID-19;
SARS2. Suggested definition: Any viral species
which can be assigned to the species SARS
Coronavirus 2.
Hours times nanogram equivalents per liter (area II SDTM, SEND-Published

under the curve obtained based on radioactivity in P43
measurements). Do not add (P43): Do
not add. Map to
h*pgEq/mL (C166078).
h*ngEq/L has been
added to C166078 as a
new synonym.
This is added in response to Ine Wolf's (Janssen) II SDTM, SEND-Published

questions about having this value in both UNIT in P42
and PKUNIT codelists.
Update NCI PT for E-TRIP for P41 QRS II SDTM-Published in P41

publication; File emailed separately
The medical definition for TRANSVESICAL is: II Do not add (P43):

passing through or performed by way of the Request withdrawn by
urinary bladder. requester.
Definition and synonym for term C163540 II SDTM-Published in P42

(JCVDNA) seem to be incorrect, as they are
duplicates of existing term C112326 (JCVAB),
please review and adjust as needed.
Please correct typo in the definition of term II

POST-CARDIAC TRANSPLANT: A procedure to
evaluate the health of the an individual after
receiving a heart transplant.
Please add term: COMPUTED TOMOGRAPHY II SDTM-Published in P45

PERFUSION with synonym 'CT Perfusion'; more
information can be found here:
https://www.radiologyinfo.org/en/info.cfm?
pg=perfusionheadct.
DAYS PER WEEK, HOURS PER DAY, II SDTM, SEND-Published

MINUTES PER DAY for the IPAQ-LF SELF- in P44
ADMINISTERED QRS instrument Do not add (P44): DAYS
PER WEEK-> Do not
add. Please use
C170633 with
submission value
days/wk. This was
recently published.
Request addition of these sample collection II SDTM-Published in P44

methods: Do not add (P46): Do
CURETTAGE: A surgical scraping or cleaning by not add. Definitive
means of a curette to obtain the specimen for Therapy is a generic
testing. term that means ‘The
DEFINITIVE THERAPY: A process to remove treatment plan for a
abnormal cells and tissue for testing. (examples disease or disorder that
are Loop Electrosurgical Excision Procedure has been chosen as the
(LEEP), laser conization, cold-knife conization, best one for a patient
cervical cryotherapy, cervical laser vaporization) after all other choices
These 2 collection methods are used to collect have been considered.’
cervical samples for HPV testing. This term is too generic
to be useful in this
context. The specific
example collection
methods given by the
requester could be
added if the requester
chose to submit new
term requests.
Limited to a subdivision or part of a structure. II SEND-Published in P43
Liver-Specific G6PC Knockout II Do not add (P43): Do

not add. For genetically
modified animal strains,
the CDISC CT team will
not publish additional
terms beyond those
which are requested by
regulatory agencies.
The codelist is
extensible so sponsors
can use terms within
their submissions which
are not published in
SEND CT.
The number of breaths (inhalation and II SDTM, SEND-Published
exhalation) taken per 30 seconds time. (NCI). in P44
The cumulative amount recovered from the II SDTM, SEND-Published

specimen type specified in PPSPEC, from the in P43
time of dosing to the last non-zero concentration.
To be used with PKPARMCD: RCAMLST.
The cumulative amount recovered from the II SDTM, SEND-Published

specimen type specified in PPSPEC, from the in P43
time of dosing to the last non-zero concentration.
To be used with PKPARM: Amt Rec to Last
Nonzero Conc.
[In 2019-12-20, RCPCLST was added.
RCAMLST is for the amount recovered instead of
the percent recovered.]
New value requested for Theradex/caDSR II Do not add (P45): Do

curation. not add. Existing term
SCINTIGRAPHY with a
LOC of BONE covers
this concept.
Create new Findings About TEST-CD terms for II SDTM-Published in P43
T1D TA Project, batch 4; File emailed separately.
There is a question about viral infection in the II SDTM-Published in P43

T1D prevention TAUG that asked whether a viral
infection was diagnosed by an actual health care
professional or not. If it is not a health care
professional, it doesn't really matter and we don't
care if it was a parent, caregiver, or guardian, etc.
In the example caption it says "Subject's Parent"
but we don't want to use parent, could we add
"NON-HEALTH CARE PROFESSIONAL" to the
codelist that could encompass everyone that is
NOT in the HEALTH CARE PROFESSIONAL
term?
Link to the TAUG example:

pageId=92793122
For the below example in the Psoriasis TAUG: II
Example in Psoriasis TAUG:
https://wiki.cdisc.org/display/TAPSOR/Example.
+SDTM+Patient+Global+Impression+-+QS
One of the sponsor defined PGI measures can

use a 5 point NRS.
We have this test in a study. Original test II SDTM, SEND-Published

description was "Phosphorylated Tau in P44
Protein/Amyloid Beta 1-42 Ratio".
Definition: The region where the right and left II SDTM, SEND-Published
hepatic ducts exit the liver and join to form the in P43
common hepatic duct that is proximal to the origin
of the cystic duct.
Definition: The region includes the common bile II SDTM, SEND-Published

duct and inserts into the small intestine. in P43
Suspect that Neutrophil-Activating Peptide 2 II SDTM, SEND-Published
(C165976) is synonymous with Chemokine (C-X- in P44
C Motif) Ligand 7 (C165955). Please double
check.
New term request for 12 new TESTs and 2 II SDTM-Published in
METHOD values. For Coronavirus research P41a, P43
related to LOINC codes; File emailed separately Do not add (P43):
SARS coronavirus 2 E
gene: Do not add. Gene
name goes into --SYM
variable. Also consider
modeling this in MB
instead of PF.
SARS coronavirus 2 N
Batch 1 new term request for Crohn's Disease II SDTM-Published
gene: Do not add.inGene P43,
TA. File emailed separately P45
An assay which relies on the binding of ligand II modeling this in MB
molecules to receptors, antibodies or other instead of PF.
macromolecules. SARS coronavirus 2
ORF1ab region : Do not
add. Gene name goes
6 new terms for Crohn's Disease TA; File emailed II SDTM-Published
into --SYM variable. in P43,
separately. P44, P45
Also consider modeling
this in MB instead of PF.
"Celiac artery" is mentioned in code C65166 II SARS
SDTM,coronavirus
SEND-Published2
CELIAC LYMPH NODE, but there is no term itself RdRp
in P43gene: Do not add.
for "celiac artery" Gene name goes into --
SYM variable. Also
I.e. for CELIAC LYMPH NODE ""A lymph node at consider modeling this
the base of the celiac artery" in MB instead of PF.
SARS-like Coronavirus
N gene: Do not add.
is not in LOC II Gene
SDTM,name goes into --
SEND-Published
SYM
in P43 variable. Also
consider modeling this
in MB instead of PF.
SARS coronavirus 2 S
gene: Do not add. Gene
modeling this in MB
instead of PF.
Dorsal pedal artery is not in LOC II SDTM, SEND-Published
in P43
Do not add (P43):
of C32478. We will add
'Dorsal Pedal Artery' as
a synonym.
"Ulnar artery is not present in LOC. II SDTM, SEND-Published

It is mentioned in BRACHIAL ARTERY: ""An in P43
artery of the forelimb; in general it arises from the
axillary artery and branches to form the radial and
ulnar arteries."" but has no own term."
Dental arch is not present in LOC II SDTM, SEND-Published

in P43
Palpebral fissure is not present in LOC II SDTM, SEND-Published
in P43
Arterial blood II Do not add (P43): These
belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C78729
Capillary blood, e.g. in "oxygen saturation in II Do not add (P43): These

Capillary blood" belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C112235
e.g. "oxygen saturation in Venous blood" II Do not add (P43): These

belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C78730
e.g. in "Oxygen saturation in Arterial cord blood" II Do not add (P43): These
belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C13300
e.g. in "Oxygen saturation in Venous cord blood" II Do not add (P43): These
belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C120840
e.g. as in "Oxygen saturation in Preductal Blood" II Do not add (P43): These

belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
They will be considered
for development within
SPEC codelist.
as e.g. in "Oxygen saturation in Postductal Blood" II Do not add (P43): These

belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
e.g. in "Oxygen saturation in Mixed venous blood" II Do not add (P43): These
belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C158281
Intravascular end systolic blood pressure II
Intravascular peak systolic blood pressure II
See: II
https://en.wikipedia.org/wiki/Intracranial_pressure
See e.g. II SDTM, SEND-Published

https://en.wikipedia.org/wiki/Common_palmar_dig in P45
ital_arteries

https://www.sciencedirect.com/topics/veterinary- in P45
science-and-veterinary-medicine/penile-artery
e.g. "systolic blood pressure index arteries" II SDTM, SEND-Published

in P45
like in "little finger arteries systolic blood II SDTM, SEND-Published
pressure" in P45
like in "systolic blood pressure middle finger II SDTM, SEND-Published
arteries" in P45
Like in "systolic blood pressure in ring finger II SDTM, SEND-Published

arteries" in P45
Like in "systolic blood pressure thumb arteries" II SDTM, SEND-Published

in P45
For "Semen temperature" (LOINC 43741-8) II Do not add (P43): These

belong in the SPEC
variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C13277
CodeList "LOC" has "BLOOD" as a location, but II Do not add (P43): These
not "ARTERIAL BLOOD". belong in the SPEC
Need it for mapping from "ARTERIAL BLOOD variable (the LOINC
TEMPERATURE" system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C78729
"BLOOD" is listed as an entry in --LOC, but II Do not add (P43): These

"venous blood" isn't. belong in the SPEC
Need it for "venous blood temperature" variable (the LOINC
system part maps to
both SPEC and LOC).
Please use existing
SPECTYPE value of
C120840
important for undercooling cases. II SDTM, SEND-Published

I don't think a combination of VSTESTCD=TEMP in P43
with a value for VSLOC can be used for this
File emailed separately 2020-03-27 II SDTM, SEND-Published

in P43
Please consider adding unit of measurement II Do not add (P44): Do
kUA/L. This unit represents kilo units of Allergen not add. Team agrees
per liter. This unit is frequently used to report that this should be
sensitization defined in specific IgE values of mapped to kU/L given
kUA/L. We are receiving this lab unit in reporting that the allergen is
inhaled allergen lab tests from Covance specified in the test.
laboratories. Additional reference: kU/L is mathematically
https://www.jaci-inpractice.org/article/S2213- synonymous with U/mL
2198(15)00515-2/pdf. therefore we will add
kU/L as a synonym to
existing term C77607.
Plain language is writing in a way that helps II
readers understand the content in a document
the first time they read it. Note: Plain writing is
clear, concise, well-organized, and follows other
best practices appropriate to the subject or field
and the intended audience. (after Plain Writing
Act of 2010
https://www.fda.gov/media/84926/download;
https://www.fda.gov/about-fda/plain-writing-its-
law/federal-plain-language-guidelines)
Health literacy - health literacy is the degree to
which an individual has the capacity to obtain,
communicate, process, and understand basic
health information and services to make
appropriate health decisions. (After The Patient
Protection and Affordable Care Act of 2010, Title
V;
https://www.cdc.gov/healthliteracy/learn/index.ht
ml)
File contains 6 new SCTEST values to publish to II SDTM-Published in P43,

support EBOLA TAUG and 1 change to a P44
published LBTEST definition for a COVID-19 trial;
I believe this term was submitted to CDISC a II Do not add (P43): Do

while back but it has not been added to the not add. We will instead
terminology as CDISC thought "Withdrawal by update definitions of
Subject" could be used instead. However existing terms to allow
"Withdrawal by Subject" means a patient for their use either as
discontinuing participation in a clinical study withdrawals from the
(withdrawal of consent); whereas we encounter entire study or a potion
scenarios where patients decide to stop the study of the study. See P43
treatment but they are happy to be followed up changes files for
and they don't withdraw the consent, they just updates to existing
stop the treatment. In that case, we would like to definitions.
be able to capture the reason for treatment
discontinuation as "Patient decision".
I know the C66727 codelist is extendable and we

can add this term as sponsor extension; however,
as it has an impact on one of the key SDTM
domain, it would be great if, instead of adding a
sponsor-extension, we could agree on a industry-
wide solution.
Cell Therapy : the prevention or treatment of II
human disease by the administration of cells that
have been selected, multiplied, and
pharmacologically treated or altered outside the
body (ex vivo), or methods (pharmacological as
well as nonpharmacological) to modify the
function of intrinsic cells of the body for
therapeutic purposes (in vivo) Note : cell therapy
classifications can be based on therapeutic
indication, cell type, source of cells, underlying
technology amongst others. Common examples
are transfusion and stem cell transplantation.
More advanced cell therapies do exist within the
field of gene therapy.
[after
https://www.sciencedirect.com/topics/neuroscienc
e/cell-therapy ]
See also regenerative medicine therapy,
regenerative medicine advanced therapy, gene
therapy
"Gene therapy : ex vivo or in vivo gene II

modification of cells using specific technologies
(eg viral vectors and direct genome editing
technologies). Note : A particular example of this
is the therapy with gene-modified T cells
(chimeric antigen receptor (CAR) T-cell therapies)
used as immunotherapy in oncology.
[after
34004/]
See also cell therapy, regenerative medicine
therapy, regenerative medicine advanced
therapy.
"
"1/ According to the existing definition an hip joint II

replacement might also be considered as
regenerative medicine therapy. Was that the
intention ? Otherwise we need to add 'biological
treatment type in the definition 2/ the Note 'may
include...' seems to refer to different other
concepts which might be overlapping, confusing
the reader.
3/ Referring to (new) terms cell therapy and gene
therapy should allow to clean up the Note 4/ Is
xenogeneic important and specific enough to be
included ? I would expect a more understandable
reference to eg allogeneic
"
"Observational study : II
An observational study draws inferences from a
sample to a population where the independent
variable (exposure, treatment, diet,.. ) is not
under the control of the researcher because of
ethical concerns or logistical constraints.
Observational studies are ones where
researchers observe the effect of a risk factor,
diagnostic test, treatment or other intervention
without trying to control who is or isn?t exposed
to it (no planned event in time by study design)
Note :One common observational study is about
the possible effect of a treatment on subjects,
where the assignment of subjects into a treated
group versus a control group is outside the
control of the investigator.[1][2] This is in contrast
with experiments such as randomized controlled
trials, where each subject is randomly assigned to
a treated group or a control group.
Note : Major subtypes of observational study are
cohort study, case control study and cross-
sectional study.
[after Observational studies: Cohort and Case-
Control Studies, JW Song, KC Chung Plast
Reconstru Surg, 2010 Dec ; after Wikipedia
Observational Study; after ""Observational
study"" after Porta M, ed. (2008). A Dictionary of
Epidemiology (5th ed.). New York: Oxford
University Press. ISBN 9780195314496.]
See also Investigational Clinical trials, cohort
study, case-control study; cross-sectional study,
longitudinal study."
Case-control study: study in which two existing II

groups differing in outcome (eg. health problem)
are identified and compared on the basis of some
supposed causal attribute(s) (retrospectively) .
Originally developed in epidemiology,
subcategory of observational clinical study
Cross-sectional study: study which involves data II

collection from a population, or a representative
subset, at one specific point in time. Cross-
sectional studies do not have a temporal
dimension. Synonym : prevalence studies
Cohort study : ( existing term in CDISC Glossary, II Glossary-Published in
to be evaluated whether subject for review)) P44
Study of a group of individuals, some of whom
are exposed to a variable of interest, in which
subjects are followed over time. Cohort studies
can be prospective or retrospective. [AMA
Manual of Style] See also prospective study.
Please consider to add "Study Data Technical II SDTM-Published in P43

Conformance Guide v4.5"
SEND-AR 1.0 II SEND-Published in P43
Also would need new SDTM-CVTESTCD - sugest II

MAXBFVEL based on existing MBFVEL. This is
needed for a study that does a Trans-cranial
Doppler Sonogram (TCD or TCDi) to determine
the maximum blood flow velocity. This is
measured to determine risk of stroke based upon
maximum flow velocity.
The unit associated to this requested test/testcd
is "cm/s"
This TEST appears to be significantly different II SDTM-Published in P45

from other tests of this type as the analyte is not
in the TEST value. This came from a new term
request in P36 regarding 'PAS+ Staining'. PAS
still belongs in METHOD, based on existing
published terminology. But since PAS stains for
Polysaccharides and Mucosubstances, that may
be a better TEST value and the existing term
moved in as a TSTDTL, which could be re-used
across other existing MITESTs as well.
Can the team please reconsider the granularity of

this published term?
Oncology studies need a protocol milestone to II SDTM-Published in P44

define subjects that are continuing into survival
follow-up phase
Oncology studies need a protocol milestone to II SDTM-Published in P44
define subjects that are not continuing on with the
survival follow-up phase
RPPAG/Rate-Pressure Product, Aggregate. II
Required for use with nonclinical SEND
Controlled Terminology because a suitable
definition is not currently available for the Rate-
Pressure-Product of the heart rate as derived
from aortic blood pressure and systolic blood
pressure.
CDISC Submission Value - RPPAG/Rate-

Pressure Product, Aggregate
CDISC Synonym(s) - Rate-Pressure Product,
Aggregate
CDISC Definition - The product of the heart rate
(derived from aortic blood pressure) and the
systolic blood pressure, termed as Rate-Pressure
Product, Aggregate. RPPAG=HR*SBP with unit
of mmHg*beats/min
NCI Preferred Term - Rate-Pressure Product,
Aggregate
QTCP/QTcP Interval, Aggregate. Required for II Do not add (P43): Do

use with nonclinical SEND Controlled not add. Standard QTcP
Terminology because a suitable definition is not is for population, this is
currently available for the QTc calculations for an not subject-level data,
individual 3 parameter exponential correction. also this is one way of
CDISC Submission Value - QTCP/QTcP Interval, calculating QTcI, and
Aggregate QTcI-related EGTEST
CDISC Synonym(s) - QTcP Interval, Aggregate measurements will not
CDISC Definition - A QT Aggregate interval that be controlled for the
is corrected for heart rate using individual 3 following reason -
parameter exponential QT/RR slopes for each QtCI by definition is
subject, based on the measurement of QT subject-specific heart
intervals from multiple beats within a single ECG rate correction of QT
or period of a continuous ECG. The method of interval where the heart
aggregation, which can vary, is typically a rate correction formula
measure of central tendency such as the mean. does not apply to the
NCI Preferred Term - QTcP Interval, Aggregate general population like
or Framingham
formulae) - This means,
and parameters are
different from subject to
subject, and as such this
results in a variety of
combinations it would
not be feasible to define
all possibilities in a
controlled terminology
list.
The EGTEST/CD
and users may choose
to create QTCI-related
I think the new P41 term, Atypical II SDTM, SEND-Published
Lymphocytes/Lymphocytes, should be in P45
"Lymphocytes Atypical /Lymphocytes" as per the
other terms e.g.
-Lymphocytes Atypical (C64818)
-Lymphocytes Atypical/Leukocytes (C64819)
PKPARM and PKPARMCD. 11 new codes II SDTM, SEND-Published

requested to be added to the PKPARM/CD in P43
codelists to reflect dose per kg body weight, as Do not add (P43):
they are currently not represented. File emailed "QAUCLSTN; AUC to
separately. Last Nonzero Conc
Norm by Dose per kg
Body Weight - Do not
add in the requested
To cover new "Corona" LOINC test codes 94643- II format, PK team agreed
4, 94642-6, 94641-8, 94640-0 to add the modified
Missing term, urgently required becaue of II Glossary
version of- this
Published
term in
COVID-19 and elusive definitions in the scientific P41a
where ""kg"" is removed
world. from PKPARM. This
Proposal sourced from A dictionary of parameter may also be
epidemiology, edited for the International used for animal studies
Epidemiological Association by John M. Last, where the body weight
OXFORD UNIVERSITY PRESS 2001 unit for an animal could
https://pestcontrol.ru/assets/files/biblioteka/file/19- be ""g"" or ""mg"". The
john_m_last- bodyweight to which the
a_dictionary_of_epidemiology_4th_edition- dose is adjusted to
oxford_university_press_usa_2000.pdf should NOT be pre-
coordinated into the
PKARM but rather, it
EPIDEMIC: The occurrence in a community or II Glossary
by UNIT.Use- Published
new in
region of cases of an illness, specific health- P41a
PKPARM in P43 =
related behavior, or other health-related events AUCLST Norm by
clearly in excess of normal expectancy. The Dose/WT.
community or region and the period in which the "QAUCINTN; AUC from
cases occur are specified precisely. NOTE The T1 to T2 Norm by Dose
number of cases indicating the presence of an per kg Body Weight - Do
epidemic varies according to the agent, size, and not add in the requested
type of population exposed; previous experience format, PK team agreed
or lack of exposure to the disease; and time and to add the modified
place of occurrence. version of this term
Missing term, urgently required because of where ""kg"" is removed
COVID-19 and elusive definitions in the scientific from PKPARM. This
world. parameter may also be
Proposal sourced from A dictionary of used for animal studies
epidemiology, edited for the International where the body weight
Epidemiological Association by John M. Last, unit for an animal could
OXFORD UNIVERSITY PRESS 2001 be ""g"" or ""mg"". The
https://pestcontrol.ru/assets/files/biblioteka/file/19- bodyweight to which the
john_m_last-a_dictionary_of_epidemiology_4th_ dose is adjusted to
should NOT be pre-
PKARM but rather, it
by UNIT.Use new
PKPARM in P43 =
AUCINT Norm by
Dose/WT"
"QAUCIFPN; AUC
Infinity Pred Norm by
Dose per kg Body
Weight - Do not add in
the requested format,
PK team agreed to add
the modified version of
Missing term, urgently required because of II Glossary - Published in
COVID-19. P41a
Proposal sourced from A dictionary of
epidemiology, edited for the International
Epidemiological Association by John M. Last,
OXFORD UNIVERSITY PRESS 2001
this term is in both METHOD (C85492) and II SDTM-Published in P45

'CVFARS' (C119016) codelists so will need to be
updated in both places.
It often happens that a datapoint is taken from a II SDTM-Published in P45

statement of the subject, especially in vital signs.
Examples are questions asked by the investigator
"what is your heigt", "what is your weight".
It might be that we do already have a "METHOD"
for that, but I couldn't find one.
like WTAPCTL but then for fetus II SDTM, SEND-Published

in P43
See e.g. http://www.scielo.br/scielo.php? II SDTM, SEND-Published

script=sci_arttext&pid=S1806- in P43
83242010000100008 and many other sources

http://www.fetalultrasound.com/online/text/3- in P43
185.htm
pls fix typo in C102286/CIRCUMFLEX, OBTUSE II SDTM, SEND-Published

MARGINALS, LEFT POSTEROLETERAL AND in P43
LEFT POSTERIOR DESCENDING ARTERY
BRANCHES.
LEFT POSTEROLETERAL is spelled as

"POSTEROLATERAL" with an "A"
A type of study designed to evaluate the II SDTM-Published in P43

expected or common reaction following vaccine
administration.
Please add Q72H meaning Every 72 hours to the II SDTM, SEND-Published

FREQ codelist. in P43
Please add the new submission value of 3 OR 4 II Do not add (P44): Do
TIMES PER WEEK to the FREQ codelist. The not add. This should be
definition is 3 or 4 times per week. treated as an extensible
term in this codelist. The
terminology team will
not control all possible
combinations of
frequency terms such as
this one.
Requesting update of 'SPONSOR REQUEST' to II Do not add (P50): Do

'SPONSOR DECISION' to be consistent within not change. The word
the codelist which also has 'PHYSICIAN 'request' was
DECISION'. Alternately update 'PHYSICIAN intentionally chosen to
DECISION' to 'PHYSICIAN REQUEST'. go with sponsor,
whereas the word
'decision' was
intentionally' chosen to
go with physician to
reflect what happens on
study. Aligning the
submission values
simply for consistency is
not appropriate here.
Erythrocytes/uL, Leukocytes/uL, nkat/gHb. The II SDTM, SEND-Published
first one is unit for 'Occult Blood', the second one in P44
is unit for 'Leukocyte Esterase', the third one is Do not add (P44): Do
unit for 'Glucose-6-Phosphate Dehydrogenase' not add. The proposed
TEST associated with
this unit seems not quite
correct since it appears
they are measuring the
number of erythrocytes
in an unspecified
specimen in order to
ascertain whether
Occult Blood is present.
If one is measuring
erythrocytes as a
surrogate to determine
whether Occult Blood is
present, then you may
actually need two rows
of data; a)
TEST=Erythrocytes,
Specimen=Urine/Feces,
and Unit=10^6/L (/uL is
a published synonym to
10^6/L); b)
TEST=Occult Blood,
Specimen=Urine/Feces,
Unit is null because
result is semi-
quantitative or ordinal.
Tanner Scale is based on the CDISC ISMT II SDTM-Published in P43

decision below:
At ISMT 12 August 2019 it was decided that the
Tanner Scale would now be developed as a QRS
supplement (i.e. not modeled in the body system
domain). The Tanner Staging example needs to
be removed from module and added to the QRS
module. I would suggest keeping the Tanner
Staging subtitle and some of the intro text but
point out to the user that this will be created as a
QRS supplement (with a hyperlink to the QRS
module).
The change control spreadsheet was sent

separately.
corresponds to LOINC code 94532-9. Please see II Do not add (P43): Do
https://loinc.org/94532-9/ not add. Duplicate
Explanation: "Qualitative detection of targeted request, map to
nucleic acids from SARS-related coronaviruses, MBTEST = SARS-
including SARS coronavirus (SARS-CoV), SARS related Coronavirus
coronavirus 2 (SARS-CoV-2), and SARS-like RNA/MERS RNA.
coronaviruses, as well as MERS coronavirus
RNA in respiratory specimens. This test detects
but does not differentiate between the viruses."
Corresponds to e.g. LOINC Code 94502-2 - This II Do not add (P43):

is a more general then Corona-Virus RNA. Duplicate request, map
Please see https://loinc.org/94502-2/. to MBTEST = SARS-
From the LOINC description: "Qualitative related Coronavirus
detection targeted nucleic acids from SARS- RNA.
related coronavirus RNA, including SARS
coronavirus (SARS-CoV), SARS coronavirus 2
(SARS-CoV-2), and SARS-like coronaviruses, in
upper or lower respiratory specimens. This test
detects but does not differentiate between the
viruses."
I am not sure how to distinguish between "rapid" II SDTM-Published in P45

immunoassay tests and "normal" immunoassay
tests in virology.
It can be that this should go into "METHOD", i.e.
"RAPID IMMUNOASSAY", or that it should go
into MBCAT or even MBSCAT. Or is there
another possibility to distinguish between results
from "rapid" immunoassay tests and "normal"
immunoassay tests?
Synonym = Observed value Definition =This II Do not add (P43): Do

method indicates PK Parameters that are not not add. This codelist
derived by any method but are read straight from supports the
the data (e.g. CMAX) PPANMETH variable
which is added to the
PP domain in SDTMIG v
3.4. This codelist should
only contain "named
mathematical or
Create a new RSCAT, TESTCD (SAS0101), and II algorithm formulas,
SDTM-Published in or
TEST for the Riker Sedation-Agitation Scale sponsor-defined
P41a
(SAS). formulas". This is also
Create a new RSCAT, TESTCD (RASS0101), described by the
and TEST for the Richmond Agitation-Sedation variable description as
Scale (RASS) the following: "Analysis
Create new RSCAT, TESTCDs (NEWS101- method applied to
NEWS111 and NEWS104A), and TESTs for the obtain a summarized
National Early Warning Score 2 (NEWS2). result. Analysis method
describes the method of
secondary processing
applied to a complex
observation result.
Examples are: a named
formula used to
calculate AUC, such as
"LIN-LOG
TRAPEZOIDAL
METHOD". Sponsor-
defined formulas can
also be represented by
this variable, an
Add to MEDEVAL Codelist the term ENT II SDTM-Published in P44
SPECIALIST with the definition:
Otolaryngologists providing surgical and medical
management of conditions of the ear, nose and
throat.
Please add new codes for the DTYPE codelist. II Do not add (P45): Do
Each entry is a type of derivation used for not add. Requester
analysis; used to report the DTYPE in the could not provide
submission. Multiple term request file emailed additional information
separately. required by team.
Please re-submit if the
information is found.
Related question on eCRF: Source for II SDTM-Published in P44

Notification of the Cause of Death (Check All That
Apply)
Checkbox results: DEATH CERTIFICATE;

HOSPITAL RECORDS; INVESTIGATOR;
FAMILY; and OTHER
Definition: An indication as to whether a death II SDTM-Published in P43

was sudden.
Notice: This e-mail message, together with any

attachments, contains information of Merck &
Co., Inc. (2000 Galloping Hill Road, Kenilworth,
New Jersey, USA 07033), and/or its affiliates
Direct contact information for affiliates is available
at
http://www.merck.com/contact/contacts.html) that
may be confidential, proprietary copyrighted
and/or legally privileged. It is intended solely for
the use of the individual or entity named on this
message. If you are not the intended recipient,
and have received this message in error, please
notify us immediately by reply e-mail and then
delete it from your system.
This term suggestion request also affects CDISC II Do not add (P45):
Code List SDTM-LBTESTCD. Do not remove. One can
measure Antithrombin
Two new terms were added in the 27Mar2020 Antigen Actual/Control
release. Could you please see if the following (Antithrombin Antigen is
terms are duplicates? synonymous with
1. New term: C170592 Antithrombin) and this is
Existing term: C147306 also LOINC coded as
2. New term: C170597 27812-7. So LOINC also
Existing term: C147447 has both types of
measurements,
therefore we will keep
this term in the codelist.
Do not remove. See
LOINC 27816-8. von
Willebrand Factor
actual/control can be
measured either as an
activity OR relative
mass concentration.
Therefore we will not
remove this term from
the codelist.
We collect this data point as a growth parameter II SDTM, SEND-Published

for late-onset SMA patients, when regular in P43
height/length measurements cannot be
performed.
I have been asked to create a new SPECTYPE II SDTM-Published in P44

for Basal Tears.
Apparently there are 3 types of tears:
https://en.wikipedia.org/wiki/Tears
But I think the Specimen is probably the same i.e.
Tears, but the different types relate to the
trigger/use of the tear. Do you agree?
If so I will request a new LOC.
Do you have any suggestions for the storage of ?
Basal/Reflex/Emotional(psychic)??
NCI & FDA have completed their review of the II QRS-Published in P46
draft PRO-CTCAE v1.0 CT and provided
comments for revisions. Some requested
revisions exceed the 40 character QSTEST name
rule and need discussion for alternatives.
As a reference, tumor lesions are identified II Do not add (P43):
thorugh series and image numbers from the Tumor Series
various sequences images of CT/MRI. These two Number/TUSENUM: Do
numbers simply provide the location of lesion in not add. This is not an
the images and support to track the leasion appropriate TEST for
during assessment for the clinical trial. Hence, it the RS domain. SDS
would be usefule to record these numbers as a oncology team
reference for further study or medical monitoring recommends using
by other /third radiologists in onoclogy. TUSPID and TRSPID
for this information. If
you are using --SPID for
another purpose, a
Suppqual may also be
used to store the
requested information.
Tumor Image
Number/TUIMNUM: Do
not add. --REFID can be
used to store image
identifiers. The
requested information is
more appropriate to be
stored in both the TU
and TR domains,
instead of the RS
domain. The description
of the TUREFID and
TRREFID variables in
the SDTMIG is: Internal
or external identifier,
such as a medical
image ID number.
Proposed Definition: The body region comprising II SDTM, SEND-Published

the cervix and vagina. in P45
This location is used to collect swab specimens

from the cervix/vagina region for Neisseria and
Chlamydia testing.
Def: A measurement of the anti-neutrophil II SDTM, SEND-Published

This test includes not only autoantibodies to
neutrophil cytoplasmic protein, but all
autoantibodies to neutrophil protein(ex.
membrane proteins). It is because flow cytometry
is used to detect anti-neutrophil antibody.
https://test-guide-en.srl.info/hachioji_en/test/
detail/008594402
CCODE: C38082 TESTCD FIO2 I am wondering II Do not add (P43): Do
is this is something measure on a subject and not move. Team agrees
whether it should indeed be a Lab Test. FIO2 is to keep in LBTEST for
the percentage of oxygen available for exchange continuity with COVID-
at the aveolar. In room air, FIO2 is 21%......for 19 TAUG.
subject on supplemental oxyen, this increases Update already made.
based on oxygen and flow rate. Whilst it is The definition of FIO2
important in the PAO2/FIO2 calculation, I am was updated with the
wondering if it should be a test in its own right 2020-05-08 release of
SDTM terminology to: A
measurement of the
volumetric fraction of
oxygen in the inhaled
gas.
The existing term in the UNIT codelist is 'tsp' is II SDTM, SEND-Published

coded as a 'dosing unit' but we can imagine a in P47
scenario where this is not used for dosing. Similar Do not add (P47): -
to other volumetric units like ounce, pint, etc. tsp_us: Do not add.
Consider creating a new term to support this use Team agrees to wait for
case a requester's use case
before adding these.
Do not add (P47): -
tbsp_us: Do not add.
Team agrees to wait for
a requester's use case
Do not add (P47): -
tbsp_au: Do not add.
Do not add (P47): -
cup_us: Do not add.
Request for a term of Total Fibronectin, which II SDTM, SEND-Published

would include the specific types that are already in P45
published like Fetal Fibronectin, Cellular
Fibronectin, etc.
Hours times picomoles per liter (area under the II SDTM, SEND-Published
curve), divided by milligrams per kilogram (dose in P43
normalized by body weight).
Multi-term request for COVID-19 batch II SDTM, SEND, CDASH,

terminology for CDISC COVID-19 TAUG. There Glossary - Published in
are 52 new terms and 7 changes to existing. P41a
Synonym = Ten Million 50 Percent Tissue Culture II SDTM, SEND-Published
Infective Dose Definition = A potency unit for in P44
measuring infectious activity of a biologic product
or infectious agent preparation at which infectious
material with numbers equal to 10 to the seventh
power of 50 percent tissue culture infective dose.
This unit is needed for a vaccine trial.
This data is coming from an external vendor. II
Definition = The average of the septal and lateral

annular velocity during early ventricular diastole
(the passive filling of the ventricle).
This data is coming in from an external vendor. II
Definition: The average of the ratio of the peak

early ventricular diastolic transmitral velocity (E)
to the peak early diastolic lateral mitral annular
motion velocity (e') and ratio of peak early
ventricular diastolic transmitral velocity (E) to the
peak early diastolic septal mitral annular velocity
(e?).
Definition: The region surrounding the urinary II SDTM, SEND-Published

bladder. in P45
Usage: Location used in a bladder cancer study.

Multiple term requests for SPEC and NONNEO II SEND-Published in P45,
codelists.. File emailed separately. P46
Do not add (P44):
TYMPANIC CAVITY
LINING and TYMPANIC
CAVITY
COMPARTMENT-> Do
not add. Requester
withdraws request. They
now are in agreement
that these would map to
TYMPANIC BULLA.
Do not add (P45):
HYALINE DROPLETS,
INCREASED -> Do not
add. 'ACCUMULATION,
HYALINE DROPLETS'
will be the preferred
term. 'Increased Hyaline
Droplets' will be added
as a synonym to the
new term for mapping
purposes.
MUSCLE, SUPERIOR
RECTUS -> Do not add.
This is the same as
'MUSCLE, DORSAL
RECTUS', which will be
added to the codelist.
'Superior Rectus
Muscle' will be added as
a synonym.
Do not add (P47): -

ENDOCARDIOSIS: Do
not add. Please use
DEGENERATION/C507
1) QTcTC Interval, Aggregate: A QT aggregate II SDTM, SEND-Published
interval that is corrected for body core in P43, P44
temperature. Do not add (P43): Do
2) QTc Interval, Mod Spence, Aggregate: A AT not add. Standard QTcP
aggregate interval corrected for heart rate using is for population, this is
Spence's formula based on analysis of not subject-level data,
covariance and modified by Miyazaki and also this is one way of
Tagawa's rate correction technique. calculating QTcI, and
3) QTcH Invterval, Aggregate: A QT aggregate QTcI-related EGTEST
interval corrected using Holzgrefe's correction measurements will not
formula. be controlled for the
following reason -QtCI
by definition is subject-
specific heart rate
Please add synonym of 'BHB' to C96568/Beta- II correction of QT interval
Hydroxybutyrate where
in P45 the heart rate
correction formula does
not apply to the general
population like
or Framingham
formulae) - This means,
and parameters are
different from subject to
subject, and as such this
results in a variety of
FIO2 has an erroneous definition. Please review? II SDTM-P41a
FiO2 is the fraction of inspired air, and the
specimen type should not be arterial blood gas. I
believe the FiO2 definition was mixed up with
another term.
FiO2 should be the fraction of oxygen that a

person inhales. It is relative to the amount of
atmospheric gas composition upon
measurement.
Please review the definition (and in addition

specimen type) for this term. Although not
technically correct, we have used ""INSPIRED
AIR"" as the specimen type for this LBTEST.
As recommended by Erin, please create the II Do not add (P43): Do

following: not add. The units of
ALPBSA : Bone Specific Alk Phosphatase Activity measure provided by
ALPISA: Intestinal Spec Alk Phosphatase Activity the requester (IU/L, U/L
ALPLSA: Liver Specific Alk Phosphatase Activity or uKat/L) suggest that
ALPA (Alkaline Phosphatase Activity) they are still measuring
concentration In these
The existing CDISC terms for these tests are instances, the activity is
required for concentration results and percentage used as a surrogate to
of total ALP. determine how much is
These have been requested for a COVID-19 there, based on the
study. provided unit of
I've tried to follow the convention of the existing measure. For the
'conc' tests for ALP and other 'activity' tests. purpose of CDISC CT,
The Definition will be 'A measurement of the we do not consider
xxxxx activity in a biological specimen.' these types of
assessments as
requiring the word
'Activity' to be pre-
submission value.
USP U (United States Pharmacopeia unit) is II SDTM, SEND-Published

present in code list, but for European in P44
Pharmacopoeia there is no option.Would it
possible to add something like EP U?.
In case of a morfine pump in SDTM-CM II Do not add (P44): Do
not add. Pump is a
device type not
pharmaceutical dosage
form. This should be
mapped to the device
domains. We suggest
the DI domain where
DIPARM = Device Type,
and the DIVAL would be
something along the
lines of "Morphine
Pump", "or just "Pump".
Dosing units for this preclinical study were II SDTM, SEND-Published

mg/cm2/day with the PK parameter of AUC in P43
normalized to dose request to be calculated.
detected is any of IgG, IgM or IgA antibodies. II SDTM-Published in P43

See e.g. (but also other) LOINC code 94769-7
"Qualitative detection of any SARS-CoV-2
antibodies (IgG, IgM, or IgA) in serum or plasma
by immunoassay methods" -
https://loinc.org/94769-7/
Definition = An indicator as to whether the subject II SDTM-Published in P44,

has a single episode with greater than 14 P47
continuous days of bleeding/spotting.
Responses = N; Y
Definition: Description of vaginal II

bleeding/spotting associated to a number of
bleeding/spotting episodes.
Possible responses: NO BLEEDING OR

SPOTTING; INFREQUENT BLEEDING OR
SPOTTING (LESS THAN 3 EPISODES);
NORMAL FREQUENCY/BLEEDING OR
SPOTTING (3 TO 5 EPISODES); FREQUENT
BLEEDING OR SPOTTING (GREATER THAN 5
EPISODES)
Please consider aligning CDISC Submission II SDTM, SEND-Published

Values for C135472 in the CDISC SDTM in P45
Laboratory Test and SDTM Microscopic Findings
Test codelists, preferably to PECAM1 and
Platelet Endo Cell Adhesion Molecule 1.
C135472: Laboratory Test - PECAM; Platelet
Endothelial Adhesion Molecule
C135472: SDTM Microscopic Findings Test -
PECAM1; Platelet Endo Cell Adhesion Molecule
1
Mentioned as specimen in some Corona and II Do not add (P44): Do
oher viral tests not add. Please use a
SPECTYPE=BLOOD or
CAPILLARY BLOOD
and Specimen
Condition=DRIED.
Required for use with nonclinical SEND II Do not add (P45): Do

Controlled Terminology because a suitable not add. This appears to
definition is not currently available for the be qualifying the result
EGCATSND category for ABSOLUTE VALUES value and not the TEST,
for cardiovascular measurement or examination hence this does not
data: belong in CAT or SCAT.
CDISC Submission Value - ABSOLUTE VALUES The team does not
CDISC Synonym(s) - Absolute values believe there is an
CDISC Definition - Absolute values for existing variable to hold
cardiovascular measurement or examination this information
data. therefore, they suggest
the use of a suppqual to
store this data.
Do not add (P47):
CHANGE FROM
PRETREATMENT - Do
not add. This value is
not appropriate for
EGCAT variable.
General consensus from
the team is that this is
considered summary
data and not appropriate
for a SEND dataset. A
data analysis tool could
also produce this data.
Required for use with nonclinical SEND II

Controlled Terminology because a suitable
definition is not currently available for the
EGCATSND category for CHANGE FROM
PRETREATMENT for the calculation change from
Pretreatment data values
CDISC Submission Value - CHANGE FROM
PRETREATMENT
CDISC Synonym(s) - Change from Pretreatment
values
CDISC Definition - The calculation change from
Pretreatment data values (includes changes from
timed Pretreatment data values)
Pls add LBTEST = Glucose Management II SDTM, SEND-Published

Indicator; LBTESTCD = GMI This is T1D TA in P43
request.
The T1D team would like to finalize all their PR
issues by COB May 15 so pls give this request
priority.
https://wiki.cdisc.org/x/eT1cB
VISUAL ANALOG SCALE (0-100) This is as per II SDTM-Published in P43
the Eq-5D-3L IG and is for the EQ5D0106 test
where the scale is 0-100 but is not measured in
mm.
Please create term II SDTM, SEND-Published

NRHDRCDN/Norhydrocodone; this is also in P45
present in LOINC, please see 78868-7, for
example
Please create term NORXYCDN/Noroxycodone; II SDTM, SEND-Published

also present in LOINC, see 77779-7 for example. in P45
Please create term HALPRZLA/Alpha II SDTM, SEND-Published

Hydroxyalprazolam; also present in LOINC, see in P45
61035-2 for example.
Codelist to be used with --ANTREG findings II Do not add (P44): Do

variable with the following codes: not add. Given the fact
LESION that ANTREG has not
NON-LESION been evaluated for use
We have a study in Psoriasis which needs to in clinical studies, the
collect the following specimens in Biomarker (LB): CT team is very
? NON-LESIONAL SKIN SAMPLE uncomfortable creating
? LESIONAL SKIN SAMPLE controlled terminology
I had asked Erin for advice and she suggested for that codelist for
using --ANTREG.I can see that in 3.3 it "has not clinical use. Therefore
been evaluated for use in human clinical trials we will not develop this
and must therefore be used with extreme terminology. We would
caution". But it fits our need exactly. be open to developing
There are 2 options: CT for ANTREG on the
SPECTYPE=TISSUE, LOC=SKIN, clinical side when a use
ANTREG=LESION or NON-LESION case for the variable is
SPECTYPE=SKIN TISSUE, ANTREG=LESION identified by CDISC
or NON-LESION I wasn't sure if we needed NON- standards development
LESION? I wondered if this as just SKIN teams.
TISSUE? The General CT team
Grateful for your opinions. discusses the use of --
ANTREG for this use
case and is not certain
that it is appropriate;
there are not enough
use cases for clinical
usage of --ANTREG for
the team to be certain
that this modeling is
correct. Therefore they
think the safer option
may be a non-standard
variable to store this
information. Consider
that there is also a
SPECTYPE of SKIN
LESION so the
Definition: Baseline corrected value if the pre- II Do not add (P47): Do
dose for the PK profile values is above LLOQ and not add. Requester did
remains elevated. The baseline correction is not provide additional
made to correct un-physiological observations. information. Please re-
Baseline refers to the level prior to dosing. submit this request
when that information is
available, if desired.
Definition: Derivation method populating AVAL II Do not add (P45): Do

with the last value observed when subject was in not add. This codelist is
trial. extensible but we don't
believe this is a
We need more granularity than what is provided sufficiently common use
with the official codelist term LOV - Last case to be added to the
Observed Value Imputation Technique controlled terminology.
Definition: Derivation method populating AVAL II Do not add (P45): Do

with the last observed value where the subject not add. This codelist is
was on treatment extensible but we don't
believe this is a
We need more granularity than what is provided sufficiently common use
with the codelist term LOV -Last Observed Value case to be added to the
Imputation Technique controlled terminology.
Definition: Result at/below LOQ: AVAL set to zero II Do not add (P47): Do
for results at/below Limit of Quantification not add. Requester did
not provide additional
We'd like to distinguish the special situation information. Please re-
where AVAL is set to zero and not a value >0. submit this request
The latter case would be use the standard LLOQ when that information is
term. available, if desired.
Also, this request was
denied in P43 so please
check denial reason
there.
Definition: Imputation method using Mixed Model II Do not add (P47): Do

Repeated Measures (MMRM) not add. Requester did
not provide additional
information. Please re-
submit this request
when that information is
available, if desired.
Definition: Imputation of missing AVAL to zero. II Do not add (P45): Do
not add. This codelist is
This could be for a finding other than LAB results, extensible but we don't
where the limit of quantification codes do not believe this is a
apply (Use case 1) , or for a LAB finding (Use sufficiently common use
case 2). case to be added to the
controlled terminology.
Use case 1: Imputing AVAL for dosing in the
case where no dose was taken/dispensed
Use case 2: Imputing AVAL in trial designs were

faeces collection in 24h cycles was planned but
not obtained.
In both cases zeros are required to support report

output.
Definition: A relative measurement (ratio or II SDTM, SEND-Published

percentage) of the oxygen-hemoglobin saturation in P43
in blood to the percentage oxygen of an inhaled
mixture of gasses.
Needed as for COVID-19 study, LB team pls give
priority for discussion.
2 TIMES PER CYCLE II SDTM-Published in P44

3 TIMES PER CYCLE Do not add (P45):
DAILY EVERY OTHER WEEK DAILY EVERY OTHER
WEEK - Do not add.
requester.
A medicinal product inducing immunity against II

disease, most often to prevent occurence of a
disease, i.e. preventative vaccine (e.g. against
infectious disease) but also to treat a disease, i.e.
therapeutic vaccine (e.g. against cancer). A
preventative vaccine is an example of
prophylaxis.
Note : The vaccines against infectious disease
may contain various ingredients of diverse origin
(such as inactivated or attenuated organisms,
particular antigens related to the infectious agent,
live recombinant vector against antigens in vivo
and adjuvants) [After NCI Dictionary of Cancer
Terms. After European Pharmacopoeia section
5.1. ] See also treatment, prevention
Prevention : Practices or interventions used to II
help people stay healthy and avoid disease. Note:
involves limiting the chances of illness, injuries, or
reduced health status from occurring (primary
prevention) and, when diseases occur, supporting
people to manage them as effectively as possible
in order to prevent progression or recurrence
(secondary prevention). Prevention is achieved
by treatment, applying vaccines, behavioral
changes, life style changes, improved nutrition,
etc. Synonym : prophylaxis [After Prevention is
better than cure, UK Department of Health and
Social Care, Nov 5th 2018. After Primary,
secondary and tertiary prevention, Institute for
Work & Health, Toronto April 2015] References :
https://assets.publishing.service.gov.uk/
government/uploads/system/uploads/
attachment_data/file/753688/
Prevention_is_better_than_cure_5-11.pdf
https://www.iwh.on.ca/what-researchers-mean-
by/primary-secondary-and-tertiary-prevention
benign deciduoma Also found in: Encyclopedia. II Do not add (P43): Do

benign deciduoma not add. Request
An overgrowth of decidual cells, following withdrawn by requester.
pregnancy or trauma to the uterus. Email 2020-05-10: Hi.
See also: deciduoma Upon further inspection
ONLY MALIGNANT DECIDUOMA IS of INHAND terminology
CURRENTLY IN THE CT and speaking with that
group it was intentional
that they left out of
terminology so the
request can be
withdrawn. Dan
Data providers mapping Skull Bone and/or Bone, II SDTM, SEND-Published

Skull for LOC. in P44
Data providers mapping Urinary Bladder in LOC. II SDTM, SEND-Published

in P44
"Tracheal Aspirate" is a commonly referred to II SDTM-Published in P44

when a wash/aspirate is performed to collect fluid
from the lumen of the trachea.
Proposed definition: A degradative change in II SEND-Published in P44
neurons that is typically spontaneous, and is
characterized by distinct membrane bound pale
eosinophilic cytoplasm, dark eosinophilic globular
material, and usually occurs with no discernable
reaction of surrounding cells and a lack of
infiltrating inflammatory cells.
This finding is mainly a primate finding.
A circumferential measurement of the calf at the II SDTM, SEND-Published

widest point. in P45
To be used with VSTEST: Calf Circumference
A circumferential measurement of the calf at the II SDTM, SEND-Published

widest point. in P45
To be used with VSTESTCD: CALFCIR

Multiple terms for SPECTYPE codelist; Multiple II SDTM-Published in P44
term file emailed separately. Do not add (P44):
FIBROID TISSUE-> Do
not add. Please use a
SPECTYPE or TUMOR
TISSUE and specify the
type of tumor (in this
instance a Fibroid is a
Leiomyoma) in a
suppqual/NSV.
ICHOR-> Do not add.
Given the antiquated
nature of this term and
the fact that there is not
medical consensus on
its definition nor
synonymy with a variety
of terms in the
SPECTYPE list already
(e.g., Pus, Discharge,
Body Fluid, etc.) the
team will not propagage
its usage in CDISC CT.
The requester can use
this term as an
extensible term in the
codelist.
not add. Infiltration may
be the finding or result
of analysis/assessment.
The tissue type that
shows infiltration may be
a better SPECTYPE to
use, such as existing
term TISSUE.
Please add 6 new terms to the PKUNIT codelist. II SDTM, SEND-Published
The multiple term request form was attached to in P43
an email sent a couple of minutes ago. File Do not add (P43):
emailed separately. ug/L; Microgram per
Liter - Do not add. Use
C67306 where ug/L is
already a synonym.
Add terms to the SEND NONNEO codelist (file II SENd-Published
h*ug/L; Hour Times in P48
emailed separately) Do not add per
Microgram (P47):
Liter- - Do
CYCLE
not add.STAGE:
Use 85624 Do not
add.
whereOut of scope
h*ug/L is a for
NONNEO
synonym. The codelist.
PK teamThe
MAMI grouph*ug/L
also added will beas a
developing
synonym toan MITEST
that will cover this use
85624/h*ng/mL.
case
/L; Perin Liter;
a future
1/LCT- Do not
publication.
add. It is been the
Do not add
CDISC (P47): -to
convention
NUMBER,
NOT use "collapsed"
DECREASED:
unit. The PK team Do had
not
add. Please explicitly
traditionally use existing
term 'CELLULARITY,
spelled out the full unit
DECREASED'.
and its normalization,
Do
suchnotasadd
the (P47):
unit -
NUMBER,
ng/ml/mg for dose-
INCREASED:
normalized Do not
add.
concentration. existing
Please use
term 'CELLULARITY,
h/L; Hours per Liter - Do
INCREASED'.
not add. It is been the
Do not add
CDISC (P47): -to
convention
SIZE,
NOT use INCREASED:
"collapsed"Do
not
unit.add.
ThePlease
PK team usehad
existing termexplicitly
traditionally
'HYPERTROPHY'.
spelled out the full unit
and its normalization,
such as the unit
h*ng/ml/mg for dose-
normalized AUC.
kg/L; Kilogram per Liter -
Do not add. Map to
C64566 in PKUNIT.
h*kg/L; Hour Times
These terms are in INHAND but not SEND. II Kilogram per Literin- Do
SEND-Published P43
not add. Map to
GLAND, PARATHYROID C12765 Adenoma: A C85613/h*g/mL. Also,
benign neoplasm arising from Chief cells. the PK team added
GLAND, PARATHYROID C12765 Carcinoma: A h*kg/L as a new
malignant neoplasm arising from Chief cells. synonym to C85613.
The tumor combination working group had a II SEND-Published in P44

question about the following: SARCOMA,
UNDIFFERENTIATED, MALIGNANT It seems to
be a human specific tumor; should we consider
removing this from the list?
Definition: The source of notification from which II SDTM-Published in P44
the cause of death was obtained.
Multiple Choice Responses: DEATH

CERTIFICATE, HOSPITAL RECORDS,
INVESTIGATOR, FAMILY, OTHER
Definition: An indication as to whether a death II

was sudden.
Definition: An indication as to whether a II SDTM-Published in P44

hospitalization occurred due to a pregnancy
complication.
Definition = The length of time an infant was in II SDTM-Published in P44
gestation.
Responses = FULL-TERM (=>37WEEKS) or

PRE-TERM
Definition = A measurement of the total number of II Do not add (P45):
pre-term weeks of gestation. Request withdrawn by
requester.
The NCI definition for C44278 does not seem II SDTM, SEND-Published
appropriate - it seems to be a definition of the in P43
"unit" concept (as in the types of thing in the Unit Do not add (P43): Do
codelist) instead of defining a specific not deprecate or add
instance/type of unit. As the NCI definition refers synonyms. We will
to "an arbitrary unit" for most of the concepts that instead update the
include "U" in the submission value (e.g. U/mL, definition of U-based
U/mg, U/m2, etc.), it seems more appropriate for units of measure to
"U" to relate to the concept of "Arbitrary Unit". remove 'arbitrary' from
the definition.
This issue was raised during development of
examples relating to insulin dosing in the Type 1
Diabetes (Pediatrics and Devices) TAUG. JIRA
ref: TADIAB-282
Please add the following synonyms to LCN2 II SDTM, SEND-Published

(Lipocalin-2): in P45
neutrophil gelatinase-associated lipocalin NGAL I
don't know if you want to do the same for
LCN2CREA?
These are being used with the following II SDTM, SEND-Published

LBTESTCD codes: in P44
KIM1CREA in Urine (to be requested) Do not add (P44): Do
LCN2CREA in Urine not add. Please use
C120843 with
The LAB specifies the unit as UG/MMOL CREAT submission value
and NG/MMOL CREAT, but I'm assuming we will mg/mol. ug/mmol is a
not include CREAT in the unit as it will be obvious listed synonym.
from the test.
KIM1CREA (Kidney Injury Molecule-1/Creatinine) II SDTM, SEND-Published
A relative measurement (ratio or percentage) of in P45
the KIM-1 to creatinine present in a sample.
We have studies where the subject could either II SDTM-Published in P44

give consent or have a parent/guardian do it. So,
the current terms WITHDRAWAL BY
PARENT/GUARDIAN and WITHDRAWAL BY
SUBJECT are too specific and would not be
correct to use without first determining how the
consent was given and it is an overkill since all
that is needed is to know that whoever gave the
consent withdrew it.
It would be better to replace the existing terms
with this more generic term.
Changes to PASI terminology, QRS, needs Other SDTM-Published in P42

request code. This is going out in P42, just need
request code.
A measurement refers to the point during II
exercise at which ventilation starts to increase at
a faster rate than VO2 (V ? volume, O2 ? oxygen)
To be used with RETEST : Ventilatory Threshold
A measurement refers to the point during II

exercise at which ventilation starts to increase at
a faster rate than VO2 (V ? volume, O2 ? oxygen)
To be used with RETESTCD : VENTTHRE
As discussed in the CDISC Lab CT terminology II SDTM-Published in P44

team meeting 20-05-2020
This term is being captured as part of a II SDTM, SEND-Published

Coronavirus study. in P43
We are also asking that the same term which was

just requested last week for the LBTEST codelist
be updated so it is more generic by removing the
mention to blood so both the VS and LB terms
can use the same C Code.
Definition = A relative measurement (ratio or

percentage) of the oxygen-hemoglobin saturation
to the percentage oxygen of an inhaled mixture of
gasses.
This term is being captured as part of a II SDTM, SEND-Published
Coronavirus study. in P43
We are also asking that the same term which is in

the LBTEST codelist (C38082) be updated so it is
more generic by removing the mention to arterial
blood so both the VS and LB terms can use the
same C Code.

percentage) of the amount of oxygen measured
to the total oxygen in the inspired air.
Multiple new microorganism terms being II SDTM-Published in P43

requested; File e-mailed separately.
Add synonym for mapping sponsor term, Right II SDTM, SEND-Published
Atrioventricular Valve. in P44
Add synonym to map sponsor term, Left II SDTM, SEND-Published

Atrioventricular Valve. in P44
Needed for covering LOINC code 95125-1: II SDTM-Published in P43

"SARS coronavirus 2 IgA+IgM [Presence] in
Serum or Plasma by Immunoassay".
See: https://loinc.org/95125-1/
Needed for covering LOINC code 95209-3: II SDTM-Published in P43
"SARS coronavirus+SARS coronavirus 2 Ag
[Presence] in Respiratory specimen by Rapid
immunoassay".
This is a commercially available test from Quidel
Sofia.
Explanation (from LOINC website): "Qualitative
detection of SARS coronavirus (SARS-CoV, also
known as SARS-CoV-1) and SARS coronavirus 2
(SARS-CoV-2) antigens in respiratory specimens
by rapid immunoassay methods. The test detects
but does not differentiate between SARS-CoV
and SARS-CoV-2. This term was created for, but
is not limited in use to, the submitter's Quidel
Sofia 2 SARS Antigen FIA test kit."
MB team added multiple new terms and made II SDTM-Published in P43

changes to existing terms during 2020-05-28
meeting, need request codes. 5 Changes total.
File emailed separately. Do not add these into II Define-XML, Protocol,

P43 working documents. SDTM, SEND-Published
in P42
The study eye is selected as defined by the II Do not add (P45): Do
clinical trial protocol criteria to be used in the not add. Please use
evaluation of trial endpoints. FOCID variable to
To be used with OETEST: Study Eye capture this information.
The TEST should reflect
what is being measured
or assessed on/in the
study eye.
The study eye is selected as defined by the II Do not add (P45): Do

clinical trial protocol criteria to be used in the not add. Please use
evaluation of trial endpoints. FOCID variable to
To be used with OETESTCD: STEYE capture this information.
The TEST should reflect
what is being measured
or assessed on/in the
study eye.
Please add term 'MACULA', which already exists II SDTM, SEND-Published

in the NCI Thesaurus with code C26464 and in P45
definition: An oval-shaped, yellow pigmented area
located on the center of the retina, which contains
a high density of cones for high-acuity vision, and
which if damaged will result in the
partial/complete loss of central vision.
Please add term 'IReST (International Reading II SDTM-Published in P45

Speed Texts) Test' used in our trials; tentative
definition: a method for assessing reading
performance which consists of paragraphs of text
(approx. 130 words per text) according to the
everyday life reading demands, with the same
difficulty, content and linguistic characteristics in
multiple languages.
For CDASH SAE data v2, request addition of II SDTM-Published in P43

indicator for Reproductive Systems Findings test
code = GRAVIDA, Reproductive Systems
Findings Test ?Gravida? equal to CI EVS
C73435; Preferred term = Gravida; Definition = A
woman who currently is pregnant or has been in
the past, irrespective of the pregnancy outcome".
CDISC Definition: An indicator to identify if a
woman is or has ever been pregnant. Codelist =
NY
This term is currently available in the LB II SDTM-Published in P43
codelists. Please consider adding this to the
respiratory test codelist as well since so many
sponsor companies are conducting COVID-19
studies. Definition: A relative measurement (ratio
or percentage) of the force per unit area
(pressure) of oxygen dissolved in arterial blood to
the percentage oxygen of an inhaled mixture of
gasses.
To be clear, this lab test is different than the II SDTM, SEND-Published

Activated Partial Thromboplastin Time (aPTT). No in P45
activator is used in the PTT test. The reference
range is longer for the PTT. The normal reference
range of the aPTT is 30-40 seconds while the
reference range of the PTT is 60-70 seconds.
Suggested definition: A measurement of the
length of time that it takes for clotting to occur
when no activating reagents are added to a
biological specimen. The test is partial due to the
absence of tissue factor (Factor III) from the
reaction mixture.
Reference:
https://emedicine.medscape.com/article/2085837-
overview
Couinaud Segment I' already exists as a II SDTM, SEND-Published

synonym for C33000 in NCIT, could you also add in P45
it as a CDISC synonym.
Every two days II SDTM, SEND, CDASH-

Published in P44
Needed for mapping LOINC test 95411-5 and II SDTM-Published in P43
95410-7 to SDTM-MB.
See https://loinc.org/95410-7/ and
https://loinc.org/95411-5
Description: Neutralizing antibody testing is
performed to determine whether the antibodies
produced after SARS-CoV-2 infection or in
response to a vaccination are able to neutralize
the virus and prevent infection or re-infection.
Different methods can be used to determine the
presence of neutralizing antibodies, including
VNT (virus neutralization test) and pVNT
(pseudovirus neutralization test).
The synonym of MINIMAL RESPONSE is MR. II Do not add (P44):
The synonym of MR is MINOR RESPONSE. Implemented with P43.
That suppose that MINIMAL RESPONSE and Minimal Response and
MINIMAL RESPONSE are the same, and should Minor Response were
have the same definition, the same c-Code. deemed to be
Please could you update? synonymous by SMEs.
We will be merging
C158264 into C123598.
The submission value
will remain 'MR' and we
will add minimal
response as a synonym
to C123598.
The codelist definition is exactly the same for II

PGTST and PGTSTCD. Usually, there a
distinguish between the code and the test name.
That is very necessary for an informatic point of
view. Could you please update the codelist
definition ?
The request is to add as synonym the term HIV- II Do not change (P44):
1/2 Antigen to the term HIV-1/2 Antibody to the Do not add synonym.
codelist Microbiology Test Name (MBTEST). In Antigen and antibody
fact, in the definition of antibody the notion of are not the same thing.
antigen is used. An antibody is a blood
Definition: A type of protein made by B protein produced in
lymphocytes in response to a foreign substance response to, binds to
(antigen). Each antibody only binds to a specific and counteracting a
antigen, helping to destroy the antigen directly or specific "antigen". They
by assisting white blood cells to destroy the are the polar opposite of
antigen. each other biomedically
speaking, and in
function and structure.
When looking at cell density for contexts wherein II SDTM-Published in P45

you have a single cell layer (the eye, tissue
culture, etc.), the density measurement is done in
2 dimensions and the result will be a unit of area.
To accommodate this scenario, I?d like to
suggest a change in the CDISC definition of
C120538 to ?A measurement of the number of
cells contained in a unit of volume or area.? This
would also correct the usage of C120710-
C120713 in a 2-dimensional context base don
area, without having to re-define each of these
terms
the code will be used in the IND and NDA II SDTM, SEND-Published
submissions for novel biologics in P45
QSTESTCD and QSTEST for all 4 IPAQ II SDTM-Published in P43
questionnaires with synonyms of IPA01, IPA02,
IPA03 and IPA04; file emailed separately
Need to determine the need for two separate II SEND-Published in P47

terms - CARCINOMA, RENAL CELL,
MALIGNANT and
CARCINOMA, RENAL, TUBULAR, MALIGNANT
In preclinical use, there could be confusion over
which term to use.
A distinct variant of renal tubular tumor composed II SEND-Published in P44

of distinct lobules of large, round to polyhedral
cells with vacuolated amphophilic to eosinophilic
cytoplasm and prominent nucleoli. It is
recommended to analyze this tumor separately
from other renal tubular tumors.
Crabbs TA, Frame SR, Laast VA, Patrick DJ,
Thomas J, Zimmerman B, Hardisty JF (2013)
Occurrence of spontaneous amphophilic-vacuolar
renal tubule tumors in Sprague-Dawley rats from
subchronic toxicity studies. Toxicol Pathol41:866?
871
Desmethyldiazepam seems to be the same as II SDTM, SEND-Published

Nordazepam. Once added in the synonyms list, in P46
one can use the CT term "Nordazepam". Please
check.
"The QRS sub-team team approved the move of II SDTM-Published in P43
KFSS (CAT, TESTCD/TESTs) from the QS to RS
following:
o The questionnaires category codelist QSCAT
value of ?KFSS? to the clinical classifications
CCCAT codelist
o Renaming the questionnaires TESTCD codelist
of ?Kurtzke Functional Systems Scores
Questionnaire Test Code? to the clinical
classifications TESTCD codelist ? Kurtzke
Functional Systems Scores Clinical Classification
Test Code ?
o Renaming the questionnaires TEST codelist
of ?Kurtzke Functional Systems Scores
classifications codelist of ?Kurtzke Functional
Systems Scores Clinical Classification Test
Name?.
as a clinical classification."
Create new MB Test Detail codelist with 5 valid II SDTM-Published in P43

values.
NCI nor C DISC has a copy of the HAMD 17 II
1967 reference. The original 1960 reference was
used for implementation of the CRF. The 1960
reference paper and CRF were sent under
separate EMAIL
Create QSCAT values only for the following II SDTM-Published in P43

OPTUM copyrighted instruments.
QSTESTCD/QSTEST CT will be created in the
future in coordination with the copyright owner,
OPTUM.
SF12 V1.0 STANDARD & SF12 V1.0 ACUTE
SF10 V1.0 CHILDREN STANDARD & SF10 V1.0
CHILDREN ACUTE
FTTESTCD and FTTEST and FTCAT for 10 II SDTM-Published in P43

meter walk test; file emailed separately
The malignant version of endometrial stromal II SEND-Published in P44
polyp. No equivalent term in SEND neoplasm list. Do not add (P44): Do
Definition: A malignant neoplasm found in the not add. Please use
uterine wall or as polypoid masses projecting into existing term
the lumen, composed of stromal spindle-shaped C8973/STROMAL
cells with variable amounts of collagen and SARCOMA,
endothelial-lined vascular spaces. ENDOMETRIAL,
MALIGNANT.We will
add a synonym to the
published term.
No benign equivalent in SEND. INHAND notes II SEND-Published in P44

that only benign tumors have been reported in
rodents.
Definition: A benign neoplasm of the smooth

muscle that arises from the mesovarium.
This term is proposed in the TAUG Multiple II SDTM-Published in P45

sclerosis.Relapse is also a synonym of recurrent
disease.
This term is used for oncology studies.
We propose to ass it in the MHEDTTYP codelist
with the definition : "The relapse is the return of
an illness suffered previously after making an
improvement."
LOC codelist, add multiple new terms for SEND II SDTM, SEND-Published
use in FX domain (FXLOC). File emailed in P44
separately. Do not add (P44):
NARIS-> Do not add.
Instead add synonym
onto existing term. This
will be covered by a
separate request.
Heart, Ventricular
Chamber-> Do not add.
This is already
published as
C12730/HEART,
VENTRICLE.
Adding some additional more specific IgE test II Do not add (P44):
names/codes and some bile acid panel test Withdrawn by requester
names/codes to LBTEST/LBTESTCD. File on 2020-06-29. This has
emailed separately. been published in P42.
Do not add (P45):
UDCA;
Ursodeoxycholate ->
Will be published with
P44. Do not re-develop.
A modification of the disk diffusion method that is II SDTM-Published in P45,
used to detect beta-lactamase production in P47
designated bacterial species. Filter paper disks
containing a specific amount of penicillin are
placed on the agar surface that has been
previously inoculated with the bacteria of interest.
Beta lactamase production is assessed by the
shape of the area around the disk that is free of
microbial growth (a sharp zone edge is Beta-
lactamase positive and a fuzzy zone edge is
Beta-lactamase negative).
Hi Erin, Jordan here, a very quick look at this

request I already don't think this is the correct
method, this looks like a MIC or Diameter of the
Zone of Inhibition test where "penicillin" goes into
MSAGENT and METHOD is DISK DIFFUSION.
Look at this example in SDTMIG 3.4:
https://wiki.cdisc.org/x/aD7zAw. Maybe ask
brenda to look into this test and confirm that this
is indeed a disk difussion type of assessment.
Gel electrophoresis for separation of large DNA II SDTM-Published in P46

fragments by applying an electric field that
periodically changes direction to a gel matrix
Used for an AP QS scale where staff and the II Do not add (P50): Do
supervisor in a unit are asked their opinions of the not add. Based on the
drug/process/situation. RELSUB was Clinician, so requester use case, the
EVAL needs to distinguish the responses from role of the person filling
the staff and their supervisor. I'm not sure if you out the questionnaire
would consider EVAL to be HEALTH CARE should be add as an
PROFESSIONAL and Staff and SUPERVISOR to NSV value, not in EVAL.
be MEDEVAL? Please refer to
published QRS
supplements for how to
model this data.
ENDOSCOPIC RETROGRADE II SDTM-Published in P46
CHOLANGIOPANCREATOGRAPHY - aka ERCP
- a technique that combines the use of endoscopy
and fluoroscopy to diagnose and treat certain
problems of the biliary or pancreatic ductal
systems.
ENDOSCOPIC ULTRASOUND - aka echo-

endoscopy; EUS - a procedure in which
endoscopy is combined with ultrasound to obtain
images of the internal organs in the chest,
abdomen and colon.
TRANSABDOMINAL ULTRASOUND - aka

abdominal ultrasound imaging; Abdominal
ultrasonography ; abdominal sonography;
Abdominal ultrasonography - a procedure which
uses transmission and reflection of ultrasound
waves to visualise internal organs through the
abdominal wall (with the help of gel, which helps
transmission of the sound waves).
A unit of mass concentration defined as the II SDTM, SEND-Published

concentration of one milligram of a substance in in P44
unit volume of the mixture equal to one cubic
deciliter or 100 cubic centimeters. It is also a unit
of mass density (volumic mass) defined as the
density of substance which mass equal to one
milligram occupies the volume one cubic deciliter
or 100 cubic centimeters.(NCI)
You will never see PT reported in % (PT activity) II Do not add (P45): Do
at US sites like for this test. Some European sites not add. Please use
think this is an accurate measure of liver failure. existing term:
Please see the details of how this test is done ... C98774/Prothrombin
Activity/PTA. Quick is
?PT was determined on freeze (-80C)-thawed more methodological
(37C) plasmas by the manual tilt-tube technique information that does
by adding 200 uL of thromboplastin reagent to not belong in the analyte
100 uL of plasma and the clotting time in seconds (LBTEST/CD) field.
was recorded. Results were expressed in
seconds (PTs), activity percentage (PTp), ratio
(PTr), and INR. To obtain PTp expression, a
saline dilution curve was constructed with normal
pool plasma and the patient?s result was
expressed as the percentage of normal plasma
yielding the same PT in seconds. (From
Prothrombin Time in Liver Failure: Time, Ratio,
Activity Percentage, or International Normalized
Ratio?
Annie Robert and Chazouilleres HEPATOLOGY
Vol. 24, No. 6, 1996?
The request is to add Thou/mcL as a synonym of II SDTM, SEND-Published

10^9/L. in P44
to add as synonym K/cu of 10^9/L. In fact, this II SDTM, SEND-Published

unit is often used for hematology, platelets and in P44
WBC.
the request is adding as synonym Mill/mcL of the II SDTM, SEND-Published

term 10^12/L in P44
New Terms: II SDTM, SEND-Published

Skin of the Upper Extremity: The integument that in P44
covers the upper extremity.
Skin of the Lower Extremity: The integument that
covers the lower extremity.
Change to Existing:
LEG definition. The definition should reflect the
various uses of LEG, both generically and as the
lower portion of the lower extremity, which is the
official anatomy definition, like Arm and Forearm.
We are using this procedure of Secondary II SDTM-Published in P47
Electrospray Ionization High-resolution Mass
Spectrometry (SESI-HRMS) in a study and the
definition is: A secondary electrospray ionization
(SESI) method was developed as a
nonradioactive ionization source for ion mobility
spectrometry. SESI coupled to high-resolution
mass spectrometry (HRMS) has been shown to
be a powerful technique for breath analysis and
biomarker identification.
This term is already in PKUNIT, but we require it II SDTM, SEND-Published

in unit to use with EX/EC records related to an in P44
infused dose.
A measurement of the Neutrophil Gelatinase - II Do not add (P45): Do
associated Lipocalin in a URINE sample by not add. Please use
Calculation method. existing term C106539.
We will add synonyms.
A relative measurement (ratio or percentage) of II SDTM, SEND-Published
the Neutrophil Gelatinase - associated Lipocalin in P45
(NGAL) to creatinine in a biological specimen. Do not add (P45):
Neutrophil Gelatinase -
associated Lipocalin
(NGAL)/Creatinine Ratio
-> Do not add. Please
use existing term
synonyms.
A relative measurement (ratio or percentage) of II SDTM, SEND-Published

the Osteopontin to creatinine in a biological in P45
specimen.
A measurement of the Lurasidone present in a II SDTM, SEND-Published
PLASMA sample by LC-MS/MS method in P45
A measurement of the Haloperidol present in a II SDTM, SEND-Published
A measurement of the Quetiapine present in a II SDTM, SEND-Published
A measurement of the Olanzapine present in a II SDTM, SEND-Published
A measurement of the Ndesmethylolanz present II SDTM, SEND-Published
in a PLASMA sample by LC-MS/MS method in P45
A measurement of the Chlorpromazine present in II SDTM, SEND-Published

a PLASMA sample in P45
A measurement of the Risperidone present in a II SDTM, SEND-Published
A measurement of the 9-hydroxyrisperidone II SDTM, SEND-Published
present in a PLASMA sample by LC-MS/MS in P45
method
A measurement of the Risperidone & 9- II SDTM, SEND-Published
Hydroxyrisperidone ,Total present in a PLASMA in P45
sample by LC-MS/MS method
A measurement of the Paliperidone present in a II SDTM, SEND-Published
A measurement of the Brexpiprazole present in a II SDTM, SEND-Published
A measurement of the Aripiprazole present in a II SDTM, SEND-Published
A measurement of the Cariprazine(CSA) present II SDTM, SEND-Published
A measurement of the Thiothixene present in a II SDTM, SEND-Published

A measurement of the Loxapine present in a II SDTM, SEND-Published
A measurement of the Thioridazine present in a II SDTM, SEND-Published
PLASMA sample in P45
A measurement of the Molindone present in a II SDTM, SEND-Published
A measurement of the Trifluoperazine present in II SDTM, SEND-Published
a PLASMA sample by LC-MS/MS method in P45
A measurement of the Prochlorperazine present II SDTM, SEND-Published
A measurement of the Iloperidone present in a II SDTM, SEND-Published

A measurement of the Asenapine present in a II SDTM, SEND-Published
A measurement of the Ziprasidone present in a II SDTM, SEND-Published
A measurement of the Pimozide present in a II SDTM, SEND-Published
A measurement of the Perphenazine present in a II SDTM, SEND-Published
A measurement of the Sonic Hedgehog present II SDTM, SEND-Published
in a SERUM sample by ELISA method in P45
File emailed separately. (Apologies if II SEND-Published in P44
spreadsheet format does not match above) Do not add (P44):
SEXUAL MATURITY->
Do not add. This does
not actually further
categorize the result
values listed in
MISXMAT and the team
agrees that it is
redundant with the test
such that it shouldn't be
added.
Addition of a unit commonly used in nonclinical II SDTM, SEND-Published
PK studies. Proposed definition: Hours times in P44
micrograms per gram (area under the curve).
During development of CTR-XML, a 'question' II SDTM-Published in P44

concept was never created to support this list of
valid values (i.e., responses), therefore CONROL
is an orphan codelist. In the interests of
consistency with other concepts that were
created for the CTR-XML project, we submitted
'Contact Role for Clinical Study' as a new
TSPARM value
LBTEST: Metanephrine+Normetanephrine II SDTM-Published in P45

LBTESTCD: MTNNMTN or MNMTN
Definition: A measurement of the metanephrine
and normetanephrine in a biological specimen.
LBTEST: Metanephrine+Normetanephrine Excr

Rate (to be under 40 characters)
LBTESTCD: MNMTNEXR
Definition: A measurement of the amount of
metanephrine and normetanephrine being
excreted in a biological specimen over a defined
amount of time (e.g. one hour).
Please consider adding to the NCOMPLT codelist II SDTM, SEND-Published

a new term of LOGISTICAL REASONS. The in P44
suggested definition is: A problem with some
logistical aspect of a clinical study, such as
temporary site closures, scheduling difficulties,
subject couldn't arrange to be at site for
appointment, other non-subject related issues,
etc.
Please add term: Superior Temporal Gyrus, also II SDTM, SEND-Published

defined in NCI Thesaurus: in P46
https://ncit.nci.nih.gov/ncitbrowser/ConceptReport
.jsp?
dictionary=NCI_Thesaurus&version=20.05d&ns=
ncit&code=C33698&key=637272612&b=1&n=null
Please add term: Middle Temporal Gyrus, also II SDTM, SEND-Published

https://ncit.nci.nih.gov/ncitbrowser/pages/concept
_details.jsf?
dictionary=NCI_Thesaurus&version=20.05d&cod
e=C33125&ns=ncit&type=properties&key=null&b
=1&n=0&vse=null
Please add term: Inferior Temporal Gyrus, also II SDTM, SEND-Published
https://ncit.nci.nih.gov/ncitbrowser/ConceptReport
.jsp?
ncit&code=C32792&key=1141823685&b=1&n=n
ull
This term suggestion also pertains to II SDTM, SEND-Published

LBTESTCD. in P46
For NCI Code C81951, instead of "Starch

Crystals Measurement", could we rename this to
"Starch Granules Measurement"? Per literature
searches and LOINC, the microscopic finding is
always granules instead of crystals.
We are using this method in a study. The term II SDTM-Published in P48

and definition are: QUANTITATIVE
METYLATION SPECIFIC-PCR - A type of assay
designed to specifically amplify bisulphite-
converted methylated DNA target sequences in
the presence of an excess of unmethylated
counterpart sequences. This can provide
accurate detection and quantitation of methylated
alleles.
We are using the METHOD of METHYLATION II SDTM-Published in P48

SENSITIVE-QUANTITATIVE LOCKED NUCLEIC
ACID PCR in a study. The proposed definition for
this METHOD is: A method which can rapidly
access the methylation status of virtually any
group of CpG sites independent of the use of
methylation-sensitive restriction enzymes.
https://en.wikipedia.org/wiki/Alpha- II SDTM, SEND-Published

Aminobutyric_acid in P46
Required for LOINC to SDTM-MB mapping e.g. II SDTM-Published in P44

for LOINC code 94661-6 (https://loinc.org/94661-
6) "SARS-CoV-2 (COVID-19) Ab [Interpretation]
in Serum or Plasma" or LOINC code 94769-7
(https://loinc.org/94769-7) "SARS-CoV-2 (COVID-
19) Ab [Units/volume] in Serum or Plasma by
Immunoassay" i.e. for the case that ANY antibody
against the virus is tested on, without exactly
specifying which antibody.
Required for LOINC to CDISC-MB mapping for II SDTM-Published in P44
e.g. LOINC code 94558-4
(https://loinc.org/94558-4) "SARS-CoV-2 (COVID-
19) Ag [Presence] in Respiratory specimen by
Rapid immunoassay", i.e. for the case that ANY
antigen agaist the virus is tested on, without
specifying exactly which antigen specifically.
no particular information II
The definition of 'Resection' according to NCI is 'A II Do not add (P45): Do

surgical procedure in which tissue is removed.' not add synonym.
and the definition of Excision is ' The act of Excision and Resection
cutting out; the surgical removal of part or all of a are not synonymous.
structure or organ.' These two terms are defined Please see NCI
similarly in NCI and 'Resection' already exists as definitions for
a synonym for 'Excision' in NCI. Could you also C15232/Excision and
add it as a synonym in CDISC? C158758/Resection for
clarity on the distinction
between the two.
Change: II Define-XML, Protocol,

"A person responsible for the conduct of the SDTM-Published in P45
clinical trial at a trial site. If a trial is conducted by Do not add (P45):
a team of individuals at the trial site, the Please rename codelist
investigator is the responsible leader of the team to C19FATS, I believe
and may be called the principle investigator." "S" is missing at the
To: end. - Do not change.
"A person responsible for the conduct of the While the team tends to
clinical trial at a trial site. If a trial is conducted by use --FATS and --
a team of individuals at the trial site, the FATSCD as root names
investigator is the responsible leader of the team for findings about TEST
and may be called the principal investigator." and TESTCD codelists,
for COVID-19, we
intentionally broke this
norm because a two-
letter beginning code for
COVID-19 was not
possible (C1 and C9
really didn't work to
convey uniqueness). So
the team chose this
name intentionally.
For term C81998, Amyloid P Measurement, is this II SDTM, SEND-Published
not also known as serum amyloid p component? in P46
Could we update the term to "Serum Amyloid P
Component Measurement", or add "Serum
Amyloid P Component" as a synonym?
Serum is not the specimen type information, but
part of the accepted name of the protein.
From Geroge: A NCI user has suggested that our II SDTM, SEND-Published
Leg and Lower Extremity definitions are in P44
contradictory. I don't think our current definitions
are necessarily wrong (though perhaps
anatomically imprecise) but I understand the
confusion from the user's standpoint especially
since the latter implies that the leg is a portion of
the lower extremity and the former equates them:
C32974/Leg
NCI Def: One of the two lower extremities in
humans used for locomotion and support.
CDISC Def: One of the two lower extremities in
humans used for locomotion and support. (NCI)
C12742/Lower Extremity
NCI Def: The limb that is composed of the hip,
thigh, leg and foot.
CDISC Def: The limb that is composed of the hip,
thigh, leg and foot. (NCI)
To end the confusion, I would propose we re-

define Leg as "The portion of the lower extremity
between the knee and the ankle. For clinical
purposes this term is also used to refer to the
whole inferior limb.", which parallels what we've
done with Arm. NCI Def for Leg will be updated
accordingly, please consider whether this change
also applies to the CDISC DEF.
Def:: The (current sum of volumes minus the II

lowest sum of volumes previously recorded)
divided by the lowest sum of volumes previously
recorded, multiplied by 100.
We already have
PCBSD Percent Change Baseline in Sum of
Diam
PCNSD Percent Change Nadir in Sum of Diam
PCBSV Percent Change Baseline in Sum of
Volume
In the COVID load, the MICROORG term SARS II Do not add (P44): Do
CORONAVIRUS (C112432) was updated to be not change.This term
SEVERE ACUTE RESPIRATORY SYNDROME- will be deprecated in
RELATED CORONAVIRUS. P44 along with its entire
However, it wasn't updated in the SPCIES codelist, hence no
codelist. Since they are the same <C> code, changes are required for
definition & NCI code I would expect them to the submission value.
have the same Submission value.
The QRS sub-team team approved the move of II SDTM-Published in P43

FAQ (CAT, TESTCD/TESTs) from the QS to RS
following:
value of ?FAQ? to the clinical classifications
CCCAT codelist
of ?Functional Activities Questionnaire Test
Code? to the clinical classifications TESTCD
codelist ?Functional Activities Questionnaire
Clinical Classification Test Code ?
of ?Functional Activities Questionnaire Test
Name? to the clinical classifications codelist of ?
Functional Activities Questionnaire Clinical
PYLORUS OF THE STOMACH:The pylorus II SDTM, SEND-Published

connects the stomach to the duodenum. The in P46
pylorus has two parts; the pyloric antrum
(opening to the body of the stomach) and the
pyloric canal (opening to the duodenum).
LESSER CURVATURE OF THE STOMACH: The

lesser curvature of the stomach extends between
the cardiac and pyloric orifices and forms the right
or medial border of the stomach.
As well as 'Target' lesions for which we will use II Do not add (P45):
PCBSV etc for, we also need to include %Change Baseline
'measured' lesions Volume Measured
Lesion -> Do not add.
Please use Percent
Change Baseline in
Sum of Volume/PCBSV
(C112372) which is
already published.
%Change Nadir Volume
Measured Lesion -> Do
not add. Please use
new term with P45
Percent Change Nadir in
Sum of Volume/PCNSV.
Can you please clarify the response given II Do not add (P47):
regarding CT request CDISC-3754 for the Question answered. We
addition of OTHER and UNKNOWN to LOC. The will be updating the
last sentence for UNKNOWN is unclear as I'm not denied request reason
sure why the term would need to be removed for UNKNOWN on row
before submission. If this is an extensible codelist 490 of the General tab
I would expect it to remain. in the denied requests
Since OTHER and UNNOWN are required file. The CT team have
frequently for LOC (and other codelists) I would intentionally not added
have thought adding it to the codelist as a CDISC terms like OTHER and
'core' code would be preferable. UNKNOWN since these
Erin also asks that the General CT team review types of values are not
the request since they have jurisdiction over the really answers to the
LOC codelist. question but rather
I also wanted to confirm that if we add OTHER or reasons for why data is
UNKNOWN to a CDISC codelist that doesn't not available.
contain it, we would add it as extensible, but still Additionally, because
use the <C> NCI code if the concept is identical sponsors can implement
to the CDISC term. 'Other, specify' types of
collected data in
different ways, the CT
teams have chosen not
Please move the KPS SCALE from QS and move II SDTM-Published
to add OTHER to in P43
many
to CC. File emailed separately. codelists (See section
This is the original 1960 reference to use for the II 4.1.2.7.1 of
CDISC Definition. SDTMIGv3.2). It is
reasonable to re-use the
The Hamilton Depression Rating Scale 17-Item c-code of OTHER and
(HAMD 17) (Hamilton M. A rating scale for UNKNOWN in
depression. J Neurol Neurosurg Psychiatry 1960; extensible codelists
23:56?62). where those values are
not present in the
I will present this at the next QRS CT team published CT.
meeting.
1. There may be a redundant tumor listing in the II SEND-Published in P44,
benign tumor P47
Tumor, Sertoli cell, benign SERTOLI CELL
TUMOR, BENIGN
C67012
Tumor, Sertoli cell, malignant SERTOLI CELL
TUMOR, MALIGNANT
C67006
not in inhand ADENOMA,
SERTOLIFORM TUBULAR, BENIGN
C92180
2. To the best of our knowledge benign Yolk Sac

Tumor has not been reported; can we check to
see where this came from?
Carcinoma, yolk sac YOLK SAC
TUMOR, MALIGNANT
C3011
SEND has a benign version; INHAND does not
YOLK SAC TUMOR, BENIGN
C84357
3. To the best of our knowledge malignant

mesovarial leiomyoma has not been reported;
can we check to see where this came from?
Leiomyoma, mesovarium No benign
equivalent in SEND; request submitted
not in inhand LEIOMYOMA,

MESOVARIAL, MALIGNANT
C124610
4. There may be a redundant tumor listing for the

benign tumor
Tumor, sex cord stromal, mixed, benign
SEX CORD STROMAL TUMOR, MIXED,
BENIGN
QSTESTCD/QSTEST/QSCAT for IBDQ (Quality II SDTM-Published in P43
of Life in Inflammatory Bowel Disease
Questionnaire) for Crohn's TAUG; file emailed
separately.
Multi term request spreadsheet emailed II SDTM-Published in P47
Do not add (P47): -
Presence of Wave V at
70 dB nHL: Do not add.
Please use ABRVP/ABR
Wave V, Presence and
put decibel levels in --
TSTCND variable
(SDTMv2.0)
Do not add (P47): -
TSTCND variable
(SDTMv2.0)
Do not add (P47): -
TSTCND variable
(SDTMv2.0)
Do not add (P47): -
TSTCND variable
(SDTMv2.0)
Do not add (P47): -
SUPERIOR-INFERIOR:
Do not add. The context
presented by the
Request for new CVTEST, DIR emailed II
separately
these new terms are required for FDA OVRR II SDTM-Published in P44
submissions
Please add term: ROTH 28 HUE TEST- a II SDTM-Published in P46

shortened version of FARNSWORTH-MUNSELL
100 HUE TEST (FM100) using every third color
cap.
Please add synonym 'Fluorescein Angiography' II Do not change (P46):
to existing term FLUORESCENCE Fluorescein is a specific
ANGIOGRAPHY. dye used in this
procedure but other
dyes may be used as
well. Please use existing
term and if important
place the Fluorescein
Dye in an AG/Procedure
Agent domain record.
Please add term: Indocyanine Green II Do not add (P47): Do

Angiography (ICG) - a diagnostic procedure that not add. Indocyanine
uses ICG dye to examine the blood flow in the Green is a specific dye
CHOROID ? the layer of blood vessels which lies used in angiogiography
underneath the retina but other dyes may be
used as well such as
fluorescein. Please use
existing term
"Fluorescence
Angiography"
(C116569) and if
important place the dye
type in an AG/Procedure
Agent domain record.
New terms for Crohn's TA WP1 and 2. Two Files II SDTM-Published in P44
emailed separately. Do not add (P44):
Imaging Quality;
IMQUAL -> Image
quality is not a biological
finding but a part of the
data quality QC process,
it really does not belong
in any body system
domains. We
understand the
precedent set by the TB
TAUG, but we do not
think this is a valid body
system assessment.
The general team does
not recommend treating
this concept as a
GITEST, you can still
map this concept to the
GI domain dataset but
pls consider creating a
non-standard variable to
house this value.
Number of Narrowings;
NUMNAR-> Withdrawn
by requester. This is the
same as Number of
Stricture/STRCTNUM,
which will be published
in P43. Modeling has
been changed to
existing terminology.
Explored Indicator -> Do
not add. Terminology
withdrawn by Crohn's
team for different
New terms for Crohn's TA WP2, batch 2. File II SDTM-Published in P44,
emailed separately. P45
Do not add (P44)-
MIANTREG->
Withdrawn by requester,
LOC SDS subteam
modeling may change
the fate of this variable
use in SDTM, hence
withdraw for now.
MIALL; Microscopic
Findings-> Do not add.
The modeling is correct
and in-line with SDTMIG
v3.2 section 4.1.5.1.2
Tests Not Done (and
later versions of the
SDTMIG). However CT
will not control this
TESTCD = --ALL (e.g.
MIALL, LBALL) because
this is not a true
biological finding. The
MITEST-CD codelists
are extensible so if
users need to report
this, they can just add
this as an extensible
value.
IMQUAL; Imaging
Quality-> Do not add.
Image quality is not a
biological finding but a
part of the data quality
QC process, it really
does not belong in any
body system or
Please add test , which is done as part of the II SDTM, SEND-Published
drug screen panel; please see reference: in P45
https://testdirectory.questdiagnostics.com/test/tes
t-detail/15922/aripiprazole-quantitative-
serumplasma?cc=MASTER
Please add test Brexipiprazole, done as part of II Do not add (P49):

the Drug Screen panel; see reference: BRXPPZL/Brexipiprazol
https://testdirectory.questdiagnostics.com/test/tes e - Do not add. Correct
t-detail/37246/?cc=MASTER spelling is
Brexpiprazole, which is
already published as
C177973.
Pls add LBTEST new terms. File emailed II SDTM, SEND-Published

separately. in P45, P47
not add. Synonymous
with C177967. We will
add synonyms instead.
Vaccine II
A medicinal product inducing immunity against
disease, most often to prevent occurence of a
disease, i.e. preventative vaccine (e.g. against
infectious disease) but also to treat a disease, i.e.
therapeutic vaccine (e.g. against cancer)
Note : The vaccines against infectious disease
may contain various ingredients of diverse origin
(such as inactivated or attenuated organisms,
particular antigens related to the infectious agent,
live recombinant vector against antigens in vivo
and adjuvants)
[After NCI Dictionary of Cancer Terms. After
European Pharmacopoeia section 5.1. ]
Diagnosis (new term) : II

Determining which disease or condition explains
the symptoms and signs occurring a patient. Note
: The information required for diagnosis is
collected from a history and physical examination
of the person seeking medical care and
confirmed by one or more diagnostic procedures
such as laboratory tests, radiologic studies and
other technical investigations.
[After ""Making a diagnosis"", John P. Langlois,
Chapter 10 in Fundamentals of clinical practice
(2002). Mark B. Mengel, Warren Lee Holleman,
Scott A. Fields. 2nd edition.]
See also treatment
Previously requested as "Alpha-1 Antitrypsin II SDTM, SEND-Published

Function (AATFUNC)" but it was rejected in P42. in P47
We still feel this test is justified to be included.
Essentially the already published term ?Alpha-1
Antitrypsin? is the total amount i.e. (functional +
non functional) Alpha-1 Antitrypsin. The test we
requested measures the functional component of
total Alpha-1 Antitrypsin.
Synthetic data II
data that is artificially created rather than being
generated by actual events. NOTE: It is often
created with the help of algorithms and is used for
a wide range of activities, including as test data
for new products and tools, for model validation,
and in AI needs. Healthcare: Synthetic data
enables healthcare data professionals to allow
the public use of record data while still
maintaining patient confidentiality.
https://research.aimultiple.com/synthetic-data/
Definition: The most recent occurrence of a II Do not add (P45): Do

episode. not add. Please use
existing term 'EPISODE'
and put 'MOST
RECENT' into a NSV;
consider --CRNORD as
per Psoriasis, HIV, MDD
TAUGs.
Definition: The patient will return home but will II SDTM-Published in P46
receive nursing support.
Definition: The patient will receive long term care II SDTM-Published in P46
at a nursing care facility.
Definition: The patient will be receive care at non- II Do not add (P46): Do
hospital intermediate care center. not add, map to
C99912/INTERMEDIAT
E CARE FACILITY.
Definition: The patient will receive care at a II SDTM-Published in P46
rehabilitation center.
The definition for the newly requested term II Do not add (P47): Do
UPPER BACK is: The upper back area includes not add. Please use
the shoulder blades and where the rib cage existing LOC=BACK
connects to the thoracic (chest region) spine. and DIR=UPPER.
The upper back is also referred to as the middle
back or the thoracic spine. The codelist currently
contains SKIN OF THE BACK and BACK. There
are entries for THORACIC SPINE, but that does
not include the entire upper back.
The definiti8on for SKIUN SUCTION BLISTER is: II SDTM-Published in P46
Suction blistering is a technique used in
dermatology to treat chronic wounds, such as
non-healing leg ulcers. When a wound is not
healing properly, an autologous skin graft is the
best option, to prevent rejection of the tissue.
Since autologous transplantation cannot always
be performed, a substitute has to be used, such
as cultured skin. However, this technique is costly
and time-consuming. Other uses of suction
blisters are to provide transplantation donor
tissue for vitiigo research. Suction blisters are
often used in tissue serum research in the
pharmaceutical and cosmetic research fields.
Many research citations are published worldwide
that support these uses.
When looking at the 2 terms the value of MR is II Do not add (P44):

related to both terms. For the term MINIMAL Implemented with P43.
RESPONSE - MR is a synonym and as you can Minimal Response and
see it is also a CDISC Submission Value. This is Minor Response were
very confusing as should be clarified. Is there a deemed to be
difference between the two Submission Values? synonymous by SMEs.
We will be merging
C158264 into C123598.
The submission value
will remain 'MR' and we
will add minimal
response as a synonym
to C123598.
This codelist was created to support the -- II SDTM-Published in P44

NSPCES variable in the version 1 of PGx user
guide and this variable has been deprecated.
Therefore this codelist is no longer needed.
PKPARMCD=QRCPCLSTI PKPARM = Pct Rec II Do not add (P45):

to Last Measured Interval Requester withdraws
request.
Thee definition is The percentage of the
administered dose that is recovered from the
specimen type specified in PPSPEC, from the
time of dosing to the last time interval of sample
collection, where the analyte was measured
including results < LLOQ.
Proposed definition: Two paired muscles (major II SEND-Published in P46

and minor) extending from the zygomatic bone to
the corners of the mouth/upper lip; primary
function is to draw the lip up and lateral.
A measurement of the phospholipase A2 in a II SDTM, SEND-Published
We ask that the Definition of the SS domain II SDTM-Published in P47

abbreviation (C117655) be updated from "A
findings domain that contains general subject
characteristics that are evaluated periodically to
determine if they have changed." to "A findings
domain that contains the subject's status that is
evaluated periodically to determine if they have
changed."
During SDS v3.4 PR Issue Resolution changes
were made to the definition of the Subject Status
domain. Use of the word 'Characteristic' in the
SS domain has now been limited to references to
the Domain Description of the SC domain (and
change notes indicating that the SS domain
should not contain data that belongs in the SC
domain).
Please see:
pageId=66272533
and
https://jira.cdisc.org/browse/SDS-1736
The definition for the DTYPE of LVWI is: A data II Do not add (P45): Do
derivation or imputation technique which sets the not add. This codelist is
analysis value on the record to the subject's last extensible but we don't
observed value within an time interval. believe this is a
sufficiently common use
case to be added to the
controlled terminology.
Not available in the current SEND list. Definition: II SEND-Published in P44

A malignant neoplasm arising from the posterior
lobe of the pituitary gland. The benign
pituicytoma will need an update to the definition.
Could you please consider the addition of II SDTM, SEND-Published

FAUCES as localisation? in P47
Please refer to "Validation of a New Scoring
System for the Assessment of Clinical Trial
Research of Oral Mucositis Induced by Radiation
or Chemotherapy"
https://acsjournals.onlinelibrary.wiley.com/doi/
10.1002/(SICI)1097-
0142(19990515)85:10%3C2103::AID-
CNCR2%3E3.0.CO;2-0
The above tumors should be synonyms of II SEND-Published in P47
GASTROINTESTINAL STROMA TUMOR,
MALIGNANT
GASTROINTESTINAL STROMAL TUMOR,
BENIGN
These are for the Duchenne TAUG, updated II SDTM-Published in P43

terminology per QRS supplement review and
CDASH review of CRF
Cycle threshold is an experimentally determined II Do not change (P44):

value, it is therefore NOT a true Device Setting. Do not remove from
The MB team has added Ct # to the MB Test codelist. In an IVD
Detail (MBTSTDTL) Codelist and this value has machine, this would be
been represented in the MBTSTDTL variable in in the software as a
several TAUGs and the SDTMIGs. The MB team setting and would fall
also consulted with the developer (Jon Nevil) who into a DOTEST in the
requested "Threshold Cycle" to be added to context of a submission
DOTEST/CD and he agrees that this value of the device to CDRH.
should be deprecated from DOTEST/CD.
"See also virtual trial/ visit. " From FDA Guidance II Glossary-Published in
on Conduct of Clinical Trials of Medical Products P44
during COVID-19 Public Health Emergency (2
July 2020) "Since trial participants may not be
able to come to the investigational site for
protocol-specified visits, sponsors should
evaluate whether alternative methods for safety
assessments (e.g. phone contact, virtual visit,
alternative location for assessment, including
local labs or imaging centers) could be
implemented when necessary and feasible, and
would be sufficient to assure the safety of trial
participants.
virtual: not physically present. Refers to visits or II

encounters between investigators and subjects
where information exchange is mediated through
telemedicine, video conference rather than by
physical presence of individuals at a shared
location. Trials with one or more virtual visits are
virtual trials. Where all data capture and trial
procedures are conducted virtually, a trial or other
investigation may be called fully virtual. See also
remote, decentralized..
Decentralized clinical trial A trial where data II
capture, administration of medication, and
possibly other procedures are done at the home
of a subject rather than at a (centralized) clinical
site serving as a common location where
procedures are done for subjects registered to
that site. NOTE: the procedures (entry of data,
medical tests, clinical evaluations, objective
measures, observations) for capturing safety and
efficacy measurements and observations may be
done in person by a traveling clinician or nurse so
DCTs are not necessarily virtual. The
responsibility for preparation, maintenance and
retention of source records may be allocated to a
centralized investigator or sponsor investigator.
See also remote, virtual, visit
CDISC Defintion is "A type of study designed to II SDTM, Protocol-

evaluate the ability of an investigational product Published in P45
and/or approved drug to delay cardiac ventricular Do not add (P45): Do
repolarization as detected by QT prolongation not use THOROUGH
and other ECG parameters." QT as a Trial Type.
Instead team thinks this
Could you please let me know if TTYPE = is a new TTYPE and will
"THOROUGH QT" is a good choice for a clinical develop a new term.
trial with the following primary objective "To
quantify the effect of [drug] on ECG parameters
(QTc, PR interval, QRS complex, heart rate, and
T wave and U wave morphology) after a single
dose." ?
If yes, is it possible to add the following CDISC
synonym : "ECG Effect" ?
Or isit possible to add a new TTYPE value with
"ECG Effect", something like that ?
Definition: The day when last sexual intercourse II SDTM-Published in P47

occurred.
This data is part of the sexual history information

for a patient.
Definition: A measurement of the total number of II SDTM-Published in P47

sexual partners.

for a patient.
Definition: An indication as to whether a condom II SDTM-Published in P47

was used.

for a patient.
in P46, P47, P48
Do not add (P47): -
SPINAL CORD GRAY
MATTER: Request
withdrawn by requester.
Do not add (P47): -
INFERIOR TEMPORAL
GYRUS: Do not add.
Will be published in P46.
Do not add (P47): -
BRAIN GRAY MATTER:
Do not add. Since grey
and white matter can be
obtained from many
locations within the brain
and spinal cord, these
are not particularly
meaningful anatomical
location type terms.
These may better fit into
the SPECTYPE codelist
to support SPEC
variable (within which
'White Matter Tissue' is
already published) with
the LOC value being a
brain
part/region/lobe/etc., of
which there are many
already defined in the
codelist.
Do not add (P47): -
BRAIN WHITE
MATTER: Do not add.
Since grey and white
matter can be obtained
SSTYP values for Animal Rule studies were II
added but there are not associated STCAT
values published.
For some SSTYP values, ""EFFICACY"" is
embedded in the SSTYP.
Since STCAT is expected by FDA, appropriate
values should be available in published CT.
SSTYP values:
EFFICACY, POST-EXPOSURE PROPHYLAXIS

EFFICACY, POST-EXPOSURE
RADIOMITIGATION
EFFICACY, PRE-EXPOSURE PROPHYLAXIS
EFFICACY, TREATMENT
NATURAL HISTORY
This unit of m% is used for a derived item on the II SDTM, SEND-Published
6MWT (6 Minute Walk Test) that is created as the in P48
product of the distance walked in meter and the
oxygen saturation in %.
Suggested definition: m% = A unit that represents

the product of meter and percentage.
There are other terms in the LOC codelist for the II SDTM, SEND-Published
PANCREAS, but PANCREAS, NECK is not in P47
among them. We need this code for a study.
The definition for PANCREAS, NECK is proposed
as: A thin section of the gland between the head
and the body of the pancreas, immediately
anterior to the superior mesenteric vein/portal
vein.
File emailed separately. II Do not add (P45):

Arbekacin -> Do not
add. This is the name of
the agent for which
microbial resistance is
tested. This does NOT
go into MSTEST, map
this value to the
MSAGENT/Agent Name
variable. See modeling
examples in SDTMIG
3.4 here:
https://wiki.cdisc.org/x/t
DzzAw
Amoxicillin/Clavulanate -
> Do not add. This is the
name of the agent for
which microbial
resistance is tested.
This does NOT go into
MSTEST, map this
value to the
MSAGENT/Agent Name
examples in SDTMIG
3.4 here:
https://wiki.cdisc.org/x/t
DzzAw
Amikacin -> Do not add.
This is the name of the
agent for which
microbial resistance is
tested. This does NOT
go into MSTEST, map
this value to the
MSAGENT/Agent Name
Definition: The numerous muscles supplied by II SDTM, SEND-Published
the facial nerve that are attached to and move the in P47
skin of the face.
This location is needed for a head and neck

oncology study.
Please add unit 'rad/s' used within wearable II SDTM, SEND-Published

device data when reporting rotational motion in P48
information.
SKIN OF THE UPPER BACK to the LOC codelist II Do not add (P47): Do
is an anatomical location used in a study. Please not add. Please use
add the new term with the definition: the skin of existing LOC=SKIN OF
the upper back area includes the skin covering THE BACK and
the shoulder blades and where the rib cage DIR=UPPER.
connects to the thoracic (chest region) spine.
The upper back is also referred to as the middle
back or the thoracic spine.
The definition for the term SKIN OF THE INNER II Do not add (P47): Do
FOREARM: the skin or integument covering the not add. Please use
inner or front surface of the forearm the existing LOC=SKIN OF
antecubital area THE FOREARM and
We are using this in studies - for allergy testing. DIR=INNER
The suggested definition for INNER FOREARM II Do not add (P47): Do

is: of or relating to the inner or front surface of the not add. Please use
forearm the antecubital area. existing
Since we also requested SKIN OF THE INNER LOC=FOREARM and
FOREARM, we also wanted to submit the request DIR=INNER
for INNER FOREARM
When tumor lesions are analyzed through II Do not add (P48):
RECIST, RANO etc, a series number and a slice Consider for future
number form the upper or lower left hand corners version of IG and Model.
of a CT or MRI image are significant references User should continue
to track down the lesions during the whole trial using these variables as
assessments. supplemental qualifiers
This is important information not only for readers until/unless they
but also for sponsors or trial-related personnel, become standard
who are not familiar with Image assessment variables in a future
procedure (e.g., RECIST) with lack of knowledge version of the IG and
for CT/MRI images. model.
I submitted these terms as a codelist about
several months ago, and left message in the
issue tracker. Then, I received a response form
the CT team, and it explained that those two
terms I requested are more appropriate for a
variable. Hence, I re-submitted these terms as
new variable for measurement type tests in TR.
Recently, our project used these terms as
variables for QNAM in TU Domain.
Artificial Intelligence - a system's ability to II

correctly interpret external data, to learn from
such data, and to use those learnings to achieve
specific goals and tasks through flexible
adaptation."[62]
Machine learning is a computing system (inspired
by biological neural networks in the human brain)
that learns (progressively improves its ability) to
do tasks by considering examples without task-
specific programming. Machine learning
algorithms build a mathematical model based on
sample data, known as "training data", in order to
make predictions or decisions without being
explicitly programmed to do so. It is a subset of
artificial intelligence
Deep learning (also known as deep structured
learning) is part of the broader family of machine
learning methods based on artificial neural
networks but a deep neural network has multiple
layers between input and output layers to
progressively extract higher level features from
the raw input.
File e-mailed separately. II ADaM, CDASH,

Protocol, SDTM, SEND-
Published in P43
Definition Taken from the NCI (C28654): X-ray II SDTM-Published in P47
images of the ureters and kidneys obtained by
injection of a radioopaque substance into the
ureter, usually done via a cystoscope.
A measurement of a Cytogenetic result in a II SDTM-Published in P47

biological specimen from KARYOTYPING Do not add (P47): Do
method. not add. Belongs in MI
or GF domains. Please
refer to those domains
in SDTMIG3.4 for how
this test should be
modeled.
for Crohn's TAUG II SDTM-Published in P44
for Crohn's TAUG II SDTM-Published in P44
IMPRESSION CYTOLOGY - a method by which II SDTM, SEND-Published

surface cells can be removed from the ocular in P46
surface epithelium and submitted for cytologic Do not add (P46):
analysis. SUPERFICIAL
SUPERFICIAL KERATECTOMY - the removal of KERATECTOMY-Do not
the corneal epithelium down to the level of add. This appears to be
Bowman membrane. a therapeutic procedure
and not necessarily a
These methods were listed as the method of method specifically for
tissue collection in an ocular study. specimen collection. It
could map to either
'SURGICAL
RESECTION' or
'BIOPSY', which are
existing terms in the
codelist. The procedure
'Superficial Keratectomy'
may be more completely
modeled in other SDTM
domain such as PR.
RELSPEC originated in SDTMIG-PGx, but is not II SDTM-Published in P47

in the SDTM Domain Abbreviation codelist. As it
is being moved to SDTMIG v3.4 along with BE
and BS, I am requesting that it be added to this
codelist.
File will be emailed separately II SDTM-Published in P45,
P46, P47, P48
Do not add (P45):
NUCLEIC ACIDS ->
requester.
Do not add (P47): -
MEASUREMENT: Do
not add. We have more
specific
'...MEASUREMENT
METHOD' types of
methods published in
the codelist but we are
not sure that is what is
intended with this
request. We see the
term request below is
describing 'estimate' so
we think they are trying
to differentiate methods
that measure something
directly versus
measuring something
indirectly or measuring
something via estimate.
We have included
'estimate' in test values
themselves when the
methodology is not a
direct measure. This
piece of information is
important but is incorrect
for use in the METHOD
variable since direct
measurements would
use more specific
Will be used when to normalize when dose is in II
mg
We received a request to review our Pleural Fluid II SDTM, SEND-Published
(C77613) concept definition. The NCI and CDISC in P45
defs currently read:
The fluid that is abnormally collected in the

pleural cavity.
The user correctly notes that the phrasing implies

a pleural effusion and not the normal
(physiologic) fluid that is ordinarily found in the
pleural space. So, Brenda and I have discussed
updating the definition to:
The fluid that is ordinarily present in the pleural

space. It allows for normal movement of the lungs
during respiration.
My question is would this affect your CDISC

mapping? Might the CDISC concept be better
aligned with Pleural Effusion (C3331)?
This test HGFR is currently in LB (C172514). For II Do not add (P45): Do

immunostaining (IHC) on tissue surfaces , this not add. Already
test needs to be added to the MI domain along published in MITS-CD
with all the synonym (ref LB). One item that is still codelist as C172514.
not clear to me though is whether HGFR should
remain in LB as is, or with Soluble Hepatocyte
Growth Factor Receptor / HGFRS should replace
the existing HGFR, or be added as an additional
term to the existing LB terminology
version 4.5.1 is available since July2020 II SDTM-Published in P45
In the draft SDTMIG v3.4 the term MEASIND is II SDTM-Published in P45

used as if it refers to the target tumors; however
the definition "An indication as to whether a
measurable tumor is present" suggests that it can
be applied to both target and non-target lesions
as both are measurable. Would it not be better to
have a term (similar to NTIND - Non-Target
Indicator) related to just target lesions, e.g. TIND
- Target Indicator? Or at least clarify the
MEASIND test so that it is clears it can only be
used in relation to the target lesions.
Definition: Guidelines for diagnosis, indications II SDTM-Published in P45
for treatment, response assessment, and
supportive management of CLL: a report from the
International Workshop on Chronic Lymphocytic
Leukemia updating the 2008 International
Workshop on Chronic Lymphocytic Leukemia
(iwCLL) published consensus guidelines for the
design and conduct of clinical trials for patients
with CLL. (Hallek M, Cheson BD, Catovsky D,
Caligaris-Cappio F, Dighiero G, Dohner H,
Hillmen P, Keating MJ, Montserrat E, Chiorazzi N,
Stilgenbauer S, Rai KR, Byrd JC, Eichhorst B, O?
Brien S, Robak T, Seymour JF, Kipps TJ. Blood.
2018 Jun 21;131(25):2745-60.)
We would like to request the creation of two new II SDTM-Published in P45

tests: 'Lip Compression Strength' or
'Compression Strength' and 'Tongue Pressure
Strength' or 'Pressure Strength' - both used in
Iowa Oral Performance Instrument (IOPI) testing;
additional references can be found here:
https://iopimedical.com/medical-professionals/.
Thank you!
Definition: Phase 3 Trial of Ibrutinib plus II SDTM-Published in P45

Rituximab in Waldenstrom's Macroglobulinemia
(Dimopoulos ma, Tedeschi A, Trotman J, Garcia
Sanz R, Macdonald D, Leblond V, Mahe B,
Herbaux C, Tam C, Orsucci L, Palomba ML,
Matous JV, Shustik C, Kastritis E, Treon SP, Li J,
Salman Z, Graef T, Buske C. Phase 3 Trial of
Ibrutinib plus Rituximab in Waldenstrom's
Macroglobulinemiafor the iNNOVATE Study
Group and the European Consortium for
Waldenstrom's Macroglobulinemia. N Engl J Med
2018;378:2399-410
Current definition mentions subject II SDTM-Published in P47

characteristics, but changes in SDTMIG v3.4 Do not add (P47): Do
mean that subject characteristics, whether not change domain long
collected once or more than once, will be name. Instead definition
represented in the SC domain. SS will be limited will be updated only.
to survival status, so request that the CDISC
Synonym be changed to "Survival Status" and the
definition be changed to say that this data
contains the results of queries about whether a
subject is alive.
This one of those chicken-or-egg things where

we'd like to change in terminology and the
change in the SDTMIG to come out at the same
time. Should we update the draft of the SDTMIG
for public review before the terminology is
official?
The QRS sub-team team approved the move of II SDTM-Published in P44
DRS (CAT, TESTCD/TESTs) from the QS to RS
following:
value of ?DRS? to the clinical classifications
CCCAT codelist
of ?Disability Rating Scale Questionnaire Test
Code? to the clinical classifications TESTCD
codelist ? Disability Rating Scale Clinical
of ?Disability Rating Scale Questionnaire Test
Name? to the clinical classifications codelist of ?
Disability Rating Scale Clinical Classification Test
Name?.
Team has requested the short name COLSTYP II SDTM-Published in P45

and long name Collected Summary Type as that
is what is published in the T1D TAUG. Team
requests only one valid value to be added for
now: MEAN. They are unsure about the rest of
the values they have used so would prefer to wait
awhile before adding them.
See examples here:
https://wiki.cdisc.org/display/DIAB1/Insulin+Mana
gement+Module;
https://wiki.cdisc.org/display/DIAB1/CGM+Module
These have also been used in Nutrition and
Crohn's TAs we think.
File e-mailed separately II SDTM-Published in P45
Do not add (P45):
PREROULC; Presence
of Erosion and/or Ulcers
-> Do not add. Please
use more generic
concept below 'Erosion
or Ulceration'. This
concept shows up in
both GHAS and RHI.
The TSTDTL and
RESTYP variables
would specify the types
of data results one
would expect for each
scale.
PRGRNLMA; Presence
of Granuloma -> This
was requested in P44.
Please re-use existing
concept. Do not add
again.
Dataset name: ADDL. Dataset Description: II Define-XML-Published

Device-Level Analysis Dataset.it is one record per in P45
device (optional: per subject). Class of Dataset:
DEVICE LEVEL ANALYSIS DATASET
This is a new class for medical device ADaM IG

currently drafted and will be in GGG review in
November, 2020
10^9 cells: Use in Exposure for the dosing of II SDTM, SEND-Published

transduced cells. in P47
10^5 CFU/mL: A unit of measurement of viable Do not add (P45): Do
bacterial organisms in a unit volume of substance not add. Already
of interest defined as the number of 10 to the fifth published in UNIT
power colony forming units in one milliliter of codelist as C166096.
substance.
10^7 CFU/mL: A unit of measurement of viable
bacterial organisms in a unit volume of substance
of interest defined as the number of 10 to the
seventh power colony forming units in one
milliliter of substance.
Please add VAGINAL RING to the FRM codelist II SDTM-Published in P47

with the definition: Polymeric drug delivery device
designed to provide controlled release of drugs
for intravaginal administration over extended
periods of time.
Please add CAPSULE FOR INHALATION to the II SDTM-Published in P47
FRM (Formulation) codelist with the definition: A
capsule composed of powders intended for oral
inhalation to be used in inhalers.
Please add DRY POWDER SUSPENSION to the II Do not add (P47): Do

FRM codelist with the definition: A powder that not add. This is
forms a suspension when reconstituted with a synonymous with
liquid solution. (Dry mixtures that require addition existing term in list
of water at the time of dispensing.) C42975
Please add READY TO USE SUSPENSION to II Do not add (P47): Do

the FRM codelist with the definition: Suspensions not add. The existing
already distributed through a liquid vehicle (with definition of
or without stabilizers and other additives). SUSPENSION/C42994
covers the definition
proposed for the new
term. We will add
'Ready to Use
Suspension' as a
synonym to C42994.
Please add TABLET, ROLLER COMPACTION to II Do not add (P47): Do

the FRM codelist with the definition: A method of not add. Roller
powder compaction of dry powders into a solid Compaction deals with
mass known as the ribbon. methodology for
manufacturing of the
tablet and based on
FDA SPL and EMA
EDQM, this type of
characteristic is
generally not in scope
for pharmaceutical
dosage forms. Therefore
the team will not add
this term at this time.
The requester could use
a suppqual with
TABLET as the dosage
form or continue using
this term as an
the dataset.
Please add TABLET, HIGH SHEAR II Do not add (P47): Do
GRANULATION to the FRM codelist with the not add. High Shear
definition: A shaping process for granulation in Granulation deals with
which a binder liquid is fed to the powder particles methodology for
in a closed container with blending tools and a manufacturing of the
chopper. Dense granules are formed through the tablet and based on
liquid and solid bridges that result. FDA SPL and EMA
EDQM, this type of
characteristic is
generally not in scope
for pharmaceutical
dosage forms. Therefore
the team will not add
this term at this time.
The requester could use
a suppqual with
TABLET as the dosage
form or continue using
this term as an
the dataset.
Please add SUBDURAL to the ROUTE codelist II SDTM, SEND-Published

with the definition: Below the dura, the outermost, in P47
toughest, and most fibrous of the three
membranes covering the brain and the spinal
cord.
Please add BASELINE INVESTIGATION to the II Do not add (P47): Do
TTYPE codelist with the definition: An information not add. Based on the
found at the beginning of a study or other initial requester information
known value which is used for comparison with this requested term
later data. appears to be capturing
a part of the trial but not
the whole trial, i.e., what
is done after baseline
values are collected.
This is an incorrect
usage of the TTYPE trial
summary parameter.
Please add DEVICE FEASIBILITY to the TTYPE II Do not add (P47): Do
codelist with the definition: Iteration of an existing not add. This requested
technology by a confident manufacturer in an term is a valid,
expected performance to move directly into a published response to
confirmatory study to demonstrate effectiveness the 'Trial Intent Type'
and safety. trial summary parameter
so team is wary of
adding it as a value to
the 'Trial Type' trial
summary parameter
response codelist as
well. Based on
requester description,
the TTYPE should be
EFFICACY, SAFETY,
USABILITY TESTING,
or another existing value
in the TTYPE codelist
and this value should be
a response to TINDTP
trial summary
parameter.
Please add GARGLE to the ROUTE codelist with II Do not add (P47): Do
the definition: To circulate or apply an active not add. Gargle is a
agent by moving a liquid around in the throat dosage form taken by
without swallowing. ORAL route of
administration. Please
use ORAL/C38288 in
ROUTE codelist and
Gargle can go into
DOSFRM variable.
Definition = The subject or patient has interacted II SDTM-Published in P45

with a healthcare professional.

with a dietary specialist.

with a mental health specialist.
We created a codelist for 'Employment Status' II SDTM-Published in P45

(C111108) but do not have a supporting Do not add (P45): Do
'question' such as a Test or Parameter to use not add. The
with the codelist. It is currently an orphan codelist. employment status
I think we could resolve this by creating a new codelist contains the
SCTEST/CD value. Otherwise we should retire responses to the subject
the codelist. characteristics test of
JOBCLAS/Employee
Job Class. We will add a
synonym instead.
File emailed separately. II SEND-Published in P48
File emailed separately. II CDASH - Published in

P45
Do not add (P45):
Create Codelist:
Standard of Care for
TSCURTRT variable -
SAE team no longer
interested in developing
codelist.
Do not add (P46):
Pregnancy Termination
Date - Do not add.
CDASH SAE team
agrees to use existing
term PRGENDTC
(test=Date Pregnancy
Ended), which is already
in codelist.
Interleukins 12 and 23 are heterodimers that II SDTM, SEND-Published

share a common sub-unit, p40 (see e.g., in P48.
Janeway's Immunobiology). We often receive Do not add (P46): Do
data from commercial lab kits that specify not change. In this
"IL-12/IL-23 p40" indicating that the detection concept, Interleukin 12
antibody binds the p40 sub-unit and therefore means both Interleukin
detects both IL-12 and IL-23 (see e.g., 12beta (containing the
https://www.thermofisher.com/order/catalog/prod p40 subunit only;
uct/EPX01A-12090-901#/EPX01A-12090-901). homodimer) and
An update to the synonyms and definition would Interleukin 12 p70 (that
make use of this controlled term more transparent contains p40 and p35
to the user base. subunits; heterodimer).
Our definition is
inclusive of all, whereas
specifying Interleukin
beta p40 only
unnecessarily narrows
the meaning of the
definition.
File emailed separately. II Do not add (P47): Do

Submission of multiple race responses should be not add 'MULTIPLE' to
represented in the demographic domain and codelist. SDTMIG v3.3
supplemental qualitfiers dataset. If mulitlple races Section 4.2.8.3;
are collecteed then the value fo RACE should be SDTMIG v3.3 Section 5
"MULTIPLE" and the additional information will be DM Assumption 6 states
included in the supplemental qualifiers dataset. that when "MULTIPLE"
Controlled terminology for RACE should be used is used, a record of
and it's not extensible. Hence it will be good if we SUPPDM.QVAL
can have "MULTIPLE" and "OTHER" added in WHERE QNAM =
current codelist of RACE. "RACEn" is expected.
One of the CDISC synonyms is incorrect: "C- II SDTM, SEND-Published
terminal Pro-peptide of the Alpha 3 Type IV in P46
Collagen Chain" It should say "C-terminal Pro-
peptide of the Alpha 3 Type VI Collagen Chain".
Addition to Oncology Codetable / II Published in P45

RS_Onc_Codetable_Map tab
Requesting the addition of the following 4 terms II SDTM-Published in P46

to the Discharge Disposition Codelist for COVID- Do not add (P46): NON-
19 Trial: HOME, NURSING CARE; LONG TERM HOSPITAL
NURSING CARE FACILITY; NON-HOSPITAL INTERMEDIATE CARE
INTERMEDIATE CARE FACILITY; FACILITY -> Do not
REHABILITATION FACILITY add, map to
C99912/INTERMEDIAT
E CARE FACILITY
A measurement of the growth differentiation II SDTM, SEND-Published

factor 15 in a biological specimen. in P47
A measurement of the suppression of II Do not add (P47): Do
tumorigenicity-2 (sST2) in a biological specimen. not add. Please use
(Suppression of tumorigenicity-2 (sST2), a existing term C142281.
member of the interleukin 1 receptor family) We will add synonyms
to help with mapping.
The LBTESTCD code REAAB (Reagin Antibody) II SDTM-Published in P48
has synonyms for RPR and VDRL. We have
been informed that these 2 synoyms use different
methods:
[The VDRL would not be Macroflocculation, but
(micro)flocculation. (?.) currently all
nontreponemal tests are flocculation tests and
both VDRL and RPR tests are modifications of
original Wasserman reaction. Unfortunately in this
test, the antibody detects antigens, which are
nonspecific, thereby yielding much false-positive
reaction (taken from
12652/ ) The ?clumping? is larger with RPR
(MACROflocculation) than with VDRL:The rapid
plasma reagin (RPR) test uses the same antigen
as VDRL, but the antigen is bound to a carbon
particle to allow visualization of the reaction
without a microscope]
So RPR uses MACROFLOCCULATION and

VDRL uses MICROFLOCCULATION It wasn't
clear if the existing term of FLOCCULATION is a
higher level term, or is actually macro or micro.
At GSK we have created MACRO and MICRO as
extensible terms awaiting your review and advice.
I would have used MMA as per the format of II No, these are not
other 'arginine' tests, but the term MMA has been synonymous. Many lab
used for Methylmalonic Acid. analytes are known by
There is already ARG for Arginine. the same abbreviation.
Are Monomethylarginine and Methylarginine Please check the
synonyms? CDISC submission
value long name and
definition to understand
the meaning of the
TESTCD value.
There is no unit for Urine Percent Recovered II Do not add (P45): Do

when the dose administered is normalized (by not add. If there is a
body weight or other). need to create a
For absolute doses, the unit is ?%?, but when descriptor in cases
normalized by BW it should be ? where multiple percent
%*<BodyMass>*(<ConcMass>/<DoseMass>)? recovered values for an
individual profile are
reported, a variable can
be created in SuppPP,
or use the analysis
method (PPANMETH)
variable to describe the
nature of normalization.
Missing R in SPECTROMETRY II SDTM-Published in P45
File e-mailed separately II SDTM-Published in P48
The codelist is not extensible, but also not II SDTM-Published in P48

mathematically complete. Do not add (P48): Do
It contains the relations < (BEFORE), > (AFTER), not add. Please use
= (COINCIDENT), but not the relations <= existing term C49640/
(BEFORE OR COINCIDENT) or >= DURING/AFTER.
(COINCIDENT OR AFTER). The latter two should Additional terms added
be added to the codelist. in P48 to support other
An example of a use case is a COVID-19 hospital mathematically possible
intensive care unit admission with known start times.
and end dates, during which a certain number of
days ventilation was used, but the exact dates of
ventilation use not known. Ventilation started >=
the admission date, and ended <= the discharge
date.
Please consider the addition of a new test of II SDTM-Published in P47

'Muscle Strength, Abduction' to use for Hand-
Held Dynamometry testing that measures the
abduction for Thumb, 5th Digit, and Index
Fingers. Thank you!
Please consider the addition of a new test of II SDTM-Published in P47
'Muscle Strength, Dorsiflexion' to use for Hand-
Held Dynamometry testing that measures ankle
dorsiflexion. Thank you!
Acute Kidney Injury v1.0 II SDTM-Published in P45
CDAD v 1.0
Crohn's Disease v1.0
T1D - Pediatrics and Devices v1.0
Heart Failure v1.0
Lung Cancer v1.0
Nutrition v1.0
Psoriasis v1.0
Traditional Chinese Medicine - Coronary Artery
Disease-Angina v1.0
To document TS parameter. II SDTM-Published in P45
Definition: A lens generally worn in front of the II SDTM-Published in P47

eye to correct issues with distance. This includes
glasses, contact lenses, and intraocular
implanted lenses.
Question Text: Does the Subject Wear Glasses
or Contacts for Distance Vision?
Responses: YES - CONTACT LENSES WITH OR
WITHOUT GLASSES; YES - GLASSES ONLY;
NO; UNKNOWN
Definition: An opaque disk with many small holes II SDTM-Published in P48

used to test visual acuity by using a simple
method to focus light, as in a pinhole camera,
temporarily removing the effects of refractive
errors.
Definition: An act or process of elucidation; II Do not add (P45): This
explication, or explanation of the meaning of the is published in the
event or thing via the assignment of objects from OETEST codelist.
the domain to the constants of a formal language,
truth-values to the proposition symbols, truth-
functions to the connectives, other functions to
the function symbols, and extensions to the
predicates, if any. The assignments are result of
human logic application and are not native to the
symbols of the formal language.
It is needed for investigator input for NORMAL
and ABNORMAL findings for ophthalmic
abnormalities based on their findings during an
exam (ex. Was There Evidence of Corneal
Abnormality (e.g., Keratopathy) on the Corneal
Exam?; or Cataracts - Right Eye)
Please add WALLACE RULE OF NINES to the II SDTM-Published in P49

METHOD codelist.
The Wallace rule of nines is a tool used in pre-
hospital and emergency medicine to estimate the
total body surface area affected by a burn. In
addition to determining burn severity, the
measurement of burn surface area is important
for estimating patients' fluid requirements and
determining hospital admission criteria.
SV is being changed from a special purpose to an II SDTM-Published in P47
events domain.
The SDTMIG gives advice on using values that II

are not in the codelist. This is inconsistent with
the designation of the RACE codelist as non-
extensible.
The SDTMIG gives advice for using values not in
the RACE codelist that is incompatible with the
codelist being non-extensible. This change is at
least a short term solution. A longer-term solution
would acknowledge that recipients (e.g.,
regulatory authorities) may have their own
terminology requirements. We have already dealt
with a situation like this with the COUNTRY
variable, where FDA require different terminology
than the default ISO terminology given in the
SDTMIG.
The long term solution to RACE may be to stop
providing CDISC CT for RACE and leave that up
to the recipient. We might also change the core
designation for RACE â€œpermissible,â€ given
that the concept of race is not really a scientific
one. Some day.
A measurement of the length of the leg from the II SDTM, SEND-Published

waist to the bottom of the heel. in P47
A measurement of the length of the leg from the II SDTM, SEND-Published

waist to the bottom of the heel. in P47

P46, P48, P49
Do not add (P45):
CENTER -> Do not add.
The example was
updated in the IG to
remove the 'LAT'
variable. No longer
needed.
RIB 3 -> Do not add.
GSK Pathologists have requested the addition of II SEND-Published
This is already in P46
ILEOCOLOCAECAL AREA to the SEND published in LOC
Specimen CT list for use on non-clinical studies. codelist.
Definition of ILEOCOLOCAECAL AREA: Reaction Score -> Do
Transitional area between terminal ileum, caecum not add. These
and beginning of colon. MITSTDTL values in the
examples are hold-overs
from SDTMIGv3.3. An
SDS subteam will form
to review the MI domain
and update the domain
specification and
examples in a version of
SDTMIG post v3.4. We
1. A category used when describing isolates that II SDTM-Published in P46,
are in the categories of ?intermediate? and/or ? P49
resistant? for an organism/drug category with Do not add (P46): NOT
intermediate and resistant interpretive categories. SUSCEPTIBLE - Do not
add, already published
2. An interpretive category used when describing and map to C85561.
isolates for which there is a high likelihood of SUSCEPTIBLE,
therapeutic success because exposure to the INCREASED
agent can be increased by adjusting the dosing EXPOSURE - Do not
regimen or by its concentration at the site of add, use Susceptible-
infection. Dose
Dependent/C85559.
3. A category used when describing an isolate for
which interpretation of the antimicrobial
susceptibility testing (AST) result is uncertain due
to the value being in an area where there are
interpretive difficulties (e.g. the breakpoint is in a
place where reproducible interpretation cannot be
achieved).
Please add this term to the CDISC glossary II Glossary-Published in

based on JIRA comment CT-771 P48
Additional information from Helle:
Phase 2 trials are sometimes further divided into:
â€¢ Phase 2a
â€¢ Phase 2b
Phase 2a is focused specifically on dosing
requirements. A small number of patients are
administered the drug in different quantities to
evaluate whether there is a dose-response
relationship, which is an increase in response that
correlates with increasing increments of dose. In
addition, the optimal frequency of dose is also
explored.
Phase 2b trials are designed specifically to
rigorously test the efficacy of the drug in terms of
how successful it is in treating, preventing or
diagnosing a disease.
Sources
1.
http://www.virginia.edu/vpr/irb/HSR_docs/CLINIC
AL_TRIALS_Phases.pdf
2. http://linus.nci.nih.gov/techreport/Optimal2-
StageDesigns.pdf
3.
http://clincancerres.aacrjournals.org/content/12/7/
1966.full.pdf
4. www.kgh.on.ca/.../Phase%20II%20Design
%20of%20Clinical%20Trials.pdf
We are creating a CRF that collects SARS-CoV-2 II Do not add (P45): Do
Antigen test results not add. This test will be
published in package 44
(December 2020 CT
release) as
MBTEST/MBTESTCD =
SARS-CoV-2
Antigen/SAR2AG.
term was added for the PanCan TAUG II
for the Crohn's TAUG II SDTM-Published in P44
Reference: Modified RECIST criteria for II SDTM-Published in P46

assessment of response in malignant pleural
mesothelioma. (Armato SG 3rd, Nowak AK.
Revised modified response evaluation criteria in
solid tumors for assessment of response in
malignant pleural mesothelioma (Version 1.1). J.
Thorac. Oncol. 2018 Apr;13(7):1012-21.)
Synonym: INTRATUMORAL RECIST II SDTM-Published in P46

Reference: Response criteria for intratumoral
immunotherapy in solid tumors: itRECIST
(Goldmacher GV, Khilnani AD, MD1, Andtbacka
RHI, Luke JJ, Hodi FS, Marabelle A, Harrington
K, Perrone A, Tse A, Madoff DC, Schwartz LH.
Response criteria for intratumoral immunotherapy
in solid tumors: itRECIST. J Clin Oncol. 2020 Aug
10;38(23):2667-2676.)
Please add to the Anatomical Location (LOC) II Do not add (P47): Do

codelist the new term PROXIMAL not add. The proximal
INTERPHALANGEAL JOINT 1 OF THE HAND interphalangeal joint(s)
with the synonym PIP1 and the definition of: A articulates the proximal
condyloid synovial joint within the first digit of the and middle phalanges
hand or foot articulating the proximal and middle on those digits that have
phalanges. proximal and middle
phalanges. Joint 1 does
not have a middle
phalange, only a
proximal and distal
phalange, so this term
as requested is not
valid.
"Standardized Uptake Value II SDTM-Published in P47

Maximum"/"SUVMAX" with definition: The
maximum standardized uptake value among the
pixels (voxels) within a region of interest.
Codelist Short Name Requested Submission II
Value Requested Synonym(s) "Requested
Definition
(For CDISC-Glossary additions, please include
citation)"
FDPL5PRS PET Score X New areas of uptake
unlikely to be related to lymphoma.
FDPL5PRS PET Score 1 The results of the
positron emission tomography are negative; there
is no detectable abnormal tracer uptake.
positron emission tomography are negative; the
tracer uptake is less than or equal to the
mediastinum.
positron emission tomography are negative; the
tracer uptake is greater than the mediastinum but
less than or equal to the liver.
positron emission tomography are positive; the
tracer uptake is moderately more than the liver
uptake, at any disease site.
positron emission tomography are positive; the
tracer uptake is markedly increased at any
disease site.
Please add new term 'Endurance'/ENDURNC II SDTM-Published in P47

used during IOPI testing:
https://iopimedical.com/medical-professionals/.
Thank you!
Needed for mapping LOINC code 95971-8 II Do not add (P45): Do
"SARS CoV-2 stimulated gamma interferon not add. Map this to the
[Presence] in Blood". LB domain where
See https://loinc.org/95971-8 LBTEST/LBTESTCD =
Interferon
Gamma/IFNG.
Interferon-Gamma
Response Assay can
apply to any microbial
antigen
stimulation/challenge
test (e.g. response to M.
tuberculosis), hence we
do not recommend pre-
coordinating SARS
coronavirus 2 into the
MBTEST. Please refer
to the Therapeutic Area
Data Standards User
Guide for Tuberculosis,
section 4.1.2 Interferon-
Gamma Response
Assays (IGRAs), pages
23-27 for mapping and
modeling reference. For
this particular test, use
NHOID = SARS-CoV-2,
and ASSYAG/Assay
Antigen for the
stimulating agents (i.e.
Negative Control,
Mitogen, SARS 2
Antigen).
Needed for mapping LOINC codes 95973-4 and II Do not add (P45): Do
95972-6 "SARS CoV-2 stimulated gamma not add. Map this to the
interferon release by T-cells [Units/volume] in LB domain. Interferon-
Blood". Gamma Response
See https://loinc.org/95973-4. Assay can apply to any
microbial antigen
stimulation/challenge
test (e.g. response to M.
tuberculosis), hence we
do not recommend pre-
coordinating SARS
coronavirus 2 into the
MBTEST. Please refer
to the Therapeutic Area
Data Standards User
Guide for Tuberculosis,
section 4.1.2 Interferon-
Gamma Response
Assays (IGRAs), pages
23-27 for mapping and
modeling reference. For
this particular test, use
NHOID = SARS-CoV-2,
and ASSYAG/Assay
Antigen for the
stimulating agents (i.e.
Negative Control,
Mitogen, SARS 2
Antigen).
The MB team
recommends the
following: use
LBTEST/LBTESTCD =
Interferon
Gamma/IFNG, the
corrected value goes
into LB SuppQual =
Needed for mapping LOINC code 95970-0 II Do not add (P49).
"SARS-CoV-2 (COVID-19) specific TCRB gene Please use a GFTEST
rearrangements [Presence] in Blood by of 'Sequence
Sequencing". Rearrangement/SEQRE
See https.//loinc.org/95970-0 AR' (which will be
published in a future
version of CDISC CT)
and put 'SARS
coronavirus 2 specific
TCRB gene' in GFSYM.
A ferret-specific region of the small intestine II SEND-Published in P46

where distinction between the jejunum and ileum
is not present. Reference is James G Fox. Robert
P. Marini in Biology and Diseases of the Ferret.
3rd edition, 2014.
We need to distinguish these between two in II Glossary-Published in
relation to the generic term 'termination (of trial)'. P48
Early Termination vs Premature Termination
appear to be child concepts of Termination. EU
specifically defines Early Termination:
https://ec.europa.eu/health/sites/health/files/files/
eudralex/vol-1/reg_2014_536/
reg_2014_536_en.pdf. Look also at
clinicaltrials.gov definitions for trial status terms
though clinicaltrials.gov may lead to more
confusion.
We need to find a new citation for this definition II Glossary-Published in

and consider a more robust definition udpate. P48
OBTURATOR LYMPH NODE II SDTM, SEND-Published

Definition: A pelvic lymph node located along the in P47
obturator artery.
NCI Code: C88141
CARDIOPHRENIC LYMPH NODE

Definition: A lymph node located in the angle
between the heart and diaphragm NCI Code:
C121555
These terms are used in an Oncology trial.
Rat Mouse II Do not add (P45): Do

not add. The team has
agreed upon a draft rule
that states that the
catalog name should be
used as extensible
terminology for the
STRAIN codelist. The
one caveat is that the
team would extend the
codelist with these kinds
of Strain values if the
FDA made a direct
request.
10^3/uL is used as WBC and differentials unit as II Do not add (P47): Do

US conventional unit. US conventional unit is not add. Please use
more widely used in the US. Reviewers in the US existing published term
often prefer to review lab data with US C67255/10^9/L, which is
conventional unit. mathematically
synonymous to the
requested term.
mapping II Do not add (P46): Do
not add. These are not
considered industry
standard, and typically
not measured for
submission to any
regulatory agency. This
codelist is extensible,
consider adding these
terms as extensible
values.
File emailed separately II Do not add (P45): Do

not change. While we
understand that the
preferred and commonly
used form for this unit is
written as ng*h/mL,
CDISC submission
value change is
disruptive, and CDISC
typically does not
update a submission
value unless it is wrong
or the concept is
erroneously coded.
Ratio of hyperchromic Erythrocytes over II SDTM, SEND-Published

Erythrocytes. in P47
LOINC code 76090-0:
Erythrocytes.hyperchromic/100 erythrocytes in
Blood (https://loinc.org/76090-0).
This is an important test - part of the "Hepatic
Panel 2000".
Ratio of hypochromic Erythrocytes over II SDTM, SEND-Published

Erythrocytes. in P47
LOINC code 76069-4 -
Erythrocytes.hypochromic/100 erythrocytes in
Blood (https://loinc.org/76069-4).
This is an important test - part of the "Hepatic
Panel 2000".
Please add the new term AJCC V8 to the II SDTM-Published in P44

ONCRSCAT codelist with the definition of:
American Joint Committee on Cancer (AJCC)
Cancer Staging Manual, 8th edition, Amin MB,
Edge SB, Greene FL et al (Eds), Springer,
Chicago 2017
Please add new term MRECIST TSAO II Do not add (P46): Do
MESOTHELIOMA 2011 to the ONCRSCAT not add. This paper is
codelist with the definition: A Practical Guide of not a tumor response
the Southwest Oncology Group to Measure criterion paper. Rather it
Malignant Pleural Mesothelioma Tumors by gives guidance on how
RECIST and Modified RECIST Criteria (Anne S. to implement one of 3
Tsao, MD, Linda Garland, MD, Mary Redman, tumor response criterion
MD, Kemp Kernstine, MD, PhD,David Gandara, for MPM. Please use
MD,and Edith M. Marom, MD) one of the existing 3
published tumor
response criterion
values in ONCRSCAT:
MRECIST BYRNE
MESOTHELIOMA 2004
(C126031), RECIST 1.1
(C124415), or RECIST
1.0 (C124414).
Please add the new term SIOPEN MIBG SCORE II SDTM-Published in P46
FOR NEUROBLASTOMA - LEWINGTON 2017 to
the ONCRSCAT codelist with the definition: 123I-
MIBG scintigraphy in neuroblastoma:
development of a SIOPEN semi-quantitative
reporting, method by an international panel by
Lewington V., Lambert B., Poetschger U., Bar
Sever Z., Giammarile F., McEwan A.J.B., Rita
Castellani R., Lynch T., Shulkin B., Drobics M.,
Staudenherz A., Landenstein R. in European
Journal of Nuclear Medicine and Molecular
Imaging (2017) 44:234-241.
Please add the new term CURIE MIBG SCORE II SDTM-Published in P46
FOR NEUROBLASTOMA - ADY 1995 to the
ONCRSCAT codelist with the definition: A new
123I-MIBG whole body scan scoring method -
application to the prediction of the response of
metastases to induction chemotherapy in stage
IV neuroblastoma by Ady N., Zucker J-M.,
Asselain B., Edeline V., Bonnin F., Michon J.,
Gongora R., Manil L. in European Journal of
Cancer V31A, N2, pp256-261, 1995
Please add the new term OWEN WALDESTROM II SDTM-Published in P46
MACROGLOBULINEMIA 2013 to the
ONCRSCAT codelist with the definition:
Response assessment in Waldenstro m
macroglobulinaemia:
update from the VIth International Workshop
(Roger G. Owen,Robert A. Kyle, Marvin J.
Stone,Andy C. Rawstron, Veronique Leblond,
Giampaolo Merlini, Ramon Garcia-Sanz, Enrique
M. Ocio, Enrica Morra, Pierre Morel8 Kenneth C.
Anderson,Christopher J. Patterson, Nikhil C.
Munshi, Alessandra Tedeschi, Douglas E.
Joshua, Efstathios Kastritis, Evangelos
Terpos,Irene M. Ghobrial, Xavier Leleu, Morie A.
Gertz, Stephen M. Ansell, William G. Morice, Eva
Kimby and Steven P. Treon
Please add the new term CANCER II Do not add (P47): Do

RECURRENCE to the ONCRSCAT codelist with not add. This is not in
the definition: The return of a dilsease after a scope for the RSCAT
period of remission. variable for oncology
studies, which holds the
name of a tumor
response criterion. If this
was submitted to the
wrong codelist,
requester can resubmit
as appropriate.
Please add the new term INTERNATIONAL II SDTM-Published in P46

THYMIC MALIGNANCY INTEREST GROUP to
the ONCRSCAT codelist with the definition:
Benveniste, M et al in "A practical guide from the
International Thymic Malignancy Interest Group
(ITMIG) regarding radiographic assessment of
treatment response of thymic epithelial tumors
using modified RECIST criteria" in J Thorac
Oncol V9 N9 Supplem 2, Sep2014
Please add the new term DOHNER ELN AML II SDTM-Published in P46
2017 to the ONCRSCAT codelist with the
definition: Diagnosis and management of AML in
adults: 2017 ELN recommendations from an
international expert panel" by Dohner et al in
Blood 2016 V129 N4 pp424-447.
From EVS editors: We've had a request to review II SEND-Published in P45
our Nerve Root (C54024) concept as its current Do not add (P45):
definition seems to make it quite similar to our Change c-code of
Spinal Nerve Root (C12791) definition. Just NERVE ROOT from
wanted to give you a heads up as to our plan, C54024 to C12791. ->
which is to modify the NCI def for C54024 by Do not make this
making it very broad and then to also change the change. Instead update
parent of C12791 to C54024, especially since definition for a broader
C54024 has a CDISC definition that is better concept.
suited to C12791.
C54024
Nerve Root
NCI Def: One of the two bundles of nerve fibers
(dorsal and ventral roots) emerging from the
spinal cord that join to form each spinal nerve.
Proposed New NCI Def: The initial segment of a
nerve after it has branched off from the central
nervous system.
CDISC Def: One of the two bundles of nerve
fibers (dorsal and ventral roots) emerging from
the spinal cord that join to form each spinal nerve.
(NCI)
Parent: Peripheral Nervous System Part
(C33968)
C12791
Spinal Nerve Root
NCI Def: Either of the two initial segments of a
spinal nerve, the dorsal sensory nerve root or the
ventral motor nerve root; once emerged, the two
fuse to form a single spinal nerve.
Parent: Central Nervous System Part (C33966)
Review these terms together to see if their II SEND-Published in P45

definitions can be updated to make clearer the
distinctions here. I think the relationship is that
the Forestomach is a particular structure that is
considered a separate entity to the stomach in
some animals (rat, mouse, ruminants) and
conversely does not appear at all in other animals
(humans, primates, cat, dog, etc.). It is
nonglandular to be sure but I believe it is not
synonymous with the nonglandular portion of the
stomach, which is found in humans, cats, dogs,
etc.
As per CDISC ;Guidance for Ongoing Studies II Do not change (P45):

Disrupted by COVID-19 Pandemic Version 1.0', Do not change CT. We
the code for 'Name of Epi/Pandemic' should be will instead create a
EPDEMIC but terminology has it as EPIDEMIC JIRA comment to get
i.e. an extra 'I' is present the TSPARMCD
changed in the CDISC
guidance document.
The CT is published and
being used.
Definition: A determination of the outcome of an II Do not add (P47): Do
ongoing pregnancy. not add. Published with
P45 (2021-03-26) as
Current definitions for live birth, still birth, PRGOUT/Pregnancy
miscarriage, etc. are written as describing "any Outcome.
pregnancies" which implies pregnancy history,
and not necessarily the outcome of a current,
ongoing pregnancy. Unless timing or other
variables are carefully considered, the current
test codes for birth outcomes are difficult to use.
In the case of subject level data not collected or II Define-XML - Published

not used for analysis in BDS, SPDEVID will be a in P45
required variable as identifier.

used for analysis in OCCDS, SPDEVID will be a in P45

used for analysis in BDSTTE, SPDEVID will be a in P45
This affects both MBTEST and MBTESTCD. II SDTM-Published in P45
Would it be possible to create terms specific for

antibodies against SARS-CoV-2 antigens?
Currently, our company has tests against both
SARS-CoV-2's nucleocapsid and spike protein
antigens. The latter is a newer assay that is more
accurate and preferred over the former. It would
be great if we could have terms specific to the
antigens the antibodies are detecting. Could we
have a test name for antibodies against each
antigen (hence, 2 new test names/codes)?
Request to add a new term of ABSENT to the II Do not add (P48):

TUIDRS codelist with the definition: Not existing Withdrawn by requester.
in a specified place at a specified time.
Request to add new term of PRESENT to II Do not add (P48): Do

TUIDRS codelist with the definition: Being or not add. For SDTM
existing in a specified place or at the specified purposes, they should
time. use the published TU
response value of
LOCATION OF
INTEREST with a
TULOC=BONE
MARROW.
Request to add a new term of II Do not add (P48): Do
EXTRAMEDULLARY DISEASE to the TUIDRS not add. For multiple
codelist with the definition: for AML: Clusters of myeloma, the Oncology
leukemic cells in locations different than blood or SDS team will be
the bone marrow. creating a new TUTEST
References: J Clin Oncol. 2016 Oct 10; 34(29): of 'Extramedullary
3544?3553; Blood . 2011 Oct 6;118(14):3785-93 Disease Indicator' with
Definition varies greatly in the literature. Some Y/N responses. TULOC
exclude spleen and LND (as they are indicates which sites of
"hematological organs"), some require biopsy extramedullary disease
while others don't. No matter the location, it are present.
seems that all extramedullary manifestations Additionally
carry worse prognosis. So the more general TUCAT=Extramedullary
definition was used. (Suggest keeping a note that Disease
this definition is for AML as other diseases may
have different definitions, like multiple myeloma.)
Request to add a new term of %min/h to the II SDTM, SEND-Published

UNIT codelist with the definition: Percent in P50
multiplied by minutes per hour.
File emailed separately II Do not add (P45):
TINT; PK Evaluation
Interval -> Do not add.
The PK team considers
TINT as a quality
parameter, or
supplemental
information used for the
computation of PK
parameters. This is not
a kinetic parameter, and
therefore the team
decides that controlled
terminology is not
needed. The PKPARM-
CD codelists are
extensible, please feel
free to submit this term
has an extensible value.
A measurement of Valproic Acid in a biological SDTM, SEND-Published

specimen. in P47
Please add VSTEST=Arm Span (Test II SDTM, SEND-Published
code=ARMSPAN) used in our SMA trials for in P47
subjects who cannot stand and therefore a
regular Height measurement cannot be
performed. Thank you!
File Emailed Separately II SDTM-Published in P45
P46, P47
Do not add (P45):
EXTRSCT; Extent of
Resection -> Do not
add. Not in TAUG
example anymore.
SDS team agreed on 2020-11-16 that there II DNA EXTRACTING
SDTM-Published ->
in P46
should be all-inclusive FA test terminology, in Do not add. Please use
addition to TA-specific FA test terminology. existing BEDECOD
value of EXTRACTING.
Please add terms: Cast Type (CSTYPE) and II Do not add (P47): - Cast
The --SPEC value holds
Crystal Type (CYTYPE) used in our trials; I am Type: Do not add. Each
the specimen that is the
also including a reference from labcorp: individual Cast Type
outcome of the event,
https://www.labcorp.com/tests/003772/urinalysis- observed should be
so DNA is correctly
complete-with-microscopic-examination listed as an individual
modeled in BESPEC.
LBTEST value; these
Do not add (P46):
generic 'what did you
PRIMARY TUMOR
see' type tests are not
STATUS -> Do not add.
appropriate for Cast
Modeling changed in
assessments/analysis.
TAUG to no longer need
Do not add (P47): -
this TEST.
Crystal Type: Do not
Do not add (P47): -
add. Each individual
Dose in Alternative Unit:
Crystal Type observed
This example CT has
should be listed as an
been removed from the
individual LBTEST
PanCan TAUG so is not
value; these generic
longer necessary to
'what did you see' type
publish.
tests are not appropriate
Do not add (P47): -
for Crystal
STEREOTACTIC BODY
assessments/analysis.
RADIATION THERAPY:
Do not add. Example
was updated to map
these more specific
procedures to
Add new terms to MICROORG and add SYs to II
RADIOTHERAPY in
existing MICROORG terms.
PRDECOD (which is
already in codelist).
Please add this value (that already exists in the II Do not add (P47): Do -
NCI thesaurus) as CDISC value for UNIT. not add. The numerator
INTRAOPERATIVE
of cells is inherent
RADIATION in the
THERAPY:
TEST
Do notvalue, hence the
add. Example
appropriate
was updatedunit of
to map
measure
these more should be /uL,
specific
which is published
procedures to in the
UNIT codelist as in
RADIOTHERAPY
C67452
PRDECOD with(which
submission
is
value
already 10^6/L.
in codelist).
Do not add (P47): -
CHROREAR: Do not
add. JIRA comment
Please add suggested term that also exists in II SDTM-Published in P49
submitted that this row
NCIt (Code C16811).
(row 10) in the example
should be removed as
A measurement of Hexosaminidase A in a II SDTM,
the team SEND-Published
has not yet
proposed a solution for
how to model this type
of data.
Do not add (P47): -
CHROREAR: Do not
add. Exampling
modeling changed in
TAUG so no longer
needed.
Here is the multiple term request file for all II Glossary, Define-XML,
approved P44 terminology that does not have a Protocol, SDTM -
request code associated with this. It contains 76 Published in P44
new terms and 93 changes to existing. File
emailed separately
New SDTM Codelist suggestion for Protocol II

Deviation Standardized Term (DVDECOD)
developed over past few years based on work
with multiple clients who wanted this codelist and
could not find any existing lists (included pharma,
biotech, CRO and vendor organizations). This list
of terms seem to be fairly comprehensive, but
suggest that this be an extensible codelist.
Wrong Treatment Given, Excluded Medication

Given, Ineligible Subject Enrolled, Required
Procedure Not Done, Informed Consent Not
Given Prior to Study Procedures,
Unqualified/Unlicensed Study Personnel,
Implementing Protocol Changes Without IRB
Approval, Samples Lost or Mishandled,
Confidentiality Breach, Data/Security Breach,
Falsified Data, Encounter / Procedure Out of
Window, Treatment Regimen Not Followed.
New Codelist for Standardized Term for Protocol

Deviations to populate DVDECOD. This has
been developed over several years with multiple
clients who were looking for a standard codelist
and could not find one.
Definition suggested : Used to define the event's II Do not add (P50): Do

type of reactogenicity. not add. Please see
This term would be needed for SDTM Mapping v1.1 Vaccines TAUG,
with vaccine studies forms. section 6 for how to
To be associated to Test Code as proposed in a model reactogenicity
separate form: REACTYP. event information (hint:
they used CAT and
SCAT for this
information).
Definition suggested : Used to define the event's II Do not add (P50): Do

type of reactogenicity. not add. Please see
This term would be needed for SDTM Mapping v1.1 Vaccines TAUG,
with vaccine studies forms. section 6 for how to
To be associated to Test Name as proposed in a model reactogenicity
separate form: Reactogenicity Event Type. event information (hint:
they used CAT and
SCAT for this
information).
Need request code for QRS instruments: NSCLC- II SDTM - Published in
SAQ and SMDDS V1 which will be published in P44
P44
Zinc transporter 8 (ZnT8) is an islet ?-cell II

secretory granule membrane protein recently
identified as an autoantibody antigen in type 1
diabetes.
VUJ, Ureterovesicular Junction, UVJ II SDTM, SEND-Published

Definition: Is the most distal portion of the ureter, in P47
at the point where it connects to the urinary
bladder.
MITESTCD = 'NAS'; MITEST = 'NAFLD Activity SDTM-Published in P47

Score'; MITSTDTL = 'STEATOSIS' Do not add (P47): Do
MITESTCD = 'NAS'; MITEST = 'NAFLD Activity not add. Please use
Score'; MITSTDTL = 'LOBULAR existing term FIBROSIS.
INFLAMMATION' The TSTDTL would
MITESTCD = 'NAS'; MITEST = 'NAFLD Activity reflect the NAFLD
Score'; MITSTDTL = 'BALLOONING' activity score paper. The
MITESTCD = 'NAS'; MITEST = 'NAFLD Activity fibrosis staging system
Score'; MITSTDTL = 'TOTAL SCORE' in the paper is novel.
MITESTCD = 'STEAT'; MITEST = 'Steatosis';
MITSTDTL = 'STEATOSIS GRADE'
MITSTDTL = 'STEATOSIS LOCATION'
MITSTDTL = 'MICROVESICULAR STEATOSIS'
MITESTCD = 'FIBROSIS', MITEST = 'Fibrosis',
MITSTDTL = 'NASH CRN FIBROSIS STAGE'
MITESTCD = 'INFLAM'; MITEST = 'Inflammation';
MITSTDTL = 'LOBULAR INFLAMMATION'
MITSTDTL = 'MICROGRANULOMAS'
MITSTDTL = 'LARGE LIPOGRANULOMAS'
MITSTDTL = 'PORTAL INFLAMMATION'
MITESTCD = 'HCINJ'; MITEST = 'Hepatocellular
Injury'; MITSTDTL = 'BALLOONING
DEGENERATION'
Injury'; MITSTDTL = 'ACIDOPHIL BODIES'
Injury'; MITSTDTL = 'PIGMENTED
MACROPHAGES'
Injury'; MITSTDTL = 'MEGAMITOCHONDRIA'
SEND PKPARM/PKPARMCD SEND PKUNIT;File II SDTM, SEND-Published
emailed separately in P46, P47
Do not add (P46):
Clearance for Dose by
AUCIFP - Do not add,
Map to either
C85796/CLFP, or
C85797/CLP
Lambda a Evaluation
Interval - Do not add for
now. This is a
compartmental analysis
(CA) parameter. The PP
domain was originally
created for the
representation of NCA
data, while this domain
allows CA data
mapping, it lacks the
appropriate structure
and variables to
sufficiently support CA
data. Therefore CA
parameters will not be
controlled at this time
until CDISC updates the
modeling of PP domain,
and creates new PP
variables to better
support CA data (this
may happen in 2021-
2022). The PK team
recommends two ways
forward: The PKPARM-
CD codelist is
extensible, you may add
this value as an
Definition: A layer of cartilage located in the II SDTM, SEND-Published
metaphysis of the tibia bone in children and in P47
adolescents that is the site of longitudinal bone
growth until skeletal maturity.
Definition suggested : Size of Needle Gauge II SDTM-Published in P48

Syringe used for injection.
This term would be needed for SDTM Mapping
with vaccine studies forms.
To be associated to Test Code as proposed in a
separate form: NGAUGESZ.
"Definition suggested : Size of Needle Gauge II SDTM-Published in P48

Syringe used for injection.
To be associated to Test Name as proposed in a
separate form: Gauge Size."
"Definition suggested : An exam of the body to II Do not add (P48): Do
check for general signs of disease.. not add. Based on
This term would be needed for SDTM Mapping requester feedback this
with vaccine studies forms. test is used when a
To be associated to Test Name as proposed in a direct assessment on
separate form: PHYSEXAM." the Clinical Event is not
done and rather they
use data from a
previous physical
examination. Said
another way, it appears
this is a clinical event
that was not followed-up
on. This is not a
recommended approach
therefore the team will
not control this FATEST.
"Definition suggested : An exam of the body to II Do not add (P48): Do

check for general signs of disease. not add. Based on
This term would be needed for SDTM Mapping requester feedback this
with vaccine studies forms. test is used when a
To be associated to Test Name as proposed in a direct assessment on
separate form: Physical Examination." the Clinical Event is not
done and rather they
use data from a
previous physical
examination. Said
another way, it appears
this is a clinical event
that was not followed-up
on. This is not a
recommended approach
therefore the team will
not control this FATEST.
"Definition suggested : Used for qualitative ECG II Do not add (P48): Do

measurements. not add. With an OBJ of
This term would be needed for SDTM Mapping TEST NAME it appears
with vaccine studies forms. that they are collecting
To be associated to Test Code as proposed in a Findings on Findings.
separate form: FINDING" The team does not think
this is at all mapped to
SDTM appropriately.
"Definition suggested : Used for qualitative ECG II Do not add (P48): Do
measurements. not add. With an OBJ of
This term would be needed for SDTM Mapping TEST NAME it appears
with vaccine studies forms. that they are collecting
To be associated to Test Name as proposed in a Findings on Findings.
separate form: Finding" The team does not think
this is at all mapped to
SDTM appropriately.
"Definition suggested : An outcome of II Do not add (P48): Do

observation represented as a text, qualitative, or not add. With an OBJ of
quantitative parameter, code, image, graph, etc. TEST NAME it appears
This term would be needed for SDTM Mapping that they are collecting
with vaccine studies forms. Findings on Findings.
To be associated to Test Code as proposed in a The team does not think
separate form: OBSR" this is at all mapped to
SDTM appropriately.
"Definition suggested : An outcome of II Do not add (P48): Do

observation represented as a text, qualitative, or not add. With an OBJ of
quantitative parameter, code, image, graph, etc. TEST NAME it appears
This term would be needed for SDTM Mapping that they are collecting
with vaccine studies forms. Findings on Findings.
To be associated to Test Name as proposed in a The team does not think
separate form: Observation Result." this is at all mapped to
SDTM appropriately.
"Definition suggested : Disease perceptible to the II Do not add (P48): Do

examining practitioner (sign) and subjective not add. Signs and
evidence of disease perceived by the patient symptoms should be
(symptom). reported as individual
This term would be needed for SDTM Mapping clinical events in
with vaccine studies forms. CETERM/CEDECOD,
To be associated to Test Code as proposed in a and not as tests/findings
separate form: SIGNSYMP." in the Findings About
record for a single
clinical event in FAOBJ.
"Definition suggested : Disease perceptible to the II Do not add (P48): Do

examining practitioner (sign) and subjective not add. Signs and
evidence of disease perceived by the patient symptoms should be
(symptom). reported as individual
This term would be needed for SDTM Mapping clinical events in
with vaccine studies forms. CETERM/CEDECOD,
To be associated to Test Name as proposed in a and not as tests/findings
separate form: Sign and Symptom." in the Findings About
record for a single
clinical event in FAOBJ.
"Definition suggested : A written or verbal II Do not add (P48): Do
account, representation, statement, or not add. The team has a
explanation of enlargement; expansion in size; concern that controlling
sign of inflammation. this value may lead to
This term would be needed for SDTM Mapping potential mis-use by
with vaccine studies forms. other companies.
To be associated to Test Code as proposed in a Additionally, narratives
separate form: SWELDESC." like this are hard to pick
apart for analysis
purposes. The requester
can continue to use this
term for the codelist but
CDISC will not control it
as there is most likely
not going to be high re-
use of the concept
across the industry.
"Definition suggested : A written or verbal II Do not add (P48): Do

account, representation, statement, or not add. The team has a
explanation of enlargement; expansion in size; concern that controlling
sign of inflammation. this value may lead to
This term would be needed for SDTM Mapping potential mis-use by
with vaccine studies forms. other companies.
To be associated to Test Name as proposed in a Additionally, narratives
separate form: Swelling Description." like this are hard to pick
apart for analysis
purposes. The requester
can continue to use this
term for the codelist but
CDISC will not control it
as there is most likely
not going to be high re-
use of the concept
across the industry.
"Definition suggested : Location of the connection II SDTM-Published in P50

point between two bones or skeletal elements
within the body.
separate form: JOINTLOC"
"Definition suggested : Location of the connection II SDTM-Published in P50
point between two bones or skeletal elements
within the body.
separate form: Joint Location."
"Definition suggested : A question about whether II SDTM-Published in P48

an individual's an event prevents or has
prevented their daily activities.
separate form: DAILYACT
"
"Definition suggested : A question about whether II SDTM-Published in P48

an individual's an event prevents or has
prevented their daily activities.
separate form: Prevents Daily Activities
"
"Definition suggested : Be specific about II Do not add (P48): Do

something; define clearly. not add. This TEST is
This term would be needed for SDTM Mapping too generic to be useful.
separate form: SPECIFY
"
"Definition suggested : Be specific about II Do not add (P48): Do

something; define clearly. not add. This TEST is
This term would be needed for SDTM Mapping too generic to be useful.
separate form: Specify
"
"Definition suggested : A characterization of a II Do not add (P48): Do

viral organism that can be assigned to the not add. Dengue
species Dengue virus based on the antigenic Serotype information
properties of the molecules on its surface. should be mapped to OI
This term would be needed for SDTM Mapping domain. This is
with vaccine studies forms." inappropriate for the FA
domain.
"Definition suggested : A characterization of a II Do not add (P48): Do
viral organism that can be assigned to the not add. Dengue
species Dengue virus based on the antigenic Serotype information
properties of the molecules on its surface. should be mapped to OI
This term would be needed for SDTM Mapping domain. This is
with vaccine studies forms. inappropriate for the FA
To be associated to Test Name as proposed in a domain.
separate form: Dengue Serotype
"
"Definition suggested : An indication as to II Do not add (P48): Do

whether the dengue infection is severe. not add. Based on
This term would be needed for SDTM Mapping additional information
with vaccine studies forms. provided by the
To be associated to Test Code as proposed in a requester who noted the
separate form: DESEVIND parent domain is MH,
" the team recommends
using the variable --SEV
with supporting codelist
SEVRS. There is no
need to create a
findings about dataset to
represent this
information.

whether the dengue infection is severe. not add. Based on
This term would be needed for SDTM Mapping additional information
with vaccine studies forms." provided by the
requester who noted the
parent domain is MH,
the team recommends
using the variable --SEV
with supporting codelist
SEVRS. There is no
need to create a
findings about dataset to
represent this
information.
"Definition suggested : Severity grade of dengue II Do not add (P48): Do

infection. Classified into 4 grades, based on not add. Based on
bleeding episodes and shock. additional information
This term would be needed for SDTM Mapping provided by the
with vaccine studies forms. requester who noted the
To be associated to Test Code as proposed in a parent domain is MH,
separate form: DENSEVGR" the team recommends
using SUPPMH to
represent this
information. An FA
dataset is unnecessary
here.
"Definition suggested : Severity grade of dengue II Do not add (P48): Do
infection. Classified into 4 grades, based on not add. Based on
bleeding episodes and shock. additional information
This term would be needed fo" provided by the
requester who noted the
parent domain is MH,
the team recommends
using SUPPMH to
represent this
information. An FA
dataset is unnecessary
here.

whether the bleeding is spontaneous. not add. Requester
This term would be needed for SDTM Mapping could not provide
with vaccine studies forms. FAOBJ value that is
To be associated to Test Code as proposed in a associated with this
separate form: FABLSYN" TEST. If this information
is found, we invite the
requester to re-submit
the request with the
additional information.

whether the bleeding is spontaneous. not add. Requester
This term would be needed for SDTM Mapping could not provide
with vaccine studies forms." FAOBJ value that is
TEST. If this information
is found, we invite the
requester to re-submit
the request with the
additional information.
"Definition suggested : Patient complaints other II Do not add (P48): Do

severe (symptoms), physical/laboratory not add. Requester
findings(signs) than those mentionned, related to could not provide
the soft internal organs of the body, including the FAOBJ value that is
lungs, the heart, and the organs of the digestive, associated with this
excretory, reproductive, and circulatory systems. TEST. If this information
This term would be needed for SDTM Mapping is found, we invite the
with vaccine studies forms. requester to re-submit
To be associated to Test Code as proposed in a the request with the
separate form: OTHSVM" additional information.
"Definition suggested : Patient complaints other II Do not add (P48): Do
severe (symptoms), physical/laboratory not add. Requester
findings(signs) than those mentionned, related to could not provide
the soft internal organs of the body, including the FAOBJ value that is
lungs, the heart, and the organs of the digestive, associated with this
excretory, reproductive, and circulatory systems. TEST. If this information
This term would be needed for SDTM Mapping is found, we invite the
with vaccine studies forms. requester to re-submit
To be associated to Test Name as proposed in a the request with the
separate form: Other Severe Visceral additional information.
Manifestation"
"The length of the closed curve of a circle; the II SDTM-Published in P50

size of something as given by the distance
around it.
separate form: CIRCUMF"
"The length of the closed curve of a circle; the II SDTM-Published in P50

size of something as given by the distance
around it.
with vaccine studies forms."
"Definition suggested : Number of weeks II Do not add (P48): Do

pregnant at the time of vaccination. not add. Based on
This term would be needed for SDTM Mapping requester information
with vaccine studies forms. this is really a question
To be associated to Test Code as proposed in a that would require an
separate form: PREGWEEK APCM dataset (since
" the weeks of pregnancy
is related to the mother
who is the AP in this
case). Team thinks a
supp APCM dataset
would be more
appropriate modeling
strategy here, instead of
FA.
"Definition suggested : Number of weeks II Do not add (P48): Do
pregnant at the time of vaccination. not add. Based on
This term would be needed for SDTM Mapping requester information
with vaccine studies forms." this is really a question
that would require an
APCM dataset (since
the weeks of pregnancy
is related to the mother
who is the AP in this
case). Team thinks a
supp APCM dataset
would be more
appropriate modeling
strategy here, instead of
FA.
C116569 II Do not change (P46):

Do not change.
I believe this term should be updated to Fluorescein is a specific
""Fluorescein Angiography"". Fluorescence dye used in this
Angiography seems to be a parent concept for procedure but other
both fluorescein angiography and Indocyanine dyes may be used as
Green Fluorescence Angiography, however well. Please use existing
sources such as: term and if important
https://en.wikipedia.org/wiki/ place the Fluorescein
Fluorescein_angiography#cite_note-1 Dye in an AG/Procedure
https://meshb.nlm.nih.gov/record/ui? Agent domain record.
name=Fluorescein%20Angiography
suggest fluorescence angiography to be a

synonym for fluorescein angiography. According
to our imaging scientists, fluorescein angiography
is the recognized term by our ophthalmic imaging
vendors.
According to our imaging scientists, fluorescein

angiography is the recognized term by our
ophthalmic imaging vendors. Could we have
"Fluorescein Angiography" replace "Fluorescence
Angiography" in C116569, and list "fluorescence
angiography" as a synonym for fluorescein
angiography?
FATEST = Adequate Treatment Indicator, II SDTM-Published in P47
FATESTCD = ADTRTIND
DEF = An indication as to whether the adequate
treatment has been administered to the subject.
SDTM Example see here -
https://wiki.cdisc.org/display/TACROH/SDTM.
+Prior+CD+Medications+-+Immunomodulators
Richard/Rebecca: this new test relates to the new

question on the CRF here:
https://wiki.cdisc.org/x/OMnwBQ
Question: If [the primary reason for
discontinuation is] "Non-response", was the
subject receiving the protocol-defined adequate
treatment for this immunomodulator?
New terms needed for codelist II SDTM-Published in P47

MUSCTS/MUSCTSCD. File emailed separately. Do not add (P47): -
Range of Motion,
Limited: Do not add.
This appears to be a
finding rather than an
assessment, therefore
we will not add to the
codelist. The requester
can use existing 'Range
of Motion'-type tests
such as C139212,
C139214. and C139214
OR submit a new
request for something
similar to be added.
Do not add (P47): -
Active Arthritis: Do not
add. This appears to be
a finding, medical
history term, diagnosis,
or clinical event as
requested, which is not
appropriate for a TEST
codelist.
Do not add (P47): -
Muscoloskeletal System
Findings All: Do not add.
This is a published
convention in the IG and
will not be created as a
valid value in any
TEST/TESTCD codelist
within CDISC. The
codelist is extensible so
this can stay as an
extensible term.
The location of a finding in two distinct areas. II Do not add (P48): Do
not add. Please use
existing term
MULTIFOCAL instead.
Please create controlled terminology for II QRS-Published in P46
Cumulative Illness Rating Scale - Geriatrics
(CCCAT and new CIRSG C and CIRSG N
codelists) and FACT-BP V4 (QSCAT and new
FAC074 C and T codelists). for QRS.
See MIFTSDTL: AJCC GRADE and AJCCGRD II SDTM-Published in P47

codelist responses. The definitions for the terms
include version-specific information but the rest of
the concepts (terms, NCI PTs, etc. are version
agnostic). Team will need to re-look at this
terminology to determine where version
information goes. Also NCI PTs may need to be
updated for the AJCCGRD codelist of responses.
NEW lab terms II SDTM, SEND-Published

in P47
The definition of this new term is: Extracorporeal II SDTM-Published in P50
cytokine hemoadsorption is an emerging
technology utilized in the treatment of
dysregulated inflammatory states such as sepsis.
Date of Request
Submission Code
Closed Friday, 8 Jan CDISC- Steve Kpoko CDISC skopko.external@c

2021 11:50 AM 4728 disc.org
Closed Friday, 15 Jan CDISC- Ying Li Charles River ying.li@crl.com

2021 01:52 PM 4729 Laboratories
Closed Friday, 15 Jan CDISC- Ying Li Charles River ying.li@crl.com
2021 01:52 PM 4730 Laboratories
Closed Friday, 15 Jan CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2021 01:54 PM 4731 ng mail.com
Open Friday, 22 Jan CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2021 12:18 PM 4732 yer.com

2021 12:18 PM 4733 yer.com

2021 12:19 PM 4734 yer.com
2021 12:19 PM 4735 yer.com

2021 12:20 PM 4736 yer.com

2021 12:20 PM 4737 yer.com

2021 12:21 PM 4738 yer.com

2021 12:21 PM 4739 yer.com

2021 12:22 PM 4740 yer.com

2021 12:23 PM 4741 yer.com

2021 12:24 PM 4742 yer.com
2021 12:24 PM 4743 nih.gov
Closed Friday, 22 Jan CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co

2021 12:26 PM 4744 m

2021 12:26 PM 4745 m

2021 12:27 PM 4746 m
Closed Friday, 22 Jan CDISC- Elaine Hazzard Janssen R&D ehazzard@its.jnj.co

2021 12:28 PM 4747 m
Closed Friday, 22 Jan CDISC- Mihaela Simion Biogen mihaela.simion@bi

2021 12:29 PM 4748 ogen.com

Jan 2021 12:58 4749
PM
Jan 2021 06:18 4750 ogen.com
PM

Jan 2021 06:19 4751 ogen.com
PM
Jan 2021 06:20 4752 yer.com
PM
Closed Thursday, 28 CDISC- DANIEL LEE PDS dan.potenta@pdslif

Jan 2021 06:20 4753 POTENTA esciences.com
PM
Closed Thursday, 28 CDISC- Dan Sinnett Emmes dsinnett@emmes.c

Jan 2021 06:21 4754 om
PM
Closed Thursday, 28 CDISC- Theresa Focella Beigene theresa.focella@be
Jan 2021 06:22 4755 igene.com
PM
Open Thursday, 28 CDISC- Janessa Pierce Merck & Co., Inc. JANESSA_PIERCE
Jan 2021 06:23 4756 @MERCK.COM
PM
Closed Thursday, 28 CDISC- Emily Canosa emily_canosa@rho

Jan 2021 06:23 4757 world.com
PM
Closed Friday, 29 Jan CDISC- Craig M Zwickl czwickl@msn.com
2021 11:26 AM 4758
Closed Friday, 29 Jan CDISC- Craig M Zwickl czwickl@msn.com

2021 11:29 AM 4759
Closed Friday, 5 Feb CDISC- aparna kulkarni Pfizer aparna.kulkarni@pf

2021 12:17 PM 4760 izer.com
Closed Friday, 5 Feb CDISC- Annie McCoy Health Decisions amccoy@healthdec

2021 12:18 PM 4761 .com

2021 12:18 PM 4762 .com

2021 12:18 PM 4763 .com

2021 12:18 PM 4764 .com
Closed Friday, 5 Feb CDISC- Steve Kopko CDISC skopko.external@c

2021 12:19 PM 4765 disc.org
2021 12:20 PM 4766 disc.org

2021 12:20 PM 4767 disc.org
Closed Friday, 5 Feb CDISC- Rahul Thandavan Hoffman La Roche rahul.thandavan@r

2021 12:21 PM 4768 oche.com
Closed Friday, 5 Feb CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2021 12:22 PM 4769 om
Closed Friday, 5 Feb CDISC- Fariba Alipour EMD Serono Fariba.alipour@em
2021 12:23 PM 4770 dserono.com
Closed Friday, 5 Feb CDISC- Yaffa Rosenblum yaffa.rosenblum@t

2021 12:24 PM 4771 eva.co.il
Closed Friday, 5 Feb CDISC- Jenny Jones Covance jenny.jones@covan

2021 12:24 PM 4772 ce.com
Closed Friday, 5 Feb CDISC- Jenny Jones Covance jenny.jones@covan
2021 12:24 PM 4773 ce.com
Closed Thursday, 11 CDISC- Annie McCoy Health Decisions amccoy@healthdec

Feb 2021 02:40 4774 .com
PM
Open Thursday, 11 CDISC- Jordan V Li NCI EVS jordan.li@nih.gov

Feb 2021 02:41 4775
PM
Closed Thursday, 11 CDISC- Barbara Lentz Bayer AG barbara.lentz1@ba
Feb 2021 02:41 4776 yer.com
PM

Feb 2021 02:42 4777 ogen.com
PM
Closed Thursday, 11 CDISC- Carrie Neeley Covance carrie.neeley@cov

Feb 2021 02:43 4778 ance.com
PM

Feb 2021 02:44 4779 nih.gov
PM
Feb 2021 02:45 4780 nih.gov
PM

2021 12:56 PM 4781 nih.gov
Closed Friday, 12 Feb CDISC- Anita Umesh Stealth anita.umesh@gmai

2021 01:04 PM 4782 l.com
Closed Thursday, 18 CDISC- Wenli Zhang navitas life wzhang@navitaslif
Feb 2021 09:55 4783 sciences esciences.com
AM
Closed Thursday, 18 CDISC- Cathy Bezek Astellas Pharma cathy.bezek@astell
Feb 2021 07:23 4784 as.com
PM
Closed Thursday, 18 CDISC- Assia Bouhadouza Sanofi CIG_MAILBOX@s

Feb 2021 07:25 4785 anofi.com
PM
Closed Thursday, 18 CDISC- Richard Marshall CDISC richard@accurates
Feb 2021 07:25 4786 ystems.co.uk
PM
Closed Thursday, 18 CDISC- Richard Marshall CDISC richard@accurates
Feb 2021 07:26 4787 ystems.co.uk
PM
Closed Thursday, 18 CDISC- Kathleen Mellars CDISC KMellars@cdisc.or

Feb 2021 07:27 4788 g
PM
Closed Thursday, 18 CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co

Feb 2021 07:29 4790 m
PM

Feb 2021 07:29 4791 m
PM
Open Thursday, 18 CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co

Feb 2021 07:31 4792 m
PM

Feb 2021 07:31 4793 m
PM

Feb 2021 07:31 4794 m
PM

Feb 2021 07:31 4795 m
PM

Feb 2021 07:32 4796 m
PM
Feb 2021 07:32 4797 m
PM
Feb 2021 07:32 4798 m
PM
Feb 2021 07:33 4799 behalf of Glossary nih.gov
PM team)

Feb 2021 07:34 4800 behalf of Glossary nih.gov
PM team)
Closed Friday, 19 Feb CDISC- Diane Corey C-Path dcorey@c-path.org

2021 11:56 AM 4801
Closed Friday, 19 Feb CDISC- Diane Corey C-Path dcorey@c-path.org

2021 11:57 AM 4802
Closed Friday, 26 Feb CDISC- Asko L tj nen Orion Pharma Asko.Lotjonen@ori

2021 12:14 PM 4803 onpharma.com
Closed Friday, 26 Feb CDISC- ARLIX Sophie Syneoshealth sophie.arlix@syneo


Inc.
Closed Friday, 26 Feb CDISC- Christine Connolly EMD Serono christine.connolly@
Closed Friday, 26 Feb CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.
2021 12:19 PM 4807 com
Closed Friday, 26 Feb CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2021 12:19 PM 4808 com
Closed Friday, 26 Feb CDISC- Courtney Shaffer Amarex Clinical courtneys@amarex

2021 12:20 PM 4809 Research cro.com
Closed Wednesday, 3 CDISC- Jordan V Li NCI EVS jordan.li@nih.gov

Mar 2021 11:24 4810
AM
Closed Friday, 5 Mar CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s
2021 11:34 AM 4811 anofi.com

2021 11:35 AM 4812 anofi.com

2021 11:35 AM 4813 anofi.com
Open Friday, 5 Mar CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 11:35 AM 4814 anofi.com
2021 11:36 AM 4815 anofi.com

2021 11:36 AM 4816 anofi.com

2021 11:38 AM 4817 anofi.com
2021 11:40 AM 4818 anofi.com
Open Friday, 5 Mar CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 11:41 AM 4819 anofi.com

2021 11:41 AM 4820 anofi.com

2021 11:42 AM 4821 anofi.com
2021 11:42 AM 4822 anofi.com

2021 11:43 AM 4823 anofi.com

2021 11:44 AM 4824 anofi.com

2021 11:44 AM 4825 anofi.com

2021 11:44 AM 4826 anofi.com

2021 11:45 AM 4827 anofi.com

2021 11:45 AM 4828 anofi.com
2021 11:46 AM 4829 anofi.com

2021 11:46 AM 4830 anofi.com

2021 11:47 AM 4831 anofi.com

2021 11:47 AM 4832 anofi.com
2021 11:48 AM 4833 anofi.com

2021 11:49 AM 4834 anofi.com

2021 11:49 AM 4835 anofi.com

2021 11:50 AM 4836 anofi.com
2021 11:51 AM 4837 anofi.com

2021 11:51 AM 4838 anofi.com

2021 11:52 AM 4839 anofi.com

2021 11:53 AM 4840 anofi.com
2021 11:53 AM 4841 anofi.com

2021 12:47 PM 4842 ogen.com
Closed Friday, 5 Mar CDISC- Deekshitha.M Zifo RnD Solutions Deekshitha.M@zifo

2021 12:49 PM 4843 rnd.com
Closed Friday, 5 Mar CDISC- Alexander Winter The Emmes awinter@emmes.c

2021 12:50 PM 4844 Company, LLC om

2021 02:48 PM 4845 anofi.com

2021 02:50 PM 4846 anofi.com
2021 02:51 PM 4847 anofi.com

2021 02:52 PM 4848 nih.gov
Closed Friday, 5 Mar CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2021 02:56 PM 4849 Pharma.com
Closed Monday, 8 Mar CDISC- Jenny Jones Covance Jenny.Jones@cova

2021 05:21 PM 4850 nce.com
Closed Monday, 8 Mar CDISC- Jenny Jones Covance Jenny.Jones@cova
2021 05:24 PM 4851 nce.com
Closed Monday, 8 Mar CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2021 05:29 PM 4852 om
Closed Tuesday, 9 Mar CDISC- Tina Lowe Theradex tina.lowe@nih.gov

2021 01:10 PM 4853
Closed Tuesday, 9 Mar CDISC- Jordan V Li (on NCI EVS jordan.li@nih.gov

2021 01:15 PM 4854 behalf of Joleen
White from SEND)
Closed Tuesday, 9 Mar CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2021 02:49 PM 4855 yer.com

Mar 2021 10:04 4856 ogen.com
AM
Closed Wednesday, 10 CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s
Mar 2021 10:07 4857 anofi.com
AM

Mar 2021 10:09 4858 anofi.com
AM
Mar 2021 10:11 4859 anofi.com
AM

Mar 2021 10:12 4860 anofi.com
AM

Mar 2021 12:57 4861 anofi.com
PM
Mar 2021 01:03 4862 anofi.com
PM
Open Wednesday, 10 CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

Mar 2021 01:03 4863 anofi.com
PM

Mar 2021 01:13 4864 anofi.com
PM
Mar 2021 03:07 4865 om
PM

Mar 2021 03:11 4866 om
PM
Open Thursday, 11 CDISC- Sunny Mankotia IQVIA sunny.mankotia@q

Mar 2021 10:47 4867 uintiles.com
AM
Open Thursday, 11 CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s
Mar 2021 10:51 4868 anofi.com
AM

Mar 2021 10:53 4869 anofi.com
AM
Closed Thursday, 11 CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s
Mar 2021 10:57 4870 anofi.com
AM

Mar 2021 12:23 4871 anofi.com
PM
Mar 2021 12:37 4872 anofi.com
PM
Open Monday, 15 Mar CDISC- Dave Scocca Rho, Inc. dave_scocca@rho

2021 12:43 PM 4873 world.com
Closed Monday, 15 Mar CDISC- MinJi Lee Celltrion, Inc. minji.lee@celltrion.
2021 12:46 PM 4874 com
Closed Monday, 15 Mar CDISC- MinJi Lee Celltrion, Inc. minji.lee@celltrion.

2021 01:12 PM 4875 com
Open Monday, 15 Mar CDISC- MinJi Lee Celltrion, Inc. minji.lee@celltrion.
2021 01:14 PM 4876 com
Closed Monday, 15 Mar CDISC- min ji lee Celltrion, Inc. minji.lee@celltrion.

2021 01:19 PM 4877 com

2021 01:25 PM 4878 com

2021 01:33 PM 4879 com
Closed Monday, 15 Mar CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 01:40 PM 4880 anofi.com
Closed Monday, 15 Mar CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s
2021 01:44 PM 4881 anofi.com
Open Monday, 15 Mar CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 01:51 PM 4882 anofi.com
Open Monday, 15 Mar CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 01:57 PM 4883 anofi.com
Closed Monday, 15 Mar CDISC- Christine Connolly EMD Serono christine.connolly@

Closed Monday, 15 Mar CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba
2021 02:22 PM 4885 yer.com
2021 02:25 PM 4886 om

2021 02:27 PM 4887 om
Open Thursday, 18 CDISC- Steve Kopko CDISC skopko.external@c

Mar 2021 01:31 4888 disc.org
PM

Mar 2021 01:54 4889 om
PM
Mar 2021 02:27 4890 om
PM
Closed Monday, 22 Mar CDISC- Steve Kopko CDISC skopko.external@c

2021 01:20 PM 4891 disc.org
Closed Monday, 22 Mar CDISC- Chunpeng Zhao Beigene chunpeng.zhao@b

2021 01:22 PM 4892 eigene.com
Closed Monday, 22 Mar CDISC- Diane Corey C-Path dcorey@c-path.org
2021 01:33 PM 4893
Closed Tuesday, 23 Mar CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2021 01:15 PM 4894 ng mail.com
Open Tuesday, 23 Mar CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2021 04:26 PM 4895 yer.com

2021 04:28 PM 4896 yer.com

2021 04:30 PM 4897 yer.com

2021 04:31 PM 4898 yer.com

2021 04:33 PM 4899 yer.com
2021 04:34 PM 4900 yer.com
Closed Wednesday, 24 CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

Mar 2021 10:20 4901 ng mail.com
AM
Closed Wednesday, 24 CDISC- Sophia Zilber Pfizer sophia.zilber@pfize

Mar 2021 10:23 4902 r.com
AM
Mar 2021 12:46 4903 anofi.com
PM

Mar 2021 12:48 4904 anofi.com
PM
Closed Wednesday, 24 CDISC- Craig M Zwickl CDISC czwickl@cdisc.org
Mar 2021 12:54 4905
PM
Open Wednesday, 24 CDISC- Steve Kopko CDISC skopko@cdisc.exte

Mar 2021 05:42 4906 rnal.org
PM
Open Wednesday, 24 CDISC- Steve Kopko CDISC skopko@cdisc.exte
Mar 2021 05:43 4907 rnal.org
PM
Closed Wednesday, 24 CDISC- Steve Kopko CDISC skopko@cdisc.exte

Mar 2021 05:44 4908 rnal.org
PM
Closed Wednesday, 24 CDISC- Rohit Dhanjal Vertex Rohit.dhanjal@gma

Mar 2021 05:56 4909 il.com
PM
Closed Thursday, 25 CDISC- Jerry Salyers Essex Management jsalyers@essexma
Mar 2021 11:33 4910 nagement.com
AM
Mar 2021 11:59 4911 anofi.com
AM

Mar 2021 12:01 4912 anofi.com
PM
Mar 2021 12:02 4913 anofi.com
PM

Mar 2021 12:04 4914 anofi.com
PM
Closed Friday, 26 Mar CDISC- Gary Walker Gary G Walker, gary.walker.ggw@g

2021 11:13 AM 4915 LLC mail.com
Closed Friday, 26 Mar CDISC- Gary Walker Gary G Walker, gary.walker.ggw@g
2021 11:15 AM 4916 LLC mail.com

Inc.
Open Friday, 26 Mar CDISC- Sharon Broderick Boehringer sharon.broderick@
Inc.
Closed Monday, 29 Mar CDISC- Christine Connolly EMD Serono christine.connolly@
Closed Tuesday, 30 Mar CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2021 02:39 PM 4920 com
Closed Friday, 2 Apr CDISC- Jenny Jones Covance jenny.jones@covan
2021 09:50 AM 4921 ce.com
Closed Monday, 5 Apr CDISC- Dr William Stevens Clinical Trial will.stevens@ndph.

2021 03:40 PM 4922 Service Unit, ox.ac.uk
Open Monday, 5 Apr CDISC- Dr William Stevens Clinical Trial will.stevens@ndph.
2021 03:41 PM 4923 Service Unit, ox.ac.uk
Closed Monday, 5 Apr CDISC- Diane Corey C-Path dcorey@c-path.org

2021 04:46 PM 4924
Closed Tuesday, 6 Apr CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo


Apr 2021 06:23 4926 anofi.com
PM

Apr 2021 06:26 4927 anofi.com
PM

Apr 2021 06:27 4928 anofi.com
PM

Apr 2021 06:29 4929 anofi.com
PM
Apr 2021 06:39 4930 anofi.com
PM

Apr 2021 06:40 4931 anofi.com
PM
Apr 2021 06:42 4932 anofi.com
PM

Apr 2021 06:45 4933 om
PM
Closed Thursday, 8 Apr CDISC- Erin Muhlbradt (on MSC Inc. muhlbradtee@mail.
2021 03:44 PM 4934 behalf of Bill nih.gov
Houser)
Closed Monday, 12 Apr CDISC- Audrey Harris Charles River Audrey.Harris@crl.
2021 03:59 PM 4935 com
Closed Monday, 12 Apr CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba

2021 04:03 PM 4936 yer.com
Closed Monday, 12 Apr CDISC- Jenny Jones Covance Jenny.Jones@Cov

2021 04:09 PM 4937 ance.com
Closed Thursday, 15 Apr CDISC- Josephine Domingo josephine.domingo
2021 03:04 PM 4938 @pfizer.com
Open Thursday, 15 Apr CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba

2021 03:06 PM 4939 yer.com

2021 03:09 PM 4940 yer.com
Closed Thursday, 15 Apr CDISC- Jordan V Li (on NCI EVS jordan.li@nih.gov

TA team)
Closed Thursday, 15 Apr CDISC- Jordan V Li (on NCI EVS jordan.li@nih.gov

TA team)
2021 11:41 AM 4943 yer.com
Open Monday, 19 Apr CDISC- Jennifer Feldmann Epreda jennifer.feldmann@

2021 01:29 PM 4944 epreda.com
Closed Monday, 19 Apr CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2021 03:54 PM 4945 nih.gov
Closed Tuesday, 20 Apr CDISC- Ivan Jiang Roche/Genentech jiangi@gene.com

2021 05:56 PM 4946
Closed Thursday, 22 Apr CDISC- Steve Kopko CDISC skopko.external@c
2021 01:10 PM 4947 disc.org
Closed Thursday, 22 Apr CDISC- Carrie Neeley Covance carrie.neeley@cov

2021 03:38 PM 4948 ance.com
Closed Thursday, 22 Apr CDISC- Rahul Thandavan Hoffman La Roche rahul.thandavan@r

2021 05:04 PM 4949 oche.com
Open Monday, 26 Apr CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2021 03:58 PM 4950 com
Closed Monday, 26 Apr CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2021 04:02 PM 4951 om
Open Wednesday, 28 CDISC- Sherry Chou Parexel sherry.chou@parex

Apr 2021 03:41 4952 el.com
PM
Closed Wednesday, 28 CDISC- Aparna Kulkarni Pfizer aparna.kulkarni@pf
Apr 2021 03:47 4953 izer.com
PM

Apr 2021 03:49 4954 Pharmaceutical m
PM Companies of
Johnson and
Johnson
Open Wednesday, 28 CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

Apr 2021 03:54 4955 ng mail.com
PM
Closed Monday, 3 May CDISC- Assia Bouhadouza Sanofi CIG_MAILBOX@s

2021 12:18 PM 4956 anofi.com
Closed Monday, 3 May CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2021 12:23 PM 4957 yer.com
Closed Tuesday, 4 May CDISC- Steve Kopko CDISC skopko.external@c

2021 04:23 PM 4958 disc.org
Closed Tuesday, 4 May CDISC- Steve Kopko CDISC skopko.external@c

2021 04:29 PM 4959 disc.org
May 2021 11:14 4960 zwick@astrazenec
AM a.com
Closed Thursday, 6 May CDISC- Sophie Arlix Syneoshealth sophie.arlix@syneo

Closed Thursday, 6 May CDISC- Diane Corey C-Path dcorey@c-path.org

2021 02:53 PM 4962
Closed Friday, 7 May CDISC- Dana Booth cdisc dbooth@cdisc.org

2021 08:48 AM 4963
Closed Friday, 7 May CDISC- Dana Booth cdisc dbooth@cdisc.org

2021 08:52 AM 4964
Closed Friday, 7 May CDISC- Muthafar Al- Bristol Myers Muthafar.Al-
2021 11:50 AM 4965 Haddawi Squibb Haddawi@bms.co
m
Closed Monday, 10 May CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2021 11:26 AM 4966 Pharma.com
Open Thursday, 13 CDISC- Sanket Sinojia IQVIA sanket.sinojia@iqvi

May 2021 09:42 4967 a.com
AM
Open Thursday, 13 CDISC- Erin Muhlbradt (on MSC Inc. muhlbradtee@mail.
May 2021 09:51 4968 behalf of Shaun nih.gov
AM Goodyear/Protocol
Team)
Closed Thursday, 13 CDISC- Dr William Stevens Clinical Trial will.stevens@ndph.
May 2021 10:30 4969 Service Unit, ox.ac.uk
AM University of Oxford
Closed Thursday, 13 CDISC- Erin Tibbs-Slone CRL erin.tibbs-

May 2021 10:32 4970 slone@crl.com
AM
Closed Friday, 14 May CDISC- Dr William Stevens Clinical Trial will.stevens@ndph.
2021 09:43 AM 4971 Service Unit, ox.ac.uk
Open Friday, 14 May CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2021 09:51 AM 4972 nih.gov
Closed Wednesday, 19 CDISC- Carrie Neeley Covance carrie.neeley@cov

May 2021 03:28 4973 ance.com
PM
Closed Thursday, 20 CDISC- Ashok Ganta Pfizer Inc ashok.ganta@pfize

May 2021 09:59 4974 r.com
AM
Closed Friday, 21 May CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2021 09:45 AM 4975 Pharma.com
2021 06:42 PM 4976 ance.com

2021 06:44 PM 4977 ance.com
Closed Wednesday, 26 CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4
May 2021 09:35 4978 Pharma.com
AM
Closed Wednesday, 26 CDISC- Jordan Li (on NCI EVS Jordan.li@nih.gov

May 2021 01:53 4979 behalf of the ECG
PM CT team)
Closed Thursday, 27 CDISC- Laura Bocchino JCHR lbocchino@jaeb.or
May 2021 10:43 4980 g
AM
Open Friday, 28 May CDISC- Jenny Jones Covance Jenny.Jones@Cov

2021 01:13 PM 4981 ance.com
Closed Friday, 28 May CDISC- Jenny Jones Covance Jenny.Jones@Cov

2021 02:40 PM 4982 ance.com
Closed Friday, 28 May CDISC- Jenny Jones Covance Jenny.Jones@Cov
2021 02:41 PM 4983 ance.com
Open Tuesday, 1 Jun CDISC- anita.umesh@gmai
2021 12:49 PM 4984 l.com
Closed Tuesday, 1 Jun CDISC- Colleen Bonjo Merck colleen_bonjo@me
2021 04:14 PM 4985 rck.com
Closed Tuesday, 1 Jun CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2021 04:21 PM 4986 com
Closed Wednesday, 2 CDISC- Helena Fung Parexel helena.fung@parex
Jun 2021 10:00 4987 International el.com
AM
Closed Wednesday, 2 CDISC- Erin Tibbs-Slone on CRL erin.tibbs-

Jun 2021 02:13 4988 behalf of SEND slone@crl.com
PM Team
Closed Wednesday, 2 CDISC- Colleen Bonjo Merck colleen_bonjo@me

Jun 2021 04:03 4989 rck.com
PM
Open Thursday, 3 Jun CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2021 10:19 AM 4990 nih.gov
Open Friday, 4 Jun CDISC- Carrie Neeley Covance carrie.neeley@cov
2021 11:02 AM 4991 ance.com
Closed Monday, 7 Jun CDISC- ARLIX Syneoshealth sophie.arlix@syneo

Closed Monday, 7 Jun CDISC- Erin Tibbs-Slone on Instem erin.tibbs-

2021 03:58 PM 4993 behalf of Ashlesha slone@crl.com
Lembhe (Instem)
Closed Wednesday, 9 CDISC- Dounia Lakhrissi dounia.lakhrissi@g

Jun 2021 09:10 4994 ortec.fr
AM
Closed Wednesday, 9 CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

Jun 2021 03:28 4995 nih.gov
PM
Closed Tuesday, 15 Jun CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba
2021 10:43 AM 4996 yer.com
Closed Wednesday, 16 CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s
Jun 2021 09:58 4997 anofi.com
AM
Closed Wednesday, 16 CDISC- Diane Ball Merck diane_ball@merck.

Jun 2021 01:31 4998 com
PM
Open Wednesday, 16 CDISC- Jenny Jones Covance Jenny.Jones@Cov
Jun 2021 03:38 4999 ance.com
PM
Closed Wednesday, 16 CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

Jun 2021 05:08 5000 ng mail.com
PM
Closed Thursday, 17 CDISC- Jenny Jones Covance Jenny.Jones@Cov
Jun 2021 09:19 5001 ance.com
AM
Open Monday, 21 Jun CDISC- Annie McCoy Health Decisions amccoy@healthdec

2021 09:43 AM 5002 .com
Closed Monday, 21 Jun CDISC- Sylvie Girond SANOFI CIG_MAILBOX@s

2021 09:44 AM 5003 anofi.com
Closed Monday, 21 Jun CDISC- Sylvie Girond SANOFI CIG_MAILBOX@s

2021 09:45 AM 5004 anofi.com
Closed Monday, 21 Jun CDISC- Annie McCoy Health Decisions amccoy@healthdec

2021 09:47 AM 5005 .com
Closed Monday, 21 Jun CDISC- Annie McCoy Health Decisions amccoy@healthdec
2021 09:53 AM 5006 .com
Open Monday, 21 Jun CDISC- Sylvie Girond SANOFI CIG_MAILBOX@s

2021 01:10 PM 5007 anofi.com

2021 01:11 PM 5008 anofi.com

2021 01:12 PM 5009 anofi.com

2021 01:13 PM 5010 anofi.com
Open Monday, 21 Jun CDISC- Annie McCoy Health Decisions amccoy@healthdec

2021 01:15 PM 5011 .com
Closed Tuesday, 22 Jun CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx

2021 11:23 AM 5012 .com
Open Thursday, 24 Jun CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail
2021 11:56 AM 5013 .nih.gov
Open Thursday, 24 Jun CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail

2021 11:58 AM 5014 .nih.gov
Closed Thursday, 24 Jun CDISC- Ben Sefing CDISC SEND LT benjamin_sefing@

2021 02:19 PM 5015 request merck.com
Closed Thursday, 24 Jun CDISC- Rahul Thandavan Hoffman La Roche rahul.thandavan@r

2021 04:54 PM 5016 oche.com
Closed Tuesday, 29 Jun CDISC- Diane Corey C-Path dcorey@c-path.org

2021 11:31 AM 5017
Open Wednesday, 30 CDISC- Erin Muhlbrad MSC Inc. muhlbradtee@mail
Jun 2021 04:34 5018 .nih.gov
PM
Closed Thursday, 1 Jul CDISC- Emily Pirc Boehringer emily.pirc@boehri

2021 05:19 PM 5019 Ingelheim nger-
ingelheim.com
Closed Friday, 2 Jul 2021 CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
09:44 AM 5020 yer.com
Closed Friday, 2 Jul 2021 CDISC- Ariadna Hoagland Cota Enterprises A.HOAGLAND@CO
04:46 PM 5021 TAENTERPRISES.CO
M
Open Thursday, 8 Jul CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2021 09:53 AM 5022 ng mail.com
Open Thursday, 8 Jul CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail
2021 09:56 AM 5023 .nih.gov
Closed Friday, 9 Jul 2021 CDISC- Jordan Li NCI EVS jordan.li@nih.gov

08:50 AM 5024
Closed Monday, 12 Jul CDISC- Claire D Sequani DataManagement
2021 04:13 PM 5025 @sequani.com
Closed Tuesday, 13 Jul CDISC- Emily Pirc Boehringer emily.pirc@boehri

ingelheim.com

Jul 2021 11:42 5027 disc.org
AM
Jul 2021 04:30 5028
PM
Open Thursday, 15 Jul CDISC- Mary Jo Brucker Merck mj_brucker@merc

2021 10:12 AM 5029 k.com
Closed Monday, 19 Jul CDISC- LACEY M WALLACE Audentes laceywallace@me.c

2021 09:57 AM 5030 Therapeutics, an om
Astellas Company
Closed Monday, 19 Jul CDISC- Daniel Potenta PDS dan.potenta@pdsli

2021 10:24 AM 5031 fesciences.com
Open Monday, 19 Jul CDISC- Helle Gawrylewski HawkwoodConsulti hmgawrylewski@g

2021 01:11 PM 5032 ng mail.com
Closed Tuesday, 20 Jul CDISC- Diane Ball Merck diane_ball@merck.

2021 12:21 PM 5033 com
Open Tuesday, 20 Jul CDISC- Diane Ball Merck diane_ball@merck.

2021 12:22 PM 5034 com
Closed Tuesday, 20 Jul CDISC- Jenny Jones Covance Jenny.Jones@Cova
2021 12:28 PM 5035 nce.com
Open Tuesday, 20 Jul CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Open Tuesday, 20 Jul CDISC- Diane Ball Merck diane_ball@merck.

2021 12:43 PM 5037 com
Closed Tuesday, 20 Jul CDISC- Diane Ball Merck diane_ball@merck.
2021 03:35 PM 5038 com
Open Wednesday, 21 CDISC- Diane Ball Merck diane_ball@merck.

Jul 2021 02:26 5039 com
PM
Closed Wednesday, 21 CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail

Jul 2021 02:28 5040 .nih.gov
PM
Open Thursday, 22 Jul CDISC- Mihaela Simion Biogen mihaela.simion@bi

2021 10:23 AM 5041 ogen.com
Open Thursday, 22 Jul CDISC- Diane Ball Merck diane_ball@merck.

2021 11:05 AM 5042 com
Closed Thursday, 22 Jul CDISC- Diane Ball Merck diane_ball@merck.
2021 11:08 AM 5043 com
Closed Thursday, 22 Jul CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail

2021 01:04 PM 5044 .nih.gov
Closed Thursday, 22 Jul CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

2021 01:47 PM 5045 zwick@astrazeneca
.com
Closed Thursday, 22 Jul CDISC- Anna Pron-Zwick AstraZeneca anna.pron-
2021 01:48 PM 5046 zwick@astrazeneca
.com
Closed Monday, 26 Jul CDISC- Diane Ball Merck diane_ball@merck.

2021 08:27 AM 5047 com

2021 08:28 AM 5048 com
2021 08:29 AM 5049 com

2021 08:30 AM 5050 com
Open Monday, 26 Jul CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co

2021 08:33 AM 5051 m
Open Monday, 26 Jul CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co
2021 08:35 AM 5052 m
Closed Monday, 26 Jul CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co
2021 08:36 AM 5053 m
Closed Wednesday, 28 CDISC- Kit Howard CDISC khoward@cdisc.or
Jul 2021 01:11 5054 g
PM
Closed Wednesday, 28 CDISC- DEBRA O'NEILL Merck debra_oneill@mer

Jul 2021 01:24 5055 ck.com
PM
Closed Wednesday, 28 CDISC- Jordan Li NCI EVS Jordan.li@nih.gov
Jul 2021 02:17 5056
PM
Closed Thursday, 29 Jul CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail

2021 11:56 AM 5057 .nih.gov
Open Monday, 2 Aug CDISC- Colleen Bonjo Merck colleen_bonjo@me

2021 09:21 AM 5058 rck.com
Open Monday, 2 Aug CDISC- Barbara Lentz Bayer Pharma barbara.lentz1@ba
2021 09:22 AM 5059 yer.com
Open Monday, 2 Aug CDISC- Mihaela Simion Biogen mihaela.simion@bi

2021 04:29 PM 5060 ogen.com
Open Monday, 2 Aug CDISC- Mihaela Simion Biogen mihaela.simion@bi

2021 04:30 PM 5061 ogen.com
Closed Tuesday, 3 Aug CDISC- Mihaela Simion Biogen mihaela.simion@bi

2021 04:05 PM 5062 ogen.com

Aug 2021 09:26 5063 ogen.com
AM
Closed Wednesday, 4 CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx
Aug 2021 12:57 5064 .com
PM
Closed Monday, 9 Aug CDISC- Carrie Neeley Covance carrie.neeley@cov

2021 09:20 AM 5065 ance.com
Closed Monday, 9 Aug CDISC- Carrie Neeley Covance carrie.neeley@cov

2021 11:15 AM 5066 ance.com
Closed Tuesday, 10 Aug CDISC- Diane Ball Merck diane_ball@merck.
2021 12:26 PM 5067 com

2021 03:43 PM 5068 com

2021 03:50 PM 5069 com
2021 03:54 PM 5070 com

2021 03:57 PM 5071 com
Open Tuesday, 10 Aug CDISC- Diane Ball Merck diane_ball@merck.

2021 04:00 PM 5072 com
Open Tuesday, 10 Aug CDISC- Diane Ball Merck diane_ball@merck.

2021 04:02 PM 5073 com
Open Wednesday, 11 CDISC- Sylvie Girond SANOFI CIG_MAILBOX@san

Aug 2021 11:53 5074 ofi.com
AM

Aug 2021 11:54 5075 ofi.com
AM
Closed Wednesday, 11 CDISC- Sylvie Girond SANOFI CIG_MAILBOX@san

Aug 2021 11:57 5076 ofi.com
AM

Aug 2021 11:58 5077 ofi.com
AM
Aug 2021 11:59 5078 ofi.com
AM

Aug 2021 12:00 5079 com
PM

Aug 2021 12:02 5080 ofi.com
PM

Aug 2021 12:04 5081 com
PM

Aug 2021 03:19 5082 com
PM
Aug 2021 03:22 5083 com
PM
Closed Thursday, 12 Aug CDISC- Michelle Szpara AbbVie Inc. michelle.hagstrom

2021 04:16 PM 5084 Hagstrom @abbvie.com
Closed Monday, 16 Aug CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2021 03:43 PM 5085 om
Closed Monday, 16 Aug CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2021 03:45 PM 5086 om
Closed Wednesday, 18 CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san

Aug 2021 12:18 5087 ofi.com
PM
Closed Wednesday, 18 CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san

Aug 2021 12:19 5088 ofi.com
PM
Open Wednesday, 18 CDISC- Erin Tibbs-Slone CRL erin.tibbs-

Aug 2021 12:22 5089 slone@crl.com
PM
Open Wednesday, 18 CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san
Aug 2021 12:26 5090 ofi.com
PM

Aug 2021 12:36 5091 om
PM
Closed Thursday, 19 Aug CDISC- Sylvie Girond SANOFI CIG_MAILBOX@san

2021 10:08 AM 5092 ofi.com
Closed Monday, 23 Aug CDISC- Angela Soriano The EMMES asoriano@emmes.

2021 10:51 AM 5093 Corporation com
Closed Monday, 23 Aug CDISC- Jerry Salyers Essex Management jsalyers@essexman

2021 05:57 PM 5094 agement.com
Closed Wednesday, 25 CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail
Aug 2021 02:05 5095 .nih.gov
PM

Aug 2021 03:04 5096 disc.org
PM

Aug 2021 03:05 5097 disc.org
PM

Aug 2021 03:06 5098 disc.org
PM

Aug 2021 03:07 5099 disc.org
PM

Aug 2021 03:08 5100 disc.org
PM

Inc.

Inc.
Closed Thursday, 26 Aug CDISC- Sylvie Girond SANOFI CIG_MAILBOX@san
2021 11:47 AM 5103 ofi.com
Closed Thursday, 26 Aug CDISC- Jordan Li MSC Inc. Jordan.li@nih.gov

2021 12:21 PM 5104
Closed Monday, 30 Aug CDISC- Steve Kopko CDISC skopko.external@c

2021 07:58 AM 5105 disc.org
Closed Monday, 30 Aug CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail
2021 08:00 AM 5106 .nih.gov
Open Monday, 30 Aug CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san

2021 11:54 AM 5107 ofi.com
Open Monday, 30 Aug CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san
2021 01:12 PM 5108 ofi.com
Closed Tuesday, 31 Aug CDISC- Flavia Bueno flavia.bueno@cline
2021 09:03 AM 5109 rgyhealth.com
Open Tuesday, 31 Aug CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san
2021 09:07 AM 5110 ofi.com
Closed Tuesday, 31 Aug CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san
2021 10:20 AM 5111 ofi.com
Closed Tuesday, 31 Aug CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@san

2021 11:10 AM 5112 ofi.com
Closed Tuesday, 31 Aug CDISC- Jordan Li NCI EVS Jordan.li@nih.gov

2021 03:18 PM 5113
Open Tuesday, 31 Aug CDISC- Himajarani CSG, an IQVIA hsurapaneni@alnyl

2021 03:38 PM 5114 Surapaneni company am.com
Open Tuesday, 31 Aug CDISC- Jordan Li NCI EVS Jordan.li@nih.gov
2021 03:41 PM 5115
Open Thursday, 2 Sep CDISC- Mihaela Simion Biogen mihaela.simion@bi

2021 09:54 AM 5116 ogen.com
Closed Thursday, 2 Sep CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co

2021 11:17 AM 5117 m

2021 11:26 AM 5118 m

2021 11:27 AM 5119 m

2021 11:29 AM 5120 m
Open Thursday, 2 Sep CDISC- Colleen Bonjo Merck colleen_bonjo@me

2021 03:35 PM 5121 rck.com
Open Thursday, 2 Sep CDISC- Colleen Bonjo Merck colleen_bonjo@me

2021 03:46 PM 5122 rck.com
Closed Thursday, 9 Sep CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail
2021 02:46 PM 5124 .nih.gov
Closed Friday, 10 Sep CDISC- Rachel Harper Insem LSS Ltd (on Rachel.Harper@ins
2021 10:39 AM 5125 behalf of MA/MI tem.com
Team)
Open Friday, 10 Sep CDISC- Erin Tibbs-Slone erin.tibbs-

2021 10:42 AM 5126 (on behalf of Susie slone@crl.com
Lendal Antvorskov)
Open Friday, 10 Sep CDISC- Diane Ball Merck diane_ball@merck.

2021 12:59 PM 5127 com

2021 01:47 PM 5128 com
2021 02:00 PM 5129 com
Closed Friday, 10 Sep CDISC- Emily Pirc Boehringer emily.pirc@boehri

ingelheim.com
Open Monday, 13 Sep CDISC- Bouhadouza Assia Sanofi cig_mailbox@sano

2021 08:18 AM 5131 fi.com
Open Monday, 13 Sep CDISC- Bouhadouza Assia Sanofi cig_mailbox@sano

2021 08:20 AM 5132 fi.com
Open Monday, 13 Sep CDISC- Diane Ball Merck diane_ball@merck.

2021 01:18 PM 5133 com
Closed Monday, 13 Sep CDISC- Diane Ball Merck diane_ball@merck.

2021 01:19 PM 5134 com
Closed Monday, 13 Sep CDISC- Mihaela Simion Biogen mihaela.simion@bi
2021 02:26 PM 5135 ogen.com
Open Tuesday, 14 Sep CDISC- Diane Ball Merck diane_ball@merck.

2021 10:50 AM 5136 com
Closed Tuesday, 14 Sep CDISC- Diane Ball Merck diane_ball@merck.

2021 10:51 AM 5137 com
Open Tuesday, 14 Sep CDISC- Diane Ball Merck diane_ball@merck.

2021 11:41 AM 5138 com
Closed Tuesday, 14 Sep CDISC- Keli Costales Pfizer keli.costales@pfize

2021 04:48 PM 5139 r.com
Sep 2021 11:45 5140 com
AM

Sep 2021 12:23 5141 com
PM
Closed Thursday, 16 CDISC- Ivan Jiang Roche/Genentech jiang.ivan@gene.co

Sep 2021 12:53 5142 m
PM
Closed Monday, 20 Sep CDISC- Anna Pron-Zwick AstraZeneca anna.pron-
a.com

a.com

a.com
Closed Monday, 20 Sep CDISC- Diane Ball Merck diane_ball@merck.
2021 12:18 PM 5146 com
Open Tuesday, 21 Sep CDISC- Erin Tibbs-Slone on CRL erin.tibbs-

2021 10:28 AM 5147 behalf of SEND slone@crl.com
PC/PP Team
Closed Tuesday, 21 Sep CDISC- Gary Walker Gary G Walker, gary.walker.ggw@g
2021 03:53 PM 5148 LLC mail.com
Closed Thursday, 23 CDISC- Kathleen Hectors Janssen R&D Khectors@its.jnj.co

Sep 2021 09:23 5149 m
AM
Open Monday, 27 Sep CDISC- Aparna Kulkarni Pfizer aparna.kulkarni@pf

2021 11:58 AM 5150 izer.com
Open Tuesday, 28 Sep CDISC- Gary Walker Gary G Walker, gary.walker.ggw@g
2021 09:39 AM 5151 LLC mail.com

Sep 2021 12:09 5152 com
PM
Sep 2021 01:45 5153 zwick@astrazenec
PM a.com
Open Monday, 4 Oct CDISC- Elisa Young Southern Star eyoung@southerns

2021 12:43 PM 5154 Research tarresearch.com
Closed Tuesday, 5 Oct CDISC- Elisa Young Southern Star eyoung@southerns
2021 10:10 AM 5155 Research tarresearch.com
Open Tuesday, 5 Oct CDISC- Elisa Young Southern Star eyoung@southerns

Closed Tuesday, 5 Oct CDISC- Elisa Young Southern Star eyoung@southerns

Closed Thursday, 7 Oct CDISC- Jenny Jones Covance Jenny.Jones@Cov
2021 12:40 PM 5158 ance.com
Open Friday, 8 Oct CDISC- Ryota Ogawa Translational ryota.ogawa@tri-

for Medical
Innovation (TRI)
Closed Friday, 8 Oct CDISC- Jerry Salyers Essex Management jsalyers@essexma
2021 10:23 AM 5160 nagement.com
Open Tuesday, 12 Oct CDISC- Gary Walker Gary G Walker, gary.walker.ggw@g

2021 08:06 AM 5161 LLC mail.com
Closed Tuesday, 12 Oct CDISC- Gitte Ullmann Novo Nordisk A/S gku@novonordisk.c
2021 08:09 AM 5162 om
Closed Tuesday, 12 Oct CDISC- ARLIX Sophie Syneoshealth sophie.arlix@syneo

Open Tuesday, 12 Oct CDISC- Erin Muhlbradt (on MSC Inc. muhlbradtee@mail.
2021 09:02 AM 5164 behalf of DDF nih.gov
team)
Closed Tuesday, 12 Oct CDISC- Gitte Ullmann Novo Nordisk A/S gku@novonordisk.c
2021 11:48 AM 5165 om
Open Tuesday, 12 Oct CDISC- Diane Ball Merck diane_ball@merck.

2021 01:06 PM 5166 com
Closed Tuesday, 12 Oct CDISC- Diane Ball Merck diane_ball@merck.

2021 03:31 PM 5167 com

Oct 2021 03:07 5168 com
PM

Oct 2021 03:08 5169 com
PM
Open Wednesday, 13 CDISC- Melanie Paules Takeda melanie.paules@ta
Oct 2021 03:44 5170 keda.com
PM
Open Thursday, 14 Oct CDISC- Erin Muhlbradt (on MSC Inc. muhlbradtee@mail.
2021 10:22 AM 5171 behalf of Guido nih.gov
Claes)
Closed Thursday, 14 Oct CDISC- Swarupa Sudini Pfizer swarupa.sudini@pfi

2021 11:21 AM 5172 zer.com
Closed Thursday, 14 Oct CDISC- Anna Pron-Zwick AstraZeneca anna.pron-

a.com
Closed Monday, 18 Oct CDISC- Diane Ball Merck diane_ball@merck.
2021 01:30 PM 5174 com
Closed Monday, 18 Oct CDISC- Barbara Lentz Bayer Pharma Barbara.lentz1@ba

2021 01:36 PM 5175 yer.com
Closed Wednesday, 20 CDISC- Ying Li Charles River Labs Ying.li@crl.com

Oct 2021 02:51 5176
PM
Closed Wednesday, 20 CDISC- Ying Li Charles River Labs Ying.li@crl.com

Oct 2021 02:51 5177
PM
Closed Thursday, 21 Oct CDISC- Diane Corey C-Path dcorey@c-path.org

2021 10:01 AM 5178
Closed Tuesday, 26 Oct CDISC- Dana Booth cdisc dbooth@cdisc.org
2021 09:21 AM 5179
Closed Tuesday, 26 Oct CDISC- Carrie Neeley Labcorp carrie.neeley@cov

2021 10:17 AM 5180 ance.com
Closed Friday, 29 Oct CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co

2021 11:11 AM 5181 m
Closed Tuesday, 2 Nov CDISC- Tonya Smoot Thereapeutics, Inc. tsmoot@therapeuti

2021 07:50 AM 5182 csinc.com
Open Wednesday, 3 CDISC- Harini Kunduru Daiichi Sankyo hkunduru@dsi.com

Nov 2021 10:10 5183
AM
Nov 2021 01:09 5184 ogen.com
PM

Nov 2021 02:09 5185 ogen.com
PM
Open Thursday, 4 Nov CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 09:54 AM 5186 anofi.com
Closed Thursday, 4 Nov CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 09:55 AM 5187 anofi.com

2021 09:56 AM 5188 anofi.com
2021 09:57 AM 5189 anofi.com

2021 09:58 AM 5190 anofi.com

2021 09:59 AM 5191 anofi.com

2021 09:59 AM 5192 anofi.com

2021 10:00 AM 5193 anofi.com
2021 10:01 AM 5194 anofi.com

2021 10:02 AM 5195 anofi.com

2021 10:03 AM 5196 anofi.com

2021 12:50 PM 5197 anofi.com
2021 12:52 PM 5198 anofi.com

2021 12:53 PM 5199 anofi.com

2021 12:56 PM 5200 anofi.com

2021 12:57 PM 5201 anofi.com
Open Thursday, 4 Nov CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2021 01:02 PM 5202 Pharma.com
Open Thursday, 4 Nov CDISC- Jozef Aerts XML4Pharma Jozef.Aerts@XML4

2021 01:03 PM 5203 Pharma.com
Open Thursday, 4 Nov CDISC- DIANE E WOLD CDISC diane.wold@cdisc.

2021 03:59 PM 5204 org
Open Thursday, 4 Nov CDISC- DIANE E WOLD CDISC diane.wold@cdisc.
2021 04:01 PM 5205 org
Open Thursday, 4 Nov CDISC- Karla Richie Westat KarlaRichie@West

2021 04:02 PM 5206 at.com
Closed Friday, 5 Nov CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s
2021 10:23 AM 5207 anofi.com
Open Friday, 5 Nov CDISC- dan potenta Instem dan.potenta@inste

2021 10:25 AM 5208 m.com
Open Friday, 5 Nov CDISC- Diane Ball Merck diane_ball@merck.

2021 11:41 AM 5209 com
Open Tuesday, 9 Nov CDISC- Diane Ball Merck diane_ball@merck.
2021 01:07 PM 5210 com
Open Tuesday, 9 Nov CDISC- Rahul Thandavan Hoffman La Roche rahul.thandavan@r

2021 04:56 PM 5211 oche.com
Open Friday, 12 Nov CDISC- DIANE E WOLD CDISC diane.wold@cdisc.
2021 07:52 AM 5212 org

2021 09:07 AM 5213 com

2021 11:44 AM 5214 com
Open Friday, 12 Nov CDISC- Erin Tibbs-Slone CRL erin.tibbs-

Open Friday, 12 Nov CDISC- David Fielding ICON plc fieldingdavid@prah

2021 04:34 PM 5216 s.com
Open Friday, 12 Nov CDISC- David Fielding ICON plc fieldingdavid@prah

2021 04:47 PM 5217 s.com
Closed Monday, 15 Nov CDISC- Yuta Sakakibara Kyowa Kirin Co. yuta.sakakibara.vb
2021 09:02 AM 5218 Ltd., @kyowakirin.com
Closed Monday, 15 Nov CDISC- Nicholas Pemble Janssen npemble@its.jnj.co

2021 09:04 AM 5219 Pharmaceutical m
Companies of
Johnson and
Johnson
Closed Monday, 15 Nov CDISC- Jordan Li on behalf NCI EVS Jordan.li@nih.gov

2021 04:14 PM 5220 of QRS team
Closed Tuesday, 16 Nov CDISC- DANIEL LEE INSTEM dan.potenta@inste

2021 08:10 AM 5221 POTENTA m.com
Closed Tuesday, 16 Nov CDISC- Jenny Jones Covance Jenny.Jones@Cov

2021 09:46 AM 5222 ance.com
Open Tuesday, 16 Nov CDISC- Priya Flatiron priya.gopal@flatiro

2021 10:40 AM 5223 n.com
Closed Tuesday, 16 Nov CDISC- Jordan Li on behalf NCI EVS Jordan.li@nih.gov
2021 03:50 PM 5224 of QRS team

Nov 2021 11:39 5225 com
AM
Nov 2021 11:43 5226 com
AM
Closed Wednesday, 17 CDISC- Jenny Jones Covance Jenny.Jones@Cov

Nov 2021 02:39 5227 ance.com
PM
Nov 2021 04:04 5228 ance.com
PM

2021 11:43 AM 5229 ance.com
2021 11:45 AM 5230 ance.com
Open Friday, 19 Nov CDISC- Jenny Jones Covance Jenny.Jones@Cov
2021 11:46 AM 5231 ance.com
2021 11:48 AM 5232 ance.com
2021 11:50 AM 5233 ance.com
2021 01:18 PM 5234 com

2021 02:14 PM 5235 com
Closed Tuesday, 23 Nov CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 10:58 AM 5236 anofi.com
2021 10:59 AM 5237 anofi.com

2021 11:00 AM 5238 anofi.com

2021 11:02 AM 5239 anofi.com

2021 11:02 AM 5240 anofi.com
Open Tuesday, 23 Nov CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2021 11:05 AM 5241 anofi.com
Closed Friday, 26 Nov CDISC- Nik Pemble Janssen npemble@its.jnj.co

2021 09:40 AM 5242 m
Closed Monday, 29 Nov CDISC- Assia Bouhadouza Sanofi CIG_MAILBOX@s

2021 09:47 AM 5243 anofi.com
Open Monday, 29 Nov CDISC- Jordan Li NCI EVS Jordan.li@nih.gov
2021 03:00 PM 5244
Open Wednesday, 1 CDISC- Angela Soriano Medidata asoriano@mdsol.c

Dec 2021 04:00 5245 om
PM

com
Open Friday, 3 Dec CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2021 10:47 AM 5247 nih.gov
Closed Monday, 6 Dec CDISC- Diane Ball Merck diane_ball@merck.

2021 01:11 PM 5248 com
Open Tuesday, 7 Dec CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s
2021 10:16 AM 5249 anofi.com

2021 10:16 AM 5250 anofi.com

2021 10:17 AM 5251 anofi.com

2021 10:17 AM 5252 anofi.com

2021 10:18 AM 5253 anofi.com

2021 10:20 AM 5254 anofi.com

2021 10:22 AM 5255 anofi.com

2021 10:27 AM 5256 anofi.com

2021 10:28 AM 5257 anofi.com

2021 10:29 AM 5258 anofi.com

2021 10:29 AM 5259 anofi.com

2021 10:45 AM 5260 anofi.com
2021 10:46 AM 5261 anofi.com

2021 10:47 AM 5262 anofi.com

2021 10:48 AM 5263 anofi.com

2021 10:49 AM 5264 anofi.com

2021 10:49 AM 5265 anofi.com

2021 10:50 AM 5266 anofi.com

2021 10:58 AM 5267 anofi.com

2021 10:59 AM 5268 anofi.com

2021 10:59 AM 5269 anofi.com

2021 11:00 AM 5270 anofi.com
2021 11:01 AM 5271 anofi.com

Dec 2021 09:17 5272 anofi.com
AM

Dec 2021 09:18 5273 anofi.com
AM

Dec 2021 09:18 5274 anofi.com
AM
Open Wednesday, 8 CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s

Dec 2021 09:20 5275 anofi.com
AM
Open Wednesday, 8 CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Dec 2021 04:45 5276 com
PM
Dec 2021 04:45 5277 com
PM
Dec 2021 04:46 5278 com
PM
Dec 2021 04:46 5279 com
PM
Dec 2021 04:48 5280 com
PM
Dec 2021 04:49 5281 com
PM
Dec 2021 04:51 5282 com
PM
Closed Thursday, 9 Dec CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s
2021 08:55 AM 5283 anofi.com
Closed Thursday, 9 Dec CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2021 01:59 PM 5284 nih.gov
Closed Monday, 13 Dec CDISC- Jenny Jones Covance Jenny.Jones@Cov

2021 11:34 AM 5285 ance.com
2021 11:35 AM 5286 ance.com
2021 11:37 AM 5287 ance.com
Open Monday, 13 Dec CDISC- Jenny Jones Covance Jenny.Jones@Cov

2021 11:38 AM 5288 ance.com
Open Tuesday, 14 Dec CDISC- Sylvie GIROND Sanofi CIG_MAILBOX@s
2021 09:34 AM 5289 anofi.com

2021 09:35 AM 5290 anofi.com

2021 09:36 AM 5291 anofi.com

2021 12:37 PM 5292 anofi.com
Dec 2021 12:06 5293 com
PM
Closed Thursday, 23 CDISC- Diane Ball Merck diane_ball@merck.

Dec 2021 01:09 5294 com
PM
Closed Monday, 27 Dec CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

2021 08:44 AM 5295 fizer.com
Open Thursday, 30 CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p
Dec 2021 04:43 5296 fizer.com
PM
Request Type
Create New SDTM- The QRSMTHOD codelist needs

Term QRSMTHOD additional terms to represent VAS
instruments that do not have units
represented on the instrument.
Create New SDTM- INTRACOCHLEAR

Term ROUTE
Create New SDTM- DESCENDING AORTA
Term ROUTE
Create New CDISC- record request a definition

Term Glossary

Term ONCRSR NO CHANGE to the ONCRSR
codelist.

Term ONCRSR ERYTHROID RESPONSE to the
ONCRSR codelist.

Term ONCRSR PLATELET RESPONSE to the
ONCRSR codelist.
Create New SDTM- Please add the new submission
Term ONCRSR value NEUTROPHIL RESPONSE to
the ONCRSR codelist.
Create New SDTM- Please add the new submission

Term ONCRSR value of CRp to the ONCRSR
codelist.

Term ONCRSR HEMATOLOGIC RELAPSE to the
ONCRSR codelist.
Create New SDTM- Please add the submission value

Term ONCRSR MOLECULAR RELAPSE to the
ONCRSR codelist.
Create New SDTM- Please add the submission value NO

Term ONCRSR RELAPSE to the ONCRSR codelist.

Term ONCRSR CRh to the ONCRSR codelist.
Create New SDTM- Requested new submission value of

Term TUTEST/CD Infiltration Due to Lymphoma to be
added to TUTEST codelist.
Create New SDTM- Requested to add the new

Term TUTEST/CD submission value of
SPLNLYM/Splenomegaly Due to
Lymphoma to be added to the
TUTESTCD/TUTEST codelist.
Modify None Please update ECG Codetable
Existing Term Mapping file to include units of
measure for each test (where
applicable) and body position
information (where applicable).
Create New SDTM- Human Rhinovirus/Enterovirus

Term MBTEST/CD
Create New SDTM- Please create a new

Term MBTEST/CD MBTEST/TESTCD for following
organism that is identified via Biofire
FilmArray panel (bioM rieux)
Bordetella pertussis
Create New SDTM- Please create a new
Term MBTEST/CD MBTEST/TESTCD for following
organism that is identified via Biofire
FilmArray panel(bioM rieux):
Mycoplasma pneumoniae
Modify SDTM- C65047, V25HD3 and C67154,
Existing Term LBTEST/CD VITDIT
Modify Modify VLDL Triglyceride + Chylomicron

Existing Term Existing Term Triglyceride
Create New SDTM- Terms requested by MB/IS team for

Term OIPARM-CD OIPARM-CD, just need request code
Create New SDTM- Alpha-Hydroxitriazolam

Term LBTEST/CD
Create New SDTM- Hydroxyethylflurazepam

Term LBTEST/CD
Create New SDTM-UNIT Please add the new submission
Term value of IU/h to the UNIT codelist.
Create New SEND- will email terms separately. This will

Term NONNEO address an industry request for
maintaining the uniqueness of these
findings
Create New SDTM- New term requests

Term OIPRM-CD
Create New SDTM-CAN We would like to add the term
Term 'MULTIPLE' for the ACN codelist.

Term Pharmacology
Modify QRS- CSS0401C/CSS0402C/CSS0403C/

Existing Term CSS04TC CSS0404C/CSS0405C/CSS0413C/
CSS0416C/CSS0418C
Modify SDTM- Remove Pulmonary Blood Flow
Existing Term RETEST (C135499) and add Blood Flow Rate
(C94866).
Modify SDTM- Delete Cerebral Blood Flow

Existing Term NVTEST (C154865) and add Blood Flow Rate
(C94866).
Create New SDTM- NEURORADIOLOGIST 1,

Term MEDEVAL NEURORADIOLOGIST
2NEURORADIOLOGIST 1,
NEURORADIOLOGIST 2
Create New CDASH- GUMMY
Term CMDOSU
Create New CDASH- ENVELOPE or envelope

Term CMDOSU
Create New CDASH- PILL

Term CMDOSU
Create New CDASH- PUMP

Term CMDOSU
Modify Multiple QRS CT Change Control for the

Existing Term Short Form 36 Health Survey
instruments
Modify Multiple QRS CT Change Control for the
Existing Term Short Form 12, 10 & 8 Health Survey
instruments QRSCAT only
Modify Multiple QRS CT for QSTESTCD/QSTEST

Existing Term for the Short Form 12, 10 & 8 Health
Survey instruments
Modify SDTM-LOC Add new synonym 'Upper Urinary

Existing Term Tract' to C142328 - UPPER
URINARY SYSTEM in LOC
Create New SDTM- TOURNIQUET TEST

Term METHOD
Modify QRS-UPD1TC Unified Parkinson's Disease Rating
Existing Term Scale Questionnaire Test Code
Unified Parkinson's Disease Rating
Scale Questionnaire Test Name
Modify SDTM-UNIT umol/L

Existing Term
Create New SDTM- SARS-CoV-2 Viral Sequencing Spike

Term LBTEST/CD Protein Region
Create New SDTM-UNIT 10^6 cells for PBMC
Term
Create New NEW QRS Codelist to capture details of

Codelist the International Prostate Symptom
Score (IPSS)
Other Other "Update the ECG Code Mapping

table to link ""normal/abnormal""
codelist to EGTEST = Interpretation "
Modify SDTM- For the DOMAIN codelist with the
Existing Term DOMAIN CDISC submission value of MO:
please modify the CDISC Synonym
from Morphology to Morphology
Findings to be in line with the other
Create New SDTM-LOC Add new LOC terms

Term
Modify SEND- Change to C176394 from

Existing Term NEOPLASM ADENOMA, AMPHOPHILIC
VACUOLAR to ADENOMA,
AMPHOPHILIC VACUOLAR,
BENIGN
Create New SDTM- To support HIV TAUG - Add

Term SETTING VEHICLE to the SETTING codelist
Modify Multiple C25335 vs C74720: This new term
Existing Term request will need to be added into
the Lab (BS), General (NV), and
Oncology (TR) working documents to
harmonize this request across all
relevant teams.
Create New Multiple CDISC P45 new terms

Codelist
Other SDTM- C142362; C103420; C124415

ONCRTSCD (RECIST 1.1)
Create New Multiple New term requests for multiple
Term codelists
Create New SDTM- new term: HOME HEALTH CARE
Term CNTMODE
Create New SDTM-DTHDX Death Expected Indicator

Term
Modify Multiple Please remove the SERVNUM /

Existing Term Number of Servings test (C174283)
from the D1FATSCD (C163027) and
D1FATS (C163028) codelists.
Create New SDTM-UNIT Please add a code for "SERVING".
Term
Modify SDTM- Retire the test Physical Activity Level

Existing Term SCTESTCD in the SC domain and add Physical
Activity Lifestyle . The proposed
SCTESTCD is PHYACLFS.
Create New SDTM- Please add Proteus mirabilis to

Term MBTEST/CD MBTEST(CD). This exists in
MICROORG codelist (C86019) but
not yet as MBTEST(CD)
Create New SDTM- Please create an MBTEST(CD) for
Term MBTEST/CD Streptococcus agalactiae. Term does
exist in MICROORG but not as
MBTEST
Create New SDTM- Please add Staphylococcus
Term MBTEST/CD saprophyticus to MBTEST(CD)
codelist. This term exists in
MICROORG but not as MBTEST
Create New SDTM- Please add Staphylococcus
Term MBTEST/CD saprophyticus to MBTEST(CD)
codelist. This term exists in
Create New SDTM- Please create new term for

Term MBTEST/CD Enterobacter in MBTEST(CD) (at
species level). Term exists in
Create New SDTM- Please create new term for
Term MBTEST/CD Acinetobacter (at species level) in
MBTEST(CD). It does exist in
Create New SDTM- Please add Serratia as
Term MBTEST/CD MBTEST(CD). Term is present in
MICROOR but not as MBTEST
Create New SDTM- Please add Morganella as
Term MBTEST/CD MBTEST(CD). This term exists in
MICROORG but not as MB test.
Create New SDTM- Please add Candida (genus level) to
Term MBTEST/CD MBTEST(CD).
Create New CDISC- Add new term: Sign
Term Glossary
Create New CDISC- Add new term: Symptom

Term Glossary
Create New Multiple Add subscale scores and total score

Term for FACT-Hep terminology (FAC015)
Create New Multiple Terminology for FAACT (FAC065):

Term QSCAT, QSTESTCD, QSTEST
Create New SDTM- Laboratory Test Name : Androgen

Term LBTEST/CD receptor variant 7 (AR-V7)
Laboratory Test Code : ARV7
Modify SDTM- Complement CH50

Create New SDTM- U/L

Term PKUNIT
Modify Multiple Codelists: Laboratory Test Code,
Existing Term Laboratory Test, SDTM Microscopic
Findings Test Code, SDTM
Microscopic Findings Test
Modify QRS-QSCAT Please see additional information.
Existing Term
Modify SDTM- PROCEDURAL COMPLICATION

Create New SDTM- Alk Phos, Placental/Total Alk Phos

Term LBTEST/CD
Modify SDTM- Retire PKPARM-CD terms

Existing Term PKPARM/CD
Modify SDTM- HANDDOM
Existing Term SCTESTCD
Create New SDTM- FOLD CHANGE

Term METHOD
Create New SDTM- Lamb's Quarters/Goosefoot IgE

Term LBTEST/CD
Create New SDTM- Beta-Smooth Muscle Actin/BSMACT

Term LBTEST/CD
Create New NEW MPSTATRS
Term
Modify SDTM-SEVRS SEVERE

Existing Term
Modify SDTM-SEVRS MILD

Existing Term
Create New NEW HPFATS/HPFATSCD
Codelist
Create New NEW Increased Physical Activity

Term Impact/PHACIMP
Create New NEW DGFATS/DGFATSCD

Codelist
Create New NEW Severity/SEV

Term
Create New NEW Serotype/SEROTYPE
Term
Create New SDTM- HAND-HELD DYNAMOMETER

Term METHOD
Create New SDTM-DIR HIND LOWER

Term
Create New SDTM-DIR HIND UPPER

Term
Create New SDTM-DIR FORE UPPER

Term
Create New SDTM-DIR FORE LOWER

Term
Create New SDTM- UNINTERPRETABLE

Term SPECCOND
Create New SDTM- Thymic Stromal Lymphopoietin/TSLP
Term LBTEST/CD
Create New SDTM- Natural Killer

Term LBTEST/CD Cells/Lymphocytes/NKCELY
Create New SDTM- Lipoprotein Lipase/LPLIPAS

Term LBTEST/CD
Create New SDTM- Indocyanine Green/ICG

Term LBTEST/CD
Create New SDTM- IDL Apolipoprotein B/IDLAPOB
Term LBTEST/CD
Create New SDTM- IgA/Complement C3 Ratio/IGAC3

Term LBTEST/CD
Create New SDTM- Ganglioside GM3/GM3

Term LBTEST/CD
Create New SDTM- VLDL Cholesterol Apo B/VLDLAPOB

Term LBTEST/CD
Create New SDTM- DIRECT REMOVAL
Term METHOD
Create New SDTM- Amyloid Beta 1-41/AMYLB41

Term LBTEST/CD
Create New SDTM- Arachidonate

Term LBTEST/CD 5-Lipoxygenase/ALOX5
Create New SDTM- Glucosylceramidase/GCASE

Term LBTEST/CD
Create New SDTM- Complement C3c/C3C
Term LBTEST/CD
Create New SDTM- GRAVITY DRIP

Term CLMETH
Modify SDTM- When a custom --TESTCD is used in

Existing Term LBTEST/CD; this case, we get an error in Pinnacle
SDTM- that use of --TESTCD and --TEST do
MBTEST/CD not have same code in CDISC CT.
Create New SDTM- Additional terms requested for the

Term MBTEST/CD Microbiology Test Code/Name
codelists
Create New SDTM- Glucosylceramide/GL1

Term LBTEST/CD
Create New SDTM- Glucopsychosine/LYSOGL1

Term LBTEST/CD
Create New SDTM- Glyceraldehyde-3-Phosphate
Term LBTEST/CD Dehydrogenase/GAPDH
Other None Most EGTEST-CD values are

missing from the codetable mapping
Create New SDTM- New LB terms

Term LBTEST/CD
Create New SDTM- Eosinophil-Derived Neurotoxin

Term LBTEST/CD
Create New SDTM- IMMUNOCAPTURE
Term METHOD
Create New SDTM- IFNA2 Interferon Alpha Type 2

Term LBTEST/CD
Create New SDTM- Multiple

Term LBTEST/CD
Create New SDTM- New ISTEST/CD terms, 36 new

Term ISTEST/CD terms
Create New SDTM-FRM Add new term of CAPSULE,
Term SOFGEL to the FRM codelist.
Create New SDTM-LOC File emailed separately

Term
Create New New AMBS01TN/C

Codelist
Create New SDTM- SWI-PHASE IMAGE

Term METHOD
Create New SDTM- ARCHIVAL
Term SPECCOND
Create New SDTM- INSUFFICIENT QUANTITY

Term SPECCOND
Create New RBDSQ1TN/C multiple term request

Term for
Questionnaire
RBDSQ
Create New RBDSQ1TN/C RBDSQ1TN/C
Codelist
Create New Multiple FES01TN / FES01TC

Codelist
Create New FES01TN/C multiple term request

Term for
Questionnaire
FES â€œFalls
Efficacy
Scaleâ€
Create New SDTM- GRO Growth Regulated Oncogene
Term LBTEST/CD
Create New SDTM- NEPHRIN Nephrin

Term LBTEST/CD
Create New New BCLC Classification: Stage 0, A, B ,

Term C, D
Create New Multiple HRPQTN / HRPQTC

Codelist
Create New HRPQ - Multiple CDISC terms submission -

Term Health Related Questionnaire HRPQ
Productivity
Questionnaire
Create New Multiple BFI9TN / BFI9TC
Codelist
Create New Multiple BDI02TN / BDI02TC

Codelist
Create New BDI02TN / Multiple CDISC terms submission -
Term BDI02TC Questionnaire BDI-II
Create New SDTM- Requesting additional allergen-

Term LBTEST/CD specific IGE test names/codes.
Create New SDTM-FREQ OTHER
Term
Create New SDTM-UNIT OTHER

Term
Create New SDTM- OTHER
Term ROUTE
Create New SDTM- SCTESTCD- FRTSTAT, SCTEST-

Term SCTEST/CD Fertility Status
Create New SDTM-TTYPE VIROLOGY

Term
Create New SDTM- IN-HOUSE, OUT-PATIENT

Term EPOCH
Create New Multiple PDQ391N/PDQ391C

Codelist
Create New PDQ391N/ Parkinson's Disease Quality of Life
Term PDQ391C Questionnaire
Create New Multiple PDCRS1TN/PCRS1TC

Codelist
Create New PDCRS1TN/ Parkinson's Disease Cognitive

Term PDCRS1TC Rating Scale
Create New SDTM- Multiple Term Request

Term MITSCD
Create New SDTM- Please add the new term of HEART
Term PRITBCON VALVE PROCEDURE to the
PROCEDUR codelist
Create New SDTM-LOC HEART, VENTRICULAR SEPTUM
Term
Create New SDTM-LOC HEART, ATRIAL SEPTUM

Term
Create New Multiple Add an additonal

Term FTTESTCD/DTTEST to the SIX
Minute Walk Test codelists
Create New SDTM-DIR CRANIOCAUDAL

Term
Create New SDTM-DIR SEPTAL
Term
Modify Multiple Modify the HAMD 19

Existing Term RSTESTCD/RSTEST codes to align
with the new CDISC HAMD 17 CRF
Create New SDTM-CAN DRUG DELAY

Term
Modify Multiple Terminology change for PASI
Existing Term
Modify CDISC- RCT Randomized controlled trial

Create New SDTM- TRTESTCD = ABSCHGSM TRTEST

Term TRTEST/CD = Absolute Change from Smallest
Sum
Create New SDTM- Please add new term for the

Term TRTEST/CD pair:TRTESTCD = ACHBLTRTEST =
Absolute Change from Baseline
Create New SDTM- Please add new term for the

Term TRTEST/CD pair:TRTESTCD =
CURISCORTRTEST = Curie Score
Create New SDTM- Please add new term for the pair:
Term TRTEST/CD TRTESTCD = INFILLYM TRTEST =
Infiltration Due to Lymphoma
Term TRTEST/CD TRTESTCD = PSSC TRTEST = 5
Points-Scale Score
Term TRTEST/CD TRTESTCD = RELSCOR TRTEST =
Relative Score
Create New CDISC- new terms in documents dealing with

Term Glossary the pandemic
Multiple See additional information for more

details
Create New SDTM- SURGICAL PROCEDURE
Term MHEDTTYP
Create New SDTM- INITIAL USAGE

Term MHEDTTYP
Modify SDTM- All terms related to "Plaque Forming

Existing Term LBTEST/CD Units" (PFC
Create New New CDISC is implementing QRS

Codelist instruments in the CDISC Library. To
do this, QRS instrument responses
CT is needed.
CT is needed.

CT is needed.
Create New SDTM- "Parity" for RPTEST and "PARITY"

Term RPTEST/CD for RPTESTCD
Create New SDTM- DISEASE RECURRENCE

Term NCOMPLT
Create New Multiple Existing codelist SDTM-PROTMLST
Term
Create New SDTM- CLINICAL ASSESSMENT

Term ONCRSCAT
Create New SDTM- CHILD-PUGH SCORE
Term ONCRSCAT
Create New SDTM- DISEASE STATUS

Term ONCRSCAT
Create New SDTM-UNIT "tuberculin unit/.1mL"

Term
Create New SDTM-UNIT ug_DF
Term
Modify SDTM-UNIT Please add CDISC Synonym =

Existing Term pgEq/mL for UNIT=ngEq/L
Modify SDTM- Please add CDISC Synonym =

Existing Term PKUNIT ngEq/L for PKUNIT=pgEq/mL
Multiple MICROFLUIDIC IMMUNOASSAY
Create New SDTM- DRGR DMEGR

Term OETEST/CD
Create New Multiple Multiple Term Request
Term
Create New SDTM- RANDOMISATION

Term EPOCH
Create New SDTM-RACE OTHER
Term
Create New SDTM- New terms for the CRFATSCD

Term CRFATSCD codelist for the Crohns TAUG
Modify SDTM- Glycocholic Acid

Create New SDTM- h*uIU/mL

Term PKUNIT
Create New SDTM-FREQ AT LEAST DAILY

Term
Create New SDTM-FREQ AT LEAST MONTHLY

Term
Create New SDTM-FREQ AT LEAST WEEKLY

Term
Create New Multiple Clinical Classification All / CCALL
Term
Create New Multiple Functional Tests All / FTALL

Term
Create New Multiple Questionnaire All / QSALL
Term
Create New SDTM- SICAM4 - Soluble Intercell Adhesion

Term LBTEST/CD Molecule 4
Modify SEND- STSPRM/STSPRMCD: C173665

Existing Term STSPRM/CD
Modify SEND- DYSPLASIA, ADNEXAL;
Existing Term NONNEO DYSPLASIA, DENTAL; DYSPLASIA,
PHYSEAL; DYSPLASIA, RENAL;
and DYSPLASIA, THYROID
Create New SDTM-UNIT Please extend the UNIT codelist by

Term adding g/m2h.
Create New Multiple Vaccinia Plaque Forming Units

Term Assay Vaccinia Virus Neutralizing
Antibody Complement C1q Soluble
ST2
Modify SDTM-RACE Add MULTIPLE and OTHER in this
Existing Term non-extensible codelist
Create New SDTM- Please add the submission value

Term ONCRSR ABSENT to the ONCRSR codelist.
Create New SDTM- Please add the term COVID-19

Term NCOMPLT PANDEMIC RELATED to the
NCOMPLT codelist.
Create New SDTM-UNIT Please add "LU" to the unit codelist.

Term This is from the T1D TAUG.
Other SDTM-UNIT This is a inquiry to the lab CT team.

In the UNIT codelist there is a unit
called "ELISA unit/mL". Should "RIA
unit/mL" be created as well?
Create New SDTM- Please add the new term of BONE
Term TUIDRS MARROW INFILTRATION to the
TUIDRS codelist.
Create New DefXML- SENDIG-AR needs to be added to

Term STDNAM the possible standard names for
define-xml
Modify Multiple Remove C38082/FIO2 from the

Existing Term LBTEST/TESTCD,
RETEST/TESTCD, and
VSTEST/TESTCD codelists.
Modify SDTM- C174301 'VLDL Triglyceride +

Existing Term LBTEST/CD Chylomicron Triglyceride' is over 40
characters. Please truncate.
Modify Multiple QRS SF8 & SF12 CT upodates to
Existing Term include the QualityMetric provided
derived variables
Create New SEND- PIGMENT, MACROPHAGE

Term NONNEO
Create New SDTM- Term->TREATMENT TERMINATED

Term NCOMPLT BY SPONSOR Proposed Definition -
>An indication that a clinical study
treatment was stopped by the
sponsor.
Create New SDTM- Right Ventricular Ejection Fraction

Term CVTEST/CD (RVEF)
Modify SDTM-FRM The terms SOLUTION, GEL
Existing Term FORMING / DROPS (C60994) and
SOLUTION/ DROPS (C60992) in the
FRM (C66726) codelist are not
formatted consistently in terms of
spaces before/after the forward
slash.
Create New New For our study which concerns the

Codelist indication SMA (Spinal Muscular
Atrophy), we now have voice
handicap index questionnaires for
different age groups (pediatric versus
non-pediatric). VHI is also used as a
questionnaire for dysphonia.
Create New Multiple Additions requested to MBTEST and
Term MICROORG codelists
Create New SDTM- CSPATH / Pathologic Casts

Term LBTEST/CD
Create New CDISC- New abbreviations used in FDA

Term Glossary PDUFA meeting
Create New SDTM- QUANTITATIVE

Term RSLSCLRS
Create New SDTM- Please add POSITIVE AIRWAY
Term PROCEDUR PRESSURE THERAPY to the
PROCEDUR codelist, with the
synonym PAP Therapy.
Create New Multiple Add the additional QuaityMetric

Term derived test for Menatl Health
Enhancement (MHE) to the
published CT for SF36 V2.0 ACUTE
and STANDARD instruments
Create New Multiple PRO-CTCAE QSTESTCD and

Codelist QSTEST codelists
Create New SDTM- Clot Retraction
Term LBTEST/CD
Create New SDTM- Study Data Technical Conformance

Term FDATSRS Guide v4.6 Study Data Technical
Conformance Guide v4.7
Modify QRS-QSCAT QSCAT for ANSD V1.0 and ADSD

Existing Term V1.0 has a typo
Modify QRS- Change "FAC070-Fatigue Subscale

Existing Term FAC070TN Score" to "FAC070-Total Score"
Create New Multiple Terminology for new scores for the

Term FACT-G, FACT-B, FACT-BL, and
FACT-HEP
Create New Multiple Multiple terms requested for NON-
Term NEO
Create New SDTM- Glucometer

Term METHOD
Create New ER - Environmental and Social

Term Factors
Create New Protocol-Study 1. Quality Assurance 2. Quality

Term Monitoring Control
Attribute
Terminology
Create New SDTM- LBTESTCD='PREGTEST'
Term LBTEST/CD LBTEST='Pregnancy test of
unknown type'
Modify SEND- Consider adding the malignancy

Existing Term NEOPLASM status to the three requested terms
to make them consistent with all
other terms on the NEOPLASM list.
Create New SDTM- RPTESTCD='PREGSUSP'
Term RPTEST/CD RPTEST='Pregnancy suspected'
Description: Participant believes that
they may be pregnant, based on
recent contraceptive and menstrual
history.
Create New SEND- LEUKEMIA, MAST CELL,

Term NEOPLASM MALIGNANT
Create New SDTM- New terms for LBTESTCD/LBTEST:

Term LBTEST/CD GRANB Granulocytes Band Form
GRANSG Granulocytes
Segmented MYPCCE Myeloid
Progenitor Cells/Total Cells DISTR
Distribution WBCB Leukocytes
Band Form
Create New SDTM-CAN Add a new term 'MULTIPLE'

Term
Other SDTM- Add "Follitropin" as synonym for

LBTEST/CD LBTESTCD=FSH, LBTEST="Follicle
Stimulating Hormone", NCI code
C74783
Create New SEND- New Terms requested for
Term SRETST/CD SRETSTCD and SRETST: Peak
Expiratory Flow per Kilogram Peak
Inspiratory Flow per Kilogram Tidal
Volume per Kilogram Minute Volume
per Kilogram Shift Angle
Create New SDTM-UNIT mmHg*beats/min mL/s/kg

Term
Create New SDTM- Multiple request file
Term LBTEST/CD CDISC_Multiple_Request_Jozef_Aer
ts_2021-05-26.xls send
Create New SDTM-UNIT Please add new term to UNIT and

Term add synonyms to existing UNIT
terms
Create New SDTM- CDISC new terminology request
Term D1FATSCD
Create New SDTM- Recombinant human PH20

Term LBTEST/CD hyaluronidase (Anti-rHuPH20)
Antibody
Create New SDTM- Ammonium/Creatinine ratio
Term LBTEST/CD
Create New SDTM- Non-HDL Cholesterol /LDL
Term LBTEST/CD Cholesterol Ratio
Create New Multiple RSTEST = 'Pathologic
Term Downstaging'RSTESTCD =
'PATHDNST'Suggested result
value(s):Complete Pathologic
Downstaging
Create New SDTM- OETEST = Corrective Lens for
Term OETEST/CD Distance OETESTCD = CRRLNDST
Create New SDTM- CDISC_Multi_Term_Request_RohitD

Term LBTEST/CD hanjal_2021-06-01
Modify SDTM- There seems to be discrepancies in
Existing Term PKUNIT the submission value for PKUNIT the
following when comparing to the
UNIT codelist:
Other Multiple Please update definitions of provided

terms to remove the word 'urinary' so
the CT can be applied to multiple
specimen types.
Create New SDTM- PINHOLE OCCLUDER

Term METHOD
Create New CDISC- Privacy - in the context of

Term Glossary subject/participant
Create New SEND-SPEC DIGIT
Term
Create New SDTM- Lymphocytes/Neutrophils LYMNE

Term LBTEST/CD
Other SEND- Requestor would like to request

STSPRM/CD clarification to the CDISC definition
for the SEND TSPARCMD/TSPARM
= Study Report Status.
Create New New Not at all, A little, Quite a bit, Very

Codelist much
Create New Multiple CDISC P46 change requests that

Term need request codes prior to
publication.
Create New SDTM-LOC Please add FINGERTIP to the LOC
Term codelist.
Create New Multiple NVTEST/NVTESTCD paired
Term codelists
Create New SDTM-LOC PECTORAL LYMPH NODE

Term
Create New Multiple Fish (Cod) Antigen IgE Antibody (f3)
Term
CDISC- meta-analysis protocol

Glossary
Create New LBTEST/CD New terms requested
Term
Create New CDASH- PUMP

Term CMDOSU
Create New SDTM- RUN-IN FAILURE

Term NCOMPLT
Create New SDTM- FOLLOW-UP NOT COMPLETED

Term NCOMPLT
Create New SDTM- segesterone acetate

Term LBTEST/CD
Create New SDTM-UNIT Abortions, Births, Pregnancies
Term
Create New SDTM- Opacity / OPACITY

Term OETEST/CD
Create New SDTM- Marginal Reflex Distance 1 /

Term OETEST/CD MRFLXD1
Create New SDTM- Marginal Reflex Distance 2 /

Term OETEST/CD MRFLXD2
Create New SDTM- Margin Limbal Distance / MLIMBD

Term OETEST/CD
Create New RPTEST/CD fields commonly collected during a

Term contraception study
Create New SDTM- Erythroferrone (ERFE)

Term LBTEST/CD
Modify None Proposed update to
Existing Term TS_Codetable_Mapping: remove any
rows where No Yes Response
codelist indicates U as a valid values.
Other None More updates to

TS_Codetable_Mapping:
Modify SEND- NOT APPLICABLE term: Change the

Existing Term NULLFLAV preferred term to "NA" to match
with clinical term from the ISO list
referenced in the SDTMIG.
Modify SDTM-TUIDRS C132467 NEW BONE LESION -

Existing Term Preferred term : New Bone Lesion
Lesion Identification
Create New SDTM- Add "16S SEQUENCING" and

Term METHOD "SHOTGUN SEQUENCING" to the
method codelist for the T1D
prevention TAUG, Microbiome
examples
Create New New For new TESTCOND codelist in P47:
Term Please add '1D COLD INCUBATION'
and 'COLLAGEN INDUCED'
Other SDTM- "WITHDRAWAL OF CONSENT" versus

NCOMPLT "WITHDRAWAL BY SUBJECT"
Create New SDTM- Request to add ACTIVITY TRACKER to

Term METHOD the METHOD codelist.
Create New SDTM- MBTESTCD = TPL MBTEST =
Term MBTEST/CD Treponema Pallidum
Create New CDISC- abbreviation not in Glossary - add

Term Glossary EOP2A - end-of-phase2A
Create New CDISC- Data Sharing
Term Glossary
Create New SDTM- term: LIPS This is a TA request from

Term METHOD T1D
Create New Multiple New term requests for SEND SPEC,
Term SEND LOC
Other SDTM-NCF Codelist Extensible=YES
Modify Multiple Modify the European Organisation

Existing Term for the Research and Treatment of
Cancer Quality of Life Questionnaire
- Core 30 Version 3.0 Questionnaire
Test Code/Test Name codelists to
include the drived scores form the
user manual
Modify Multiple update definition for CCCAT for
Existing Term KDIGO AKI
Create New SEND- DP - Developmental Milestones.

Term SDOMAIN
Create New ADaM-DTYPE CL DTYPE CDISC Submission Value -

Term COPY CDISC Synonym - Copy CDISC
Definition - NCI Preferred Term -
Copy Duplication Imputation
Technique
Other SEND-SPEC remove ALL TISSUES from CT SPEC -

IG and examples support WHOLE
ANIMAL for use in its place.
Create New CDISC- covid-19 - coronavirus disease

Term Glossary 2019SARS-CoV-2 - severe acute
respiratory syndrome coronavirus 2,
novel coronavirus causing covid-19
disease
Create New CDISC- Codelist Short Name BSTEST

Term Glossary Requested Submission Value
Dimension Requested Synonym
SIZE
Create New Multiple Terms PULMONARY VEIN PELVIC

Term SIDEWALL SUBDURAL SPACE
VISCERAL ADIPOSE TISSUE
Create New Multiple 2021-07-
Term 23_CDISC_Multi_Term_Request
20JulJ2021_JJ
Create New SDTM-LOC FOVEA

Term
Create New CDISC- Codelist Short Name - CVTEST

Term Glossary Submission Value - Aortic
Distensibility Synonym - AISTBTY
Create New CDISC- LBTEST
Term Glossary
Create New CDISC- CODELIST- DTDECOD 1. Submission

Term Glossary Value - AVAILABLE FOR RETURN 2.
Submission Value - RETURNED

Existing Term SZFATSCD
Create New SDTM-LOC Sural Nerve

Term
Create New CDISC- CODELIST - Category of

Term Glossary Questionnaire QSCAT Submission
Value ? HVIVO SYMPTOM DIARY
CARD Synonym - HSDC01
Create New CDISC- CODELIST - METHOD Submission
Term Glossary Value - LAG AVIDITY EIA
Modify Multiple 13 changes to existing terms based

Existing Term on old CT JIRA comments that were
not processed during past CT public
reviews (no component added by
the commenter so got lost in the
system).
Create New SDTM- Circulating Tumor Cells, Traditional

Term LBTEST/CD
Create New SDTM- Circulating Tumor Cells, Apoptotic
Term LBTEST/CD
Create New SDTM- Codelist Short Name - MSTEST CDISC

Term MSTEST/CD Submission Value - Microbiological
Response CDISC Synonym -
MICRORSP
Create New MICROORG Codelist Short Name - MICROORG

Term
Create New MICROORG Codelist Short Name - MICROORG
Term Submission Value - ACINETOBACTER
PITTII
Create New MIFTSDTL Codelist Short Name - MIFTSDTL

Term Submission Value - STAINING
INTENSITY 3+
Create New SDTM- Please add DNVIGGAB - Dengue

Term MBTEST/CD Virus IGG Antibody
Create New SDTM- Please add DNVIGMAB - Dengue
Term MBTEST/CD Virus IGM Antibody
Create New SDTM- Please add DNGNS1AG - Dengue
Term MBTEST/CD Virus NS1 Antigen
Other SDTM- Change synonym for C101858 with
PROCEDUR CDISC submission value of BILEVEL
POSITIVE AIRWAY PRESSURE
VENTILATION from BPAP to BIPAP.
Create New SDTM- INDIRECT ELISA; SANDWICH ELISA;

Term METHOD Direct ELISA
Existing Term ECOG101STR C180257:
Create New New Create a response codelist to

Codelist support published TSPARM value of
CMSPSTAT/Commercial Sponsor
Status.
Create New SDTM-LOC VISCERA

Term
Create New SDTM- Please add new term to
Term TSPARM TSPARMCD/TSPARM codelist as
SDTIGMDV/ SDTM IG Medical Device
Version.
Create New SDTM-LOC Peroneal Nerve

Term
Create New SDTM-LOC Tibial Nerve

Term
Modify SDTM-EVAL Caretaker

Existing Term
Modify SDTM- EMG

Existing Term METHOD
Create New SDTM- TNFR2 (Tumor Necrosis Factor
Term LBTEST/CD Receptor 2)
Create New SEND- Allograft (or Allograft cells);

Term NONNEO Xenograft (or Xenograft cells);
Implanted cells
Create New SDTM-UNIT mL/s/kg

Term
Create New MBTEST/CD Code List - Microbiology Test Name
Term
Create New MEDEVAL Codelist - Medical Evaluator (CDISC

Term MEDEVAL)
Create New NVTEST/CD Codelist - nervous system physiology

Term test (CDISC NVTEST)
Create New PROCEDUR MICROWAVE THERAPY
Term
Create New UNIT UNIT

Term
Create New RPTEST/CD Codelist - reproductive system

Term findings test (CDISC RPTEST)
Create New RETEST/CD Codelist - respiratory test (CDISC

Term RETEST)Term - Blood Vessels/Total
Blood Vessel VolumeSynonym -
BVBVVOL
Create New SDTM- June Grass/Kentucky Blue Pollen IgE

Term LBTEST/CD
Create New SDTM- Perennial Rye Grass Pollen IgE

Term LBTEST/CD
Create New SDTM- Nuclear Mitotic Apparatus Protein

Term LBTEST/CD 1 / NUMA1
Create New SDTM- Nuclear Matrix Protein 22 / NMP22

Term LBTEST/CD
Create New SDTM- Peptidylprolyl Isomerase A / PPIA
Term LBTEST/CD
Create New LBTEST/CD Proton Density Fat Fraction

Term
Create New SDTM- PHARMACOKINETICIST

Term MEDEVAL
Create New SDTM Codelist - SDTM Microscopic

Term Microscopic Findings Test Name
Findings Test
Name
Create New Category of DOHNER AML 2017

Term Oncology
Response
Assessment
Create New TRTEST/CD Thickness
Term
Create New LBTEST/CD New LBTEST and LBTESTCD for

Term immunophenotyping
measurements.
Create New SDTM- TOXIN NEUTRALIZATION ASSAY

Term METHOD
Create New SDTM- MASS CYTOMETRY
Term METHOD
Create New SDTM- ASPIRATE

Term SPECTYPE
Create New SDTM- FIBROBLASTS

Term SPECTYPE
Create New New SEND Team requests creation of

Codelist SEND specific EPOCH codelist.
Create New SDTM- BROKEN TUBE
Term SPECCOND
Create New SDTM- ANTIBODY DEPENDENT CELLULAR

Term METHOD CYTOTOXICITY ASSAY
Modify SDTM- Liver Kidney Microsomal Type 1

Existing Term LBTEST/CD Antibody/LKM1AB
Create New SDTM- HEMOZOIN

Term MBTEST/CD
Create New SDTM-UNIT cells/m2

Term
Create New SDTM- Add new terms: MAXIMUM;
Term COLSTYP MINIMUM; MEDIAN; NADIR
Create New Multiple The KPS SCALEQRS instrument

Term responses CT for implementation in
the CDISC Library.
Create New Multiple The AIMS QRS instrument responses

Term CT for implementation in the CDISC
Library.
Create New Multiple The ATLAS QRS instrument

the CDISC Library.
Create New Multiple The KFSS QRS instrument responses

Term CT for implementation in the CDISC
Library.
Create New Multiple The HAM-A QRS instrument

the CDISC Library.
Create New SDTM-UNIT ngEq

Term
Create New SDTM-UNIT ngEq/g

Term
Create New SDTM- MUC5AC Gene/MUC5AC
Term PGTST/CD
Create New SDTM- Pls add the parameter term

Term OIPRM/CD "spoligotype" to OIPARM/CD.
Create New Multiple QRS Instrument APACHE II responses

Term CT
Modify SDTM-UNIT C101687: coding update or removal
Existing Term of C101687 from the UNIT codelist
Modify SDTM- Immature Basophils/Leukocytes /

Existing Term LBTEST/CD BASOIMLE
Create New SDTM- Staphylococcal Enterotoxin A
Term LBTEST/CD Antigen IgE Antibody
Modify None C41259 AMERICAN INDIAN OR
Existing Term ALASKA NATIVE
Create New SDTM- Staphylococcal Enterotoxin B IgE
Term LBTEST/CD Antibody
Create New SDTM- Hypoxanthine-Guanine
Term LBTEST/CD Phosphoribosyltransferase /HGPRT
Create New SDTM- Hemoglobin Variant / HGBVAR

Term LBTEST/CD
Create New Multiple Create two new ECG related

Codelist codelists: HEGRDMTH and
TWOFFMTH. They are result
codelists to support two TSPARM
values.
Create New Multiple PEDSQL ESRD V3 PARENT. Please

Codelist qdd ESRD (End Stage Renal Disease)
to PQL questionnaire.
Other TS codetable Pls update the TS Codetable
Mapping File Mapping file.
Create New SDTM- STIMTECH / Stimulation Technique

Term DUTEST/CD
Create New SDTM- Please add following test to

Term MBTEST/CD MBTESTCD code list:CMV -
Cytomegalovirus
Create New SDTM- Please add new test to MBTESTC

Term MBTEST/CD EBOV - Ebola Virus
Create New SDTM- Please add new test to MBTESTCD

Term MBTEST/CD codelist: INFABV - Influenza A/B
Virus
Create New SDTM- Please add following test to

Term MBTEST/CD MBTESTCD code list EBV - Epstein-
Barr Virus
Create New SDTM- Term = Breastfeeding Start Date

Term RPTEST/CD TESTCD = BFSTDTC
Create New SDTM- Term = Breastfeeding End Date

Term RPTEST/CD TESTCD = BFENDTC
Other Multiple Need request codes for all new
terms and changes in CDISC P47
publication that do not yet have NCI
request codes.this encompasses 314
changes to existing and 238 new
terms.
Create New Multiple These terms were discussed as part

Term of the CDISC MA/MI Team
evaluation of Reproductive Cycle
Phase data modelling for SENDIG
3.2. We have approval from SLTX
and CORE.
Other Multiple Please add Capillary Refill time to

either the SEND Vital Signs Test
Code/Test Name or SEND
Cardiovascular Test Code/Test Name
codelists.
Create New SDTM- Test Name: Bone Marrow

Term ONCRTS ResponseTESTCD: BMRESP
Create New New Please create a new Codetable IWC

Codelist HALLEK CLL 2018
Other Multiple Update terminology in existing
Codelists, RS_iRANO Mapping 2020-
09-25, RS_RECIST 1.0 Mapping 2016-
09-30, RS_RECIST1.1 Mapping 2020-
09-25, RS_RECIST1.1 Mapping 2018-
12-21RS_RANO Mapping 2019-12-
20,
Other SDTM-NCF For Codelist Name

'Never/Current/Form Classification',
should / can Extensible be set to
'No'?
Modify SDTM- Please harmonize format within the

Existing Term SDTMIGRS codelist, is it dot or comma ?
Create New Multiple Could you please consider adding

Codelist SDTM-SDTMIGRS codelist into
DefXML terminology?
Create New SDTM- Test Name - Neurological Status

Term ONCRTS TESTCD - NEURSTAT
Create New SDTM- Test Name - FUHRMAN TUMOR

Term MIFTSDTL GRADE Test Name - WHO/ISUP
GRADE
Create New SDTM- Phosphorylated Tau 181
Term LBTEST/CD
Other SDTM- Please add to the

ONCRTS RS_Onc_Codetable_Map for the
TESTCD: BESTRESP-
MORPHOLOGIC LEUKEMIA-FREE
STATE- MR- RELAPSED DISEASE-
INDETERMINATE RESPONSE
Create New SDTM- CDISC Submission Value - DECLINED

Term PROTMLST TO CONTINUE INTO NEXT TRIAL
SEGMENT CDISC Submission Value -
OPTED TO CONTINUE INTO NEXT
TRIAL SEGMENT
Other SDTM- Please as VGPR to the RS_RECIST1.1

ONCRTS Mapping 2020-09-25 Codelist
Create New SEND- Endometriosis

Term NONNEO
Create New SDTM- MID-STREAM CLEAN CATCH
Term CLMETH INDWELLING CATHETER STRAIGHT
CATHETER SUPRA-PUBIC
ASPIRATION CYSTOSCOPY
NEPHROSTOMY URETEROSTOMY
MINI-BRONCHOALVEOLAR LAVAGE
PROTECTED-BRUSH SAMPLING
ENDOTRACHEAL TUBE ASPIRATION
TRANSTRACHEAL
Other SDTM- Please consider adding to the

TUTEST/CD TU_Codetable_Mapping: NEW
NON-TARGET EXTRA NODAL NEW
NON-TARGET NODAL NEW TARGET
EXTRA NODAL NEW TARGET NODAL
Modify SDTM- Dual-probe in Situ Hybridization

Existing Term METHOD (Code C159521) HER2/Neu Status
by Validated Dual-probe in Situ
Hybridization (Code C156892)
Create New SDTM- Apoptotic Cells
Term LBTEST/CD
Create New SDTM- Necrotic Cells

Term LBTEST/CD
Create New SDTM- Necrotic Cells/Total Cells

Term LBTEST/CD
Create New SDTM- CDISC_Multi_Term_Request_MBTE
Term MBTEST/CD ST_DianeBall_17SEP21
Create New SEND- PI; Pharmacokinetics Input

Term SDOMAIN
Create New SDTM- Site Transfer (no code suggestion)

Term OTHEVENT
Create New SDTM- Please add 2 new MB tests: INFA,

Term MBTEST/CD Influenza A Virus INFB, Influenza B
Virus
Create New Multiple MUSCTS: Bone Mass; MUSCTSCD:

Term BONEMASS VSTEST: Extracellular
Water/Total Body Water;
VSTESTCD: ECWTBW
Create New SDTM-LOC Two new terms: 1) EYE, LEFT and
Term 2) EYE, RIGHT.
Create New SDTM- DIMOPOULOS IWWM-7

Term ONCRSCAT CONSENSUS 2014
Create New SDTM- Euglobulin Clot Lysis Time
Term LBTEST/CD
Create New SDTM-UNIT AU / ARMOUR UNITS

Term
Create New Multiple LBTESTCD/LBTESTCD for
Term NEUTLYMPH /
Neutrophils/Lymphocytes A relative
measurement (ratio or percentage) of
the neutrophils to lymphocytes in a
Create New SDTM- BCIND / Birth Control Indicator

Term RPTEST/CD
Create New SDTM-UNIT mm3 (cubic millimeter)

Term
Create New SDTM- Infliximab, Adalimumab,
Term LBTEST/CD Certolizumab, Tysabri, Golimumab,
Vedolizumab, Ustekinumab
Create New SDTM- Lost Amount/LOSTAMT

Term DATEST/CD
Create New Multiple AJCC2TC and AJCC2TN
Codelist
Create New CDISC- Experimental Unit

Term Glossary
Create New Multiple 10^5 cells

Term
Create New SDTM- Please consider the addition of "

Term FDATSRS Study Data Technical Conformance
Guide v4.8"
Modify SDTM- The EPOCH codelist definition needs
Existing Term EPOCH to be updated. Currently it is defined
as the name of the Epoch but the
valid values really refer to epoch
types/categorizations. Epoch names
tend to be sponsor defined and
contain more information (like
numbers, etc.).
Create New Multiple cells

Term
Create New SDTM- Term - STUDY MEDICATION Term

Term DSSCAT - TRIAL SEGMENT
Create New SDTM- Term Suggestion for CDISC

Term LBTEST/CD Terminology: 12-OCT-21
Create New SDTM- Add PAENICLOSTRIDIUM

Term MICROORG SORDELLI as a synonym to the
existing CDISC Submission Value
CLOSTRIDIUM SORDELLII Add
PARACLOSTRIDIUM
BIFERMENTANS as a synonym to
the existing CDISC Submission
Value CLOSTRIDIUM
BIFERMENTANS
Create New SDTM- CDISC Submission Value -

Term MBTEST/CD Bartonella Antibody CDISC Synonym
- BRTAB
Create New Multiple EUROPEAN LEUKEMIANET
Term BACCARANI CML 2013.
Modify CDISC- C142474/data collection instrument:

Existing Term Glossary Update definition
Create New Multiple The QRS sub-team approved the

Codelist move of FAQ-NACC UDS V2.0 from
QS to RS and similarly FAS-NACC
UDS V3.0 from QS to RS.
Create New SDTM- PTT/Standard
Term LBTEST/CD
Create New SDTM- CONTINUING INTO SURVIVAL
Term PROTMLST FOLLOW-UP NOT CONTINUING
INTO SURVIVAL FOLLOW-UP RE-
RANDOMIZATION
Create New SDTM- Please add to SPECTYPE new

Term SPECTYPE submission value of EXTRACTED
NUCLEIC ACID with the proposed
definition of: Nucleic acid (DNA or
RNA) that has been extracted and
purified from a biological sample as a
basis for subsequent analyses (e.g.
molecular testing)
Create New LBTESTCD V25HD (Synonyms: 25

Term Hydroxyvitamin D; 25-
hydroxycholecalciferol (25[OH]D);
25-Hydroxyvitamin D Metabolism;
25-OH Vitamin D; calcidiol 25-
hydroxycholecalcifoerol)
Create New LBTEST 25-Hydroxyvitamin D Synonym (25

Term Hydroxyvitamin D; 25-
hydroxycholecalciferol (25[OH]D);
25-Hydroxyvitamin D Metabolism;
25-OH Vitamin D; calcidiol 25-
hydroxycholecalcifoerol)

Term DIBSS-C
SDTM- Please update the Subject Visit
DOMAIN domain definition
Create New SDTM- New term request:

Term PKUNIT h*ng/mL/(ug/kg/day)ng/mL/(ug/kg/da
y)
Create New SDTM- Streptococcus pneumoniae

Term MBTEST/CD Moraxella catarrhalis Klebsiella
pneumoniae Klebsiella aerogenes
Aspergillus niger Aspergillus
fumigatus
Create New SDTM- 4-hydroxynonenal and

Term LBTEST/CD malondialdehye
Create New SDTM-ACN DOSE DELAY

Term
Create New SDTM- Hydroxychloroquine
Term LBTEST/CD
Create New SDTM- Lupus Anticoagulant

Term LBTEST/CD
Create New SDTM- Immunogenetic variation

Term GFTEST/CD
Create New SDTM- GRANULOCYTE

Term SPECTYPE
Create New SDTM- NATURAL KILLER CELL

Term SPECTYPE
Create New SDTM- LYMPHOCYTE
Term SPECTYPE
Create New SDTM- CD38 mRNA Isoform A

Term LBTEST/CD
Create New SDTM- CD38 mRNA All Isoforms

Term LBTEST/CD
Create New SDTM- CD38 Soluble

Term LBTEST/CD
Create New SDTM- CD38 MAb1 sABC

Term LBTEST/CD
Create New SDTM- CD38 MAb2 sABC
Term LBTEST/CD
Create New SDTM- CD38 Receptor Density

Term LBTEST/CD
Create New SDTM- CD38 RECEPTOR OCCUPANCY

Term LBANMET
Create New New ISTSTDTL

Codelist
Create New New PERCENTAGE OCCUPANCY
Term
Create New New BOUND CONCENTRATION

Term
Create New New PERCENT INHIBITION

Term
Create New New TOTAL CONCENTRATION

Term
Create New SDTM- Orthostatic blood pressure:

Term VSTEST/CD difference between BP after 5 minute
lying followed by standing up and
then measuring after 1 and 3
minutes.
Create New SDTM- Orthostatic heart rate: difference

Term VSTEST/CD between HR after 5 minute lying
followed by standing up and then
measuring after 1 and 3 minutes.
Modify SDTM- "collected" is not an appropriate

Existing Term DOMAIN description of data in an SDTM
domain.
Other SDTM- The term "Skin Type" should be
SCTEST/CD moved to a codelist for the body-
system domain for the body system
that includes the skin.
Create New SDTM-LOC OPTIC CHIASM
Term
Create New SDTM- IDL Cholesterol/LDL Cholesterol
Term LBTEST/CD IDLLDL
Create New Multiple MIRESMOD - result modifier

Codelist previously mapped to SUPPMI, this
is being elevated to the parent MI
domain with controlled terminology.
The preliminary list is attached, and it
contains both noun and adjective
terms which will have CT per SLTX
agreement.
Create New SDTM-LOC Please add to anatomical location

Term (CDISC LOC) dictionary. DURA
MATER
Create New SDTM-LOC SCALENE LYMPH NODE
Term PULMONARY LYMPH NODE
INFERIOR MEDIASTINAL LYMPH
NODE SUPERIOR MEDIASTINAL
LYMPH NODE LEVEL VII Subaortic
Lymph Node
Create New SDTM- PHASE IA TRIALPHASE IB

Term TPHASE TRIALPHASE I/III TRIAL
Create New SDTM- APRELSUB
Term DOMAIN
Create New SDTM- Submission Value - NON-HOSPITAL

Term DISCHDX INTERMEDIATE CARE FACILITY
Create New SDTM- BEYOND STABILITY CDISC

Term SPECCOND Submission Value: Beyond Stability
Specimen
Create New SEND-SSTYP CARDIOVASCULAR AND
Term RESPIRATORY PHARMACOLOGY
Create New SDTM-UNIT mkat/L

Term
Create New SDTM-UNIT mmol/L/h; nmol/s/L; umol/s/L

Term
Create New SEND- Oxygen Saturation OXYSAT
Term SCVTST/CD
Create New SDTM- LBTESTCD=AMSH LBTEST=Alpha

Term LBTEST/CD Melanocyte Stimulating Hormone
DEFN: A measurement of alpha
melanocyte stimulating hormone in a
Create New Multiple I just need a request code for these

Codelist three requests: Changes to Existing
QRS CATs; New EORTC CATs; New
FACIT Searchable Item Library
Terminology
Create New new MARESMOD

Codelist
Create New Multiple Norfluoxetine OD Venlafaxine

Term Norsertraline Desmethyl Citalopram
Trazodone Escitalopram Duloxetine
Milnacipran Vortioxetine Vilazodone
Create New SDTM-OUT ONGOING

Term
Modify QRS-QSCAT Request to update NCI PTs for the
Existing Term following C-codes C161653 C161654
C170644 Change "organisation" to
"organization"
Create New SDTM- Term - Breastfeeding End

Term RPTEST/CD DateSynonym - BFENDTC
Create New SDTM- SARS-CoV-2 S Protein RBD

Term RPTEST/CD Neutralizing Ab Dengue
Virus 1/2/3/4 RNA
SARS-CoV-2 Spike Protein IgG
Antibody
Create New SDTM- Selenium

Term LBTEST/CD
Create New Multiple LBMETHOD CO-oximetry Cell-based

Term luciferase reporter virus Indirect
immunofluorescence Colloidal gold
immunofiltration assay
Create New SDTM- Retinoic Acid

Term LBTEST/CD
Create New SDTM- Carbohydrate Antigen 19-9 (CA-19-
Term LBTEST/CD 9)
Create New SDTM- Interferon 21-gene Type I Assay
Term LBTEST/CD
Create New SDTM- Interferon-inducible Gene Expression
Term LBTEST/CD
Create New SDTM- Adeno-associated Virus 2
Term LBTEST/CD Neutralizing Antibody
Create New SDTM-UNIT CDISC Submission Value: /10
Term HPFs CDISC Submission
Value: /2 mm2
Create New SDTM-UNIT CDISC Submission Value - Binding

Term AB Unit/mLSynonym - Binding
Antibody Unit per Milliliter
Create New SDTM- Neutrophils with Pseudo Pelger-Huet

Term LBTEST/CD Nucleus / NEUPPH
Create New SDTM- Herpes Simplex Virus Common
Term LBTEST/CD Antigen / HSVAG
Create New SDTM- Lipase, Hepatic / LIPASEH

Term LBTEST/CD
Create New SDTM- Chitotriosidase-1 / CHIT1

Term LBTEST/CD
Create New SDTM- Methyltransferase / METHYLAS

Term LBTEST/CD
Create New SDTM- ANA Pattern / ANAPATT

Term LBTEST/CD
Create New SDTM- Tomoregulin-2

Term LBTEST/CD
Create New SDTM- Please add LBTEST=Interpretation

Term LBTEST/CD (LBTESTCD=INTP)
Create New Multiple New term requests from the
Term DRAGON TA project
Create New SDTM- Pre-Ejection Period

Term CVTEST/CD
Create New Multiple new SDTM terms and tests for

Term existing codelists
Other none Update to RS_Lugano_Codetable
Create New SDTM- CDISC Term - FIGO Tumor Grade

Term MIFTSDTL
Create New SDTM- Meadow Fescue Pollen IgE
Term LBTEST/CD
Create New SDTM- Wall Pellitory Pollen IgE

Term LBTEST/CD
Create New SDTM- Sagebrush Mugwort Pollen IgE

Term LBTEST/CD
Create New SDTM- Oat Cultivated Pollen IgE

Term LBTEST/CD
Create New SDTM- Nettle Pollen IgE

Term LBTEST/CD
Create New SDTM- Italian Cypress Pollen IgE

Term LBTEST/CD
Create New SDTM- Alder Grey Pollen IgE

Term LBTEST/CD
Create New SDTM- Trichinella IgM Antibody / TRIIGMAB

Term LBTEST/CD
Create New SDTM- Trichinella IgG Antibody / TRIIGGAB

Term LBTEST/CD
Create New SDTM- Toxocara canis IgG Antibody /

Term LBTEST/CD TOCIGGAB
Create New SDTM- Taenia solium IgG Antibody /

Term LBTEST/CD TASIGGAB
Create New SDTM- Oriental Cockroach Antigen IgE

Term LBTEST/CD Antibody
Create New SDTM- Influenza A H3N2 Antibody /
Term MBTEST/CD FAH3N2AB
Create New SDTM- Influenza A H1N1 Antibody /

Term MBTEST/CD FAH1N1AB
Create New SDTM- Epidemic Parotitis Virus IgM

Term MBTEST/CD Antibody / EPIGMAB
Create New SDTM- Echinococcus multilocularis IgG

Term LBTEST/CD Antibody / ECMIGGAB
Create New SDTM- Echinococcus granulosus IgG

Term LBTEST/CD Antibody / ECGIGGAB
Create New SDTM- EBV Nuclear Antigen IgG Antibody /

Term MBTEST/CD EBVNIGAB
Create New SDTM- Dengue IgM Antibody / DENIGMAB

Term MBTEST/CD
Create New SDTM- Dengue IgG Antibody / DENIGGAB

Term MBTEST/CD
Create New SDTM- Ascaris IgG Antibody / ASIGGAB

Term LBTEST/CD
Create New SDTM- Anti-Zinc Transporter 8 Antibody /

Term LBTEST/CD AZNT8AB
Create New SDTM- Anti-Indole 3 Acetic Acid Antibody /
Term LBTEST/CD AIAAAB
Create New SDTM- Chemokine (C-X-C Motif) Receptor 4

Term LBTEST/CD / CXCR4
Create New SDTM- Chemokine (C-C Motif) Ligand 22 /

Term LBTEST/CD CCL22
Create New SDTM- Chemokine (C-C Motif) Ligand 2 /

Term LBTEST/CD CCL2
Modify SDTM- ADENOVIRIDAE

Create New SDTM- AMTREC Amount Recovered

Term PKPARM/CD
Create New SDTM- MRAUCIFP Metabolite Ratio for

Term PKPARM/CD AUC Infinity Pred
Create New SDTM- MRAUCINT Metabolite Ratio AUC
Term PKPARM/CD from T1 to T2
Create New SDTM- MRCMAX Metabolite Ratio for

Term PKPARM/CD Max Conc
Create New SDTM- PCTREC Percent Recovered

Term PKPARM/CD
Create New SDTM- VZF Vz by F

Term PKPARM/CD
Create New SDTM- mg/(h*ug/mL)

Term PKUNIT
Create New SDTM- Chloroquine / CHLOQUIN

Term LBTEST/CD
Other Multiple CDISC P48 new term requests that

need a CDISC change request
number
Create New SDTM- Endothelin-3

Term LBTEST/CD
Create New SDTM- Phosphatidylethanol
Term LBTEST/CD
Create New SDTM- Interferon-inducible Protein-10
Term LBTEST/CD
Create New SDTM- Mesothelin

Term LBTEST/CD
Create New SDTM- Biclonal M Protein / BMCPROT
Term LBTEST/CD
Create New SDTM- Digitoxin / DIGITOX

Term LBTEST/CD
Create New SDTM- TATA Box Binding Protein / TBP

Term LBTEST/CD
Create New LBTEST / FERROQUI, LYSOGL1, HEPCIDIN,

Term LBTESTCD KETA, MEFLOQUI, QUININE
Multiple MODIFIED ROSS CLASSIFICATION
Class I Class Il Class Ill Class lV
Modify SDTM-QSCAT https://npitest.net/about-npi.html

Existing Term http://npitest.net/images/stories/pdf/n
pi-q.pdf
Create New SDTM- STREPTOCOCCUS

Term MICROORG GALLOLYTICUS SUBSP.
PASTEURIANUS
Create New SDTM-UNIT copies/10 ng gDNA
Term
Final
Change Outcome
Type -
Additional
The QRSMTHOD codelist needs additional terms II QRS-Published in P46
to represent VAS instruments that do not have
units represented on the instrument. The EQ-5D-
3L & EQ-5D-5L instruments are examples of this
use case with the final items on those
instruments. The list of new terms is included in
the separate EMAIL message.
Administration within the cochlea. II SDTM, SEND-Published

in P48
The portion of the thoracic aorta that follows the II SDTM, SEND-Published
subclavian artery origin in the aortic arch in P49
Would be help to define since there are folks who II Glossary-Published in

confound regs by believing that an electronic P48
record exists before it is saved. In other words,
an unrecorded record is a record for them.
Important since electronic thinking happens on a

screen of a device while a patient decides what
option to ?record?. Some compulsives think that
the interim positions of a cursor on a VAS or
interim selections tapping between two choices
are ?records? even if not recorded.
Please add the submission value of NO CHANGE II

to the ONCRSR codelist. The definition
suggested is No change in tumor size (<=5 mm in
SOM for new lesion target or any increase for
new lesion non target) or number of lesions.
Please add the submission value of ERYTHROID II

RESPONSE to the ONCRSR codelist with the
definition Hematological improvement in
myelodysplastic syndrome reflected by increase
of hemoglobin or relevant reduction of units of
RBC transfusion
Please add the submission value of PLATELET II

RESPONSE to the ONCRSR codelist with the
definition Hematological improve,ent in
myelodyspastic syndrome reflected by increase in
patelet counts.
Please add the new submission value II
NEUTROPHIL RESPONSE to the ONCRSR
codelist with the definition Hematological
improvement in myelodysplastic syndrome
reflected by increase in neutrophil count.
Please add the new submission value of CRp to II

the ONCRSR codelist with the definition
Complete remission with partial platelet recover
(less than 100x10E9/L platelets).
Please add the submission value of II

HEMATOLOGIC RELAPSE to the ONCRSR
codelist with the definition of Hematologic relapse
(after CR MRD neg, CR, CRi).
Please add the submission value MOLECULAR II

RELAPSE to the ONCRSR codelist with the
defintiion Molelecular response (after CR MRD
Neg).
Please add the submission value NO RELAPSE II Do not add (P48): Do

to the ONCRSR codelist with the definition No not add. Withdrawn by
relapse (after CR). requester.
Please add the submission value of CRh to the II

ONCRSR codelist with the definition Complete
remission with partial hematological recovery.
Requested new submission value of Infiltration II Do not add (P48): Do

Due to Lymphoma to be added to TUTEST not add. Withdrawn by
codelist with the definition Bone marrow requester.
infiltration due to lymphoma.
Requested to add the new submission value of II Do not add (P48): Do

SPLNLYM/Splenomegaly Due to Lymphoma to not add. For SDTM
be added to the TUTESTCD/TUTEST codelist purposes, this test
with the definition Spleen enlargement due to should be modeled in
lymphoma. the TR domain, not the
TU domain. Additionally,
team will not add this
test specifically but
rather the requester
should use the
published
TRTEST=Organ State
with extensible response
value of
ENLARGEMENT DUE
TO LYMPHOMA.
This request is coming from the CT Relationships II
team in which they completed an exercise I had
them do to identify new codetable mapping files
that could be created or existing codetable
mapping files that could do with an update. ECG
was one that could do with an update.
Please create a new MBTEST/TESTCD for II SDTM-Published in P46

following organism that is identified via Biofire
FilmArray panel (bioM rieux) Human
Rhinovirus/Enterovirus (test cannot discriminate
between the 2).
A measurement of Human Rhinovirus or
Enterovirus (cannot be discriminated) in a
Measurement of Bordetella pertussis in a II SDTM-Published in P46

biological specimen
A measurement of Mycoplasma pneumoniae in a II Do not add (P46): Do not add, already published, map to C1565
It appears that two tests for Vitamin D have the II SDTM, SEND-Published
same synonym. Both have synonym = Calcidiol. in P46
Is this correct?
LBTEST value of 'VLDL Triglyceride + II SDTM, SEND-Published

Chylomicron Triglyceride' is longer than 40 in P46
character limit, please update accordingly. Thank
you!
Terms requested by MB/IS team for OIPARM-CD, II SDTM-Published in P46

just need request code
Please add new lab test of 'Alpha- II SDTM, SEND-Published

Hydroxitriazolam' with test code HTRZLMA; also in P47
present in LOINC as 'Alpha hydroxytriazolam'.
Please add new lab test of II SDTM, SEND-Published

'Hydroxyethylflurazepam' with test code in P47
HEFLZPM; also present in LOINC as
'Hydroxyethylflurazepam'.
Please add the new submission value of IU/h to II SDTM, SEND-Published
the UNIT codelist with the definition: A unit of in P47
substance (biologic activity) flow rate equal to one
international unit per hour. This new definition is
in line with the defintion for IU/day definition of: A
unit of substance (biologic activity) flow rate equal
to one international unit per day.
"WHAT IS THE JUSTIFICATION FOR THE II Do not add (P49):

ADDITION OF NEW TERM. INFILTRATE,
MACROPHAGE - Do
INHAND TERMINOLOGY HAS THESE AS not add. We will
RECOMMENDED MODIFIERS FOR THE consider this type of
INFILTRATE AND INFLAMMATION result modifier
MAINTAINING THE INHAND terminology within the
RECOMMENDATION, THESE ARE INDUSTRY new MIRESMOD
WIDE ACCEPTED TERMS AND SHOULD BE codelist to be developed
CONSIDERED THE BASE PROCESS. in 2022.
The converse rejecting a term would be that if it Do not add (P49):
does not exist in INHAND terminology ? it could INFILTRATE, MAST
be rejected. CELL - Do not add. We
will consider this type of
INHAND RECOMMENDS USING MODIFIER result modifier
WITH INFLAMMATION AND INFILTRATE TO BE terminology within the
THE UNIQUE FINDING. THIS IS UNIQUE AS IT new MIRESMOD
USES A LIMITED NUMBER OF CELL TYPES codelist to be developed
ACROSS TISSUES TO MAINTAIN THE in 2022.
FINDING INDIVIDUALITY. Do not add (P49):
" INFILTRATE, MIXED
CELL - Do not add. We
will consider this type of
result modifier
terminology within the
new MIRESMOD
codelist to be developed
in 2022.
Do not add (P49):
INFILTRATE,
MONONUCLEAR CELL
- Do not add. We will
consider this type of
result modifier
terminology within the
new MIRESMOD
codelist to be developed
New term requests. File emailed separately. II SDTM-Published in P46
Do not add (P46): Virus
Category; WHO
Candidate Vaccine
Virus; Host;
Pseudotyped Virus
Infectivity - Withdrawn
by requester
Peptide Pool - Do not
add, map to
ISCNDAGT.
WHO Reference
Antigen Lot Number -
Do not add, not in scope
for OI.
The investigator is able to enter one action taken II Do not add (P47): Do
with study drug or select multiple actions taken. If not add. Please use
one action is selected, then the value of ACN MULTIPLE convention
contains one of the current terms allowed. outlined in SDTMIG.
However, if the investigator selects multiple
actions, we enter 'MULTIPLE' as the value of
ACN; then we enter the specific actions (using
the current terms allowed) in variables ACN1, ...,
ACNn. You need to add 'MULTIPLE' to account
for such cases.
REASON: Study type needed to support a II

combination Pharmacology study (i.e.
Cardiovascular and Respiratory Telemetry
Study). Previous term request submitted
(Request Code: CDISC-3793) was denied on
2019-04-15 for P39. The final decision was to add
multiple records for a single TSPARM Study
Type. However, the recently published
Conformance Rules v2.0 for SEND contains a
new rule #345, which states "Only a single record
for TSPARM Study Type should exist".
DEFINITION: The study of the effects of drugs
upon the heart or circulatory system along with
the branch of pharmacology that deals with the
respiratory system.
The above terms are for descriptions of lifetime or II Do not add (P50): Do
past _ months/years suicide severity questions not change. The "if yes,
answered in the affirmative; however, there is no describe" item under the
way to distinguish between descriptions referring first five questions
to lifetime versus past _months/years. This is a (CSS0401X to
problem as these descriptions are separate fields CSS0405X) in the
on the CRF and need to be mapped to 2 different suicide ideation section
terms when a subject answers both conditional in this questionnaire
questions in the affirmative. does not refer to a
CSS0406B/CSS0406D are correct examples of particular time frame,
the descriptions being captured by 2 different i.e. lifetime vs past_M/Y.
terms as expected. This question is meant
to capture the
description of why the
various elements of
suicide ideation were
contemplated regardless
of when those thoughts
occurred - there was no
time frame attached.
"Based on recent rejection of a request for a II SDTM-Published in P46
similar term for the Cardiovascular test codelist,
which also contained location information and
that the existing term does not specify 'rate' in the
test name, team determined to update the
codelist to direct usage toward the more generic
Blood Flow Rate (C94866) term that was created
for the cardiovascular request."
Based on recent rejection of a request for a II SDTM-Published in P46

similar term for the Cardiovascular test codelist,
which also contained location information and
that the existing term does not specify 'rate' in the
test name, team determined to update the
codelist to direct usage toward the more generic
Blood Flow Rate (C94866) term that was created
for the cardiovascular request.
NEURORADIOLOGIST 1, II SDTM-Published in P48

NEURORADIOLOGIST 2
I am increasingly seeing 'gummy' or 'gummies' II SDTM-Published in P49

entered for 'Other, specify' fields regarding the
CM dose unit. This value is not listed as a
synonym nor is there a clear value for mapping to
a pre-existing term.
The term 'envelope' is being used for 'Other, II SDTM-Published in P49

specify' when reporting CM dose units. These
values are often linked to cold and flu treatments
used in our international sites (e.g., Tapsin
noche). Could 'envelope' be added as a new
code or perhaps a synonym to an existing code?
Is it possible to have 'PILL' as its own term? I do II SDTM-Published in P49

not see it listed as a synonym for TABLET or
CAPLET.
We work on a lot of studies where a gel is II SDTM-Published in P49

administered and subjects are asked to apply '1
pump'. Can 'PUMP' be added as its own term?
"The change control spreadsheet for the following II QRS-Published in P45

istruments is sent separately
SF36 V1.0 ACUTE
SF36 V1.0 STANDARD
SF36 V2.0 ACUTE
SF36 V2.0 STANDARD"
The change control spreadsheet for QSCAT only II QRS-Published in P45
for the following istruments is sent separately
SF10 V1.0 CHILDREN ACUTE

SF10 V1.0 CHILDREN STANDARD
SF12 V1.0 ACUTE
SF12 V1.0 STANDARD
SF12 V2.0 ACUTE
SF12 V2.0 STANDARD
SF8 V1.0 ACUTE
SF8 V1.0 STANDARD
The QRS CT spreadsheet for II QRS-Published in P45

QSTESTCD/QSTEST for the following istruments
is sent separately
SF10 V1.0 CHILDREN ACUTE
SF10 V1.0 CHILDREN STANDARD
SF12 V1.0 ACUTE
SF12 V1.0 STANDARD
SF12 V2.0 ACUTE
SF12 V2.0 STANDARD
SF8 V1.0 ACUTE
SF8 V1.0 STANDARD
The CDISC definition of 'Upper Urinary System' II SDTM, SEND-Published

reads -> 'The division of the urinary tract in P46
comprising the kidney and the ureters.' .
We have a need to represent 'Upper urinary tract'
which sounds synonymous to the existing 'Upper
Urinary System'. Could this be added as a
synonym to the existing term?
Definition: A technique to assess capillary fragility II SDTM-Published in P49

in which a tourniquet or inflated blood pressure
cuff is applied superior to the antecubital fossa for
a period of time after which any resulting
petechiae below the antecubital fossa are
assessed.
Reason: Does not currently exist and is being
used as a clinical assessment tool in a Dengue
fever trial. See also
https://www.cdc.gov/dengue/training/cme/ccm/pa
ge73112.html. An alternate or synonym could be
CAPILLARY FRAGILITY TEST or RUMPEL-
LEEDED CAPILLARY FRAGILITY TEST (as per
Wikipedia,
https://en.wikipedia.org/wiki/Tourniquet_test)
UPDRS (CAT, TESTCD/TESTs) from the QS to
RS domain as a clinical classification based on
the instrument definition. This involves moving
the following:
value of ?UPDRS? to the clinical classifications
CCCAT codelist
of ?Unified Parkinson's Disease Rating Scale
classifications TESTCD codelist ? Unified
Parkinson's Disease Rating Scale Clinical
of ?Unified Parkinson's Disease Rating Scale
classifications codelist of ?Unified Parkinson's
Disease Rating Scale Clinical Classification Test
Name?.
current Terminology for UNIT CT, does not II Do not add (P47): Do
include umol/L, it include "umol" which is for not add. Already
"Micromole" and mmol/L which is for "Millimole published in the UNIT
per Liter" , but not "Micromole per Liter" codelist as C48508.
A measurement of the SARS-CoV-2 Viral II Do not add (P47): Do

Sequencing Spike Protein Region in a biological not add. If sequencing
specimen. information is being
reported in the dataset,
please use GF domain
with GFTEST of Short
Variation/SHRTVAR or
Single Nucleotide
Variation/SNV with the
appropriate GFTSTDTL
value that pertains to
what exactly is being
assessed. If this test is
being used to detect the
presence of a specific
COVID-19 virus varient,
the MB domain structure
should be used instead.
A unit of measurement equal to 10 to the sixth II Do not add (P48): Do
power of the number of cells per unit of volume not add. PBMC is
normally measured in
the thousands/uL
(10^3/uL = 10^6/mL =
10^9/L). 10^3/uL is
already published as a
synonym of 10^9/L, so
please use existing term
C67255. Since the
definition sent by the
requester specifies the
unit of volume in the
denominator, the team
would recommend the
use of a unit with a
volume denominator.
I could not readily find a code list for the II QRS-Published in P48
International Prostate Symptom Score (IPSS).
This questionnaire is commonly used for prostate
cancer. If one does not exist, could it be added?
Details can be found on the first page at the
following link:
https://www.inova.org/sites/default/files/Services/
cancer/ilh/docs/Prostate-Symptom-Score-
Chart.pdf
Update the ECG Code Mapping table to link II

"normal/abnormal" codelist to EGTEST =
Interpretation
Other findings domains have "Findings" in the II Do not add (P47): Do
synonym. The CDISC definition also states that not update. The MO
Morphology is a findings domain. domain is being
removed from codelist
Examples are: BS Biospecimen Findings, CV with P47 as it is not in
Cardiovascular System Findings, ED Endocrine SDTMIGv3.4
System Findings, FA Findings About Events or
Interventions, GI Gastrointestinal System
Findings, HM Hematopoietic System Findings, IG
Integumentary System Findings, MI Microscopic
Findings
Findings Domains that do not have "Findings" in

the CDISC Synonym:
EG EG Test Results, FT Functional Tests, IS
Immunogenicity Specimen Assessments, LB
Laboratory Test Results, MB Microbiology
Specimen, etc.
MO Morphology is not very descriptive of the

contents as the other findings domains in the
examples named above.
Add new LOC terms; File emailed separately II SDTM, SEND -

Published in P49
not add. Already
published as C150852.
Benign is not included in the Submission Value. II SEND-Published in P46
FDAB085, business rule, that MISTRESC using
NEOPLASM terms should align with MIRESCAT
term. The Pinnacle21 performs a search to verify
that MIRESCAT BENIGN or MALIGNANT match
with the MISTRESC. Since BENIGN is not
included the submission value, it flags the rule as
a potential issue.
It appears other published NEOPLASMs include
BENIGN or MALIGNANT, but I'm not sure if it's a
CT rule to include it.
In pregnancy example 1 of the HIV TAUG; II SDTM-Published in P47

Section 5.3 page 27
The --TEST/CD of 'Volume' has different c-codes II SDTM-Published in P46
across different codelists. In NVTEST-CD,
BSTEST/CD, and TRTESTCD the test is coded
to C25335, which is the concept of Volume.
Whereas in LBTEST-CD, the concept C74720 is
used to represent 'Volume Measurement'. The
lab team believes that any --TEST/CD
terminology concepts for volume should be
matched to C74720 'Volume Measurement'.
Therefore please update the C-code from
C25335 to C74720 in the NVTEST-CD,
BSTEST/CD, and TRTEST/CD codelists.
CDISC P45 new terms and changes that need II CDASH, Define-XML,
request codes: This multiple term request Protcol, SDTM, SEND -
contains 54 new term and 63 changes to existing Published in P45
terms.
"C142362; C103420; C124415 (RECIST 1.1) II Do not add (P47):

Question answered: In
I have recently been looking at the Oncology the Lung Cancer TAUG,
Codetable mapping (2020.09.26) for the various NEWLIND is associated
Response Criteria that is available on the CDISC with iRECIST, not
website, and noticed that for: (1) RECIST 1.1 in RECIST 1.1. Team
the Codetable Mapping spreadsheet, that there is confirms that iRECIST
now a test for ""New Lesion Progression""; and codetable mapping
(2) In the Lung Cancer TAUG, there is use of contains the NEWLIND
RSTEST = 'New Lesion Indicator'. test value. NEWLIND is
I realize that the Lung Cancer TAUG was not valid for use with
published before the updates to the Codetable RECIST 1.1, hence is
Mapping file, and that therefore the latter is the not included in that
current preferred thinking (i.e., usage of 'New codetable mapping.
Lesion Progression' versus 'New Lesion iRECIST is RECIST up
Indicator'). until the first
Is there an explanation available somewhere progression.
(either on the wiki or elsewhere) as to the
introduction of ""New Lesion Progression"" as an
RSTEST for use with RECIST 1.1? -- and how
this ""new lesion"" that is referred to in the RS
domain differs from what is captured and
measured at the visit level in the TU/TR domains
for the appearance and monitoring of new
lesions?
Thank you,
Anita Umesh
(email also sent to Erin M. on 2021.02.11)
Reason for requesting information is to
understand the rationale behind differences in
terminology implementation."
(P49):
New term requests for multiple codelists II SDTM-Published in P47, Trunk,
P48, P49, P50 Superficia
Do not add (P47): - l - Do not
Clotted: Do not add. add.
Already published in Please
codelist as C78724 use
Do not add (P47): - Not existing
Specified: Do not add. LOC
In this instance, better concept
practice is to keep the C12295.
cell in the dataset blank, Do not
instead of using a value add
like this one. CDISC (P50): Do
teams will not control not add.
this value generally This is not
across most all an
codelists. anatomica
Do not add (P47): - Bile l location;
(Biliary Obstruction): Do it is a
not add. Please use specimen
existing term type.
C64481/Direct Bilirubin. Please
Do not add (P47): - use SPEC
Polyclonal Protein: Do variable
not add. Request for this
withdrawn by requester. concept
Do not add (P47): - HLA and LOC
DQB1 Antigen: Do not variable
add. Already published for where
as C154750 on the
Do not add (P47): - HLA body the
DRB1 Antigen: Do not examinati
add. Already published on or
as C154749/HLA DR finding is
Beta1 Antigen relevant.
Do not add (P47): -
Iodine, Concentration:
Definition: Interaction between participant and II SDTM-Published in P48
healthcare professional that takes place at the Do not add (P48): Do
participant?s home or place of residence. not add. Please use
An example of where this could be used is in "IN PERSON" and use
VECNTMOD (or SVCNTMOD), when a visit is an HO dataset to specify
performed in the participant's home, instead of at "HOME HEALTHCARE
the site. In the CDISC Guidance for Ongoing VISIT" as the
Studies Disrupted by COVID-19, --CNTMOD HODECOD value. The
contains values such as REMOTE AUDIO, purpose of the Contact
REMOTE AUDIO VIDEO, TELEPHONE CALL. Mode NSV is to simply
Interaction could also occur by a home health to identify the means by
care professional. [Note, HODECOD was also which contact occurred,
considered, but if is preferable to include this data whereas HODECOD
on the VE/SV record, as the purpose is more specifies the
similar to CNTMOD]. person/place of the
contact. Adding this
term into the CNTMOD
codelist is not consistent
with the usage of the
variable. The team will
add HOME
HEALTHCARE VISIT to
the HODECOD codelist
to finish out this request.
Related to question "Was Death expected?" in II SDTM-Published in P48

Death Report Form (DD domain).
This term was originally added to support II SDTM-Published in P46

modeling in the Type 1 Diabetes Exercise and
Nutrition TAUG. During Public Review, a
comment was raised pointing out the
inconsistency between the TESTCD value
("SERVNUM") and the name of the
corresponding non-standard "Number of
Servings" variable, "--SVGNUM". Also, in
response to a separate Public Review comment,
the modeling for representation of number of
servings served and returned was changed not to
use the SERVNUM / Number of Servings
Findings About test. This was discussed at the
Terminology team meeting on 2021-02-12 and it
was agreed that it would be better to retire this
test instead of changing it to be consistent with
the NSV.
This request is being raised to support the II SDTM, SEND-Published
modeling of examples in the Nutrition module of in P48
Type 1 Diabetes Exercise and Nutrition TAUG.
There already appears to be term for "Serving"
("An individual portion of food or drink") in the NCI
metathesaurus:
https://ncim.nci.nih.gov/ncimbrowser/ConceptRep
ort.jsp?dictionary=NCI
Metathesaurus&code=C1519269
This is used in the TAUG for Type 1 Diabetes - II SDTM-Published in P46

Exercise and Nutrition Therapeutic Area User
Guide. This was discussed and agreed to at the
CT meeting on Feb 12,
Definition: A measurement of the Proteus II SDTM-Published in P46

mirabilis species.
A measurement of the Streptococcus agalactiae II SDTM-Published in P46

species.
A measurement of the Staphylococcus II

saprophyticus species
A measurement of the Staphylococcus II SDTM-Published in P46

saprophyticus species Do not add (P46):
Staphylococcus
saprophyticus - Do not
add. Duplicate request.
A measurement of the Enterobacter species. II
A measurement of the Acinetobacter species. II SDTM-Published in P46
A measurement of Serratia species in a biological II SDTM-Published in P46

specimen
A measurement of Morganella in a biological II SDTM-Published in P46

specimen
A measurement of Candida genus in a biological II SDTM-Published in P46

specimen.
sign : an observation found by an another person II Glossary-Published in
than the subject during a physical exam or from a P48
technical investigation (eg. laboratory test) that
shows that a person may have a condition or
disease.
Note : some examples of signs are fever,
swelling, skin rash, high blood pressure, and high
blood glucose.
See also diagnosis, symptom.
[After NCI dictionary]
https://www.cancer.gov/publications/dictionaries/
cancer-terms/def/symptom
symptom : a physical or mental effect that a II Glossary-Published in

person experiences that may indicate a disease P48
or condition.
Note : symptoms cannot be seen and do not
show up on medical tests. Some examples of
symptoms are pain, fatigue, nausea.
See also diagnosis, sign.
[After NCI dictionary]
cancer-terms/def/symptom
Add subscale scores and total score for FACT- II QRS-Published in P46
Hep terminology (FAC015)
Terminology for FAACT (FAC065): QSCAT, II QRS-Published in P46

QSTESTCD, QSTEST
Androgen receptor variant 7 (AR-V7) has been II SDTM, SEND-Published

suggested as potential marker for treatment in P48
selection in men with metastatic castration-
resistant prostate cancer (mCRPC). The aim of
the present review is to critically analyze:
frequency of the AR-V7 expression in mCRPC
cases-impact of AR-V7 expression on
abiraterone, enzalutamide, and taxane therapy.
(Sciarra et al.
https://pubmed.ncbi.nlm.nih.gov/31083254/ )
Could you please consider the addition of "total II SDTM, SEND-Published

hemolytic complement" as synonym for this in P47
parameter ?
A unit of substance concentration equal to the II SDTM, SEND-Published

concentration at which one liter of mixture in P46
contains one unit of a substance.
Note: U/L is alredy included in the UNIT codelist

with C-Code=C67456
Hi. I realize this is a multiple term request and I II Do not add (P47):
have not submitted a request spreadsheet (yet). Question answered. The
Before submitting I am hoping to explain what I CP and LB teams are
am seeing and am more than happy to submit a removing these terms
request spreadsheet if this is needed. from the LBTEST-CD
For test codes related to CD# expressing cells codelist with P47 since
(e.g., CD10, CD23) some definitions specify "A they are cell
measurement of CD# cells..." while other phenotyping-related
definitions specify "A count of the CD# expressing tests and should be
cells...". Is there a reason for this inconsistency modeled in the CP
across definitions and could all definitions be domain, which will be
updated to the "measurement of" definition"? The published in Q4 2021.
concern is the "count of" definition restricts the The inconsistency in
value of ORRES to only counts of expressing definitions was not
cells. Further, it is a bit confusing as some of the intentional and any
codes for with "counts" in their definition have terms with definitions
"measurement" specified in the NCI Preferred using 'count' could be
Term (e.g., CD2, CD20) and the other way used for present/absent
around (e.g., CD22 and CD23). or other datatype
Please let me know if a spreadsheet with all results.
terms is required.
"Currently the NCI codelist Category of II Do not add (P50): Do
Questionnaire (C100129) for Pediatric Quality of not change. The CDISC
Life (PedsQL) Neuromuscular Module Acute synonyms are usually
related questionnaires don?t not reflect the the known abbreviation
version or the name or the questionnaire. for the instrument. A
PedsQL has a large pool of questionnaires other sequence number is
than Neuromuscular Module Acute. To allow then added to the short
other PedsQL questionnaires being mapping in a name. This number
reasonable logic, we would like to propose the represents the
following changes. This should allow us to use chronological order for
the similar approaches for other PedsQL under which the terminology of
various versions. the instrument is
created. If an instrument
CDISC Submission Value|CDISC Synonym(s)| has multiple commonly
Proposed Synonym(s) known acronyms and
abbreviations, users
PEDSQL NEUROMUSCULAR MODULE ACUTE may include them as
V3 CHILD|PQL14|PNA3C PEDSQL additional CDISC
NEUROMUSCULAR MODULE ACUTE V3 synonyms. The
CHILD PARENT REPORT|PQL15|PNA3CP proposed SYs are all
PEDSQL NEUROMUSCULAR MODULE ACUTE sponsor-defined; they
V3 TEEN|PQL12|PNA3T PEDSQL are not industry
NEUROMUSCULAR MODULE ACUTE V3 TEEN standard, and hence will
PARENT REPORT|PQL13|PNA3TP PEDSQL not be added as CDISC
NEUROMUSCULAR MODULE ACUTE V3 SY.
TODDLER PARENT REPORT|PQL18|PNA3OP
PEDSQL NEUROMUSCULAR MODULE ACUTE
V3 YOUNG ADULT|PQL10|PNA3A PEDSQL
NEUROMUSCULAR MODULE ACUTE V3
YOUNG ADULT PARENT REPORT|PQL11|
PNA3AP PEDSQL NEUROMUSCULAR
MODULE ACUTE V3 YOUNG CHILD|PQL16|
PNA3Y PEDSQL NEUROMUSCULAR MODULE
ACUTE V3 YOUNG CHILD PARENT REPORT|
PQL17|PNA3YP PEDSQL NEUROMUSCULAR
MODULE V3 CHILD|PQL05|PNM3C PEDSQL
NEUROMUSCULAR MODULE V3 CHILD
Non-completion of protocol defined procedure II Do not add (P49).
(Ex: infusion procedure) due to procedural Based on the context
complications (Ex: Portal Vein Pressure sent within the request,
increase). please use the
published term
'ADVERSE EVENT' and
'procedural complication'
could be the DSTERM
value.
This was recently reported by a lab and it could II SDTM, SEND-Published

not be found in the current LBTEST codelist. The in P48
results are for ALP placental isoenzyme/Total
ALP (%) and the value of LBTERM above was
modeled after the 3 Alk Phos isoenzyme LBTEST
values already in the codelist for bone, liver and
intestinal.
Retire PKPARM-CD terms, 6 terms, use newer II SDTM, SEND-Published

versions of the terms instead in P46
Existing discrepancy between the CT available II Do not add (P50): Do
term and the SDTM mapping of a Nine-Hole Peg not change. There will
Functional Test (NHPT). always be discrepancies
Please check the code to be used with term between CDISC
SCTEST: ""Dominant Hand"": TAUGs, SDTMIGs, QRS
either HANDDOM available in the CT or supplements and
DOMHAND available on the SDTMIG. controlled terminology.
To be consistent between CT and SDTM Users should always
mapping Information. use and refer to the
most recent version of
CT. Additionally, the
QRS supplement team
plans to make an
update to the entire
Nine-Hole Peg
Functional Test (NHPT)
supplement which will
include the change to
SCTESTCD.
FOLD CHANGE term requested for codelist II Do not add (P49): FOLD
METHOD with definition: "A measure describing CHANGE - Do not add.
how much a quantity changes between an This is a result qualifier,
original and a subsequent measurement".? not a METHOD value.
Please use a suppqual.
This Method requested by Vaccine studies for IS Additionally, this should
domain External data. IgG AB measurements on only be put into the
the Blood 1 and Blood 2 performed and then The SDTM dataset if the lab
Interpretation of the fold change between BL2 vendor provides this
and BL1 has been done as a result (positive or information. If this is
negative). derived by the sponsor,
this should be
represented in ADaM.
Please create new term "Lamb's II SDTM, SEND-Published

Quarters/Goosefoot IgE" in LBTEST codelist with in P48
definition "A measurement of the Lamb's
Quarters/Goosefoot IgE antibody in a biological
specimen".
Lamb's Quarters/Grosefoot IgE is testing an

allergic reaction to the weed Lamb's Quarters
(Goose Foot) and its pollen.
Please create pair Beta-Smooth Muscle II

Actin/BSMACT for codelist LBTEST/LBTESTCD
with definition "A measurement of the beta-
smooth muscle actin in a biological specimen."
Term used at sponsor level "Actin, Beta". In order
to follow the CDISC existing term Alpha-Smooth
Muscle Actin/ASMACT (C163422).
New codelist nedded for variable RPORRES with II SDTM-Published in P49
RPTEST = Menopause Status (C106541). To be
consistent with NCI information Create codelist
MPSTATRS: Menopause Status Response with
terms:
-PERIMENOPAUSAL
-POSTMENOPAUSAL
-PREMENOPAUSAL
See also what should do for RPTEST =

""Menarchal Status"" sponsor term. At that time
codelist used at DC level is MENARCHE codelist.
see to submit the RPTEST? and the
corresponding response codelist MCSTATRS
Menarchal Status Response or MENARCHE
Please create new synonym ""Major"" to the II Do not add (P49) - Do

existing CDISC term SEVERE (C70667) of not add as synonyms.
codelist SEVRS Severity Response with These are not always
definition"" Intensely bad or major in degree, synonymous in all
quality or extent"". contexts so cannot be
New term needed to evaluate the Bleeding CDISC synonyms.
episode Severity bassedfrom ITSHfor Instead these should be
classification of bleeding episode severity treated as extensible
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC41 terms. The requester
95109/figure/f1-hcfr-84-supp-033/ may choose to submit a
https://cdn.ymaws.com/www.isth.org/resource/ request to add Major as
resmgr/ssc/isth-ssc_bleeding_assessment.pdf a new value to SEVRS.
https://www.isth.org/
https://bleedingscore.certe.nl/
Please create new synonym "Minor" to the II Do not add (P49) - Do

existing CDISC term MILD (C70666) of codelist not add as synonyms.
SEVRS Severity Response with definition "Slight These are not always
or minor in degree, quality or extent.". synonymous in all
New term needed to evaluate the Bleeding contexts so cannot be
episode Severity bassedfrom ITSH for CDISC synonyms.
classification ofbleedingepisodeseverity Instead these should be
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC41 treated as extensible
95109/figure/f1-hcfr-84-supp-033/ terms. The requester
https://cdn.ymaws.com/www.isth.org/resource/ may choose to submit a
resmgr/ssc/isth-ssc_bleeding_assessment.pdf request to add Major as
https://www.isth.org/ a new value to SEVRS.
https://bleedingscore.certe.nl/
Please create new codelist HPFATS/HPFATSCD: II Do not add (P50): Do
with defintion "Haemophilia Findings About Test not create new codelist.
Name/Haemophilia Findings About Test We will not create TA-
Name/Code". Term "Increased Physical Activity specific FATEST/CD
Impact/PHACIMP" is needed for the SDTM codelists for those TAs
mapping of the Form: CE_BLEED: Bleeding that have not yet been
episode. developed by CDISC.
?Term created following existing CDISC term However we will add
QOL Impact/QOLIMP in PSFATS/PSFATSCD requested terms (if
(Psoriasis Findings About Test) codelist. appropriate) into the
generic
FATEST/TESTCD
codelist instead for use.
Please create new term "Increased Physical II

Activity Impact/PHACIMP" in the new codelist
HPFATS/HPFATSCD: with defintion
"Haemophilia Findings About Test
Name/Haemophilia Findings About Test
Name/Code" for the SDTM mapping of the Form:
CE_BLEED: Bleeding episode.
?Term created following existing CDISC term
QOL Impact/QOLIMP in PSFATS/PSFATSCD
(Psoriasis Findings About Test) codelist?.see
WIKI site regarding Haemophilia: <a
href="https://www.phusewiki.org/docs/2016">http
s://www.phusewiki.org/docs/2016</
a> Denmark SDE Presentations/CDISC
Implementation on Haemophilia trial_Final.pdf.
Please create a new codelist pair II Do not add (P48): Do

DGFATS/DGFATSCD: Dengue Virus Findings not create codelist.
About Test Name/Dengue Virus Findings About None of these
Test Code. requested terms are
To develop a specific CT relative to the Dengue valid values for the
virus findings about test. reasons below.
See available CDISC term (C25676) on Additionally, since
EBFATS/EBFATSCD: Ebola Virus Findings CDISC has not
About Test Name/Ebola Virus Findings About published a Dengue-
Test Code Codelist. Virus specific TAUG, the
CDISC CT teams will
not create Dengue-virus
specific FATEST-CD
codelists.
Please create a new term: Severity/SEV to the II Do not add (P48): Do

new requested codelist DGFATS/DGFATSCD: not add. This should use
Dengue Virus Findings About Test Name/Dengue CESEV variable. A FA
Virus Findings About Test Code. dataset is not
Needed for SDTM Mapping of vaccine studies appropriate here.
forms.
Please create a new term: serotype/SEROTYPE II Do not add (P48): Do
to the new requested codelist not add. This should be
DGFATS/DGFATSCD: Dengue Virus Findings modeled in OI domain.
About Test Name/Dengue Virus Findings About
Test Code.
Needed for SDTM Mapping of vaccine studies
forms.
See to add a Sponsor term HAND-HELD II SDTM-Published in P49

DYNAMOMETER in the METHOD CDISC
codelist.
This term used on a new Global standard form

MK_HHD: Hand Held Dynamometry (HHD) to
evaluate the Isometric Muscle Strength.
Add new term in the CDISC codelist DIR: II Do not add (P47): Do
Directionality term:HIND LOWER. not add. Please use the
Needed for theForm CE_BE: Bleeding Episode?. Multiple convention
To avoid two variables Directionality for reported outlined in SDTMIG.
LOWER/UPPER and FORE/HIND part of the
body
Directionality term:HIND UPPER Needed for not add. Please use the
theForm CE_BE: Bleeding Episode. Multiple convention
body
Directionality: term: FORE UPPER Needed for not add. Please use the
theForm CE_BE: Bleeding Episode. To avoid two Multiple convention
variables Directionality for reported outlined in SDTMIG.
body
Directionality Codelist term: FORE LOWER not add. Please use the
Needed for theForm CE_BE: Bleeding Episode. Multiple convention
body
Please create the term UNINTERPRETABLE in II Do not add (P48): Do

codelist SPECCOND. not add. Team feels that
Preferred Name:Uninterpretable this is better assigned
Definition:Not able to be understood in terms of as a reason not done. It
meaning or significance. could also potentially be
Label:Uninterpretable a test result but in either
case, this is not valid as
a specimen condition.
Please add a new CDISC term in II SDTM, SEND-Published
LBTEST/LBTESTCD codelist:Thymic Stromal in P48
Lymphopoietin/TSLP:A measurement of thymic
stromal lymphopoietin in a biological specimen.
This role is supported by the finding that TSLP
expression is upregulated in keratinocytes of
atopic dermatitis skin lesions and in bronchial
epithelial cells in asthma.

LBTEST/LBTESTCD codelist:Natural Killer in P48
Cells/Lymphocytes/NKCELY:A relative
measurement (ratio or percentage) of the natural
killer cells to all lymphocytes in a biological
specimen.
See https://loinc.org/8112-5/
Please add a new CDISC term in II Do not add (P48): Do

LBTEST/LBTESTCD codelist:Lipoprotein not add. Already
Lipase/LPLIPAS:A measurement of the Published as C174291
lipoprotein lipase in a biological specimen.(code
updated from LIPOLIP to LPLIPAS according to
existing CDISC term)
loinc Ref: https://loinc.org/2572-6/
Genetic deficiency of the enzyme causes familial
hyperlipoproteinemia Type I.

LBTEST/LBTESTCD codelist:Indocyanine in P48
Green/ICG or test code IG according to the Loinc
(see below):A measurement of the indocyanine
greenin a biological specimen.
loinc ref: https://loinc.org/77339-0/
Indocyanine green is a tricarbocyanine dye used
diagnostically in liver function tests and to
determine blood volume and cardiac output. The
indocyanine green clearance (IGC).
LBTEST/LBTESTCD codelist:IDL Apolipoprotein in P48
B/IDLAPOB:A measurement of the intermediate
density lipoprotein apolipoprotein B in a biological
specimen.
Used on Cardiovascular studies :
https://www.merckmanuals.com/-/media/Manual/
LabTests/ApoB.html
An enzyme called lipoprotein lipase (LPL)

removes triglycerides from VLDL to
produceintermediate density lipoproteins (IDL)
first and thenLDL. Each VLDL particle contains
one molecule of apo B-100, which is retained as
VLDL loses triglycerides and shrinks to become
the more cholesterol-rich LDL. Apo B-100 is
recognized by receptors found on the surface of
many of the body's cells. These receptors
promote the uptake of cholesterol into the cells.

LBTEST/LBTESTCD codelist:codelist in P48
IgA/Complement C3 Ratio/IGAC3 (Arelative
measurement (ratio or percentage) of the IgA to
complement C3 in a biological specimen.)
The serum immunoglobulin A (IgA)/C3 ratio is
considered to be an effective predictor of IgA
nephropathy (IgAN).
Please add the LBTEST/LBTESTCD: Ganglioside II SDTM, SEND-Published

GM3/GM3 used with synonym in P48
Monosialodihexosylganglioside.
Definition: A measurement of ganglioside GM3 in
Please consider Loinc information:
https://loinc.org/LP99621-2/
Needed for pediatric studies having patients with

Gaucher disease type 1 and type 3 Exploratory
assessments will include:
Efficacy biomarkers GM3 ganglioside [GM3],
macrophage inflammatory protein 1- (MIP1-),
plasma D dimers, lyso-GL1. Additionally for
Cohort 2, P1NP (bone formation) and CTX (C-
telopeptide, bone resorption).

LBTEST/LBTESTCD codelist: VLDL Cholesterol in P48
Apo B/VLDLAPOB. A measurement of the very
low density lipoprotein cholesterol apolipoprotein
B in a biological specimen.
Considering LBTEST/LBTESTCD VLDL II Do not add (P49):
Cholesterol Apo B/VLDLAPOB (Measurement of DIRECT REMOVAL -
the very low density lipoprotein cholesterol Do not add. Based on
apolipoprotein B in a biological specimen) this paper provided by
submitted in an other request we would need a the requester
new term ?DIRECT REMOVAL? to be added to https://www.sciencedire
METHOD codelist. ct.com/science/article/pii
/S0085253815342988,
Definition the aspect of 'direct
suggested: "Direct uptake of VLDL by an apoB removal' is describing
receptor mediated pathway". the physiological
process the VLDL-apoB
undergoes in vitro to
convert it to LDL and
IDL. The lab team does
not agree that this is a
METHOD since the
METHOD variable
captures how the
analyte is
counted/measured. As
per the paper, the
method of assessment
is described in this
paper here:
https://pubmed.ncbi.nlm.
nih.gov/3821506/. If it is
important to specify the
concept of 'direct
removal' within the
dataset, it could be
associated with another
variable or NSV within
the dataset. We do not
recommend pre-
coordination into the
TEST value itself.
LBTEST/LBTESTCD codelist: Amyloid Beta 1- in P48
41/AMYLB41: A measurement of amyloid beta
protein which is composed of peptides 1 to 41 in

LBTEST/LBTESTCD codelist: Arachidonate 5- in P48
Lipoxygenase/ALOX5: A measurement of
arachidonate 5-lipoxygenase in a biological
specimen.

LBTEST/LBTESTCD codelist: in P48
Glucosylceramidase/GCASE. A measurement of
glucosylceramidase in a biological specimen.
LBTEST/LBTESTCD codelist: Complement in P48
C3c/C3C: A measurement of the complement
C3c in a biological specimen.
Please add term 'GRAVITY DRIP' to CLMETH, II SDTM, SEND-Published
used in our trials for CSF collection; here is a in P48
helpful link:
52410/.
Most of the values for SDTM-LBTESTCD and II Do not add (P47): The
SDTM-MBTESTCD are same as Code value. For CDISC Lab and
example, For CDISC synonym - 'Bermuda Grass Microbiology teams
Pollen IgA', LBTEST is 'Bermuda Grass Pollen have established and
IgA' and LBTESTCD is 'C130069' published rules that
Can you please update this? state that certain types
of LBTESTCD and
MBTESTCD values are
NCI C-codes. It is
intended that the NCI C-
codes should be used
as the TESTCD values
and submitted in the
dataset. If you are
creating a custom
TESTCD for a TEST
already exists in
published CT, then you
are not in fact using the
correct TESTCD
submission value as
prescribed by CDISC
CT.
Additional terms requested for the Microbiology II SDTM-Published in P47

Test Code/Name codelists

Glucosylceramide/GL1: A measurement of
the glucosylceramide in a biological specimen.

Glucopsychosine/LYSOGL1: A measurement of
the glucopsychosine in a biological specimen.
Loinc ref: LP310332-4 Glucopsychosine with the
Sponsor Sanofi term as a synonym:
Glucosylsphingosine.
LBTEST/LBTESTCD codelist: Glyceraldehyde-3- in P48
Phosphate Dehydrogenase/GAPDH: A
measurement of Glyceraldehyde-3-Phosphate
Dehydrogenase in a biological specimen.
Loinc ref: LP15029-9 Glyceraldehyde 3
phosphate dehydrogenase.
Add all EGTEST values into codetable mapping II

file. This is in keeping with new rule that all TEST
values should be listed in the codetable mapping
files, regardless of whether they are associated
with controlled response values.
The EGTESTCD of INTP is missing from column

B of the EG codetable mapping file dated 2020-
03-27. It should be associated with the
NORMABNM codelist of valid response values.
As discussed with Erin. The list has been II SDTM, SEND-Published

developed to extend LOINC-CDISC mappings for in P47, P48
toxicology / drug abuse. Compounds were added Do not add (P48): 3,4-
when all three of the following requirements were Methylenedioxyampheta
met: mine - Do not add.
1. The compound is in the list of DEA Drugs of Already published as
Abuse C174294
(https://www.dea.gov/sites/default/files/drug_of_a Do not add (P48): 3,4-
buse.pdf) Methylenedioxymetham
2. There is at least one lab test available for that phetamine - Do not
compound described by a LOINC Code 3. No add. Already published
value (based on a search in the CDISC Library - as C75359
latest CT version 2020-06) for Do not add (P48):
LBTESTCD/LBTEST is already available. Formebolone - Do not
In order to be able to extend my LOINC-CDISC add. The LOINC term
mapping for SDTM-LB for toxicology, I generated does not provide
a list of drug compounds (marked by DEA as sufficient information as
"drugs of abuse") for which there are lab tests to what metabolite is
available. being assayed.
I would like to request pairs of Therefore this term
LBTESTCD/LBTEST for these. should be considered an
The list is attached as an Excel "New term extensible term.
request" file. Do not add (P48):
Mestanolone - Do not
Compounds were added to the list ONLY when add. The LOINC term
all three of the following requirements were met: does not provide
1. The compound is in the list of DEA Drugs of sufficient information as
Abuse to what metabolite is
(https://www.dea.gov/sites/default/files/drug_of_a being assayed.
buse.pdf) Therefore this term
2. There is at least one lab test available for that should be considered an
compound described by a LOINC Code extensible term.
3. No value (based on a search in the CDISC Do not add (P48):
Library - latest CT version 2020-06) for Halazepam - Do not
LBTESTCD/LBTEST is already available. add. Already published
as C139078.
A measurement of the Eosinophil-Derived II SDTM, SEND-Published
Neurotoxin (EDN) in a biological sample in P48
IMMUNOCAPTURE (IC) II Do not add (P49):
IMMUNOCAPTURE -
Do not add. Based on
review of Sciex6500
instrument
documentation, the
resulting method is
'LC/MS/MS', which is a
published term.
Immunocapture in this
context is an assay prep
step and if this is an
important piece of
information to capture,
then one could either
use a suppqual (if using
a multi-stage
instrument) or consider
use of BE domain if
multiple, standalone
steps are used to prep
the specimen.
A measurement of the interferon alpha type 2 in a II SDTM, SEND-Published

IFNA2 was specified in a commercial assay; it is

highly likely what is being measured is
synonymous with current CT (e.g.,
29289/). However, the assay specified interferon
alpha type 2 specifically, thus this request.
File emailed separately. This request is submitted II Do not add (P48):

on behalf of Theradex for caDSR curation. CD4+CD7- - Do not
add. CPTEST value
should contain the
specific cell type of
interest with marker
strings and cell states
(E.g., ACTIVATED)
added into the
New ISTEST/CD terms, 36 new terms. File II appropriate
SDTM-Publishedvariables as
in P47
emailed separately. per SDTMIGv3.4 CP
domain model.
Do not add (P48):
CD4+CD26- - Do not
add. CPTEST value
should contain the
specific cell type of
interest with marker
strings and cell states
(E.g., ACTIVATED)
added into the
appropriate variables as
per SDTMIGv3.4 CP
domain model.
Do not add (P48):
CD426R - Do not add.
CPTEST value should
contain the specific cell
type of interest with
Add new term of CAPSULE, SOFGEL to the FRM II SDTM, SEND-Published
codelist with the definition: A capsule, covered in P48
with a soft gelatin shell and containing a liquid,
suspension, or semisolid, that is designed to
release active and/or inert ingredient(s) upon
ingestion.
Please note that the term CAPSULE, SOFGEL,

EXTENDED RELEASE is already present in the
codelist.We need as version that is not extended
release.

in P49, P50
Please create new codelist AMBS01TN/C. II Do not add (P49). ALL

Definition: Ambulation Score functional test test FT Codelists - FDA
name./ Ambulation Score functional test test regulators CDISC had
code. spoken to do not prefer
the use of the xxALL
2 terms needed for this codelist for alemtuzumab convention because
Study as follow: there should be a record
for all items on a
AMBS0101 / AMBS01-Ambulation Score for instrument, this includes
"Ambulation Score Functional Test - Ambulation missed visits and items
Score." not done. CDISC is
FTALL / Functional Tests All for "Generic test waiting for the official
derived in SDTM when all functional tests are not publication of agency
done." rules to be included in
the newest version of
the TCG. In the
SDTMIG v3.4, the
Please add to codelist METHOD term "SWI- II SDTM-Published
following statement in has
P49
PHASE IMAGE" with def: "Phase map derived also been added:
from multi-echo gradient echo MRI". This Regulatory agencies
METHOD has been requested for External data may require a record for
GENETIC Domain. all items on a CRF in
QRS datasets (e.g., FT,
More information regarding this method is QS, and clinical
available on NCI site as Susceptibility Weighted classifications in RS).
Imaging (Code C121377).
Please add term "ARCHIVAL" in a CDISC II Do not add (P48): Do
codelist SPECCOND. Definition suggested: not add. The requested
"Collected and stored sample." term is a qualifier of a
material source, rather
Cf NCI term: Archival Tissue def: Tissue stored in than a specimen
a biospecimen repository for future study use. condition. Current
thinking is that this
should be an NSV, CAT,
or SCAT value instead.
The team will consider
this for example and
terminology
development in a future
version of the IG but will
not develop it as a
specimen condition.
Please add new CDISC term INSUFFICIENT II Do not add (P48): Do

QUANTITY in SPECCOND (Specimen Condition) not add. This is not a
codelist with definition as "Specimen in specimen condition; one
insufficient quantity for analyze". doesn't know whether
the quantity is
insufficient until one
knows what test it is
being used for. Team
agrees that this concept
is better modeled as a
value for REASND.
Please find attached the multiple term request II QRS, SDTM-Published

form for terms suggested by the Sanofi CIG in P50
Team for CDISC terminology. Do not add (P50):
CDISC is unable to
obtain copyright
permission for this
instrument at this time,
consequently, the
CDISC QRS CT team
develop TEST and
TESTCD terminology
questionnaire.
Please create new codelist RBDSQ1TN/C for II QRS, SDTM-Published
questionnaire RBDSQ with definition : " in P50
"Terminology for REM Sleep Behavior Disorder Do not add (P50):
Screening Questionnaire test name./Terminology CDISC is unable to
for REM Sleep Behavior Disorder Screening obtain copyright
Questionnaire test code." permission for this
reference: consequently, the
https://www.ncbi.nlm.nih.gov/pmc/articles/ CDISC QRS CT team
PMC6033034/ had only created a CAT
https://pubmed.ncbi.nlm.nih.gov/17894337/ value for this instrument
File emailed separately for terms suggested for of this, CDISC will NOT
this questionnaire. develop TEST and
TESTCD terminology
questionnaire.
Please create new codelist FES01TN / FES01TC II

for questionnaire FES (Falls Efficacy Scale) with
definition "Determines the question name for Falls
Efficacy Scale questionnaire."
This questionnaire has some reference. Tinetti,

M., D. Richman, et al. (1990). "Falls efficacy as a
measure of fear of falling." Journal of gerontology
45(6): P239.
File emailed separately for terms suggested for

this questionnaire.
Please find attached the multiple term request II

form for terms suggested by the Sanofi CIG
Team for CDISC terminology.
Requested new codelist: FES01TN/C for
Questionnaire FES â€œFalls Efficacy Scaleâ€.
Terms currently exist for GRO-alpha (CXCL1) II SDTM, SEND-Published
and GRO-gamma (CXCL3); no term currently in P49
exists for GRO-beta (CXCL2). However we're
receiving results from a multiplexed bead-based
immunoassay whose beads are "pan-GRO, i.e.
they bind all three isoforms (GRO-alpha, -beta
and -gamma)" for which no term exists. Draft
definition: "A measurement of the GRO-alpha,
GRO-beta, and/or GRO-gamma in a biological
specimen."
An alternate LBTESTCD could be GROABG. A

second alternative could follow the CXCL motif of
naming, e.g., CXCL123, but I'm not sure if this
structure would be confusing. I leave it to the Lab
CT group to determine the most appropriate
code/name.
Nephrin is a biomarker that may used to assess II SDTM, SEND-Published

kidney injury (e.g., in P48
https://biomarkerres.biomedcentral.com/articles/1
0.1186/2050-7771-2-21) which may be collected
as part of a sickle cell disease study, the term
does not currently exist in CT. Draft definition: "A
measurement of nephrin in a biological
specimen."
https://www.cancerresearchuk.org/about-cancer/ II
liver-cancer/stages/bclc-staging-system-child-
pugh-system
Please create codelist HRPQTN / HRPQTC II
Health Related Productivity Questionnaire.
This questionnaire is used for one of our
Parkinson Disease Study developpement .
File emailed separately for terms requested for

this codeist and related questionnaire.

Requested new codelist: HRPQ - Health Related
Productivity Questionnaire
Please create codelist BFI9TN / BFI9TC for Brief II QRS, SDTM-Published
Fatigue Inventory questionnaire. in P50
Do not add (P50):
Reference : Copyright 1997 - The University of CDISC is unable to
Texas M. D. Anderson Cancer Center. obtain copyright
permission for this
consequently, the
CDISC QRS CT team
develop TEST and
TESTCD terminology
questionnaire.
Please create new CDISc codelist BDI02TN / II QRS, SDTM-Published

BDI02TC with definition "Beck Depression in P50
Inventory, Second Edition (BDI-II) Test Name. / Do not add (P50):
Beck Depression Inventory, Second Edition (BDI- CDISC is unable to
II) Test Code." obtain copyright
permission for this
Submission of questionnaire Beck Depression instrument at this time,
Inventory, Second edition - Copyright 1996 consequently, the
Aaron T. Beck to the CDISC QRS team. CDISC QRS CT team
File emailed separately for terms attached to this value for this instrument
codelist. Initial questionnaire is also attached to in Package 50. Because
separate email. of this, CDISC will NOT
develop TEST and
TESTCD terminology
questionnaire.
Requested new codelist: BDI02TN / BDI02TC for CDISC is unable to
â€œBeck Depression Inventory, Second Edition obtain copyright
(BDI-II)â€ Questionnaire. permission for this
consequently, the
CDISC QRS CT team
develop TEST and
TESTCD terminology
questionnaire.
Requesting additional allergen-specific IGE test II

names/codes.
Please generate OTHER term in FREQ codelist. II Do not add (P49).
If frequency data is selected as OTHER and Please refer to all other
specified information is also collected, we want to denied request
assign OTHER to CMDOSFRQ and store the instances wherein the
specified information in supp domain. teams have denied the
request to add 'Other'
into various codelists.
Please generate OTHER term in UNIT codelist. If II Do not add (P47): Do

unit data is selected as OTHER and specified not add. Any specific
information is also collected, we want to assign values associated with
OTHER to CMDOSU and store the specified an “Other, Specify”
information in supp domain. response in collected
data should be either
mapped to published
submission values or
added to the dataset as
an extensible term. If the
requester continues to
use suppqual for this
information, the concept
of OTHER can be used
as an extensible term
but CDISC CT teams
generally do not support
the inclusion of OTHER
into published codelists.
Please generate OTHER term in ROUTE codelist. II
If route data is selected as OTHER and specified
information is also collected, we want to assign
OTHER to CMROUTE and store the specified
information in supp domain.
For the case that fertility status is collected when II SDTM-Published in P49
informed consent form is signed, please generate
SCTESTCD- FRTSTAT, SCTEST- Fertility Status
terminology.
Please generate VIROLOGY term too for II Do not add (P49). The
reflecting variant study protocol. trial type codelist is
defined as related to 'the
type of primary outcome
or endpoint that the
protocol is designed to
evaluate.' The concept
of Virology does not fit; it
is too generic to be
useful.
Please generate IN-HOUSE, OUT-PATIENT II Do not add (P49). This

terms. is not an Epoch as per
the definition of the
EPOCH variable.
Please create codelist PDQ391N/PDQ391C for II QRS, SDTM-Published
questionnaire "Parkinson's Disease Quality of Life in P50
Questionnaire" (PDQ-39) . Do not add (P50):
Definition "Parkinson's Disease Quality of Life CDISC is unable to
Questionnaire Test Name". / "Parkinson's obtain copyright
Disease Quality of Life Questionnaire Test Code". permission for this
Copyright reference PDQ-39 Oxford University consequently, the
Innovation Limited 1993. All Rights Reserved. CDISC QRS CT team
The authors, being Professor Crispin Jenkinson, had only created a CAT
Professor Ray Fitzpatrick and Ms Viv Peto, have value for this instrument
asserted their moral rights. in Package 50. Because
File emailed separately for terms requested to be develop TEST and
attached to this codelist questionnaire. TESTCD terminology
questionnaire.
Requested new codelist: PDQ391N/PDQ391C CDISC is unable to
â€œParkinson's Disease Quality of Life obtain copyright
Questionnaire". permission for this
consequently, the
CDISC QRS CT team
develop TEST and
TESTCD terminology
questionnaire.
Please create ew codelist PDCRS1TN/PCRS1TC II

for questionnaire "Parkinson's Disease Cognitive
Rating Scale".
Definition: "Terminology for Parkinson's Disease
Cognitive Rating Scale Test Name" /
"Terminology for Parkinson's Disease Cognitive
Rating Scale Test Code".
File emailed separately for terms requested for

this codelist questionnaire.
A publication from the "Journal of Neurology
Sciences" describing the Parkinson's Disease
Cognitive Rating Scale is also attached into this
separate email.

Requested new codelist:
PDCRS1TN/PDCRS1TC for Questionnaire
â€œParkinson's Disease Cognitive Rating Scale".
Please find our spreadsheet to support this II SDTM-Published in P47

request attached.
Pl;ease add the new term of HEART VALVE II SDTM-Published in P49
PROCEDURE to the PROCEDUR codelist with
the definition: Surgery or intervention performed
with the purpose of correcting a degenerated,
calcified, malformed, dysfunctional, etc. heart
valve or replacing it with a bioprosthetic,
homograft or autograft valve.
The current definition for HEART, SEPTUM is II SDTM, SEND-Published
"The tissue in the heart that separates the two in P50
atria (atrial septum) and the two ventricles Do not add (P50): Do
(ventricular septum). (NCI)" which implies two not add. Use existing
sub-locations - atrial septum and ventricular term
septum. However, it does not currently exist and C32874/INTERVENTRI
is being included forms for sickle cell disease CULAR SEPTUM. We
studies. have added 'Ventricular
Definition: "The tissue in the heart that separates Septum' as a SY to this
the two ventricles (ventricular septum)." term in P49 to help with
mapping. We will also
add Heart, Ventricular
Septum as a synonym
with P50.
The current definition for HEART, SEPTUM is II Do not add (P50): Do

"The tissue in the heart that separates the two not add. Use existing
atria (atrial septum) and the two ventricles term
(ventricular septum). (NCI)" which implies two C32818/INTERATRIAL
sub-locations - atrial septum and ventricular SEPTUM. We have
septum. However, it does not currently exist and added 'Atrial Septum' as
is being included forms for sickle cell disease a SY to this term in P49
studies. to help with mapping.
Definition: "The tissue in the heart that separates We will also add Heart,
the two atria (atrial septum)." Atrial Septum as a
synonym with P50.
Convert the exisitng QNAM = FTASSTDV to a II

new FTTESTCD = SIXMW107 based on the
previosu decision made with the Timed 25-Foot
Walk Test that was published a few years ago
Jordan,
Attached is the CT change control spreadsheet
for this request. Please let me know if you have
any questions?
Steve
Definition: Pertaining to a line extending between II SDTM, SEND-Published

the cranial (towards the head) and caudal in P49
(towards the tail) portions of a body.
In consultation with a SME for a splenic imaging

question re "spleen size (mm)," our SME stated
that the measurement most likely pertains to the:
" "height? (more properly, craniocaudal length)."
The intent would be to have a --TESTCD of
LENGTH, --LOC of SPLEEN, and ---DIR of
CRANIOCAUDAL in a Lymphatic System based
findings domain.
Definition: Situated at or extending toward the II SDTM, SEND-Published
septum of a body structure. in P49
An echocardiography study is capturing both

"Septal e' velocity" and "Lateral e' velocity" of the
mitral valve in the heart. The intended modeling is
CVTEST = "Annular e' Velocity" CVLOC =
MITRAL VALVE, CVDIR = SEPTAL or CVDIR =
LATERAL as appropriate. It is not clear whether
modeling this way versus using CVLOC =
MITRAL VALVE, ANTERIOR ANNULUS or
CVLOC = MITRAL VALVE, POSTERIOR
ANNULUS without directionality is more
appropriate (the POSTERIOR portion being in the
lateral direction, the ANTERIOR portion being in
the septal direction of the hear)..
CDISC decided to create their own HAMD 17 II QRS-Published in P46

CRF. The new CRF has a number iof spelling
differences compared to the current puvblish CT
that nees to be updated. The QRS CT chnag
control spreadsheet will be sent separately.
Jordan,
CDISC decided to create their own HAMD 17
CRF. The new CRF has a number of spelling
differences compared to the current published
CT. Attached is the updated annotated CRF and
CT change control spreadsheet for the QRS CT
team review. Please let me know if you have any
questions.
Steve
Jordan,
Attached is an updated HAMD 17 CT change
control spreadsheet with the CCCAT definition
updated to include the 5 references used on the
CDISC developed CRF by Dana. Please let me
know if you have any questions.
Steve Do not add (P49). The
Action Taken with Study
Treatment variable was
intended to be for
describing an overall
change to the planned
If drug is administrated through infusion, we need II dosing schedule in
a new term to describe following scenario. A response to an adverse
patient's status is not good enough at some visit, event. A drug that is
doctors delay drug administration start. Several delayed but ultimately
hours later, the patient gets better. Then doctors given would not warrant
start drug infusion. DRUG INTERRUPTED is not an ACN record. Rather
precise enough for that. the delay in dosing
should be documented
in the EC dataset.
Changes were made to comply with reference II QRS-Published in P46
change and FDA review.
Hi Brenda,
Here is the proposed change term
request. This is what I will be presenting to the
QRS terminology team.
Thanks,
Diane
more frequent use; add note that RCT is also II Glossary-Published in

used for randomized clinical trial, but not P48
frequently.
Request to add a new term to II
TRTESTCD/TRTEST as ABSCHGSM Absolute
Change from Smallest Sum with the definition of:
Absolute scores are obtained by adding the
scores of the nine regions. Ref: Ady N, Zucker
JM, Asselain B, Edeline V, Bonnin F, Michon J,
Gongora R, Manil L. A new 123I-MIBG whole
body scan scoring method--application to the
prediction of the response of metastases to
induction chemotherapy in stage IV
neuroblastoma. Eur J Cancer. 1995;31A(2):256-
61.
Please add the new term for II

TRTESTCD/TRTEST of ACHBL Absolute
Change from Baseline with the definition: The
current value minus the recorded at baseline.
TRTESTCD/TRTEST of CURISCOR Curie Score
with the definition: Curie score for Bone Marrow.

TRTESTCD/TRTEST of INFILLYM Infiltration Due
to Lymphoma with the definition: Bone Marrow
Infiltration due to Lymphoma identified by biopsy
or PET
TRTESTCD/TRTEST of PSCC 5 Points-Scale
Score with the definition: Five-point Scale for
Positron Emission Tomography Assessment in
Lymphoma
TRTESTCD/TRTEST of RELSCOR Relative
Scoree with the definition: Relative scores are
calculated by dividing the absolute score at each
time by the corresponding pretreatment score.
Ady N, Zucker JM, Asselain B, Edeline V, Bonnin
F, Michon J, Gongora R, Manil L. A new 123I-
MIBG whole body scan scoring method--
IV neuroblastoma. Eur J Cancer.
1995;31A(2):256-61.
virulence - the ability of an infectious agent to II Glossary-Published in

cause severe disease, measured as the P48
proportion of persons with the disease who
become severely ill or die.
https://www.cdc.gov/csels/dsepd/ss1978/
glossary.html
zoonosis - characteristic of an infectious disease
that is transmissible from animals to humans.
add abbreviations: PHE - public health
emergency; FAERS - federal adverse event
system; RCT randomized controlled trial (most
frequent use)

BARS (CAT, TESTCD/TESTs) from the QS to RS
following:
value of ?BARS? to the clinical classifications
CCCAT codelist
o Renaming the questionnaires TESTCD
codelist of ?Barnes Akathisia Rating Scale
classifications TESTCD codelist ? Barnes
Akathisia Rating Scale Clinical Classification Test
Code ?
of ?Barnes Akathisia Rating Scale Questionnaire
Test Name? to the clinical classifications codelist
of ?Barnes Akathisia Rating Scale Clinical
Definition: A diagnostic or treatment procedure II
performed by manual and/or instrumental means,
often involving an incision and the removal or
replacement of a diseased organ or tissue; of or
relating to or involving or used in surgery or
requiring or amenable to treatment by surgery.
(NCI)
Definition: An indication of the first time a device II

was employed.
Team to check definitions to determine whether II SDTM, SEND-Published

they should be written to include cells so the in P47
terms are not restricted to viruses and bacteria. Do not add (P47): -
Refer to wording recently done for definitions of log10 PFU: No change
Colony Forming Units (CFU). necessary. The
published definition
does not restrict the
term’s usage to viruses
and bacteria.
Do not add (P47): -
log10 PFU/mL: No
change necessary. The
and bacteria.
Do not add (P47): -
PFU/animal: No change
necessary. The
and bacteria.
The provided CGI QRS Responses CT II

spreadsheet needs to be reviewed with the QRS
CT team.
Jordan,
CDISC is implementing QRS instruments in the
CDISC Library. To do this, QRS instrument
responses CT is needed. The provided CGI, PGI,
and ECOG QRS Responses CT spreadsheet
needs to be reviewed with the QRS CT team.
Please let me know if you have any questions.
Steve
The provided PGI QRS Responses CT II
CT team.
Jordan,
Steve
The provided ECOG QRS Responses CT II QRS-Published in P46

CT team.
Jordan,
Steve
- II Do not add (P47): Do

not add. Published with
P45 2021-03-26.
It is understood that because "Disease II Do not add (P50): Do
Recurrence" is listed as a synonym for "Disease not add. Please use
Relapse", that the addition of this new term would existing term DISEASE
need cross-team discussion, The original RELAPSE for
requester, Shanda Finnegan of NIH says that DSDECOD value.
Recurrence usually refers to a cancer coming Proposed term can go
back after it was undetectable for a period of into DSTERM. EVS
time. Relapse occurs after a period of editors agree
improvement, but the cancer may or may not unequivocally that these
have been undetectable prior to relapse. are synonymous. The
Obviously, if implemented, the NIH Preferred description of the
Term for DISEASE RELAPSE would need to be difference by the
modified as well. requester is not shared
by all in the oncology
ManyThanks for considering this new term. community.
File emailed separately for 8 terms requested. II Do not add (P49):
INFORMED CONSENT
Please find attached the multiple term request OBTAINED FOR
form for terms suggested by the Sanofi CIG PHARMACOGENETIC
Team for CDISC terminology for codelist BANKING FROM
PROTMLST. LEGAL
Thank you. REPRESENTATIVE -
the existing published
term 'INFORMED
CONSENT OBTAINED'
and put the specifics, as
requested, in the
DSTERM value.
Do not add (P49):
INFORMED CONSENT
OBTAINED FOR DRUG
METABOLISM
ENZYME - Do not add.
published term
'INFORMED CONSENT
OBTAINED' and put the
specifics, as requested,
in the DSTERM value.
Do not add (P49):
INFORMED CONSENT
OBTAINED FOR
PHARMACOGENETIC
ANALYSIS - Do not add.
published term
'INFORMED CONSENT
OBTAINED' and put the
specifics, as requested,
in the DSTERM value.
Do not add (P49):
Please create new term CLINICAL II Do not add (P47): Do
ASSESSMENT in codelist ONCRSCAT with not add. In oncology
definition "Category use to retrieve information studies, the RSCAT
regarding clinical assessment.". variable holds tumor
response criterion
names, which is
supported by the
ONCRSCAT codelist.
For RSCAT, please use
existing term
PROTOCOL DEFINED
RESPONSE
CRITERIA/C126042.
And the request value
could potentially go into
the RSSCAT field, which
is not controlled with
CDISC CT.
Please create term CHILD-PUGH SCORE in II Do not add (P47): Do
codelist ONCRSCAT with definition "Category not add. This is
use to retrieve information regarding Child-Pugh published as a Clinical
Classification score.". Classification CAT value
(C121007) in the
CCCAT codelist, which
is used with the RSCAT
variable for non-
oncological contexts. It
doesn't belong in
ONCRSCAT codelist as
that codelist is reserved
for oncology-only
specific disease
response criterion.
Please create new term DISEASE STATUS in II Do not add (P47): Do

codelist ONCRSCAT with definition "Category for not add. In oncology
disease status.". studies, the RSCAT
variable holds tumor
response criterion
names, which is
supported by the
ONCRSCAT codelist.
For RSCAT, please use
existing term
PROTOCOL DEFINED
RESPONSE
CRITERIA/C126042.
And the request value
could potentially go into
the RSSCAT field, which
is not controlled with
CDISC CT.
This seems to be a standard used, as the number II SDTM, SEND-Published

of TU, with the standard dose volume of .1mL. in P48
The labeling of Mantoux uses this volume.
Research conducted testing various number of
TU per volume seem to use #TU/.mL as a
standard concentration. See
https://link.springer.com/article/10.1186/1757-
1626-1-115.
Working on the CDISC project for T1d-Dexi / II Do not add (P50): Do
JAEB and found that dietary folate id collected as not add. Please use
the number of ug of "Folate food" in test "Folate existing UNIT term
(food) (ug)", as well as the number of ug of DFE C48152/ug. The Test
(Dietary Folate Equivalents) in test "Folate (ug of value is being published
dietary folate equivalents (DFEs))". The test data as DFE/Dietary Folate
uses the unit of ug_DF for the second test, but Equivalents.
another appropriate unit representation that
reflects the concept should be fine. I suspect both
tests would be for "Dietary Folate"
Folate (Î¼g of dietary folate equivalents

(DFEs))â€ which would be â€œFolate (ug of
dietaryâ€¦â€ if I substitute the mu symbol with
the u as used in the CDISC CT for micrograms or
ug: â€œFolate (ug of dietary folate equivalents
(DFEs))â€. Similarly the first test of â€œFolate
(food) (Î¼g)â€ would be â€œFolate (food)
(ug)â€ using CDISC CT for micrograms.
Please add CDISC Synonym = pgEq/mL for II SDTM, SEND-Published

UNIT=ngEq/L in P47
Please add CDISC Synonym = ngEq/L for II

PKUNIT=pgEq/mL
No synonyms. II SDTM-Published in P49

Definition: An automated method to quantitate
biotherapeutics and/or endogenous proteins for
small volume samples in biological matrix.
Please find additional information here:
https://www.gyrosproteintechnologies.com/gyrola
b-technology
Thank you!!
DRGR Diabetic Retinopathy Grade II SDTM-Published in P50

DMEGR Diabetic Macular Edema Grade
File emailed separately II Do not add (P49):
Human Papillomavirus
SARS-CoV-2 Plaque Forming Units Assay 16 Genotype -
Human Papillomavirus 16 Genotype 'Genotype' should be
Kidney Injury Molecule-1/Creatinine modeled in GFTSTDTL,
Hemophilia A F8 Intron 1/22 Inversion 'Human Papillomavirus
Androgen Receptor Variant 7 ( ARV7) biomarker 16' should be modeled
in circulating tumor cells (CTCs) in GFSYM variable, and
the TEST value should
reflect the overall
assessment for which
the overall reportable of
Genotype was derived.
Do not add (P49):
Hemophilia A F8 Intron
1/22 Inversion - Do not
add. This would be
better modeled in the
new GF domain
(SDTMIGv3.4). The
requested value would
go into the GFGENLOC
variable (if the expected
result value is related to
the inversion). Please
review the published
GFTEST codelist for the
appropriate GFTEST
value to use. If the
existing, published list is
inadequate, please
submit a new term
request for an
appropriate GFTEST
value.
Do not add (P49):
Kidney Injury Molecule-
Definition: A period in a clinical study that occurs II Do not add (P49). The
before the commencement of the primary clinical randomization activity is
study investigation, during which subjects may be generally considered
assessed for suitability in the clinical study or part of the Screening
evaluated for any other protocol-specified reason, Epoch. Therefore, use
and during which subjects are allocated the published term
therapeutic treatment. SCREENING instead.
The fact that the subject
was randomized can be
Reason needed: This new term is needed in represented in the DS
order to fully comply with ICH E3 10.1 When domain as a protocol
accounting for the progression of subjects in a milestone.
study, it is necessary to describe how many
patients were excluded during each epoch. A
participant may be excluded during each of these
epochs: SCREENING, RUN-IN,
RANDOMISATION, TREATMENT. The
RANDOMISATION epoch is different from both
the RUN-IN epoch and the TREATMENT epoch:
the criteria for exclusion may differ from those
during the RUN-IN epoch, and may involve
additional measurements, or repeats of
measurements done at screening. The participant
doesn't receive treatment until the
RANDOMISATION epoch ends. For an example,
see figure S1 here:
https://www.nejm.org/doi/suppl/10.1056/NEJMoa
1706444/suppl_file/nejmoa1706444_appendix_1.
pdf
The RACE codelist is currently impossible to use II
correctly - 1. It is not defined as extensible. 2 It
doesn't cover all possibilities. Adding 'OTHER'
would fix this contradiction. N.B. The suggestion
of using 'UNKNOWN' in place of 'OTHER' is not
correct, UNKNOWN is defined as 'Not known, not
observed, not recorded, or refused. (NCI)'
whereas 'OTHER' means that the race is known
or recorded, but doesn't belong in any of the
other groupings in the RACE codelist.
These are new terms requested for the

Crohnâ€™s TAUG.
The term "Glycocholic Acid" is reported both as II SDTM, SEND-Published

synonym value for LBTESTCD = GLYHLACD and in P47
LBTESTCD = GCHT
Please create new term h*uIU/mL in codelist II SDTM, SEND-Published
PKUNIT with definition "Hours times micro in P47
international unit per milliliter (area under the
curve)." with synonym uIU*h/mL.
Please create new term AT LEAST DAILY in II Do not add (P49). These
codelist FREQ with definition "At least daily.". can continue to be used
as extensible terms. But
the values because the
terms themselves are
too vague to be defined
well.
Please create term AT LEAST MONTHLY in II Do not add (P49). These

codelist FREQ with definition "At least Monthly.". can continue to be used
well.
Please create new term AT LEAST WEEKLY in II Do not add (P49). These
codelist FREQ with definition "At least weekly.". can continue to be used
well.
New term needed to be added to the Following II Do not add (P47): Do
questionnaires (non extensible codelists): not add. Per FDA's
recommendation, there
CPS01TN/C is a record for every
LPPSS1TN/C item in a instrument,
TANN01TN/C including missed visits.
TANN02TN/C
Please find attached the multiple term request

form for a term suggested by the Sanofi CIG
Team for CDISC terminology of non-extensible
Questionnaires.
Term is â€œClinical Classification Allâ€ /
CCALL.
New term needed to be added to the following II Do not add (P47): Do

Questionnaires (with non extensible codelists): not add. Per FDA's
NHPT01TN/C is a record for every
SIXMW1TN/C item in a instrument,
T25FW1TN/C including missed visits.
TMT01TN/C

Questionnaires.
Term is â€œFunctional Tests Allâ€ / FTALL.
New term needed to be added to the following II Do not add (P47): Do
Questionnaires (non extensible codelists): not add. Per FDA's
CSS02TN/C is a record for every
CSS04TN/C item in a instrument,
DLQI1TN/C including missed visits.
ECOG1TN/C
EDSS01TN/C
EQ5D01TN/C
EQ5D02TN/C
HAQ01TN/C
KFSS1TN/C
KPSSTN/C
MFIS01TN/C
PI01TN/C

Questionnaires.
Term is â€œQuestionnaire Allâ€ / QSALL.
Soluble Intercellular Adhesion Molecule 4 is of II SDTM, SEND-Published

interest to a sickle cell disease study and does in P49
not currently exist in lab CT. Definition: A
measurement of the soluble intercellular adhesion
molecule 4 in a biological specimen.
I believe Study should not be included in the II Do not add (P47): -
Synonym(s) column. Alternate Subject Identifier ALTSID: Update
should be added as a synonym and Alternate synony: Will be
Study Identifier should be removed as a published in P46 as this
synonym. is an error. Team agrees
also that 'Alternate
Identifier' should be
removed as well.
Do not add (P47): -
Alternate Subject
Identifier: Update
synonym: Will be
published in P46 as this
is an error. Team agrees
also that 'Alternate
Identifier' should be
removed as well.
"Do not add (P47): -
Request format of ADNEXAL DYSPLASIA; II PHYSEAL DYSPLASIA
DENTAL DYSPLASIA; PHYSEAL DYSPLASIA; DYSPLASIA,
RENAL DYSPLASIA; and THYROID DYSPLASIA PHYSEAL: Do not
be updated to DYSPLASIA, ADNEXAL; change submission
DYSPLASIA, DENTAL; DYSPLASIA, PHYSEAL; value. The submission
DYSPLASIA, RENAL; and DYSPLASIA, values were purposely
THYROID, respectively. chosen to be published
without commas to
File emailed separately signify that these are
unique terms and not
modifiers of 'dysplasia'."
RENAL DYSPLASIA
DYSPLASIA, RENAL:
Do not change
submission value. The
submission values were
purposely chosen to be
published without
commas to signify that
these are unique terms
and not modifiers of
'dysplasia'."
THYROID DYSPLASIA
DYSPLASIA, THYROID:
Do not change
submission value. The
submission values were
purposely chosen to be
published without
commas to signify that
these are unique terms
and not modifiers of
'dysplasia'."
Please add g/m2h to the UNIT with the definition II SDTM-Published in P50
of: A unit of transepidermal water loss (TEWL)
expressed as gram per square meter times the
number of hours of transpiration.
Vaccinia Plaque Forming Units Assay II SDTM-Published in P47,

Vaccinia Virus Neutralizing Antibody P49
Complement C1q Do not add (P49):
Soluble ST2 Soluble ST2 - Do not
File emailed separately term C142281. The
requested term is listed
as a synonym
In SDTM IG v3.2 and 3.3, one of the sections II Do not add (P47): Do
mentioned about using RACE = MULTIPLE or not add 'MULTIPLE' to
OTHER where necessary. codelist. SDTMIG v3.3
Section 4.2.8.3;
SDTMIG v3.3 Section 5
DM Assumption 6 states
that when "MULTIPLE"
is used, a record of
SUPPDM.QVAL
WHERE QNAM =
"RACEn" is expected.
Please add the submission value ABSENT to the II

ONCRSR codelist with the definition Not existing
in a specified place at a specified time. (NCI)
Please add the term COVID-19 PANDEMIC II Do not add (P49).

RELATED to the NCOMPLT codelist. If it is felt Please see section 5
that this term is too restrictive or specific, please (Disposition)of the
alternatively consider adding the code CDISC "Guidance for
PANDEMIC RELATED to the NCOMPLT codelist. Ongoing Studies
We We strongly feel that this type of code is COVID-19" for how to
needed as the collection of pandemic related handle pandemic-
disruptions are required by CDISC and Health related subject non-
Authorities. completion in the DS
domain.
The suggested definition for the proposed new
term to NCOMPLT of COVID-19 PANDEMIC
RELATED is: A COVID-19 pandemic related
disruption that led to a subject's premature
discontinuation from the study or a segment of
the study. If it is felt that this term is too specific,
please alternatively consider adding the term
PANDEMIC RELATED to the NCOMPLT codelist
with the definition: A pandemic related disruption
that led to a subject's premature discontinuation
from the study or a segment of the study.
Here is the example: II SDTM, SEND-Published

https://wiki.cdisc.org/display/TADIABPR/SDTM. in P48
+T1D+IA+Example, row 8
This questions is raised by the T1D TA team. See II Do not add (P48): Do
the following JIRA issues: not add. Removed from
https://jira.cdisc.org/browse/TADIAB-1130 TAUG example.
https://jira.cdisc.org/browse/TADIAB-1129
This question pertains to this example:

https://wiki.cdisc.org/display/TADIABPR/SDTM.
+T1D+IA+Example, row 6. The ORRESU is U/ml,
should the STRESU be "RIA unit/ml"? If yes, pls
create a new UNIT term for "RIA unit/ml'.
Please add the new term of BONE MARROW II Do not add (P48): Do
INFILTRATION to the TUIDRS codelist with the not add. Withdrawn by
definition of: Disease that infiltrates bone marrow requester.
such as Lymphoma, Multiple Myeloma, etc.
SEND Animal Rule is a published standard but is II

not included in the define-xml list of standards.
(it was added to the SNDIGVER codelist in
package 43)
codelists. : Do not
Change implementation instructions should read, II remove from the
please use --TSTCND variable to house this codelist. Keep as is for
information in relation to each TEST record where now.
this is relevant and necessary.
More
As per the ISMT meeting 2021-04-19 the decision discussion/clarification
was made the retire FIO2 from the LB, RE, and of the TSTCND variable
VS TEST/TESTCD codelists because FIO2 will be required before
measures the amount of supplemental oxygen in moving forward with the
the gas that may be given to the subject during a proposed change. For
procedure, assessment, or during when vital now, FIO2 will stay in
signs are taken. Since this is not a test per se RE-, VS-, and LBTEST
(since it is measuring what is being given to the codelists."
subject) the ISMT determined that the new "Do not add (P47): -
variable --TSTCND, which is being published in Remove FIO2 (C38082)
SDTMv2.0 and SDTMIGv3.4, should be used for
this purpose instead. Remove C38082/FIO2
from the
It was determined that this was not appropriate LBTEST/TESTCD,
for the AG or another interventions domain RETEST/TESTCD, and
because this information is important for the VSTEST/TESTCD
assessment and analysis of other, related codelists.: Do not
respiratory or blood gas analysis type testing. It is remove from the
better to be kept in the findings dataset. codelist. Keep as is for
now.
Additionally, in the --TSTCND example column in
SDTMv2.0, it actually uses response values like More
"21% O2", "18% O2" for ostensibly this purpose. discussion/clarification
See this page: of the TSTCND variable
https://wiki.cdisc.org/display/SDTM2DOT0/Findin will be required before
gs+Variables , row 8 moving forward with the
proposed change. For
now, FIO2 will stay in
RE-, VS-, and LBTEST
codelists."
C174301 'VLDL Triglyceride + Chylomicron II SDTM, SEND-Published

Triglyceride' is over 40 characters. Please in P46
truncate.
QRS CT change control spreadsheets for the II QRS-Published in P46
additional derived variables in the SF8 & SF12
QSTESTCD/QSTEST codelists will be mailed
separately
Jordan,
Attached are the SF8 & SF12 CT change control
spreadsheets for the QRS CT team review.
Steve
New Term request for "PIGMENT, II Do not add (P49):

MACROPHAGE". PIGMENT,
MACROPHAGE - Do not
Proposed definition: Presence of phagocytized add. We will consider
exogenous or endogenous colored material within this type of result
macrophages. I like presence (no activity implied) modifier terminology
better than accumulation or storage. within the new
MIRESMOD codelist to
be developed in 2022.
We had a scenario in which the sponsor II SDTM-Published in P49

terminated the study treatment but the subjects Do not add (P49). We
continued to be followed up as part of the study. will instead update the
Looking at the NCOMPLT codelist, there is an definition of SPONSOR
existing term "SPONSOR REQUEST" with PT " REQUEST to make it
"Subject Removed at Sponsor Request" - In the clear that this could refer
definition, this refers to both the study as well to a treatment epoch or
sections of the study. the study as a whole.
This would very well apply to this situation, but we

have heard from study teams that this term is
confusing to the sites at data collection as it is not
specific to Treatment and could be misinterpreted
as termination of the study itself.
Will it be possible to create a term specific for this

situation TREATMENT TERMINATED BY
SPONSOR, along the lines of 'SITE
TERMINATED BY SPONSOR', 'STUDY
TERMINATED BY SPONSOR' ?
In the latest SDTM NCI, LVEF(left VEF), RVEF_E II

(estimated RVEF) and RVEF_C (calculated
RVEF) are all there. It seems that RVEF is
accidentally left out from SDTM NCI
Formatting should be consistent when it comes to II Do not change (P49).
spaces before or after the forward slash in the We acknowledge the
two terms mentioned. inconsistency but we
also have a rule that we
do not change
submission values that
have been in use for a
long time just for the
sake of consistency.
The use of the forward
slash in the CDISC
submission value
appears to come from
the FDA's preferred term
from its SPL list.
Therefore is it possible for CDISC to implement II

this set of terminology in?
/*Pediatric Voice Handicap Index (QSCAT =

PEDIATRIC VOICE HANDICAP INDEX;
QSSCAT = PEDIATRIC)*/
QSTESTCD QSTEST
PVHI0001 VHI-P: Rate Child's Talkativeness
PVHI1001 VHI-P: Difficult For People To Hear
PVHI1002 VHI-P: Difficulty Understanding
PVHI1003 VHI-P: Difficulty Hearing When
Called
PVHI1004 VHI-P: Avoid Communication
PVHI1005 VHI-P: Speak Less To Friends
Neighbours
PVHI1006 VHI-P: Asked To Repeat
PVHI1007 VHI-P: Restrict Personal Social Life
PVHI2001 VHI-P: Run Out Of Air When Talk
PVHI2002 VHI-P: Voice Varies Throughout
Day
PVHI2003 VHI-P: Ask What's Wrong With
Voice
PVHI2004 VHI-P: Voice Sounds Dry And
Hoarse
PVHI2005 VHI-P: Quality Of Voice
Unpredictable
PVHI2006 VHI-P: Great Effort To Speak
PVHI2007 VHI-P: Voice Worse In Evening
PVHI2008 VHI-P: Voice Gives Out When
Speaking
PVHI2009 VHI-P: Has To Yell To Be Heard
PVHI3001 VHI-P: Tense When Talking Due To
Voice
PVHI3002 VHI-P: People Irritated With Voice
PVHI3003 VHI-P: Don't Understand Voice
Problem
PVHI3004 VHI-P: Frustrated With Voice
P48
Please find attached a multi-term request for Do not add (P48):
additions to MBTEST/MBTESTCD and Detection of pathogens
MICROORG CT. using Multiplexed PCR
for enteritis - Do not
add. The result for the
Microbial Organism
Identification test is
typically a single
organism. The Microorg
codelist does not
contain combination
terms.
Reference loinc https://loinc.org/72224-9/ It was II SDTM, SEND-Published

not clear whether pathologic casts were in P49
synonymous with mixed (cellular) casts, but since
LOINC contains both 72224-9 and 34173-5, we
wondered if CDISC should contain both concepts
whereby pathologic casts are a mix of casts
determined to be of a pathological nature
KASA- Knowledge-aided Assessment & II

Structured Application (KASA); a new FDA
pharmaceutical quality assessment system
ESG - electronic submission gateway
FHIR - Fast Healthcare Interoperability

Resources; a next generation standards
framework created by HL7
Definition: An outcome or conclusion that can be II Do not add (P47): Do

arrived at by measurement. not add. Being
Also to be consistant with SDTM IG examples for published with P46
lab results. SDTM CT.
The definition for POSITIVE AIRWAY II SDTM-Published in P49
PRESSURE THERAPY is: a generic term applied
to all sleep apnea treatments that use a stream of
compressed air to support the airway during
sleep.
Additional information to clarify the definition is:

there are three main types of positive airway
pressure therapy:
Continuous positive airway pressure (CPAP)
Automatic positive airway pressure (APAP)
Bilevel, or variable positive airway pressure
(Bi-PAP,VPAP), used mostly in hospital
CPAP delivers one continuous pressure level of

air. APAP automatically adjusts to meet each
specific person?s breathing needs, which often
change throughout the night as we move in and
out of different stages of sleep.
QualityMeric left off this variable from the original II QRS-Published in P46
specifications provided for the SF36 V2.0 ACUTE
and STANDARD instruments CT
Jordan,
The attached EMAIL explains that QualityMetric
left off the derived variable Mental Health
Enhancement (MHE) form their original CT
specifications. This requests adds it to the
existing published CT. Please let me know if you
have any questions.
Steve
NIH provided the fianl approved PRO-CTCAE CT II QRS-Published in P46

spreadsheet for review/approval with the QRS CT
team. The spreadsheet will be sent separately.
Jordan,
Attached is the PRO-CTCAE V1.0 VERSION
DATE 4/26/2020 CT Spreadsheet for QRS CT
team review. Please let me know if you have any
questions.
Steve
New CDISC code for lab test required; Please II Do not add (P49): Clot
consider adding Clot Retraction as a CDISC Retraction - Do not add.
Submission Value; Blood Clot Retraction has a Please use existing
CPT code of 85170; Specimen type is whole C181438 or C181437,
blood collected in a non-anticoagulated tube. depending on need.
Draft Definition: A qualitative assessment of clot
retraction in a biological specimen; Lab units
reported are arbitrary units/textual responses;
Expected results are clot retraction complete,
normal, incomplete, abnormal, etc. CPT Code
Reference: https://www.cms.gov/regulations-and-
guidance/legislation/clia/downloads/
subjecttoclia.pdf
Please consider the addition of these 2 values II SDTM-Published in P47

since v4.6 was release on November 2020 and
v4.7 on March 2021
Reference paper has a typo. II QRS-Published in P46
per QRS CT team II QRS-Published in P48
FAC00128-FAC00132 - terminology for new II QRS-Published in P46

scores for the FACT-G; FAC00538-FAC00545 -
terminology for new scores for the FACT-B;
FAC00641-FAC00648 - terminology for new
scores for the FACT-BL; and FAC01546-
FAC01553 - terminology for new scores for the
FACT-HEP
FACT terminology for these instruments did not

include terminology for subscores and total score.
File emailed separately II SEND-Published in P48
Do not add (P48):
Hello NCS Vocabulary Services ATYPIA - Do not add.
This will be handled as a
Please see the attached spreadsheet requesting modifier term and not
multiple terms to be added to the NON-NEO the 'main' diagnosis.
Codelist. Do not add (P48):
CHOLESTASIS - Do not
Contact: Muthafar Al-Haddawi (member of SEND add. Use PIGMENT with
CT Team) modifiers such as Bile,
etc.
Regards, Cheryl Do not add (P48):
POLYARTERITIS
Cheryl Sloan NODOSA - Do not add.
This has been
previously denied by
CDISC and INHAND CV
groups. Please use
Degeneration/Necrosis
or
Necrosis/Inflammation
instead (whichever is
most relevant).
needed for LB II Do not add (P50): Do

not add. Glucometer is a
device, the method
would be TEST STRIP
or something else (most
likely described in the
device literature).
Please use existing
METHOD terminology or
request a new term
when the Method is
known. Use Device
domains to specify the
device in use.
SUPPER Term is present in CDISC Terminology II

DOMAIN however main domain ER is not
present.
Add these two new terms to bottom of table on II
this page:
https://wiki.cdisc.org/display/PRG/Protocol+Entity
+-+Study+Monitoring
It may be known that a person has had a II Do not add (P49):
pregnancy test, but the type of test is not known Pregnancy test of
or does not need to be collected. unknown type - Do not
An efficient clinical trial shouldn't ask people to add. We think this TEST
spend time collecting and entering more specific is valuable for collection
data if that data isn't going to be used for but if it is unknown
anything. There are other instances in whether
LBTEST/LBTESTCD where there is a term for a Choriogonadotropin
generic type of test, along with terms for more itself was tested (i.e. no
specific tests (e.g. GFRE), so this is another lab value is received)
instance that is needed. and instead a generic
pregnancy test question
was asked, then this
data belongs in another
domain, either RP or
MH. In the instance
described by the
requester, the requested
term is out of scope for
lab domain. The
purpose of the lab
domain is that one
declares the analyte
being measured; if no
analyte, then no lab
record should be
created.
ADENOMA, AMPHOPHILIC VACUOLAR --> II SEND-Published in P46,

ADENOMA, AMPHOPHILIC VACUOLAR, P47
BENIGN CARCINOMA, AMPHOPHILIC Do not add (P47): -
VACUOLAR --> CARCINOMA, AMPHOPHILIC ADENOMA,
VACUOLAR, MALIGNANT CARCINOMA, AMPHOPHILIC
ZYMBAL'S GLAND --> CARCINOMA, ZYMBAL'S VACUOLAR;
GLAND, MALIGNANT ADENOMA,
AMPHOPHILIC
VACUOLAR, BENIGN:
Will be published with
P46.
Do not add (P47): -
CARCINOMA,
AMPHOPHILIC
VACUOLAR;
CARCINOMA,
AMPHOPHILIC
VACUOLAR,
MALIGNANT: Will be
published with P46.
This is needed in the following scenario: II SDTM-Published in P49
Participant is asked whether they suspect they
may be pregnant, based on recent contraceptive
and menstrual history. If yes then a pregnancy
test is carried out.
RPTEST/RPTESTCD already have a term

(PCONFIND) for confirmed pregnancy. There is
also a term PREGIND, but the wording for this is
too strong for 'suspected pregnancy'. (In practice,
most who have yes to PREGSUSP will probably
have no for PCONFIND)
Maps to C3169. This term is in INHAND II

Hematolymphoid system publication and is
needed to support the tumor combinations
workstream.
Proposed definitions for terms: II SDTM, SEND-Published
Granulocytes Band Form: A measurement of the in P49, P50
banded granulocytes in a biological specimen. Do not add (P50):
Granulocytes Segmented: A measurement of the Leukocytes Band Form -
segmented granulocytes in a biological specimen. Request withdrawn by
Myeloid Progenitor Cells/Total Cells: A relative requester.
measurement (ratio or percentage) of the myeloid
progenitor cells to total cells in a biological
specimen.
Distribution: An examination or assessment of
the distribution of cells in a biological specimen.
Leukocytes Band Form: A measurement of the
banded white blood cells in a biological
specimen.
We have a combination therapy using two drugs II Do not add (P48): Do

to treat the indication. For some AE's we may not add. As per section
need to with drawn/ reduce the dose or 4.2.8.3 of SDTMIGv3.3,
temporarily interrupt both the drugs. To handle please use MULTIPLE
such scenarios, I am under the impression that convention for AEACN
we need to new terms to the existing ACN variable.
codelist, which is non-extensible at this point.
Thank you very much
See e.g. II Do not add (P49):

https://de.wikipedia.org/wiki/Follikelstimulierendes Follicle Stimulating
_Hormon Hormone - Do not add.
Already published in
LBTEST-CD as C74783.
Proposed terms and definitions for II SEND-Published in P49
SRETSTCD/SRETST:
Peak Expiratory Flow per Kilogram, defined as

Maximum flow rate generated during expiration
divided by body weight of the animal.
Peak Inspiratory Flow per Kilogram, defined as
Maximum flow rate generated during inspiration
divided by body weight of the animal.
Tidal Volume per Kilogram, defined as The
volume of air moved into and out of the lungs
during breathing at rest divided by body weight in
kilogram.
Minute Volume per Kilogram, defined as The
amount of gas inspired or expired in one minute
divided by body weight in kilograms.
Shift Angle, defined as Shift of a full breathing
period (360 degree) between thorax and
abdominal signals.
These terms are needed for parameters that are

regularly normalized to body weight.
Proposed terms and definitions for units used for II SDTM, SEND -
respiratory and cardiovascular tests: Published in P50
mmHg*beats/min The product of bpm and mmHg
mL/s/kg Milliliters per second per kilogram
in P49
Please find my multiple term request file Do not add (P49): Cyclic
attached. adenosine
This is about new terms for monophosphate - Do
SDTM-LBTESTCD/LBTEST. not add. Already
published as
With best regards, C124339/Cyclic
Jozef Aerts Adenosine 3,5-
XML4Pharma Monophosphate.
Do not add (P49):
Androstanolone - Do not
add. Published as
C74853/DHT. We will
add a synonym instead.
Do not add (P49): C
peptide / Creatinine
RATIO - Do not add.
C150837.
Do not add (P49):
Catecholamines free
fractionate - Do not add.
In the LB SDTM dataset,
you would represent this
as multiple rows of data
using individual LBTEST
values of
Norepinephrine,
Epinephrine, and
Dopamine, which are
already published.
Do not add (P49): D-
Lactate - Do not add.
Please use
C79450/LACTICAC.
Do not add (P49):
While updating the ECG codetable mapping file, II CDASH, SDTM, SEND-
the ECG team had identified a new unit for Published in P48, P49,
EGTESTs, and would also like to request new P50
synonyms to be added to existing units. File
emailed separately
Attached is the supplemental file for the request I

just submitted, thank you
Jordan
P49
Hello, Do not add (P48):
Dietary Beans and Peas
Please find attached file for new term request Vegetables - Do not
dated May 27, 2021. add. Please re-use
'Dietary Beans and
Peas' and use other
variables to distinguish
Best, whether the amount is
Laura being considered with
other vegetables or
June 2, 2021: proteins. GRPID or
Hi Brenda, SCAT could be used to
distinguish the fact that
Please find attached updated spreadsheet with the TEST result is going
two changes highlighted in red. Let me know if I toward a total vegetable
should re-submit via the system. or total protein count.
Do not add (P48):
Dietary Folate -
Best, Withdrawn by requester.
Laura Do not add (P48):
Dietary Other Fruits - Do
not add. The use of
'other' here does not
make sense from a
controlled term
standpoint and is not
possible to be defined
for all use cases.
Therefore we will not
control this with CDISC
terminology.
Do not add (P48):
Dietary Other Red and
Orange Vegetables - Do
not add. The use of
Recombinant human PH20 hyaluronidase (Anti- II
rHuPH20) Antibody from PLASMA via
ELECTROCHEMILUMINESCENCE Method
Ammonium/Creatinine ratio - Calculation with II SDTM, SEND-Published
Specimen type Urine in P49
Non-HDL Cholesterol /LDL Cholesterol Ratio, II SDTM, SEND-Published
fasting with Specimen type of Serum in P49
See references: II
https://pubmed.ncbi.nlm.nih.gov/31956078/
https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC6859003/
https://www.onclive.com/view/nivolumab-
neoadjuvant-regimen-nears-50-pcr-in-mibc
Definition = A lens generally worn in front of the II SDTM-Published in P47
eye, mainly used to treat myopia (near
sightedness). This includes glasses, and/or
contact lenses.
For our Oncology Trials we are collecting

information in the OE Domain and one question
that we are asking is: Does the Subject Wear
Glasses or Contacts for Distance Vision? The
results are being mapped to the OEORRES and
OESTRESC. Possible results are: YES -
CONTACT LENSES WITH OR WITHOUT
GLASSES; YES - GLASSES ONLY; NO;
UNKNOWN
File emailed separately Insulin, Intact Donor- II SDTM, SEND-Published

Specific HLA Class I Antibody Donor-Specific in P49
HLA Class II Antibody
HLA-A11 Antibody
HLA-A32 Antibody
HLA-B27 Antibody
HLA-B35 Antibody
HLA-C15 Antibody
HLA-C4 Antibody
HLA-DQB5 Antibody
HLA-DQB7 Antibody
HLA-DR11 Antibody
HLA-DR14 Antibody
HLA-DPA1*01:03 Allele Antibody
HLA-DPB1*04:01 Allele Antibody
HLA-DQA1*01:XX Allele Antibody
HLA-DQA1*05:XX Allele Antibody
Zinc Transporter 8 Antibody
Pathologic Casts
Hi,
I have attached the detailed file here.
Thank you,
Rohit
in the PK Units of
There seems to be discrepancies in the II Measure codelist, and
submission value for PKUNIT the following when ug/L in the UNIT
comparing to the UNIT codelist: codelist. The two
submission values are
NCI Code, CDISC Submission Value as per mathematically
C85494, CDISC Submission Value as per equivalent (synonyms),
C71620: and represent typcial
C25529, h, HOURS values derived from
C67306, ng/mL, ug/L different types of
C67327, pg/mL, ng/L analysis, i.e. PK study
analysis for the former
This is causing some Pinnacle 21 validation and, presumably lab
issue, and I think we should consider updating tests for the latter.
the CT for the next release to consistently report Thusly, It wouldn't make
the Submission Value. sense to use the version
of the unit designed for
PK analysis when lab
tests and data are
performed and
analyzed.
Please contact Pinnacle
21 for the validation
warnings, this is out of
scope for controlled
terminology. This might
be a configuration issue
as well, so check
internally to verify that
the correct codelist is
used for PC/PP
domains. Alternatively
you could explain the
warnings in the
commentary section of
Pinnacle 21e."
Excretion rate curve definitions contain 'urinary' in II SEND-Published in P48

their definitions, limiting their use (for example,
fecal specimens). We would like to propose
'urinary' be removed and a more broad definition
that references PPSPEC be used.
(Specific terms provided separately).
Definition: An instrument composed of an opaque II Do not add (P50): Do

disk with many small holes through it, used to test not add. Please use
visual acuity. The occluder is a simple way to existing METHOD term
focus light, temporarily removing the effects of C184680/PINHOLE
refractive errors. OCCLUSION.
Used as a response mapping to OEMETHOD for

the question text of: Best Corrected Visual Acuity
Method. Possible response are: PHOROPTER
and PINHOLE OCCLUDER
Confidentiality is defined in the glossary but not II

privacy. Think we need both with clear definitions
to differentiate.
New term request for DIGIT. II
Proposed definition of "The most distal part(s) of
a limb in some tetrapods."
Finger could be listed as a synonym.
Could you please consider the addition of II SDTM, SEND-Published
"Lymphocytes/Neutrophils" in LBTESTCD in P49
codelist.
Definition currently states "The status of the study II SEND-Published in P48
report associated with the datasets", but
Requestor questions if this could be clearer as it
currently invites the question: status of the study
report at the point of submission or the status of
the study report at the point the SEND datasets
creation.
List code for the QRS domain for the QLQ30 and II Do not add (P49).
HN35 questionnaires CDISC currently does
not create response
terminology for
copyrighted instruments.
File e-mailed separately II SDTM, SEND, Define-

72 new terms XML, Protocol-
36 changes to existing Published in P46
Please add FINGERTIP to the LOC codelist with II SDTM, SEND -
the proposed definition: The most distal part of a Published in P50
finger.
Please refer to the file emailed separately with II SDTM - Published in
the list of terms suggested for this existing CDISC P50
paired codelist. Do not add (P50):
Nervous System
Dear CDISC-NCI, Findings All / NVALL -
Do not add. This is a
Please find attached the multiple term request published SDTMIG
form for terms suggested by the Sanofi CIG convention and
Team for CDISC terminology. therefore will not be
Existing codelist: NVTEST/NVTESTCD. added to any
Thank you. TEST/TESTCD pairing.
Do not add (P50):
Ataxia / ATAXIA-Do not
add. Based on the CRF
sent in by the requester,
they are modeling this
as a FT instrument
(Friedreich's Ataxia
Rating Scale (FARS)) so
is inappropriate for the
NVTEST codelist.
Do not add (P50):
Reflex / REFLEX-Do not
add. Based on the CRF
sent in by the requester,
this is a CAT value, not
a test.
Do not add (P50): Gait /
GAIT- Do not add.
Based on the CRF sent
in by the requester, this
is a SCAT value, not a
test.
Do not add (P50):
Visual Acuity /
VISACUIT-Do not add.
These appear to be
Definition = An axillary lymph node located along II Do not add (P50): Do
the lower edge of the pectoralis minor. (NCI not add. Already
C120322) published as C120322/
PECTORAL LYMPH
NODE
Fish (Cod) Antigen IgE Antibody (f3) Sesame II
seed Antigen IgE Antibody (f10) Almond Antigen
IgE Antibody (f20) Shrimp Antigen IgE Antibody
(f24) Salmon Antigen IgE Antibody (f41) Whole
egg Antigen IgE Antibody (f245) Pistachio
Antigen IgE Antibody (f203) Pecan nut Antigen
IgE Antibody (f201) Milk, boiled Antigen IgE
Antibody (f231) Cow's whey Antigen IgE Antibody
(f236)
Fish(Cod) Antigen IgG4 Antibody (f3)
Wheat Antigen IgG4 Antibody (f4)
Sesame seed Antigen IgG4 Antibody (f10)
Peanut Antigen IgG4 Antibody (f13) Soybean
Antigen IgG4 Antibody (f14) Hazel nut Antigen
IgG4 Antibody (f17) Almond Antigen IgG4
Antibody (f20) Shrimp Antigen IgG4 Antibody
(f24) Salmon Antigen IgG4 Antibody (f41) Pecan
nut Antigen IgG4 Antibody (f201) Cashew nut
Antigen IgG4 Antibody (f202) Pistachio Antigen
IgG4 Antibody (f203) Whole egg Antigen IgG4
Antibody (f245) Walnut Antigen IgG4 Antibody
(f256) Milk,boiled Antigen IgG4 Antibody(f231)
Cow's whey Antigen IgG4 Antibody (f236)
Hi CDISC Team-
New terms requested
Thanks,
Jenny
valuable new definition to understand sufficient II Glossary-Published in

evidence requirement. P48
The term meta-analysis, as used in this
document, refers to the combining of evidence
from relevant studies using appropriate statistical
methods to allow inference to be made to the
population of interest. The most common reason
for performing a meta-analysis is to provide an
estimate of a treatment effect or measure of
relative risk associated with an intervention and to
quantify the uncertainty about the estimated
effect or risk, when data from a single existing
study are insufficient for this purpose, and the
conduct of a new, large study would be
impractical,
Source:
https://www.fda.gov/media/117976/download
Hi CDISC Team- II Do not add (P49): O-
New terms requested Desmethyltramadol - Do
not add. Published in
Thanks, P47 as C181402.
Jenny
Some of our treatments are a gel administered II

through a pump and subjects are asked to apply
"1 pump".
Definition suggested: "The screened subject who II Do not add (P49).
does not meet one or more criteria required for Please use existing term
participation in a trial after run-in phase." 'FAILURE TO MEET
CONTINUATION
CRITERIA'. The
proposed value can be
used as the DSTERM if
this information is
important for the
dataset.
Definition suggested: "Not to have performed II Do not add (P49).

every necessary or normal part or component or Please use the existing
step of the follow-up visit." term 'LOST TO
FOLLOW-UP'. The use
case provided by the
requester suggests that
the subject was not able
to complete follow-up
tasks and therefore is
lost to follow-up, based
on the published CDISC
definition in the
NCOMPLT codelist.
Our study is collecting plasma segesterone II Do not add (P49):

acetate (mg/L) levels, Is it possible to add to segesterone acetate -
LBTEST/LBTESTCD? Do not add. This can
continue to used as an
extensible term. CDISC
CT only controls
exogenous compounds
if they are considered
drugs of abuse and part
of toxicology screening
panels.
The RP domain has values to capture # of II Do not add (P49). Since
abortions (RPTESTCD=ABORTN), # of births the Test value clearly
(RPTESTCD=BRTHN), and # of pregnancies describes what is being
(RPTESTCD=PREGNN). RPSTRESN is counted, the result value
populated since these are counts. Can we get is effectively unitless. If
UNIT values to avoid the warning of RPSTRESN a Unit value is
populated but RPSTRESU is missing? absolutely required by
the company, the
published unit EVENTS
(C150901) could be
used.
New term needed for OETEST/CD codelist with II

definition "The degree to which something
reduces the passage of light.".
New term needed for codelist OETST/CD with II
definition : "Measurement in millimeters from the
light reflex on the patient?s cornea to the level of
the center of the upper-eyelid margin, with the
patient gazing in the primary position.".
New term would be needed for codelist II

OETEST/CD with definition : "Measurement in
millimeters from the light reflex on the patient?s
cornea to the level of the center of the of the
lower eyelid margin, with the patient?s eyes in the
primary gaze.".
New term needed for codelist OETEST/CD with II

definition : "Distance from the inferior limbus to
the central upper-eyelid margin when the patient
looks in extreme up gaze.".
To Whom It May Concern: II
Please find the attached document containing a

list of fields commonly collected during a
contraception study that are not currently listed in
the RPTEST(CD) extensible list(s). We are
hoping many of these could be added.
Thank you for your attention and assistance with

this matter!
Annie
https://en.wikipedia.org/wiki/Erythroferrone II SDTM, SEND -

Published in P49
In the TS domain, the variable TSVALNF handles II
flavors or null like Not Applicable, Unknown, etc.
in the case where the TSVAL is unknown, the NY
response codelist value U should not be used and
the value should be null. Therefore for all
indicator-type TSPARMs, the only allowable
values shall by N and Y.
The request comes from the CT Relationships

team.
1. For TSPARM value C119562, this TSPARM II

should be associated with the EGLEAD C90013
codelist.
2. For TSPARM value C119564, this TSPARM

should be associated with the EGRDMETH
C172333 codelist.
FDA OBI would like this change to be done ASAP. II SEND-Published in P48
Not sure if this was raised already. There appears II Do not add (P50): Do
to be a typo in the preferred term of "NEW BONE not change. This is an
LESION"- the word 'Lesion' appears twice. intentional duplication.
Lesion Identifier = New
Bone Lesion
file emailed separately II
Hi, Do not add (P48): 16S

This is a new term request for the SEQUENCING - Do not
Method codelist for the T1D Prevention TAUG, add. The example was
Microbiome example. updated to use 'NEXT
GENERATION
Thanks, SEQUENCING' as the
METHOD, which is
Diane Corey BS already published.
Data Manager Do not add (P48):
SHOTGUN
SEQUENCING - Do not
add. The example was
updated to use 'NEXT
GENERATION
SEQUENCING' as the
METHOD, which is
already published.
Based on SDTMIGv3.4 example terminology: II
https://wiki.cdisc.org/display/SDTMIG/LB+Examp
le+1
The term "WITHDRAWAL BY CONSENT" was II Do not add (P50):

added in P44/Dec 2020 CTs. We are looking for Question answered
guidance as this term and definition is very based on the
similar to "WITHDRAWAL BY SUBJECT". In assumption that the
addition, we noticed that the term "INFORMED requester is asking for
CONSENT WITHDRAWN" was previously what the difference is
proposed and subsequently denied with the between
reason=Do not add. Please use existing terms 'WITHDRAWAL OF
WITHDRAWAL BY PARENT/GUARDIAN/C102355 CONSENT' and
or WITHDRAWAL BY SUBJECT/C49634 for 'WITHDRAWAL BY
DSDECOD. SUBJECT'. The term
'Withdrawal of Consent'
is a formal, legal
designation/process that
revokes a previously
signed consent form.
Withdrawal from a study
or part of a study can be
done without
withdrawing legal
consent. "INFORMED
CONSENT
WITHDRAWN" could be
covered by
'WITHDRAWAL OF
CONSENT' (we will add
a synonym with P50).
The draft definition for the new METHOD term of II SDTM-Published in P50
ACTIVITY TRACKER is: An activity tracking is done
with a (wearable) device that (continuously)
monitors one or more aspects that reflect your
activity or rest and sleep patterns, habits, stages,
quality, and/or duration.
These wearables cover the basics, tracking steps,
distance, calories burned and serving up
inactivity alerts and it will also may continuously
monitor heart rate through the day and the
night.
This measurement is relying on more easily
detectable physical signals of activity, position,
acceleration , rather than basing it on brain
activity and eye movement as they do in some
formal medical tests.
The data collected doesn't mention the method II SDTM-Published in P48
for detecting the specimen, so it's unknown
what's being detected other than the organism. I
like to add a definition written following the style
of other terms in the codelist, such as "A
measurement of the total Treponema pallidum
present in a biological specimen."
team is preparing update II
On behalf of CDISC Protocol Entities team, please II

define the concept of 'Data Sharing'
https://grants.nih.gov/grants/policy/
data_sharing/data_sharing_guidance.htm#goals
https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-21-013.html
CDISC submission Value: LIPS II SDTM-Published in P50

SY: Luciferase Immunoprecipitation System Assay
Example page:
https://wiki.cdisc.org/display/TADIABPR/SDTM.
+T1D+IA+E=xample
File emailed separately II SEND-Published in P48,
P49
Hello, Do not add (P48): BAT,
Aortic - Do not add. The
Please find attached the CDISC multi term SPEC should make use
request file. of the published term
"ADIPOSE TISSUE,
These terms are requested for addition to the BROWN" and the
SEND SPEC and LOC categories. anatomical region
information can be
We look forward to hearing from you. added into --ANTREG
variable.
Regards Do not add (P48): BAT,
Claire Axillary - Do not add.
The SPEC should make
use of the published
term "ADIPOSE
TISSUE, BROWN" and
the anatomical region
information can be
added into --ANTREG
variable.
Do not add (P48): BAT,
Cervical - Do not add.
The SPEC should make
use of the published
term "ADIPOSE
TISSUE, BROWN" and
the anatomical region
information can be
added into --ANTREG
variable.
Do not add (P48): BAT,
Hibernating gland - Do
not add. The SPEC
should make use of the
published term
We have noticed that the SDTM Terminology II SDTM-Published in P50
NCF codelist is listed as Extensible=Yes.
Is this intended? Based on the codelist name, we
are not sure when a new value would be
submitted and/or accepted.
The QRS CT change control spreadsheet will be II QRS-Published in P47

sent separately
Jordan,
Attached is the EORTC C30 CT change control
spreadsheet to review with the QRS CT team at
this weekâ€™s meeting. Please let me know if
you have any questions.
Steve
Update title for measure to be more consistent II QRS-Published in P47
with reference paper.
Hi,
KDIGO update to definition of CCCAT:
KDIGO AKI. Will go over this with QRS
terminology team this week.
Thanks,
Adding new domain for SENDIG-DART for II

Juvenile Animal Toxicity Studies which have
developmental milestone testing. DP was
previously reserved for this.
CL DTYPE CDISC Submission Value - COPY CDISC II ADaM-Published in P48

Synonym - Copy CDISC Definition - A data
imputation technique that uses assignment logic
to duplicate an analysis value to be used in
multiple evaluations.
NCI Preferred Term - Copy Duplication
Imputation Technique
tissues should be accounted for individually, ALL II SEND-Published in P49

TISSUES as a specimen should be removed
Brenda, something went amiss in this request.

NAME Daniel Potenta, somehow Daniel Corassa
was inserted, and the CT term preferred is
actually WHOLE ANIMAL (I inadvertently typed in
Whole Body) SORRY!!!! Dan
Daniel Lee Potenta

SEND Product Manager, Manager QC
Add 2 additional abbreviations are needed, II

especially since the novel virus and disease are
part of new terms and research
a numerical expression, in appropriate units, of a II SDTM-Published in P48

linear measurement of an object, such as an
organ or body part. Dorland's Illustrated Medical
Dictionary 30th edition
****File emailed separately. II

Beta Isomer of C-Terminal Telopeptide of Type I II SDTM-Published in P50
Collagen Inversion-Intron 22 Inversion?Intron 1 Do not add (P49):
HGVS Transcript HGVS Protein Inversion-Intron 22 and
HLA-DQA1 (HLA DQ Alpha 1 Antigen) Inversion-Intron 1 -
B-Domain Deleted Factor VIII Antigen These would be better
Adeno-associated virus 5 Neutralizing Antibody modeled in the new GF
domain (SDTMIGv3.4).
Cell-based transduction inhibition The requested value
Reverse hybridization would go into the
GFGENLOC variable (if
File emailed separately the expected result
value is related to the
Hi CDISC Team- inversion). Please
Please consider these new Term requests. review the published
GFTEST codelist for the
Thanks, appropriate GFTEST
Jenny value to use. If the
existing, published list is
inadequate, please
submit a new term
request for an
appropriate GFTEST
value.
Do not add (P49): HLA-
DQA1 (HLA DQ Alpha 1
Antigen) - Do not add.
C181416.
Do not add (P50):
Reverse sequence
specific oligonucleotides
- Do not add. This is a
step within a multi-step
genotyping process. Not
the resulting method.
The resulting method for
the reagent kit given in
Definition from Oxford Dictionary: A small II
depression in the retina of the eye where visual
acuity is highest. The center of the field of vision
is focused in this region, where retinal cones are
particularly concentrated.
"https://www.ncbi.nlm.nih.gov/pmc/articles/ II
PMC3038969/
measurement of the relative change in the cross-

sectional area of the aorta divided by the pulse
pressure, which reflects the stiffness of the
aorta."
in P49, P50
Do not add (P50):
Blasts, Monocytic
AML/Leukocytes - Do
not add. Use existing
term
C74646/Monoblasts/Leu
kocytes. The AML
subtype may need to be
added in as a suppqual.
Definition - AVAILABLE FOR RETURN - A status II

indicating that the product is ready to be
transported or conveyed back to the sender.
Definition - RETURNED - The act of giving back or

the getting back of a product.
This value was created to support the II SDTM-Published in P50

Schizophrenia TAUG as a FATEST value meaning
the physical location of where treatment was
received or occurred. It is a different concept
semantically from the published NSV TRTSTT,
which has been published in a couple of TAUGs,
namely oncology TAUGs and the draft PanCan
TAUG. This NSV has a published response
codelist "Treatment Setting". The FATEST value
does NOT have a published response codelist.
NSV team asks that the FATEST value be

renamed.
Please add anatomical location of 'Sural Nerve', II

defined as: A minor branch of the sciatic nerve
that includes the lateral and caudal sural nerves,
which innervates the skin of the crus, tarsus and
metatarsus. It is also present in SEND Specimen
codelist. Thank you!

Definition - an in-vitro quantitative limiting II SDTM-Published in P50
antigen (LAg) avidity enzyme immunoassay for
distinguishing recent HIV-1 infections from those
which are long-term.
https://www.maximbio.com/Products/92001/
Maxim-HIV-1-Limiting-Antigen-Avidity-(LAg-
Avidity)-EIA-Kit%2C-192-Tests
File e-mailed separately II SDTM-Published in P48,

P49, P50
not add. The terms in
question (below) are
animal and study
specific and therefore,
not considered as
industry standard.
Therefore, the ECG CT
team never added these
terms. The ECG Test
Method and ECG Lead
codelists are extensible
and users may add
these values to both
codelists as extensible
values.
9 LEAD STANDARD,
NON-HUMAN
LEAD MV1
LEAD MV2
LEAD MV3
Do not add (P49): Stent
Placement Terms: Do
not remove. The team
feels that the procedure
codelist terms should be
a little more granular to
reflect the individual
procedure that is
occurring and not split it
out into multiple
variables. This is
consistent with other
procedure coding
systems like CPT and
Suggested Definition: A measurement of II SDTM, SEND -
traditional circulating tumor cells in a biological Published in P49
specimen. Traditional CTCs are characterised by
an intact, viable nucleus; the expression of
EpCAM and cytokeratins, which demonstrate
epithelial origin; the absence of CD45, indicating
the cell is not of hematopoietic origin; and their
larger size, irregular shape or subcellular
morphology.
Suggested definition: A measurement of II SDTM, SEND -
apoptotic circulating tumor cells in a biological Published in P49
specimen.. Apoptotic CTCs are circulating tumor
cells that are undergoing apoptosis (programmed
cell death). These may be used to monitor
treatment response, as done experimentally by
the Epic Sciences method, which identifies
nuclear fragmentation or cytoplasmic blebbing
associated with apoptosis. Measuring the ratio of
traditional CTC to apoptotic CTCs?from baseline
to therapy?provides clues to treatment efficacy
in targeting and killing cancer cells.
Definition - Microbiological response outcome of II Do not add (P48):

an organism for a patient. Microbiological
Response - 2021-08-19:
Do not add. Some of the
response terms for this
test, such as
ERADICATION,
PERSISTENCE,
INDETERMINATE could
be mapped to the
MSRESCAT values,
which suggest that you
should use the
Microbial Susceptibility
test in MS. The
SUPERINFECTION, NEW
INFECTION,
RECURRENCE are not
responses to a
susceptibility testing,
which suggest that your
requested clinical
statement values do not
belong in MS, or any
findings domains since
they are more about
treatment efficacy. May
consider using FA, AE or
CE for these events.

Definition - Any bacterial organism that can be II SDTM-Published in P48
assigned to the species Acinetobacter pittii.
Definition - A strong degree or magnitude of II SDTM- Published in P49

staining within a biological specimen.
To be able to map data generated by Abbott/SD II

Bioline Dengue duo test
To be able to map data generated by Abbott/SD II
To be able to map data generated by Abbott/SD II SDTM-Published in P48
C101858 with CDISC submission value of BILEVEL II SDTM-Published in P50
POSITIVE AIRWAY PRESSURE VENTILATION has a
synonym listed as BPAP. I have only ever seen
BIPAP as the short form of this procedure, and a
search of the net didn't yield BPAP as a term. Is
this perhaps a typo?
Request addition of 2 new terms and a synonym. II SDTM-Published in P50

Please add the 2 new terms:
INDIRECT ELISA (This type of ELISA assay detects
the binding antibody using a second, conjugated
antibody) SANDWICH ELISA (This type of ELISA
assay is when the antibody is adsorbed onto the
ELISA plate as opposed to the antigen. The
antigen is recognized by two antibodies, one
capture and one detection, thus forming a
complex like a "sandwich")
Reference:
https://www.cellsignal.com/applications/elisa/ty
pes-of-elisa-tests
Also request addition of synonym Direct ELISA

for the existing term ELISA
Update CDISC definition for C180257: II QRS-Published in P47
Published: Eastern Cooperative Oncology Group

Performance Status standardized character
result for ECOG101-Ambulatory and capable of
all selfcare but unable to carry out any work
activities. Up and about more than 50% of
waking hours times.
Change to: Eastern Cooperative Oncology Group

Performance Status standardized character
result for ECOG101-Ambulatory and capable of
all selfcare but unable to carry out any work
activities. Up and about more than 50% of
waking hours.
Hi Brenda, the CDISC codelist for this one is

SDTM-ECOG101STR, This is a QRS request.
From CT Relationships team II SDTM-Published in P50
Definition: Two or more internal organs. (Existing II

NCI Code C28287)
So that we can report that the SDTM IG for II
Medical Devices has been used.
Please add term 'Peroneal Nerve' to SDTM CT; II

already exists in NCIt and SEND (C52814). Thank
you!
Please add 'Tibial Nerve' to SDTM Anatomical II

Location codelists; already exists in NCIt and
SEND (C52809). Thank you!
Please add 'caretaker' as a synonym of the II SDTM-Published in P50

existing value of 'caregiver'. Thank you!
Please add synonym 'EMG' to existing submission II SDTM- Published in P49

value of 'ELECTROMYOGRAPHY'. Thank you!
A measurement of the tumor necrosis factor II SDTM, SEND-Published
receptor superfamily member 1B in a biological in P50
specimen. Do not add (P50):
Tumor Necrosis Factor
Receptor 2 - Do not add.
Use existing term
synonyms to making
mapping easier in
future.
Allograft (or Allograft cells): The presence of II Do not add (P49):

individual cells, an organ, or tissue mass(es) Allograft (or Allograft
derived from another animal of that species cells) - Request
(typically syngeneic rodents). withdrawn by requester.
Xenograft (or Xenograft cells): The presence of MAMI team will discuss
individual cells, an organ, or tissue mass(es) this in future modeling
derived from another animal of a different discussions.
species. Do not add (P49):
Implanted cells: The presence of individual cells, Xenograft (or Xenograft
or tissue mass(es) derived from experimentally cells) - Request
implanted cells. withdrawn by requester.
MAMI team will discuss
Use cases: this in future modeling
For documenting presence of injected/grafted discussions.
cells in tumor-bearing rodent study, irrespective Do not add (P49):
if the study was a toxicity study or an efficacy Implanted cells -
study. Request withdrawn by
Data for Intratumoral Injection Site: Allograft requester. MAMI team
cells (Present) Data for induced tumor (not an will discuss this in future
injection site: Tissue (Site of injection ? Adipose modeling discussions.
tissue; mammary fat pad, etc. (tumor): Allograft
cells (Present).
Data for metastatic foci: Lung (as an example):
Allograft cells, secondary site (Present, or
graded/enumerated if desired)
Xenograft cells or Implanted cells could be used

instead of Allograft cells in the above examples.
Another possible use case in a monkey ocular

study:
Retina: Xenograft cells (Present)
Such experimentally injected cell-line masses

have historically not been assigned Peto scores
as part of the study data; therefore their
presence should be documented as a non-
Proposed definition: Milliliters per second (flow II SDTM, SEND-Published
rate), divided by kilograms (weight) or milliliters in P50
per kilogram per second.
Used in safety pharm studies.
The flow unit is ml/s and then adjusted by the
BW.
P49, P50
Do not add (P48):
Leukocytes - Do not
add. This is a LBTEST,
map to C51948/WBC.
Do not add (P48):
Epithelial Cells - Do not
add. This is a LBTEST,
map to C64605.
Do not add (P48):
Culture Result - Do not
add, map to MBTEST =
Microbial Organism
Identification/C132416
Do not add (P48):
Culture Colony Count -
Do not add, map to
MBTEST = Name of the
microorganism,
MBTSTDTL = COLONY
COUNT
Do not add (P49):
GARDBCDL - Do not
add. The MB team has
reservation for the use
of the term "like" in the
submission value, this is
really vague and
unspecific and LOINC
and Google search yield
no result for this
organism. This codelist
is extensible, pls add as
an extensible value.
Do not add (P49):
BVSCREEN - Do not
Codelist - Medical Evaluator (CDISC MEDEVAL) II SDTM-Published in P48
1. NEUROONCOLOGIST
2. NEURORADIOLOGIST
3. NEURORADIOLOGIST 1
4. NEURORADIOLOGIST 2
5. NUCLEAR MEDICINE PHYSICIAN

Codelist - procedure (CDISC PROCEDUR) II SDTM-Published in P50
Term - MICROWAVE THERAPY
Synonym - Microwave Thermotherapy

in P49, P50
Definition: The proportion of blood vessels in II

comparison to the total blood vessel volume.
New term would be needed for this lab test II

defined as "A measurement of the Poa pratensis
pollen antigen IgE antibody in a biological
specimen.".
A new term would be needed for this lab test II

defined as : "A measurement of the Lolium
perenn pollen antigen IgE antibody in a biological
specimen.".
New LBTEST/CD suggested Nuclear Mitotic II SDTM, SEND-Published

Apparatus Protein 1 / NUMA1 defined as "A in P49, 50
measurement of nuclear mitotic apparatus Do not add (P50):
protein 1 in a biological specimen.". And put the Nuclear Mitotic
existing CDISC term C156509 (Nuclear Matrix Apparatus Protein 1 -
Protein 22 / NMP22) as a synonym as referred in Do not replace existing
NCI (an associated request is also sent for this term with new
modification): submission value.
https://nciterms.nci.nih.gov/ncitbrowser/ Instead we will add
ConceptReport.jsp? synonyms from term
dictionary=NCI_Thesaurus&ns=ncit&code=C3398 request into existing
5 published term
C156509.
Please modify lab test "Nuclear Matrix Protein 22 II SDTM, SEND-Published

/ NMP22" (C156509) as a synonym of the new in P49, P50
term just requested "Nuclear Mitotic Apparatus Do not add (P50):
Protein 1 / NUMA1 defined as "A measurement Nuclear Matrix Protein
of nuclear mitotic apparatus protein 1 in a 22 / NMP22 - Do not
biological specimen." as referred in NCI: replace existing term
https://nciterms.nci.nih.gov/ncitbrowser/Concep with new submission
tReport.jsp? value. Instead we will
dictionary=NCI_Thesaurus&ns=ncit&code=C3398 add synonyms from
5 term request into
C156509.
New LBTEST/CD suggested "Peptidylprolyl II SDTM, SEND-Published
Isomerase A / PPIA" defined as "A measurement in P49, P50
of peptidylprolyl isomerase A (cyclophilin A) in a
biological specimen.". Please refer to NCI:
https://nciterms.nci.nih.gov/ncitbrowser/Concep
tReport.jsp?
dictionary=NCI_Thesaurus&ns=ncit&code=C1569
29
Codelist - laboratory test (CDISC LBTEST) II
Term - Proton Density Fat Fraction
Synonym - PDFF
New term "PHARMACOKINETICIST" is suggested II

for MEDEVAL codelist defined as "A person
qualified to analyse the data that characterize
movements of drugs within biological systems, as
affected by absorption, distribution, binding,
elimination, biotransformation, and excretion;
particularly the rates of such movements.".

P50
Codelist Name - Category of Oncology Response II Do not add (P48): Do

Assessment not add. Already
published with
Term - DOHNER AML 2017 submission value 'ELN
DOHNER AML 2017'
Definition - Diagnosis and management of AML (C179779)
in adults:
2017 ELN recommendations from an
international expert panel. (Dohner H, Estey E,
Grimwade D, Amadori S, Appelbaum FR,
BFCchner T, Dombret H, Ebert BL, Fenaux P,
Larson RA, Levine RL, Lo-Coco F, Naoe T,
Niederwieser D, Ossenkoppele GJ, Sanz M, Sierra
J, Tallman MS, Tien HF, Wei AH, Lowenberg B,
Bloomfield CD. Blood. 2017 Jan 26;129(4):424-
447.)
Codelist Name - tumor or lesion properties test II SDTM-Published in P49
(CDISC TRTEST)
Term -Thickness
Synonym - THICK
Definition - The dimension between two surfaces

of an object, usually the smallest dimension as
opposed to the width or the length.
NCIthesaurus code C41145
File emailed separately. II Do not add (P48): CD4+

CD25+ - Do not add.
Please see the attached new term request for CPTEST value should
LBTEST and LBTESTCD. contain the specific cell
marker strings and cell
states (E.g.,
ACTIVATED) added into
the appropriate
Definition: An in vitro assay that is used to II SDTM-Published
variables as per in P50
determine whether antibodies that can block SDTMIGv3.4 CP
toxin activity are present in a biological domain model.
specimen. Do not add (P48): CD4+
ICOS+ - Do not add.
Antibodies in subject serum capable of CPTEST value should
neutralizing heat-labile toxin from contain the specific cell
enterotoxigenic E. coli are being assessed via an type of interest with
assay similar to other neutralization-type assays marker strings and cell
already defined by CT. Definitions in existing CT states (E.g.,
all refer to infectious agents as opposed to a ACTIVATED) added into
toxin. CELL CYTOTOXICITY NEUTRALIZATION the appropriate
ASSAY is not appropriate as the definition variables as per
indicates use for detection of toxin, and not of SDTMIGv3.4 CP
antibodies to that toxin. domain model.
Do not add (P48): CD4+
Ki67+ - Do not add.
CPTEST value should
states (E.g.,
the appropriate
variables as per
SDTMIGv3.4 CP
domain model.
Do not add (P48): CD8+
Gran B+ - Do not add.
CPTEST value should
states (E.g.,
the appropriate
variables as per
SDTMIGv3.4 CP
domain model.
Definition: A flow-cytometric mass spectrometry II SDTM-Published in P50
technique in which heavy metal-conjugated
antibodies are bound to intra- or extra-cellular
analytes of interest on single cells. Cells are
atomized and the heavy metal ions that were
attached to the staining antibodies and analytes
are assessed by time-of-flight mass
spectrometry.
Synonyms: Time-of-flight cytometry, ToF

Cytometry.
See e.g.,
https://www.sciencedirect.com/topics/medicine-
and-dentistry/mass-cytometry
New term suggested defined as "Fluid withdrawn II Do not add (P48): Do

from a body cavity, organ, cyst, or tumor." Please not add. Please use
refer to NCI: existing FLUID
https://ncithesaurus.nci.nih.gov/ncitbrowser/ specimen type from
ConceptReport.jsp? published codelist and
dictionary=NCI_Thesaurus&ns=ncit&code=C1334 collect ASPIRATION as
7 a suppqual using the
CLMETH codelist.
New term suggested for codelist SPECTYPE II SDTM-Published in P48

defined as "Definition:Connective tissue cells that
make and secrete collagen proteins."
Mostly known to be widely used for cell cultures,
fibroblasts can also be sampled for clinical
analysis that imply a skin biopsy or the collection
of wound fluid. Please refer to NCI:
URL:https://ncithesaurus.nci.nih.gov/
ncitbrowser/ConceptReport.jsp?
2
SEND team would like to create a SEND EPOCH II

codelist, similar to the SDTM EPOCH codelist
(C99079). Not all terms will be needed, but
harmonization where possible would be ideal.
SEND Extended Leadership approval to move
forward with this request received 18-Aug-2021.
Links to JIRA-301 and JIRA-514 (in part).
New term needed for codelist SPECCOND II
defined as: "A part of a tube device has been
fractured or damaged."
Definition: An in vitro assay used to determine II SDTM-Published in P50

the presence of antibodies capable of inducing
effector cell cytotoxicity.
Synonyms: ADCC
For reference, see
https://www.promega.com/-/media/files/resour
ces/protocols/technical-manuals/101/adcc-
reporter-bioassay-core-kit-protocol.pdf?la=en.
This assay is being used in an influenza trial.
New synonym "Liver Cytosolic Protein Type 1 II Do not add (P50): Do

Antibody" suggested for term "Liver Kidney not add. These are not
Microsomal Type 1 Antibody/LKM1AB" synonymous (see
(C96683?). Please refer to the article of "J https://pubmed.ncbi.nlm.
Immunol Methods" 1995 Dec 1:259-64. nih.gov/9659171/).
"Detection of anti-liver cytosol antibody type 1
(anti-LC1) by immunodiffusion,
counterimmunoelectrophoresis and
immunoblotting: comparison of different
techniques"; L Muratori 1, M Cataleta, P
Muratori, P Manotti, M Lenzi, F Cassani, F B
Bianchi.
Haemozoin is a disposal product formed from II SDTM-Published in P50

the digestion of blood by some blood-feeding
parasites. These hematophagous organisms such
as malaria parasites, Rhodnius and Schistosoma
digest haemoglobin and release high quantities
of free heme, which is the non-protein
component of haemoglobin.
CAR (Chimeric Antigen Receptor) T cells are given II SDTM, SEND-Published

to cancer patients as a way of boosting their in P49
immune response to cancer cells. After the
patient's own T cells are genetically modified,
they are infused back into the patient's body at a
"rate" of so may cells per m2 of body surface
area. So 'cells/m2' would be the "protocol
specified unit" to be captured in ECDOSU.
These values have been used in the Diabetes II SDTM-Published in P50
User Guides and are listed in the CDISC notes in
both SDTMIGv3.4 and SDTMv2.0.
The KPS SCALE QRS responses CT spreadsheet II QRS-Published in P48

will be sent separately for QRS CT team review.
The AIMS QRS responses CT spreadsheet will be II QRS-Published in P48

sent separately for QRS CT team review.
The ATLAS QRS responses CT spreadsheet will be II QRS-Published in P48

The KFSS QRS responses CT spreadsheet will be II QRS-Published in P48

The HAM-A QRS responses CT spreadsheet will II QRS-Published in P48

be sent separately for QRS CT team review.
Synonym: Nanogram Equivalent II SDTM, SEND-Published

Definition: A unit of relative amount of in P49
substance concentration equal to one nanogram
of an equivalent weight.
Nanogram equivalents of a radiolabeled II SDTM, SEND-Published

substance per gram of matrix or tissue. in P49
New term needed as "MUC5AC Gene/MUC5AC" II Do not add (P49).
with synonym "Mucin 5AC, Oligomeric Please use the
Mucus/Gel-Forming" defined as: "A published GFTEST of
measurement of Mucin 5AC, Oligomeric 'Transcription' and put
Mucus/Gel-Forming in a biological specimen." MUC5AC gene symbol
This gene into the GFSYM
plays a major role in the protection of the variable.
respiratory and gastrointestinal tracts. Under
pathological conditions, MUC5AC expression can
be altered. For example, MUC5AC level is
increased in asthma, Cystic Fibrosis and COPD.
MUC5AC is also used as a marker of gastric
phenotype in stomach tumours.
Please refer to NCI:

tReport.jsp?
2 and article
http://atlasgeneticsoncology.org/Genes/GC_MU
C5AC.html.
This term is mentioned in the SDTMIG 3.4 OI II SDTM-Published in P50

assumptions and is a non-traditional taxonomic
parameter used to describe Mycobacterium
tuberculosis.
https://wiki.cdisc.org/display/SDTMIG/
OI+Assumptions
https://www.mbovis.org/spoligotype-
nomenclature.php
http://www.pasteur-guadeloupe.fr:8081/
SITVITDemo/
APACHE II responses CT spreadsheet will be sent II QRS-Published in P48

separately for QRS CT team review
Jordan,
Attached is the draft APACHE II responses CT
spreadsheet for QRS CT team review. Please let
me know if you have any questions.
Steve
If doing a coding update, consider submission II SDTM, SEND-Published
value 'ga'). But consider if needle gauge is in P49
actually a TEST (General team is adding a FATEST
value of 'Needle Gauge') so could this be unitless
such that the term should just be removed?
Please create synonym "Mast Cells/Leukocytes" II

for lab term C96671 "Immature
Basophils/Leukocytes / BASOIMLE" defined as:
"A relative measurement (ratio or percentage) of
immature basophils to total leukocytes in a
biological specimen".
Mastocytes (or Mast Cells) are very similar to

basophilic granulocytes in the blood but they are
"housed" in the tissues. Bone marrow precursor
mast cells and basophils are thought to express
the CD34 molecule. The basophil leaves the
already mature bone marrow, while the mast cell
circulates in an immature form, maturing only
once in a tissue site.
Searchers have demonstrated the clinical II
significance of the measurement of serum
concentrations of specific IgE antibodies to
staphylococcal enterotoxin (SE) A- and SEB in
some atopic diseases such as asthma or atopic
dermatitis.
Please refer to the article of J. bras. pneumol. 42

(05) Sep-Oct 2016, Jose Elabras, Filho,Fernanda,
Carvalho de Queiroz, MelloOmar LupiBlanca,
Elena Rios, Gomes BicaJose, Angelo de Souza,
PapiAlfeu, Tavares Franca - "Staphylococcal
superantigen-specific IgE antibodies: degree of
sensitization and association with severity of
asthma".
And also article of Pediatr Int. 2004

Jun;46(3):337-41, Fumihito Ide, Tomoyo
Matsubara, Miho Kaneko, Takashi Ichiyama,
Tokuko Mukouyama, Susumu Furukawa -
"Staphylococcal enterotoxin-specific IgE
antibodies in atopic dermatitis".
The term "American Indian" is not representative II Do not add (P48): Do
of the plurality of indigenous people in the not change. The team
Americas. Southamerican native people have agrees in principle to
been fighting to stop the so-called "Indian" what the requester is
name, a term original from colonization and saying here, however,
decimation of these populations. Most do prefer the submission values
the term "indigenous" or "native people" as within the RACE codelist
indigenous means native of a site. must reflect those valid
The suggestion is that the term is not only values set out by the US
corrected but also divided, as the native Government's Office of
population in North America is very and Management and
extremely different from the hundreds of Budget:
indigenous populations in Brazil for example. https://obamawhitehous
e.archives.gov/omb/fedr
A better representation could be: eg_1997standards. The
- native American (indigenous/native people US FDA is required, by
from North America) law, to collect those
- indigenous people (indigenous/native people values specifically in
from South America) data submissions. The
- other indigenous people (any other native team agrees in principle
background). to what the requester is
saying here, however,
the submission value for
this concept must reflect
those valid values set
out by the US
Government's Office of
Management and
Budget:
https://obamawhitehous
e.archives.gov/omb/fedr
eg_1997standards.
However, the 'Race as
Collected' codelist may
include more inclusive
terms suggested by the
requester as additional
Searchers have demonstrated the clinical II
significance of the measurement of serum
concentrations of specific IgE antibodies to
staphylococcal enterotoxin (SE) A- and SEB in
some atopic diseases such as asthma or atopic
dermatitis.
Please refer to the article of J. bras. pneumol. 42

(05) Sep-Oct 2016, Jose Elabras, Filho,Fernanda,
Carvalho de Queiroz, MelloOmar LupiBlanca,
Elena Rios, Gomes BicaJose, Angelo de Souza,
PapiAlfeu, Tavares Franca - "Staphylococcal
superantigen-specific IgE antibodies: degree of
sensitization and association with severity of
asthma".
And also article of Pediatr Int. 2004

Jun;46(3):337-41, Fumihito Ide, Tomoyo
Matsubara, Miho Kaneko, Takashi Ichiyama,
Tokuko Mukouyama, Susumu Furukawa -
"Staphylococcal enterotoxin-specific IgE
antibodies in atopic dermatitis".
A new CDISC term would be needed for II SDTM, SEND-Published
"Hypoxanthine-Guanine in P50
Phosphoribosyltransferase" /HGPRT defined as:
"A measurement of hypoxanthine
phosphoribosyltransferase 1 (Lesch-Nyhan
Syndrome) in a biological specimen".
Please refer to NCI URL:

tReport.jsp?
6
Hypoxanthine-guanine
phosphoribosyltransferase (or Hypoxanthine
Phosphoribosyltransferase 1) is encoded by the
human HPRT1 (or HGPTR) gene. This protein
plays a role in nucleoside metabolism.
Hypoxanthine guanine phosphoribosyl
transferase (HGPRT) deficiency is an inherited
disease of purine metabolism with
overproduction of uric acid and a spectrum of
neurological manifestations depending on the
degree of enzyme deficiency. The most severe
expression is the Lesch-Nyhan Syndrome that is a
rare genetic disease.
https://www.orpha.net/data/patho/Han/Int/fr/L
aMaladieDeLeschNyhan_FR_fr_HAN_ORPHA510.
pdf
A new CDISC term would needed for II SDTM, SEND-Published

"Hemoglobin Variant" / HGBVAR defined as "The in P50
measurement of hemoglobin variants in a
biological specimen.".
Please refer to NCI:

URL:https://nciterms.nci.nih.gov/ncitbrowser/Co
nceptReport.jsp?
45
Craig, these codelists have already been II SDTM - Published in P48

developed by the ECG team so we just need a
request number. Please see the ECG working
doc, and HEGRDMTH and TWOFFMTH tabs.
Thank you. Jordan

1. link TSPARM/CD = ECG Read II
Method/EGRDMETH (C119564) to the NEW
result codelist: HEGRDMTH (in the ECG working
doc); and existing result codelist: ECG Read
Method Response (C172333) 2. link TSPARM/CD
= ECG Twave Algorithm/EGTWVALG (C119582) to
the NEW result codelist: TWOFFMTH (in the EG
working doc) 3. link TSPARM = ECG Planned
Primary Lead to the ECG LEAD codelist (C90013).
Please add terms 'STIMTECH' / 'Stimulation II

Technique' to DUTEST/CD codelist to map
information on sensory nerve action potential
tests performed; see references available
(https://www.ncbi.nlm.nih.gov/pmc/articles/PM
C6123936/) that provide details on
antidromic/orthodromic responses collected
when performing these tests. Thank you!
A measurement of the Cytomegalovirus in a II SDTM - Published in

For scenarios when methodology used is

unknown or unspecified
A measurement of the Ebola virus in a biological II SDTM - Published in

specimen. P48
A measurement of the influenza A and/or B in a II SDTM - Published in

A measurement of the Epstein-Barr Virus in a II SDTM - Published in

biological specimen P48
When method is unknown or unspecified
Definition = The date breastfeeding started. II
Definition: The date breastfeeding ended. II

File Emailed Separately II SDTM, SEND, CDASH,
Protocol, Define-XML -
Please find attached those new terms and Published in P47
changes in CDISC P47 that just require request
codes. These do not need to be added into the
team working documents.
Erin
Please see file provided to Erin Tibbs Slone II SEND-Published in P49
Hello,
Please find attached new term request.
Please could you let me know when these terms

will be discussed as I'd like to join the meeting.
Best regards
Rachel
CPLRFLT (C168125) and Capillary Refill Time II

(C168125) currently exist on the Vital Signs Test
Code / Vital Signs Test Name SDTM codelists
(C66741/C67153) but do not exist in SEND
codelists. Requestor is also curious if the
cardiovascular lists are a more appropriate place
than vital signs.
Definition: An assessment of the bone marrow II

response of the disease to the therapy
Reference - 2018 Hallek Paper IWCLL Criteria
Responses collected for this item include CR, PR,

SO, PD, NE
Please reference Table 4 in the 2018 Hallek II

paper IWCLL Criteria.
Consistency with similar Codelist Oncology II
Response Assessment Test Name.
Test Name - Non-target Response update to

Non-Target Response
Test Name - Non-target Enhancing Response

update to Non-Target Enhancing Response
Test Name - Non-target Non-enhancing

Response update to Non-Target Non-Enhancing
Response
Based on the name and definition of the codelist, II SDTM-Published in P50

it does not seem that a new term would ever be
appropriate.
SDTMIGRS II
3.1.1
3.1.2
3.1.3
3.2 (old 3,2)
3.3 (old (3,3)
Version 3.1.2 Amendment 1
Needed for define XML specifications. See II

section 4,1,1 in Define XML v2,1 specifications
for example.
Definition - An assessment of the Neurological II

Status as a condition of disease response to
therapy.
Oncology Response Assessment Result include:

IMPROVED
STABLE
WORSENED
NE
Definition - FUHRMAN TUMOR GRADE - A II SDTM, SEND-Published

system used to grade certain types of kidney in P50
cancer.
Definition - WHO/ISUP GRADE - A histological

system used to grade subtypes of renal cell
carcinoma.
Please create new test name 'Phosphorylated II SDTM, SEND-Published
Tau 181' with test code 'PTAU181'. Than k you! in P50
This data is being collected in clinical trials. II
Definition: II SDTM-Published in P49
DECLINED TO CONTINUE INTO NEXT TRIAL

SEGMENT - An indication that the subject has
declined to continue into the next trial segment.
OPTED TO CONTINUE INTO NEXT TRIAL

SEGMENT - An indication that the subject has
opted to continue into the next trial segment.
Collected response within clinical trials. II
Definition: Presence of endometrial tissue II SEND-Published in P49

outside of endometrium and myometrium,
consisting of both endometrial glands and
stroma
Adenomyosis can be seen in many species.

Endometriosis is just as the definition implies ?
glands implant on serosal surfaces throughout
the abdomen and can be much more serious
than adenomyosis.
Need for NHP studies. It was last requested in

2019, asking for it to be put on hold until the
INHAND terms were complete. It has now been
another 2 years since that request and we are
using it on studies
This information is being collected clinical trials. II
*** File emailed separately
This data is being collected in clinical trials. II
Hi NCI, II Do not add (P50): Dual-

probe in Situ
I am submitting this via email as the NCI term Hybridization (Code
suggestion portal is generating and internal C159521) - Do not
server error. discuss. This is out of
scope for CDISC CT as
We have considered extending the method this NCI C-code is not in
codelist to accommodate these two terms: use as a CDISC term.
Dual-probe in Situ Hybridization (Code C159521) EVS personnel to follow
--> could you please double check the definition? up with the requester
Why does the definition specifically mention the separately.
targets of HER2/Chr 17? We purposely did not Do not add (P50):
use this term as we thought the definition was too HER2/Neu Status by
target speciifc, where there are applications to Validated Dual-probe in
use DISH in the context of not only breast, but Situ Hybridization (Code
also prostate cancer as well. C156892) - Do not
discuss. This is out of
HER2/Neu Status by Validated Dual-probe in Situ scope for CDISC CT as
Hybridization (Code C156892) --> If this term is this NCI C-code is not in
the status (result), why does the definition reflect use as a CDISC term.
the method/assay instead? EVS personnel to follow
up with the requester
Instead, we created a separate sponsor- separately.
extension term linked to code C159521, with the
definition: A laboratory procedure that uses two
different DNA or RNA probes to detect the
presence of complementary sequences in
chromosomes, cells, or tissues.
Thanks,
Ivan
Please consider adding term "Apoptotic Cells" to II Do not add (P50):
LB Codelists. Cells which have undergone Request withdrawn by
programmed cell death. This begins when cells requester.
receive internal or external signals, then proceed
through a series of characteristic stages typically
including rounding-up of the cells, retraction of
pseudopods, reduction of cellular volume
(pyknosis), chromatin condensation, nuclear
fragmentation (karyorrhexis), plasma membrane
blebbing, ending with the death of the cells and
rapid phagocytosis by neighboring cells.
Detection of apoptotic cells in tissue samples
currently relies on the TUNEL assay. Suggested
CDISC definition: The measurement of apoptotic
cells in a biological specimen. Suggested
LBTESTCD: APOPCE. Thank you.
Please consider adding term "Necrotic Cells" to II Do not add (P50):

LB Codelists. Necrotic cells have undergone a Request withdrawn by
type of cell death that is morphologically requester.
characterized by an increasingly translucent
cytoplasm, swelling of organelles, minor
ultrastructural modifications of the nucleus
(specifically, dilatation of the nuclear membrane
and condensation of chromatin into small,
irregular, circumscribed patches) and increased
cell volume (oncosis), culminating in the
disruption of the plasma membrane and
subsequent loss of intracellular contents. Necrotic
cells do not fragment into discrete corpses as
their apoptotic counterparts do. Moreover, their
nuclei remain intact and can aggregate and
accumulate in necrotic tissues. This lab data is
being reported qualitatively, e.g., present, many,
occasional, etc.. Suggested CDISC definition: A
measurement of necrotic cells in a biological
specimen. Suggested LBTESTCD: NECRCE
Reference: II Do not add (P50):

https://www.cellsignal.com/pathways/necrotic- Request withdrawn by
cell-death-pathway. requester.
Please consider adding term Necrotic Cells/Total
Cells to LB Codelists. This lab data is being
reported as a %. Suggested CDISC definition: A
necrotic cells to total cells in a biological
specimen. Suggested LBTESTCD: NECRCECE.
Thank you.
P50
Submission Value:SARS-CoV-2 Antibody Do not add (P50):
Signal/CutoffCytomegalovirus PJRAG - Do not add.
AntibodyPneumocystis jiroveci Published in P49.
AntigenHelicobacter pylori
AntibodyStaphylococcus aureus DNALegionella
pneumophilaHepatitis D Virus RNAEnterobacter
cloacaeHerpes Simplex Virus 1/2
DNAPneumocystis jiroveci AntigenHuman
Parainfluenza Virus 1Human rhinovirusInfluenza
AInfluenza BAspergillus IgE AntibodyHIV-1/2 IgG
AntibodyEscherichia coli VerotoxinVibrio
parahaemolyticus DNALegionella longbeachae
DNA
For SENDIG v3.2. Request received from PCPP II

Team on 16-Sept-2021.
It was suggested during a Demographics As II SDTM-Published in P49

Collected SDTM sub-team working meeting that
site transfers could be identified using DS as an
"Other Event", such that any data collected
before or after the DSSTDTC associated with this
"other event" of Site Transfer could be attributed
as being collected by the appropriate site.
A measurement of the Influenza A virus an II SDTM-Published in P50

A measurement of the Influenza B virus an
Hi,
Please find attached multiple term requests for

MUSCTS/MUSCTSCD and
VSTEST/VSTESTCD.
Thanks!
Aparna
Similar to other organs where there are two II
laterally opposed parts of the same "organ" these
values would allow for test results that result from
tests performed on a specific eye (which is not
the FOCID of the study) can be attributed to the
correct eye, as well as the findings be designated
with the proper laterality/directionality within the
context of each eye. Synonym values of these
two locations are defined and in regular use in
ophthalmology and optometry, using the values of
OD (oculus dextrus) meaning the right eye, and
OS (oculus sinister) meaning the left eye. The
SDTM LOC codelist already has some examples
of side-specific parts of an organ bi-lateral,
complex organ in Colon (Left / Right), Cerebral
Hemisphere (Left/Right) and Colon (Left/Right).
One could even imaging that Kidney should have
the same distinction with a left and right
delineation.
To be used in clinical studies II
Treatment recommendations for patients with

Waldenstrom macroglobulinemia (WM) and
related disorders: IWWM-7 consensus. (Meletios
A. Dimopoulos, Efstathios Kastritis, Roger G.
Owen, Robert A. Kyle, Ola Landgren, Enrica
Morra, Xavier Leleu, Ramon Garcia-Sanz, Nikhil
Munshi, Kenneth C. Anderson, Evangelos
Terpos, Irene M. Ghobrial, Pierre Morel, David
Maloney, Mathias Rummel, Veronique Leblond,
Ranjana H. Advani, Morie A. Gertz, Charalampia
Kyriakou, Sheeba K. Thomas, Bart Barlogie,
Stephanie A. Gregory, Eva Kimby, Giampaolo
Merlini, and Steven P. Treon)
Lab test "Euglobulin Clot Lysis" has a CPT Code: II SDTM, SEND-Published
85360; CPT Description: Euglobulin lysis (clot in P50
dissolving) measurement.
LOINC has deprecated this lab test code;
however, several laboratories still refer to this lab
test as Euglobulin Clot Lysis or Euglobulin Lysis
Time. NCI Metathesaurus has Euglobulin lysis
time measurement (CUI C0427599).
Other References:
https://testdirectory.questdiagnostics.com/test/tes
t-detail/462/euglobulin-clot-lysis-time?
cc=MASTER -and-
https://www.labcorp.com/assets/5191 -and-
https://www.mayocliniclabs.com/test-catalog/Over
view/75738
Proposed CDISC LBTEST Name: Euglobulin Clot
Lysis Time; Proposed LBTESTCD: ECLT;
Proposed CDISC definition: A measurement of
the amount of time it takes for dissolution of a
fibrin clot from the euglobulin fraction of blood in a
Trypsin and Chymotrypsin treatments are II

associated with ARMOUR UNITS (or AU).
The Neutrophil/lymphocyte ratio (NLR) is used to II SDTM, SEND-Published
assess criticality of illness. in P50
Eligibility often requires subjects to be on birth II

control, which leads to the CRF collecting
whether the subject is on birth control (Yes/No)
without collecting specific birth control method.
tumor volume is commonly reported in mm^3 II Do not add (P50): Do

units. not add. Synonym of
C67452 with CDISC
submission value uL.
Hi CDSIC Team- II Do not add (P50):
Please see our New CDISC Term request. Infliximab - Do not add.
The names for
Thank you, Therapeutic drug
Jenny measurement tests are
not controlled in LB
domain; only drugs of
abuse.
Do not add (P50):
Adalimumab - Do not
add. The names for
Therapeutic drug
measurement tests are
abuse.
Do not add (P50):
Certolizumab - Do not
add. The names for
Therapeutic drug
abuse.
Do not add (P50):
Tysabri - Do not add.
The names for
Therapeutic drug
abuse.
Do not add (P50):
Golimumab - Do not
add. The names for
Therapeutic drug
The quantity of a product that has been lost. II
File emailed separately. AJCC Version 8 was II QRS-Published in P48
created to improve staging and prognostication
as well as overall risk assessment.
While the identified resources highlight Version
8's use for melanoma staging and pancreatic
cancer staging, the proposed test codes and tests
would be applicable for TNM Staging for most
types of solid tumor cancers. Currently, within
CT, AJCC Version 8 is shown in the CCCAT
clinical classification codelist, however, test codes
and test names have not as yet been requested.
External resources used include
52033/; https://www.nature.com/articles/s41598-
018-28193-4
Folks at NCI/EVS,
In support of the just submitted "New Term

Request Form", for new codelists AJCC2TC and
AJCC2TN, please find attached the "CDISC Multi
Term Request" spreadsheet with the detailed
information in the "New Codelist - New Term" tab.
Please let us know if any more information is

required. Many thanks.
To help explain the use of the SDTM variable II

FOCID in clinical research, it would be useful to
have reference within the CDISC glossary of this
concept. It comes from the BRIDG model and is
defined as "A physical entity which is the primary
unit of interest in a specific research objective".
Within a study the Experimental Unit is often the
same as the glossary term of "clinical research
subject", but based upon the CDISC
Knowledgebase Article at
https://www.cdisc.org/kb/articles/study-subject-vs-
experimental-unit the Experimental Unit can be a
site or location on or in the Clinical Research
Subject, especially when different parts of the
subject's body are treated differently, as directed
by the protocol.
Use in Exposure for the dosing of cells II SDTM, SEND-Published

in P50
Version was released on September 2021 II SDTM-Published in P50

The EPOCH codelist definition needs to be II
updated. Currently it is defined as the name of
the Epoch but the valid values really refer to
epoch types/categorizations. Epoch names tend
to be sponsor defined and contain more
information (like numbers, etc.).
Use in Exposure for the dosing of cells II SDTM, SEND-Published

in P50
STUDY MEDICATION - The act of taking a study II

medication in the treatment phase of a study.
TRIAL SEGMENT - The act of taking part in a

segment of a study.

in P50
Submission Values:
Neuronal Nuclear Type 1 Antibody
Neuronal Nuclear Type 2 Antibody
Amphiphysin Antibody
CV2 Antibody
Ma1 Antibody
Ma2 Antibody
Purkinje Cells Antibody
Cytosolic 5 prime-nucleotidase 1A Ab
Legionella pneumophila
Artemisia vulgaris IgE Antibody
Cryptomeria japonica IgE Antibody
Cancer Antigen 50
Anti-Streptokinase Antibody
Glycylproline Dipeptidyl Aminopeptidase
Ovarian Antibody
Anti-Endometrial Antibody
MDA5 Antibody
TIF1 Gamma Antibody
https://bmcmicrobiol.biomedcentral.com/articles/ II SDTM-Published in P50

10.1186/s12866-019-1427-5
https://pubag.nal.usda.gov/catalog/5919774
Definition - A measurement of the bartonella II

https://neurology.testcatalog.org/show/BART
European LeukemiaNet recommendations for the II
management of chronic myeloid leukemia: 2013.
The 2006 version has been updated.
The existing definition does not have a citation. II
Another (US authority) reference 45 CFR 63.32 -
Data collection instruments mentions :Data-
collection instruments means tests,
questionnaires, inventories, interview schedules
or guides, rating scales, and survey plans or any
other forms which are used to collect information
on substantially identical items from 10 or more
respondents. I would propose a text change
to :Data-collection instruments : Documents or
tools which are used to collect, record or
transcribe information on substantially identical
items from a group of respondents NOTE
instruments can be either electronic or paper
based tests, questionnaires, inventories, interview
schedules or guides, rating scales, and survey
plans or any other forms [after 45 CFR 63.32]
Files emailed separately II QRS-Published in P48
Please consider adding the non-activated PTT II SDTM, SEND-Published

relative measurement LBTEST similar to what in P50
CDISC currently has for Activated PTT/Standard
(C98862). Proposed definition for new term: A
subject's partial thromboplastin time to a standard
or control partial thromboplastin time. In a related
change, please update the current definition for
C98862 to "A relative measurement (ratio or
percentage) of the subject's activated partial
thromboplastin time to a standard or control
activated partial thromboplastin time. Thank you.
Spreadsheet emailed separately. II SDTM-Published in P49
Do not add (P49):
CONTINUING INTO
SURVIVAL FOLLOW-
UP - Do not add. Please
use existing term
C176357/OPTED TO
CONTINUE INTO
SURVIVAL FOLLOW-
UP
Do not add (P49): NOT
CONTINUING INTO
SURVIVAL FOLLOW-
UP - Do not add. Please
use existing term
C176358/DECLINED
TO CONTINUE INTO
SURVIVAL FOLLOW-
UP
We have a lot of this type of specimen types for II Do not add (P49): Do
oncology studies. not add. The concept of
extraction should be
modeled in BE and
RELSPEC, not pre-
proposed SPECTYPE
value. Additionally,
genetic specimen types
belong in GENSMP,
A measurement of the 25-Hydroxyvitamin D in a II Do not add
codelist not (P50): Do
SPECTYPE
biological specimen. not add. Please
codelist (The SPEC use
existing
variable term 'C156529'.
is supported by
25-Hydroxyvitamin D is
both codelists and the
a synonym
team agreesoftothis
keep
concept.
genetic sample
materials separate from
other material types in
A measurement of the 25-Hydroxyvitamin D in a II Do not add (P50): Do
SPECTYPE.
biological specimen. not add. Please use
existing term 'C156529'.
25-Hydroxyvitamin D is
a synonym of this
concept.
This is for a FDA COA developed by C-Path II QRS-Published in P48

This is for SDTMIG v3.4. II SDTM - Published in
P48
Please update the Subject Visit domain definition
from "An events domain that contains information
for each subject's actual and planned visits and
contact events." to "A special purpose domain
that contains information for each subject's actual
and planned visits."
For SEND purposes. Suggested definitions II SDTM, SEND-published

would be: in P49
Do not add (P49).
h*ng/mL/(ug/kg/day): Hours times nanograms per ug/mL/(mg/kg/day) and
milliliter (concentration), divided by micrograms ng/mL/(ug/kg/day) are
per kilogram per day (daily dose normalized by mathematical
body weight). synonyms. Consider
using ng/mL/(ug/kg/day)
ng/mL/(ug/kg/day): Nanograms per milliliter in the PK Units of
(concentration), divided by micrograms per Measure - Dose ug
kilogram per day (daily dose normalized by body subset codelist, or you
weight). can add this term as an
extensible value to
Reason for request: The existing published terms PKUNIT.
are not considered synonyms since one term is
the test article concentration and the other term is
the dose.
Dear CDISC,
Please find multiterm request attached.
Kind regards,
Kathleen
Our team is supporting a study that is testing for II SDTM, SEND-Published

4-hydroxynonenal and malondialdehye. Addition in P50
to the codeslist is requested.
Oncology compounds requiring to differentiate II
DOSE DELAY from DOSE INTERRUPTED for
the AEs. ACN is non-extensible code list so
please consider to add this value.
Please add test name Hydroxychloroquine; II Do not add (P50): Do
suggested test code: HDRXCLQ. Thank you! not add. This is not
considered a drug of
abuse and therefore will
not be included with Lab
CDISC CT. It can be an
extensible term IF it is
determined that it should
be modeled in LB
domain.; please use
standard drug
nomenclature from
another source.
Please create a new Lupus Anticoagulant test II

(with suggested test code of 'LA') which we need
for our trials; please note that there is an existing
test DRVVT/Dilute Russell's Viper Venom Time
that has a synonym of 'Lupus Anticoagulant Test',
however I don't think there is true synonymy
between these two tests; please see
https://www.labcorp.com/resource/lupus-
anticoagulants for reference. Thank you!
New GFTEST/CD term Immunogenetic II

variation/IMGEVAR needed for different genes or
variants used in oncology or Imunology &
Inflammation studies. Definition suggested is "A
quantitative or qualitative assessment of the
number of genomic alterations found in
immunogenetic material as compared to a
reference sequence, in a biological specimen."
New term GRANULOCYTE is needed in II SDTM-Published in P49

SPECTYPE codelist defined as "A type of
immune cell that has granules with enzymes that
are released during infections, allergic reactions,
and asthma. Neutrophils, eosinophils, and
basophils are granulocytes. A granulocyte is a
type of white blood cell or polymorphonuclear
leukocyte." (NCI)
New term NATURAL KILLER CELL is needed in II SDTM-Published in P49

SPECTYPE codelist defined as "A type of white
blood cell that contains granules with enzymes
that can kill tumor cells, microbial cells or target
cells using antibody-dependent cell-mediated
cytotoxicity. Also called large granular
lymphocytes which do not express markers of
either T or B cell lineage."(NCI).
New term LYMPHOCYTE needed in SPECTYPE II SDTM-Published in P49
codelist defined as "A type of immune cell that is
made in the bone marrow and is found in the
blood and in lymph tissue. The two main types of
lymphocytes are B lymphocytes and T
lymphocytes. B lymphocytes make antibodies,
and T lymphocytes help kill tumor cells and help
control immune responses. A lymphocyte is a
type of white blood cell."(NCI).
New term needed defined as "A measurement of II

the CD38 mRNA isoform A in a biological
specimen."
New term needed defined as "A measurement of II
the CD38 mRNA all isoforms in a biological
specimen."
New term needed defined as "A measurement of II SDTM, SEND-Published
the soluble form of CD38 in a biological in P50
specimen.".
A new term is requested for "A measurement of II Do not add (P50): Do
the CD38 MAb1 sABC expressing cells per unit in not add. Please use
a biological specimen.". CPTEST of Target
Occupancy and
CD38 is used as a marker to assess in vitro CD38 following modeling
receptor occupancy in different types of cells strategies in
(below we have lymphocytes, monocytes, cancer SDTMIGv3.4 CP
cells, polymorph cells, Natural Killer cells) and to examples 7-9 for more
determine the CD38 receptor density (RD) and detailed explanation of
occupancy (RO), based on the use of two murine how to use the rest of
MAbs, one competing with an investigational drug the variables in the CP
to determine the number of free CD38 receptors domain.
(MAb1) and one recognizing a different binding
epitope on CD38 to measure the total number of
receptors (MAb2) at the cell surface.
The sABC (specific antibody binding capacity)

provide the corresponding numbers of bound
MAb molecules.
A new term is requested for "A measurement of II Do not add (P50): Do
the CD38 MAb2 sABC expressing cells per unit in not add. Please use
a biological specimen.". CPTEST of Target
Occupancy and
CD38 is used as a marker to assess in vitro CD38 following modeling
receptor occupancy in different types of cells strategies in
(below we have lymphocytes, monocytes, cancer SDTMIGv3.4 CP
cells, polymorph cells, Natural Killer cells) and to examples 7-9 for more
determine the CD38 receptor density (RD) and detailed explanation of
occupancy (RO), based on the use of two murine how to use the rest of
MAbs, one competing with an investigational drug the variables in the CP
to determine the number of free CD38 receptors domain.
(MAb1) and one recognizing a different binding
epitope on CD38 to measure the total number of
receptors (MAb2) at the cell surface.
The sABC (specific antibody binding capacity)

provide the corresponding numbers of bound
MAb molecules.
A new term is needed for "A measurement of the II Do not add (P50): Do
CD38 receptor density of cells in a biological not add. Please review
specimen." Request linked to the 2 previous SDTMIGv3.4 CP
others for CD38 MAb1 sABC and CD38 MAb2 domain example 9 for
sABC measurements. how to model this data.
New term "CD38 RECEPTOR OCCUPANCY" is II
needed defined as"An unspecified formula to
estimate the CD38 receptor occupancy of cells in
a biological specimen."
This calculation is based on two murine MAbs,

one competing with a drug to determine the
number of free CD38 receptors (MAb1) and the
other recognizing a different binding epitope on
CD38 to measure the total number of receptors
(MAb2) at the cell surface.
Please refer to article: Cytometry Part B (Clinical

Cytometry) 90B:150?158 (2016), "How Validated
Receptor Occupancy Flow Cytometry Assays
Can Impact Decisions and Support Drug
Development", Maxime Moulard and Marie-Laure
Ozoux, Biomarkers Department, BioCytex,
Marseille, France.
Creation of a new codelist is requested : II

ISTSTDTL. Definition suggested : "Terminology
relevant to the additional descriptions of the test
being performed to produce the immunogenicity
test result."
A new term "PERCENTAGE OCCUPANCY" II
would be needed in codelist ISTSTDTL. Definition
suggested is "A measurement of the percentage
occupancy in a biological specimen."
A new term "BOUND CONCENTRATION" would II

be needed in codelist ISTSTDTL. Definition
suggested is "Describes the amount of trimers
related to a standard curve that have bound the
drug in comparison to a situation were with an
excess of drug."
A new term "PERCENT INHIBITION" would be II

needed in codelist ISTSTDTL. Definition
suggested is :"The rate of measured normal
activity minus inhibited activity, divided by the rate
of normal activity of a given object. It is expressed
as a percentage."
A new term "TOTAL CONCENTRATION" would II

be needed in codelist ISTSTDTL. Definition
suggested is "The total quantity of a specified
substance in a unit volume or weight of another
substance."
I presume the 1 and 3 minutes are covered by II
time points, but I presume this requires a new
VSTESTCD/VSTEST pair. Or, would "difference"
go into VSMETHOD or another variable?
Also see:
https://www.cdc.gov/steadi/pdf/Measuring_Orthos
tatic_Blood_Pressure-print.pdf
and
https://www.aafp.org/afp/2011/0901/p527.html
I presume the 1 and 3 minutes are covered by II

time points, but I presume this requires a new
VSTESTCD/VSTEST pair. Or, would "difference"
go into VSMETHOD or another variable?
Also see:
https://www.cdc.gov/steadi/pdf/Measuring_Orthos
tatic_Blood_Pressure-print.pdf
and
https://www.aafp.org/afp/2011/0901/p527.html
SC definition is "A findings domain that contains II

subject-related data not collected in other
domains." However, SDTM domains represent
data, they do not collect them. Suggest changing
"collected" to "represented". Also, this "not
elsewhere represented" definition is weak and
could easily result in many kinds of data being
represented in SC.
This may need to wait until the Integumentary II
System domain is created.
Capture tumor location for optic glioma II
New term needed IDLLDL/"IDL Cholesterol/LDL II SDTM, SEND-Published

Cholesterol" defined as "A relative measurement in P50
(ratio or percentage) of the intermediate density
lipoprotein cholesterol to low density lipoprotein
cholesterol in a biological specimen."
This ratio can provide with an estimate of the
relative risk for coronary atherosclerotic disease.
Please refer to article
https://pubmed.ncbi.nlm.nih.gov/1505659/ (IDL,
VLDL, chylomicrons and atherosclerosis).
EXCEL FILE OF TERMS EMAILED II

SEPARATELY
DOMAIN LABEL
Variable Name: MIRESMOD
Variable Label: Result modifier(s) of finding
Type: Char
Controlled Terms, Codelist, or Format: To be

determined by CT
Role: Variable Qualifier
CDISC Notes: Key noun or adjective modifiers in

addition to MISEV, MICHRON and MIDISTR that
further describe or qualify the base pathological
process contained in MISTRESC
Core: Exp
Definition: The tough outer layer of tissue that II

covers and protects the brain and spinal cord and
is closest to the skull. The dura mater is one of
the three layers that form the meninges.
cancer-terms/def/dura-mater
This domain has somehow been left out of CT. II

The domain is described in the SDTM and in the
SDTMIG-AP. A suggested draft definition: A
dataset used to represent relationships between
associated persons and study subjects.
Definition: The patient will be receiving care at II

non-hospital intermediate care center.
Definition: A specimen that has gone beyond the II

defined stability limit.
Both CARDIOVASCULAR PHARMACOLOGY II

and RESPIRATORY PHARMACOLOGY are
separate published terms. The combination was
previously rejected as parts of Packages 26 and
39 with guidance given to use two rows for
SSTYP. A conformance rule has since been
published indicating that only one SSTYP
TSPARMCD should be included in TS.
mkat/L or Millikatal per Litre is used in a original II

lab tests. mkat, nkat/L, pkat/L and ukat/L exists
in the 2021-09-24 release. It doesn't appear that
this would be a synonym of another value and
could be added.
Hello,
Attached request for multiple term request for
your consideration.
Thanks,
David Fielding
According to the Change Request Tracker, for II SEND-Published in P50
Oxygen Saturation measured by a pulse
oximetry, "Oxygen Saturation" has added into
VSTEST in SDTM since 2012. In order to use the
same, please add the term into the codelist
"SVSTST" referred from variable "VSTEST" in
SENDIG v3.1.
According to the Change Request Tracker, for

Oxygen Saturation measured by a pulse
oximetry, "OXYSAT" has added into VSTESTCD
in SDTM since 2012. In order to use the same,
please add the term into the codelist
"SVSTSTCD" referred from variable
"VSTESTCD" in SENDIG v3.1.
Terminology currently missing from SDTM Lab II SDTM, SEND-Published

CT in P50
I just need a request code for these three II QRS-Published in P48

requests: Changes to Existing QRS CATs; New
EORTC CATs; New FACIT Searchable Item
Library Terminology
These requests have been approved, developed

and are ready for P48 CT publication.
ADD MARESMOD TO THE MA DOMAIN AS A II Do not add (P50): Do

PERMISSIBLE VARIABLE, TO HOUSE not add. Out of scope
RESULTS MODIFIERS INSTEAD OF SUPPMA for CT as this is a
DOMAIN. THIS IS IN KEEPING WITH THE variable request.
CURRENT SENDIG V3.2 ELEVATION OF THE
MIRESMOD TO THE MI DOMAIN.

in P50
Hi CDISC Team- Do not add (P50): OD
New terms to consider Venlafaxine - Do not
Thanks, term
Jenny C147333/Desvenlafaxin
e (O-
desmethylvenlafaxine is
listed as a synonym).
In FHIR AE standards there is a code ONGOING II

for outcome of event. There are no such code in
CDISC. Can this be added to controlled
terminology. If this term is considered same as
NOT RECOVERED/NOT RESOLVED then can
we please harmonize FHIR and CDISC code
values.
Request to update NCI PT for the following C- II QRS-Published in P48
codes
C161653
C161654
C170644
Change "organisation" to "organization"
Hi Brenda, this request has already been

processed by the QRS team, I just need a
request code. Thank you!.
Definition: The date breastfeeding ended. II
Requested Submission Value II SDTM-Published in P49,

Requested Synonym(s) P50
SARS-CoV-2 S Protein RBD Neutralizing Ab

SAR2RBAB
Dengue Virus 1/2/3/4 RNA
DNVRNA
SARS-CoV-2 Spike Protein IgG Antibody
SAR2SIGG
Definition:
SARS-CoV-2 S Protein RBD Neutralizing Ab - A

measurement of the SARS-CoV-2 S protein
receptor binding domain (RBD) neutralizing
Dengue Virus 1/2/3/4 RNA - A measurement of

the Dengue virus serotypes 1, 2, 3 or 4 RNA in a
SARS-CoV-2 Spike Protein IgG Antibody - A

measurement of the SARS-CoV-2 spike protein
A measurement of the Selenium in a biological II SDTM, SEND-Published

specimen. in P50
Hi CDISC Team-
More METHODs to consider
Thanks,
Jenny
SERUM by ELISA method II SDTM, SEND-Published

in P50
SERUM by ELECTROCHEMILUMINESCENCE II Do not add (P50): Do
IMMUNOASSAY Method not add. Please use
'C81982'. A synonym
has been added with
P50.
REAL-TIME POLYMERASE CHAIN REACTION II
ASSAY method
REAL-TIME POLYMERASE CHAIN REACTION II
ASSAY Method
SERUM via Cell-based luciferase reporter virus II
Method
CDISC Definition: A unit of measurement of the II
number of entities per unit of area equal to 10
high powered fields.
Unit used for Mitotic Count

Reference:
https://staging.seer.cancer.gov/cs/input/02.05.50/
net_stomach/ssf6/?version=/tnm/home/1.0/
/2 mm2
Unit used for Mitotic Count

Reference:
http://www.essentialpathology.info/TumorChecklis
t/index.html?Staging4"
The unit BAU/mL is associated to COVID tests II

(i.e. SARS Coronavirus 2 IgG Binding Antibody),
however the unit BAU/mL currently exists in
CDISC as Bioequivalent Allergy Unit per milliliter.
The acronym BAU/mL can have multiple
meanings:
1. Binding Antibody Units/mL (BAU/mL)
2. Binding Activity Units/mL (BAU/mL)
3. Binding Arbitrary Units/mL (BAU/mL)
4. Bioequivalent Allergy Unit/mL (BAU/mL) The
generic unit of U/mL cannot be used for items 1
and 2 above because the conversion factor from
BAU/mL to U/mL are assay specific, therefore we
are requesting a more specific unit be added."
New lab term needed for acquired pseudo II SDTM, SEND-Published

Pelger-Huet nucleus neutrophils with synonym in P50
"Hyposegmented Neutrophils".
Definition suggested: "A measurement of the
neutrophils with pseudo Pelger-Huet nucleus
(hyposegmented neutrophils) in a biological
specimen."
This is different from the genetic "Pelger Huet
Anomaly" (C74617).
Please refer to
https://nciterms.nci.nih.gov/ncitbrowser/ConceptR
eport.jsp?
4 (NCI).
A new lab term is needed for HSV common II Do not add (P50): Do
antigen(HSV1 or HSV2) defined as: "A not add, map to the
measurement of the antigen of the Herpes published value Herpes
Simplex Virus Type 1 or Type 2 in a biological Simplex Virus 1/2
specimen." Antigen.
A new lab test woud be needed for hepatic lipase II SDTM, SEND-Published
defined as : "A measurement of hepatic in P50
triacylglycerol lipase in a biological specimen."
A new lab test would be needed for II SDTM, SEND-Published
Chitotriosidase-1 defined as "A measurement of in P50
the chitotriosidase-1 enzyme in a biological
specimen."
A new lab term would be needed for II SDTM, SEND-Published
Methyltransferase measurement defined as : "A in P50
measurement of the methyltransferase enzyme in
a biological specimen.".
A new lab term would be needed to describe an II
Antinuclear Antibody Pattern defined as "A
description of the antinuclear antibodies
(antibodies that attack the body's own tissue)
pattern in a biological specimen."
Reference : Front Immunol. 2015 Aug
20;6:412,E.K.L. Chan, J. Damoiseaux, O.G.
Carballo, K. Conrad, W. de Melo Cruvinel, P.L.C.
Francescantonio, M.J. Fritzler, I. Garcia-De La
Torre, M. Herold, T. Mimori, M. Satoh, C.A. von
Muhlen, and L.E.C. Andrade. Report of the First
International Consensus on Standardized
Nomenclature of Antinuclear Antibody HEp-2 Cell
Patterns.
Propose II SDTM, SEND-Published

LBTESTCD=TOMREG2 in P50
LBTEST=Tomoregulin-2
SYNONYMS=Tomoregulin-2; TMEFF2;
Transmembrane Protein With EGF-Like And Two
Follistatin-Like Domains 2
DEFN: A measurement of the tomoregulin-2 in a
biological specimen
This test is used to collect overall assessment of II Do not add (P50): Do

several lab parameters. not add. The 'what' you
are interpreting should
still be considered as
the test value, and
interpretation is more of
a result type (which is
either a NSV or Variable
depending on which
version of the IG you are
using). Please use the
published Result type
Response value of
'IMPRESSION' for this
purpose.
New term requests from the DRAGON TA project. II
Hi Brenda,
Pls see the attached multiple term request file.
Thank you,
Jordan
The preejection period (PEP) is the time elapsed II

between the electrical depolarization of the left
ventricle (QRS on the ECG) and the beginning of
ventricular ejection and represents the period of
left ventricular contraction with the cardiac valves
closed.

Do not add (P50):
Dear Madam/Sir, HCVRNA - Do not add.
Map to
Please see attached spreadsheet with a request C142330/Hepatitis C
for some new terms in sheets â€œExist Codelist - Virus RNA
New Test PARMâ€ and â€œExist Codelist -
New Termâ€.
Thanks,
Anje
When the Lugano paper Addendum (Prologue II

collaboration) gets published in future (check in
2022), the oncology SDS team agrees to add the
following comment on rows 36-39 of the
RS_Lugano_Codetable:
Regarding the upcoming addendum to the

Lugano Classification (to be published in future),
the response values Complete Anatomic
Response (CAR), Partial Anatomic Response
(PAR), Stable Anatomic Disease (SAD), and
Progressive Anatomic Disease (PAD) should be
considered functionally synonymous with the
existing published terms of CR, PR, SD, and PD
such that the existing response values should be
used instead of CAR, PAR, SAD, or PAD.
Definition: FIGO (International Federation of II SDTM-Published in P50

Gynecology and Obstetrics system for grading
the pathological stage of endometrial cancer.)
https://www.cancer.org/cancer/endometrial-
cancer/detection-diagnosis-staging/staging.html
New lab test would be need defined as "A II
measurement of the Festuca elatior pollen
antigen IgE antibody in a biological
specimen.".Other synonyms are Festuca
pratensis, Lolium pratense, Meadow ryegrass,
Schedonorus pratensis.

measurement of the Parietaria officinalis pollen
antigen IgE antibody in a biological specimen.".

measurement of the Artemisia vulgaris pollen
antigen IgE antibody in a biological specimen.".

measurement of the Avena sativa pollen antigen
IgE antibody in a biological specimen.".

measurement of the Urtica dioica pollen antigen
IgE antibody in a biological specimen.".
New term would be needed for Italian Cypress II

Pollen IgE defined as "A measurement of the
Cupressus sempervirens pollen antigen IgE
antibody in a biological specimen."
New lab test needed for Alder Grey Pollen IgE II
defined as "A measurement of the alder grey
pollen IgE antibody in a biological specimen."
A new lab test would be needed for Trichinella II
IgM Antibody defined as "A measurement of the
Trichinella IgM antibody in a biological specimen."
A new lab test would be needed for Trichinella II

IgG Antibody defined as "A measurement of the
Trichinella IgG antibody in a biological specimen."
A new lab test would be needed for Toxocara II

canis IgG Antibody defined as "A measurement of
the Toxocara canis IgG antibody in a biological
specimen."
New lab test needed for Taenia solium IgG II
Antibody defined as "A measurement of the
Taenia solium IgG antibody in a biological
specimen."
New tem would be needed for Oriental II
Cockroach Antigen IgE Antibody defined as "A
measurement of the blatta orientalis antigen IgE
antibody in a biological specimen."; LBTEST
German or Amercican Cockroach Antigen IgE
Antibody already exists in CDISC but not
Oriental.
New lab test is needed for Influenza A H3N2 II
Antibody defined as "A measurement of the Anti-
Influenza A H3N2 Antibody in a biological
specimen." MBTEST Influenza A IgG Antibody
(C103408) already exists in CDISC but not type
H3N2
New lab test is needed for Influenza A H1N1 II

Antibody defined as "A measurement of the Anti-
Influenza A H1N1 Antibody in a biological
specimen." MBTEST Influenza A IgG Antibody
(C103408) already exists in CDISC but not type
H1N1..
New lab test needed defined as "A measurement II

of the Epidemic Parotitis Virus IgM antibody in a
New lab test needed for Echinococcus II
multilocularis IgG Antibody defined as "A
measurement of the Echinococcus multilocularis
IgG antibody in a biological specimen.."
New lab test needed for Echinococcus II

granulosus IgG Antibody defined as "A
measurement of the Echinococcus granulosus
IgG antibody in a biological specimen.."
New lab test needed for EBV Nuclear Antigen II
IgG Antibody defined as "A measurement of the
Epstein-Barr Virus Nuclear Antigen IgG Antibody
in a biological specimen." MBTEST Epstein-Barr
Nuclear Antibody (C96603) already exists in
CDISC but with no more precision upon type of
antibody.
New lab test needed for Dengue IgM Antibody II

defined as "A measurement of the Dengue virus
IgM antibody in a biological specimen." MBTEST
Dengue Virus Antibody (C147332) already exists
in CDISC but with no more precision upon type of
antibody.
New lab test needed for Dengue IgG Antibody II

defined as "A measurement of the Dengue virus
IgG antibody in a biological specimen." MBTEST
Dengue Virus Antibody (C147332) already exists
in CDISC but with no more precision upon type of
antibody.
New lab test term needed for Ascaris IgG II

Antibody defined as "A measurement of the
Ascaris IgG antibody in a biological specimen."
A new lab test would be needed for Anti-Zinc II

Transporter 8 Antibody defined as "A
measurement of the anti-zinc transporter 8
antibodies in a biological specimen."
A new lab test wuld be needed for Anti-Indole 3 II
Acetic Acid Antibody defined as "A measurement
of the anti-indole 3 Acetic Acid antibodies in a
A new lab test would be needed for Chemokine II SDTM, SEND-Published
(C-X-C Motif) Receptor 4 defined as "A in P50
measurement of the CXCR4, chemokine (C-X-C
motif) receptor 4, in a biological specimen."
A new lab test would be neeeded for Chemokine II Do not add (P50): Do
(C-C Motif) Ligand 22 defined as "A not add. Already
measurement of the CCL22, chemokine (C-C published as
motif) ligand 22, in a biological specimen." C81956/MDC. We will
A new lab test would be neeeded for Chemokine II Do not add (P50): Do
(C-C Motif) Ligand 2 defined as "A measurement not add. Already
of the CCL2, chemokine (C-C motif) ligand 2, in a published as
biological specimen." C81956/MDC. We will
2 new synonyms are suggested for term II
MICROORG/ADENOVIRIDAE defined as "Any
viral organism that can be assigned to the family
Adenoviridae" if we consider that
ADENOVIRIDAE is a synonym of ADENOVIRUS
as suggested by the NCI (please refer to
eport.jsp?
9).
If we consider 'ADENOVIRIDAE' as the name of
the family for Adenoviruses then term
'ADENOVIRIDAE' should be replaced by
'ADENOVIRUS' in the codelist MICROORG.
According to the 'International Committee on
Taxonomy of Viruses (ICTV), we have 6 genus
for Adenoviruses mainly Mastadenoviruses for
human infections,
Dear Brenda,
Sorry : this request has been sent with the 2
synonyms missing.
Please add the 2 new synonyms 'ADV' and
'Adenovirus' in the request.
Thank you.
Best regards,
Sylvie
II
II
II
II
II
II
This is needed for "Renal CL" parameter II
A new lab test would be needed for Chloroquine II Do not add (P50): Do
defined as "A measurement of the amount of not add. This is not
chloroquine in a biological specimen." considered a drug of
abuse and therefore will
not be included with Lab
CDISC CT. It can be an
extensible term IF it is
determined that it should
be modeled in LB
domain.; please use
standard drug
nomenclature from
another source.
No need to add these into the working II Protocol, Glossary,

documents; they've already been dispositioned SEND, SDTM-Published
as part of P48 in P48
Stat: 113 changes and 84 new terms Do not add (P49):
TUEMPIND / Percent
Change Baseline in
Organ Enlargement /
Abs Change Nadir Org
Enlarg in Orgn Enlg -
request withdrawn by
requester as per e-mail
2021-10-08
A measurement Endothelin-3 in a biological II SDTM, SEND-Published

specimen. in P50
A measurement Phosphatidylethanol in a II SDTM, SEND-Published
A measurement Interferon-inducible Protein-10 in II Do not add (P50): Do
a biological specimen not add. This is
synonymous with
C112238/CXCL10. We
will add a synonym
instead.
A measurement Mesothelin in a biological II

specimen.
A new lab test would be needed for Biclonal M II
protein defined as "A quantitative or qualitative
measurement of biclonal M protein in a biological
specimen."
This is linked to biclonal gammopathy due to the
primary disturbance in immunoglobulin synthesis
characterized by the presence of two distinct
monoclonal immunoglobulins in the serum or
urine." Please refer to http://nciws-
p803.nci.nih.gov:9080/ncitbrowser/ConceptRepor
t.jsp?
6.
A new lab test would be needed for Digitoxin II

defined as "A measurement of the amount of
Digitoxin in a biological specimen."
A new lab test would be needed for TATA Box II
Binding Protei defined as "A measurement of
TATA sequence-binding protein in a biological
specimen."
TATA-box-binding protein is encoded by the
human TBP gene and is involved in both DNA
binding and gene transcription initiation. Please
refer to
URL:https://nciterms.nci.nih.gov/ncitbrowser/Conc
eptReport.jsp?
8.
Please find file emailed separately. Thanks. II
Dear CDISC-NCI,

form for a few terms suggested by the Sanofi CIG
Team for SDTM terminology in
LBTEST/LBTESTCD paired codelist.
Thank you in advance.
Contact information:
* Business Email: CIG_MAILBOX@sanofi.com
* Name: Sylvie Girond
* Organization: Sanofi
Codelist: II
Category of Clinical Classification
Submission Value
Synonym
MODIFIED ROSS CLASSIFICATION

MDRSC1
Codelist:
Category of Questionnaire
Submission Value
Synonym
Class I
MODIFIED ROSS CLASS I
Class Il
MODIFIED ROSS CLASS Il
Class Ill
MODIFIED ROSS CLASS Ill
Class lV
MODIFIED ROSS CLASS Ill
Submission Value NPI currently exists in the II QRS-Published in P49

STDM Terminology. However, there are two NPI
tests, NPI 10, the original, and NPI 12 which
contains two additional sub-domains: night-time
behavioral disturbances and appetite and eating
abnormalities.
The Codelist currently within the STDM

terminology is NPI 12 as it contains the two
additional sub-domains.
Please update the current CDISC Submission

Value of NPI to NPI-12 and update definition to
Neuropsychiatric Inventory (NPI) (1995
JCummings; all rights reserved NPI-12 - United
States/English ? Original version.
NPI-12_AU1.1_eng-USori.doc
Add as a separate CDISC Submission Value,

NPI 10 with the corresponding CDISC Synonym
NPI2
Definition: Any bacterial organism that can be II SDTM, SEND-Published

assigned to the species Streptococcus in P50
gallolyticus subspecies pasteurianus.
Definition: A unit of measurement equal to the II
number of copies per unit of mass of genomic
DNA equal to ten nanograms.
dy published, map to C156543.
Date of Request
Submission Code
Open Monday, 3 Jan CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

2022 03:58 PM 5297 fizer.com
Open Tuesday, 4 Jan CDISC- Veerle Coenen Galapagos veerle.coenen@glp

2022 10:28 AM 5298 g.com
Closed Tuesday, 4 Jan CDISC- Veerle Coenen Galapagos veerle.coenen@glp

2022 10:29 AM 5299 g.com
Open Thursday, 6 Jan CDISC- Diane Ball Merck diane_ball@merck.
2022 11:00 AM 5300 com
Closed Thursday, 6 Jan CDISC- Diane Ball Merck diane_ball@merck.
2022 11:02 AM 5301 com
Closed Thursday, 6 Jan CDISC- Jordan Li MSC jvl1230@gmail.com

2022 01:28 PM 5302

2022 01:29 PM 5303 com

2022 01:31 PM 5304 com
Closed Friday, 7 Jan CDISC- Diane Ball Merck diane_ball@merck.

2022 09:22 AM 5305 com
Open Friday, 7 Jan CDISC- Diane Ball Merck diane_ball@merck.
2022 09:59 AM 5306 com

2022 10:02 AM 5307 com
Closed Monday, 10 Jan CDISC- Stephanie Berry Instem stephanie.berry@in
2022 11:58 AM 5308 stem.com
Closed Monday, 10 Jan CDISC- Steve Kopko CDISC skopko.external@c

2022 05:00 PM 5309 disc.org
Closed Monday, 10 Jan CDISC- Steve Kopko CDISC skopko.external@c

2022 05:03 PM 5310 disc.org
Closed Tuesday, 11 Jan CDISC- Diane Ball Merck diane_ball@merck.
2022 11:30 AM 5311 com
Open Wednesday, 12 CDISC- dan potenta Instem dan.potenta@inste

Jan 2022 09:13 5312 m.com
AM
Open Thursday, 13 CDISC- Diane Ball Merck diane_ball@merck.
Jan 2022 12:48 5313 com
PM

2022 12:58 PM 5314 com
Open Tuesday, 18 Jan CDISC- Jenny Jones Covance Jenny.Jones@Cov

2022 11:28 AM 5315 ance.com
Open Tuesday, 18 Jan CDISC- Jenny Jones Covance Jenny.Jones@Cov

2022 11:29 AM 5316 ance.com
Open Tuesday, 18 Jan CDISC- Diane Ball Merck diane_ball@merck.

2022 11:30 AM 5317 com
Closed Tuesday, 18 Jan CDISC- Jenny Jones Covance Jenny.Jones@Cov
2022 01:03 PM 5318 ance.com

Jan 2022 10:53 5319 com
AM
Jan 2022 03:01 5320 com
PM
Open Friday, 21 Jan CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

2022 09:13 AM 5321 fizer.com
Open Wednesday, 26 CDISC- Martin Gram Novo Nordisk xmgm@novonordis

Jan 2022 08:11 5322 k.com
AM
Closed Thursday, 27 CDISC- Steve Kopko CDISC skopko.external@c
Jan 2022 02:16 5323 disc.org
PM
Open Monday, 31 Jan CDISC- Manolya Ezgimen AbbVie manolya.ezgimen

2022 10:04 AM 5324 @abbvie.com
Open Monday, 31 Jan CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2022 02:27 PM 5325 nih.gov
Open Monday, 31 Jan CDISC- Jordan Li MSC Jordan.li@nih.gov
2022 04:44 PM 5326
Open Tuesday, 1 Feb CDISC- Jozef Aerts XML4Pharma jozef.aerts@xml4p

2022 12:11 PM 5327 harma.com
Open Tuesday, 1 Feb CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.
2022 03:20 PM 5328 com
Open Wednesday, 2 CDISC- Svetlana Koltsova Rancho svetlana.koltsova@

Feb 2022 08:40 5329 Biosciences ranchobiosciences.
AM com

Feb 2022 11:51 5330 anofi.com
AM

Feb 2022 02:26 5331 ance.com
PM

Feb 2022 02:26 5332 ance.com
PM
Feb 2022 02:27 5333 ance.com
PM
Feb 2022 02:28 5334 ance.com
PM
Open Thursday, 3 Feb CDISC- Mary Jo Brucker Merck mj_brucker@merck
2022 09:38 AM 5335 .com
Open Thursday, 3 Feb CDISC- Mary Jo Brucker Merck mj_brucker@merck
2022 09:39 AM 5336 .com
Open Thursday, 3 Feb CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2022 09:47 AM 5337 anofi.com

2022 09:47 AM 5338 anofi.com

2022 11:13 AM 5339 anofi.com

2022 11:17 AM 5340 anofi.com
Open Friday, 4 Feb CDISC- Fausto Zuzarte Bayer fausto.zuzarte@ba

2022 09:05 AM 5341 yer.com

2022 09:05 AM 5342 yer.com

2022 09:06 AM 5343 yer.com
2022 09:07 AM 5344 yer.com

2022 09:08 AM 5345 yer.com

2022 09:08 AM 5346 yer.com

2022 09:10 AM 5347 yer.com

2022 09:12 AM 5348 yer.com
2022 09:13 AM 5349 yer.com

2022 09:14 AM 5350 yer.com

2022 11:18 AM 5351 yer.com
Open Friday, 4 Feb CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2022 11:54 AM 5352 om
Open Monday, 7 Feb CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s

2022 09:49 AM 5353 anofi.com

2022 09:50 AM 5354 anofi.com

2022 09:51 AM 5355 anofi.com
Open Monday, 7 Feb CDISC- Manolya Ezgimen AbbVie manolya.ezgimen

2022 09:54 AM 5356 @abbvie.com
2022 11:30 AM 5357 anofi.com

2022 11:31 AM 5358 anofi.com
Open Monday, 7 Feb CDISC- Varma Nadimpalli NIAID varma.nadimpalli@

2022 11:34 AM 5359 nih.gov
Open Monday, 7 Feb CDISC- Diane Ball Merck diane_ball@merck.

2022 12:26 PM 5360 com
Open Monday, 7 Feb CDISC- Diane Ball Merck diane_ball@merck.
2022 04:06 PM 5361 com
Open Tuesday, 8 Feb CDISC- Diane Ball Merck diane_ball@merck.

2022 10:53 AM 5362 com
Open Tuesday, 8 Feb CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s

2022 11:03 AM 5363 anofi.com

2022 11:03 AM 5364 anofi.com

2022 11:04 AM 5365 anofi.com
Closed Tuesday, 8 Feb CDISC- Diane Ball Merck diane_ball@merck.
2022 12:09 PM 5366 com
Open Tuesday, 8 Feb CDISC- Diane Ball Merck diane_ball@merck.

2022 12:10 PM 5367 com
Feb 2022 01:36 5368 anofi.com
PM

Feb 2022 01:41 5369 anofi.com
PM
Open Thursday, 10 CDISC- Arjun Sridharan Novartis arjun.sridharan@no

Feb 2022 09:57 5370 vartis.com
AM
Closed Thursday, 10 CDISC- Jintao Shi Boehringer jintao.shi@boehrin
Feb 2022 10:06 5371 Ingelheim ger-ingelheim.com
AM
Open Thursday, 10 CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

Feb 2022 02:01 5372 om
PM
Open Thursday, 10 CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
Feb 2022 02:02 5373 om
PM
Open Friday, 11 Feb CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s

2022 10:58 AM 5374 anofi.com

2022 11:00 AM 5375 anofi.com

2022 11:00 AM 5376 anofi.com

2022 11:01 AM 5377 anofi.com
Closed Friday, 11 Feb CDISC- Diane Ball Merck diane_ball@merck.
2022 02:58 PM 5378 com
Open Friday, 11 Feb CDISC- Diane Ball Merck diane_ball@merck.

2022 02:59 PM 5379 com
Open Monday, 14 Feb CDISC- Jordan Li NCI EVS Jordan.li@nih.gov

2022 09:16 AM 5380
Open Monday, 14 Feb CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2022 12:22 PM 5381 com
Open Tuesday, 15 Feb CDISC- Daniel Sinnett Emmes dsinnett@emmes.c
2022 09:18 AM 5382 om
Open Tuesday, 15 Feb CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2022 03:09 PM 5383 com
Open Wednesday, 16 CDISC- Thangaraj Emmes tgovindaswamy@e

Feb 2022 09:40 5384 Govindaswamy mmes.com
AM

2022 11:05 AM 5385 anofi.om

2022 11:06 AM 5386 anofi.om
2022 09:28 AM 5387 anofi.com
Closed Tuesday, 22 Feb CDISC- Erin Tibbs-Slone CRL erin.tibbs-

2022 09:32 AM 5388 slone@crl.com

2022 09:42 AM 5389 anofi.com

2022 09:45 AM 5390 anofi.com
2022 09:46 AM 5391 anofi.com

2022 09:47 AM 5392 anofi.com

2022 09:48 AM 5393 anofi.com
2022 09:49 AM 5394 anofi.com
Open Thursday, 24 CDISC- Sylvie GIROND SANOFI CIG_MAILBOX@s

Feb 2022 11:27 5395 anofi.com
AM
Open Friday, 25 Feb CDISC- Santosh Kumar Gilead Sciences santoshkumar.linga

2022 09:40 AM 5396 Lingala la@gilead.com

2022 11:07 AM 5397 anofi.com

2022 11:08 AM 5398 anofi.com

2022 11:08 AM 5399 anofi.com

2022 11:09 AM 5400 anofi.com
Closed Monday, 28 Feb CDISC- Kimberly Minkalis The Griesser Group kminkalis@gmail.co
2022 03:57 PM 5401 m
Open Tuesday, 1 Mar CDISC- Carrie Neeley LabCorp carrie.neeley@cov

2022 01:47 PM 5402 ance.com
Open Tuesday, 1 Mar CDISC- DIANE E WOLD CDISC diane.wold@cdisc.

2022 03:32 PM 5403 org
Open Wednesday, 2 CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

Mar 2022 09:33 5404 fizer.com
AM
Open Wednesday, 2 CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

Mar 2022 09:34 5405 fizer.com
AM
Open Thursday, 3 Mar CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co
2022 08:50 AM 5406 m
Open Friday, 4 Mar CDISC- fausto zuzarte Bayer fausto.zuzarte@ba

2022 02:41 PM 5407 yer.com

2022 02:42 PM 5408 yer.com

2022 02:42 PM 5409 yer.com
Open Monday, 7 Mar CDISC- fausto zuzarte Bayer fausto.zuzarte@ba

2022 09:17 AM 5410 yer.com
Open Monday, 7 Mar CDISC- Gary G Walker Gary G Walker LLC gary.walker.ggw@g
2022 03:00 PM 5411 mail.com
Open Tuesday, 8 Mar CDISC- Diane Ball Merck diane_ball@merck.

2022 02:14 PM 5412 com
Open Tuesday, 8 Mar CDISC- Diane Ball Merck diane_ball@merck.

2022 02:16 PM 5413 com
Open Wednesday, 9 CDISC- Yueh-Chang Chi Rosetta charlie.chi@rosetta
Mar 2022 08:57 5414 Pharmamate Co. .com.tw
AM Ltd.
Closed Wednesday, 9 CDISC- Yueh-Chang Chi Rosetta charlie.chi@rosetta

Mar 2022 08:57 5415 Pharmamate Co. .com.tw
AM Ltd.

Mar 2022 10:37 5416 com
AM

Mar 2022 10:44 5417 com
AM

Mar 2022 10:55 5418 ng mail.com
AM
Open Wednesday, 9 CDISC- Virginie ORY; Ipsen virginie.ory@ipsen.
Mar 2022 11:41 5419 Dominique PONS com ;
AM Dominique.pons@i
psen.com ;
ipsen.standards@i
psen.com
Mar 2022 12:16 5420 com
PM

Mar 2022 02:26 5421 m
PM
Open Friday, 11 Mar CDISC- Ivan Jiang Roche/Genentech jiangi@gene.com
2022 04:30 PM 5422
Open Monday, 14 Mar CDISC- Amy, Shuk Man Novo Nordisk VSQH@novonordis
2022 09:42 AM 5423 Heung k.com
Open Tuesday, 15 Mar CDISC- Rachel Zieverink Medpace r.zieverink@medpa
2022 11:41 AM 5424 ce.com
Open Tuesday, 15 Mar CDISC- Luke Reinbolt Navitas Life luke.reinbolt@navit

2022 02:46 PM 5425 Sciences aslifesciences.com
Open Tuesday, 15 Mar CDISC- fausto zuzarte Bayer fausto.zuzarte@ba

2022 03:25 PM 5426 yer.com
Open Tuesday, 15 Mar CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

2022 04:44 PM 5427 com
Open Wednesday, 16 CDISC- Atul Ninawe Novartis atul.ninawe@novar

Mar 2022 09:00 5428 tis.com
AM
Open Wednesday, 16 CDISC- fausto zuzarte Bayer fausto.zuzarte@ba

Mar 2022 09:03 5429 yer.com
AM
Closed Wednesday, 16 CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.
Mar 2022 10:16 5430 nih.gov
AM
Open Wednesday, 16 CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

Mar 2022 10:59 5431 nih.gov
AM

Mar 2022 12:34 5432 anofi.com
PM
Mar 2022 12:35 5433 anofi.com
PM
Mar 2022 12:35 5434 anofi.com
PM
Mar 2022 12:37 5435 anofi.com
PM
Open Friday, 18 Mar CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

2022 09:46 AM 5436 fizer.com
Open Friday, 18 Mar CDISC- Aruna Jayaprakash Merck Healthcare aruna.jayaprakash
2022 09:55 AM 5437 KGaA @merckgroup.com
Open Friday, 18 Mar CDISC- Aruna Jayaprakash Merck Healthcare aruna.jayaprakash

2022 09:56 AM 5438 KGaA @merckgroup.com
Open Friday, 18 Mar CDISC- Glenn Beeman Merck Healthcare glenn.beeman@me

2022 10:00 AM 5439 KGaA rckgroup.com







Open Monday, 21 Mar CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
2022 04:38 PM 5449 yer.com

2022 04:39 PM 5450 yer.com
Open Wednesday, 23 CDISC- Dagmar Kottig-Roth Merck Healthcare dagmar.kottig-

Mar 2022 12:17 5451 KGaA roth@merckgroup.c
PM om
Open Thursday, 24 CDISC- Dan Sinnett Emmes dsinnett@emmes.c

Mar 2022 11:19 5452 om
AM
Open Thursday, 24 CDISC- Rachel Zieverink Medpace r.zieverink@medpa

Mar 2022 04:34 5453 ce.com
PM
Open Thursday, 24 CDISC- Rachel Zieverink Medpace r.zieverink@medpa

Mar 2022 04:35 5454 ce.com
PM
Mar 2022 05:14 5455
PM

2022 10:20 AM 5456
Open Friday, 25 Mar CDISC- Melanie Paules Takeda melanie.paules@ta

2022 12:49 PM 5457 keda.com
Open Monday, 28 Mar CDISC- Keli Costales Pfizer Inc. keli.costales@pfize

2022 12:06 PM 5458 r.com
Open Monday, 28 Mar CDISC- Keli Costales Pfizer Inc. keli.costales@pfize
2022 12:07 PM 5459 r.com
Open Monday, 28 Mar CDISC- Daniel Sinnett Emmes dsinnett@emmes.c

2022 12:13 PM 5460 om

2022 12:13 PM 5461 om
2022 12:14 PM 5462 om
Closed Monday, 28 Mar CDISC- Jordan Li NCI EVS jordan.li@nih.gov

2022 12:27 PM 5463

2022 12:30 PM 5464 om

2022 01:52 PM 5465 om
Open Monday, 28 Mar CDISC- Nghi LaTran Genentech LA.NGHI@GENE.

2022 03:20 PM 5466 COM
Open Wednesday, 30 CDISC- Barbara Lentz AbbVie barbara.lentz@abb

Mar 2022 02:42 5467 vie.com
PM
Mar 2022 03:27 5468 ng mail.com
PM

Mar 2022 09:34 5469 m
AM
Mar 2022 09:34 5470 m
AM
Closed Thursday, 31 CDISC- Karin A LaPann Independent lapannk@gmail.co

Mar 2022 09:36 5471 Consultant m
AM
Open Thursday, 31 CDISC- Glenn Beeman Merck Healthcare glenn.beeman@me

Mar 2022 12:34 5472 KGaA rckgroup.com
PM
Open Thursday, 31 CDISC- Rohit Dhanjal Vertex rohit_dhanjal@vrtx.

Mar 2022 02:51 5473 com
PM
Open Thursday, 31 CDISC- Jordan Li NCI EVS jordan.li@nih.gov
Mar 2022 04:19 5474
PM
Open Friday, 1 Apr CDISC- Kit Howard CDISC khoward@cdisc.org

2022 09:55 AM 5475
Open Friday, 1 Apr CDISC- Craig Zwickl CDISC czwickl@cdisc.org

2022 01:30 PM 5476
Closed Monday, 4 Apr CDISC- Dana Booth CDISC dbooth@cdisc.org

2022 11:00 AM 5477
Open Monday, 4 Apr CDISC- Phillip Jackson IQVIA Phillip.Jackson@iq

2022 01:45 PM 5478 via.com
Open Monday, 4 Apr CDISC- Rachel Zieverink Medpace r.zieverink@medpa

2022 01:47 PM 5479 ce.com
Open Tuesday, 5 Apr CDISC- Rahul Thandavan Hoffman La Roche rahul.thandavan@r

2022 12:28 PM 5480 oche.com
Open Tuesday, 5 Apr CDISC- Violeta Labarta Merck KGaA, violeta.labarta-

2022 01:37 PM 5481 Beceiro Darmstadt, beceiro@merckgro
Germany up.com
Open Wednesday, 6 CDISC- Devi Gohimukkula BeiGene devi.gohimukkula@
Apr 2022 01:33 5482 beigene.com
PM
Open Thursday, 7 Apr CDISC- liming xie BeiGene liming.xie@beigene
2022 09:35 AM 5483 .com
Open Friday, 8 Apr CDISC- Erin E Muhlbradt MSC Inc. muhlbradtee@mail.

2022 10:36 AM 5484 nih.gov

2022 10:37 AM 5485 nih.gov

2022 10:59 AM 5486 nih.gov
Open Monday, 11 Apr CDISC- Erin E Muhlbradt MSC Inc. muhlbradtee@mail.

2022 09:43 AM 5487 nih.gov
Open Tuesday, 12 Apr CDISC- Colleen Bonjo Merck colleen_bonjo@me

2022 10:37 AM 5488 rck.com
Open Wednesday, 13 CDISC- GIROND Sylvie Sanofi CIG_MAILBOX@s

Apr 2022 08:58 5489 anofi.com
AM
Open Wednesday, 13 CDISC- GIROND Sylvie Sanofi CIG_MAILBOX@s

Apr 2022 08:59 5490 anofi.com
AM
Open Friday, 15 Apr CDISC- Diane Ball Merck DIANE_BALL@ME

2022 01:12 PM 5491 RCK.COM
Open Thursday, 21 Apr CDISC- Angela Tseng A2 Healthcare angela-
2022 09:21 AM 5492 Taiwan Corporation tseng@a2healthcar
e.com

Apr 2022 11:44 5493 anofi.com
AM

Apr 2022 11:44 5494 anofi.com
AM

Apr 2022 11:45 5495 anofi.com
AM

Apr 2022 11:46 5496 anofi.com
AM

Apr 2022 11:46 5497 anofi.com
AM
Open Thursday, 28 Apr CDISC- Anthony Fata AstraZeneca anthony.fata@astra

2022 11:44 AM 5498 zeneca.com
Open Thursday, 28 Apr CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s
2022 11:58 AM 5499 anofi.com
Open Thursday, 28 Apr CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2022 12:12 PM 5500 anofi.com
Open Tuesday, 3 May CDISC- Sylvie Girond Sanofi CIG_MAILBOX@s

2022 11:10 AM 5501 anofi.com
Closed Tuesday, 3 May CDISC- Jordan Li NCI EVS jordan.li@nih.gov
2022 11:19 AM 5502
Open Thursday, 5 May CDISC- Erin Muhlbradt MSC Inc. muhlbradtee@mail.

2022 05:14 PM 5503 nih.gov
Open Friday, 6 May CDISC- Stephanie Berry Instem stephanie.berry@in

2022 10:19 AM 5504 stem.com
Open Tuesday, 10 May CDISC- Kathleen Hectors Janssen R&D khectors@its.jnj.co

2022 10:57 AM 5505 m

May 2022 10:59 5506 ogen.com
AM
May 2022 11:00 5507 ogen.com
AM
Open Thursday, 12 CDISC- fausto zuzarte Bayer fausto.zuzarte@ba

May 2022 12:09 5508 yer.com
PM

May 2022 12:10 5509 yer.com
PM

May 2022 12:11 5510 yer.com
PM

May 2022 12:59 5511 yer.com
PM

May 2022 01:24 5512 yer.com
PM
Open Friday, 13 May CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

2022 09:20 AM 5513 fizer.com
Open Friday, 13 May CDISC- Erin E Muhlbradt MSC Inc. muhlbradtee@mail.
2022 03:44 PM 5514 nih.gov
Open Tuesday, 17 May CDISC- Jenny Jones Covance jenny.jones@covan

2022 02:00 PM 5515 ce.com
Open Wednesday, 18 CDISC- Joyce Hernandez Eliassen jhernandez@eliass

May 2022 11:58 5516 en.com
AM
Open Friday, 20 May CDISC- Erin Muhlbradt (on MSC Inc. muhlbradtee@mail.
2022 10:08 AM 5517 behalf of the nih.gov
Pediatrics TAUG
team)
Closed Friday, 20 May CDISC- Jordan Li NCI EVS Jordan.li@nih.gov
2022 10:57 AM 5518
Open Friday, 20 May CDISC- Colleen Bonjo Merck colleen_bonjo@me

2022 11:46 AM 5519 rck.com
Open Monday, 23 May CDISC- Aparna Kulkarni Pfizer Aparna.Kulkarni@p

2022 12:43 PM 5520 fizer.com
Open Wednesday, 25 CDISC- Debbie O'Neill Merck debra_oneill@merc

May 2022 04:14 5521 k.com
PM
Open Thursday, 26 CDISC- Mihaela Simion Biogen mihaela.simion@bi

May 2022 10:34 5522 ogen.com
AM
Open Tuesday, 31 May CDISC- Erin E Muhlbradt MSC Inc. muhlbradtee@mail.

2022 04:17 PM 5523 (On behalf of EVS nih.gov
editing staff)
Open Friday, 3 Jun CDISC- Deborah CSLBehring deborah.rittenhous
2022 12:27 PM 5524 Rittenhouse e@cslbehring.com
Open Tuesday, 7 Jun CDISC- Rahul Thandavan Hoffman La Roche rahul.thandavan@r

2022 04:05 PM 5525 oche.com
Open Wednesday, 8 CDISC- Anne-Marie LE Ipsen virginie.ory@ipsen.

Jun 2022 09:55 5526 MENEC on behalf com
AM of Virginie ORY
Jun 2022 10:13 5527 anofi.com
AM

2022 09:00 AM 5528 om
Closed Friday, 10 Jun CDISC- Erin E Muhlbradt MSC Inc. muhlbradtee@mail.
2022 09:04 AM 5529 nih.gov

2022 09:12 AM 5530 om
Open Friday, 10 Jun CDISC- DEBRA O'NEILL Merck debra_oneill@merc
2022 09:17 AM 5531 k.com
Open Friday, 10 Jun CDISC- Sharanya Emmes Canada skomuravelli@emm

2022 09:19 AM 5532 Komuravelli es.com
Open Friday, 10 Jun CDISC- Sharanya Emmes Canada skomuravelli@emm

2022 09:21 AM 5533 Komuravelli es.com
2022 09:28 AM 5534 om
Open Friday, 10 Jun CDISC- Agnieszka AstraZeneca agnieszka.wasowsk

2022 10:31 AM 5535 Wasowska a@astrazeneca.co
m
Open Friday, 10 Jun CDISC- Erin E Muhlbradt MSC Inc. muhlbradtee@mail.
Oncology team)
Open Tuesday, 14 Jun CDISC- Sylvie GIROND Sanofi CIG_MAILBOX@s

2022 09:56 AM 5537 anofi.com
Open Tuesday, 14 Jun CDISC- Sharon Broderick Boehringer sharon.broderick@

Inc.
Open Tuesday, 14 Jun CDISC- Sylvie GIROND Sanofi CIG_MAILBOX@s
2022 11:32 AM 5539 anofi.com
Open Tuesday, 14 Jun CDISC- Jenny Jones Covance Jenny.Jones@Cov

2022 01:40 PM 5540 ance.com

2022 01:41 PM 5541 ance.com

2022 01:41 PM 5542 ance.com
Open Wednesday, 15 CDISC- Sylvie GIROND Sanofi CIG_MAILBOX@s

Jun 2022 09:49 5543 anofi.com
AM
Jun 2022 09:50 5544 anofi.com
AM

Jun 2022 09:54 5545 anofi.com
AM
Jun 2022 02:59 5546 com
PM
Open Thursday, 16 CDISC- Angela Soriano Medidata angela.soriano@3d

Jun 2022 10:38 5547 s.com
AM
Open Thursday, 16 CDISC- Sylvie GIROND Sanofi CIG_MAILBOX@s

Jun 2022 10:41 5548 anofi.com
AM
Open Friday, 17 Jun CDISC- Carol Kopp Charles River Labs carol.kopp@crl.com
2022 11:29 AM 5549
Open Friday, 17 Jun CDISC- Barbara Lentz AbbVie barbara.lentz@abb

2022 12:41 PM 5550 vie.com
2022 12:42 PM 5551 vie.com

2022 12:42 PM 5552 vie.com
Open Friday, 17 Jun CDISC- Erin E Muhlbradt MSC Inc. muhlbradtee@mail.

2022 04:44 PM 5553 nih.gov
Request Type
Create New PFTEST/CD Pharmacogenomics Findings Test

Term Name: Vector Copy Number
Pharmacogenomics Findings Test
Code: VCOPYNUM
Other Multiple not all terms are available in the

FATEST/FATESTCD codelists in the
separate TA Findings About codelists
Other Multiple codelist terms not 'linked' with the

NCI Code
Create New SDTM- Requested Submission Value
Term LBTEST/CD
Create New SDTM- Requested Submission Value
Term MBTEST/CD
Create New Multiple I just need a C-code for all the

Term changes and new terms proposed by
the MB team for P50 so far.
Create New SDTM- Submission Value - Lean Body

Term MUSCTS/CD MassSynonym - LBM
Create New SDTM-UNIT Submission Value nmol/L/sec

Term
Create New SDTM- Submission Value RESTRICTION

Term METHOD FRAGMENT LENGTH
POLYMORPHISM Synonym: RFLP
Create New SDTM-CCCAT SDTM-CCCAT* Enter Term or
Term Codelist Request Information:
Submission Value BARCELONA
CLINIC LIVER CANCER SYSTEM
Synonym BCLC1
Create New SDTM- Submission Value: Hepatitis D Virus

Term METHOD RNA Synonym: HDRNA
Create New SEND- SINGLE GROUP
Term DESIGN
Create New Multiple QualityMetric new instrument SF6D

Codelist V2.0 ACUTE and STANDARD
versions draft QRS
Modify Multiple Quality Metric SF36 V1.0 ACUTE

Existing Term and STANDARD QRS CT change
control to add the new SF6D V2.0
derived items
Create New SDTM- Spreadsheet emailed separately.
Term MIFTSDTL
Create New SDTM-UNIT mg/ml

Term
Create New SDTM- Submission Value:Alnus japonica IgE

Term LBTEST/CD AntibodyL. lycopersicum IgE
AntibodyBasement Membrane IgG
AntibodyDopamine Receptor D2
AntibodyDipeptidyl Aminopeptidase-
Like Prot 6 Ab Metabotropic
Glutamate Receptor 5 Ab Purkinje
Cell Cytoplasmic-Tr Antibody
Create New SDTM- Submission Value: Epstein-Barr

Term MBTEST/CD Nuclear Antigen IgG AbSynonym:
EBNIGAB
Create New SDTM- Simple Plex

Term METHOD
Create New SDTM- S. pneumoniae Sero 6A IgG AB (S.

Term MBTEST/CD pneumonia Sero 6A IgG AB;
Streptococcus pneumoniae Serotype
6A IgG Antibody)
Create New SDTM- Submission Value:
Term FATEST/CD Study Medication
Taken IndicatorStudy Medication
TimeEat/Drink Besides Water
IndicatorEat/Drink Besides Water
Time
Create New SDTM- Infliximab Adalimumab Certolizumab
Term LBTEST/CD Tysabri Golimumab Vedolizumab
Ustekinumab
Create New SDTM- HUMAN IMMUNODEFICIENCY

Term MICROORG VIRUS 1 SUBTYPE A SUBTYPE B
SUBTYPE C SUBTYPE D
SUBTYPE F SUBTYPE G
SUBTYPE AE SUBTYPE AG
Create New SDTM- Submission Value:FIGO 2018FIGO
Term ONCRSCAT UNSPECIFIED
Create New SDTM-LOC File emailed

Term separately:CDISC_Multi_Term_Requ
est_LOC_Pfizer20Jan22.xls
Create New SDTM-UNIT mm2/usec to be added to the UNIT

Term codelist in controlled terminology
Modify SDTM- New Term of Numeric Rating Scale
Existing Term QRSMTHOD 7-Point needs to be added
Create New SDTM- LBTEST = Leukemic

Term LBTEST/CD Blasts/Leukocytes, LBTESTCD =
BLSTLMLE
Modify CDISC- Re-code Glossary concept C84731

Existing Term GLOSSARY 'packaging'
Create New SDTM- LBTEST = Oxygenation Index;
Term LBTEST/CD LBTESTCD = OI
Create New SDTM New terms for SDTM RSTYPRS

Term RSTYPRS codelist
Create New SDTM- REQUIRES PROHIBITED
Term NCOMPLT MEDICATION
Modify Multiple Bone

Existing Term
Create New SDTM- Bone Lytic Disease Response /

Term ONCRTS BNDSRESP
Create New SDTM- Infliximab Antibody Adalimumab

Term LBTEST/CD Antibody Anti-Golimumab Antibody
Anti-Vedolizumab Antibody Anti-
Ustekinumab Antibody
Create New SDTM- Connective Tissue Growth Factor

Term LBTEST/CD (CTGF)
Create New SDTM- 11-Deoxycortisol

Term LBTEST/CD
Create New SDTM- 11-Deoxycorticosterone

Term LBTEST/CD
Other Multiple PYTEST/PYTESTCD (add test),

PYFINDRS update (and deprecate
terms), New codelist for results of
new PYTEST.
Other Multiple New SEND Codelists / Terms for
DPTEST/DPTESTCD, DPFINDRS
(DP - Developmental Milestones).
Create New SDTM- Bacilliform

Term LBTEST/CD
Create New SDTM- Bacilliform/Leukocytes

Term LBTEST/CD
Create New SDTM- Lithium / LITHIUM

Term LBTEST/CD
Create New SDTM- Cedar Japanese IgE

Term LBTEST/CD
Create New SDTM- ABSOLUTE SCORE

Term TRTEST/CD
Create New SDTM- ABSOLUTE CHANGE FROM

Term TRTEST/CD BASELINE
Create New SDTM- ASSESSMENT OF LESION BY

Term TRTEST/CD T2/FLAIR
Create New SDTM- CURIE SCORE
Term TRTEST/CD
Create New SDTM- INFILTRATION DUE TO

Term TRTEST/CD LYMPHOMA
Create New SDTM- LYMPHOMA INVOLVEMENT

Term TRTEST/CD
Create New SDTM- HIGHEST 5 POINT SCALE SCORE

Term TRTEST/CD
Create New SDTM- SUM OF THE NON-PLEURAL

Term TRTEST/CD TARGET LESIONS
Create New SDTM- SUM OF NON-PLEURAL AND
Term TRTEST/CD PLEURAL LESIONS
Create New SDTM- T1 SUM OF PRODUCTS OF

Term TRTEST/CD PERPEND DIAMETERS
Create New SDTM- RESPONSE OF TARGET LESIONS

Term ONCRTS SUPERSCAN RESPONSE OF
T2/FLAIR AND NON-MEASURABLE
NON-PLEURAL/PLEURAL TARGET
LESIONS RESP RESPONSE OF
NEW LESION IGM
RESPONSECA125 RESPONSE
Create New SDTM- SUPERNATANT, LAVAGE FLUID

Term SPECTYPE
Create New SDTM- LDL Triglycerides / LDLTRI

Term LBTEST/CD
Create New SDTM- IDL Triglycerides / IDLTRI

Term LBTEST/CD
Create New SDTM- LDL Apolipoprotein B / LDLAPOB

Term LBTEST/CD
Create New SDTM- LBTESTCD = SAR2NPAG, LBTEST

Term LBTEST/CD = SARS-CoV-2 Nucleocapsid Protein
Antigen
Create New SDTM- Sweet Vernal Grass IgE
Term LBTEST/CD
Create New SDTM- Melaleuca/Bottlebrush IgE

Term LBTEST/CD
Modify Multiple URNSTSCD, URNSTS, METHOD

Existing Term
Create New SDTM- Submission Value:EBV Antibody

Term MBTEST/CD Signal/EBV Antibody CutoffMumps
Virus RNAHerpes Simplex Virus 7
DNARubeola Antigen
Create New SDTM- SDTM-LBTEST Multiple Term
Term LBTEST/CD Reqeust
Create New SDTM- Submission Value:NEW NON-

Term TUIDRS TARGET EXTRA NODALNEW NON-
TARGET NODALNEW TARGET
EXTRA NODALNEW TARGET
NODAL
Create New SDTM- HLA-DR51 Antigen Type
Term LBTEST/CD

Term LBTEST/CD

Term LBTEST/CD
Create New SDTM- Submission Value: VISUAL ANALOG
Term QRSMTHOD SCALE (0-100)Synonym: VAS (0-
100)
Create New SDTM- Submission Value: Last Menstrual
Term RPTEST/CD Period StatusSynonym: LMPDST
Create New SDTM- Schuffner's Granules / SCHUGRAN
Term LBTEST/CD
Create New SDTM- Firmicutes/Bacteroidetes Ratio /

Term LBTEST/CD FIRMBCTD
Create New SDTM- PHARMACOGENETIC INFORMED

Term DSSCAT CONSENT, BIOPSY INFORMED
CONSENT
Create New Multiple False True Response
Codelist
Create New SDTM- KI-67 STAIN

Term METHOD
Create New SDTM- MCM2-TOP IIA STAIN
Term METHOD
Create New SDTM- Prothrombin Fragment 2

Term LBTEST/CD
Create New SDTM- Prostaglandin D2 Receptor 2 /

Term LBTEST/CD PTGDR2
Create New SDTM- Leukotriene C4 Synthase / LTC4S

Term LBTEST/CD
Create New SDTM- Cysteinyl Leukotriene Receptor 1 /

Term LBTEST/CD CYSLTR1
Create New SDTM- Requested Synonym(s)
Term MICROORG Clostridioides difficile Clostridioides
colicanis Paeniclostridium sordelli
Paraclostridium bifermentans
Cutibacterium acnes Cutibacterium
Create New SDTM- CPTEST - TLym

Term CPTEST/CD Reg/LymCPTESTCD - TLRLY
Create New SDTM- Pls add two new terms: Irish,

Term ETHNIC English.This is from the DRAGON
TA project.
Create New SDTM- PHASE I/II/III

Term TPHASE
Create New SDTM-UNIT OD Unit AUC
Term
Modify SDTM- PREGNANCY

Create New SDTM- p16 STAIN

Term METHOD
Create New SDTM- Intraerythrocyte Crystals / CYINERY

Term LBTEST/CD
Create New SDTM- Pigment Casts / CSPIGMEN

Term LBTEST/CD
Create New SDTM- Intraerythrocyte Crystals / CYINERY
Term LBTEST/CD
Create New SEND- SEND IMPLEMENTATION GUIDE

Term SNDIGVER VERSION 3.1.1 should be added to
the CT list as it is now included in the
FDA Data Standards Catalog.
Create New SDTM- Monoclonal Protein Spike Region 1 /

Term LBTEST/CD MSPIKER1

Create New SDTM- Myelo Immunofixation Impression 1 /

Term LBTEST/CD MYELII1

Create New SDTM- 17p deletion / 17PDEL

Term GFTEST/CD
Create New New This is for ADaM- ADAE dataset

Codelist where the SMQ scope will be defined
as Broad or Narrow.
Create New SDTM- Germline DNA/ GNLDNA

Term LBTEST/CD
Create New SDTM- Ketone Bodies Excretion Rate /

Term LBTEST/CD KETBDEXR
Create New SDTM- Beta-Hydroxybutyrate Excretion Rate

Term LBTEST/CD / BHYXBEXR
Create New SDTM- Acetoacetic Acid Excretion Rate /

Term LBTEST/CD ACEACEXR
Other Multiple Add Subscore QSTESTCD/QSTEST
for CHART-SF Interview and Paper
versions. Discuss ADaM
PARAMCD/PARAM which is needed
as both versions may be analyzed
together according to the author of
the scale. Steve Kopko to provide
terminology
Create New SEND- SEND IMPLEMENTATION GUIDE

Term SNDIGVER VERSION 3.1.1
Other SDTM- Split this codelist into at least two

STENRF separate codelists. One for
comparisons to the study reference
period (used with --STRF and --
ENRF) and the other for
comparisons to a point in time (used
with --STRTPT and --ENRTPT).
Create New SDTM- Multi_Term_Request_MBTEST_PFI

Term MBTEST/CD ZER_20220301.xls
Create New SDTM- LACTICASEIBACILLUS

Term MICROORG PARACASEI SUBSP. PARACASEI
Create New SDTM-UNIT Please add new term FFU/ml
Term
Create New SDTM- Cycle ergometer

Term METHOD
Create New SDTM- Treadmill (Stage protocol)

Term METHOD
Create New SDTM- Treadmill (Continuous ramp protocol)

Term METHOD
Create New SDTM- Exhaled particles

Term SPECTYPE
Create New SDTM- AP domain code indicating
Term DOMAIN "Associated Persons" domain
Create New SDTM-MITS Bone Marrow InvolvementBone

Term Marrow Involvement Indicator
Number of Lymph Nodes
Positive
Create New SDTM- Submission Value

Term MHEDTTYP CURRENT DIAGNOSIS MOST
RECENT PROGRESSION OR
RELAPSE
Create New SDTM-QSCAT BSRS-5
Term
Create New SDTM-QSCAT SSS

Term
Create New SDTM- Rash/Lesion Appearance

Term VNFATS Rash/Lesion Pruritic Indicator
Rash Distribution
Lesion Count
Total
Lesion Count
Create New SDTM- MASMKIND PPLHSHN CHLDHSHN

Term SCTEST/CD DYCARIND VAXPGIND
Create New CDISC- NEST in the Glossary acronyms.

Term GLOSSARY National Evaluation System for
health Technology
Create New Multiple 1-request for new terms 2-request for
Term new association of existing terms to
existing codelist 3-request for change
to existing terms (addition of
synonyms)
Create New SDTM- Acid Sphingomyelinase Centromere
Term LBTEST/CD A Antibodies Mitochondria M2-3E
Antibody D-3-Phosphoglycerate
Dehydrogenase Ab PML Antibody
RNA Polymerase III Antibody Retinol
Binding Protein 4 Beta-
Hydroxybutyric Acid
Create New SDTM- Please add: MBTESTCD = CDU;

Term MBTEST/CD MBTEST = Candida dubliniensis
Other Multiple Request for:One New Term for

ISTEST/TESTCDRevisions for
C147302 and C147300 on C120525
and C120526 codelists.
Create New SDTM- #NAME?

Term ROUTE
Create New SDTM- Sum of Diameters Nadir
Term TRTEST/CD
Create New DefineXML- Add ADPPK as a sub class of BDS

Term BDSSC
Create New SDTM- OUT OF SAMPLE VOLUME RANGE

Term SPECCOND
Create New SDTM-QSCAT We are requesting to create codelists

Term related to 'KDQOL-36 Survey' which
in public domain at
https://www.rand.org/health-care/sur
veys_tools/kdqol.html
Create New Multiple HETEST/HETESTCD - Summary,

Codelist Atrial Flutter Duration / AFLUDUR
HETEST/HETESTCD - Summary,
Atrial Fibrillation Duration / AFIBDUR
VSTEST/VSTESTCD - Tibial
Length / TIBIALEN
Create New SDTM-UNIT mg/CAPSULE

Term
Other Multiple Need request number for CDISC P49
content that has not yet been
assigned a NCI JIRA code
Modify SDTM- Update definition of C181329

Existing Term GFANMET
Create New SDTM- Inflammatory Cells /INFLAM

Term LBTEST/CD
Create New SDTM- Inflammatory Cells/Total Cells /

Term LBTEST/CD INFLAMCE
Create New SDTM- Pyknotic Cells / PYKNOTCE

Term LBTEST/CD
Create New SDTM- Squamous Cells / SQUAMCE

Term LBTEST/CD
Create New Multiple TRTEST/TRTESTCD

Term
Create New SDTM- ALLELE ZYGOSITY
Term GFTSDTL
Create New SDTM- QUALITY SCORE

Term GFTSDTL
Create New SDTM- CD16X

Term CPTEST/CD
Create New SDTM- CD86X

Term CPTEST/CD
Create New SDTM- HLADRX

Term CPTEST/CD
Create New SDTM- PLABLST

Term CPTEST/CD
Create New SDTM- PLABLSTS

Term CPTEST/CD
Create New SDTM- BLYTS

Term CPTEST/CD
Create New SDTM- BLYNMAS
Term CPTEST/CD
Create New SDTM- MNNCLS

Term CPTEST/CD
Create New SDTM- MNCLS

Term CPTEST/CD
Create New SDTM-UNIT /400 cells

Term
Create New SDTM- Requested to add to CNTMODE new

Term CNTMODE submission value of IN PERSON AT
SITE, with the definition of: An
interaction that takes place in the
physical presence of someone else
at the Study Site.
Create New SDTM- IN PERSON AT HOME

Term CNTMODE
Create New SDTM- Propose new METHOD ( e.g. used

Term METHOD for LB) : BIURET REACTION
Create New SDTM- RAPID FLUORESCENT FOCUS

Term METHOD INHIBITION ASSAY
Create New SDTM- X-RAY WITHOUT CONTRAST

Term METHOD
Create New SDTM- PET SCAN WITHOUT CONTRAST

Term METHOD
Modify Multiple Change the "&" to the Underscore
Existing Term sign in C182477 and C182515.
Create New Multiple Create new SDTM and ADaM

Term terminology for CHART-SF
Create New SDTM- IDC-O

Term DICTNAM
Create New SEND- Glomerular Lipidosis

Term NONNEO
Create New SEND- Spheroid
Term NONNEO
Create New SDTM- HHV8DNA / Human Herpesvirus 8

Term MBTEST/CD DNA
Create New SDTM- HBV / Hepatitis B Virus

Term MBTEST/CD
Create New SDTM- HCV / Hepatitis C Virus
Term MBTEST/CD
Modify Multiple Update CDISC submission value, SY

Existing Term and NCI PT for Sheehan Disability
Scale item C111526
Create New SDTM- VZV / Varicella Zoster Virus

Term MBTEST/CD
Create New Multiple Please see the attached file for

Term additions to the MBTESTCD and
MICROORG code lists.
Create New Multiple LYMPH NODE, PARATHYMIC

Term
Create New SDTM- Please add new submission values

Term PKPARM/CD for PKPARMCD of LAMZINTC with
PKPARM of Lambda z Intercept.
Create New CDISC- Intercurrent Events:
Term GLOSSARY
Create New SDTM- Please add Campylobacter as

Term MBTEST/CD TESTMBTESTCD = CAMPY
(?)MBTEST = Campylobacter
Create New SDTM- Please create a new term for
Term MBTEST/CD Norovirus in MBTESTCD
MBTESTCD = NV (or NOROVIRU?)
MBTEST = Norovirus
Create New Multiple Submission value HAMD17TS" CT

Term value 'HAMD1PC' for Parameter
code.Submission value "HAMD17-
Total Score - Analysis" for the full
Parameter name and CT value of
'HAMD1PN' for parameter code.
Create New SDTM- Multiplex IF

Term METHOD
Create New SDTM- A1ANTRPZ (Alpha-1 Antitrypsin Z-

Term LBTEST/CD Polymers)
Create New SDTM- Please create: RETEST/RETESTCD:
Term RETEST/CD Oxygenation Index/OI
Create New New Codelist for Medical Devices for

Codelist DTPARTY, with values SPONSOR,
SITE and SUBJECT.
Modify SEND-SPEC Pulmonary Vein

Existing Term
Other Multiple requesting a revised submission

value for DLQI to clarify which
version of DLQI the terminology is
for. Also requesting new CT for
DLQI1TC/TN codelists for 6 subscale
scores that are not currently included
in the terminology.
Modify SDTM- For term "REVERSE

Existing Term METHOD TRANSCRIPTASE PCR" the CDISC
Definition has an incorrect spelling.
The word "complimentary" should be
"complementary".
Modify SDTM- Add 'Klebsiella aerogenes' as a
Existing Term MICROORG synonym for Enterobacter aerogenes
(C86356)
Modify SDTM- Codelist - C124301 Medical
Existing Term MHEDTTYP History Event Date Type Term -
C156813 INTIAL DIAGNOSIS
Modify SDTM- NFLP
Create New SDTM- GATED HEART POOL SCAN
Term METHOD
Create New SDTM-LAT MIDDLE

Term
Create New SDTM- FLC ASSAY

Term METHOD
Create New SDTM- New lab test for multiple myeloma:

Term LBTEST/CD KLCLLCFR= Kappa Lt
Chain,Free/Lambda Lt Chain,Free Or
consider test name KLCLLCFR=
Kappa/ Lambda FLC Ratio
Create New SDTM- NEXT GENERATION FLOW

Term METHOD CYTOMETRY
Other none Change column A header in all tabs

of the Denied requests file from
'Codelist Name' to 'Codelist Short
Name'
Modify SDTM- C156813 = INTIAL DIAGNOSIS
Existing Term MHEDTTYP
Create New SDTM-SEVRS MAJOR

Term
Create New SDTM-SEVRS MINOR

Term
Create New SDTM- AUDIOLOGIST

Term MEDEVAL
Create New Multiple CDISC New Term Request - From
Term Angela Tseng
Create New SDTM- Gamma Delta T Cells / GDTCE

Term LBTEST/CD
Create New SDTM- Gamma Delta T Cells/Lymphocytes /

Term LBTEST/CD GDTCELY
Create New SDTM- Mucus-Secreting Cell/ MUCC

Term LBTEST/CD
Create New SDTM- Mucus-Secreting Cell"/ Total

Term LBTEST/CD Epthelial Cells" / MUCEPIC
Create New SDTM- Tlym Help Reg/Lym / TLYHPLY

Term CPTEST/CD
Create New New Want to create two new CT terms for

Codelist the TKDESC parameter within TX.
The terms would be "TK" and "NON-
TK".
Create New New THERAREA codelist
Codelist
Create New Multiple THERAREA

Term
Modify SDTM- SOUTHERN AFRICAN COLORED

Existing Term RACEC
Modify Multiple Fix TYPO in NCI PT, CDISC PT and
Existing Term SY for C185769 This is a QRS
Request.For QS-SF6D Version 2.0
Acute TEST/QS-SF6D Version 2.0
Acute TEST CD codelists
Create New New Create codelist to support --PARTY

Codelist variable used in BE and DT domains.
(Craig, add this to Biospecimens
team working document only)
Create New New From CDISC SEND PCPP subteam.

Codelist New codelist with three terms to
apply to SEND variables PCCAT,
PICAT and PPSCAT.
Create New SDTM- Staphylococcus coagulase,

Term MBTEST/CD Streptococcus group A,
Streptococcus group B,
Streptococcus pneumoniae,
Klebsiella pneumoniae
Create New SDTM- Anti-MOG Antibody

Term LBTEST/CD
Create New SDTM- Anti-AQP4 Antibody
Term LBTEST/CD
Modify SDTM- CELL SLIDE (syn)

Existing Term METHOD
Modify SDTM- TRANSCATHETER AORTIC VALVE

Existing Term PROCEDUR IMPLANTATION (syn)
Modify SDTM- HEART VALVE SURGERY (syn)

Existing Term PROCEDUR
Create New SDTM- CARDIAC ABLATION

Term PROCEDUR
Create New SDTM- COMBINED FLUORESCEIN

Term METHOD ANGIOGRAPHY AND ICGA
Create New SDTM- CORD PLASMA

Term SPECTYPE
Modify CDISC- Regarding JIRA DDF-296: definition
Existing Term GLOSSARY of study_phase to be improved
Create New Multiple Amitriptyline Imipramine Desipramine

Term Nortriptyline EDDP Doxepin
Nordoxepin Protriptyline
Phosphatidylethn Lysosome-
associated membrane protein 2
Lysosome-associated membrane
protein 2/Glyceraldehyde-3-
Phosphate Dehydrogenase
Create New SDTM- MRCEXWM MRCEXNH

Term GFTEST/CD WIDE/MODERATE NARROW/HIGH
Create New Multiple 58 new terms and changes to

Term existing to support the Pediatrics
TAUG. Multiple term request file will
be emailed separately.
Modify Multiple Need a request code for the changes
Existing Term made to PRO-CTCAE and ADaM
QRS terminology.
Modify SDTM- C156813 = INTIAL DIAGNOSIS

Existing Term MHEDTTYP
Create New SDTM- STENOTROPHOMONAS

Term MICROORG ACIDAMINIPHILA
Create New SDTM- NOT REPORTED

Term SPECTYPE
Create New SDTM- Hepatitis B Virus Core IgG/IgM

Term MBTEST/CD Antibody/HBCGMAB
Modify SDTM-LOC Potential definition update to

Existing Term C103438 based on NCI definition
change
Other SDTM- Entries exist for POSITIVE and
LBSTRESC NEGATIVE. However, Urine Drug
Screen results are often reported as
"Detected" or "Not Detected". Please
consider adding these as synonyms
Create New SDTM- APOLO BLADDER CANCER 2019

Term ONCRSCAT
Create New SEND, MYELOPOIESIS, INCREASED

Term NONNEO GANDY-GAMNA BODY LIPID
VACUOLES, DECREASED
HEMOSIDERIN DEPOSITION
Create New Multiple SPECCOND
Term
Create New SDTM- BONE MARROW, ASPIRATE

Term SPECTYPE
Create New Multiple New terms and changes to existing
Term for P50 that need a new term request
number: 208 new and 85 changes
Create New SDTM- BONE MARROW, CORE

Term SPECTYPE
Create New SDTM-LOC INTERNAL CAPSULE; EXTERNAL
Term CAPSULE
Create New SDTM- HBV

Term MBTEST/CD
Create New SDTM- HCV

Term MBTEST/CD
Create New SEND- HMPADI
Term MITEST/CD
Create New SDTM- Failure to Meet Inclusion/Exclusion

Term NCOMPLT Criteria
Modify Multiple For Total Plasma Cells/Total Cells in
Existing Term LB/MI domains - confirm/clarify that
what is meant is 'Total Nucleated
Cells' in the denominator and
consider addition of synonyms or a
new concept.
Create New SDTM-UNIT CAE Unit

Term
Create New SDTM-UNIT Arbitrary U/mL

Term
Create New SDTM- ACTIGRAPHY

Term METHOD
Create New SDTM- Liver Cytosolic Antigen Type 1 (LC-

Term LBTEST/CD 1) Antibody IgG
Create New SDTM- RBC lysis (Red blood cell lysis)

Term METHOD
Create New SDTM- Complement Activation

Term LBTEST/CD
Create New SDTM- SUBJECT STATUS

Term DSSCAT
Create New SDTM-DTHDX Hospitalization Indicator
Term
Create New SDTM- First Menstrual Period Start Date

Term RPTEST/CD
Modify SDTM-UNIT Please fix the case of 'LB' to 'lb'

Existing Term
Create New SDTM-UNIT /1000 RBC

Term
Create New SDTM- SUCCESSFULL SURVEILLANCE

Term OTHEVENT CONTACT
Create New Multiple Adactyly, Brachydactyly, Polydactyly,

Term Syndactyly, Sternoschisis,
Supernumerary Site,
Arhinencephaly, Increased
Ossification, Full, Closed
Create New SDTM-LOC Please add the new submission
Term value of SKIN ABOVE THE
SUPRAORBITAL REGION to the
Anatomical Location / LOC codelist.
Create New SDTM-LOC Please add the submission value of
Term EYE, SKIN OF THE OUTER
CANTHUS to the LOC / Anatomical
Location codelist, with a synonym of
Crow's Feet.
Create New SDTM-LOC Please add the new submission

Term value of SKIN, UNDER EYE to the
LOC / Anatomical Location codelist
with a synonym of Skin Under Eye.
Modify SDTM- C25250 - COMPLETED

Change
Type
Hi,
Attaching terminology request for PFTEST and

PFTESTCD
Thanks!
Aparna
The FATEST/FATESTCD codelists are re- II

instated, containing all terms as available in the
separate TA Findings About codelists. There is
however 1 exception: For the
CRFATS/CRFATSCD codelists, not all terms are
available in the FATEST/FATESTCD codelists
e.g. TPDEPIND (Unable to Taper Dependent
Indicator). Why this exception?
There are now several codelists available for the II Do not add (P50):
QRS results --ORRES/--STRESC variables. I was Cannot fulfill request.
expecting these codelist terms to be 'linked' with The amount of work
the NCI Code (as done for the linked test and test required for CDISC to
codes), so we can easily define the 'decode' of implement this request
the coded values. However, the only way to is too prohibitive at this
identify for the results which text belongs to which time, also CDISC will
code is embedded within the 'Definition', so not be able to include
difficult to retrieve programmatically. What was ORRES/STRESC
the reason for not linking these terms? responses for
copyrighted instruments.
The QRS team believes
that this is something
that should be managed
at the sponsor level.
Alk Phos, Placental/Total Alk Phos

Alk Phos, Liver + Bone/Total Alk Phos
Sp100 Antibody
Fibrin Monomer
Total Plasma Cells/Lymphocytes
Liver Cytosol Type 1 Antibody
Actin Antibody, Filamentous
Citrulline/Creatinine
Muscle Specific Kinase Antibody
OJ Antibody
PL-12 Antibody
PL-7 Antibody
Mi-2 Antibody
SUMO-Activating Enzyme Subunit 2 Ab
SUMO-Activating Enzyme Subunit 1 Ab
MJ Antibody
EJ Antibody
Gamma Aminobutyrate B Receptor Antibody
Basement Membrane Zone BP180 Antibody
Collagen Type VII Antibody
Basement Membrane Zone BP230 Antibody
AMPA Receptor 2 Antibody
AMPA Receptor 1 Antibody
AMPA Receptor 1 + 2 Antibody
NMDA Receptor Antibody
Adrenal Antibody
Leucine Rich Glioma-Inactiv Protein 1 Ab
Contactin-Associated Protein 2 Antibody
Normoblasts Glial Nuclear Type 1 Antibody
Myelin Oligodendrocyte Glycoprotein Ab
TIF1 Gamma IgG Antibody
Ku Antibody
Zinc Transporter 8 Antibody
Penicillin IgE Antibody
Cardiolipin Antibody
Do not add (P50): CMV
Adenovirus Nucleic Acid - Do not add, map to
Streptococcus pyogenes C184672.
Mycoplasma Do not add (P50):
Streptococcus anginosus Enterohemorrhagic
Candida glabrata Escherichia Coli request
Enterococcus as a Synonym for
Pneumocystis jiroveci DNA Escherichia coli Shiga-
Hepatitis A Virus RNA like Toxin - Do not add.
Acinetobacter, Carbapenem-resistant Enterohemorrhagic
Streptococcus Escherichia Coli is not
Yersinia the same as Escherichia
Prevotella bivia coli Shiga-like Toxin.
Citrobacter koseri The latter is testing for
Streptococcus pneumoniae the toxin.
Nocardia cyriacigeorgica
Rickettsia DNA
Cytomegalovirus
Borrelia DNA
Anaplasma DNA
Ehrlichia DNA
Babesia DNA
Staphylococcus epidermidis
Parvovirus B19 DNA
M. tuberculosis, Rifampin-resistant
Nontuberculous Mycobacteria Nucleic Acid
Listeria monocytogenes Chlamydia psittaci DNA
Helicobacter pylori Ureaplasma urealyticum
Enterococcus faecium Fusobacterium nucleatum
Epstein-Barr Early Antigen IgM Ab Human
Papillomavirus 6 IgG Antibody Epstein-Barr Virus
Antibody Aspergillus Antigen Candida Antigen
Giardia lamblia/Cryptosporidium Antigen
Legionella pneumophila Sg 1 Antibody Epstein-
Barr Early Antigen IgA Antibody Influenza B IgM
Antibody
I just need a C-code for all the changes and new II SDTM-Published in P50
terms proposed by the MB team for P50 so far.
Craig, please do not triage this request, they are
already in the MB working doc, i just need a C-
code. Thank you!
Definition: The weight of all organs and tissue in II

an individual less the weight of the individual's
body fat.
Definition - A rate unit equal to the number of II
nanomoles per unit of volume equal to one liter
per unit of time equal to one second.
Definition: A technique that uses restriction II SDTM-Published in P50
digestion of purified DNA from bacteria where
variation in the banding pattern in the digestion
reveals the genetic diversity.
References: II
https://www.medscape.com/answers/2007061-
199239/what-is-the-barcelona-clinic-liver-cancer-
staging-system-for-hepatocellular-carcinoma-hcc
https://radiopaedia.org/articles/liver-cancer-bclc-
staging?lang=us
Definition: a method used to detect Hepatitis D II

Virus RNA.
We have seen a couple of studies where only one II SEND-Published in P50
group is present, but where the study is not a
Crossover, Latin Square or Dose Escalation
design as only one dose level is provided. As
Parallel requires there to be two or more
treatment groups this term does not seem to fit.
The term proposed would be intended for studies
where only one group receiving the same dose
level throughout the study is present in the
dataset.
Draft definition:
A study that consists of only a single group of
subjects included in the study design, in which all
subjects received a single intervention and the
outcomes are assessed over time
QualityMetric new instrument SF6D V2.0 ACUTE II QRS-Published in P49

and STANDARD versions draft QRS CT
spreadsheet sent separately
Jordan,
Attached is the QualityMetric new instrument
SF6D V2.0 ACUTE and STANDARD versions
draft QRS CT spreadsheet for QRS CT team
review. Please let me know if you have any
questions.
Steve
Quality Metric SF36 V1.0 ACUTE and II QRS-Published in P49

STANDARD QRS CT change control draft QRS
CT spreadsheets sent separately
Jordan,
Attached are the QualityMetric SF36 V2.0
ACUTE and STANDARD QRS CT change control
draft QRS CT spreadsheet for QRS CT team
review. Please let me know if you have any
questions.
Steve
Submission Value: II SDTM-Published in P50
HISTOLOGICAL GRADE
2010 WHO CLASSIFICATION OF TUMORS OF

THE GASTROINTESTINAL TRACT, LIVER, AND
PANCREAS
2017 WHO CLASSIFICATION OF PANCREATIC

NEUROENDOCRINE NEOPLASMS
2019 WHO CLASSIFICATION OF

NEUROENDOCRINE NEOPLASMS OF THE
GASTROINTESTINAL TRACT AND
HEPATOBILIARY ORGANS
WHO NEUROENDOCRINE NEOPLASMS
FUHRMAN NUCLEAR GRADE
this is only listed in the PK units, have seen II

multiple studies where this is the unit for dosing
and it is not in the UNIT codelist.
Definition: II
A measurement of the Epstein-Barr nuclear

antigen IgG antibody in a biological specimen.
Simple Plex is an integrated immunoassay II

system that consists of a disposable microfluidic
cartridge and an automated analyzer
A measurement of the Streptococcus II

pneumoniae serotype 6A IgG antibody in a

File emailed II Do not add (P50):
Infliximab - Do not add.
The names for
Therapeutic drug
abuse.
Do not add (P50):
Adalimumab - Do not
add. The names for
Therapeutic drug
abuse.
Do not add (P50):
Certolizumab - Do not
add. The names for
Therapeutic drug
abuse.
Do not add (P50):
Tysabri - Do not add.
The names for
Therapeutic drug
abuse.
Do not add (P50):
Golimumab - Do not
add. The names for
Therapeutic drug
Spreadsheet emailed separately. II
Submission Value
HUMAN IMMUNODEFICIENCY VIRUS 1

SUBTYPE A
SUBTYPE B
SUBTYPE C
SUBTYPE D
SUBTYPE F
SUBTYPE G
SUBTYPE AE
SUBTYPE AG
Definition: II
FIGO 2018 - The staging of cervical cancer using

the 2018 International Federation of Gynecology
and Obstetrics (FIGO) staging system which
incorporates the use of imaging.
FIGO UNSPECIFIED - The staging of cervical

cancer using an unspecified version of the
International Federation of Gynecology and
Obstetrics (FIGO) system.
References:
https://pubs.rsna.org/doi/full/10.1148/
rg.2020200013
https://www.ajronline.org/doi/full/10.2214/
AJR.19.21819?mobileUi=0
File emailed II
separately:CDISC_Multi_Term_Request_LOC_Pf
izer20Jan22.xls
Hi!
Please find attached Multi-term request form for

LOC codelist.
Thanks!
Aparna
Units for area per time does not exist in CT. The II
usage for these units would be to assess
apparent diffusion coefficient (ADC) in kidney
images from the medulla and cortex using MRI. In
short, diffusion weighted images (DWI) are pulled
from a scanner. Then ADC is calculated on a
pixelwise basis using these DWIs as input. This is
done in the cortex and medulla of the ADC maps
and the median values are determined. In the
literature the unit is often written as
"10^-6*mm2/sec" but this way of writing units is
not found in CT. Instead a possibility could be
"mm2/usec". Please advise.
The EORTC-QLQ-C30 V3..0 instrument has 2 II QRS, SDTM-Published in
items that are represented with a Numeric Rating P50
Scale 7-Point format. This needs to be added to
the QRS Method codelist, since it is used in this
instruments supplement.
Jordan,
Attached is the spreadsheet for the new
Numeric Rating Scale 7-Point term for the QRS
Method codelist. Please let me know if you have
any questions.
Steve
In order to determine the proportion of leukemic II

blasts in total leukocytes in myeloproliferative
disorders such as AML, MDS or MF, the term
"Leukemic Blasts/Leukocytes" will be needed.
The method of usage is blood smear examination
under the microscope.
In this case the leukemic blasts refer to leukemic
myeloid cells (and not immature lymphoblasts as
per CDISC definiton) that differentiate and
develop into healthy granulocytes. Draft Definition
for "Leukemic Blasts/Leukocytes" in this case: "A
leukemic blasts (leukemic myeloid cells) to
Leukocytes in a biological specimen." I wonder if
the CT term "Leukemic Blasts" in general should
be re-visited as leukemic blasts can originate in
different cell differentiations (lymphoid, myeloid)..
Consider coding to either C185295 or a CNEW II

child concept.
Draft DEF: A measurement of the efficiency of II
oxygen exchange by the lungs, which is
calculated by multiplying fractionâ€‰of inspired
oxygen (Fio2) to mean airway pressure (Mpaw) to
100, and divided by pressure of arterial oxygen
(Pao2).
https://en.wikipedia.org/wiki/Oxygenation_index
Other supporting info:

OI = (Fio2 x mean airway pressure x 100)/Pao2
https://wiki.cdisc.org/display/DRAGON/
DRAGON+-
+Controlled+Terminology+Development
This is submitted on behalf of the DRAGON TA

team.
I asked the developer why this is considered as a

lab test instead of RE, here is the response: It
was grouped with the arterial blood gas results. I
think you are correct though that it would go with
RE. I will let you decide the correct domain
because I am conflicted. I can argue both ways. I
will defer this to the lab team to decide as well.
Extending the LOINC-SDTM-LB mappings II
- file e-mailed separately
Dear colleagues,
Please find a set of new term requests for the
SDTM codelist RSTYPRS (see attachment)
Background is that I am extending the LOINC-

SDTM-LB mapping and that there are some
missing values for RSTYPRS.
Many thanks in advance!

Jozef
Jozef Aerts
XML4Pharma
We had requested this before but it was rejected. II
We would request you to reconsider. This term is
used when the subject needs to be taken off the
drug/study because subject needs to start taking
a prohibited medication in near future, so the
subject has not actually taken the prohibited
medication. Hence using PROTOCOL
DEVIATION, or PROTOCOL VIOLATION is not
appropriate as no deviation/violation has
happened.
Hello, II
The definition for the concept Bone (Code

C12366) in NCIt has been modified from
"Connective tissue that forms the skeletal
components of the body." to "The structural organ
comprised of specialized connective tissue that
forms the skeletal components of the body." As
CDISC uses NCIt's definition for this term I'm
wondering if CDISC definition will be update as
well?
Thank you,
Svetlana
New term Bone Lytic Disease Response / II

BNDSRESP would be needed defined as "An
assessment of the destruction of an area of bone
due to a disease process, such as cancer."
Hi CDISC Team-
Attached are New terms to consider.
Thanks,
Jenny
A measurement of the Connective Tissue Growth II

Factor (CTGF) in a biological specimen.
A measurement of 11-Deoxycortisolin a biological II

specimen.
A measurement of the 11-Deoxycorticosterone in II

Spreadsheet: Exist Codelist - New Test PARM

(PYTEST/PYTESTCD = Pregnancy
Outcome/PREGOUT)
Spreadsheet: New Codelist - New Terms
(Pregnancy Outcome Findings Result)
Spreadsheet: Changes to Existing Term Codelist
Name Pregnancy Findings Result
New Codelist - Test or PARM

(DPTEST/DPTESTCD CT list) New Codelist -
New Terms (DPFINDRS for DPSTRESC)
A new term would be needed for II
LBTEST/Bacilliform defined as "A measurement
of bacilliform in a biological specimen."
A new LNBTEST would be needed for II

Bacilliform/Leukocytes defined as "A relative
measurement (ratio or percentage) of the
bacilliform to leukocytes in a biological
specimen.".
A new LBTEST would be needed for Lithium II
defined as "A measurement of the Lithium in a
A new term would be needed for Cedar Japanese II
IgE defined as "A measurement of the Cedar
Japanese IgE in a biological specimen.".
Requested to add to TRTEST new submission II

value of ABSOLUTE SCORE with the definition
of: Absolute scores are obtained by adding the
scores of the nine regions.
Ref: Ady N, Zucker JM, Asselain B, Edeline V,
Bonnin F, Michon J, Gongora R, Manil L. A new
123I-MIBG whole body scan scoring method--
IV neuroblastoma. Eur J Cancer.
1995;31A(2):256-61.

value of ABSOLUTE CHANGE FROM
BASELINE, with the definition of: The current
value minus the value recorded at baseline.
value of ASSESSMENT OF LESION BY
T2/FLAIR, with the definition of: An assessment
of the lesions on T2/Flair.
Ref: Okada H, Weller M, Huang R, Finocchiaro G,
Gilbert MR, Wick W, Ellingson BM, Hashimoto N,
Pollack IF, Brandes AA, Franceschi E, Herold-
Mende C, Nayak L, Panigrahy A, Pope WB, Prins
R, Sampson JH, Wen PY, Reardon DA.
Immunotherapy response assessment in neuro-
oncology: a report of the RANO working group.
Lancet Oncol. 2015 Nov;16(15):e534-e542. doi:
10.1016/S1470-2045(15)00088-1. PMID:
26545842; PMCID: PMC4638131.
value of CURIE SCORE, with the definition of:
Curie score for Bone Marrow. Ref: Ady N, Zucker
JM, Asselain B, Edeline V, Bonnin F, Michon J,
Gongora R, Manil L. A new 123I-MIBG whole
body scan scoring method--application to the
prediction of the response of metastases to
induction chemotherapy in stage IV
neuroblastoma. Eur J Cancer. 1995;31A(2):256-
61.

value of INFILTRATION DUE TO LYMPHOMA,
with the definition of: Bone Marrow Infiltration due
to Lymphoma identified by biopsy or PET
Ref: Bruce D. Cheson, Richard I. Fisher, Sally F.
Barrington, et.al., Recommendations for Initial
Evaluation, Staging, and Response Assessment
of Hodgkin and Non-Hodgkin Lymphoma: The
Lugano Classification. J Clin Oncol 32:3059-
3067. 2014 by American Society of Clinical
Oncology

value of LYMPHOMA INVOLVEMENT, with the
definition of: increase in spleen size >13cm.
Ref: Bruce D. Cheson, Richard I. Fisher, Sally F.
Barrington, et.al., Recommendations for Initial
Evaluation, Staging, and Response Assessment
of Hodgkin and Non-Hodgkin Lymphoma: The
Lugano Classification. J Clin Oncol 32:3059-
3067. 2014 by American Society of Clinical
Oncology

value of HIGHEST 5 POINT SCALE SCORE, with
the definition of: Highest 5 point scale from all the
lesions devised to assess the response to
treatment of Hodgkin and aggressive Non-
Hodgkin lymphoma. (Barrington SF, Mikhaeel
NG, Kostakoglu L, Meignan M, et al. Role of
imaging in the staging and response assessment
of lymphoma: consensus of the International
Conference on Malignant Lymphomas Imaging
Working Group. J Clin Oncol. 2014 Sep
20;32(27):3048-58.)

value of SUM OF THE NON-PLEURAL TARGET
LESIONS, with the definition of: A calculation of
the aggregated diameter values for tumors other
than pleural measurements.
value of SUM OF NON-PLEURAL AND
PLEURAL LESIONS, with the definition of: The
result of the addition of the pleural measurements
and diameter values of non-pleural lesions.

value of T1 SUM OF PRODUCTS OF PERPEND
DIAMETERS, with the definition of: The result of
the addition of the products of perpendicular
diameters of selected lesions in T1.
file emailed separately II
Dear Colleagues
Good morning or afternoon.
Please check the suggested new terms attached.

Terms suggestion were also sent via CDISC
Terminology online submission form.
Best regards,
Fausto
Definition: "The liquid lying above a liquid, solid or II

semi-solid residue, which is separated by
crystallization, precipitation or centrifugation of a
lavage fluid sample."
Current term does not exist; antibodies found in

the supernatant of nasal lavage fluid is being
analyzed for an influenza study.
A new lab test would be needed for LDL II

Triglycerides defined as "A measurement of the
low density lipoprotein triglyceride in a biological
specimen."
A new lab test would be needed for IDL II
Triglycerides defined as "A measurement of the
intermediate density lipoprotein triglyceride in a
A new lab test would be needed for LDL II
Apolipoprotein B defined as "A measurement of
the apolipoprotein B in the low density lipoprotein
fraction of a biological specimen."
Labs have the possibility to detect the SARS- II
CoV-2 Antigen via a Rapid Immunoassay.
Draft definition: A measurement of the SARS-
CoV-2 nucleocapsid protein antigen in a
A new lab test would be needed for Sweet Vernal II
Grass IgE defined as "A measurement of the
Sweet Vernal Grass IgE antibody in a biological
specimen."
A new lab tst would be needed for II
Melaleuca/Bottlebrush IgE defined as "A
measurement of the Sweet Vernal Grass IgE
antibody in a biological specimen."
Hi: II
I am working on the Urinary System Findings
which is very similar to other Findings domain.
But I noticed that the Code list for Urinary
Systems Test Code is URNSTSCD and for Test
Name it's URNSTS. It's really confusing. Can
these be modified similar to other Findings
domain Test Codes as URTESTCD and
URTEST? Also, the Code list "METHOD" does
not have the value "PARA-AMINO HIPPURIC
ACID CLEARANCE". It's given in the SDTM
Sample dataset published in v3.3. Could the code
list be updated using this value? Please feel free
to let me know if you have any questions.
Thanks.
Best Regards,
Varma Nadimpalli.

Submission Values:
Neutrophilic Metamyelocytes/Total Cells

Aspartate Aminotransferase Isoenzyme
Alternaria alternata IgE AB MAST
Aspergillus Species IgE AB MAST
Musa Species IgE AB MAST
Beef IgE AB MAST
Fagopyrum esculentum IgE AB MAST
Candida Species IgE AB MAST
Cat Dander IgE AB MAST
Cedar IgE AB MAST
Chicken IgE AB MAST
Cancer pagurus IgE AB MAST
D. farinae IgE AB MAST
Dog Dander IgE AB MAST
Egg White IgE AB MAST
Chamaecyparis obtusa IgE AB MAST
House Dust IgE AB MAST
Alnus japonica IgE AB MAST
Kiwifruit IgE AB MAST
Latex IgE AB MAST
Milk Protein IgE AB MAST
Artemisia vulgaris IgE AB MAST
Orchard Grass Pollen IgE AB MAST
Ovomucoid IgE AB MAST
Prunus persica IgE AB MAST
Arachis hypogaea IgE AB MAST
Pork IgE AB MAST
Ragweed Mix Pollen IgE AB MAST
Oryza sativa IgE AB MAST
Salmo salar IgE AB MAST
Sesamum indicum IgE AB MAST
Shrimp IgE AB MAST
Glycine max IgE AB MAST
A new lab test would be needed for HLA-DR51 II

Antigen Type defined as "The identification of the
type of human leukocyte antigen, class II,
antigen-D-related (HLA-DR1), in a biological
specimen."
specimen."
specimen."
Definition: A questionnaire, rating and scale II QRS, SDTM-Published in
(QRS) data type using a visual analog scale P50
(VAS) 0-100 scale with no units.
Definition: The status of a female with respect to II
her last menstrual period.
A new lab test would be needed for Schuffner's II
Granules defined as "An observation of
Schuffner's Granules in a biological specimen."
Schuffner dots are coarse, red, polychrome
methylene blue staining granules found in
erythrocytes infected with Plasmodium ovale or
P. vivax malaria.
A new lab test would be needed for II

Firmicutes/Bacteroidetes Ratio defined as "A
firmicutes to bacteroidetes in a biological
specimen."
In NCI, Bacteroidetes is a phylum of bacteria
composed of three large classes of bacteria that
are widely distributed in the environment,
including in soil, in sediments, sea water and in
the guts of animals.
And Firmicutes is a taxonomic phylum within
kingdom Bacteria consisting of mostly gram-
positive bacteria with a low G+C ratio. The
phylum is highly diverse in phenotypic
characteristics.
These are further categorizations to collect the II

type of consent provided by the patient. For these
records, the DSCAT would be "PROTOCOL
MILESTONE" and DSSCAT would be
"PHARMACOGENETIC INFORMED CONSENT",
"BIOPSY INFORMED CONSENT". Please let me
know if these values can be added to the
DSSCAT codelist.
Dear NCI CT team, II Do not add (P50): Do
Here I would like to request one new codelist - not add. All QRS
True False codelist. The details can be found in responses, for public
the attached file. Please kindly let me know if any domain and copyrighted
further information is required. instruments, are
controlled in Section 4 of
Best wishes, the QRS supplements.
Jintao However, CDISC
currently will only
publish controlled
response terminology
for public
domain instruments
that are also
implemented in the
CDISC Library, as a part
of the SDTM
terminology set. The
SGRQ Past 4 Weeks
questionnaire is
copyrighted so at this
time, CDISC will not
create response
terminology for this
instrument.
The QRS CT team also
wants to mention that
CDISC advises users to
create QRS instrument-
specific True/False,
Yes/No responses
codelists; should NOT
use the general SDTM-
Y/N codelist for QRS
instruments. CDISC will
enforce this rule for all
future QRS response
Definition: "A microscopy staining method that II
utilizes a monoclonal antibody (mAb) to bind the
KI-67 nuclear protein, a marker of cellular
proliferation. A counter stain (e.g., hematoxylin)
or other reagent is added allowing detection of
mAb-bound KI-67."
See, e.g.,
https://acsjournals.onlinelibrary.wiley.com/doi/abs
/10.1002/1097-
0142(19910801)68:3%3C549::AID-
CNCR2820680318%3E3.0.CO;2-J
KI-67 staining is being used a comparator

screening method for detection of anal and
cervical cancers.
Definition: "A microscopy staining method that II
utilizes monoclonal antibodies to bind the cell-
cycle regulators MCM2 (minichromosome
maintenance protein 2) and TOP IIA (DNA
topoisomerase II alpha). Addition of other
reagents allows for detection of mAb-bound
MCM2 and TOP IIA. Over-expression of these
cell-cycle regulators indicates abnormal cell
reproduction."
See, e.g.,
and/or https://www.bd.com/documents/bd-
legacy/directions-for-use/womens-health/
DS_WH_BD-ProEx-C-ICC_DF_EN.pdf
MCM2-TOP IIA staining is being used in a study

for detection of anal and cervical cancers.
A new lab test would be needed for Prothrombin II

Fragment 2 defined as "A measurement of the
prothrombin fragment 2 in a biological specimen."
A new lab test would be needed for Prostaglandin II

D2 Receptor 2 defined as "A measurement of
Prostaglandin D2 Receptor 2 in a biological
specimen."
Please refer to NCI URL:http://nciws-
p803.nci.nih.gov:9080/ncitbrowser/ConceptRepor
t.jsp?
ncit&code=C161834
A new lab test would be needed for Leukotriene II
C4 Synthase defined as "A measurement of
Leukotriene C4 Synthase in a biological
specimen."
A new lab test would be needed for Cysteinyl II
Leukotriene Receptor 1 defined s "A
measurement of Cysteinyl Leukotriene Receptor
1 in a biological specimen."
Do not add (P50):
Requested Synonym(s) Cutibacterium - Do not
add. Cutibacterium is
Clostridioides difficile - Add as a synonym for not a synonym to
existing CDISC Submission Value PROPIONIBACTERIUM
CLOSTRIDIUM DIFFICILE Clostridioides . According to NCBI
colicanis - Add as a synonym for existing CDISC Taxonomy,
Submission Value CLOSTRIDIUM COLICANIS Propionibacterium and
Paeniclostridium sordelli - Add as a synonym for Cutibacterium are two
existing CDISC Submission Value different genera.
CLOSTRIDIUM SORDELLII Paraclostridium
bifermentans - Add as a synonym for existing
CDISC Submission Value CLOSTRIDIUM
BIFERMENTANS Cutibacterium acnes - Add as a
synonym for existing CDISC Submission Value
PROPIONIBACTERIUM ACNES Cutibacterium -
Add as a synonym for existing CDISC
Submission Value PROPIONIBACTERIUM
Definition: A relative measurement (ratio or II

percentage) of the regulatory T-lymphocytes to
total lymphocytes in a biological specimen.
These terms are for the SDTM-ETHNICC II
(Ethnicity As Collected, 128690) codelist.
Submission Value: Irish

CDISC DEF: A person of Irish descent.
Submission Value: English

CDISC DEF: A person of English descent.
Trial Phase 1-3 (A class of clinical study that II

combines elements characteristic of traditional
Phase I, Phase II and Phase III trials. See also
Phase I, Phase II, Phase III.
Definition: "A unit representing the area under the II
curve (AUC) of a dilution series of optical density
measurements (expressed as the degree of
absorption of light at a specified wavelength by a
solution or suspension). The AUC may represent
the sum of the OD Unit measurements at each
dilution or the integrand of a model fit to those
measurements."
Titers are generally calculated as the reciprocal

dilution at which there is a certain percent
reduction in signal compared to a control (e.g.,
50% neutralization) or as an endpoint titer (last
dilution at which signal is detectable). However, I
have increasingly seen the use of "area under the
curve" as a type of titer measurement where the
AUC represents the sum of OD unit results at
each dilution (or the integrand of a 4- or 5-
parameter logistic fit to the data). For instance,
see Figure 2 of
https://www.nejm.org/doi/full/10.1056/NEJMoa20
22483 as well as the supplemental material.
Since the sum/integrand is of the OD unit results,
"OD Unit AUC" would make more sense as a unit
than "titer AUC" or similar.
For our studies, even if the subject does not get II

pregnant but the partner gets pregnant, then the
subject is discontinued from the treatment. It
would be best if 'PREGNANCY' can be updated
to 'PREGNANCY (SELF OR PARNTER)'.
Alternately, either consider addition of

'PREGNANCY (SELF OR PARNTER)' as another
term, or update the definition of PREGNANCY to
clarify that it is applicable 'for subject or partner'
CDISC Definition: A microscopy staining method II

that used to facilitate the diagnosis of human
papillomavirus (HPV)-associated cervical
precancerous lesions.
NCI Preferred Term: P16INK4a Staining Method
A new lab test would beneeded for Intra- II

erythrocyte Crystals defined as "A measurement
of the Intra-erythrocyte crystals in a biological
specimen."
A new lab test would be needed for Pigment II
Casts defined as "A measurement of pigment
casts in a biological specimen.".
A new lab test needed for Intra-erythrocyte II
Crystals defined as "A measurement of the
Intraerythrocyte crystals in a biological
specimen."
N/A II SEND-Published in P50
This new lab test would be needed defined as II

"The measurement of M Protein M Spike Region
These tests of SERUM PROTEIN

ELECTROPHORESIS were done for Multiple
Myeloma studies.
If one monoclonal spike is present it is reported
as M-spike region 1. If two are present then they
are reported as M-spike region 1 and M-spike
region 2 respectively. There is a place holder in
the laboratory information system for a third M-
spike named M-spike 3. This is theoretical as no
third M-spike has yet to be reported at CCLS. If
no monoclonal spike is detected, then these
regions are reported as not detected.


Myeloma studies.


Myeloma studies.

"The measurement of Myeloma Protein
Immunofixation Impression 1 in a biological
specimen."
These tests of SERUM
IMMUNOELECTROPHORESIS were done for
Multiple Myeloma studies to determine the
immunotype of monoclonal proteins present in a
sample. If one is present it is reported under
impression 1. If two are present then they are
reported as impressions I and 2, etc. IFE results
cannot be quantitated. Potential results include
IgG, IgM, IgA, IgD, IgE, kappa light chains,
lambda light chains and oligoclonal bands.

specimen."
specimen."
A new term would be needed for 17 p deletion II

defined as "An assessment of the 17p deletion in
Synonym of "Loss of Chromosome 17p" with
NCI definition: "A cytogenetic abnormality that
refers to the loss of all or part of the short arm of
chromosome 17 (17p)". please refer to
eptReport.jsp?
9.
Detected by FISH that is a sensitive and
quantitative method for the detection of del(17p)
and is the method of choice of most laboratories
to date (present in CDISC as C17563.
In ADaM ADAE.SMQzzSC for the values II

"BROAD" and "NARROW" , there is currently no
codelist that exists. Pinnacle 21 fires a warning
when the variable values do not meet the above
mentioned values. It can be easily missed to
assign to lower case and then realize from the
Pinnacle warning at later stage.

"The determination of the amount of germline
DNA in a biological specimen."
This new lab test term woud be needed defined II
as "A measurement of the amount of ketone
bodies being excreted in urine over a defined
amount of time (e.g. one hour)."
as "A measurement of the amount of beta-
hydroxybutyrate being excreted in urine over a
defined amount of time (e.g. one hour)."
as "A measurement of the amount of acetoacetic
acid being excreted in urine over a defined
amount of time (e.g. one hour)."
Files emailed separately II QRS, SDTM-Published in
P50
SEND IGv3.1.1 was final on 2021-03-30. II
Proposed definition: The 3.1.1 version of the

standard for exchange of nonclinical data (SEND)
implementation guide.
The values that should be in the separate II
codelists are described in SDTMIG v3.4 Section
4.4.7. If there are values that are relevant only
for starts or ends, we may need up to four
separate codelists.
The fact that one codelist is used with all the

relative timing variables, but not all values are
appropriate for use with all relative timing
variables has been a source of continuing
confusion. Not all users will find and understand
Section 4.4.7.
"File emailed separately" II
Hello,
Please find attached the multi-term request form.
Thanks!
Aparna
Definition: Any bacterial organism that can be II

assigned to Lacticaseibacillus paracasei subsp.
Paracasei
Draft definition: A unit of measurement of the II
number of visible clusters of transformed or
infected cells in a unit volume of substance of
interest defined as the number of Focus-forming
Units in one milliliter of substance
This definitions is based on combination of

following 3 CDISC definitions:
10^3 CFU A unit of measurement of
colony forming cells or microorganisms equal to
10 to the third power colony forming units.
CFU/mL A unit of measurement of
colony forming cells or microorganisms in a unit
volume of substance of interest defined as the
number of colony forming units in one milliliter of
substance.
and FFU A unit of measurement of the
number of visible clusters of transformed or
infected cells.
Requested to add to METHOD new submission II

value of Cycle ergometer, with the definition of:
Stationary exercise bicycle equipped with an
ergometer instrument that measures the amount
of work done by the individual.

value of Treadmill (Stage protocol), with the
definition of: Cardiorespiratory fitness treadmill
protocol characterized by specified stages, at
which gradient and / or speed of treadmill are
stepwise increased.

value of Treadmill (Continuous ramp protocol),
with the definition of: Cardiorespiratory fitness
treadmill protocol characterized by a continuous
increase of gradient and / or speed over time
Requested to add to SPECTYPE new submission II

value of Exhaled particles, with the definition of:
Endogenously generated droplets present in
exhaled air, containing water and non-volatile
material.
As the "AD" domain code is reserved in the II
SDTM domain code, but is used to indicated the
first two characters of an ADaM dataset, the AP
letters should be reserved for use in SDTM as the
first two characters for Associated Persons
datasets/domains, as defined/explained in the
SDTM-IG for Associated Persons. Having these
reserved in the CT would keep the AP codes from
being used for another domain with another topic,
either by CDISC, or more likely by a sponsor for a
custom domain.
Submission Value II
Synonym
Bone Marrow Involvement

BMIVL
Bone Marrow Involvement Indicator
BMIVLIND
Number of Lymph Nodes Positive
LMNDPNUM
Definitions:
Bone Marrow Involvement - A measurement of

the bone marrow involvement in a biological
specimen.
Bone Marrow Involvement Indicator - An

indication as to whether disease is present in the
bone marrow.
Number of Lymph Nodes Positive - The number

of subject lymph nodes that were positive for
presence of disease.
Definitions: II
CURRENT DIAGNOSIS - The current diagnosis

of the disease.
MOST RECENT PROGRESSION OR RELAPSE

- The latest progression or relapse of the disease.
The BSRS-5 is a 5-item, self-administered II
questionnaire that is derived from the 50-item
brief symptom rating scale, which measures
anxiety (feeling tense or high-strung), depression
(feeling depressed or in a low mood), hostility
(feeling easily annoyed or irritated), interpersonal
sensitivity (feeling inferior to others), and
additional symptoms (having trouble falling
asleep in the past week).
It will be used for suicidal ideation and behavior
assessment.
The SSS (Stanford Sleepiness Scale) is a self- II QRS, SDTM-Published in

rating scale which is used to quantify progressive P50
steps in sleepiness at a certain point in time. It is
seven?point Likert-type scale, has descriptors
ranging from ?feeling active, vital alert, or wide
awake? (score = 1) to ?no longer fighting sleep,
sleep onset soon and having dream-like
thoughts? (score = 7)
Requested Submission Value

Requested Synonym(s)
Rash/Lesion Appearance
LSNAPPR
Rash/Lesion Pruritic Indicator
PRURIND
Rash Distribution
RSDSTRBN
Lesion Count
LSNCNT
Total Lesion Count
TOLSNCNT

Maternal Smoking Indicator
MASMKIND
Number of People in Household
PPLHSHN
Number of Children in Household
CHLDHSHN
Day Care Indicator
DYCARIND
Maternal Vaccine During Preg Indicator
VAXPGIND
used in a recent FDA RWD/RWE draft guideline. II

File emailed separately 1-request for new terms II
2-request for new association of existing terms to
existing codelist 3-request for change to existing
terms (addition of synonyms)
Dear all,
Please find the completed file for Term

suggestion for CDISC controlled terminology
(SEND).
It contains new terms request, some new
associations of existing code to existing codelist
are added in the "Exist Codelist - New Term" part.
One code is added both on "Exist Codelist - New
Term" part and "Changes to Existing Term" part :
request for new association and addition of a
synonym.
Thanks a lot for taking into account these
requests, best regards,
Anne-Marie LE MENEC (anne-

marie.lemenec@keyrus.com)
Keyrus
155 rue Anatole France
92300 Levallois-Perret, FRANCE
on behalf of Virginie ORY

(virginie.ory@ipsen.com)
Ipsen
Z.A Courtaboeuf
5 Avenue du Canada
91940 Les Ulis, FRANCE

Acid Sphingomyelinase
ACSPGM
Centromere A Antibodies
CENTRAAB
Synonym: Centromere Protein A (CENP-A)
Antibody
Mitochondria M2-3E Antibody
MM23EAB
D-3-Phosphoglycerate Dehydrogenase Ab
PGDHAB
PML Antibody
PMLAB
RNA Polymerase III Antibody
RP3AB
Retinol Binding Protein 4 Retinol

Binding Protein - Add as a synonym to existing
term
Beta-Hydroxybutyric Acid Beta-
Hydroxybutyrate - Add as a synonym to existing
term
A measurement of the Candida dubliniensis in a II

Hello NCI,
Please see attached for new term request.
This forwarded email chain also provides more

context.
Thanks,
Ivan
To record the procedure of taking biopsy, we put II

the data in PR domain.
And we also want to know how the biopsy was
taken. And the variable that seems most correct
to store this is PRROUTE.
What will you suggest in putting this data of "How
the biopsy was performed?" If route of
administration is the correct place to store this
data, then I would like tot request the codes to be
added in the ROUTE codelist.
Or do you have other suggestion on where to
store this piece of information?
Thank you in advance.

There are several 'percent change nadir...' but no II
test that just displays the Nadir value
File emailed seperately. Add ADPPK as a sub II

class of BDS.
Thank you, Tatiana, for your help in filling out the

form.
Here is the request spreadsheet. I have also
filled out the information at the link provided in the
earlier email.
Thanks,
Luke
Requested to add to SPECCOND new II

submission value of OUT OF SAMPLE VOLUME
RANGE, with the definition of: Radiolabelled
blood samples volumes differ from set ranges.
Hi,
I have attached the file related to this request

here.
Thank you,
Rohit
Dear Team,
Greetings!
Attached herewith is the template with details of

the requested terms.
Please let me know if you require any additional

information.
Regards,
Atul Ninawe
Requested to add to UNIT new submission value II

of 'mg/CAPSULE', with the definition of: A unit of
measure expressed in milligram(s) per capsule.
Current SDTM value of mg/DOSE does not
correctly represent individual capsule component.
Total Numbers: II SDTM, SEND, Protocol
198 new - Published in P49
55 changes
No need to put these into the team working

documents as they have already been resolved.
Attached is the supplemental file for the below

request.
Erin
From: A unique pattern of gene expression of one II

to many combinations of genes that is associated
with type 1 interferon activity.
To: A unique pattern of gene transcription of one

to many combinations of genes that is associated
with type 1 interferon activity.
Team generally agrees to this definition update

on team call 2022-03-16
This new lab test would be needed defined as "A II

measurement of Inflammatory Cells in a biological
specimen.".
measurement of Inflammatory Cells/Total Cells in
a biological specimen.".
measurement of pyknotic cells in a biological
specimen."
This new lab test woubd be needed defined as "A II
measurement of Squamous Cells in a biological
specimen."
Please refer to NCI
eport.jsp?
ictionary=NCI_Thesaurus&ns=ncit&code=C12849
.
"File emailed separately": II
CDISC_Multi_Term_Request_TRTEST_Pfizer20
220317.xls
Hi,
Please find attached the multi term request form

for TRTEST/TRTESTCD
Thanks!
Aparna
This would paired with GFTESTCD=SNV and II
would include result like heterozygous,
hemizygous and homozygous.
A supporting measurement that indicates a

logical comparison between the matched pair of
nucleotides found at the indicated position.
Homozygous indicates that the matched pair of
nucleotides are the same, while Heterozygous
indicates that the matched pair of nucleotides are
different.
Hemizygous indicated that the one copy of
nucleotide (chromosome) without allelic
counterparts.
This would paired with GFTESTCD=SNV and II

would related to the result quality score.
A supporting measurement that indicates the

confidence of the nucleotide determination.
The synonyms : Q20; Q score; PHRED
CPTESTCD=CD16X II
CPTEST=CD16 Expression
Definition=A measurement of CD16 expression in
Would be used when reporting a

FLUORESCENCE INTENSITY result type.
CPTESTCD=CD86X II
CPTEST=CD86 Expression
Definition=A measurement of CD86 expression in
Would be used when reporting result type

FLUORESCENCE INTENSITY
CPTESTCD=HLADRX CPTEST=HLADR II
Expression Definition=A measurement of HLA-
DR expression in a biological specimen.
Would be used when reporting result type

FLUORESCENCE INTENSITY
CPTESTCD=PLABLST CPTEST=Plasmablast II
Definition=A measurement of the plasmablast
cells in a biological specimen.
CPTESTCD=PLABLSTS CPTEST=Plasmablast II
Sub Definition=A measurement of a sub-
population of plasmablast cells in a biological
specimen.
CPTESTCD=BLYTS CPTEST=BLym Trans Sub II
Definition=A measurement of a sub-population of
transitional B-lymphocytes in a biological
specimen.
CPTESTCD=BLYNMAS CPTEST=BLym Naive II
Mat Sub Definition=A measurement of a sub-
population of naive mature B-lymphocytes in a
CPTESTCD=MNNCLS CPTEST=Mono II
NonClassic Sub Definition=A measurement of a
sub-population of non-classical monocytes in a
CPTESTCD=MNCLS CPTEST=Mono Classic II
Sub Definition=A measurement of a sub-
population of classical monocytes in a biological
specimen.
Proposed definition: Unit of measurement for a II
portion of a particular type of cell per 400 cells.
This is relevant in context of decentralized clinical II

trials, a new trend in clinical trial design.
Requested to add to CNTMODE new submission II

value of IN PERSON AT HOME, with the
definition of: An interaction that takes place in the
physical presence of someone else at the
individual's home.
Additional Information:
This is relevant in context of decentralized clinical
trials, a new trend in clinical trial design.
The biuret reaction method is frequently used for II

protein determination. There seems no
appropriate term in the method codelist that could
be used instead.
Definition: A fluorescent immunoassay used to II
determine the presence of neutralizing antibodies
in specific concentrations in a biologic specimen
that can block viral replication.
Reason: Other methods have separate terms for II

CONTRAST ENHANCED and WITHOUT
CONTRAST. Draft definition: A type of X-ray in
which images are not enhanced by the addition of
contrast agents into the body.
Reason: CONTRAST ENHANCED PET SCAN II
exists currently, but not WITHOUT CONTRAST.
Draft definition: A type of PET scan in which
images are not enhanced by the addition of
contrast agents into the body.
Change the "&" to the Underscore sign in II QRS, SDTM-Published in
C182477 and C182515. This is a QRS request. P50
-KFSS102A&6AOR, Change to
KFSS102A_6AOR
-KFSS102A&6ASTR, Change to
KFSS102A_6ASTR
Create new SDTM and ADaM terminology for II QRS, SDTM-Published in

CHART-SF. This is a QRS request, also I just P50
IDC-O is the International Classification of II

Diseases for Oncology
https://apps.who.int/iris/bitstream/handle/10665/9
6612/9789241548496_eng.pdf
Note that the WHO classification for tumors is

follows ICD-O, so IDC-O is needed by oncology
studies.
Starting place for Definition: Glomerular lipidosis II

(GL) is characterized by dilated glomerular
capillary loops containing lipid-laden cells (foam
cells) (Kohken et al 2017)
Reason for Request: Common finding in the

kidney of dogs. Observed as an incidental finding
as well as with clinical renal dysfunction and/or
Juvenile nephropathies.
Reference used for definition: Kohnken RA,

Amerman H, Brown CA, Furrow E, Lees GE,
Cianciolo RE. Glomerular Lipidosis in Dogs. Vet
Pathol. 2017 Sep;54(5):795-801.
Start for Definition: Swollen eosinophilic axons II
observed during early stage of axonal
degeneration (Kaufman et al. 2012, Bradley et al.
2020)
Reason for request: This is an early-stage lesion

during axonal degeneration where myelin sheaths
are typically unaffected. This will help distinguish
from late-stage lesion which is characterized by
axonal fragmentation with formation of digestion
chambers and presence of degenerated myelin.
References used for definition: Kaufmann W,

Bolon B, Bradley A, Butt M, Czasch S, Garman
RH, George C, Groters S, Krinke G, Little P,
McKay J, Narama I, Rao D, Shibutani M, Sills R.
Proliferative and nonproliferative lesions of the rat
and mouse central and peripheral nervous
systems. Toxicol Pathol. 2012 Jun;40(4
Suppl):87S-157S.
Bradley AE, Bolon B, Butt MT, Cramer SD,

Czasch S, Garman RH, George C, Groters S,
Kaufmann W, Kovi RC, Krinke G, Little PB,
Narama I, Rao DB, Sharma AK, Shibutani M, Sills
R. Proliferative and Nonproliferative Lesions of
the Rat and Mouse Central and Peripheral
Nervous Systems: New and Revised INHAND
Terms. Toxicol Pathol. 2020 Oct;48(7):827-844.
Definition: "A measurement of the Human II

Herpesvirus 8 DNA in a biological specimen."
Synonyms: HHV-8; Kaposi's sarcoma-associated
herpesvirus; KSHV
HHV-8 exists in the MICROORGANISM codelist,

but not in MBTESTCD. It is one of the viruses
screened and quantified (if present) in an
oncology study.
Definition: "A measurement of the hepatitis B II

virus in a biological specimen."
"HBV" on its own does not exist as an
MBTESTCD; it's being screened for (without
specify antigen, antibody, etc.) in an oncology
study. HBV is the current synonym for
HEPATITIS B VIRUS in the MICROORGANISM
codelist.
Definition: "A measurement of the hepatitis C II
HCV on it's own does not exist in MBTESTCD

and is being screened for in an oncology study.
It's the current synonym for the virus in the
MICROORGANISM codelist.
For C111526, change all instances of II QRS, SDTM-Published in

"Unproductive" to "Underproductive" in the P50
CDISC submission value, SY and NCI PT. This is
a QRS Request.
Definition: "A measurement of the Varicella II
Zoster virus in a biological specimen."
Synonyms: Human Herpesvirus 3, HHV-3,
Herpes Zoster
VZV on its own does not exist in MBTESTCD; it's

being screened for in an oncology study. While
HUMAN HERPESVIRUS 3 is the submission
value in the MICROORGANISM codelist, existing
terminology in MBTESTCD uses the "VZV" prefix.
I'd note that "Herpes Zoster" is sometimes used
as a synonym, which is currently missing from
existing values in CT.
Please see the attached file for additions to the

MBTESTCD and MICROORG code lists.
Thanks,
-Dan
Reason for suggestion - parathymic lymph node II

is present in rats and no synonyms are currently
available in the system to indicate such lymph
node Draft definition - Lymph node(s) adjacent to
the thymus Examples of how this new term will be
used - lymph node, parathymic: discoloration -
red
Please add new submission values for: II

PKPARMCD of LAMZINTC
PKPARM of Lambda z Intercept
Both with the definition: The intercept associated
with the terminal (log-linear) portion of the curve.
Events occurring after treatment initiation that II
affect either the interpretation or the existence of
the measurements associated with the clinical
question of interest. Intercurrent events should be
addressed when describing the clinical question
of interest to precisely define the treatment effect
that is to be estimated.
term used to define estimand in the ICH E9

Addendum
A measurement of any member of the genus II

Campylobacter in a biological specimen.
A measurement of any member of the genus II

Norovirus in a biological specimen.
This is for the ADQRS team's guidance on the II QRS, SDTM-Published in

HAMD 17 Questionnaire, and the ADaM specific P50
CT that is new and not copied from SDTM.
codelist name" HAMD 17 Questionnaire

Parameter Code" , Submission value
HAMD17TS" CT value 'HAMD1PC' for Parameter
code.
Codelist name "HAMD 17 Questionnaire
Parameter Name" Submission value "HAMD17-
Total Score - Analysis" for the full Parameter
name and CT value of 'HAMD1PN' for parameter
code
Draft Definition: A method that enables II

simultaneous detection of multiple biomarkers on
a single tissue section using immunofluorescence
techniques.
Synonyms: MxIF, Multiplexed

Immunofluorescence NCI Thesaurus Code:
C181928
A measurement of Polymers of Z ?1-antitrypsin in II

Please create: RETEST-CD: OI/Oxygenation II
Index
DEF: A measurement of the efficiency of oxygen
exchange by the lungs, which is calculated by
multiplying fraction?of inspired oxygen (Fio2) to
mean airway pressure (Mpaw) to 100, and
divided by pressure of arterial oxygen (Pao2).
https://en.wikipedia.org/wiki/Oxygenation_index
This is from the DRAGON TA project. This was

submitted to the Lab team for review first but
ultimately the LB team decided that this should be
controlled and modeled in RE.
Pls also include this request code: CDISC-5326.
These terms represent entities to which or whom II

a device may be transferred or who take custody
of a device. May also be known as the
responsible party. Does not necessarily represent
a specific individual or a geographic location, but
may represent a legal entity.
May also be used for BEPARTY.
Question: Ask SEND CT to review definition. II

Does the vein empty into the left atrium in all
species or should it just say that it carries
oxygenated blood from the lung to the heart?
Psoriasis TA team request II QRS, SDTM-Published in
P50
The CDISC definition uses the word II

"complimentary", but the correct word is
"complementary".
Klebsiella aerogenes is the new preferred name II

in NCBI Tax
Typo in submission value - Missing 'I' in INITIAL II
Please add NEFL and NF-L as synonyms. NEFL II

is the official gene symbol. NF-L is commonly
used by the biologist. I would consider changing
NFLP with NEFL.
A Nuclear imaging test used to assess ventricular II
function, wall motion and ejection fraction of the
heart.
please help to add this term into SDTM-LAT code II
list, which will be useful for mapping 'middle
thoracic'. thanks.
KLCLLCFR= Kappa Lt Chain,Free/Lambda Lt II
Chain,Free MISPEC=BONE MARROW
MICLMETH=BIOPSY MIMETHOD=FLC ASSAY
(vendors Freelite or Siemens)
Note: assumes >= 100 plasma cells in the biopsy
sample.
KLCLLCFR= Kappa Lt Chain,Free/Lambda Lt II

Chain,Free MISPEC=BONE MARROW
MICLMETH=BIOPSY MIMETHOD=FLC ASSAY
requested from Oncology SDS team for multiple II

myeloma example modeling using the CP
domain.
for consistency with the diff files, etc. II
C156813 = INTIAL DIAGNOSIS - is spelt II

incorrectly and needs to be updated to read as:
INITIAL DIAGNOSIS
Following to CDISC-4816 request, new term II
'MAJOR' would be needed in codelist SEVRS
defined as "Major disease manifestations such as
more important complications than principal
diagnosis, and non emergency life support
procedures.".
Following to CDISC-4817 request, new term II

'MINOR' would be needed in codelist SEVRS
defined as "Asymptomatic disease with none or
very minor complication, and non invasis
diagnostic or minor therapeutic.".
Definition: A licensed hearing healthcare II
professional who specializes in the diagnosis and
treatment of hearing loss and balance disorders.
Hi, II
Attached please find my new term request.

As I am the programmer, some data were
provided by vendor that I have no further
information on the meaning of the tests.
Angela Tseng | Principal Programmer Analyst,

DM & BS Department
A2 Healthcare Taiwan Corporation
A new lab test would be needed for "Gamma II

Delta T Cells / GDTCE" defined as "A
measurement of Gamma Delta T Cells in a
biological specimen.". This term exists in NCI
defined as "A resting, mature T cell that probably
plays a primary role in suppressor/cytotoxic
phenomena.". Please refer to
eport.jsp?
5.
A new lab test would be needed for "Gamma II

Delta T Cells/Lymphocytes / GDTCELY" defined
as "A relative measurement (ratio or percentage)
of Gamma Delta T Cells to Lymphocytes in a
A new lab test would be needed for "Mucus- II
Secreting Cell"/ MUCC defined as " A
measurement of the epithelial cells that produce
mucin gel adherent to the mucosal surface in a
biological specimen" . This term already exist in
NCI. Please refer to
eptReport.jsp?
2.
A new lab test would be needed for "Mucus- II
Secreting Cell"/ Total Epthelial Cells" / MUCEPIC
defined as " A measurement of the epithelial cells
that produce mucin gel adherent to the mucosal
surface, to total epithelial cells in a biological
specimen" .
A new test would be needed for Tlym Help II

Reg/Lym / TLYHPLY defined as "A relative
measurement (ratio or percentage) of of helper
regulatory T-lymphocytes to total lymphocytes in
Believe this should be non-extensible. II
According to the study technical conformance II
guide of the FDA, for TS (Trial Summary) domain
we would need a new codelist THERAREA for
therapeutic area terms as it is a FDA desired
parameter.
List of multiple terms for therapeutic areas II
(Cardiovascular, Dental and Oral Health,
Dermatology, Devices, Endocrinology,
Gastroenterology, Hematology, Hepatology,
Immunology, Infectious Disease,
Musculoskeletal, Nephrology, Neurology/CNS,
Nutrition and Weight Loss,
Obstetrics/Gynecology, Oncology,
Ophthalmology, Other, Otolaryngology, Pain,
Pediatrics/Neonatology, Pre-Clinical,
Psychiatry/Psychology, Pulmonology/Respiratory,
Rare Diseases, Tobacco Research, Transplant,
Urology, Vaccines) sent separately to populate
the new codelist THERAREA requested.
Dear CDISC-NCI,

Team for CDISC SDTM terminology.
Requested new codelist: THERAREA.
Thank you.
Best regards,
Term "SOUTHERN AFRICAN COLORED?" is the II

only one in the RACEC codelist with a mixed
race. It is an ambiguous term as defined "A
person of mixed race, whose ancestry is from one
or more of the naturalized racial groups of
Southern Africa (typically Western European,
South Asian, or Southeastern Asian) and one or
more of the indigenous Southern African
peoples." Definition should be modified or term
removed
Change "Utililty" to "Utility" II QRS, SDTM-Published in
P50
SF6D Version 2.0 Acute - Utililty Index Score UK
Weights (NCI PT)
SF6D2-Utililty Index Score UK Weights (CDISC
PT)
SF6D2-Utililty Index Score UK Weights (CDISC
SY)
The valid values would be: II

1. SITE
2. SPONSOR
3. SUBJECT
4. MANUFACTURER (added by Kit)
Also, invite KitHoward to the Biospecimens team

meeting to develop this codelist.
Hello,
Please find attached the form to support the new

codelist request submitted today.
Best regards,
Stephanie Berry
Dear CDISC, dear NCI,
Please find attached a multi term request to add

new terms to MBTESTCD (SDTM) code list.
Thank you in advance,
Kind regards,
Kathleen
Please add new lab test: Anti-MOG Antibody. For II

additional information, please see:
https://gcc02.safelinks.protection.outlook.com/?
url=https%3A%2F%2Fltd.aruplab.com%2FTests
%2FPub
%2F3001277&data=05%7C01%7Cbrenda.p
etty%40nih.gov
%7Cc5f0b585afbe4134552b08da33457377%7C
14b77578977342d58507251ca2dc2b06%7C0%7
C0%7C637878670633486527%7CUnknown
%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLC
JQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0
%3D%7C3000%7C%7C
%7C&sdata=WtsDLjau8LtlZckZgaDsEi0zwS
gbaevbkkCmL%2BT0z1M%3D&reserved=0
Please add new lab test: Anti-AQP4 Antibody; for II
additional references please see
url=https%3A%2F%2Farupconsult.com%2Fati
%2Fneuromyelitis-
optica&data=05%7C01%7Cbrenda.petty
%40nih.gov
%7Cd70c6f633cc0487edbda08da33462779%7C
14b77578977342d58507251ca2dc2b06%7C0%7
C0%7C637878673642981225%7CUnknown
%3D%7C3000%7C%7C
%7C&sdata=8iNXlnDdCsf
%2BGqwRH4jK6q0SAUH2pfHOZ406nkHLzD0%
3D&reserved=0. Thank you!
In context of lavage fluid analysis such as BALF II

(bronchoalveolar lavage fluid), slides are
prepared for cell count during smear test, which
may also be termed as "cell slide"; we therefore
request placement of a synonym "cell slide" for
"smear" (available code).
Requested to add a synonym TRANSCATHETER II

AORTIC VALVE IMPLANTATION (NCIT available
synonym) to code TRANSCATHETER AORTIC
VALVE IMPLANT.
Request placement of synonym HEART VALVE II

SURGERY to available code CARDIAC VALVE
PROCEDURE, considering the definition
available in NCIT "Surgical replacement and/or
repair of a cardiac valve, by any approach. This
includes percutaneous valve procedures and
valvuloplasty".
Requested to add term CARDIAC ABLATION II

with the definition (available at NCIT) :A
procedure intended to eliminate or modify a focus
or re-entry circuit that causes an arrhythmia in the
heart. (ACC)
value of COMBINED FLUORESCEIN
ANGIOGRAPHY AND ICGA, with the definition
of: Examination technique that uses fluorescent
dye and a specialized camera to inspect blood
flow within vessels combined with ICGA
(Indocyanine Green Angiography).
Hello!
Please find attached a new term request.
Thanks!
Aparna
a "step" is considered to be too granular as a II
description for a full phase in clinical
development. To consider as an alternative
definition : :A set of activities grouped in studies
or substudies which are executed in the course of
clinical research or development and resulting in
readiness for a next step in regulatory approval"
Please contact the CDISC Glossary team for

further discussion (Submitted by Guido Claes)
Hello CDISC Team-

New term request attached
Thanks,
Jenny
PFTESTCD | PFTEST | PFTSTDTL II

MRCEXWM
Min Redundant Exon Cov Wide/Moderate
500x Standard Sensitivity depth
MRCEXNH
Min Redundant Exon Cov Narrow/High
2000x Enhanced Sensitivity depth
WIDE/MODERATE
Minimum redundant coverage obtained by at
least 85% of targeted exons for regions within the
baitset that are sequenced to a 500x "Standard
Sensitivity" depth.
NARROW/HIGH - Minimum redundant coverage

obtained by at least 85% of targeted exons within
the baitset that are sequenced to a 2000x
"Enhanced Sensitivity" depth
Comprehensive Example in an Excel was

emailed to Christine Connolly on May 10th 2002.
File Emailed Separately II

spreadsheet for the Pediatrics TAUG requests.
Need a request code for the changes made to II QRS, SDTM-Published
PRO-CTCAE and ADaM QRS terminology. in P50
These changes have been processed for P50
QRS release, I just need a request code.
Update C156813 = INTIAL DIAGNOSIS to read II
as INITIAL DIAGNOSIS. There is a typo in the
word INITIAL
Hi,
Please find attached a request for MICROORG

codelist.
Thanks!
Aparna
The variable MISPEC is a required item per the II

SDTMIG, therefore we are requesting the
addition of the term NOT REPORTED for the
specimen type codelist to accomodate scenarios
where STAT = NOT DONE for the MI domain.
In addition, should MISPEC be Required as the
other lab type domains such as LB, MB and IS
are not marked as Required. Should the
requirement for the specimen type variable be
consistent across these domains?
Please create new Test Name: Hepatitis B Virus II

Core IgG/IgM Antibody, with Test Code:
HBCGMAB. The LONC Code for this test is:
83100-8. Thank you!
From NCIt: II
We've had a requester make a valid point about
our Rectosigmoid Colon (C103438) concept. Her
position is that the descending colon should not
be included in the definition so we're opting to
make the following modification:
C103438 Rectosigmoid Colon: A portion of the

large intestine that includes the sigmoid colon
and rectum.
Since the NCI and CDISC definitions are

identical, I wanted to give you a heads up in case
you wanted to suggest a similar change to
CDISC.
Entries exist for POSITIVE and NEGATIVE. II
However, Urine Drug Screen results are often
reported as "Detected" or "Not Detected". Please
consider adding these as synonyms to provide
clear traceability from the source data to the
selected standard terminology
Internal Data Management audit comment "Lab

value COTININE was "not detected" in source
data and as per Celerion SOP this test result
should be considered as negative."
APOLO BLADDER CANCER 2019 II

Apolo Bladder Cancer 2019 Oncology Response
Criteria
Assessment of bladder cancer in the adjuvant
setting. (Apolo A, et al; Eligibility and Radiologic
Assessment in Adjuvant Clinical Trials in Bladder
Cancer. JAMA Oncol. 2019 Dec 1;5(12):1790-
1798.)
Response criteria that is not currently in the

ONCRSCAT codelist.
Dear all, II
Please find the file for Term suggestion for

CDISC controlled terminology (SEND, NONNEO
codelist).
It contains new terms request, and one
association of an existing code to existing codelist
( in the "Exist Codelist - New Term" part.)
Thanks a lot for taking into account these
requests, best regards,
Anne-Marie LE MENEC (anne-

marie.lemenec@keyrus.com)
Keyrus
155 rue Anatole France
92300 Levallois-Perret, FRANCE
on behalf of Virginie ORY

(virginie.ory@ipsen.com)
Ipsen
Z.A Courtaboeuf
5 Avenue du Canada
91940 Les Ulis, FRANCE
The following 9 new terms are requested: COLD II
CHAIN BREAK, OUT OF STABILITY,
PLATELETS AGGREGATION, QUESTIONABLE
INTEGRITY, CONTAINS WHOLE BLOOD,
UNAPPROVED VIAL, SAMPLE TOO DILUTED,
ATYPICAL COLOR, NOT CENTRIFUGED.
Please find "file emailed separately".
Dear CDISC-NCI,

Team for CDISC SDTM terminology.
Requested new codelist: SPECCOND.
Thank you.
Best regards,
Definition: The liquid portion of the tissue II

occupying the spaces of some bones. It consists
of small tissue fragments, hematopoietic cells,
and peripheral blood.
Separate specimen types do not exist for bone

marrow aspirate (collected via aspiration) and
bone marrow core. While aspiration and biopsy
as collection methods exist, the collected
specimen types are distinctly different and should
be represented as such.
File emailed separately; These do not need to be II SDTM, SEND, Protocol,
integrated into the CDISC team working CDASH - Published in
documents. I just need a request number for P50
these for P50 publication. Do not add (P50):
GDRS - CDISC is
Please see the attached. These do not need to unable to obtain
be integrated into the CDISC team working copyright permission for
documents. I just need a request number for this instrument at this
these for P50 publication. time, consequently, the
CDISC QRS CT team
Erin E Muhlbradt, PhD had only created a CAT
Biomedical/Clinical Information Specialist value for this instrument
Medical Science and Computing (MSC), a in Package 50. Because
Guidehouse company of this, CDISC will NOT
240-778-5416 develop TEST and
TESTCD terminology
questionnaire.
Definition: The solid, spongey portion of the II

tissue occupying the spaces of some bones. It
consists of blood vessel sinuses, hematopoietic
cells, and trabecular bone.
Separate specimen types do not exist for bone

marrow aspirate (collected via aspiration) and
bone marrow core. While aspiration and biopsy
as collection methods exist, the collected
specimen types are distinctly different and should
be represented as such.
Requesting the addition of 2 terms to the II
anatomical location codelist: EXTERNAL
CAPSULE and INTERNAL CAPSULE. These 2
terms are currently available in the NCI
THesaurus.
The definitions and NCI Codes are:
NCI Definition for INTERNAL CAPSULE: A white
matter structure in the subcortical region of the
brain that contains a high concentration of motor
and sensory projection nerve fibers. It consists of
the anterior limb, genu, posterior limb, and the
retrolentiform and sublentiform parts. (Code
C13082) CDISC currently has: PYRAMIDAL
TRACTS, INTERNAL CAPSULE this is a
separate term in NCI (CDISC Code C142309) so
I think this is a different term NCI Definition for
EXTERNAL CAPSULE: A thin lamina of white
matter comprising long association fibers located
between the claustrum and putamen in the brain,
and which connects the midportion of the
superotemporal region with the midportion of the
ventral and lateral aspects of the prefrontal
cortex. (Code C32550)
Definition: "A measurement of the Hepatitis B II

Test code doesn't currently exist, needed for
measurements of viral load.
Definition: "A measurement of the Hepatitis C II
Test code doesn't currently exist, needed for
measurements of viral load.
MITEST: "Hematopoietic Cells/Adipocytes" II
Definition: "A relative measurement (ratio or
percentage) of the hematopoietic cells to
adipocytes in a biological specimen"
Synonyms: Hematopoietic Cells/Fat Cells,
Hematopoietic Cells/Lipocytes, Hematopoietic
Cells/Fat Cells
Term does not exist but is being used in an

oncology study to assess the ratio of
hematopoietic cells to fat cells in bone marrow.
See e.g., Figure 1 of:
url=https%3A%2F%2Fonlinelibrary.wiley.com
%2Fdoi%2Fpdf
%2F10.1002%2Fjmri.1105%23%3A~%3Atext
%3Da%253A%2520Normal%2520hypocellular
%2520marrow%2520in%2Ccell-to-fat
%2520ratio&data=05%7C01%7Cbrenda.pet
ty%40nih.gov
%7C7d71f4201c424011e12508da4a5e348c
%7C14b77578977342d58507251ca2dc2b06%7C
0%7C0%7C637904065718899261%7CUnknown
%3D%7C3000%7C%7C
%7C&sdata=jfyuaITMl1oTXRciaBrLaQpqhW
SDWLmbJrHbSm7PF7A%3D&reserved=0.
We would like to request to add the option II

"Failure to Meet Inclusion/Exclusion Criteria\" for
the value list NCOMPLT to be used for Subject
discontinuation post-screening. There is an
available option C105448 (FAILURE TO MEET
RANDOMIZATION CRITERIA) that seems to be
fitting only for randomized studies, the option
which we are requesting will only be applicable
for non-randomized studies. The terminology
"Inclusion/Exclusion" is a commonly used term
across the Pharmaceutical Industry, and is
available as an SDTM domain as well. We have
noticed that there is also value C139236
(FAILURE TO MEET CONTINUATION
CRITERIA), however, the definition for that valid
value does not clearly state that this option can
be used for non-randomized studies instead of
FAILURE TO MEET RANDOMIZATION
CRITERIA. If this C139236 option should be
used, we would like to request a more precise
definition, that will cover our scenario.
Amgen and J&J reps on oncology team both II
report that there is confusion from central labs
(LabCorp being one of them) as to whether 'Total
Cells' in the denominator is total cells (all) or total
nucleated cells. Sponsors are asking for both
instances and it is not clear from the published
test what is meant.
A new term would be needed for "CAE Unit" II

defined as "A unit for measurement of enzymatic
activity of plasma and membrane-bound proteins
that comprise a complement system and their
split products indicative of the activity of the
classical and alternative pathways designed to
ward off invading pathogens.".
Please refer to
eptReport.jsp?
ictionary=NCI_Thesaurus&ns=ncit&code=C67270
A unit of concentration based on or subject to II

individual judgment, preference, or predetermined
reference per milliliter of solution.
A new term would be needed for ACTIGRAPHY II

defined as "A method for continuous recording of
body movement that uses an actimetry sensor
worn by an individual to measure rest/activity
(sleep/wake) cycles. Monitoring can last several
days to several weeks."
Please refer to
eport.jsp?
83
Use to evaluate for autoimmune hepatitis of II

unknown etiology. Use in combination with Liver-
Kidney Microsome - 1 Antibody, IgG on Serum by
Immunoblot method.
This method is a measure of the total II
complement activation in human plasma which is
determined by the degree of hemolysis of
activated sheep erythrocytes. This method is
being used to assess the complement inhibition
elicited by client peptide drug in human subjects.
Measure of the total complement activation in II

plasma which is determined by RBC lysis Method
A new term would be needed for DSSCAT / II

SUBJECT STATUS defined as "Category used to
retrieve information regarding the subject status.".
A new term would be needed for DTHDX / II
Hospitalization Indicator defined as "Indicates if
the subject was hospitalized at time of death.".
This new term would be needed defined as "The II

first date of the first menstrual cycle.".
https://gcc02.safelinks.protection.outlook.com/? II
url=https%3A%2F%2Fen.wikipedia.org%2Fwiki
%2FPound_&data=05%7C01%7Cbrenda.pe
tty%40nih.gov
%7Cdf0b83c60258421f8c1c08da4effc544%7C14
b77578977342d58507251ca2dc2b06%7C0%7C0
%7C637909157676336071%7CUnknown
%3D%7C3000%7C%7C
%7C&sdata=EGgKLawLHx6r44TsAUNwwR
MFfWRZWoK6FvcvV9pDfyU
%3D&reserved=0(mass)#:~:text=The
%20international%20standard%20symbol
%20for,for%20the
%20apothecaries'%20pound).&text=The%20unit
%20is%20descended%20from,the
%20abbreviation%20%22lb%22).
Natural number unit of measurement for a portion II
of a particular type of cell (excluding red blood
cell subtypes) per 1000 red blood cells.
New term SUCCESSFULL SURVEILLANCE II

CONTACT would be needed in codelist
OTHEVENT defined as "An indication regarding
the surveillance contact done successfully.".
Please add the new submission value of SKIN II

ABOVE THE SUPRAORBITAL REGION to the
LOC codelist with a synonym of SKIN ABOVE
THE EYEBROW and a suggested definition of
Skin in the area above the eyebrow.
This is to assess the results of an injection into

the skin above the eyebrow; Please refer to the
email I sent to Erin Muhlbradt for input.
Please add the submission value of EYE, SKIN II
OF THE OUTER CANTHUS to the LOC /
Anatomical Location codelist with a synonym of
Crow's Feet and the suggested definition of The
skin of the outer corner of the eye were the upper
and lower eyelids meet.
To provide feedback about results of injection to

skin of the outer canthus of the eye or crow's feet.
Please add the new submission value of SKIN, II

UNDER EYE to the LOC / Anatomical Location
codelist with a synonym of Skin Under Eye.
Suggested definition is The skin below the eye,
This is needed to assess results from injection

onto skin under eye.
Team to consider updating NCI C-code for this II

concept. The concept is meant to be conveying
that the study subject has completed the study.
As of now, the c-code is simply reference that
something is completed but isn't specifying what,
which could be mis-construed.
Also, a question for the team, is COMPLETED

only to be used when the subject completes the
entire study and not just a period or part of the
study, e.g., an Epoch or Element?

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Package Number Publication Date(s)

Closed 1/21/2009 18854 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 1/21/2009 18855 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9346

Closed 1/21/2009 18856 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9347

Closed 1/21/2009 18857 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9348

Closed 1/22/2009 18881 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9349

Closed 1/23/2009 18905 Mauron, Hoffmann-La charlotte.mauron 41-61-688 9316

Closed 1/23/2009 18906 Quinn, Theresa NCI quinnt@mail.nih.g 757-238-3582

Closed 2/3/2009 19115 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/3/2009 19116 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/3/2009 19120 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/3/2009 19122 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/3/2009 19123 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/3/2009 19125 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/4/2009 19140 Mattson, Monica Celgene mmattson@celge Not given

Closed 2/12/2009 19374 Stoner, Gail Johnson & gstoner@its.jnj.com610-889-4652

Closed 2/17/2009 19:24 19449 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 19:29 19450 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 19:31 19451 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 19:33 19452 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 19:37 19454 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 19:48 19455 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 19:56 19456 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 19:58 19457 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 20:04 19460 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 20:17 19461 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 21:25 19463 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/17/2009 21:38 19466 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/20/2009 8:27 19507 Quinn, Theresa NCI quinnt@mail.nih.g 757-238-3582

Closed 2/25/2009 8:01 19574 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:04 19575 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:08 19576 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:11 19577 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:16 19578 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:19 19579 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:23 19581 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:26 19582 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:29 19583 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:35 19584 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/25/2009 8:37 19585 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 10:26 19653 Gromen, Not Provided andreas.gromen@bayerhealthcare.com

Closed 2/27/2009 18:50 19678 Matejunas, Shire amatejunas@shir 484-595-8324

Closed 2/27/2009 19:25 19681 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:28 19682 Tolk, Chris CDISC ctolkl@cdisc.org 203-220-9345

Closed 2/27/2009 19:30 19683 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:32 19684 Tollk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:35 19685 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:38 19686 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:41 19687 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:47 19688 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:49 19689 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:52 19690 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:55 19691 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 2/27/2009 19:59 19692 Tolk, Chris CDISC ctolk@cdisc.org 203-220-9345

Closed 3/18/2009 17:59 20003 Mary Lenzen Octagon mlenzen@octago 401-364-7402

Closed 3/18/2009 18:03 20004 Mary Lenzen Octagon mlenzen@octago 401-364-7403

Closed 3/18/2009 18:07 20005 Mary Lenzen Octagon mlenzen@octago 401-364-7404

Closed 3/24/2009 16:23 20131 Cheng, Yuan ImClone yuan.cheng@imcl 646-638-5043

Closed 4/7/2009 16:12 20530 Austin, Randall GlaxoSmithKlin randall.r.austin@g 919.483.1379

Closed 4/14/2009 13:24 20704 Facile, Rhonda CDISC rfacile@cdisc.org 5122639529

Closed 4/14/2009 13:36 20706 Facile, Rhonda CDISC rfacile@cdisc.org 5122639530

Closed 4/20/2009 14:30 20825 Lenzen, Mary Octagon mlenzen@octago 484-881-2295

Closed 4/20/2009 14:54 20830 Lenzen, Mary Octagon mlenzen@octago 484-881-2295

Closed 4/20/2009 15:00 20831 Lenzen, Mary Octagon mlenzen@octago 484-881-2295

closed 5/19/2009 3:45 21353 Pemble, Nik J&J npemble@its.jnj.com