/*********************************************************** CDISC HUMAN TRAILS

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SDTM Variables:

1. Identifier Variables

2. Topic Variables

3. Timing Variables

4. Qualifier Variables

a. Grouping Qualifiers

b. Record Qualifiers

c. Result Qualifiers

d. Synonym Qualifiers

e. Variable Qualifiers

5. Rule Variables

SDTM Core Variables:

1. Required Variables: Must Include in Dataset + Not null

2. Expected Variables: Must include in Dataset + May include Null

values

3. Permissible Variables: May or May not include in Dataset + May

include null values

Define-XML specifications:

1. Variable Name limited to 8 characters.

2. A descriptive Variable Label, using up to 40 characters.

3. Data Type: character or numeric

4. Set Controlled Terms, Codelist, or Format

5. Origin of each variable

6. Role of the variable, which determines how the variable is

used in the dataset

7. Comments or other relevant information about the variable or

its data included by the sponsor as

necessary to communicate information about the variable or its

contents to a regulatory agency.

Controlled terminology (CT):

 1. * - Aingle asterisk when there is no specific CT available
at the current time.

2. A list of controlled terms for the variable when values

are not yet maintained externally

3. External codelist

4. ISO 8601

SDTM Standard Domain Models:

A. Special-Purpose Domains:

1. Comments (CO)

2. Demographics (DM)

3. Subject Elements (SE)

4. Subject Disease Milestones(SM)

5. Subject Visits (SV)

B. Interventions:

1. Procedure Agents(AG)

2. Concomitant/Prior Medications(CM)

3. Exposure as Collected(EC)

4. Exposure

5. Meals Data(ML)

6. Procedures(PR)

7. Substance Use(SU)

C. Events:

1. Adverse Events(AE)

2. Clinical Events(CE)

3. Disposition(DS)

4. Protocol Deviations(DV)

5. Healthcare Encounters

6. Medical History(MH)

7. Cardiovascular System Findings(CV)

8. Product/Drug Accountability(DA)
 9. Death Details(DD)

10. ECG Test Results(EG)

11. Functional Tests(FT)

12. Inclusion/Exclusion Criteria Not Met(IE)

13. Immunogenicity Specimen Assessments(IS)

14. Laboratory Test Results(LB)

15. Microbiology Specimen(MB)

16. Microscopic Findings(MI)

17. Musculoskeletal System Findings(MK)

18. Morphology(MO)

19. Microbiology Susceptibility(MS)

20. Nervous System Findings(NV)

21. Ophthalmic Examinations(OE)

22. Pharmacokinetics Concentrations(PC)

23. Physical Examination(PE)

24. Pharmacokinetics Parameters(PP)

25. Questionnaires(QS)

26. Respiratory System Findings(RE)

27. Reproductive System Findings(RP)

28. Disease Response and Clin Classification(RS)

29. Subject Characteristics(SC)

30. Subject Status(SS)

31. Tumor/Lesion Results(TR)

32. Tumor/Lesion Identification(TU)

33. Urinary System Findings(UR)

34. Vital Signs(VS)

D. Findings About:

1. Findings About Events or Interventions(FA)

2. Skin Response(SR)

E. Trial Design Domains:

 1. Trial Arms(TA)

2. Trial Disease Assessments(TD)

3. Trial Elements(TE)

4. Trial Inclusion/Exclusion Criteria(TI)

5. Trial Disease Milestones(TM)

6. Trial Summary Information(TS)

7. Trial Visits(TV)

F. Relationship Datasets:

1. Related Records(RELREC)

2. Related Subjects(RELSUB)

3. Supplemental Qualifiers for [domain name]

(SUPP__)

G. Study Reference:

1. Non-host Organism Identifiers(OI)

General rules:

1. The Identifier variables, STUDYID, USUBJID, DOMAIN, and --SEQ are

required in all domains based on the

general observation classes

2. Any Timing variables are permissible for use in any submission

dataset based on a general observation

class except where restricted by specific domain assumptions.

3. Any additional Qualifier variables from the same general observation

class may be added to a domain model

except where restricted by specific domain assumptions.

4. The addition of non-standard variables will compromise the FDA�s

abilities to populate the data repository

and to use standard tools. The SDTM allows for the inclusion of the
sponsors non-SDTM variables using the

Supplemental Qualifiers special-purpose dataset structure. Relating

Non-Standard Variables Values To A

Parent Domain. As the SDTM continues to evolve over time, certain

additional standard variables may be added
 to the general observation classes.

5. Standard variables and their Metadata must not be renamed or

modified for novel usage.

6. As long as no data was collected for Permissible variables, a

sponsor is free to drop them

Creating a New Custom Domain:

1. A custom domain may only be created if the data are different in

nature and do not fit into an existing published domain.

A. Creating a custom domain, which must be based on one of the

three SDTM general observation classes.

B. Establish a domain of a common topic.

C. Do not create separate domains based on time, rather represent

both prior and current observations

in a domain.

D. How collected data are used (e.g., to support analyses and/or

efficacy endpoints) must not result in

the creation of a custom domain.

E. Data that were collected on separate CRF modules or pages may

fit into an existing domain.

F. If it is necessary to represent relationships between data

that are hierarchical in nature (e.g.,

a parent record must be observed before child records), then

establish a domain pair.

2. If no existing model seems appropriate, choose the general

observation class (Interventions, Events, or Findings) that best

fits the data by considering the topic of the observation The

general approach for selecting variables for a custom domain.

A. Select and include the required Identifier variables (e.g.,

STUDYID, DOMAIN, USUBJID, --SEQ) and

any permissible Identifier variables.

B. Include the Topic variable from the identified general

observation class

C. Select and include the relevant Qualifier variables from the

identified general observation class. Variables

belonging to other general observation classes must not be

added.

D. Select and include the applicable Timing variables.

 E. Apply the two-character domain code to the appropriate
variables in the domain.Replace all variable prefixes

(shown in the models as two hyphens �--�) with the domain

code.

F. Requests for new domain codes must include:

1. Two-letter domain code and

description

2. Rationale for domain code

3. Domain model with assumptions

4. Examples

G. Set the order of variables consistent with the order defined

in SDTM depending upon the general observation class

the custom domain is based on.

H. Adjust the labels of the variables only as appropriate to

properly convey the meaning in the context of the data

being submitted in the newly created domain. Use title case

for all labels (title case means to capitalize the first

letter of every word except for articles, prepositions, and

conjunctions).

I. Ensure that appropriate standard variables are being properly

applied by comparing the use of variables in standard domains.

J. Describe the dataset within the define.xml document

K. Place any non-standard (SDTM) variables in a Supplemental

Qualifier dataset.

SDTM variables Allowed in SDTMIG:

1. SDTM variables, defined for use in non-clinical studies

(SEND), must NEVER be used in the

submission of SDTM-based data for human clinical trials:

1. --DTHREL (Findings)

2. --EXCLFL (Findings)

3. --REASEX (Findings)

4. --DETECT (Findings)

2. SDTM variables can be used for non-clinical studies (SEND) but

must NEVER be used in the

Demographics domain for human clinical trials. The use of

these variables is currently being

evaluated in Findings general observation class domains being

developed for use in the

tabulations of virology data:

1. SPECIES (Demographics)

2. STRAIN (Demographics)

3. SBSTRAIN (Demographics)

3. SDTM variables have not been evaluated for use in human

clinical trials and must therefore be

used with extreme caution:

1. --ANTREG (Findings)

2. SETCD (Demographics)

4. SDTM identifier variable can be used for non-clinical studies

(SEND), and may be used in human

clinical trials when appropriate:

1. POOLID