MedDRA Coding Basics

MedDRA trademark is owned by IFPMA on behalf of ICH

MedDRA was developed under the auspices of the

International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The activities
of the MedDRA Maintenance and Support Services
Organization (MSSO) are overseen by an ICH MedDRA
Management Board
Board, which is composed of the six ICH
parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the
Medicines and Healthcare products Regulatory Agency
(MHRA) of the UK, Health Canada, and the WHO (as
Observer).

MSSO-DI-6275-16.0.0

Disclaimer and Copyright Notice

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t d into
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t
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3

MSSO-DI-6275-16.0.0

Course Objectives/Overview
Learn the reasons we code data
MedDRA s
Gain knowledge of MedDRAs
structure, scope, and characteristics
Learn about the MedDRA Term

Selection: Points to Consider

document
Learn some basic coding approaches,
including some coding pearls
pearls
MSSO-DI-6275-16.0.0

Wh Do
Why
D W
We C
Code?
d ?

What Is Coding?
Code
1 : a systematic statement of a body of law; especially
one given statutory force
2 : a system of principles or rules <moral code>
3 a : a system of signals or symbols for communication
b : a system of symbols (as letters or numbers) used
t representt assigned
to
i
d and
d often
ft secrett meanings
i
4 : genetic code
5 : a set of instructions for a computer
MSSO-DI-6275-16.0.0

Why Do We Code?
Retrieve
Present
Analyze
Communicate

MSSO-DI-6275-16.0.0

Role of a Terminology
Provides a TOOL to represent data/
concepts using place
place-holder
holder terms
Assists in retrieval, analysis, and
comprehension
h
i off data
d t

MSSO-DI-6275-16.0.0

What Does MedDRA Offer?

Size and specificity (granularity)
Hierarchy/grouping terms
Support SOCs widen data
collection/analysis options
Up-to-date and medically rigorous
User-responsive
STANDARDIZATION

MSSO-DI-6275-16.0.0

M dDRA O
MedDRA
Overview
i

MedDRA Definition
MedDRA is a clinically-validated
international medical terminology used by
regulatory authorities and the regulated
biopharmaceutical industry. The
terminology is used through the entire
regulatory process, from pre-marketing to
post-marketing,
post
marketing, and for data entry,
retrieval, evaluation, and presentation.

11

MSSO-DI-6275-16.0.0

Scope of MedDRA
Not a drug
dictionary

Patient demographic
terms

Clinical trial study

design terms

OUT
IN

Frequency
qualifiers

Medical conditions
Indications
Investigations (tests, results)
Medical and surgical procedures
Medical,, social,, familyy historyy
Medication errors
Product quality issues
Device-related issues
Pharmacogenetic terms
Toxicologic issues
Standardized queries

Numerical values for

results

Severity descriptors

Not an equipment, device,

diagnostic product dictionary
MSSO-DI-6288-16.0.0

12

MedDRA Structure
System Organ Class (SOC) (26)
High Level Group Term (HLGT) (334)
High Level Term (HLT) (1,717)
P f
Preferred
dT
Term (PT) (20,057)
(20 057)
Lowest Level Term (LLT) (71,326)
(71 326)
MedDRA Version 16.0
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13

MedDRA Term Level Definitions

SOC - Highest level of the terminology, and
representing an anatomical or physiological system,
etiology,
ti l
or purpose
HLGT - Subordinate to SOC, superordinate grouping
for one or more HLTs
HLT - Subordinate to HLGT, superordinate grouping
for one or more PTs
PT - Represents a single medical concept
LLT - Lowest level of the terminology, related to a
single PT as a synonym, lexical variant, or quasis non m (Note:
synonym
(Note All PTs have
ha e an identical LLT)
MSSO-DI-6288-16.0.0

14

System Organ Classes

Blood and lymphatic system disorders

Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders and administration site
conditions
Hepatobiliary disorders
I
Immune
system
t
di
disorders
d
Infections and infestations
Injury, poisoning and procedural
complications
p
Investigations
Metabolism and nutrition disorders

Musculoskeletal and connective tissue

disorders
Neoplasms benign, malignant and unspecified
((incl cysts
y
and polyps)
p yp )
Nervous system disorders
Pregnancy, puerperium and perinatal
conditions
P hi t i disorders
Psychiatric
di d
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders

15

MSSO-DI-6275-16.0.0

Examples of LLTs
SOC = Cardiac
C di di
disorders
d
HLGT = Cardiac arrhythmias
HLT = Rate and rhythm disorders NEC
PT = Arrhythmia
LLT
Arrhythmia
NOS
MSSO-DI-6275-16.0.0

LLT
A h th i
Arrhythmia

LLT
Dysrhythmias
LLT (N
(Non-current))
Other specified cardiac
dysrhythmias

16

Non-Current Terms
N
Non-currentt tterms are fl
flagged
d att th
the
LLT level within MedDRA
Not recommended for continued use
Retained within the terminology to
preserve
p
ese e historical
sto ca data for
o retrieval
et e a a
and
d
analysis
Terms that are vague, ambiguous, outd t d truncated,
dated,
t
t d or misspelled
i
ll d
Terms derived from other terminologies
that do not fit MedDRA rules
17

MSSO-DI-6275-16.0.0

MedDRA Codes
Each MedDRA term assigned an 8
8-digit
digit
numeric code
The code is non-expressive
Codes can fulfill a data field in various
electronic submission types (e
(e.g.,
g E2B)
Initially assigned alphabetically by term
starting with 10000001
New terms are assigned sequentially
Supplemental terms are assigned codes
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18

A Multi-Axial Terminology
M
Multi-axial
lti i l = the
th representation
t ti off a
medical concept in multiple SOCs
Allows
All
grouping
i by
b different
diff
t classifications
l ifi ti
Allows retrieval and presentation via different
data sets

Purpose of Primary SOC

Determines which SOC will represent a PT
during cumulative data outputs
Is used to support consistent data
presentation for reporting to regulators
19

MSSO-DI-6275-16.0.0

A Multi-Axial Terminology (cont)

SOC = Respiratory, thoracic and
mediastinal disorders
HLGT = Respiratory tract
infections

HLT = Viral upper respiratory

tract infections

SOC = Infections and

infestations
HLGT = Viral infectious
disorders
HLT = Influenza viral
infections

PT = Influenza
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A Multi-Axial Terminology (cont)

PTs in the following SOCs only appear in
that p
particular SOC and not in others,,
i.e., they are not multi-axial
Investigations
Surgical and medical procedures
Social circumstances

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21

Rules for Primary SOC Allocation

PTs for diseases
diseases, signs and symptoms are assigned to
prime manifestation site SOC
Congenital and hereditary anomalies terms have SOC
C
Congenital,
l familial
f
l l and
d genetic disorders
d d
as Primary SOC
Neoplasms terms have SOC Neoplasms benign,
malignant
g
and unspecified
p
(incl
(
cysts
y and p
polyps)
yp ) as
Primary SOC
Exception: Cysts and polyps have prime manifestation site SOC
as Primary SOC

Infections and infestations terms have SOC Infections

and infestations as Primary SOC

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Primary SOC Priority

If a PT links to more than one of the exceptions,
the following priority will be used to determine
primary SOC:

1st: Congenital, familial and genetic disorders

2nd: Neoplasms benign, malignant and
unspecified (incl cysts and polyps)
3rd: Infections and infestations

23

MSSO-DI-6275-16.0.0

MedDRA Term Selection:

Points to Consider Document

Why Do We Need Coding

Conventions?
Differences in medical aptitude of coders
Consistency concerns (many more
choices to manuallyy code terms in
MedDRA compared to older
g )
terminologies)
Even with an autoencoder, may still need
manual coding
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MedDRA Term Selection:

Points to Consider (MTS:PTC)
An ICH-endorsed guide for MedDRA users
Provides term selection advice for industry
and regulatory purposes
Objective is to promote accurate and
consistent term selection to facilitate a
common understanding
d t di off shared
h d data
d t
Recommended to be used as the basis for
i di id l organizations
individual
i ti
coding
di
conventions
MSSO-DI-6275-16.0.0

26

MedDRA Term Selection: PTC (cont)

Developed by a working group of the ICH Steering
Committee
Regulators and industry representatives
EU, Japan, USA
Canadian observer, MSSO, JMO

U
Updated
d t d twice
t i yearly
l with
ith each
h MedDRA
M dDRA release
l
Available on MSSO, JMO, and ICH Web sites
English and Japanese
Variety of file formats for ease of viewing and editing
Summary of Changes document

27

MSSO-DI-6275-16.0.0

General Term Selection Principles

MSSO-DI-6275-16.0.0

Quality of Source Data

Quality Assurance
Do Not Alter MedDRA
Always Select a Lowest Level Term
Select Only Current Lowest Level Terms
When to Request a Term
Use of Medical Judgment in Term Selection
Selecting More than One Term
Check the Hierarchy
Select Terms for All Reported Information, Do Not
Add Information
28

Quality
Q
lit off Source
S
D t
Data
Quality Assurance
Quality of original information impacts quality of
output
Obtain clarification of data
Can be optimized by careful design of data
collection
ll ti forms
f
and
d proper training
t i i off staff
t ff
Organizations coding guidelines should be
consistent with MTS:PTC
Review of term selection by qualified individuals
g of automated coding
g results
Human oversight
29

MSSO-DI-6275-16.0.0

Do Not Alter MedDRA

MedDRA is a standardized terminology
with a pre-defined
pre defined term hierarchy
Users must not make ad hoc structural
alterations, including changing the
primary SOC allocation
If terms are incorrectly placed, submit a
change request to the MSSO

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30

Always Select a Lowest Level Term

Select Only Current LLTs
Lowest Level Term that most accurately
reflects
fl t th
the reported
t d verbatim
b ti information
i f
ti
should be selected
Degree of specificity may be challenging
Example: Abscess on face select Facial
abscess, not simply Abscess

Select current LLTs only

Non-current terms for legacy conversion/historical
purposes
31

MSSO-DI-6275-16.0.0

When tto Request

Wh
R
t a Term
T
Use of Medical Judgment
Avoid company-specific work-arounds for
MedDRA deficiencies
deficiencies. If concept not
adequately represented in MedDRA, submit
Change
g Request
q
to MSSO.
If no exact match in MedDRA, use medical
judgment to match to an existing term that
adequately
d
t l represents
t th
the conceptt

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32

Selecting
S
l ti M
More th
than O
One Term
T
Check the Hierarchy
Can select more than one LLT to represent
reported information
information. Document procedures
procedures.
Selecting one term may lead to loss of specificity
Selecting more than one term may lead to
redundant counts

Check the hierarchy above a selected LLT

(PT HLT
(PT,
HLT, HLGT,
HLGT SOC) to ensure
ens e placement
accurately reflects meaning of reported term

33

MSSO-DI-6275-16.0.0

S l t Terms
Select
T
for
f All Reported
R
t d
Information
Select terms for every AR/AE reported,
regardless of causal association
Select terms for device-related events,
product quality issues,
issues medication errors,
errors
medical and social history, investigations
and indications as appropriate
If diagnosis reported with characteristic
signs and symptoms, preferred option is to
select term for diagnosis only
MSSO-DI-6275-16.0.0

34

Do Not Add Information

Do not make diagnosis if only
signs/symptoms reported
Reported

LLT Selected

Comment

Abdominal pain
Abdominal pain,
increased serum
amylase, and increased
serum lipase

Serum amylase
i
increased
d

It is inappropriate
to assign
g an LLT for
diagnosis of
pancreatitis

Lipase increased

35

MSSO-DI-6275-16.0.0

Pitfalls and Solutions

In selecting an LLT for a result of an
investigation, parent PT of the selected LLT should
contain a qualifier/adjective
E.g., present/absent, increased/decreased, etc.

If parent PT of selected LLT does not contain a

qualifier/adjective,
lifi / dj ti
you may have
h
inadvertently
i d t tl
selected an LLT for the test name, not a result
E.g.,
E g Blood
Blood found in urine
urine, select LLT Blood in
urine (PT Blood urine present). Do not select LLT
Blood urine (PT Blood urine has no qualifier/
adjective
dj ti and
d thus
th represents
t the
th test
t t name only)
l )

MSSO-DI-6275-16.0.0

36

Pitf ll and
Pitfalls
d Solutions
S l ti
((cont)
t)
Inappropriate terms may be selected by
autocoder
Review all autocoding carefully
Allergic to CAT scan autocoded as
LLT Allergic to cats
Myocardial infarction in the fall of 2000
autocoded as LLT Myocardial infarction and
LLT Fall
F ll

37

MSSO-DI-6275-16.0.0

FDA-Defined Coding Errors

Missed Concepts
All medical concepts described after the product is
taken should be coded
Example: The patient took drug X and developed
alopecia, increased LFTs and pancreatitis.
p
and increased
Manufacturer onlyy codes alopecia
LFTs (missed concept of pancreatitis)
Example: The patient took drug X and developed

interstitial nephritis which later deteriorated into

renal failure. Manufacturer only codes interstitial
nephritis (missed renal failure concept)

Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance

and Epidemiology, CDER
MSSO-DI-6275-16.0.0

38

FDA-Defined Coding Errors (cont)

Soft Coding
Selecting a term which is both less specific and less
severe than
th another
th M
MedDRA
dDRA term
t
is
i soft
ft coding
di
Example: Liver failure coded as hepatotoxicity or
increased LFTs
Example: Aplastic anemia coded as unspecified
anemia
Example: Rash subsequently diagnosed as Stevens
Johnson syndrome coded as rash
Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance
and Epidemiology, CDER
39

MSSO-DI-6275-16.0.0

Term Selection Points

Diagnoses
g
and Provisional Diagnoses
g
with or without Signs
g and
Symptoms
Death and Other Patient Outcomes
Suicide and Self-Harm
Conflicting/Ambiguous/Vague Information
Combination Terms
Age vs. Event Specificity
Body Site vs.
vs Event Specificity
Location Specific vs. Microorganism Specific Information
Modification of Pre-existing Conditions
Exposures During Pregnancy and Breast Feeding
Congenital Terms
Neoplasms
Medical and Surgical Procedures
Investigations
MSSO-DI-6275-16.0.0

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T
Term
Selection
S l ti Points
P i t (cont)
(
t)
Medication/Administration Errors, Accidental Exposures and
Occupational Exposures
Misuse, Abuse and Addiction
Transmission of Infectious Agent via Product
Overdose,
Overdose Toxicity and Poisoning
Device-related Terms
Drug Interactions
No
N Adverse
Ad
Effect
Eff t and
d Normal
N
l T
Terms
Unexpected Therapeutic Effect
Modification of Effect
Sociall Circumstances
Medical and Social History
Indication for Product Use
Off Label Use
Product Quality Issues
41

MSSO-DI-6275-16.0.0

Diagnoses and Provisional Diagnoses

SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS

Single diagnosis without signs

and
d symptoms
t

PROVISIONAL DIAGNOSIS

Single provisional diagnosis

without
ith t signs
i
and
d symptoms
t

Diagnosis (only possible option) Provisional diagnosis (only

possible option)
Example: Myocardial
infarction select

Myocardial infarction

Example: Possible myocardial

infarction select
Myocardial infarction (select
term as if definitive diagnosis)

Similar principles apply for multiple diagnoses

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Diagnoses and Provisional Diagnoses (cont)

SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS

PROVISIONAL DIAGNOSIS

Single diagnosis with signs/

symptoms

Single provisional diagnosis with

signs/symptoms

Preferred: Diagnosis only

Preferred: Provisional
diagnosis and signs/symptoms

Example: Anaphylactic

Example: Possible myocardial

reaction with rash, dyspnea,

hypotension, and laryngospasm
hypotension
select Anaphylactic
reaction

infarction with chest pain,

dyspnea, diaphoresis select
dyspnea
Myocardial infarction Chest
pain, Dyspnea, and
Diaphoresis

Similar principles apply for multiple diagnoses

MSSO-DI-6275-16.0.0

43

Diagnoses and Provisional Diagnoses (cont)

SINGLE DIAGNOSIS
DEFINITIVE DIAGNOSIS

PROVISIONAL DIAGNOSIS

Single diagnosis with signs/

symptoms
ymp m

Single provisional diagnosis with

signs/symptoms
g / ymp m

Alternate: Diagnosis and

signs/symptoms

Alternate: Signs/symptoms
only (as provisional diagnosis
may change

Example: Anaphylactic reaction Example: Possible myocardial

with rash,, dyspnea,

y p , hypotension,
yp
, infarction with chest p
pain,,
and laryngospasm select
dyspnea, diaphoresis select
Anaphylactic reaction, Rash, Chest pain, Dyspnea, and
Dyspnea, Hypotension, and
Diaphoresis
Laryngospasm
Similar principles apply for multiple diagnoses
MSSO-DI-6275-16.0.0

44

Conflicting/Ambiguous Information
First, try to obtain more specific information
Reported
Hyperkalemia with a
serum potassium of 1.6
mEq/L

GU pain

LLT Selected

Serum potassium
abnormal

Pain

Comment
LLT Serum
S
potassium
t i
abnormal covers both of

the reported concepts

(note: serum potassium of
1 6 mEq/L
1.6
E /L is
i a low
l
result,
lt
not high)
GU could be either
genito-urinary or gastric
ulcer. If additional
information is not available,
then select a term to
reflect the information
that is known, i.e., LLT Pain

45

MSSO-DI-6275-16.0.0

Vague Information
First, try to obtain more specific information
Reported

Turned green

Patient had a medical

problem of unclear type

MSSO-DI-6275-16.0.0

LLT Selected

Comment

Unevaluable event

Turned green reported

alone is vague; this could
refer to a patient condition
or even
n to
t a product
p d t (e.g.,
(
pills)

Ill-defined disorder

Since it is known that there

is some
s m form
f m of
f a medical
m dic l
disorder, LLT Ill-defined
disorder can be selected

46

Investigations
Medical condition vs. investigation result
Reported

LLT Selected

Comment

Hypoglycemia

Hypoglycemia

yp g y
LLT Hypoglycemia
links to SOC

Decreased glucose

Glucose decreased

Metabolism and
nutrition disorders
LLT Glucose
decreased links to
SOC Investigations

47

MSSO-DI-6275-16.0.0

Investigations (cont)
Unambiguous investigation result
Reported

LLT Selected

Comment

Glucose 40 mg/dL

Glucose low

Glucose is clearly
below the reference
range

Ambiguous investigation result

Reported

His g
glucose was 40

MSSO-DI-6275-16.0.0

LLT Selected

Comment

Glucose abnormal

No units have been

reported. Select LLT
Glucose abnormal iff
clarification cannot
be obtained.
48

Investigations (cont)
Investigation results consistent with diagnosis
Reported
Elevated potassium,
potassium K
7.0 mmol/L, and
hyperkalemia

LLT Selected

Comment

Hyperkalemia

It is not necessary to
select LLT Potassium

increased

Grouped investigation result terms

Reported

LLT Selected

Increased alkaline
phosphatase,
increased SGPT,
increased SGOT and
elevated LDH

Alkaline phosphatase
increased
SGPT increased
SGOT increased
LDH increased

Comment
Select four individual
terms. A single term
such as LLT Liver

function tests
abnormal should not
be selected.

49

MSSO-DI-6275-16.0.0

MSSOs MedDRA Browsers

MedDRA
M dDRA Desktop
D kt Browser
B
Download from MSSO Web site
View/search MedDRA and SMQs
Export functionality

MedDRA Web-Based Browser

https://www.meddrabrowser.org/dsnavigator/
Requires specific user ID and password
Access
A
to
t allll MedDRA
M dDRA versions
i
in
i English
E li h and
d
available EU languages (and Chinese, if subscribed)
View/search MedDRA and SMQs
Export functionality
MSSO-DI-6275-16.0.0

50

Browser Demonstration/
A
Approaches
h tto Finding
Fi di
the Best LLT

Assessing the Reported Information

Consider what is being reported. Is it a:

Clinical condition - Diagnosis, sign or symptom?

Indication?
Test result?
Injury?
Procedure?
The type of report will
M di ti error??
Medication
influence the way you
search for a suitable LLT.
Product quality issue?
It may indicate in which
Social circumstance?
SOC you expect to find the
Device issue?
closest match.
Procedural complication?

Is it a combination of these?
MSSO-DI-6275-16.0.0

52

Coding Example 1
Specificity
The patient suffered from an allergic
reaction to an antibiotic

53

MSSO-DI-6275-16.0.0

Coding Example 2
Symptoms
The patient states she has been
experiencing cold sweats

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54

Coding Example 3
Investigations
Lab results indicate the patient has
increased troponin and increased CPK-MB

55

MSSO-DI-6275-16.0.0

Coding Example 4
Medication errors
Patient took drug Y instead of drug X
and became short of breath

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56

Coding Example 5
Patient demographics
A 2 day old baby was noted to have a
mild fever

57

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Coding Example 6
Indications
A 35 year old woman was taking Drug X
to prevent relapses of multiple sclerosis

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Coding Example 7
Narrative
N
ti vignette
i
tt
A 75-year-old male receiving Drug X for
rheumatoid arthritis developed
symptomatic aortic valve stenosis. The
patients medical history is significant for
colon cancer and cigarette smoking. He
underwent an aortic valve replacement
and developed a sternal wound infection
three days post-surgery.
59

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Coding Example 8
Liver failure secondary to Hep B liver
cirrhosis and sepsis leading to shock
(from possible spontaneous bacterial
peritonitis or bowel perforation)

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60

Assessing the Reported Information

Liver failure = complication of liver
cirrhosis and Hep B
Hep
H B = underlying
d l i cause off cirrhosis
i h i
Liver cirrhosis = complication of Hep B
Possible spontaneous bacterial
peritonitis or bowel perforation
p
p
=
provisional diagnoses, likely cause of:
Sepsis
Shock = complication of sepsis
61

MSSO-DI-6275-16.0.0

Term Selection
Liver failure
LLT Liver failure

Hep
H B liliver cirrhosis
i h i
No combination term available, select both:
LLT Liver
Li
cirrhosis
i h i
LLT Hepatitis B
Do not use non
non-current
current LLT Hep B
Query if abbreviation is unacceptable

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62

Term Selection (cont)

Sepsis leading to shock
Combination term available, select:
LLT Septic shock
Preserves relationship between the conditions
Better choice than LLT Sepsis
p and LLT Shock

Possible spontaneous bacterial

peritonitis or bowel perforation
p
p
Select both provisional diagnoses:
LLT Spontaneous bacterial peritonitis
LLT Bowel perforation
63

MSSO-DI-6275-16.0.0

MedDRA Coding Pearls

Fi
First,
t ttry using
i reporters
t actual
t l words
d
Be aware of MedDRAs specificity
Exploit MedDRAs hierarchy if an LLT
is close to what yyou need,, look at its
siblings and parent
Check where the LLT lies in MedDRA
(i.e., check the hierarchy above to be
sure it represents the verbatim term
accurately)
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64

M dDRA Coding
MedDRA
C di P
Pearls
l ((cont)
t)
Use top
top-down
down and bottom
bottom-up
up navigation
Try synonyms if its not renal try
kid
kidney,
etc.
t
Use word stems, e.g., Pancrea
Search different word orders, and, or
Use available resources for difficult
verbatim terms (web search, medical
dictionaries, colleagues)
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MedDRA Coding Pearls (cont)

And most important of all get more
g training!
g
coding

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Summary
IIn thi
this course, we:
Learned the reasons we code data and the
role of a coding terminology
Reviewed the structure, scope, and
characteristics of MedDRA
Were introduced to the MedDRA Term
Selection: Points to Consider document and
some off it
its specific
ifi principles
i i l
Learned basic approaches to coding, including
some coding pearls
pearls
67

MSSO-DI-6275-16.0.0

MSSO Contacts
Web site
www.meddramsso.com

E-mail
E
il
mssohelp@mssotools.com

Telephone
International AT&T Toll Free: 877.258.8280
Direct Dial (USA): +1 571.313.2574

Fax (USA)
+1 571.313.2345
MSSO-DI-6275-16.0.0

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