2. Objectives:
Promote Consistent term Selection
Organization should document their term
selection strategies in a specific guidelines
The guidelines should be consistent with the
Point to Consider documents of MSSO
3. Scope of the documents:
Term selection for data entry of
Adverse events
Adverse drug reaction
Medical history
Social history
Indications
Investigatios
4. Level of Term Selection:
SOC
HLGT
HLT
PT
Lowest Level Term (LLT)
Current LLT
Terms related to this is used for the
purpose of Data archival, analysis
and retrieval
Lowest Level Term (LLT)
6. Brittle hair No Exact match
MedDRA Search: LLT
-Term Selection
Hair texture abnormal
Hair Disorder
hair
If an exact match cannot be
found, use a specific existing term.
7. Metastatic Gall Bladder
No Exact match
MedDRA Search: LLT
-
Metastatic or Gall bladder
If an exact match cannot be
found, it is more appropriate to
select ›1 Associated term
Term Selection
Gall Bladder Cancer And/or
Metastasis
9. Abdominal pain
Increased Serum Amylase
It is inappropriate to assign a
diagnosis “Pancreatitis”
Abdominal pain
Term Selection
Increased Serum Amylase
Increased Serum Lipase
Increased Serum Lipase
Symptoms of What
?
10. Anaphylactic reaction
Rash, dysponea, hypotension,
laryngospasm
Anaphylactic reaction
Term Selection
If both a diagnosis and its
characteristics sign and symptoms
are reported, it is sufficient to
select a term for diagnosis.
11. Myocardial infraction,
Chest pain, diaphoresis, ECG changes
Jaundice
Terms should be selected for signs
& symptoms that are not generally
recognized as part of that
diagnosis.
Myocardial infraction
Term Selection
Jaundice
13. Possible Myocardial infraction,
If only a provisional diagnosis is
reported without additional clinical
information it should be assigned
as if a confirm.
Myocardial infraction
Term Selection
(Probable, presumed, likely, questionable) ?
14. Chest pain, diaphoresis, ECG changes
Jaundice
(Possible Myocardial infraction)
Myocardial infraction
Term Selection
Jaundice
If both provisional diagnosis and its
characteristics sign and symptoms are
reported, it is sufficient to select a
term for only provisional diagnosis.
15. Chest pain, dysponea, diaphoresis, Jaundice
(Possible Myocardial infraction)
Alternatively, it is considered
sufficient to select terms for only sign
& symptoms
Diaphoresis
Chest pain
Term Selection
Dysponea
Jaundice
17. Pulmonary embolism, Myocardial infraction,
Congestive heart failure
If multiple provisional diagnoses without
sign & symptoms, terms for each
provisional diagnosis can be selected.
Myocardial infraction
Pulmonary embolism
Term Selection
Congestive heart failure
18. Pulmonary embolism, Myocardial infraction,
Congestive heart failure
If multiple provisional diagnoses reported together
with sign & symptoms, it is sufficient to select
terms for only sign & symptoms,
Chest pain, shortness of breath, blood pressure decreased,
cyanosis
Shortness of breath
Chest pain
Term Selection
blood pressure decreased
Cyanosis
19. Death due to Myocardial
infraction
Myocardial infraction
Term Selection
Why is it So?
Death is an out come and is not
considered to be an AE/ADR.
21. Constipation, ruptured bowel, peritonitis,
sepsis
Patient died
Ruptured bowel
Constipation
Term Selection
Peritonitis
Sepsis
Death?
It must be captured as the outcome.
22. A patient was found dead
Term Selection
Found dead
Why?
If the only information is reported as
death, then the most specific death
term available should be selected.
Is it outcome?
23. Hospitalization due to
congestive heart failure
Term Selection
Congestive heart failure
Patient outcomes
e.g. Hospitalization/ disability etc. are the criteria to
be considered whether the ADR/ AE is Serious or non Serious.
Hence, are generally not considered to be
ADR/AE.
24. A patient was hospitalized
Term Selection
Hospitalization
So when the only information reported is the
outcome term, then the most specific
term available should be selected.
26. Hyperkalemia with a serum potassium of 1.6
mEq/L.
When conflicting information is reported , attempts
should be made to obtain more specific information.
As per MedDRA Exclusion Criteria Numerical values are
excluded from Coding.
How will one code the above terminology?
Serum potassium abnormal
Term Selection
But when Clarification attempts have failed
How do coder Code?
An appropriate closely associated term
should be selected.
27. Pain
Term Selection
GU pain
Genito-urinary
Gastric ulcer ?How will one Code?
When ambiguous information is reported , attempts
should be made to obtain more specific information.
But when Clarification attempts have failed
An appropriate available term should be
selected.
28. A patient experienced every listed
adverse event
When vague information is reported , attempts
should be made to obtain more specific information.
But when Clarification attempts have failed
An appropriate available term should be
selected.
Unevaluable event
Term Selection
30. Arrhythmia due to atrial fibrillation
If one of the term is a diagnosis and there is a
characteristics sign and/or symptom.
The diagnosis term can be selected.
Atrial fibrillation
Term Selection
31. Hepatic function disorders (Acute
hepatitis)
If one of the term is more specific than others
The most specific term should be selected.
Hepatitis acute
Term Selection
32. Retinopathy due to diabetes
The term exists that describes the
combination, it should be selected/used.
Diabetes retinopathy
Term Selection
33. Rash with itching
The term exists that describes the
combination, it should be selected/used.
Itchy Rash
Term Selection
34. Diarrhoea ash Vomiting
If splitting provides more specific clinical
information of an ADR it is considered
appropriate to select more than one term.
Diarrhoea
Term Selection
Vomiting
35. DIC due to sepsis
Diarrhoea
Term Selection
Vomiting
If splitting provides more specific clinical
information, hence more than one term must
be used.
36. Wrist fracture due to fall
Wrist fracture
Term Selection
Fall
If splitting provides more specific clinical
information, hence more than one term must
be used.
37. Pain due to cancer
Cancer pain
Term Selection
If reported term is a combination of an
event and a pre-existing condition and more
specific combination term does not exist it
is pragmatic to select a term for the event.
38. Shortness of breath due to cancer
Shortness of breath
Term Selection
If reported term is a combination of an
event and a pre-existing condition and more
specific combination term does not exist it
is pragmatic to select a term for the event.
40. Skin rash on face
Rash on face
Term Selection
If the reported term describes both body
site location and the event available, the
term with both specific body site and the
event should be selected.
41. Skin rash on face and neck
Skin rash
Term Selection
If a term contain multiple body site and all
link the same PT, the relevant medical event
should be selected.
44. Respiratory Chlamydial infection
Chlamydial infection
Term Selection
If the suitable term is not available, the
infective agent should generally have
priority during selection of term