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ICH ICSR Implementation Guide 12 April 2013
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H.2 Reporter's Comments
User Guidance This data element captures the reporter's comments on the diagnosis,
causality assessment or other issues considered relevant.
Conformance Optional
Data Type 20000AN
OID None
Value Allowed Free text
Business Rule(s)
H.3.r Sender's Diagnosis (repeat as necessary)
H.3.r.1a MedDRA Version for Sender's Diagnosis /Syndrome and /or Reclassification of
Reaction /Event
User Guidance This data element provides the MedDRA version for H.3.r.1b.
Conformance Optional, but required if H.3.r.1b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
H.3.r.1b Sender's Diagnosis /Syndrome and /or Reclassification of Reaction /Event
(MedDRA code)
User Guidance This data element provides the sender with an opportunity to combine
signs and symptoms that were reported into a succinct diagnosis.
Supporting rationale for the term selection is included in Section H.4.A
MedDRA LLT code should be used.
Conformance Optional, but required if H.3.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)