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ICH ICSR Implementation Guide 12 April 2013
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H NARRATIVE CASE SUMMARY AND FURTHER INFORMATION
Sections H.3 and H.5 are repeatable to allow for sufficient space to describe and comment on
the reaction/event and to accommodate for the use of different languages.
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and
Additional Relevant Information
User Guidance This data element captures a focused, factual and clear description of the
case, including the words or short phrases used by the reporter.
Conformance Required
Data Type 100000AN
OID None
Value Allowed Free text
Business Rule(s)
Each ICSR must include a narrative.
This data element should not be confused with Reporter’s or Sender’s
comments.
ICH ICSR Implementation Guide 12 April 2013
-138-
H NARRATIVE CASE SUMMARY AND FURTHER INFORMATION
Sections H.3 and H.5 are repeatable to allow for sufficient space to describe and comment on
the reaction/event and to accommodate for the use of different languages.
H.1 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and
Additional Relevant Information
User Guidance This data element captures a focused, factual and clear description of the
case, including the words or short phrases used by the reporter.
Conformance Required
Data Type 100000AN
OID None
Value Allowed Free text
Business Rule(s)
Each ICSR must include a narrative.
This data element should not be confused with Reporter’s or Sender’s
comments.