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ICH ICSR Implementation Guide 12 April 2013
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C.5.4 Study Type Where Reaction(s) /Event(s) Were Observed
User Guidance This information should be provided if the ‘Type of Report’(C.1.3) has
been populated with ‘Report from study’.
Conformance Optional, but required if C.1.3=2 (Report from study).
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.8
Value Allowed 1=Clinical trials
2=Individual patient use(e.g. ‘compassionate use’ or ‘named patient
basis’)
3=Other studies (e.g. pharmacoepidemiology, pharmacoeconomics,
intensive monitoring)
Business Rule(s)

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