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ICH ICSR Implementation Guide 12 April 2013
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G.k.9.i.2.r Assessment of Relatedness of Drug to Reaction(s) /Event(s) (repeat as
necessary)
G.k.9.i.2.r.1 Source of Assessment
User Guidance This data element indicates the source of the assessment provided in
G.k.9.i.2.r.3.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.9.i.2.r.2Method of Assessment
User Guidance This data element indicates the method of the assessment provided in
G.k.9.i.2.r.3.For example global introspection, algorithm, Bayesian
calculation, etc.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
Business Rule(s)
G.k.9.i.2.r.3 Result of Assessment
User Guidance This data element capturesthe result of the assessment for relatedness.
The ‘value’ will depend on the method used for the assessment.
Conformance Optional
Data Type 60AN
OID None
Value Allowed Free text
Business Rule(s)
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