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G.k.9.i.1 G.k.9.i.2.r.1 G.k.9.i.2.r.2 G.k.9.i.2.r.3
technical reference to
event 1 in E.i
Reporter global introspection related
Company algorithm possibly related
Company Bardi 0.76
technical reference to
event 2 in E.i
Reporter global introspection not related
Company algorithm possibly related
Company Bardi 0.48
technical reference to
event 3 in E.i
Company algorithm unlikely related
Company Bardi 0.22
If an event is spontaneously reported to a company about a patient who took that
company's drug, and the relationship is unstated, it implies a suspected causal
relationship to the drug. However, data elements G.k.9.i.1 through G.k.9.i.2.r.3
should be left blank unless otherwise required by local regulation.
The company's causality assessment can be captured in data elements G.k.9.i.1
through G.k.9.i.2.r.3. Additionally, the Sender's Comments in Section H.4 can be
used to further elaborate sender’s position or assessment.
Local regulatory requirements regarding expedited and periodic reporting determine
whether inclusion of sponsor assessments is necessary.
G.k.9.i.1 Reaction(s) /Event(s) Assessed
User Guidance This data element captures a technical reference within the message that is
used to identify which reaction /event in Section E.i is being assessed.
This is not a user entered element.
Conformance Optional
Data Type N/A
OID None
Value Allowed N/A
Business Rule(s)
This is not a user entered element.