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E.i.7 Outcome of Reaction /Event at the Time of Last Observation
User Guidance This data element captures the latest outcome of the reaction /event at the
time of the report.
In case of irreversible congenital anomalies, the choice not recovered/not
resolved/ongoing should be used. For other irreversible medical
conditions, recovered/resolved with sequelae should be used.
Fatal should be used when death is possibly related to the reaction/event.
Considering the difficulty of deciding between ‘reaction/event caused
death’ and ‘reaction/event contributed significantly to death’, both
concepts are grouped in a single category. Where the death is unrelated to
the reaction/event, according to both the reporter and the sender, ‘fatal’
should NOT be selected here nevertheless, death should be reported
under Section D.9.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.11
Value Allowed 1 =recovered/resolved
2 =recovering/resolving
3 =not recovered/not resolved/ongoing
4 =recovered/resolved with sequelae
5 =fatal
0 =unknown
Business Rule(s)
E.i.8 Medical Confirmation by Healthcare Professional
User Guidance If an event is reported by a non healthcare professional (e.g. lawyers,
consumers), this data element indicates whether the occurrence of the
event was subsequently confirmed by a healthcare professional. If the
healthcare professional also provides an assessment of causality (related
or not to the suspect drug), that should be recorded in G.k.9.
Conformance Optional
Data Type Boolean
OID None
Value Allowed false
true
Business Rule(s)
‘False’ means the event is not confirmed, it does not mean the event did
not occur. If the event is reported by a healthcare professional, this is not
transmitted.
ICH ICSR Implementation Guide 12 April 2013
-107-
E.i.7 Outcome of Reaction /Event at the Time of Last Observation
User Guidance This data element captures the latest outcome of the reaction /event at the
time of the report.
In case of irreversible congenital anomalies, the choice not recovered/not
resolved/ongoing should be used. For other irreversible medical
conditions, recovered/resolved with sequelae should be used.
Fatal should be used when death is possibly related to the reaction/event.
Considering the difficulty of deciding between ‘reaction/event caused
death’ and ‘reaction/event contributed significantly to death’, both
concepts are grouped in a single category. Where the death is unrelated to
the reaction/event, according to both the reporter and the sender, ‘fatal’
should NOT be selected here nevertheless, death should be reported
under Section D.9.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.11
Value Allowed 1 =recovered/resolved
2 =recovering/resolving
3 =not recovered/not resolved/ongoing
4 =recovered/resolved with sequelae
5 =fatal
0 =unknown
Business Rule(s)
E.i.8 Medical Confirmation by Healthcare Professional
User Guidance If an event is reported by a non healthcare professional (e.g. lawyers,
consumers), this data element indicates whether the occurrence of the
event was subsequently confirmed by a healthcare professional. If the
healthcare professional also provides an assessment of causality (related
or not to the suspect drug), that should be recorded in G.k.9.
Conformance Optional
Data Type Boolean
OID None
Value Allowed false
true
Business Rule(s)
‘False’ means the event is not confirmed, it does not mean the event did
not occur. If the event is reported by a healthcare professional, this is not
transmitted.