100
ICH ICSR Implementation Guide 12 April 2013
-101-
E.i REACTION(S)/EVENT(S) (REPEAT AS NECESSARY)
A minimum of one reaction/event needs to be provided for each valid ICSR.The designation of
‘i’ in this section indicates that each item is repeatable and that it corresponds to the same ‘i’ in
all subsections.
For technical reason, each reaction /event should be assigned an internal ID so that
G.k.9.i.1 can refer to the reaction /event from the drug /event matrix.
A separate block (i) should be used for each reaction/event term. For example, if two
reactions are observed, the first reaction would be described in items E.1.1 through
E.1.9, and the other reaction would be described in items E.2.1 through E.2.9.
ICH ICSR Implementation Guide 12 April 2013
-101-
E.i REACTION(S)/EVENT(S) (REPEAT AS NECESSARY)
A minimum of one reaction/event needs to be provided for each valid ICSR.The designation of
‘i’ in this section indicates that each item is repeatable and that it corresponds to the same ‘i’ in
all subsections.
For technical reason, each reaction /event should be assigned an internal ID so that
G.k.9.i.1 can refer to the reaction /event from the drug /event matrix.
A separate block (i) should be used for each reaction/event term. For example, if two
reactions are observed, the first reaction would be described in items E.1.1 through
E.1.9, and the other reaction would be described in items E.2.1 through E.2.9.