72
ICH ICSR Implementation Guide 12 April 2013
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section. There will be one ICSR for the baby, with the adverse event/reaction of foetal
distress. The Caesarean section should not be considered an adverse event/reaction for
the mother. The mother’s characteristics, should be captured in Section D with the
Caesarean section as relevant medical history (D.10.7).
If both parents are the suspect source of exposure to the suspect drug(s) then the case should
reflect the mother’s information in Section D.10 and the case narrative (Section H.1) should
describe the entire case, including the father’s information.
ICH ICSR Implementation Guide 12 April 2013
-73-
section. There will be one ICSR for the baby, with the adverse event/reaction of foetal
distress. The Caesarean section should not be considered an adverse event/reaction for
the mother. The mother’s characteristics, should be captured in Section D with the
Caesarean section as relevant medical history (D.10.7).
If both parents are the suspect source of exposure to the suspect drug(s) then the case should
reflect the mother’s information in Section D.10 and the case narrative (Section H.1) should
describe the entire case, including the father’s information.