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G.k.1 Characterisation of Drug Role
User Guidance This data element contains the characterisation of the drug role as
provided by the primary reporter or, if this information is missing, by the
sender. All spontaneous reports should have at least one suspect drug (See
Section 3.3.1).
If the reporter indicates a suspected interaction with other drug(s),
‘interacting’ should be selected for all suspected interacting drug(s). If an
interaction is suspected with food or other non-drug compounds,
‘interacting’ should be selected for the suspect drug. For evaluation
purposes, all interacting drugs are considered to be suspect drugs. The
type of interaction (e.g. drug interaction, food interaction, alcohol
interaction, etc.), should be captured with the appropriate MedDRA
LLT(s) in Section E.i Reaction(s) /Event(s) along with any event(s)
resulting from the suspected interaction.
‘Drug not administered’ can be used in two circumstances:
In clinical trial: if the adverse event occurred after the informed consent
was signed but prior to the administration of the study drug (e.g. during
the screening period or the washout procedure), the adverse event should
in general be reported as per the trial procedure. In that case, only sections
G.k.1, G.k.2 and G.k.8 are to be filled out for that Section G. The
information on the suspect cause of the event should be provided in the
narrative H.1. In addition, comments can be provided by the reporter in
H.2 and by the sender in the H.4.
Medication error: if the patient did not receive the actual prescribed drug
ICH ICSR Implementation Guide 12 April 2013
-116-
G.k.1 Characterisation of Drug Role
User Guidance This data element contains the characterisation of the drug role as
provided by the primary reporter or, if this information is missing, by the
sender. All spontaneous reports should have at least one suspect drug (See
Section 3.3.1).
If the reporter indicates a suspected interaction with other drug(s),
‘interacting’ should be selected for all suspected interacting drug(s). If an
interaction is suspected with food or other non-drug compounds,
‘interacting’ should be selected for the suspect drug. For evaluation
purposes, all interacting drugs are considered to be suspect drugs. The
type of interaction (e.g. drug interaction, food interaction, alcohol
interaction, etc.), should be captured with the appropriate MedDRA
LLT(s) in Section E.i Reaction(s) /Event(s) along with any event(s)
resulting from the suspected interaction.
‘Drug not administered’ can be used in two circumstances:
In clinical trial: if the adverse event occurred after the informed consent
was signed but prior to the administration of the study drug (e.g. during
the screening period or the washout procedure), the adverse event should
in general be reported as per the trial procedure. In that case, only sections
G.k.1, G.k.2 and G.k.8 are to be filled out for that Section G. The
information on the suspect cause of the event should be provided in the
narrative H.1. In addition, comments can be provided by the reporter in
H.2 and by the sender in the H.4.
Medication error: if the patient did not receive the actual prescribed drug