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ICH ICSR Implementation Guide 12 April 2013
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G.k DRUG(S) INFORMATION (REPEAT AS NECESSARY)
This section covers both suspect and concomitant medications (including biologics) including
drugs suspected to have a type of interaction (e.g. drug, food, tobacco, etc).A minimum of one
suspect medication needs to be provided for each valid ICSR. Medications used to treat the
reaction/event should not be included here.
For each drug, the ‘Characterisation of the Drug Role’ (G.k.1) is the one reported or implied by
the primary reporter (e.g. the original source of the information).Suspect medications are those
health products taken by the patient and suspected by the reporter to have contributed to the
adverse reaction described in Section E. The suspect medication might have been stopped
before the reaction is observed, for example, a single dose of an antibiotic could be suspected to
cause diarrhoea one week later. However, concomitant medications are only those health
products taken by the patient at the time the reaction is observed other relevant medication
history should be recorded in Section D.8.
As for the designation ‘i’ in Section E above, the designation of ‘k’ in this section indicates that
each item is repeatable and that it corresponds to the same ‘k’ in all subsections. A separate
block (k) should be used for each health product. Within a block (k), subsections can also repeat
using the designation ‘r’, and within a subsection (r), further sub-subsections can repeat using
the designation ‘i’.
The designation of ‘k’ in this section indicates that each item is repeatable and that
it corresponds to the same ‘k’ in all subsections. A separate block (k) should be
used for each drug. Drugs used to treat the reaction/event should not be included
here.
ICH ICSR Implementation Guide 12 April 2013
-114-
G.k DRUG(S) INFORMATION (REPEAT AS NECESSARY)
This section covers both suspect and concomitant medications (including biologics) including
drugs suspected to have a type of interaction (e.g. drug, food, tobacco, etc).A minimum of one
suspect medication needs to be provided for each valid ICSR. Medications used to treat the
reaction/event should not be included here.
For each drug, the ‘Characterisation of the Drug Role’ (G.k.1) is the one reported or implied by
the primary reporter (e.g. the original source of the information).Suspect medications are those
health products taken by the patient and suspected by the reporter to have contributed to the
adverse reaction described in Section E. The suspect medication might have been stopped
before the reaction is observed, for example, a single dose of an antibiotic could be suspected to
cause diarrhoea one week later. However, concomitant medications are only those health
products taken by the patient at the time the reaction is observed other relevant medication
history should be recorded in Section D.8.
As for the designation ‘i’ in Section E above, the designation of ‘k’ in this section indicates that
each item is repeatable and that it corresponds to the same ‘k’ in all subsections. A separate
block (k) should be used for each health product. Within a block (k), subsections can also repeat
using the designation ‘r’, and within a subsection (r), further sub-subsections can repeat using
the designation ‘i’.
The designation of ‘k’ in this section indicates that each item is repeatable and that
it corresponds to the same ‘k’ in all subsections. A separate block (k) should be
used for each drug. Drugs used to treat the reaction/event should not be included
here.