Individual Case Safety Report in Pharmacovigilance

Information to validate an Individual Case Safety Report in Pharmacovigilance when they receive it from a source( Clinical Trial & Spontaneous):

The criteria for a valid case are:

● an identifiable patient;

● a suspect drug;

● a suspect reaction;

● an identifiable HCP reporter.

In the context of expedited reporting, day zero should be considered the day on which the minimum criteria for a reportable adverse reaction report becomes available to the MAH.