Definition

An adverse event report that contains the four minimum required elements: an identifiable patient, an identifiable reporter, a suspect product, and an adverse event or outcome.

Example

A physician (reporter) calls to report that a 45-year-old male patient (identifiable patient) developed severe headache (adverse event) after taking Drug X (suspect product). This meets all four criteria and is a valid case.

Regulatory source

ICH E2D, FDA 21 CFR 314.80

Common mistakes

Accepting cases where the reporter is completely anonymous with no way to follow up, or where the adverse event is actually a lack of efficacy without any actual adverse reaction.

Inspector question

How do you determine if a case is valid? Show me your SOP and demonstrate with a recent example how you applied the minimum criteria.

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