Definition

The Marketing Authorization Holder's or sponsor's evaluation of causality, which may differ from the reporter's assessment but must be documented and justified.

Example

A physician reports a case as 'definitely related' but company assessment after full review concludes 'possible' due to confounding factors. Both assessments are captured in the ICSR.

Regulatory source

ICH E2B(R3), EU GVP Module VI

Common mistakes

Automatically adopting the reporter's assessment without independent medical review, or routinely downgrading without documented rationale.

Inspector question

How do you reconcile differences between reporter and company causality? Who has authority to make the final company assessment?

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