Definition

MAH's assessment of causal relationship between drug and event; uses criteria (e.g., WHO-UMC, Naranjo) and is documented in case file.

Example

Company causality 'probable' based on rechallenge and temporal relationship.

Regulatory source

GVP Module VI, ICH E2D

Common mistakes

Using causality to avoid reporting (reportability is independent).

Inspector question

How do you perform and document causality assessment?

Related terms