Definition

A causality assessment conclusion indicating a reasonable possibility that the drug caused or contributed to the adverse event, triggering reporting obligations.

Example

A patient develops a known drug-class effect with appropriate timing and positive dechallenge. The assessment concludes the event is 'related' to the suspect drug.

Regulatory source

21 CFR 312.32, ICH E2A

Common mistakes

Requiring certainty for a 'related' assessment. Regulatory definitions typically use 'reasonable possibility' as the threshold.

Inspector question

What threshold do you use for a 'related' assessment? How do you document the rationale?

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