Definition

A causality assessment conclusion indicating no reasonable possibility that the drug caused or contributed to the adverse event, typically due to clear alternative etiology or implausible timing.

Example

A patient in a clinical trial has a car accident causing fractures. With no plausible mechanism linking the study drug to the accident, the event is assessed as 'unrelated.'

Regulatory source

ICH E2A, Company SOPs

Common mistakes

Assessing events as unrelated simply because they are listed in the label or because they seem unlikely, without proper evaluation.

Inspector question

What criteria must be met to classify an event as unrelated? Show me documentation from a case assessed as unrelated.

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