Definition

The systematic evaluation of the likelihood that a suspect drug caused or contributed to an adverse event, using clinical judgment and established algorithms.

Example

After reviewing timing, dechallenge, rechallenge, alternative causes, and biological plausibility, the assessor concludes the drug is 'probably' related to the patient's hepatotoxicity.

Regulatory source

ICH E2A, WHO-UMC Guidelines

Common mistakes

Relying solely on algorithms without clinical judgment, or conversely, making assessments without any structured approach.

Inspector question

Describe your causality assessment methodology. How do you ensure consistency across assessors?

Related terms