Definition

A post-mortem examination that may provide definitive information about cause of death in fatal adverse event cases.

Example

A patient death initially attributed to the study drug is later found via autopsy to result from a massive pulmonary embolism unrelated to the drug. This changes the causality assessment.

Regulatory source

ICH E2D, GVP Module VI

Common mistakes

Not actively pursuing autopsy results for fatal cases where they could clarify causality.

Inspector question

What is your procedure for requesting and following up on autopsy results in fatal cases?

Related terms