Definition

The initial assessment process to prioritize incoming adverse event reports based on seriousness, expectedness, and regulatory reporting requirements.

Example

Upon receipt, a case describing hospitalization for anaphylaxis is triaged as high priority (serious, potentially unexpected), while a case of mild headache is routine priority.

Regulatory source

Company SOPs, EU GVP Module VI

Common mistakes

Triaging based solely on seriousness without considering expectedness. An unexpected non-serious event may require faster assessment than an expected serious event.

Inspector question

Walk me through your triage criteria. How do you ensure expedited cases are identified within appropriate timeframes?

Related terms