Definition

The person reporting the adverse event who can be identified by name, initials, address, qualification, or contact information sufficient for follow-up if needed.

Example

A nurse who provides her name and hospital phone number is identifiable. An anonymous caller who refuses to provide any identifying information is not identifiable.

Regulatory source

ICH E2D Section 3.1.2

Common mistakes

Assuming consumer reports are invalid because the reporter isn't a healthcare professional. Consumers are valid reporters if identifiable.

Inspector question

How do you handle situations where a healthcare professional requests anonymity but provides valid case information?

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