Definition

Classification of the person reporting an adverse event: healthcare professional (HCP), consumer/patient, lawyer, regulatory authority, or other. This affects follow-up strategy and some regulatory reporting.

Example

A physician report may carry more clinical weight, but a patient's first-hand account of symptoms can provide unique detail. Both are valid but may be weighted differently in causality assessment.

Regulatory source

ICH E2B(R3) Data Elements

Common mistakes

Automatically assuming healthcare professional reports are more reliable than consumer reports. Consumers often provide critical real-world usage information.

Inspector question

How does reporter type influence your case processing and follow-up activities?

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