Definition

A medically qualified person such as a physician, pharmacist, nurse, or dentist who reports or is involved in an adverse event case. HCP reports may be weighted differently in safety assessments.

Example

An oncologist reporting a patient's unexpected reaction has medical training to describe symptoms accurately, note relevant medical history, and assess potential causality.

Regulatory source

ICH E2D, EU GVP Module VI

Common mistakes

Including medical students or administrative hospital staff as HCPs. The definition typically requires licensed practitioners.

Inspector question

What qualifications do you require to classify a reporter as a healthcare professional in your database?

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