Definition

An adverse event case where the diagnosis or clinical details have been verified by a healthcare professional, enhancing the reliability of the reported information.

Example

A consumer reports a cardiac event. Follow-up with the treating cardiologist confirms the diagnosis as myocardial infarction based on ECG, enzymes, and angiography. The case is now medically confirmed.

Regulatory source

ICH E2D, FDA Guidance

Common mistakes

Assuming all HCP-reported cases are medically confirmed. The event itself, not just the reporter, must be professionally diagnosed.

Inspector question

How do you document medical confirmation? What follow-up efforts do you make to obtain confirmation for serious reports?

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