A question on a medical form that made me shake my head!

[Donkees]

5. ''standard part of serious adverse event reporting and is not meant for the patient filling out the form...

It is used in clinical trials and by regulators to track and monitor medication safety.

You, the living patient, did not suffer a fatal adverse reaction. The form is likely one also used by doctors, clinical researchers, or family members to report a death to regulatory bodies like the U.S. Food and Drug Administration (FDA).

Pharmacovigilance: The practice of monitoring adverse reactions is called pharmacovigilance. It helps regulators identify, assess, and address the safety risks of medicines.

To be completed by a third party: In the event of a death, a healthcare professional or designated family member would use this form to report the fatality. Information is then used to update drug labels, issue warnings, or remove dangerous medicines from the market.

How to answer the question
Assuming you are alive and filling out the form for yourself, simply mark "No" or leave the box unchecked. This question is irrelevant to your personal medical history.