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For RED Use Only St. Michael's Research Ethics Board (RED) EXTERNAL SERIOUS ADVERSE EVENT / UNANTICIPATED PROBLEM REPORTING FORM See Guidelines for Reporting Serious Adverse Events/Unanticipated Problems

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What is external serious adverse event?

An external serious adverse event is a severe and unexpected reaction or side effect to a drug or medical device that occurs outside of a controlled clinical trial.

Who is required to file external serious adverse event?

Health care providers, manufacturers, and sponsors are required to file external serious adverse events.

How to fill out external serious adverse event?

External serious adverse events can be filled out using specific reporting forms provided by regulatory agencies.

What is the purpose of external serious adverse event?

The purpose of reporting external serious adverse events is to monitor the safety and effectiveness of drugs and medical devices.

What information must be reported on external serious adverse event?

Information such as patient details, adverse event description, date of occurrence, severity, and outcome must be reported on external serious adverse events.