How do I report adverse events?

Developing a plan for reporting adverse events is essential to maintaining good clinical practices and ensuring safety of participants in clinical studies. Your data monitoring plan should describe the mechanism for reporting adverse events to your IRB, the DSMB, the FDA and other parties responsible for receiving and reviewing them.

NHLBI is concerned about patient safety in clinical trials. Reports of all serious adverse events which are expected or unexpected must be sent to your NHLBI Program Director or Clinical Trials Specialist as outlined in a Policy for Reporting Clinical Study Serious Adverse Events.

You may wish to view or use the FDA adverse event reporting form called MedWatch. These forms may be a useful starting point for you if you do not have study-specific forms developed already.