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How do I report adverse events?

Developing a plan for reporting Adverse Event is essential to maintaining Good Clinical Practices ( GCP ) 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 Trial. Reports of all Serious Adverse Events ( SAE ) 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.

Related Documents Concerning FDA IND Reporting Requirements:

Guidance for Industry and Investigators: FDA Safety Reporting Requirements for INDs and BA/BE Studies

Page Last Updated: September 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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