FDA Guidance on Adverse Event Reporting to IRBs - Improving Human Subject Protection

• By: www.fda.gov
• Date: December 02, 2011

The Food and Drug Administration (FDA) has issued guidelines for adverse event reporting because adverse event reports were found to be inhibiting, rather than enhancing, the ability of IRBs to protect the human subjects. Institutional Review Board (IRB) reviews and approves the clinical protocol, informed consent forms, study advertisements, and patient brochures.

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