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Medical Devices, Pharmaceuticals

BIMO Part 50 56 Institutional Review Boards

About the Course

This is the third training program in a series of online courses that provide an overview of FDA’s Bioresearch Monitoring (BIMO) program and the methods and techniques used in conducting and reporting Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor, and in vivo Bioequivalence inspections. This eLearning course provides an overview of the regulations applicable to the protection of human subjects who participate in clinical research typically involving test articles which are unapproved for marketing, but approved for research by FDA.