How are clinical investigator inspections conducted?

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FDA investigators must display his/her FDA credentials and issue a completed Form FDA 482 (Notice of Inspection) upon arrival. During the inspection, the FDA investigator willy verify compliance with the regulations governing the use of investigational products and human subject protections at 21 CFR parts 50, 56, 312, and/or 812 by inspecting records and talking to individuals involved in the conduct of the study.

About the Author
Proxima CRO Team
Alisa Hamilton
Mgr. of Ops, Marketing & Comms.

Alisa graduated from Stephen F. Austin State University with a B.B.A in May of 2016, where she was a 4-year letterman scholarship-athlete. She has over eight years of business management experience. Previous to Proxima, she was a customer relations specialist at Baylor Scott and White.

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