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Institutional Review Board Requirements
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Item Number: NWRR3016
A procedure that describes the requirements for establishing an Institutional Review Board (IRB) and to define what studies and supporting information are subject to IRB approval, including: IRB composition, responsibility, functions, and review process; expedited IRB review; clinical studies exempt from IRB monitoring; FDA inspections of IRBs; and IRB disqualification and reinstatement. This 11-page procedure applies to all clinical trials for an investigational drug, biologic, or device that involves human subjects.
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