An audit, or “inspection,” is an expected event in the course of New Drug Application (NDA) approval, typically involving pivotal Phase III or bioequivalency studies. Whether concurrent with these landmarks or prompted by suspicion that the study site failed to adhere to regulatory standards, the inspector will verify that informed consent was obtained, real patients were enrolled, the protocol was adhered to, Good Clinical Practice was used, medication was administered, log sheets were kept, and data reported were correct. Recommended tools for completing a successful inspection are Organization, Documentation, and Cooperation.
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