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U.S. Department of Health and Human Services

Science & Research

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Bioresearch Monitoring Program (BIMO)

FDA uses Compliance Program Guidance Manuals (CPGM) to direct its field personnel on the conduct of inspectional and investigational activities. The CPGM's described below form the basis of FDA's Bioresearch Monitoring Program. The purpose of each program is to ensure the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application.