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.
- CPGM for Clinical Investigators
- CPGM for Sponsors, Contract Research Organizations, and Monitors
- CPGM for Good Laboratory Practice (Non-Clinical Laboratories)
- CPGM for In-Vivo Bioequivalence Compliance Program 7348.001
- CPGM for Institutional Review Boards [1.02 MB]
(For help in viewing this document, contact the HHS Help Desk.)