FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

Bioresearch Monitoring Program

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, Monitors, and Contract Research Organizations
• 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.)

Some of these documents are in Portable Document Format (PDF) to retain the original format. To view or print these documents, you must use the Adobe Acrobat viewer. Acrobat is free and available directly from Adobe's website with full installation instructions.

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Good Clinical Practice Program