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Office of Good Clinical Practice
The Office of Good Clinical Practice is the focal point within FDA for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in human research trials regulated by FDA. The Office of Good Clinical Practice:
- Advises and assists the Commissioner and other key officials on GCP and HSP issues arising in clinical trials that have an impact on policy, direction, and long-range goals.
- Leads, supports, and administers FDA's Human Subject Protection/Bioresearch Monitoring Council that manages and sets agency policy on bioresearch monitoring (BIMO), GCP, and HSP affecting both clinical and non-clinical trials regulated by FDA. The office also coordinates and provides oversight of working groups established by this Council.
- Coordinates FDA's Bioresearch Monitoring program with respect to clinical trials, working together with all FDA Centers as well as FDA's Office of Regulatory Affairs (ORA)
- Plans and conducts training and outreach programs, both internally and externally.
- Serves as a liaison with other Federal agencies (e.g., the HHS Office for Human Research Protection (OHRP) and the Veterans Administration), outside organizations, regulated industry, and public interest groups on BIMO, GCP, and HSP policies and regulatory matters.
- Contributes to international Good Clinical Practice harmonization activities.
- Coordinates and supports compliance and enforcement activities related to the NIH clinical trial registration databank.