The Office of Good Clinical Practice is the focal point within the Food and Drug Administration (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 and policy.
- Leads FDA's Human Subject Protection/Bioresearch Monitoring Council that manages and sets agency policy on GCP and HSP affecting clinical trials regulated by FDA.
- Advises FDA’s Centers and the Office of Regulatory Affairs (ORA) on GCP and HSP policy and guidance relevant to the agency-wide Bioresearch Monitoring (BIMO) program for inspecting clinical investigators, sponsors, and institutional review boards (IRBs).
- Serves as a liaison to other Federal agencies (e.g., the Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP), the Veterans Administration), professional organizations, regulated industry, and public interest groups on GCP and HSP policy.
- Contributes to international GCP and HSP harmonization activities.
- Provides advice on research ethics to FDA Centers related to medical product applications.
- Coordinates and supports FDA compliance and enforcement activities related to the National Institutes of Health (NIH) clinical trial registration databank.
- Plans and conducts training and outreach programs for FDA staff and external organizations.
Office of Good Clinical Practice Staff
- Joanne R. Less, PhD, Director
- Sheila Brown, RN, MS, Policy Analyst
- Janet Donnelly, RAC, Policy Analyst
- Carol Drew, JD, Senior Regulatory Counsel
- Bridget Foltz, MS, MT(ASCP), Policy Analyst
- Doreen Kezer, MSN, Senior Health Policy Analyst
- David Markert, JD, Senior Regulatory Counsel
- Janet Norden, MSN, RN, Senior Regulatory Policy Advisor
- Kevin A. Prohaska, DO, MPH, Senior Medical Policy Analyst
- Jeff Ramsay, PMP, Project Manager
Resources For You
- Office of Good Clinical Practice
Office of Clinical Policy and Programs
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993