Office of Clinical Policy Also referred to as: OCLP
Who We Are
The Office of Clinical Policy (OCLP) develops cross-cutting clinical research policies, regulation and guidance in collaboration with FDA’s medical product centers. OCLP also focuses on clinical policy issues that arise in assuring the ethical conduct of research supporting medical product development.
What We Do
- Develop and implement clinical policy related to medical product development and regulation.
- Lead policy related to the protection of clinical trial participants.
- Serve as the liaison to other federal agencies, organizations and people focused on protecting the rights, safety and welfare of people participating in clinical trials.
- Coordinate and collaborate with offices across the FDA on timely and consistent clinical policy to advance the FDA’s public health mission.
- Coordinate across the FDA for clinical trial regulation, international engagement on research ethics, and outreach activities.
- Lead and implement special programs and initiatives that are cross-cutting and clinical, scientific, or regulatory in nature to support innovation in medical product development and review. Advise and assist the Commissioner and other FDA officials on ethical issues in clinical trials that may have an impact on policy and the safety of people participating in clinical trials.
- Provide outreach to organizations and people inside and outside of the FDA about policies related to clinical trials and the ethical treatment of research participants.
Contact us
Email: gcpquestions@fda.hhs.gov
Phone: 301-796-8340
Office of Clinical Policy
Office of the Chief Medical Officer
U.S. Food and Drug Administration
10903 New Hampshire Ave. WO-32
Silver Spring, MD 20993