Office of Clinical Policy
Who We Are
The Office of Clinical Policy (OCLiP), located in the Office of Clinical Policy and Programs (OCPP), addresses key clinical policy issues across the FDA’s medical product centers. OCLiP is comprised of the Clinical Policy Program (CPP) and the Office of Good Clinical Practice (OGCP).
Clinical Policy Program (CPP)
The Clinical Policy Program (CPP) develops and implements cross-center FDA clinical policy primarily related to medical product development, evaluation, and use. CPP works in close collaboration with FDA centers, especially the medical product centers, other FDA offices, and HHS Operational Divisions (OpDivs) to coordinate and collaborate on timely and consistent FDA-wide clinical policy and deliverables that respond to FDA’s mission, such as legislative mandates or public health priorities.
Office of Good Clinical Practice (OGCP)
The Office of Good Clinical Practice (OGCP) serves as the FDA focal point for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues related to FDA-regulated clinical trials. OGCP sets priorities for the development of GCP and HSP policy, works to ensure consistency in GCP and HSP policy across the agency, participates in international GCP and HSP harmonization activities, and serves as the liaison to other federal agencies and external stakeholders committed to the protection of human research participants.