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Clinical Trials and Human Subject Protection

Clinical Trials and Human Subject Protection

Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as a critical requirement to the ethical conduct of research involving human subjects. The Food and Drug Administration (FDA) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP. FDA regulations and guidance documents, and international GCP guidance documents on which FDA has collaborated, and that have been adopted as official FDA guidance, are also found here.   

Office of Good Clinical Practice

The Office of Good Clinical Practice (OGCP) serves as the FDA focal point for GCP and 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 liaison to other Federal agencies and external stakeholders committed to the protection of human research participants. (For more information, see OGCP's mission statement.)

Bioresearch Monitoring

FDA’s bioresearch monitoring (BIMO) program conducts on-site inspections of both clinical and nonclinical studies performed to support research and marketing applications/submissions to the agency.  Links to the compliance programs for each inspection type and contact information for each Center’s BIMO program are also accessible from this site.

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