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.)

In The News

• Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
• FDA Publishes Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020)
• FDA Publishes Guidance on Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During COVID-19 Public Health Emergency
• FDA issues Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic
• FDA Reopens the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations (February 2019)
• Good Clinical Practice: Previous "In the News" Items

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.

Workshops, Meetings, and Conferences

• Conferences
• Workshops and Meetings

Contacts

• Good Clinical Practice Contacts
• IND/IDE Contacts
• Bioresearch Monitoring Program Contacts (FDA Centers)
• How to Report Complaints or Problems About Clinical Trials to FDA

Resources For You

• Clinical Trial Forms
• ClinicalTrials.gov (NIH)
• FDA Basics
• FDA Basics for Industry
• Laws Enforced by FDA
• Freedom of Information
• Dockets Management
• Approvals of FDA-Regulated Products
• Websites with Information About Clinical Trials