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                                 Clinical Trials and Human Subject Protection
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   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
         FDA Reopens the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for
         Minimal Risk Clinical Investigations (February 2019)

         FDA Extends the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for Minimal
         Risk Clinical Investigations (December 2018)
         Proposed Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
         (November 15, 2018)
         Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors,
         Investigators, and Institutional Review Boards (October 2018)
         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




   Content current as of:
   04/22/2019




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