Science & Research
Clinical Trials and Human Subject Protection
Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations. The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP. These FDA regulations and guidance documents are accessible from this site. International GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance are also be found here. Finally, this site includes links to other sites relevant to the conduct of clinical trials, both nationally and internationally.
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.
Office of Good Clinical Practice
See the Office of Good Clinical Practice's (OGCP's) mission statement on the OGCP's Web page.
In June 2009, FDA redesigned its web site. As a result, some links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document’s title. For additional assistance, go to Contact FDA. We apologize for any inconvenience this redesign might have caused.
In The News
- Meeting Announcement: Public hearing to seek input on the inclusion of women, minorities and the elderly in clinical trials (April 1, 2014)
- Draft guidance: Humanitarian Device Exemption (HDE): Questions and Answers (PDF - 175KB)
- Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 288KB)
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (August 27, 2013)
- Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (August 7, 2013) (PDF - 109KB)
Good Clinical Practice: Previous "In the News" Items