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Running Clinical Trials
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.
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.
Office of Good Clinical Practice
See the Office of Good Clinical Practice’s (OGCP’s) mission statement on the OGCP's Web page.
Sign up for Good Clinical Practice/Human Subject Protection e-mail updates
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 As a result, some links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid.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
Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (PDF - 352KB)FDA Inspections of Clinical Investigators - Information Sheet (PDF - 55KB)Frequently Asked Questions – Statement of Investigator (Form FDA 1572) - Information Sheet (PDF - 105KB)Clinical Investigator Administrative Actions - Disqualification (PDF - 79KB)Proposed Rule - Reporting Information Regarding Falsification of Data (Feb. 19, 2010) IRB Continuing Review After Clinical Investigation Approval - Draft Guidance (PDF - 125KB)Proposed rule - addition of an informed consent required element to 21 CFR 50.25 (Dec. 29, 2009) Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB)FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs FDA Enhances Speed and Transparency of Actions Taken Against Misconduct in Drug and Device Development FDA, European Medicines Agency Launch Good Clinical Practices Initiative Frequently Asked Questions - IRB Registration (PDF - 48KB)Good Clinical Practice: Previous "In the News" Items
Contact Us
Office of Good Clinical Practice
- 301-796-8340
- gcp.questions@fda.hhs.gov
Food and Drug Administration
Office of Good Clinical Practice
Office of Special Medical Programs
10903 New Hampshire Ave., WO32-5103
Silver Spring, MD 20993