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The U.S. Food & Drug Administration (FDA) recently redesigned the FDA Web site. As a result, the Good Clinical Practice Program was moved.
Additionally, some Web links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid.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 title. For more assistance, go to Contact FDA
We apologize for any inconvenience this redesign might have caused.
Good Clinical Practice Program Mission
The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA. In relation to Good Clinical Practice, the Good Clinical Practice Program:
- Coordinates FDA policies
- Contributes to leadership and direction through participation in FDA's Human Subject Protection/Bioresearch Monitoring Council
- Coordinates FDA's Bioresearch Monitoring program with respect to clinical trials, working together with FDA's Office of Regulatory Affairs (ORA)
- Contributes to international Good Clinical Practice harmonization activities
- Plans and conducts training and outreach programs
- Serves as a liaison with the HHS Office for Human Research Protection (OHRP) and other federal agencies and external stakeholders committed to the protection of human research participants
In The News
- 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 - 181KB)
- FDA's HSP/BIMO Initiative Accomplishments - Update
- Adverse Event Reporting to IRBs - Improving Human Subject Protection (PDF - 79KB)
- Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - Information Sheet (PDF - 399KB)
- FDA Imposes Restrictions on Coast IRB due to Violations
- Disqualification of a Clinical Investigator Hearing Process
- FDA announces availability of documents from the Global Harmonization Task Force (GHTF)
- FDA announces availability of documents from the Global Harmonization Task Force (GHTF) - PDF Version
- Final rule on IRB Registration requirements publishes [PDF]
- Final rule on IRB Registration requirements publishes
- The 2009 edition of the International Compilation of Human Subject Protections