Science & Research
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 As a result, some links (URLs) embedded within Guidance documents, Rules, and other documents are no longer valid.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
- Final Rule: Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (21 CFR Parts 50 and 56) (February 26, 2013)
- Guidance for Clinical Investigators, Industry, and FDA Staff- Financial Disclosure by Clinical Investigators ( February 26, 2013) (PDF - 165KB)
- Proposed Rule: Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices (February 25, 2013)
- Guidance for Industry and Food and Drug Administration Staff - Humanitarian Use Device (HUD) Designations (January 2013) (PDF - 92KB)
- Guidance for Industry and Investigators- Safety Reporting Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide (December 2012) (PDF - 35KB)
- Guidance for Industry and Investigators- Safety Reporting Requirements for INDs and BA/BE Studies (December 2012) (PDF - 227KB)
- Draft Guidance for IRBs, Clinical Investigators, and Sponsors - IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (Nov. 20, 2012) (PDF - 62KB)
- Draft Guidance for Industry - Electronic Source Data in Clinical Investigations (Nov. 20, 2012) (PDF - 271KB)
Good Clinical Practice: Previous "In the News" Items