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.
[COLOR=“blue”]Office of Good Clinical Practice
The Office of Good Clinical Practice is the focal point within FDA for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in human research trials regulated by FDA. The Office of Good Clinical Practice:
Advises and assists the Commissioner and other key officials on GCP and HSP issues arising in clinical trials that have an impact on policy, direction, and long-range goals.
Leads, supports, and administers FDA’s Human Subject Protection/Bioresearch Monitoring Council that manages and sets agency policy on bioresearch monitoring (BIMO), GCP, and HSP affecting both clinical and non-clinical trials regulated by FDA.
The office also coordinates and provides oversight of working groups established by this Council.
Coordinates FDA’s Bioresearch Monitoring program with respect to clinical trials, working together with all FDA Centers as well as FDA’s Office of Regulatory Affairs (ORA)
Plans and conducts training and outreach programs, both internally and externally.
Serves as a liaison with other Federal agencies (e.g., the HHS Office for Human Research Protection (OHRP) and the Veterans Administration), outside organizations, regulated industry, and public interest groups on BIMO, GCP, and HSP policies and regulatory matters.
Contributes to international Good Clinical Practice harmonization activities.[/color]