Does FDA Conduct GCP Training?
Yes, the Food and Drug Administration (FDA) conducts GCP training. As described below, the agency conducts some GCP training on site, but also partners with other federal agencies and organizations across the United States to conduct additional training. FDA also has recently made GCP training available online.
In the fall of 2009, FDA's Critical Path Initiative launched a Clinical Investigator Training Course targeted at medical professionals who participate in FDA-regulated clinical trials. This 3-day course includes lectures given by senior FDA experts and guest lecturers from industry and academia. It provides FDA's perspectives on new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research, and acceptable scientific and analytic standards in clinical study design and conduct. See FDA's Clinical Investigator Training Course for further information.
Throughout the year, FDA district offices co-sponsor two-day workshops with the Society of Clinical Research Associates (SoCRA). These conferences are entitled, “FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference.” FDA personnel from both the co-sponsoring district office and headquarters participate in these workshops. Locations and dates for future workshops are available at the SoCRA website. FDA personnel, from both headquarters and the district offices, also regularly present at meetings of various professional organizations. In addition to SoCRA, these include the Drug Information Association (DIA), Public Responsibility in Medicine and Research (PRIM&R), the Association of Clinical Research Professionals (ACRP), the Regulatory Affairs Professionals Society (RAPS), and others.
FDA routinely collaborates with the Office for Human Research Protections and the Department of Veterans Affairs on regional programs focused on human subject protection in regulated research. Information about these programs is available at:
- The Educational Materials/Workshops page on FDA's Good Clinical Practice Web site
- The Conferences page on the Office for Human Research Protections Web site
Both the Center for Drug Evaluation (CDER) and the Center for Devices and Radiological Health (CDRH) provide online training relevant to clinical trials on their respective websites. These training programs are accessible at CDERLearn and CDRH Learn respectively.
Other agencies in the Department of Health and Human Services do provide training in this area:
- Online training on Human Subject Protection is provided by the Office for Human Research Protections.
- Clinical Research Training is a course developed by the National Institutes of Health to train its own investigators. It may be accessed by others to enhance their knowledge of clinical research.
Finally, there are numerous references related to good clinical practice (GCP) and human subject protection (HSP), available on FDA's website, including:
- FDA's GCP and HSP regulations found in Title 21 of the Code of Federal Regulations, Parts 50, 54, 56, 312, and 812
- Preambles related to these regulations
- ICH E6 Good Clinical Practice Consolidated Guidance [261KB PDF]
- FDA Information Sheets for IRBs and Clinical Investigators
- Compliance Program Guidance Manuals
- FDA guidance for industry: Finalized documents and draft guidance documents (and proposed regulations).