Does FDA Conduct GCP Training?

The Food and Drug Administration does not routinely conduct good clinical practice training, nor does the agency currently have any online training in this area.

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.

Although FDA does not have any online classes, the agency has numerous excellent references that may be used to enhance your knowledge of good clinical practices and human subject protection issues, including the following:

• FDA's GCP and HSP regulations found in Title 21 of the Code of Federal Regulations, Parts 50, 54, 56, 312, and 812
• the 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 Manual
• FDA Guidance for Industry Entitled "Computerized Systems Used in Clinical Trials" (if applicable) [47KB PDF]

You may also be interested to know that although FDA itself does not typically conduct GCP training, we do collaborate with the Office for Human Research Protections and the Department of Veterans Affairs on regional programs focused on human subject protection in regulated research. You may find information about these programs on:

• 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