Good Clinical Practice Training
Researchers working in behavioral or biomedical clinical research must sometimes complete training in Good Clinical Practice (GCP) in order to meet the requirements of the organizations they are affiliated with, funding agencies, or study sponsors. GCP training educates researchers on the fundamental principles of conducting high quality clinical trials.
University of Washington Requirements
The UW and HSD do not currently require that researchers complete GCP training.
FDA Regulated Research
The FDA does not have specific GCP training requirements, but sponsors of FDA regulated research, such as industry partners developing a new drug or device, may require that researchers complete GCP training in order to demonstrate that the researcher is qualified to work on the study.
Industry Sponsored FDA Studies
Work with the sponsor to complete the training they provide.
Investigator Sponsored FDA Studies
Sponsor-Investigators may make use of several free GCP training options for themselves and their staff.
- The CITI Program offers a 4 – 6 hour online course that is free if you are affiliated with UW or collaborating with someone who is affiliated with UW.
- The National Institutes of Health offers free online courses at:
- Training obtained through workshops and conferences co-sponsored by the FDA or provided by industry partners and recognized by TransCelerate can also be used.
Funding Organization Requirements
Currently, the only funding organization that requires that researchers complete GCP training is the National Institutes of Health.
National Institutes of Health (NIH)
Principal Investigators and clinical trial staff who work on new and ongoing NIH-funded clinical trials must complete training in Good Clinical Practice (GCP) to be renewed every 3 years.
For more information see UW’s Frequently Asked Questions.
- The CITI Program offers two online options that are free if you are affiliated with UW or collaborating with someone who is affiliated with UW.
- 4 – 6 hour online course tailored to drug and device trials
- 2-3 hour course tailored to behavioral trials (this is the same content offered by the Society of Behavioral Medicine)
- The National Institutes of Health offers two, free online courses at:
- Training obtained through workshops and conferences co-sponsored by the FDA or provided by industry partners and recognized by TransCelerate can also be used to meet requirements.
Collaborating Institution Requirements
UW researchers who work with collaborating institutions as part of a research study may be required to complete training in order to meet that institution’s requirements. Check with the collaborating organization to confirm their requirements. Common collaborators: