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.

Users Requiring the TransCelerate Mutual Recognition Statement

For the CITI GCP Refresher training, all required and optional modules must be taken to generate the TransCelerate Mutual Recognition statement.

Work with the sponsor to complete the training they provide.

Sponsor-Investigators may make use of several free GCP training options for themselves and their staff.
Training Options:

  • 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. If you complete the CITI Good Clinical Practice course, you will automatically be enrolled in the refresher course 180 days before the training expires.
  • The National Institutes of Health offers free online courses at:
  • Training 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.

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.
Training Options:

  • 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)
  • If you complete either CITI Good Clinical Practice course, you will automatically be enrolled in the refresher course 180 days before the training expires.
  • The National Institutes of Health offers two, free online courses at:
  • Training 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: