The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. GCP training aims to ensure that the rights, safety, and well-being of human subjects are protected, clinical trials are conducted in accordance with approved plans with rigor and integrity, and data derived from clinical trials are reliable.
In January of 2017, the NIH implemented a policy mandating that all NIH-funded clinical investigators and clinical trial staff be training in Good Clinical Practice.
Who needs to complete GCP Training?
All key personnel1 listed on a research study that meets the NIH definition of a clinical trial.
1For purposes of this training requirement, key personnel is defined as the principal investigator as well as individuals involved in identifying/recruiting subjects, obtaining informed consent, or interacting and intervening with subjects (those listed in questions 4.1, 4.2, and 4.3 of the "Study Team: Roles" section of the IRB application.
What is an easy way to tell if this training requirement applies to my study?
Provided that your ARROW application is accurately completed, completing a Human Subjects Training Snapshot will indicate whether or not GCP training is required. The snapshot will also tell you which GCP course should be taken for that given study as well as the personnel that have not yet completed that appropriate course. You can also email UW CITI Support for clarificaiton.
How do I access these GCP training courses?
Both GCP training courses can be accessed via the UW CITI Portal, and are accessed in the same manner as the CITI human participants training. If you have never taken CITI human participants training, you should complete that first (instructions are here). GCP specific instructions are below.
What if I have completed a GCP training course outside of CITI?
If you have never completed GCP training, follow the steps below:
If you have completed GCP training in the past, you will receive an email reminder when your GCP training is expiring.
For external personnel without NetIDs, please see the Training Options for External Personnel.
If you experience any difficulty accessing GCP Training or need assistance determining which GCP course you should take, please contact the Office of Research Compliance at UW CITI Support or 608-262-1703. Support is provided Monday - Friday during normal business hours.