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 trained in Good Clinical Practice.
Who needs to complete GCP Training?
All key personnel listed on a research study that meets the NIH definition of a clinical trial.
For 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.
- For studies that meet the clinical trial definition and involve drugs, devices, biological agents, or radioisotopes, key personnel must complete CITI’s “Good Clinical Practice for Drug/Device Researchers” course regardless of funding.
- For all other studies meeting the definition, key personnel must complete either the CITI “GCP – Social and Behavioral Research Best Practices for Clinical Research” or the “Good Clinical Practice for Drug/Device Researchers” course if that study is NIH-funded.
- NOTE: If personnel might be engaged in clinical trials using drugs, devices, biological agents, or radioisotopes in the future, it is recommended they complete the “Good Clinical Practice for Drug/Device Researchers,” as it is the only GCP course that is accepted for clinical trials of that type.
What is an easy way to tell if this training requirement applies to my study?
Provided that your ARROW application is accurately completed, clicking “View Study Team Training” in the study’s ARROW workspace 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 clarification.
What if I have completed a GCP training course outside of CITI?
Only the CITI GCP courses listed above will be accepted for UW-Madison personnel.
What options are available for external personnel?
External personnel with NetIDs should complete the CITI training as described in the instructions below. External personnel without NetIDs can complete either of the options listed on the Training Options for External Personnel page.
How do I access these GCP training courses?
Both GCP training courses can be accessed via the UW CITI Portal following the instructions below.
GCP Completion Instructions
If this is your first time completing GCP training at UW-Madison, follow the steps below:
- Log in to CITI via the UW CITI Portal using your NetID and password. If you are accessing the UW CITI Portal for the first time, see “Completion Instructions for First Time Users” here before proceeding to the next steps.
- Click “View Courses” next to the “University of Wisconsin-Madison.”
- Click “Add a Course” at the bottom of the page.
- In Question 3, check the box next to the appropriate GCP course (see above) and click submit at the bottom of the page.
- Click on the appropriate GCP course you added in step 2 to start the training.
Training must be renewed every three years. You will receive an email reminder when it is time to renew your training.
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.