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Good Clinical Practice (GCP) Training Guidance and Instructions
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.
1 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 (this course is identical to the previous "Good Clinical Practice" course in CITI - it was renamed to distinguish it from the course below).
For all other studies meeting the definition (including those with social science or behavioral interventions), key personnel* must complete CITI's "GCP - Social and Behavioral Research Best Practices for Clinical Research" course if that study is NIH funded.
NOTE: If you work on multiple studies that meet both of the above criteria, you should complete the "Good Clinical Practice for Drug/Device Researchers" course. The "Good Clinical Practice for Drug/Device Researchers" course will be accepted for both types of research, but the "GCP - Social and Behavioral Research Best Practices for Clinical Research" course will not fulfill this requirement if you are conducting clinical trial research involving drugs, devices, biological agents or radioisotopes.
What is the best way to tell if this training requirement applies to my study?
Come May, if the initial sections of your IRB application are filled out in ARROW (or your study is already approved), 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.
Prior to May, you can direct any questions about whether or not the reqiurement applies to you or individuals in your research program to UW CITI Support.
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 are conducting clinical trials involving drugs, devices, biological agents or radioisotopes, only CITI's "Good Clinical Practice for Drug/Device Researchers" course will be accepted.
If you are required to complete CITI's "GCP - Social and Behavioral Research Best Practices for Clinical Research" and have completed a GCP training for Social and Behavioral Researchers via another online platform, please reach out to UW CITI Support for guidance.
GCP Completion Instructions
If you have never completed GCP training, follow the steps below:
- Log in to CITI via the UW CITI Portal using your NetID and password.
- Click on the “Add a Course” link under the "University of Wisconsin–Madison Courses" drop-down.
- Note to VA Users: You may need to click on the "University of Wisconsin–Madison Courses" blue bar in order to access the appropriate "Add Course" link.
- 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.
If you have completed GCP training in the past, you will receive an email reminder when your GCP training is expiring.
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.