Good Clinical Practice (GCP) Training Frequently Asked Questions
Who needs to complete GCP Training?
All UW-Madison and UW Health personnel involved in identifying/recruiting subjects, obtaining informed consent, and/or interacting and intervening with subjects on a non-observational, intervention study involving a drug, device, biologic and/or radiologic that is approved by a UW-Madison IRB or an IRB that UW-Madison has ceded review to. Principal Investigators of such studies must also complete the training.
Why do we need to take GCP Training?
This training requirements is in response to a National Institutes of Health (NIH) mandate. The mandate also includes the requirement of GCP refresher training every three years.
How do I fulfill this GCP training requirement?
The required GCP training is hosted on the Collaborative Institutional Training Initiative (CITI) website, and is 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 here). GCP specific instructions are below.
Are there benefits to completing the GCP Training?
This training will help provide those engaged in the type of research described above the knowledge and skills needed to successfully conduct their research. Additionally, this course will also likely satisfy GCP training requirements for many industry sponsors and funding agencies, thus eliminating the need to complete multiple sponsor/agency-specific GCP training courses. CITI also offers (for a fee) continuing education credits for completion of the GCP course.
What if I have completed a GCP training course outside of CITI?
Unfortunately, only CITI's GCP training course will satisfy this requirement, so you would need to complete the CITI GCP training as well.
GCP Completion Instructions
Considering many individuals may have already completed CITI's GCP course, instructions for fulfilling this requirement vary depending when the course was completed. If you think you have completed CITI's GCP training in the past, you can verify this and make a note your completion date using the Research Certification Lookup.
Find the bolded heading below that describes your CITI GCP Course completion history:
I have never completed CITI's GCP course.
- Log in to CITI via the UW CITI Portal using your NetID and password.
- Click on the “Add Course or Update Your Learner Groups” 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.
I have completed CITI's GCP training in the past.
- If you took CITI's GCP training longer than three years ago, you can access the refresher course by logging in to CITI via the UW CITI Portal using your NetID and password and clicking on the "Good Clinical Practice" Course link.
- If you took the training within the previous 3 years, you will receive email reminders for when your GCP training is nearing expiration. The email will contain these instructions.
If you experience any difficulty, please contact the Office of Research Compliance at email@example.com or 608-262-1703. Support is provided Monday - Friday during normal business hours.