Overview of GCP updates

On October 15, 2025, the CITI Program will update the modules in UW–Madison’s “Good Clinical Practice for Drug/Device Researchers” basic and refresher courses to reflect the ICH E6(R3) guidelines, which were adopted by the FDA.

UW-Madison does not require that study personnel update their training until their existing training expires. Details about UW-Madison’s GCP training requirements can be found on the Good Clinical Practice (GCP) Training Guidance and Instructions page.

Individual research sponsors may require that study personnel update their GCP training prior to their existing training expiration. In order to get an updated course completion date (and extend the training expiration date an additional three years), study personnel should review and follow the below information.

To check whether the training you completed refers to ICH E6(R2) or ICH E6(R3), see CITI’s help page.

For questions about GCP training, contact citisupport@research.wisc.edu.

How to complete the updated GCP training

Learners should complete the following instructions in order to receive an updated course completion date (and extended expiration date). NOTE: these steps should not be taken prior to October 15, 2025, as the training will not be updated until that date:

1. Determine if you most recently completed the “Basic Course” or a “Refresher Stage”
   • Log into the UW CITI Portal (https://irb.research.wisc.edu/CITI).
   • Click “My Records” at the top of the page (see Screenshot 1 at the bottom of this page).
   • Scroll through your records until you find “Good Clinical Practice for Drug/Device Researchers” and determine whether you most recently completed the “Basic Course” or a “Refresher Stage” (see Screenshot 2 at the bottom of this page).
2. Based on what you determined in Step 1, follow the applicable instructions set
   • If you most recently completed the “Basic Course”, complete this brief form to request that the refresher course be added to your account. Requests may take several days to fully process. You will receive additional instructions once the request is processed.
   • If you most recently completed the “Refresher Stage”, you have two options. Option 1 will result in the Basic Course being added to your account immediately. Option 2 will result in the Refresher Course being added to your account, but this may take several days for CITI to process. The Basic and Refresher courses contain the same number of primary modules; one does not necessarily take longer than the other.
     • For option 1, click “My Courses” at the top of the page (see Screenshot 3 at the bottom of this page), then click “View Courses” next to University of Wisconsin-Madison.
       • Scroll to the bottom and click on “Remove a Course” under “Learner Tools for University of Wisconsin – Madison” (see Screenshot 4 at the bottom of this page).
       • Check the box next to “Good Clinical Practice for Drug/Device Researchers” and press “Submit”. If needed, click “View Courses” next to University of Wisconsin – Madison again.
       • Now click “Add a Course” under “Learner Tools for University of Wisconsin – Madison” to re-add the course by checking the box next to “Good Clinical Practice for Drug/Device Researchers” and pressing “Submit”. The “Good Clinical Practice for Drug/Device Researchers” course should now state “Stage 1 – Basic Course” and be ready to begin. If it does not, please contact citisupport@research.wisc.edu. Completing the newly added Basic Course will result in an updated completion certificate.
     • For option 2, complete this brief form to request that a new Refresher course be added to your account. Requests may take several days to fully process. You will receive additional instructions once the request is processed.

Screenshot 1: My Records

Screenshot 2: Determining which stage you most recently completed

Screenshot 3: My Courses

Screenshot 4: Learner Tools for “Add a Course” and “Remove a Course”