08 Oct Update to CITI GCP training modules – transition to ICH E6(R3)

On October 15, 2025, the CITI Program will update the modules in UW–Madison’s Good Clinical Practice for Drug/Device Researchers and Refresher courses to reflect the ICH E6(R3) guidelines, which were adopted by the U.S. Food and Drug Administration on September 8, 2025.

Summary of key changes and what this means for you.

The ICH E6(R3) guideline introduces substantial updates to reflect the evolving landscape of clinical research. Compared to E6(R2), the new version emphasizes Quality by Design, risk-based trial management, and modernized data governance. It supports flexible trial designs, including decentralized and adaptive models, and integrates technological advancements such as electronic informed consent and remote monitoring.

Currently, UW–Madison is not requiring immediate retraining. Faculty and staff who have previously completed GCP training based on ICH E6(R2) may wait until their next scheduled refresher (every 3 years) to complete the updated E6(R3)-based training. Details about UW-Madison’s GCP training requirements can be found on the Good Clinical Practice (GCP) Training Guidance and Instructions page.

Sponsor requirements may vary.

Please note that individual research sponsors may require updated GCP training prior to your scheduled refresher. Faculty and staff are encouraged to check with sponsors to confirm specific expectations.

To meet sponsor requirements, individuals may complete the updated CITI training early by following the instructions on the UW’s CITI Training page. Those who complete the updated training before their renewal date must follow the above instructions to receive an updated completion date and have their GCP training extended for another 3 years.

Recommended for industry-sponsored and investigator-initiated research.

Faculty and staff routinely involved in industry-sponsored clinical research are strongly encouraged to complete the updated E6(R3) training sooner rather than later to ensure alignment with sponsor expectations moving forward.

Research teams developing clinical trials are also encouraged to review the ICH GCP E6(R3) updates and complete the updated training to take advantage of these changes.

Questions may be directed to Jake Rome, administrative director, FDA Regulated Research Oversight Program.