The International Council for Harmonisation (ICH) released the revised Good Clinical Practice guideline, ICH GCP E6(R3), in January 2025. The FDA subsequently adopted and issued guidance to industry in September 2025. These revisions modernize clinical research practices by incorporating decentralized trial models, electronic data capture, and risk-based oversight.
UNC’s Approach Vs. Industry Expectations
UNC has integrated these updates into our existing training process without requiring additional or early training for research personnel. However, there is an Industry-wide expectation that all research personnel need to complete updated GCP training aligned with ICH GCP E6(R3) to ensure compliance with these new standards.
New CITI Program Course
UNC is pleased to announce the availability of a new CITI Program course designed to provide the relevant ICH GCP E6(R3) updates and fulfill any industry-wide expectations for such training.
Course Title: ICH GCP E6(R3): An Introduction
The addition of this course provides an overview of the updated principles and key changes to ensure continued compliance with Good Clinical Practice, without having to complete the entire CITI GCP Refresher.
Who should take this course?
All UNC research personnel who have completed ICH GCP E6(R2) training and wish to stay current with the latest guidance.
Key Points:
- This course is not required by UNC
- You may take this course to satisfy requirements of the sponsor
- Taking this course will not reset your current ICH GCP expiration date
- This course is in addition to your other ICH GCP courses
- The ICH GCP E6(R3): An Introduction course has 5 modules specific to the revisions made to the guidelines.
Access this Course
Log in to your CITI Program account and select ICH GCP E6(R3): An Introduction from the available courses. Please also see attached guide on “How to Add a Course in CITI.”
Questions
For more detailed information, please refer to the full guideline document or contact the Clinical Research Compliance Office (CRCO).