The International Council for Harmonisation (ICH) released the revised Good Clinical Practice guideline ICH E6(R3) in January 2025. These revisions reflect current approaches to clinical research, including decentralized models, electronic data capture, and risk-based oversight.
UNC’s Approach
UNC will integrate these updates into our existing training process without requiring
additional or early training for staff.
- Training Requirements: Researchers are not required to retake GCP training early solely due to ICH E6(R3).
- Renewal Cycle: NIH-funded investigators and clinical trial staff must continue to complete GCP training every 3 years.
- Updated Content: Beginning with upcoming renewals, all GCP training completed through the CITI Program will reflect the ICH E6(R3) updates.
- Optional Early Access: Staff who wish to familiarize themselves with the new content may voluntarily re-enroll in the updated CITI modules at any time.
Next Steps
- No immediate action is required for staff who are current with their GCP training.
- The CRCO will continue monitoring sponsors and federal guidance related to E6(R3).
- Additional resources and instructions will be shared as implementation progresses.
Resources
For those who would like to explore the ICH E6(R3) updates now:
- ACRP Comparison Table – outlines the key changes between ICH E6(R2) and E6(R3).
- ACRP Resources – the Association of Clinical Research Professionals (ACRP) ICH E6(R3) have prepared webinars, guidance documents, articles, and other handouts to clarify the changes.
- CITI Program – updated GCP training modules reflecting E6(R3) are now available.
Key Message
The transition to ICH E6(R3) will occur naturally as researchers complete their scheduled
GCP renewals. UNC remains committed to ensuring participant protection and data
integrity while minimizing burden on study teams.
Questions
For more detailed information, please refer to the full guideline document or contact the Clinical Research Compliance Office (CRCO).