ICH E6(R3) Good Clinical Practice

The International Council for Harmonisation (ICH) released its revised Good Clinical Practice (GCP) guideline, ICH E6(R3), in January 2025. These updates reflect modern approaches to clinical research, including decentralized trials, electronic data collection, and risk-based monitoring. On September 8, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance for industry: “E6(R3) Good Clinical Practice.”

Training Integration

The Georgetown and MedStar Institutional Review Boards (IRBs) will incorporate these updates into existing GCP training workflows. No additional or early training will be required for staff at this time.

Training Requirements and Updates

• No Early Retraining Required: Researchers are not required to retake GCP training early solely due to the release of ICH E6(R3).
  
• Renewal Cycle: Investigators and clinical trial staff funded by the NIH must continue to renew GCP training every three years.
  
• Updated Content: All future GCP renewals completed via the CITI Program will include content reflecting ICH E6(R3).
  
• Optional Early Access: Staff who wish to review the updated material sooner may voluntarily re-enroll in the revised CITI modules at any time.

If a research sponsor requests immediate proof of updated GCP training, follow the CITI Program instructions to complete the revised modules.

Next Steps

• No immediate action is needed for staff who are current with their GCP training.
  
• The Georgetown and MedStar IRBs will continue to monitor sponsor and federal guidance related to ICH E6(R3).
  
• Additional resources and implementation guidance will be shared as available.

Resources

To learn more about the ICH E6(R3) updates:

• ACRP Comparison Table – Highlights key changes from ICH E6(R2) to E6(R3)
  
• ACRP Resources – Includes webinars, articles, and guidance documents
  
• CITI Program – Updated GCP training modules now reflect ICH E6(R3)
  

Key Message

The transition to ICH E6(R3) will occur naturally as researchers complete GCP training renewals. Georgetown and MedStar IRBs are committed to maintaining high standards for participant protection and data integrity while minimizing burden on research teams.

Questions?

For additional information, please refer to the full ICH E6(R3) guideline or contact:

• Georgetown University IRB: IRBoard@georgetown.edu
  
• MedStar Health Research Institute IRB: ORI.helpdesk@medstar.net