Key Update on Guideline for Good Clinical Practice E6(R3)

January 6, 2025: ICH assembly agreed that ICH GCP E6 R3 Principles and Annex 1 could be adopted to advance the topics in R2, and is now moving to Step 5 of the ICH process, acceptance by health authorities.

This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. ICH GCP E6 R3 promotes a culture of quality in clinical trials and drug development.

Here is Halloran’s Summary of ICH GCP E6 R3 changes by theme (for Principles and Annex 1):

• Focus on Quality by Design and Risk Proportionality – emphasis on proactively identifying and managing risks critical to participant safety and data reliability.
• Defined Expanded parameters on Data Governance – new dedicated section addresses data integrity and traceability throughout the entire data life cycle (capture, review, transfer, retention).
• Allowance for Varied Trial Designs and Technological Advances - Recognizes the growing use of innovative designs (adaptive, platform, decentralized elements), encourages electronic informed consent, and remote monitoring.
• Clearer Definition of Roles and Responsibilities - Strengthened and more detailed descriptions of sponsor, investigator, and service provider obligations.
• Augmented Requirements for Ethical and Patient Protections - Reinforced obligations for IRBs/IECs, focusing on independence, protocol review, and continuing safety oversight.

What’s next for your organization?

1)           Update procedures and documentation

• Sponsor and Investigators will need to update their procedures and documentation to reflect the new guidelines.

2)           Train clinical trial staff

• Training for clinical trial staff on the revised guidelines will be crucial.

3)           Assess governance structures

• Organizations should assess whether their current governance structures are fit for purpose.

4)           Plan for ongoing monitoring and adaptation

• Organizations will need to continuously monitor and adapt their processes to ensure they remain effective.
• Ensure robust risk management principles

Want to learn more about our expertise, watch our webinar: Impacts of GCP E6 R3 on Regulatory, Clinical & Quality

https://event.on24.com/wcc/r/4697919/263982C68840735F691B0B810C118DBA

For more detail on ICH_E6(R3): https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf