In January 2025, the International Council for Harmonisation (ICH) announced the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical studies [1, 2].
The ICH E6(R3), or ‘Good Clinical Practice’ Guideline, now provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. The guideline builds on key concepts outlined in ICH E8(R1) - General Considerations for Clinical Studies [3].
The Guideline comprises of Principles and Annexes that expand on the principles. The ICH outline that the principles laid out in the guideline may be satisfied using different approaches and, in each case, should be applied to fit the clinical trial’s intended purpose.
The guideline has been endorsed by the ICH Assembly. Having now reached Step 4 of the ICH process, this indicates it is ready for adoption by regulatory authorities. The document was initially released as Step 2, a draft, which was available for public consultation on 19 May 2023 [3].
Not only does the guideline cover key principles for conducting clinical trials, but it also outlines the responsibilities and composition for institutional review boards and independent ethics committees (IRB/IEC).
The guideline includes some minor revisions from the draft version, such as the addition of new language on data governance. Additionally, there is now also a section on retention and access to trial data and a new section on destruction of trial data. New subsections have also been added to the section on computer systems, specifically on security, validation, release of trial-specific systems, addressing computer system failures, technical support, and user management.
The guideline outlines investigator qualifications and training, covering responsibilities, communication with IRBs/IECs, protocol compliance, trial suspension or termination, informed consent, and patient randomization procedures.
For sponsors, it addresses clinical trial design, investigator selection, and communication with IRBs, IECs, and regulators.
Additionally, the guideline provides guidance on data management for both investigators and sponsors, detailing procedures for data capture, metadata review, data transfer, and data exchange.
It also includes three appendices:
- Appendix A: Covers the content of the Investigator’s Brochure, including data capture, metadata review, data corrections, data transfer, and procedures for computerized systems, training, and validation.
- Appendix B: Details the clinical trial protocol and amendments, addressing trial design, participant screening, safety and efficacy assessment, and data handling.
- Appendix C: Outlines essential records required for conducting clinical trials.
These appendices aim to provide guidance on appropriately applying the principles to clinical trials. In the future, additional annexes may be developed to respond to different parties' needs and address emerging innovations in trial design and conduct.
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References
1. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf
2. https://www.ich.org/page/efficacy-guidelines#6-2
3. https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf
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