The International Council for Harmonisation (ICH) announced on Tuesday the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical studies.
The guideline received endorsement from the ICH Assembly, reaching Step 4 of the ICH process and indicating it is ready for adoption by regulatory authorities. The document was initially released as Step 2 and made available for public consultation on 19 May 2023. (RELATED: E6(R3): ICH releases draft of revamped GCP guideline for consultation, Regulatory Focus 25 May 2023)
Overall, the guideline covers some key principles of for conducting clinical trials, as well as the responsibilities and composition for institutional review boards and independent ethics committees (IRB/IEC).
The guideline includes some minor revisions from the draft version, including the addition of new language on data governance in Section 4. These include a new section 4.2.7 on retention and access to trial data and a new section 4.2.8 on destruction of trial data.
New subsections have been added to the section on computer systems, including section 4.3.3 on security, 4.3.4 on validation, 4.3.5 on release of trial-specific systems, 4.3.6 addressing computer system failures, 4.3.7 on technical support, and 4.3.8 on user management.
The guideline covers investigator qualifications and training, which address responsibilities, communication with IRBs/IECs, compliance with protocols, premature termination or suspension of trials, informed consent of trial participation, and procedures for randomizing patients.
For sponsors, the guideline addresses the design of clinical trials, selecting investigators, and communicating with IRBs, IECs, and regulators.
The guideline also touches on how investigators and sponsors can manage their data and includes the procedures that should be in place to manage data capture, reviewing the content of metadata, and data transfer and data exchange.
The guideline also has three appendices:
- Appendix A covers the content of the Investigators’ brochure such as data capture, relevant metadata, review of data and metadata, data corrections, and data transfer. It also covers procedures for the use of computerized systems, training systems, and validation.
- Appendix B contains the clinical trial protocol and protocol amendments, which cover trial designs, screening participants, assessing safety and efficiency, and handling data.
- Appendix C covers the essential records for conducting clinical trials.
The appendices are “intended to provide information on how the principles can be appropriately applied to clinical trials.”
