Are you ready for the new update?
The most fundamental document for clinical research worldwide is getting closer to its second update in the last 20 years, and this time there are many changes. A key change is a reference to the ICH E8 (R1) general considerations for clinical studies to emphasize designing quality into a clinical trial, identifying factors that are critical to trial quality, and engaging stakeholders with a proportionate risk-based approach.
The ICH E6 (R3) GCP has been restructured as follows:
I. Introduction
II. Principles of ICH GCP
III. Annex 1 (IRB/ICH, Investigator, Sponsor, Data Governance)
Appendix A: Investigator Brochure
Appendix B: Clinical Trial Protocol
Appendix C: Essential Records
This blog will go over each part individually and cover the key changes.
Principles of ICH GCP:
- Use a quality management system that is "fit for purpose".
- Only record what is necessary.
- Clinical trials and their outcomes should be more visible!
- Delegation must be clearly structured in writing, and oversight must be maintained.
Annex 1:
IRB/IEC (previously ICH E6 (R2) section 3)
- Expansion of the IP information from just the investigator brochure.
- Address trials where prior consent is not possible, for example, for emergency research, and include the IRB/IEC review of assent materials for trial participants who are minors.
- Change to state that reasonable travel and lodging expenses being reimbursed to trial participants are not considered coercive.
- Inclosing a member of the reviewing IRB or IEC who is not involved in "medical sciences".
Investigator (previously ICH E6 (R2) section 4)
- Documentation of delegation is not required when trial activities align with routine clinical care.
- Expands the scope of medical care beyond physicians or dentists.
- Excludes the text regarding the reporting of SUSARs to the IRB.
- The frequency of progress reports was eliminated, leaving it to be determined according to local regulations.
- Requirement for explaining protocol deviations to only significant deviations.
- Regarding the informed consent of trial participants, there have been numerous changes made.
- There have been updates made to ensure that decentralized trials can be accommodated.
Sponsor (previously ICH E6 (R2) section 5)
- The sponsor responsibility for delegated activities has been expanded to include protection of the rights, well-being and safety of trial participants and there is a requirement on service providers to report to the sponsor any incident that could affect this and the reliability of the trial results.
- There is new text that sets out the requirements for documenting responsibilities if more than one sponsor is involved in the trial
Data Governance (new section)
- Introduces a new section in R3 that pertains to both sponsors and investigators.
- Critical data in the data life cycle should be implemented proportionately to the risks to this and to the safety of participants.
- Much-expanded section on the maintenance of the blinding of treatment allocation
- New and expanded text on data capture, data verification, metadata, data corrections, data transfers, and finalization of datasets prior to analysis.
Appendix A: Investigator Brochure (previously ICH E6 (R2) Section 7)
- Some minor restructuring at the start.
- While there is clarification that the sponsor is responsible for ensuring an appropriate IB is produced, the key change is the inclusion of text concerning the reference safety information.
Appendix B: Protocol (previously ICH E6 (R2) Section 6)
- Text has been added that encourages the use of stakeholders in protocol development where appropriate and to develop a concise and operationally feasible protocol.
- The protocol should include a description of identified quality factors and associated risks in the trial, monitoring processes, and handling of non-compliance.
Appendix C: Essential Records (previously ICH E6 (R2) Section 8)
- The guidance has moved from using the term "documents" to the more generic term "records".
- Some essential records are not trial-specific, and to avoid duplication of such records across TMFs, Addressed version control of records.