Question Time: ICH E6(R3) The Final Countdown / 3rd Feb 2025
Research Quality Association (RQA)
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This is an AI generated summary from the transcript of the above Question Time session.
The latest RQA Question Time session gathered a global audience to discuss challenges and best practices for implementing ICH E6 (R3) Step 5 guidelines. With live interaction and input from attendees, the session covered topics such as document transitions from R2 to R3, gap analysis strategies, and the role of Quality Management Systems (QMS) in ensuring a smooth transition. Participants also discussed support resources that RQA could provide to assist its members.
The session began with questions about how to manage the transition of SOPs, protocols, and manuals during the interim period. The consensus was that organisations can proceed under either R2 or R3, provided the chosen approach is justified and documented. Attendees agreed that regulators value seeing evidence of careful planning during inspections.
Gap analysis was a major focus, as participants acknowledged the complexity of transitioning from R2 to R3 due to the substantial differences between the guidelines. Various approaches were discussed, including comparing R3 clauses directly against SOPs and dividing responsibilities among process owners. One participant commented that “a divide-and-conquer approach can help manage gaps effectively.”
On the topic of support from RQA, the discussion explored possible resources such as e-learning courses, documentation templates, and regular Q&A forums. The office stated that while no formal templates are currently available, future sessions will focus on sharing knowledge and practical guidance, with further discussions planned at upcoming conferences, including the virtual European QA Conference event in May featuring representatives from the EMA.
From a QA perspective, participants highlighted key updates in areas like risk-based quality management, data governance, and metadata requirements. A significant takeaway was the shift towards more proportional quality activities, reducing the need for blanket approaches to training and monitoring. Attendees stressed the importance of risk management to comply with R3.
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Regional implementation challenges were also discussed, particularly the UK’s July 2023 deadline and upcoming clinical trial regulations for January 2026. In the US, progress has been slower due to a current communication blackout affecting the FDA and an upcoming event planned with Health Canada. However, attendees remained optimistic, emphasising collaboration, knowledge sharing, and leveraging community resources to stay ahead of the changes.
Questions Asked During the Session
- Should we release documents under R2 or R3 during the transition period?
- How are organisations preparing for gap analysis between R2 and R3?
- Will RQA provide any formal documentation or templates for R3 implementation?
- What are the key differences between R2 and R3 from a QA perspective?
- Has the FDA endorsed R3 yet?
- What is the UK’s implementation timeline for R3, and how does it align with clinical trial regulations?
- How should we handle documentation of non-trial-specific IT systems used in trials?
- What guidance documents have participants found useful so far for R3?
- How many organisations have started incorporating R3 into their QMS?
- What approach will be taken to share study results with participants?
Regular Sessions
The RQA office will provide these session over the next six months for members of the association, via the Community Hub.
Board Member of The Institute of Clinical Research | Clinical Research Operations and GCP Training Consultant
9moGreat summary Shaun, the questions being asked are spot on. Thank you for sharing.