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TMF Expert Insights
Tuesday, October 21, 2025 | 11:23 AM
Catch up on OpTImize London and see the conversation that set the tone for where TMF practice is heading. Watch the full recording to hear Laurel Ann Schrader, Gill Gittens, and Daliah Wojtkowski explain how ICH E6 (R3) is reshaping oversight, digital records, and inspection readiness. [Watch the recording]
The room in London gathered around a simple idea. The Trial Master File should show how quality is managed in an ongoing manner, not only when an inspection is looming. Laurel Ann, Gill, and Daliah moved past slides and shared what teams are doing now to stay ready, collaborate across functions, and document evidence of oversight in the TMF.
The first point landed quickly. Oversight remains with the sponsor. Delegation never replaces accountability.The TMF must show that decisions were made with intention, that service providers were guided by clear controls, and that evidence of review exists. Under ICH E6 (R3) this is no longer a preference. It is the operating reality.
Risk proportionality shaped much of the discussion. Reviewing everything the same way does not protect quality. Teams need to look at where risk actually lives and put their attention there. This shift can feel uncomfortable for organizations used to total verification, yet it delivers stronger outcomes and a clearer story in the TMF. The evidence tells what mattered, who acted, and why it worked.
The panel then turned to digital systems and the CDISC TMF Reference Model. The next stage of the model will lean further into digital integration and align with the principles of data integrity and governance in E6 (R3). That means validation records, user acceptance testing outcomes, and audit trails need to be visible within the TMF. The TMF becomes a living record of how systems support the trial rather than a static store of documents.
Artificial intelligence entered the conversation with healthy curiosity. Automation can remove routine friction and speed maintenance work, but it cannot rescue a weak process. People, process, and technology need to move together. AI scales what already works and human oversight keeps quality intact.
A theme that resonated with everyone was inspection steadiness. Readiness is not a sprint. It is a steady habit. Inspections offer a snapshot, and that snapshot should look consistent at any point in the study. The only way to achieve that is to bring Clinical, QA, Data Management, Biostats, and vendors This level of consistency is only possible when TMF management becomes more than a task—it becomes a shared culture, into one rhythm where evidence flows into the TMF as work happens.
The atmosphere at OpTImize London supported that mindset. The format encouraged open questions and honest lessons learned. Attendees asked about oversight practices, risk documentation, and what E6 (R3) looks like in daily work. The conversation felt accessible and practical. Many left with clarity on how to make their TMF a stronger, more transparent reflection of operations.
The core takeaway is straightforward. E6 (R3) is not just a guidance update. It is a shift in how the industry proves compliance. The TMF becomes active evidence of accountability, data integrity, and collaboration. Teams that embrace this approach will be prepared for the next inspection and ready for the next generation of clinical operations.
If you missed the event, you can still experience the discussion and share it with your team. Watch the OpTImize London recording and use it as a springboard for your next internal conversation on oversight, risk, and digital readiness. [Watch the recording]
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