The CDISC + TMF Europe Interchange, held recently in Geneva, brought together industry leaders, experts, and innovators to discuss the evolving landscape of clinical trials, with a specific Trial Master File (TMF) management track. This year marked 25 years since the Clinical Data Interchange Standards Consortium (CDISC) formed, with the event highlighting several themes and hot topics clearly shared across the industry as a whole.
At times the days of paper-filled boxes and physical binders seem like another lifetime, but the event showed there is still a long way to go in the world of TMF management. We continue to strive for the most organized, timely, and complete TMF, not just to maintain inspection readiness but to really see and experience the health benefits to people in our lives and the world around us.
The TMF Interchange, with more than 125 TMF professionals and 30 speakers over two days, provided an extensive amount of pragmatic information from a range of perspectives. There were great discussions around how to improve processes, new technologies and their impact on TMF professionals, and more. Following is a roundup of the hot topics from the event.
1 Collaboration is essential
Innovation in TMF management cannot happen in isolation. Many speakers emphasized the need for cross-functional collaboration between sponsors, CROs, vendors, and regulators. From updates to the CDISC TMF Reference Model and Risk Management Tool, to sharing best practices across the industry, we rely on volunteers, focus groups, and communication between us all to drive the changes needed.
The sense of a TMF “family” was strong, with colleagues old and new keen to hear updates, share their experiences and work together to move forward. As Paul Fenton Carter, Chair of the TMF Reference Model Steering Committee put it, “Our community is our strength.”
2 Breaking habits and embracing change.
One recurring message was the need to challenge current systems and ideas. Many organizations continue to operate within legacy frameworks, which can hinder progress. To move forward, we must be willing to let go of outdated habits and adopt a mindset open to continuous improvement and digital transformation. Much of how the TMF is collected and structured is reflective of the days of paper documents and physical binders. Even the term eTMF seems unsuitable at times, the “e” implying that it is outside of the norm.
When presenting on the upcoming ICH E6 (R3), Torsten Stemmler, Head of GCP Inspections at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, discussed the habit everyone has been guilty of at times: keeping too much “clutter” in the TMF. It is difficult to justify removing items once in the TMF, but owning the decision to re-assess what is actually essential – and documenting the decision to stop collecting non-essential records at a certain point – could be one of the smartest choices a team can make.
3 The transformation of artificial intelligence (AI)
One of the biggest changes in recent years has been the incredibly rapid evolution of AI, with the TMF world as no exception.
The Interchange highlighted real-world examples where AI is improving record classification, quality checks, and risk mitigation. Rather than resisting, professionals are now encouraged and keen to build trust in AI systems through transparency, validation, and education. During their presentation “AI Versus the Geek,” Cencora’s Jacki Petty and Rob Jones debated the strengths of both AI and TMF specialists. One trend was clear: AI is not being used to replace TMF experts as many have feared, but rather is helping to enhance their work and free up valuable time from rote work to focus on other critical initiatives.
4 Standards in TMF management.
As we have observed with the TMF, the need for standardization continues to be crucial in ensuring consistency, compliance, and efficiency. As clinical research becomes increasingly complex in nature, anywhere the TMF can be standardized helps sponsors, CROs and regulatory authorities maintain clear expectations for record organization and accessibility.
While there have been significant improvements in this regard – notably with the evolution of the CDISC TMF Reference Model – a number of attendees still highlighted the desire for more standardized structures when it comes to naming, dating and source material, i.e. metadata. It was evident from the discussions that there is no simple way to achieve this goal. There was general consensus, however, that the best way forward is to continue the broad collaboration model set by the original founders of the TMF Reference Model: work together as an industry to share ideas and push for clear conventions to finalize the best possible TMF standards.
5 The Patient is the most important stakeholder
Above all, the CDISC + TMF Europe Interchange underscored that every process, tool, and innovation must ultimately serve the patient. By maintaining a patient-first mindset, TMF professionals support clinical research that is ethical, efficient, and meaningful. Companies are rightly fixated on keeping their TMFs validated, organized, and timely in order to pass inspections and audits, but it is crucial to remember that the real reason for staying in scope of ICH E6 is to help patients. This is why we do what we do, and that feeling – the human impact behind every trial and every record – was evident across the event.
About the author:
Jenny Fisher is a Study Resourcing and Consulting Lead for Cencora, with 12 years’ experience in all areas of TMF management, working with customers across many projects. She is passionate about mentoring others and developing high-performing teams.
