Shaping the Future of Clinical Operations: Key Takeaways from the CDISC and TMF US Interchange Conference

For clinical operations leaders, navigating rapid advancements in clinical data and document management is essential for ensuring efficient trial oversight and regulatory compliance. At the recent CDISC and TMF US Interchange Conference, leaders from across the industry gathered to explore innovations in digital protocols, risk-based TMF management, and the evolving TMF Reference Model. Here are five key takeaways from the sessions, featuring insights directly from industry professionals and FDA guidance.

1. Digital Protocols and M11: Toward a Standardized Approach

The M11 digital protocol, a focal point at the conference, is poised to transform how clinical teams access and utilize protocol data. This upcoming standard aims to harmonize protocol formats and enhance real-time data utilization. Ben Rogers from LMK Clinical Research highlighted M11’s potential to "transform protocol access and improve real-time decision-making." For clinical operations leaders, this translates into streamlined processes and reduced friction when coordinating across teams and vendors. Now is the time to start assessing your organization’s readiness for this protocol shift, as the digital standard is expected to influence trial management over the next few years.

2. Preparing for The TMF Reference Model Version 4: Enhancing Interoperability and Compliance 

A critical update at the conference was the upcoming launch of TMF Reference Model Version 4, designed with digital efficiencies and interoperability at its core. Gillian Gittens, a Steering Committee member, shared that V4 will align with industry digital standards to enable seamless data exchange across clinical trial systems. The new model promises to simplify regulatory reporting and enhance compliance across global studies. The takeaway was to start thinking about submitting change requests and improvement suggestions, as community feedback will be a crucial part of its evolution. Everyone has a role to play in the launch of TMF Ref Model V4.

3. Embracing Risk-Based TMF Management 

A risk-based approach to TMF management can significantly improve oversight while minimizing time and resource allocation. At the conference, risk-based TMF strategies were recognized as essential for scaling trial operations without compromising quality. Ben Rogers emphasized the importance of a defensible approach: “Your risk model should be able to withstand regulatory scrutiny and align with historical performance data.” This means that while risk-based methods can reduce review efforts, clinical operations leaders need to ensure that the chosen approach is risk proportionate, adaptable and defendable in audits. With increased expectations for sponsors to oversee TMFs—particularly when outsourced—prioritizing a robust risk-based strategy will help protect the organization’s compliance and regulatory standing. We also heard from Jessica Jackson Head of Clinical Operations at Galderma on this topic "You have to look at the critical docs that impact the safety and data integrity of the clinical trial and help tell the full story of the trial, so that an inspector can come in and immediately visualize how the study started, this is how the study progressed, and this is how it was completed. It's critical to take a risk-based approach. When you bring in that risk-based approach you are bringing in efficiencies."

4. FDA's Stance on TMF inspection Readiness

A key session featured insights from an FDA inspector, who shared best practices for preparing for TMF inspections including sites. The FDA expects sponsors to manage TMF data proactively and conduct regular quality checks. The inspector’s advice was straightforward: “Do not put things in the TMF you don’t want us to see.” The FDA reminded attendees that sponsors have to give Investigators access to eTMF systems and expects companies to manage TMFs in real-time, reflecting ongoing study progress. FDA Inspectors can tell from day 1 if a TMF has been part of the study design or an afterthought. They encouraged attendees to make TMF a priority as this can lead to a more successful inspection.

5. Implementing TMF Storyboards for Continuity

Maintaining continuity within the TMF is essential, as trials span multiple years and staff turnover occurs. TransPerfect’s storyboard approach offers an innovative solution, providing a detailed narrative of decision-making within the TMF. This tool allows teams to document the reasons behind specific actions, ensuring consistency across trial phases and simplifying responses during inspections. For executives, TMF storyboards deliver a high-level summary that supports seamless team transitions, bolsters regulatory confidence, and reduces the risk of compliance issues during inspections.. This was further confirmed by Jessica Jackson at Galderma “We utilize the TMF Study Owner (TMFSO) support from TransPerfect TI team. We started small with one or two studies, and we are now implementing them in 100% of our clinical trials. The TMFSO support and the Storyboards themselves help mapping of literally every clinical document and plan, such as the Data Management plan, Safety Plan, Medical Monitoring plan, regulatory documents, monitoring reports, etc.. Prior to the Storyboard and TMFSO support, we struggled to obtain a listing of critical documents, so putting the Storyboard in place was essential. It's a Master document list and we have a TransPerfect TMF Study Owner that goes into our TMF and does the work for us. We find it incredibly efficient for us to then present the Storyboard to the CRO, outlining missing documents to be file. Accountability and responsibility stays with the Sponsor, it’s our TMF - we need to own it so it’s important to have the transparency and oversight.”

The CDISC and TMF US Interchange Conference demonstrated that the future of clinical data management lies in digital standardization and proactive risk based quality control. From the digital protocol to TMF Reference Model V4, these advancements will not only improve operational efficiency but also elevate industry-wide data integrity standards. For sponsors, CROs, and TMF professionals, these insights underscore the importance of adopting flexible, digitally aligned strategies that meet evolving regulatory expectations.

Stay tuned as these initiatives roll out, and consider how your organization can engage with upcoming standards to remain at the forefront of clinical research compliance and efficiency.