Lessons from the 2025 CDISC US + TMF Interchange
— By Kathleen Mellet, Business Analyst at Just in Time GCP and Project Manager for The CDISC TMF Standard Model
How the TMF Community Is Shaping the Next Era of Standardization
At this year’s CDISC US Interchange in Nashville, the Trial Master File (TMF) community came together to exchange ideas, compare lessons learned, and discuss where we’re headed next.
During the conference, between deep dives on ICH E6(R3), risk management, and data integrity, one topic clearly captured the energy of the week: the evolution of the CDISC TMF Reference Model into the TMF Standard Model (TMF SM).
Moreover, as someone who has supported CDISC TMF initiatives—including being the Project Manager for the TMF Reference Model Refresh Project—I left the conference with a renewed appreciation for how our industry continues to collaborate and evolve. This shift is about more than renaming the model. It redefines how we manage trial evidence in a digital world.
From Reference to Standard: A Shift in Mindset
The move from reference to standard represents a philosophical change as much as a technical one. The TMF Standard Model (TMF SM) shows our intent to move from “guidance” to “governance.”
As a result, by establishing common structures, metadata, and identifiers, the TMF SM promotes interoperability, clarity, and alignment across sponsors, CROs, and system providers. Additionally, it supports what ICH E6(R3) calls for—risk-proportionate TMF oversight and fit-for-purpose processes—while enabling the automation and data connectivity today’s digital trials require.
What’s Changing in the TMF Standard Model v1
At the Interchange, the project team outlined several meaningful updates that will shape the model’s next release:
- Updated terminology.
The familiar terms “Artifact” and “Sub-artifact” are being replaced with “Record Group” and “Record Type.” This aligns the TMF structure more closely with regulatory language. It also reinforces the principle that every record represents evidence of trial conduct. - Expanded content and regulatory alignment.
The expert team is reviewing each line of the Reference Model to ensure alignment with ICH E6(R3), EU CTR, and related guidance. The next version will include nearly 2,000 record types. That expansion reflects the scale and complexity of today’s decentralized, data-driven trials. - Enhanced metadata and interoperability.
Furthermore, the introduction of unique IDs at the record-type level and streamlined metadata fields will make record exchange and system integration far more efficient. These updates lay the groundwork for machine-readable TMFs and digital traceability.
In addition, these refinements build directly on the foundation established in the Reference Model and move us toward a truly standardized digital TMF ecosystem.
Why This Matters Now
The evolution toward a formal TMF standard is more than a technical milestone—it’s a cultural one. It reflects a broader commitment to treating clinical documentation as data—not just static files to be stored.
However, sponsors who start preparing now—by strengthening metadata practices, aligning TMF processes with ICH E6(R3), and improving reconciliation across repositories—will be ready when the TMF SM v1 standard becomes reality.
Getting Involved
The CDISC TMF Standard Model v1 Project Team will continue sharing updates through CDISC communications and webinars. If you’d like to contribute to shaping the model, here’s how to get involved:
- Step 1: Create a CDISC ID Account → https://www.cdisc.org/volunteer/tmf/form
- Step 2: Register as a TMF Volunteer → https://www.cdisc.org/volunteer/tmf/form?check_logged_in=1
Final Reflection
The conference reinforced what makes this community so powerful: collaboration. The TMF Standard Model isn’t just a technical evolution. It’s a shared commitment to stronger evidence, clearer communication, and better outcomes for patients.
Consequently, by aligning around common standards today, we’re building a TMF environment that’s connected, compliant, and ready for the future of clinical research.
