TMF Standard Model V1: Key Updates from CDISC Europe and What Clinical Teams Should Know
Clinical trials are becoming more digital, more system-dependent, and more complex. At the same time, clinical teams are managing growing volumes of trial evidence across sponsors, service providers, systems, and repositories.
That matters because the Trial Master File (TMF) is more than a filing structure.
It is the evidence of how a trial was conducted:the story of oversight, decisions, quality, accountability, and ultimately patient protection. As trials evolve, the way that evidence is organized, exchanged, inspected, and understood matters more than ever.
For many clinical teams, the TMF Reference Model has long provided the common structure and language used to organize TMF content across studies, organizations, and systems. Over time, however, increasingly digital, outsourced, and system-enabled trials have created new expectations for consistency, interoperability, and structured data exchange.
As a result, the model is evolving into the TMF Standard Model (V1), a shift intended to support greater consistency, digital readiness, and regulatory alignment while preserving the practical utility teams rely on today.
Why This Update Matters
At the CDISC Europe Interchange in May of 2026, Donna Dorozinsky, TMF Standard Model (V1) Project Lead, and Founder and CEO of Just in Time GCP, shared an update on the progress of TMF Standard Model (V1) and the decisions shaping its future.
Her message was clear: this is not change for the sake of change. V1 focuses on consistency, interoperability, digital readiness, regulatory alignment, and broader industry adoption. These changes solve real problems while avoiding unnecessary complexity.
Before diving into structure and timelines, Donna emphasized something important: this work is community-driven. Sponsors, CROs, technology providers, quality professionals, archivists, sites, and TMF experts are all involved and driving this forward. This collective effort shapes decisions intended to support not only today’s clinical trial environment, but also what comes next.
At the same time, regulators are signaling interest in more timely operational visibility into trial conduct. FDA’s recent Real-Time Clinical Trials (RTCT) pilot reflects a broader shift toward increasingly connected and operationally visible trials. In that environment, consistent and digitally structured trial evidence becomes even more important to how organizations explain decisions, demonstrate oversight, and maintain confidence in trial conduct.
The Work Is Moving Quickly
Progress on V1 is moving quickly.
During the update, Donna shared that the team completed zone reviews, incorporated revisions from ISF, device, and real-world evidence (RWE) models, and continues reviewing the model zone by zone to improve consistency and prepare the final draft of record types.
That level of progress reflects extensive review, collaboration, and practical decision-making across many contributors working to create greater consistency across the model.
Importantly, this is no longer a distant future conversation. According to the timeline shared at CDISC Europe, a draft list of record types and Record Groups is planned for the Vendors Group in June, and a draft version is currently targeted for community review in September 2026 of this year.
The team plans to release the draft version of The TMF Standard (V1) for community review in September 2026.
For clinical teams, that matters because key decisions are steadily moving toward broader industry visibility and input. Rather than covering every detail, these are three of the most important developments emerging in V1 and why they matter in day-to-day TMF operations.
1. eClinical Systems Are Becoming Part of the TMF Story
One of the biggest developments is the introduction of Zone 12: eClinical Systems. The team is considering artifacts such as validation plans, risk assessments, and executed test scripts, all evidence that increasingly supports how modern clinical trials are conducted.
For many clinical professionals, this reflects an operational reality that already exists: important evidence often lives across systems, vendors, and repositories. When questions arise months later, whether during oversight activities, issue investigations, or a clinical inspection, teams are often reconstructing not only what happened, but how systems supported what happened.
V1 brings greater visibility to those system-related artifacts within the broader TMF structure, helping the model better reflect increasingly digital trial environments.
For organizations already investing in stronger visibility across systems and repositories — including through Clinical Study Data Flow Maps — this shift toward clearer structure and interoperability will likely feel familiar.
2. A Simpler Structure for Organizing Evidence
Another important shift is the move toward a three-level structure:
- Zones
- Record Groups
- Record Types
As part of this change, Sections and Artifacts are being combined into Record Groups. Donna described Record Groups as a way of organizing like records more meaningfully, while still retaining the option of a tree view. Additionally, she notes that Record Groups may exist across zones and are being driven by ICH E6(R3), while keeping industry terminology in mind.
For clinical teams managing complex studies, evidence rarely fits neatly into one operational lens. Monitoring activities, agreements, study plans, qualifications, resources, and quality activities often intersect across functions and partners.
The intent is not added complexity. It is clearer organization.
3. Greater Consistency Across the Standard
Several additional decisions point toward a broader goal: consistency.
Among the developments discussed:
- Elimination of Core vs Recommended
- Movement from Vendor to Service Provider across the model
- Integration of ISF, device, and RWE-related revisions into the broader structure of the Standard Model
These may sound like small terminology or structural decisions, but anyone responsible for TMF oversight understands how ambiguity compounds quickly across studies, partners, systems, and expectations.
Consistency matters because teams must understand, exchange, and explain trial evidence — not just file it.
What Happens Next
The timeline shared at CDISC Europe reflects the pace of progress underway:
- May 2026: Final draft list of record types
- June 2026: Vendors receive draft record types and Record Groups
- September 2026: Draft version released for community review
- January 2027: Final draft to Controlled Terminology team
- April 2027: V1 Standard released to industry
Why This Matters
Donna closed with an important reminder: standards do not limit progress. They make progress scalable.
The TMF has always been more than a filing structure. It is evidence of oversight, quality, decisions, accountability, and patient protection. As trials are becoming more digital, distributed, and system-enabled, the way that evidence is described and organized must evolve alongside them.
Perhaps most importantly, V1 is being shaped through broad community engagement. The model is not being developed in isolation. It is being refined through practical discussion, difficult decisions, and the ongoing work of contributors across the industry who are collectively trying to build something usable, durable, and fit for the future of clinical research.
The opportunity of V1 is not simply a new model.
It is greater consistency so evidence can be understood. Greater interoperability so information can move. Greater digital readiness to support the future of clinical trials, while remaining grounded in practical realities and shaped by the community it serves.
Standards do not limit progress. They make progress scalable.
