TMF Standard Model V1
Updates, Resources, & Practical Guidance for the Clinical Research Industry
TMF Standard Model V1 represents more than an update to the TMF Reference Model. It is a shift in how the industry defines, organizes, exchanges, and understands the evidence of how a clinical trial was conducted.
Just in Time GCP is helping shape that evolution. Founder & CEO Donna Dorozinsky serves as Project Leader for the CDISC TMF Standard Model V1, helping lead the transition from an industry reference model to a Standard designed for ICH E6(R3) and the digital future.
Table of Contents
What Is the TMF Standard Model V1?
For years, the TMF Reference Model has provided the clinical research industry with a common framework for organizing Trial Master File content across sponsors, CROs, sites, systems, and technology providers.
TMF Standard Model V1 takes that concept further.
V1 is being developed as a shared industry Standard for clinical trial evidence, with greater consistency, interoperability, regulatory alignment, and digital readiness built into its foundation.
Rather than simply asking where a record should be filed, V1 starts with a more fundamental question:
What evidence does this record represent?
That shift changes how we think about the TMF. During the development of V1, what began as an effort to modernize the TMF Reference Model evolved from an exercise in records management to an exercise in evidence control.
From Records Management to Evidence Control
- Record Type tells us what the evidence is.
- Metadata tells us more about what that evidence is about.
- The study determines which evidence is applicable.
V1 is designed to standardize the evidence without dictating how every organization performs its processes.
Why TMF Standard Model V1 Matters
GCP is not simply about accumulating records. Clinical trial organizations must be able to demonstrate how a trial was designed, conducted, overseen, and controlled, including evidence supporting participant protection and the reliability of trial results.
As trials become more digital, distributed, and system-dependent, that evidence increasingly exists across systems, organizations, functions, and technologies.
V1 is intended to provide a common language for that evidence.
What's Changing in TMF Standard Model V1?
V1 is not simply a renamed Reference Model. Its development has required the industry to reconsider how clinical trial evidence is defined and organized.
What's Changing
What V1 introduces
What this means for you
A simpler model structure
Three levels: Zones → Record Groups → Record Types. Record Groups represent enduring business activities rather than acting simply as filing containers.
Expect familiar TMF structures and mappings to look different. Focus on the purpose of the evidence rather than recreating your existing folder structure.
Fewer, more standardized Record Types
The work began with approximately 2,000 Record Types and has been consolidated to fewer than 600.
Don’t assume every artifact in your current TMF index will have a one-to-one V1 equivalent. Several existing artifacts may map to a single Record Type.
Greater use of metadata
Record Types identify what the evidence is; metadata provides additional context about what the evidence is about.
Some distinctions currently handled through separate artifacts or filing locations may instead be represented through metadata.
Evidence over format
A log, report, form, listing, system output, or dataset does not automatically require a different Record Type. Classification starts with what the evidence demonstrates.
When mapping your current TMF to V1, look beyond record names and formats to understand the underlying evidence.
Applicability is study-specific
V1 defines an evidence universe. Inclusion of a Record Type in the Standard does not mean that record is required for every study.
Avoid treating V1 as a checklist. Study design, activities, responsibilities, systems, and risks determine which evidence is applicable.
Communications and Notes to File are treated differently
Records are classified according to the evidence they represent rather than being placed in generic catch-all categories.
Teams may need to rethink familiar filing conventions and focus on the activity, decision, or oversight the record evidences.
Meetings are explicitly recognized as evidence
V1 includes specific Record Types for meetings where the meeting itself represents important trial evidence.
Consider what the meeting demonstrates, not simply where meeting minutes have historically been filed.
eClinical systems are more explicitly represented
Zone 12 expands the model to address records associated with the lifecycle and oversight of eClinical systems used in clinical research.
TMF thinking increasingly needs to extend beyond records stored in the eTMF to evidence generated or maintained across the clinical technology environment.
Direct connection to ICH E6(R3)
Every V1 Record Type has been mapped to ICH E6(R3).
Teams can more clearly connect the evidence represented in the TMF Standard Model with modern GCP requirements.
Some familiar concepts are changing, too.
- Record Groups replace the old Section/Artifact structure.
- Core vs. Recommended goes away.
- Vendor becomes Service Provider.
- Communications are classified according to the evidence they represent.
- Notes to File aren’t a catch-all.
- Meetings are explicitly recognized as evidence.
- Every Record Type is mapped to ICH E6(R3).
Where Does TMF Standard Model V1 Stand Today?
CURRENT STATUS | OCTOBER 2026
V1 remains in development. The integrated Standard has been submitted to the Steering Committee for review, with the next phase focused on broader community review and finalization.
OCTOBER 19, 2026
Community release for review
Q1 2027
Planned final public review
APRIL 2027
Planned V1 release
V1 is still evolving.
Some elements, including provisional metadata, are not yet final. Just in Time GCP will continue updating this page as the Standard moves through community review and toward final release.
What Should Trial Sponsors Be Doing Now?
Prepare now, with a measured approach.
Organizations do not need to rebuild their TMF overnight. But V1 represents more than a filing-structure change, and understanding its potential impact should not wait until final release.
Actions you can take now:
- Identify where trial evidence is maintained across repositories.
- Review current classification and metadata practices.
- Discuss potential changes with Quality, technology teams, CROs, and service providers.
- Follow draft releases and contribute feedback before finalizing migration plans.
The objective today is not premature implementation. It is informed preparation.
TMF Standard Model V1 Resources
A foundational introduction to the TMF model, how it has helped create a common framework for organizing clinical trial records, and why standardization matters across the clinical research industry.
Explore the evolution from the TMF Reference Model to a formal CDISC Standard and what the transition could mean for interoperability, standardized metadata, digital traceability, automation, and the future of TMF management.
Follow the Evolution of TMF Standard Model V1
V1 has continued to evolve through extensive industry collaboration. Follow key milestones, decisions, and developments as the TMF Reference Model moves toward the first version of the TMF Standard Model.
An early look at the work underway to transform the TMF Reference Model into a formal CDISC Standard, including the goals driving the initiative, emerging structural changes, and the industry’s vision for a more standardized and digitally enabled TMF.
What does the move from a Reference Model to a Standard actually mean? Explore the shift toward greater consistency, interoperability, and digital readiness and some of the practical considerations for organizations preparing for what’s ahead.
A closer look at key V1 developments shared at CDISC Europe, including the new three-level structure, Record Groups, Zone 12 for eClinical Systems, terminology changes, and the continued evolution of the Standard.
Stay Informed
TMF Standard Model V1 is changing. Make sure you're keeping up.
With significant developments ahead, understanding what’s changing and what it means for your organization will be increasingly important.
As the Standard evolves, we’ll share insights from the development process, practical guidance for preparing your organization, and opportunities to learn directly from the experts helping shape V1.
Join our mailing list so you don’t miss important updates, new resources, and upcoming webinars.
Ask A Question
Have a question about TMF Standard Model V1?
As the Standard evolves, we know questions are emerging across the clinical research industry. Whether you’re wondering about Record Types, metadata, ICH E6(R3) alignment, implementation, or what these changes mean for your organization, we want to hear from you.
Submit your question to the Just in Time GCP team. Your questions will also help shape future FAQs, articles, webinars, and educational resources so we can address the topics that matter most to the clinical research community.