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 ANNOUNCED: Donna Dorozinsky has been elected incoming Chair of the CDISC TMF Steering Committee. She’ll start her three-year term in January 2027.
The TMF Standard Model V1 Draft Is Here!
Submit Comments by November 20
As of Monday, October 19, the CDISC TMF Standard Model V1 draft is open for community review. Explore the draft and submit your comments by November 20,2026.
Table of Contents
TMF Standard Model V1 – Rethinking the Evidence of GCP Compliance
How the New TMF Standard Supports ICH E6(R3) Compliance, Sponsor Oversight, and Inspection Readiness
Virtual Education & Engagement
Tuesday, November 3, 2026 | 11 AM – 12:30 PM ET
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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. V1 brings pharmacologic, medical device, IVDR, real-world evidence, and Investigator Site File content together within one integrated Standard.
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 Document 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, decentralized, 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 more streamlined classification framework
Zones, Record Groups, and Record Types provide a streamlined framework for classifying clinical trial evidence. Record Groups represent enduring business activities.
A more consistent approach to identifying and classifying clinical trial evidence, supporting greater standardization across the industry.
Fewer, more standardized Record Types
By establishing a common language across different subsets of clinical research, V1 has consolidated the anticipated Record Types to around 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
Communications and Notes to File are classified according to the evidence they represent, rather than being assigned to generic categories.
Consider what each communication or Note to File demonstrates when determining its appropriate classification.
Meetings are explicitly recognized as evidence
V1 includes specific Record Types for study-specific meetings, each with its own designated filing location.
Study-specific meeting records can be classified according to the meeting they represent, providing greater clarity and consistency in how this evidence is managed.
eClinical systems are more explicitly represented
Zone 12 expands the model to address study-specific evidence associated with the lifecycle and oversight of eClinical systems used.
Greater clarity in identifying and managing study-specific eClinical system evidence relevant to demonstrating GCP compliance.
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 former Sections and can span multiple Zones.
- 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
V1 remains in development.
OCTOBER 19, 2026
Community release of draft for review. Feedback is due November 20, 2026, at 5:00 PM Pacific Standard Time, through the official CDISC community review page.
The TMF Standard Model V1 Draft Is Here!
Help Shape the Future of Clinical Trial Evidence
As of Monday, October 19, the CDISC TMF Standard Model V1 draft is open for community review. Explore the draft and submit your comments by November 20,2026.
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 clinical trial evidence currently resides across systems and repositories.
- Review classification and metadata practices, working toward greater consistency within and across studies.
- Evaluate whether existing processes support the creation, management, and oversight of evidence aligned with ICH E6(R3).
- Work with Quality, clinical operations, technology teams, CROs, and service providers to identify gaps in the processes that generate and maintain clinical trial evidence.
- Stay informed about V1 developments and participate in industry discussions as the Standard evolves
With V1 aligning clinical trial evidence to ICH E6(R3), organizations have a valuable blueprint for evaluating and strengthening the processes that generate that evidence.
TMF Standard Model V1 Resources
Just in Time GCP has been helping the clinical research industry understand the evolution of the TMF Reference Model into the highly anticipated TMF Standard Model V1. Through articles, expert insights, and updates from key industry meetings, we’re sharing the developments shaping the Standard and what they mean for the future of clinical trial evidence.
Section 1: Understanding the TMF Standard Model
Start here to explore the evolution from the TMF Reference Model to a formal CDISC Standard, why this change matters, and the opportunities it creates for clinical research.
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. Click Here to Read
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. Click Here to Read
Section 2: Following the Development of V1
Explore key milestones, decisions, and insights from industry meetings as TMF Standard Model V1 takes shape.
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. Click Here to Read
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. Click Here to Read
A closer look at key V1 developments shared at CDISC Europe, including the new structure, Record Groups, Zone 12 for eClinical Systems, terminology changes, and the continued evolution of the Standard. Click Here to Read
Check back often! We’ll continue adding new articles, insights, and practical guidance as TMF Standard Model V1 evolves.
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.
As clinical research and trial management evolve, there is value in periodically looking at the technology that supports it with a fresh perspective.
Not because the technology needs to change.
Because the way we use it can continue to mature.
That is the inspiration behind Veeva Clinical and Veeva Quality Cloud Revisited, a new series from Just in Time GCP exploring existing Veeva capabilities through the lens of today’s clinical research environment.
