We are excited to announce that the CDISC TMF Standard Model V1 Draft is now available for community review!
After nearly three years of collaboration, discussion, and countless decisions, we have reached an important milestone in the evolution of the Trial Master File. What began as an effort to modernize the TMF Reference Model has evolved into something much more significant: the development of an industry Standard designed to support ICH E6(R3), increasingly complex clinical trials, and the digital future of clinical research.
This is not simply a revision of TMF Reference Model 3.3.1. It represents a fundamental shift in how we define, organize, and manage clinical trial evidence.
Throughout this journey, one principle has guided our work: the TMF is not simply a collection of records. It is the evidence that allows us to demonstrate how a clinical trial was conducted, how decisions were made, how risks were managed, and how oversight and compliance were maintained.
Our goal has been to develop a single, globally applicable Standard that provides a common language for clinical trial evidence while remaining flexible enough to accommodate different study designs, organizational structures, technologies, and operating models.
Now we need your input to help shape the final Standard.
Understanding the V1 Draft
Before beginning your review, we encourage you to become familiar with several important decisions that shaped the development of V1.
1. Evidence, not artifacts, drives the structure.
The Standard is organized around Zones, Record Groups, and Record Types. Record Groups represent enduring business activities, while Record Types identify the distinct evidence generated through those activities. We have intentionally consolidated records where the underlying evidence serves the same purpose, using metadata to distinguish differences in context rather than creating separate Record Types for every variation. The Purpose/Description column is particularly important. It explains why the record exists and what evidence it represents. We encourage reviewers to read these descriptions carefully before concluding that a particular record is missing.
2. Communications are classified at the Record Type level.
We have eliminated the concept of a general correspondence filing location. Communications are essential evidence, but their significance comes from the activity, decision, or oversight they demonstrate, not simply from the fact that a communication occurred. For example, a communication concerning a specific protocol deviation would be classified under the Protocol Deviation Record Type rather than in a general correspondence category. Additional definitions and guidance on how to classify and apply metadata to Communications will be provided in a future Provisional Metadata update.
3. Notes to File follow the same principle.
Rather than maintaining a generic Note to File Record Type, these records should be classified according to the evidence they provide. This ensures that Notes to File remain connected to the activities and decisions they support, making the evidence easier to understand, evaluate, and retrieve. Additional definitions and guidance on how to classify and apply metadata to Notes to File will be provided in a future Provisional Metadata update.
4. Core and Recommended classifications have been eliminated.
V1 defines the universe of potential clinical trial evidence. It does not prescribe which records are required for every study. The applicability of a Record Type depends on the study design, activities performed, regulatory requirements, responsibilities, and risks. This approach is better aligned with the principles of ICH E6(R3) and supports a more risk-proportionate approach to TMF management and oversight.
5. The Standard accommodates different types of clinical research.
V1 integrates evidence associated with drug and biologic trials, medical devices, IVDR, real-world evidence (RWE), and the Investigator Site File (ISF). Where the underlying evidence is the same, Record Types may be shared across these different study contexts. Metadata and other attributes help distinguish the context in which the evidence is generated.
6. Zone 12 – eClinical has been introduced for study-specific clinical system records.
As clinical trials become increasingly digital, essential evidence may be generated and maintained within systems beyond the traditional eTMF. Zone 12 was created to accommodate study-specific records associated with the implementation, configuration, testing, operation, and oversight of clinical systems. It is not intended to serve as a general repository for all records generated by electronic clinical systems, nor does it replace existing Record Types in other Zones. As with the rest of V1, classification is driven by the purpose of the evidence, not simply by the system in which it was created or maintained.
Navigating the Draft Workbook
The V1 Draft is provided as an Excel workbook containing several worksheets. Each serves a different purpose, and we encourage you to use them together as you review the Standard.
V1 Draft: The primary worksheet containing the proposed Zones, Record Groups, Record Types, Purpose/Descriptions, levels, dating conventions, ICH E6(R3) mapping, and other attributes. This should be the primary focus of your review.
Attributes: Provides definitions of the columns included in the V1 Draft worksheet used to describe and classify Record Types. These definitions are intended to support consistent understanding and interpretation of record type attributes across the model. We encourage you to reference this worksheet when you have questions about what an attribute means or how it should be interpreted.
Metadata: Provides additional context for how records may be described and distinguished without creating separate Record Types for every variation. In this draft standard metadata is defined and provisional metadata will be defined fully in a future draft. The Potential Provisional Metadata column in the main sheet is intended to illustrate where provisional metadata may be applicable in the future and provide context for certain record type decisions. This column is illustrative and not exhaustive. A future draft of the model will include a comprehensive list of proposed provisional metadata.
Additional Reference Worksheets: Provide supporting information, including dating conventions and acronyms, to assist you in interpreting the draft.
Our primary objective during this community review is to validate the structure, content, and meaning of the proposed Record Types.
You will also notice that the Record Groups are not presented alphabetically. Within each Zone, we have attempted to organize them in a logical sequence reflecting the progression of activities during study conduct. This is intended to make the Standard easier to navigate and does not prescribe a required sequence of activities.
Introducing the TMF Standard Model Navigator
To support this review, we are also pleased to provide the TMF Standard Model Navigator, an interactive tool developed to help individuals and organizations explore the V1 Draft in multiple dimensions.
The Navigator allows you to examine the Standard by Zone, Record Group, Record Type, level, study subset, and dating convention. It also provides access to the Purpose/Descriptions and related attributes, making it easier to understand how the different components of V1 fit together.
Whether you are reviewing individual Record Types, considering how the Standard would apply to your organization, or exploring how the new structure differs from the existing Reference Model, the Navigator offers an additional way to examine the draft.
The Navigator is provided as a supplemental review resource. It can be used offline and does not require installation.
Please note: The Excel workbook and Navigator are tools to support your review.
All official community feedback must be submitted through the Microsoft Forms feedback form.
Navigator How-To Video | Navigator User Guide
How to Provide Your Feedback
We are asking the community to carefully review the proposed Standard and provide specific, actionable feedback.
As you review, we encourage you to consider:
Does the Record Type accurately represent the intended evidence?
Is the Purpose/Description clear, accurate, and sufficiently comprehensive?
Is there evidence that is missing or unnecessarily duplicated?
Are the Record Groups and Zones logically organized?
Are the proposed levels, dating conventions, and applicability appropriate?
Does the Standard accommodate the needs of different study designs and operating models?
An important consideration when identifying potential gaps:
Before proposing a new Record Type, please review the Purpose/Description of existing Record Types and consider whether the evidence is already represented, potentially with additional context provided through metadata. A difference in record name, format, or originating system does not necessarily require a new Record Type.
One of the foundational principles of V1 is that a separate Record Type should exist only when the evidence is meaningfully different.
We encourage you to consider this principle throughout your review.
Submitting Your Feedback
All official community feedback must be submitted using the CDISC TMF Standard Model V1 Community Review Feedback Form:
When submitting feedback, please:
- Identify the applicable Zone, Record Group, Record Type, or attribute.
- Clearly describe your comment, concern, or proposed change.
- Provide the rationale for your recommendation, including relevant regulatory references or practical examples where appropriate.
- Where possible, suggest specific alternative wording or an approach that would address your concern.
Specific, actionable feedback will be especially valuable as the development team evaluates and reconciles comments from across the community.
All feedback must be submitted by Friday, November 20, 2026, at 5:00 PM Pacific Standard Time (PST).
What Happens Next?
Following the community review, the development team will evaluate the feedback received and incorporate appropriate changes into the next version of the Standard. Additional work will continue on finalizing metadata, controlled terminology and definitions, and supporting implementation guidance.
We anticipate a final public review during the first quarter of 2027, with the release of TMF Standard Model V1 currently planned for April 2027.