The End of the TMF Reference Model as we Know it

What You Need to Know

The Bottom Line: The TMF Reference Model is evolving into the TMF Standard Model V1, a complete transformation designed for digital clinical trials. V3.3.1 ends in 2027; V1 marks a new era.

Key Changes:

• From Model to Standard: Standards are definitive; models allow too much interpretation and inconsistency
• 2,000+ Record Types: More granular structure for precision and clarity in digital systems
• Regulatory Alignment: Built to reflect ICH E6 R3 guidelines, with engagement from EMA, FDA, and MHRA
• Artifacts → Record Groups: Rethinking how we organize and connect record types
• Metadata Standards: Aligning with USDM for seamless communication across clinical systems

What's Coming:

• ICH M11 mapping for digital protocol integration
• 2,000+ Record Types: More granular structure for precision and clarity in digital systems
• Regulatory Alignment: Built to reflect ICH E6 R3 guidelines, with engagement from EMA, FDA, and MHRA
• Artifacts → Record Groups: Rethinking how we organize and connect record types
• Metadata Standards: Aligning with USDM for seamless communication across clinical systems

What This Means: This isn't just a version update, it's a foundation for interoperability, automation, and the next decade of clinical research.

Now, let's dive into how we got here, and what it means for the future of clinical trials.

Building a Standard for the Digital Future

During this year’s recent CDISC + TMF Interchange 2025, I had the privilege of helping unveil something that represents years of collaboration, discussion, and shared vision: the TMF Standard Model V1. 
 
Why are we moving from a "model" to a "standard"? Because the flexibility of a model has its limits. A model allows for interpretation and variation, which has led to inconsistency across the industry. A standard is sturdier, more definitive. It's designed to stand the test of time as we shift from interpreting regulatory guidance to reflecting it directly. Most importantly, it moves us toward a future where we can finally minimize that dreaded question: "Where's that file?" 

This isn't just the next iteration of the TMF Reference Model—it's a complete reimagining of how our industry approaches clinical documentation for a digital future. With V3.3.1 of the TMF Reference Model closing its chapter in 2027, V1 will begin a new era: one grounded in interoperability, regulatory alignment, and a true digital foundation for the future of clinical research. The ICH R3 guidelines are pushing us to evolve and will fundamentally influence how we build this standard. 

A Vision Built on Principle 

What excites me most about this milestone is the intent behind it. The TMF Standard Model isn't about making change for change's sake. It's about building a model that serves the entire industry—from sponsors to CROs to technology providers. It's about creating a structure that's adaptable, scalable, and ready for automation and analytics that will define the next decade of clinical trials. 

We've established guiding principles that keep us honest and focused: 

• Every change must have clear justification
• Consistency and interoperability must drive every decision
• The model must work for everyone, or it doesn't work at all
• The standard does not interpret regulations—it reflects them
• Above all, we build for the digital future, not the digital present

Addressing the Elephant in the Room: 2,000+ Record Types 

Yes, V1 will introduce more Record Types—around 2,000+—and yes, that number raised eyebrows. But what this really represents is clarity and precision. We're moving away from forcing documents into ill-fitting categories and toward a granular structure that reflects how modern trials truly operate. This expansion isn't complex for its own sake; it's about providing the specificity that digital systems need to function effectively and that regulatory requirements demand. 

The Roadmap: A Comprehensive Approach to Digital Transformation 

Of course, everyone was curious about the roadmap to bring this initiative to life. The comprehensive set of steps to bring the standard to life is outlined below.  

Core Standard Development 

1. Records: Our first area of focus is (to no surprise) record types, the foundation of everything we're building. We're bringing in feedback from across the community and all subgroups to create that master record type list. This collaborative approach ensures the standard reflects real-world needs and use cases. 
2. Artifacts: Next, we're fundamentally rethinking artifacts. We've made the strategic decision that artifacts will become Record Groups—essentially containers for record types. This shift will enable us to think more systematically about how we connect record types together, creating a more logical and navigable structure.
3.  ICH E6 R3: Alignment with ICH guidelines is also a priority. This presents a crucial opportunity to ensure we're properly aligned with international regulatory standards and expectations. 
   
4. Controlled Terminology: Finally, we're developing comprehensive controlled terminology for all record types. This common language will enable seamless communication with all the other standards in the clinical research ecosystem. CDISC develops controlled terminology and is mandated by ICH to create the controlled terminology for M11, positioning us uniquely to drive this standardization.

Metadata Standards 

In addition to records, we are developing a metadata standard that will serve as a critical bridge to other systems. Within V3, there was a certain amount of metadata, but we're taking this much further. Our goal is to align metadata standards with the Unified Study Definitions Model (USDM). This alignment will be transformative, making it far easier to communicate with upstream and downstream clinical systems that need to provide or consume TMF information. 

The metadata working group run by Aaron Grant will be looking closely at USDM to ensure we're building connections that work seamlessly across the clinical trial ecosystem. 

Ancillary Standards and Mapping 

Beyond the core standard, we're developing a comprehensive suite of ancillary standards and mappings: 

• ICH M11 Mapping: Connecting TMF Reference Model record types to M11, enabling digital protocol integration with the TMF and capturing specific information about trial design
• ISF RM R2: Updating the Investigator Site File Reference Model for the new era
• Real World Evidence RM R2: Establishing a new working group to address this rapidly growing area, which presents different angles and requirements that need careful consideration
• Medical Device RM R1: Rather than trying to force medical device trials into the general TMF structure, we're creating a dedicated Reference Model that addresses the unique requirements of device studies
• CSV Cross-Reference: Developing cross-references of Computer System Validation records for trial-relevant systems, covering both trial-specific and enterprise aspect

 Standard Management Tools 

To support this expanded and more complex standard, we're developing sophisticated management tools: 

• Defining requirements for a database-type tool to manage the standard effectively
• Implementing a tool to manage TMF RM and facilitate migration to V4
• Developing APIs that will allow querying of the TMF RM Standard, enabling integration with vendor systems and internal tools
• Updating the TMF RM Implementation Guide to reflect all these changes and provide practical guidance 

Training, Guidance, and Frameworks 

A standard is only as good as its implementation, which is why we're investing heavily in training and guidance: 

• Comprehensive training programs to help the industry understand and adopt the new standard
• A risk framework to help organizations prioritize and manage TMF-related risks
• Updated standard conventions that reflect current best practices
• A revised TMF plan template that better aligns with digital TMF concepts and ICH R3 requirements 

Regulatory Engagement: Building Global Consensus 

I'm incredibly encouraged by the level of engagement from regulators. We will be presenting to the  European Medicines Agency (EMA) IWG later this  month, and conversations with the FDA and MHRA are on the horizon. Our goal is clear: to achieve formal recognition and inclusion in future regulatory guidelines, ensuring the TMF Standard Model becomes the global foundation for clinical documentation. 

This regulatory engagement isn't an afterthought, it's a core pillar of our strategy. We want this standard to be more than industry best practice; we want it to be the recognized framework that regulators expect and that sponsors can implement with confidence. 

A Community-Led, Technology-Enabled Future 

As Chair of the TMF RM Steering Committee and in my role at Montrium, I'm deeply proud of how far we've come—and even more excited about what comes next. This is a community-led, regulator-engaged, and technology-enabled effort, built by and for the people who live and breathe TMF every day. 

The TMF Standard Model V1 isn't just about documentation, it's about redefining quality itself. It's about creating a foundation that will enable the next generation of clinical trials: more efficient, more transparent, more data-driven, and ultimately, more focused on getting life-changing therapies to patients faster. 

This is just the beginning. The roadmap ahead is ambitious, but with the engagement and expertise of this community, I'm confident we'll build something truly transformative. 

What questions do you have? I know there are many, and I welcome the dialogue. After all, this standard belongs to all of us, and it will only succeed if it reflects the collective wisdom and practical needs of everyone who depends on it.

Watch the TMF Standard Model v1 webinar here.

What aspects of the TMF Standard Model V1 are you most interested in learning more about?