TMF Standard Model V1: A Major Change Is Coming to Clinical Research
October 22, 2026
CDISC is introducing TMF Standard Model V1, the next evolution of the widely used TMF Reference Model. This is more than a new version – it represents a shift toward standardized, digitally managed clinical trial records.
What’s changing?
- A new structure based on Record Groups and Record Types, replacing the traditional artifact-based approach – with around 600 Record Types in total.
- Standardized metadata and closer alignment with ICH E6(R3).
- A new Zone 12 for eClinical Systems, covering study-specific system documentation.
- A unified framework covering drug trials, medical devices, real-world evidence, and Investigator Site Files.
- Better foundations for interoperability, automation, and AI.
When will it happen?
Community review of the draft is scheduled to begin this autumn, with the final V1 release planned for April 2027.
What should organizations do now?
Adoption is not mandatory, and there is no regulatory deadline for migration. However, sponsors, CROs, and eTMF providers should start assessing the impact on their systems, processes, and existing TMF structures.
The transition will take preparation – and now is the right time to start.
Learn more: https://www.cdisc.org/tmf
What about AI?
TMF Standard Model V1 lays the foundation for smarter, AI-powered TMF management. Standardized record types, metadata, and regulatory mappings will enable more accurate document classification, automated metadata extraction, and proactive gap detection – paving the way for continuous, AI-driven inspection readiness.
Expanded metadata designed to support automation and AI integration is part of the standard’s development.
