TMF Standard Model v1 – Call for Community Review

This month saw the release of the TMF Standard Model v1 for community review. This release provides the TMF community with the opportunity to provide feedback on the initial draft of the standard and help shape its future.

The new TMF Standard Model has been the culmination of three years’ work from over 1,500 individuals who have been part of the TMF Standard Model Project team. Those 1,500 people come from over 280 different organisations across 30 countries.

The community review is open until the 20^th November. There are plans for a final public review in Q1 2027 with the final release of the TMF Standard v1 in April 2027.

You can find out more about the community review and how to submit feedback on the CDISC website.

What is the TMF Standard Model?

The TMF Standard Model provides a standardised structure and language to help manage and organise the Trial Master File (TMF) throughout the lifecycle of a clinical trial.

Supporting both electronic and paper TMFs, the Standard Model is an adaptable template that outlines what content should be filed within a TMF and the metadata that should be captured alongside that content.

Usable by trial sponsors, CROs, vendors and sites, the TMF standard can;

• Support regulatory compliance and inspection readiness
• Improve collaboration between trial stakeholders
• Reduce inefficiencies, minimise risk and improve trial timelines
• Increase organisational confidence in the quality and data integrity of trial records.

Once launched, the TMF Standard Model will be free to download from the CDISC website.

The TMF Standard Model is an evolution from the previous TMF Reference Model (v3.3.1) and is managed as part of the CDISC suite of Standards.

What are the major changes in the TMF Standard Model v1?

The TMF Standard Model v1 is an evolution from the previous TMF Reference Model 3.3.1, resulting in one of the most significant changes for the TMF community. It reflects the changed nature of how clinical trials are managed, and the digital tools used by most trial stakeholders today.

While we’ll not cover all the changes in detail in this post, here are some of the main changes coming with the release of the TMF Standard Model v1;

• The name: The shift from a Reference Model to a Standard Model is not to be underestimated. A Standard provides a more formalised approach, leading to better standardisation across the industry, and ultimately resulting in wider adoption.
• Alignment to ICH E6(R3): With the release of Annex 1 of ICH E6(R3) in 2025, the new standard is aligned to the latest approach to Good Clinical Practice (GCP). This includes dropping ‘Core’ and ‘Recommended’ records, with applicability aligned to ICH E6(R3) guidelines.
• Changes to how records are organised: v1 has moved away from ‘Sections’ and ‘Artifacts’ to ‘Record Groups’ and ‘Record Types’. The goal here is to shift the Standard from a document centric structure, to a more dynamic evidence-based structure.
• More granular record types: v1 will not only shift from using ‘artifacts’ to ‘record types’ but introduce over 2,000 record types, a significant increase over the Reference Model (which had 250 artefacts and +600 sub-artefacts). This more granular approach will improve precision, enabling organisations to file records in more appropriate sections.
• Zone 12 for eClincal systems: Due to the significant increase in the use of eClinical systems during a trial, the Standard will introduce a new 12^th This has been created to centralise records related to eClincal systems, which had historically been scattered across other general oversight zones.

Does Arkivum support the TMF Standard Model v1?

The Arkivum solution, is a vendor (and standard) neutral solution, enabling customers to organise their records however they choose. Many of our existing customers have archived their TMF in line with the previous Reference Model structure.

The Arkivum team have reviewed the new TMF Standard Model and we are confident that the Arkivum system can fully support the new structure, attributes and metadata in the Standard Model.

If you would like to speak to our team about how we can support your TMF archiving and retention requirements, please visit our contact us page.