The Future of the TMF Reference Model

Adapted from a Phlexglobal Ask An Expert interactive discussion, “TMF Reference Model Q&A,” held April 6, 2022 and available on-demand here. Hosted by Karen Roy and Lisa Mulcahy, co-founders of the TMF Reference Model and respectively Chair and Member of the Model’s Steering Committee, attendees had a unique opportunity to pose their questions about the Model’s future.   

Since its inception in 2009, the Trial Master File Reference Model (TMF RM) has become the de facto standard for Trial Master File management. The chaos of every company having its own TMF structure and naming conventions (and worse) has been replaced by a common structure where inspectors, sponsors, CROs and others can all speak the same language. The resulting gains in efficiency and compliance are incalculable.   

Yet despite (or because of) its success, the TMF RM is at a tipping point. How will the model evolve to help manage increasing trial complexity and compliance demands?  

In January 2022, the TMF RM Steering Committee published the TMF Reference Model Position Paper on CDISC Affiliation. This document describes the committee’s recent activities and outlines its intent to formally affiliate the TMF RM with CDISC. The steps toward affiliation started as the TMF RM volunteers wanted to align with other clinical standards, increase their ability to execute the initiatives identified by members and expand relationships with regulators. It was evident that partnering with an established, global standards development organization was the path forward. 

The TMF RM approached CDISC about a partnership, and, on April 27, 2022, CDISC formally announced via press release the “expansion of its offerings with the official affiliation of the volunteer-based Trial Master File (TMF) Reference Model Group.” This strategic alignment positions the model for continued success and expansion.  

Benefits of CDISC Alignment  

First and possibly foremost, CDISC supports the TMF RM Steering Committee’s strategic focus on Evolution, Community, Formalization, and Expansion that will help to “future-proof” the reference model.  The CDISC organization, with its formal standards governance process and its active global community, are well-positioned to support the Steering Committee’s strategic focus.    

For over 25 years, CDISC has been serving the industry by bringing together a global community of experts to develop and advance data standards of the highest quality to enable the accessibility, interoperability, and reusability of data for more meaningful and efficient research that has a greater impact on global health. CDISC today employs approximately 40 professionals who lead standards’ initiatives as well as associated functions and infrastructure needed to support standards development and curation. As TMF RM is onboarded to the CDISC ecosystem, requests to expand the model with more extensive metadata, mapping the model to other models and standards, and training development can be more fully supported.  

Additionally, bringing the TMF RM into the robust CDISC organization and its member community will also increase awareness of the model, its benefits to trial sponsors and regulators, and its use throughout the industry. CDISC’s annual global “Interchange” conferences offer broader exposure for the TMF RM, along with more opportunities for volunteers to convene during the meetings.   

In the position paper, the Steering Committee noted that the TMF RM Charter has two objectives: 

• To develop and maintain the TMF RM so that it remains aligned with regulatory requirements and the expectations of regulatory inspectors  
• To develop supporting materials that assist in the understanding, interpretation, utilization, and adoption of the TMF RM 

Trusted and required by the United States FDA and Japan’s PMDA and recommended by the China NMPA, CDISC is uniquely qualified to further the TMF RM goals related to continuing interactions with regulators and supporting their requirements for inspections and audits.  

CDISC also has an extensive training program that delivers online, public, and private courses with learning records accessible through their learning management system. The TMF RM team will benefit from CDISC’s training logistics, resources, and organizational support.   

The alignment between CDISC and the TMF RM creates value for both parties. As CDISC continues its mission to advance data standards, the organization will be able to connect the TMF RM and other related existing or emerging data standards. Since CDISC interacts with the same stakeholders on a broader scale, it will be able to offer greater value to a larger audience through its alignment with the TMF RM.  

CDISC and TMF RM volunteers are moving slowly and thoughtfully to ensure the sustainability of the reference model. In the initial six-month period, minimal change is expected as the groups get to know each other and plan their future together. A member of the TMF RM will be joining the CDISC Board of Directors to represent the TMF RM and its strategic vision as the two organizations move forward.  

As CDISC and the TMF RM Strategic Committee and volunteers start down this path together, the synergies are obvious, and the future of the TMF RM looks very bright!