Trial Master File Reference Model

The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. The Model is not intended to be taken and used “off-the-shelf” but can be adapted to an electronic or paper TMF, and does not endorse, nor require, any specific technology for application. Organizations are under no obligation to adopt the TMF Reference Model.

It should be noted that we use the words “standard” and “standardized” in their general sense* and NOT to imply the creation of a formal, enforceable standard.

• The TMF Reference Model is a valuable tool for:

• Biopharmaceutical sponsors of any size, both commercial and institutional, involved in clinical studies

• Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.

• Contract Research Organizations and vendors servicing TMFs, including technology providers

• TMF consultants

• Site staff, including investigators and coordinators

• Regulators who wish to overcome the challenges of different TMF terminology and file structures that create inefficiency and a higher degree of variability during sponsor audits

• Biopharmaceutical sponsors of any size, both commercial and institutional, involved in clinical studies

• Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.

The TMF Reference Model initiative was formerly a sub-group of the Document and Records Management Community of the Drug Information Association (DIA). Since June 2022, it has become part of CDISC, based on the position paper found here. The TMF Reference Model initiative is governed by the rules and procedures of CDISC but the work products are a Public Domain work. The CDISC TMF Reference Model Initiative Charter can be found here.

There are in excess of 1,500 individuals who have been members of the TMF Reference Model Project team, from over 280 different organizations and over 30 countries globally. The membership profile includes biopharmaceutical clinical trial sponsors, non-commercial trial sponsors, CROs, service vendors, technology vendors, consultants, and non-profit organizations. Of course, not everyone contributes but by being a member they receive regular emails containing information updates, can participate in our collaboration platform, and have the opportunity to contribute if they so wish. Since its inception in 2009, the TMF Reference Model initiative has received specific contributions from over 400 individuals globally. The latest major release (v3) involved around 110 individual members who worked on 15 sub-teams over a period of around 9 months and we have within our records the details of who those specific individuals are. We also retain a copy of the attendees’ list for each project team meeting we hold. Whilst we have no intention to be secretive, we do not publish the list of contributors for data privacy reasons; release of member information would put us in breach of data privacy laws. In addition, some members participated as individuals whilst others participated as an official representative of their employer and we do not have permission of those employers to publish company contributor details.

The initiative is overseen by a Steering Committee which is democratically elected by the members. Any registered member who has been involved on one or more project teams in the last 12 months can put themselves forward for a position on the Steering Committee as 3-year positions become vacant. The activities are governed by a published Charter.

Some shortcomings of the Reference Model have been voiced but these are mostly based on the premise that the Reference Model is a formal standard based on published vocabularies and that it is intended to be used as a data or document exchange tool. Neither of these assertions are correct. As a reference model, the tool has proven to be extremely valuable. A survey conducted by this initiative in 2022 showed that 96% of eligible respondents are currently using the Model. It is based upon ICH vocabulary, ICH regulatory requirements, and commonly accepted principles for TMF management. The authors of the Model are, in general, experienced TMF managers from sponsor companies, CROs, non-commercial organizations, and TMF vendors; experts in TMF management from in excess of 250 different organizations.

We are very proud that the discussion forum, LinkedIn group, and this website contain uncluttered useful information and discussions. When members use these facilities to interact with other members we ask that the following rules are respected:

• No job postings at all

• No recruitment

• No company advertising, which includes company-specific ‘advertorial’ postings and promotions embedded in email signatures

• No conference, webinar, or blog advertising, including links to these

• No advertising in responses to discussions

There are plenty of places for people to advertise their companies, including webinars and other events, but this just isn’t one of them! But members should feel free to share any interesting information or pose any challenges or questions around TMFs and eTMFs.

However, one of the values of having such a network of peers is to share information about bona fide educational events. In this regard, the Steering Committee may promote through its meetings, group communications, the TMF Reference Model website conferences, and other educational events that will be of interest to colleagues working with trial master files. Events will NOT be promoted that:

• are ‘advertorial’ in nature

• are run for a member’s commercial interest or financial gain; or

• promote a specific company, vendor, or technology/services solution.

Typically, events that may be promoted by the Steering Committee include industry conferences and educational offerings from professional associations and other not-for-profit organizations. Please contact a Steering Committee member if you become aware of an event that might be of interest to others and we will share the information if it is appropriate to do so.

It can be retrieved for free HERE.

You can join our regular project meetings. These are usually held every six weeks at 8 AM PT, 11 AM ET, 4 PM UTC, 5 PM CET. You just need to register here to receive the schedule and dial-in details for these meetings. 

If you want to actively participate in the development of the Model or any of the supporting tools, you are welcome to join the project…. but this is only for those who have the time to participate and join a team!