What is the TMF 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. DIA members and industry members are under no obligation to adopt the TMF Reference Model.
Is it a Standard?
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, enforeceable 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
Who owns the TMF Reference Model?
The TMF Reference Model initiative is a sub-group of the Document and Records Management Community of the Drug Information Association (DIA). The TMF Reference Model initiative is governed by the rules and procedures of the DIA but the work products are not owned, governed, managed or endorsed by the DIA, per DIA bylaws. The TMF Reference Model is a Public Domain work. The work has been recognized and promoted by the DIA:
“DIA strives to serve as a knowledge resource for the dissemination of information to help professionals overcome some of their most challenging issues,” explains Paul Pomerantz, DIA Worldwide Executive Director. “With the support of an engaged group of industry leaders, our Document and Records Management SIAC has published a valuable resource for the clinical research community.”
Can I find out who created the TMF Reference Model?
There are in excess of 500 individuals who are 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 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 other 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.
Are there any recognized issues with the TMF Reference Model?
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 DIA survey conducted in 2015 showed that 85% of elligible respondents are either currently using the Model, are currently implementing the Model or are considering 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 240 different organizations.
Why is Yahoo used by the project team?
Whilst the initiative comes under the auspices of the DIA, it was considered important to also allow participation and discussion amongst non-members. The DIA Connect collaboration tool is restricted to DIA members only. We therefore use a publicly-available online collaboration tool (Yahoo Groups) to facilitate communication between TMF Reference Model members whether they are a DIA member or not. We also have a LinkedIn group which is accessible to any LinkedIn member. The use of these external tools does not imply any separation from DIA but is simply a pragmatic decision to assist communication.
Can I use the TMF Reference Model Group to promote something my company is doing?
We are very proud that the discussion forum, LinkedIn group and this website contains uncluttered useful information and discussions. When members use these facilities to interact with other members we ask that the follow 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 bone fide educational events. In this regard, the Steering Committee may promote through its meetings, group communications and 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 appropriate to do so.
How can I get a copy of the Model?
It can be retrieved for free HERE.
How can I find out more about the TMF Reference Model?
You can join our regular project meetings. These are usually held every six weeks on Mondays at 8AM PT, 11AM ET, 4PM UTC, 5PM CET. You just need to be a subscriber to receive the schedule and dial-in details for these meetings. They are also publicised on our Yahoo discussion group. If you sign up to either or both of these, you can join the meeting! 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!
Why have we provided this information?
It is unfortunate that there are a very small number of individuals who are opposed to the TMF Reference Model and the way that the work has been managed / is being managed. Some have deliberately spread information that is intended to focus on Reference Model weaknesses only and in some cases, information which is simply untrue. This page is intended to set the record straight. We have always publicly recognized the limitations of our work products and understand that companies may choose not to adopt the Model and/or to also adopt other tools for TMF management to operate alongside the Model.
* Standard (adj): used or accepted as normal or average; viewed as authoritative and so widely read. [Oxford English Dictionary]