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Welcome to the website of the TMF Reference Model. The TMF Reference Model was originally developed under the auspices of the Drug Information Association (DIA) Document and Records Management Community and is now part of the Clinical Data Interchange Standards Consortium (CDISC).

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.

Over the next few months, the content of this website will be transitioning to the CDISC website. Once this transition is complete, only the Discussion Forum and Change Request process will remain on this site. If you want to contribute to the Discussion Forum, please ensure you REGISTER. Please respect the rules of the forum or you will be removed!

GETTING INVOLVED

If you just want to receive all CDISC TMF communications, you need to create a CDISC account and tick the checkbox for CDISC Communications.

If you are interested in actively participating in this initiative and are prepared to contribute on a regular basis, you can volunteer on the CIDISC website.

The TMF Reference Model is maintained by a team of industry volunteers, under the auspices of CDISC. Activities conducted by the Project are progressed through a number of sub-groups, including maintenance and development of the Reference Model itself. Sub-groups meet as needed, usually for an hour, to discuss issues and to progress their work streams.

If you would like to be actively involved in this initiative, you need to register as a volunteer on the CDISC website and agree to the CDISC rules that apply to CDISC initiatives. There is no charge to join the project team and your company does not need to be a CDISC member but if you are interested in joining we ask that you agree to the following:

    • you have the time available to participate in your chosen sub-group(s) on the project;
    • where applicable, you have any necessary authorisation from your employer to participate;
    • you will make every effort to participate and to contribute on a regular basis;
    • you agree to the relevant CDISC rules.