On 28/29 September, a conference is being held that has been created by and for the TMF Reference Model community! The first CDISC TMF Interchange will be held in Baltimore. This promises to be a fantastic opportunity to learn more about the Reference Model, about standards, about best practices for managing TMF content, impact of […]
Inaugural TMF Interchange Conference Read More »
With immediate effect, the online form to submit a suggestion for Reference Model change has been transferred to the CDISC website. You can still find a link on this website but this will now refer you to: https://www.cdisc.org/tmf/feedback If you have any suggestions for change, please submit your ideas online. This could be an artifact
Reference Model Change Request Form has Moved Read More »
The Trial Master File Reference Model (TMF RM) group held a workshop in April 2022, bringing together around 70 people across multiple companies to discuss the impact of the EU Clinical Trial Regulation (CTR) on the content of the TMF. A document that summarises the workshop has now been made available on the TMF Reference
The Impact of the EU CTR on the TMF Content and Process Read More »
We are pleased to announce that a revision to the TMF Plan template (v2.0) is now available. This template replaces v1.0 which was originally approved in February 2018. The revised template was developed across 7 months of work by a cross-industry group led by Jamie Toth (Sr. Director/Global Head, TMF Management & Records, BeiGene). The
CDISC TMF Plan Template v2 Available Read More »
CDISC today (April 27, 2022) announced an expansion of its offerings with the official affiliation of volunteer-based Trial Master File (TMF) Reference Model Group. The combined organizations will operate under the CDISC brand and continue serving the clinical research community by providing resources that foster greater efficiencies across the industry ecosystem. Like CDISC, the TMF
TMF Reference Model Group Officially Affiliates with CDISC Read More »
The TMF Reference Model is becoming part of the CDISC organization in order to align with other clinical standards, increase our ability to execute the initiatives identified by members, expand our relationships with regulators, and more. To learn more, see the Position Paper on CDISC Affiliation here (February 8, 2022).
The TMF Reference Model Steering Committee has authored a position paper which outlines the future direction that it feels the TMF Reference model should head in, its reasoning for affiliating to a more formal organisation and the subsequent proposition to affiliate with CDISC. The position paper was authored to allow us to formally communicate with
Position Paper on CDISC Affiliation Read More »
Please note that the link for today’s meeting is: https://zoom.us/j/97348320139?pwd=NlhSSFNKRlpMcGx5Uk5DS2tGU09wUT09 Please refer to online calendar and Event information for full details. We apologise for any inconvenience.
CORRECTION TO MEETING INFORMATION Read More »
Following the recent update to the TMF Reference Model (to v3.2.0 on 02-Nov-2020), the accompanying User Guide has also been revised. The new version is now available to download from our Resources page. As well as providing a great overview of the most recent changes to the Reference Model, the document provides a useful guide
TMF Reference Model User Guide – Revised Read More »
The TMF Reference Model Steering Committee today announces that version 3.2.0 of the Trial Master File Reference Model is now available to download free of charge. The TMF Reference Model project originated in the DIA Document and Records Management Community in 2008. This latest release incorporates updates developed in response to 25 requests from industry
Version 3.2.0 of the TMF Reference Model Launched Read More »
