Reference Model Change Request Form has Moved
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 …
News
The Impact of the EU CTR on the TMF Content and Process
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 …
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CDISC TMF Plan Template v2 Available
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 …
TMF Reference Model Group Officially Affiliates with CDISC
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 …
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CDISC Affiliation
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 …
Position Paper on CDISC Affiliation
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 …
CORRECTION TO MEETING INFORMATION
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.
TMF Reference Model User Guide – Revised
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 …
Version 3.2.0 of the TMF Reference Model Launched
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 …
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Announcing: Real-World Study Document Index
Why is a stand alone index needed? Those of you who are involved in real world studies (RWS) know that trying to file your documents using the existing TMF Reference …