|Articles|June 15, 2015

Version 3.0 of the Trial Master File Reference Model is here!

Building on the most widely leveraged standardized reference in TMF management today, with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors, Version 3.0 of the TMF Reference Model (released at the DIA Annual Meeting in Washington, DC on June 16th) incorporates feedback from its extensive industry use to enhance content clarity. Highlights of V 3.0:

Updated artifacts – Additions, deletions, consolidations

Updated zones – Zones have been reassessed for logical artifact inclusion – E.g. local labs

Updated definitions – That more accurately describe the TMF RM components

Sub-artifact examples – assists with mapping to and understanding purpose of artifacts

TMF Reference Model User Guide – Provides step-by-step process for mapping your organization’s TMF to the TMF RM

An improved presentation of the model will be available soon after the release to facilitate easier navigation.

In addition, by Q4 2015, an XML-based mechanism for simplifying the inter-change of electronic TMF content between organizations will be added.

Join us at the DIA Annual Meeting

TMF RM members will be networking at DIA and will be holding a Meet & Eat in the Community Networking Area on Tuesday the 16th at 12:30pm. This area is adjacent to the Member Lounge and both are near the Lunch Voucher Pick-up at the entrance to Hall B in the Exhibit Hall.

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