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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
