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 and 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 the fourth quarter of 2015, an XML-based mechanism for simplifying the inter-change of electronic TMF content between organizations will be added.
Additional Information is available at the Trial Master File Reference Model website.