TMF Reference Model eTMF EMS Sub-Group Launches Industry Survey

November 13, 2020

The TMF Reference Model eTMF Exchange Mechanism Standard (EMS) sub-group is pleased to announce the launch of an industry survey on TMF interchange. The first version of the EMS was launched in 2019 with the goal of facilitating the interchange of TMF content between organizations and systems. The standard allows organizations to send artifacts and their related metadata and audit trail information to other organizations and systems. The goal is to greatly facilitate TMF content exchange, both during and at the end of a clinical study.

The survey will collect feedback on the use of the EMS and the future direction of the standard. The EMS team invites all industry stakeholders, including sponsors, CROs and vendors, to respond to the survey. The feedback that we collect will be published and will help define the future direction of the standard.

According to EMS Co-Chair Paul Fenton, “Improving the way we move TMF content between organizations is one of the key challenges that our industry faces. The EMS promises to help us meet this challenge. Making sure that we understand how organizations want to use the EMS standard is key to ensuring its successful adoption as well as its future evolution, and we hope to gain significant industry insight from our survey”. EMS Co-Chair Elvin Thalund said, “Successful collaboration across sponsors, sites, CROs, and ethical authorities, is today hampered by inefficient transfer of TMF content from one organization to another, and often requires that content has to be reindexed and reverified. This is where an industry TMF exchange mechanism can be the key to solve this major problem.”

The Survey will be closed on Dec 31, 2020 and the results will be shared early 2021.

About the eTMF Exchange Mechanism Standard

Sponsors and CROs who have traditionally managed their Trial Master Files (TMFs) on paper have seen significant improvements when migrating to an electronic Trial Master File (eTMF) system. However, the exchange of TMF content between sponsors, CROs and other stakeholders has remained challenging as they often use systems provided by different eTMF vendors. The TMF Reference Model has partially solved this problem. The model is an emerging standard that has provided a common structure for essential TMF documents. However, exchanging TMFs between different vendor systems remains due to the lack of a common exchange standard. The eTMF Exchange Mechanism Team, a sub-group of the TMF Reference Model project, has published the eTMF Exchange Mechanism Standard (eTMF-EMS) v1.0.1 as a specification for transferring TMF data between different eTMF systems.

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