eTMF Exchange Mechanism Standard

Sponsors and CROs 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 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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