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TMF Reference Model & eTMF Exchange Mechanism Standard

12 Sep 2019
9:00am-9:45am

TMF Reference Model & eTMF Exchange Mechanism Standard

The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. This session will give an update on the model and exchange mechanism standard, along with issues and future trends.

  • TMF Reference Model v3.1.0
    • Overview of the standard
    • Project overview and next steps
  • eTMF Exchange Mechanism Standard (eTMF-EMS) v1.0
    • How does it work?
    • Use Cases:
      • Final eTMF transfer to sponsor from CRO for archiving
      • Interim transfer of eTMF content to central eTMF or other trial management system
      • Migration of eTMF content following merger and acquisition
      • Migration of eTMF content following upgrade or change of eTMF system
      • Long term archiving of eTMF content and associated metadata
  • Solving interoperability issues
  • Vendor adoption & the way forward?