Exchange Mechanism Standard

The eTMF Exchange Mechanism Team – a sub-group of the TMF Reference Model project – has been working on a standard1 for the transfer of TMF data between different eTMF systems for around three years. The objective is to define a simple standard that could be used in a number of scenarios:

  • Final export of eTMF content for archiving;
  • Interim transfer of eTMF to a central eTMF or other document repository;
  • Migration of eTMF during mergers/acquisions;
  • Migration of eTMF for system upgrades or change;
  • Final transfer of eTMF content from third party (e.g. CRO) to sponsor.

Further news: Coming soon!


1Standard: the term is used here in its general sense i.e. “used or accepted as normal or average; viewed as authoritative and so widely read”. Currently, the specification will not be authorized or published by a recognized standards body, though this may be considered at a future time. Following the closure of the OASIS eTMF Technical Committee prior to finalization of an eTMF standard, this is the only eTMF technical standard under development at this time and has the support of all major eTMF vendors.