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, the problem of 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) v1.0.2 as a specification for transferring TMF data between different eTMF systems (you can find a Charter for the team HERE).
*Standard: 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.
Regular news regarding the eTMF Exchange Mechanism Standard can be found on our EMS News page. If you have any queries regarding the Exchange Mechanism Standard,
please contact us using the form below.