eTMF Exchange Mechanism Standard Moves Ever Closer

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.

We are very pleased to announce that the draft standard is now ready for industry review.

A technical team has already been established for the technical review of the standard. This comprises representatives from companies such as Veeva, TransPerfect, Phlexglobal, Montrium, MasterControl, Arisglobal, Wingspan/IQVIA, goBalto, OpenText and Navitas. This team will be focussed on reviewing the metadata structure, XML definitions and structure, and adaptability and utility from a technical perspective.

The Exchange Mechanism team are now looking for volunteers to participate in a business review of the standard, looking at how well the specification as a whole would satisfy business needs. Volunteers will be invited to a one hour orientation meeting in December to get insights on the review and feedback process. The estimated total effort for the meeting, your review and submission of feedback is four to six hours over a 6 – 8 week period.

To join the team and become a business reviewer, simply register online and select “Exchange Mechanism” from the list of active work groups. You must have the time available to participate; there will be other opportunities for you to have visibility of the draft specification if this is your only reason for joining!

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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.

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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