As a follow-up to last week’s blog instalment about the TMF reference model, we will now discuss the exchange mechanism standard (EMS). The EMS was developed by a sub-group of the TMF Reference Model to provide a standard way to transfer content between different eTMF systems. It provides a best practice methodology for:
- Migrating TMF content between different systems.
- Ensuring that content is uploaded in a manner that preserves its integrity and ensure its ongoing availability.
Whereas the TMF reference model seeks to establish a unified approach to how the TMF is structured, the EMS provides a unified approach to transferring TMF content between systems and organisations.
The EMS is becoming increasingly relevant
The growing number of e-clinical solutions has made the interoperability between them a necessity.
Additionally, increasing adoption of technology as part of the clinical trial process (which has been accelerated by COVID-19) has increased the need for better and more efficient synergies between different systems.
The EMS in action
The TMF reference model website has listed various use cases to demonstrate the usability of the EMS, including:
- 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.
The EMS is monitored to ensure it remains current and up to date, with the latest release (19.3.2) having been published on the 25th October 2019.
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