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.
To learn more about how our service can help unify your documents and ensure you’re complying with regulations, contact us today.
05 Oct, 2021
What is the TMF Reference Model?
The Trial Master File Reference Model (TMF reference model) was created over 10 years ago with support from the Drug Information Association (DIA) Document and Records Management…
27 Apr, 2021
FAIR data principles, what are they and how can they support compliance?
Life Sciences organisations are becoming big data enterprises, generating large amounts of data from clinical studies, lab equipment and drug development. However, this plethora of data is…
06 Sep, 2021
Four crucial reasons why Dropbox isn’t an appropriate archive for pharma documentation
As a digital preservation provider, we are often asked about alternate tools to safeguard pharmaceutical documentation. One in particular we’re regularly asked about is Dropbox. Today I…