There’s an important new global standards initiative that quietly launched on December 16th  in the BioPharma regulatory area called the OASIS eTMF Standard.   For clinical trial practitioners, the OASIS eTMF Standard represents a new high-water mark for delivering on the vision of 100% paperless clinical trials and clinical trial process automation across organization boundaries.   For the majority of you consumed by the day-to-day reality of conducting a global trial, you’re may be thinking, “I have a TMF document repository. It works, so why is this OASIS eTMF initiative so important?”

In a nutshell, there has been a proliferation of software vendors that are attaching the moniker of “eTMF compliant” to their systems. However, like all emerging information technologies, many eTMF application vendors haven’t tackled the fundamental challenge of how their solutions will share data across systems, platforms and organizations.   Behind a veil of proprietary solutions, the life sciences industry isn’t any better off when it comes to readily sharing data with IRBs, CROs, consultants, or regulatory bodies outside their four walls.

The new OASIS eTMF Standard is chartered to solve this problem. The initiative is an open source effort that enables organizations to share electronic trial master file (eTMF) information between systems and organizations via a published machine readable format. In other words, “eTMF compliant” will no longer be solely a paper classification system or a meaningless acronym. Rather, the eTMF standard will now enforce a systematic approach – in industry parlance, an “ontology” – and a communication framework that enables the free exchange of data across systems with cloud-based technologies.

If your organization is considering deployment of an eTMF application, you will need to consider how this new standards initiative can impact how you organize, capture, store, share and work with regulatory documents. Moreover, you’ll want to know that your vendor’s system has adopted the OASIS eTMF framework for both system interoperability and organizational scalability.

The OASIS eTMF Technical Committee is comprised of contributors from CareLex, Forte Research Systems, Mayo Clinic, Oracle, Paragon Solutions, SAFE-BioPharma, and SterlingBio.   The members of the eTMF Standard Technical Committee wisely realize the importance of information sharing between organizations and the increased productivity that a standards-based eTMF data classification and exchange format will provide to everyone equally in the industry.   As the industry moves to adopt eTMF standards, beware of eTMF application vendors who claim that they are standards-based – ask them if they support the new global OASIS eTMF Standards initiative.

I’m honored to be part of this new era in clinical trial process automation, and I’m further honored to have been elected Chair of the OASIS eTMF Standard Technical Committee. Going forward I’ll continue to post updates and developments of the OASIS eTMF Standard TC in this blog.

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