OASIS Electronic Trial Master File (eTMF) Standard TC

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Defining machine readable formats for clinical trial master file content interoperability and data exchange

Zack Schmidt, zs@sureclinical.net, Chair

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eTMF was named as a 2014 Open Standards Cup Finalist in the Outstanding New Technical Committee category. Congratulations!

The eTMF TC recently hosted a series of complementary educational webinars tailored for various audiences who wish to understand the OASIS eTMF Specification Version 1.0. These webinars offered an overview of the Specification contents, implications, and how to provide input. All webinars were recorded and posted on the OASIS YouTube Channel.

On June 24, 2014, OASIS announced a 45-day public review for the eTMF TC Committee Specification Draft 01 Electronic Trial Master File (eTMF) Specification Version 1.0. Comments on the draft should be submitted using the OASIS comment facility; postings to the comment list are publicly archived.

Participation in the OASIS eTMF TC is open to all interested parties. Contact join@oasis-open.org for more information.


The purpose of the OASIS eTMF Standard TC is to define machine readable formats for clinical trial master file content interoperability and data exchange to include: (a) an eTMF content classification model comprised of a standards-based vocabulary and content classification ontology; (b) a set of eTMF content classification rules and policies; (c) an eTMF Data Model and format for the interoperable exchange of electronic trial master file information for the clinical trials domain, whereby eTMF content can be exchanged through either cloud or physical media and viewed online or offline in web browsers.

For more information on the eTMF TC, see the TC Charter.


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