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

Table of Contents


Announcements

Electronic Trial Master File (eTMF) Specification Version 1.0 is now an approved OASIS Committee Specification. As an OASIS Deliverable, completed and approved by the TC, it is fully ready for testing and implementation. Find details in the announcement at https://www.oasis-open.org/news/announcements/electronic-trial-master-file-etmf-specification-v1-0-published-by-the-etmf-tc.

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.

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


Overview

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.


Subcommittees


TC Liaisons


TC Tools and Approved Publications


Technical Work Produced by the Committee

Electronic Trial Master File (eTMF) Specification Version 1.0. Edited by Aliaa Badr, Jennifer Alpert Palchak, Rich Lustig, Catherine Schmidt, Zack Schmidt, Airat Sadreev,Troy Jacobson, and Prabhat Vatsal. 25 October 2016. OASIS Committee Specification 01. http://docs.oasis-open.org/etmf/etmf/v1.0/cs01/etmf-v1.0-cs01.html. Latest version: http://docs.oasis-open.org/etmf/etmf/v1.0/etmf-v1.0.html.


Expository Work Produced by the Committee

There are no approved expository work products for this TC yet.


External Resources

Although not produced by the OASIS eTMF Standard TC, the following information may offer useful insights into its work.


Mailing Lists and Comments

etmf: the discussion list used by TC members to conduct Committee work. TC membership is required to post, and TC members are automatically subscribed. The public may view the list archives.

etmf-comment: a public mailing list for providing feedback on the technical work of the OASIS eTMF TC. Send a comment or view the comment list archives.


Press Coverage and Commentary