OASIS Electronic Trial Master File (eTMF) Standard TC
Defining machine readable formats for clinical trial master file content interoperability and data exchange
Zack Schmidt, firstname.lastname@example.org, Chair
Table of Contents
- TC Liaisons
- TC Tools and Approved Publications
- Technical Work Produced by the Committee
- Expository Work Produced by the Committee
- External Resources
- Mailing Lists and Comments
- Press Coverage and Commentary
- Additional Information
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.
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.
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.
There are no approved expository work products for this TC yet.
Although not produced by the OASIS eTMF Standard TC, the following information may offer useful insights into its work.
- "New Standard for Clinical Trial Data"; Connected World, 16 April 2014
- "Pharmaceutical and IT Communities Collaborate on OASIS Clinical Trial Data Standard for Content Management Systems": Forte Research, HL7, Kaiser Permanente, Mayo Clinic, Oracle, SureClinical, and Others Advance Interoperability Standard for Exchanging Clinical Trial Content in the Cloud; 20 May 2014
Providing Feedback: OASIS welcomes feedback on its technical activities from potential users, developers, and others to better assure the interoperability and quality of OASIS work.