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

Jennifer Alpert Palchak, jalpert@carelex.org, Chair
Zack Schmidt, zs@sureclinical.net, Chair

Table of Contents


On 20 May 2014, OASIS issued a press release, 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.

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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