Electronic Trial Master File (eTMF) Specification Version 1.0

Publishes details of an interoperable content classification system with rules, policies and procedures for how electronic content can be shared and customized for clinical trials. Machine readable, open standards-based technologies are used in a vendor neutral approach.

Instructions on converting the eTMF schema spreadsheet to an OWL RDF/XML ontology are available from IEEE.

Produced by:

OASIS Electronic Trial Master File (eTMF) Standard TC

Voting history:

October 2016

Voting History

OASIS Standard:

Committee Specification 01

HTML
PDF
DOCX

Schema documentation
Metadata vocabulary

Distribution ZIP file

Cite as:

Cite as:
[eTMF-v1.0]
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.