45-Day Committee Specification Draft Public Review Request for OASIS eTMF Standard

Submitted on Monday, June 16, 2014 - 05:22
Submitted by user:
Submitted values are:

Submitter's Name: Zack Schmidt
TC Name: Oasis eTMF Standard Technical Committee
TC Email Address: tmf@lists.oasis-open.org
Work Product Title: OASIS eTMF Standard Committee Specification Draft
201406-R01
Committee Specification Draft ##: CSD-201406-R01
CSD URI: TBD
Additional Resources :
https://www.oasis-open.org/committees/document.php?document_id=53345&wg_abbrev=etmf
Approval Link:
https://www.oasis-open.org/committees/document.php?document_id=53346&wg_abbrev=etmf
Abstract: In order to enable clinical trial stakeholders to rapidly achieve
the
benefits of interoperable electronic trial master file (eTMF) systems and
technologies in life sciences, the OASIS eTMF Standard technical committee
has
developed a DRAFT eTMF system specification using an open architecture and
technology neutral approach. As a standard built upon standards, the OASIS
eTMF
Standard DRAFT specification includes the following components:
Specification,
Metadata Vocabulary based on a controlled vocabulary from the National Cancer
Institute, machine readable code using RDF/XML. We welcome industry feedback
and participation in the refinement of this proposed standard.
TC Description: The Oasis eTMF Standard Technical Committee is chartered to
define open technologies for clinical trial master file content
interoperability
and data exchange that will enable safe and rapid delivery of drug and device
therapies globally.
Notification List: To be provided
Notes: Additional details can be provided as needed. Please contact Zack
Schmidt, TC Chair.

The results of this submission may be viewed at:
http://tools.oasis-open.org/issues/browse/TCADMIN