Document Actions  

Document:
03003: Approve Electronic Trial Master File (eTMF) Specification Version 1.0 with Non-Material Changes as a CS?

Draft (A preliminary unapproved sketch, outline, or version.)

Details

Submitted By Mr. Chet Ensign on 2016-10-26 12:03 am UTC

Publication Type

None at this time.

Group / Folder

OASIS Electronic Trial Master File (eTMF) Standard TC / System Ballot Results

Modified by

Not modified.

Copy

This document is not a copy.

Technical Contact

None at this time.

Download Count

1003

Download Agreement

None at this time.

Description

This ballot requires a Special Majority Vote [3]. The TC roster currently lists 10 voting members. In order to pass, at least 7 members have to vote Yes and no more than 2 members may vote No. [1] URI for the specification http://www.oasis-open.org/committees/document.php?document_id=59146&wg_abbrev=etmf [2] The Working Draft for this Committee Specification contains changes made since its last public review. The changes made are documented in https://www.oasis-open.org/committees/document.php?document_id=59147&wg_abbrev=etmf. The TC judges these changes to be Non-Material Changes in accordance with the definition in the OASIS TC Process (http://www.oasis-open.org/policies-guidelines/tc-process#dNonmaterialChange). [3] http://www.oasis-open.org/committees/process-2010-07-28.php#dSpecialMajority