OASIS Electronic Trial Master File (eTMF) Standard TC Public Documents

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OASIS Electronic Trial Master File (eTMF) Standard TC   (Showing 10 of 172)
Document Name # Size State Submitter Date Action
0
14K
Draft
Chet Ensign
2016-10-25
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
0
465K
Draft
Zack Schmidt
2016-10-17
Oct 17 2016 Meeting Minutes - approval by TC of OASIS eTMF Specification 1.0
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322K
Approved Document
Zack Schmidt
2016-10-16
Oct 16 2016 meeting minutes
0
186K
Draft
Zack Schmidt
2016-10-16
Summary of Changes, OASIS Electronic Trial Master File (eTMF) Specification, CSD Draft 03 201607
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4MB
Draft
Zack Schmidt
2016-10-16
For TC approval at 16 October 2016 meeting.
0
358K
Approved Document
Zack Schmidt
2016-08-15
Aug 8 2016 TC minutes. Contains motion and vote to approve OASIS eTMF committee spec draft for publication
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358K
Approved Document
Zack Schmidt
2016-08-08
TC Vote on Committee Spec Draft V3.0
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Committee Draft
Paul Knight
2016-08-08
CSPRD02: Electronic Trial Master File (eTMF) Specification Version 1.0 Committee Specification Draft 02 / Public Review Draft 02 08 August 2016 http://docs.oasis-open.org/etmf/etmf/v1.0/csprd02/etmf-v1.0-csprd02.docx http://docs.oasis-open.org/etmf/etmf/v1.0/csprd02/etmf-v1.0-csprd02.html http://docs.oasis-open.org/etmf/etmf/v1.0/csprd02/etmf-v1.0-csprd02.pdf Schema: http://docs.oasis-open.org/etmf/etmf/v1.0/csprd02/schema/ Metadata vocabulary: http://docs.oasis-open.org/etmf/etmf/v1.0/csprd02/vocabulary/
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Committee Draft
Paul Knight
2016-08-08
CSD02: Electronic Trial Master File (eTMF) Specification Version 1.0 Committee Specification Draft 02 08 August 2016 http://docs.oasis-open.org/etmf/etmf/v1.0/csd02/etmf-v1.0-csd02.docx http://docs.oasis-open.org/etmf/etmf/v1.0/csd02/etmf-v1.0-csd02.html http://docs.oasis-open.org/etmf/etmf/v1.0/csd02/etmf-v1.0-csd02.pdf Schema: http://docs.oasis-open.org/etmf/etmf/v1.0/csd02/schema/ Metadata vocabulary: http://docs.oasis-open.org/etmf/etmf/v1.0/csd02/vocabulary/
0
2MB
Draft
Zack Schmidt
2016-07-29
OASIS eTMF Standard, Committee Specification Draft (CSD) V3. Published for review and vote by Technical Committee (TC). Note: The specification cover page may change slightly prior to TC vote to conform to OASIS policies and to include important OASIS information such as URL resources.