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Subject: RE: [etmf-comment] regarding Post: OASIS eTMF Standard Draft Approved
Thank you, Chet. I appreciate the feedback. Regards, Karin From: Chet Ensign [mailto:chet.ensign@oasis-open.org]
Hi Karin, I am requesting clarification from the Technical Committee regarding this issue. In addition, to eliminate any confusion that has been generated by the post, please note that there is no public review of the eTMF Committee Specification
Draft underway at this time and that there is no formal Committee Specification Draft yet published. The link provided in the post is to the TC's current working draft. /chet On Wed, Jun 18, 2014 at 1:08 PM, Schneider, Karin [JRDUS] <KSchnei1@its.jnj.com> wrote: Hi, few comments regarding this post:
OASIS eTMF Standard
Draft Approved
·
There is a 45-day public review period but I find the information on NCI as if it was final, why? ·
The source is identified as “CareLex”, I thought this is an independent Oasis initiative, am I wrong? ·
It states: Support for the TMF Reference model — OASIS eTMF Standard controlled
vocabulary terms were reviewed by members of the TMF Reference Model community to provide a cross-reference between terms in the OASIS eTMF Standard controlled vocabulary and terms in the TMF Reference Model. Published in the OASIS eTMF Standard controlled
vocabulary, the cross-referencing resource is designed to provide a path forward to groups who may have implemented the TMF Reference model terms and are interested in migrating to the OASIS eTMF Standard for existing or new clinical studies.
I am part of the TMF Ref model community and would be surprised if my fellow members approved the term below (example) which has an altered definition and is misspelled. ·
What is the level of no NCI governance that was applied to approve new terminology and position its use accurately?
Thank you,
Karin Schneider
TMF Reference Model SC team member
-- Check your work using the Support Request Submission Checklist at http://www.oasis-open.org/committees/download.php/47248/tc-admin-submission-checklist.html |
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