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
/chet
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Chet Ensign
Director of Standards Development and TC Administration
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