[OASIS Issue Tracker] (ETMF-17) Reference to "...Preparing for regulatory submissions"..

[OASIS Issues Tracker <workgroup_mailer@lists.oasis-open.org>]

Jennifer Alpert Palchak created ETMF-17:
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             Summary: Reference to "...Preparing for regulatory submissions"..
                 Key: ETMF-17
                 URL: https://issues.oasis-open.org/browse/ETMF-17
             Project: OASIS Electronic Trial Master File (eTMF) Standard TC
          Issue Type: Task
          Components: Core Terms
    Affects Versions: CSD-PR-1 Comments
         Environment: Eldin Rammell  <eldin.rammell@rammell.com>
            Reporter: Jennifer Alpert Palchak
            Priority: Minor
             Fix For: CSD-PR-1 Comments


The phrase “as well as preparing content for regulatory submissions” in paragraph 3 of 2.1 is not clear, is often not true and adds ambiguity to the definition of an eTMF. Regulatory submission preparation systems are more commonly completely separate from eTMF so to include this phrase is likely to result on reader confusion.



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