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Subject: [OASIS Issue Tracker] (ETMF-14) Questions if Specification pertains to Clinical Trial Content/Domain or only eTMF Content/Domain


Jennifer Alpert Palchak created ETMF-14:
-------------------------------------------

             Summary: Questions if Specification pertains to Clinical Trial Content/Domain or only eTMF Content/Domain
                 Key: ETMF-14
                 URL: https://issues.oasis-open.org/browse/ETMF-14
             Project: OASIS Electronic Trial Master File (eTMF) Standard TC
          Issue Type: Task
          Components: Specification
    Affects Versions: CSD-PR-1 Comments
         Environment: Eldin Rammell <eldin.rammell@rammell.com>
            Reporter: Jennifer Alpert Palchak
             Fix For: CSD-PR-1 Comments


The phrase “clinical trial content” is used incorrectly. This specification is limited to the content of the trial master file and not ALL clinical trial content. Please replace with “clinical trial master file content”....
Please change “clinical trial domain” in paragraph 3 of 2.1 to “clinical trial master file domain”; this specification is limited in scope to the trial master file only.




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