[OASIS Issue Tracker] (ETMF-11) Questions whether Specification is applicable to eTMF only or Clinical Trials domain

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

Jennifer Alpert Palchak created ETMF-11:
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             Summary: Questions whether Specification is applicable to eTMF only or Clinical Trials domain
                 Key: ETMF-11
                 URL: https://issues.oasis-open.org/browse/ETMF-11
             Project: OASIS Electronic Trial Master File (eTMF) Standard TC
          Issue Type: Bug
          Components: Specification
    Affects Versions: CSD-PR-1 Comments
         Environment: Eldin Rammell <eldin.rammell@rammell.com>
            Reporter: Jennifer Alpert Palchak


"The text is not specific enough for an introduction to a global specification of this kind. The specification is specifically for content of the trial master file and NOT the “clinical trial domain”. The conduct of clinical trials creates numerous other data, documents and records – together with the systems that manage those data, documents and records - which are outside the scope of this specification."



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