[OASIS Issue Tracker] (ETMF-13) Focus problem addressed on exchange of content between systems e.g. from CRO to sponsor.

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

Jennifer Alpert Palchak created ETMF-13:
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             Summary: Focus problem addressed on exchange of content between systems e.g. from CRO to sponsor.
                 Key: ETMF-13
                 URL: https://issues.oasis-open.org/browse/ETMF-13
             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
            Priority: Minor
             Fix For: CSD-PR-1 Comments


The abbreviation EDMS is more commonly used for “Electronic Document Management System” and not “Enterprise Document Management System”.  The problem that this specification addresses is not limited to those with ENTERPRISE Document Management Systems. The problem affects any organization using an ELECTRONIC record-keeping, ELECTRONIC records management or ELECTRONIC document management system for clinical trial documents or records.
The examples chosen to demonstrate the problem do not include the most common and most problematic issue facing the clinical trial domain, namely exchange of content between systems e.g. from CRO to sponsor. The ability to conduct searches across distributed sets of trial data is not the principal problem that stakeholders align themselves with.




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