[OASIS Issue Tracker] (ETMF-16) Clarify definition used as "Archive"

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

Jennifer Alpert Palchak created ETMF-16:
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             Summary: Clarify definition used as "Archive"
                 Key: ETMF-16
                 URL: https://issues.oasis-open.org/browse/ETMF-16
             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


For many readers, including the vast majority of those outside the US, the term “archive” has a very specific meaning in a regulated environment. An archive is a repository specifically designed for the long-term retention and preservation of documents and records and NOT a pseudonym for a file system or other repository. Whilst an electronic trial master file system may additionally provide appropriate features to be an archive repository too, they are more often 2 separate entities. An electronic trial master file is more usually unlikely to be suitable for retention of trial master file content for periods in excess of 25 years, as required by EU Clinical Trial Regulation 536/2014.



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