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Subject: [OASIS Issue Tracker] Updated: (ETMF-8) Export formats for interoperability

     [ http://tools.oasis-open.org/issues/browse/ETMF-8?page=com.atlassian.jira.plugin.system.issuetabpanels:all-tabpanel ]

Zack Schmidt updated ETMF-8:

    Fix Version/s: Pre-Working Draft
      Component/s: Data Model 
                       (was: General)

> Export formats for interoperability
> -----------------------------------
>                 Key: ETMF-8
>                 URL: http://tools.oasis-open.org/issues/browse/ETMF-8
>             Project: OASIS Electronic Trial Master File (eTMF) Standard TC
>          Issue Type: Task
>          Components: Data Model 
>            Reporter: Eldin Rammell
>             Fix For: Pre-Working Draft
> In relation to the general point about export formats for TMF content, I think we need to be wary about precluding specific content types unless there are strong technical reasons for doing so. The primary objective of the standard is to facilitate the exchange of TMF content between systems. If we put artificial barriers in place that only allow, for example, PDF documents to be exchanged, this will severely limit the utility of the standard. If eTMF system X provides for the storage and management of Microsoft Word documents and eTMF system Y also provides for the storage and management of Microsoft Word documents, the interoperability standard should permit the exchange of Microsoft Word documents between these two systems and should not mandate that those documents first be rendered to PDF. This is particularly important for the exchange of TMF content between CRO eTMF and sponsor eTMF, where the original native file format is often required to be transferred. In addition, whilst many eTMF systems currently in use automatically generate a PDF rendition of final documents, this is by no means applicable to all eTMFs.

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