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| Element Name | ODM |
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| Element XPath(s) | /ODM |
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| Element Textual Value | None |
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| Attributes | FileType, Granularity, Context, FileOID, CreationDateTime, PriorFileOID, AsOfDateTime, ODMVersion, Originator, SourceSystem, SourceSystemVersion |
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| Child Elements | (Description?, Study*, AdminData*, ReferenceData*, ClinicalData*, Association*) |
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| Usage/Business Rules | - Requirement: Required
- Other Information: The whole document (but essentially each extensible element within the ODM document) can be signed off through an electronic signature (e.g., XAdES) by adding a suitable element as last element, such as ds:Signature in the namespace "http://www.w3.org/2000/09/xmldsig#".
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