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Old Version 11

changes.mady.by.user Marcelina Hungria

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New Version 12

changes.mady.by.user Lex Jansen

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Key

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Element NameODM
Parent Element(s)None
Element XPath(s)

/ODM

Element Textual ValueNone
AttributesFileType, Granularity, Context, FileOID, CreationDateTime, PriorFileOID, AsOfDateTime, ODMVersion, Originator, SourceSystem, SourceSystemVersion
Child Elements(Description?, Study*, AdminData*, ReferenceData*, ClinicalData*, Association*)
Usage/Business Rules
  • Requirement: Required
    • Cardinality: Exactly one
  • 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#".