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changes.mady.by.user Sally Cassells

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changes.mady.by.user Lex Jansen

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Element NameMetaDataVersion
Parent ElementsStudy
Element XPath(s)

/ODM/Study/MetaDataVersion

Element Textual ValueNone
Usage/Business Rules
AttributesOID, Name, CommentOID
Child Elements

(Description?, Include?, Standards?,

 

AnnotatedCRF?,

Include?, 

SupplementalDoc?, ValueListDef*, WhereClauseDef*, Protocol?, WorkflowDef*

, StudyTiming?

, StudyEventGroupDef*, StudyEventDef*, ItemGroupDef*, ItemDef*, CodeList*, ConditionDef*, MethodDef*, CommentDef*, Leaf*)

Attributes:

...

Contained in:

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A metadata version defines the types of study structural elements, workflows, event timings, study event groups, study events, item groups, and items that form the study data.

Usage/Business Rules
  • Business Rule(s):
    • Required when ODM/@Granularity is in  (All | Metadata).

  • Other Information:

    • The Include element references a prior metadata version. This causes all the definitions in that prior metadata version to be automatically included in this one.

...

    • Any of the included definitions can be replaced (overridden) by explicitly giving a new version of the definition (with the same OID) in the new metadata version

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    • . See Section 3.2.2.1.1, Include, for more information on how the Include element works. New definitions (with new OIDs) can be added in the same way.

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