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Element NameCoding
Parent Element(s)
ParameterValue

StudyParameter, ParameterValue, StudyIndication, StudyIntervention, StudyTargetPopulation, CriterionStudyEventGroupDef, StudyEventDef, ItemGroupDef

, Origin, SourceItems, SourceItem, ItemDefCodeListCodeListItem

EnumeratedItem

,

 

Annotation

Element XPath(s)
  • /ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter/ParameterValue/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndications/StudyIndication/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulation/Coding
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion/Coding
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion/Coding
  • /ODM/Study/MetaDataVersion/StudyEventGroupDef/Coding
  • /ODM/Study/MetaDataVersion/StudyEventDef/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Source/Coding
  • /ODM/Study/MetaDataVersion
/ItemDef
  • /ItemGroupDef/ItemRef/Origin/Source/SourceItem/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Origin/Coding
  • /ODM/Study/MetaDataVersion/
CodeList
  • ItemGroupDef/Origin/Source/Coding
  • /ODM/Study/MetaDataVersion/
CodeList
  • ItemGroupDef/Origin/Source/SourceItem/Coding
/CodeListItem
  • /ODM/Study/MetaDataVersion/ItemDef/Coding
  • /ODM/Study/MetaDataVersion/CodeList/Coding
/EnumeratedItem
  • /ODM/Study/MetaDataVersion/CodeList/CodeListItem/Coding
  • /ODM/ClinicalData/Annotations/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/StudyEventData/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation/Coding
Element Textual ValueNone
Usage
AttributesCode, System, SystemName, SystemVersion, href, ref, CommentOID
Child ElementsNone

...

Reference to a CommentDef
CodetextSystemURISystemNametext(optional)SystemVersiontext(optional)
hrefURI(optional)URI reference to the Code definition
CommentOID See ODM2DEV-64text(optional)Usage/Business Rules