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Element NameKeySet
Parent ElementsAssociation
Element XPath(s)

/ODM/Association

Element Textual ValueNone
Attributes

StudyOID, SubjectKey, MetaDataVersionOID, StudyEventOID, StudyEventRepeatKey, ItemGroupOID, ItemGroupRepeatKey, ItemOID 

Child ElementsNone
Usage/Business Rules

AttributeSchema Type or Enumeration ValuesUsageDefinitionBusiness Rule(s)
StudyOIDoidref
References the StudyOID in an ODM/ClinicalData element.
  • Matches the Association/@StudyOID.
SubjectKeysubjectKeyOptionalReference to a SubjectKey attribute value for a SubjectData child element of this ClinicalData element.
  • Matches the SubjectKey attribute for a ClinicalData/SubjectData element.


MetaDataVersionOIDoidrefOptionalReference to a MetaDataVersionOID attribute value for this ClinicalData element.
  • Matches the MetaDataVersionOID attribute for this ClinicalData element.
StudyEventOIDoidrefOptional

Reference to a StudyEventOID attribute value for a StudyEventData child element of this ClinicalData/SubjectData element.

  • Matches the StudyEventOID attribute for a StudyEventData child element of this ClinicalData/SubjectData element.
StudyEventRepeatKeyrepeatKeyOptionalReference to a StudyEventRepeatKey attribute value for a StudyEventData child element of this ClinicalData/SubjectData/StudyEventData element.
  • Matches the StudyEventRepeatKey attribute for this ClinicalData/SubjectData/StudyEventData element.
ItemGroupOIDoidrefOptionalReference to an ItemGroupOID attribute value for an ItemGroupData child element of this ClinicalData/SubjectData/StudyEventData element.
  • Matches the ItemGroupOID attribute for an ItemGroupData child of this ClinicalData/SubjectData/StudyEventData.
ItemGroupRepeatKeyrepeatKey(OptionalReference to an ItemGroupRepeatKey attribute value for an ItemGroupData child element of this ClinicalData/SubjectData/StudyEventData element. 
  • Matches the ItemGroupRepeatKey value for this ClinicalData/SubjectData/StudyEventData/ItemGroupData element.
ItemOIDoidrefOptionalReference to an ItemOID attribute for an ItemData child  element of this ClinicalData/SubjectData/StudyEventData/ItemGroupData element.
  • Matches the ItemOID for an ItemData child of this ClinicalData/SubjectData/StudyEventData/ItemGroupData element.


A KeySet references a single entity: a study, a subject, a study event, etc. Only the attributes needed to specify the particular entity are required, and all others must be omitted (see Section 2.7, Clinical Data Keys).

ODM-32 - Getting issue details... STATUS

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