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

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.


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