The type of flag. This determines the purpose and semantics of the flag.

Element NameFlagType
Parent ElementsFlag
Element XPath(s)
  • /ODM/ReferenceData/Annotation/FlagType
  • /ODM/ReferenceData/ItemGroupData/Annotation/FlagType
  • /ODM/ReferenceData/ItemGroupData/ItemData/Annotation/FlagType
  • /ODM/ClinicalData/Annotation/FlagType
  • /ODM/ClinicalData/ItemGroupData/Annotation/FlagType
  • /ODM/ClinicalData/ItemGroupData/ItemData/Annotation/FlagType
  • /ODM/ClinicalData/SubjectData/Annotation/FlagType
  • /ODM/ClinicalData/SubjectData/StudyEventData/Annotation/FlagType
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation/FlagType
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation/FlagType
Element Textual Valuename (name is a text with no whitespace)
AttributesCodeListOID
Child ElementsNone
Usage/Business Rules
  • Business Rule(s):
    • The Flag text must be a value from the CodeList definition.
  • Other Information:
    • The meaning of this value is typically dependent on the associated FlagType.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
CodeListOIDoidrefRequiredReference to the CodeList definition.
  • The valid values for a FlagType are provided by the study sponsor. 
  • Must match the OID for a CodeList element in the Study/MetaDataVersion.

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