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Element NameItemDef
Parent Element(s)MetaDataVersion
Element XPath(s)/ODM/Study/MetaDataVersion/ItemDef
Element Textual ValueNone
AttributesOID, Name, DataType, Length, DisplayFormat, VariableSet, CommentOID
Child Elements(Description?, Definition?, Question?, Prompt?, CRFCompletionInstructions?, ImplementationNotes?, CDISCNotes?,  RangeCheck*, CodeListRef?, ValueListRef?, Coding*, Alias*)
Usage/Business Rules
  • Business Rule(s):
    • There must be an ItemDef element for each unique ItemOID attribute value in the study.
  • Other Information:
    • The Question element contains the text shown to a human user when prompted to provide data for this Item.
    • The Alias element may be added to represent an alternative name for the ItemDef, for example setting with Context="SASFieldName" for SAS dataset variable names.
    • The RangeChecks constrain the acceptable values for items of this type.
    • The CodeListRef (if present) constrains the acceptable values for items of this type to be members of the referenced codelist.
    • The Origin attribute in ODM v1.3 has been replaced by an Origin element attached to the ItemRef. This allows a different Origin to be specified depending on where the Item is used.