| Element Name | ItemDef |
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| Parent Element(s) | MetaDataVersion |
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| Element XPath(s) | /ODM/Study/MetaDataVersion/ItemDef |
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| Element Textual Value | None |
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| Usage | Conditional. There must be an ItemDef element for each unique ItemOID attribute value in the study. |
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| Attributes | OID, Name, DataType, Length, DisplayFormat, VariableSet, CommentOID |
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| Child Elements | (Description?, Definition?, Question?, Prompt?, CRFCompletionInstructions?, ImplementationNotes?, CDISCNotes?, RangeCheck*, CodeListRef?, ValueListRef?, Coding*, Alias*) |
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| 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- The Origin attribute in ODM v1.3 has been replaced by an Origin element attached to the ItemRef.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.
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