| Element Name | ItemDef |
|---|
| Parent Element(s) | MetaDataVersion |
|---|
| Element XPath(s) | /ODM/Study/MetaDataVersion/ItemDef |
|---|
| Element Textual Value | None |
|---|
| Attributes | OID, 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- The Origin attribute in ODM v1.3 has been replaced by an Origin element attached to the ItemRef.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.
|
|---|