| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| ItemOID | oidref | Required | Reference to the ItemDef. | Must match the OID atttribute for an ItemDef in the Study/MetaDataVersion. |
| Mandatory | (Yes | No) | Required | Indicator of whether this ItemGroup must appear in the study clinical data for each subject per the study protocol. | When the value is Yes, the data for each subject in the study must include an ItemData element with this ItemOID. |
| OrderNumber | integer | Optional | Indicates the order in which this ItemDef appears in Metadata displays or data entry applications. | OrderNumber must be a positive integer. The ItemRefs within an ItemGroupDef must not have duplicate OrderNumber values. |
| KeySequence | integer | Optional | Indicates that this item is a key for the enclosing ItemGroup. It also provides an ordering for the keys. | KeySequence must be a positive integer. The ItemRefs within an ItemGroupDef must not have duplicate KeySequence values. |
| MethodOID | oidref | Optional | Reference to a MethodDef. | The MethodOID value must match the OID attribute for a MethodDef in this Study/MetaDataVersion. |
| UnitsItemOID | oidref | Optional | Reference to a sibling ItemRef element that represents the unit specification for this ItemRef. | The sibling ItemRef element will have ItemOID=UnitsItemOID and the UnitsItemOID value must match the OID attribute for the ItemDef that defines the units for this Item. |
| Repeat | (Yes) | Optional | Indicates that the item serves as the item over which repeats are to be performed. | The corresponding ItemDef must have an associated CodeList containing the items over which the repeat is to be performed. |
| Other | (Yes) | Optional | Indicates that the Item represents "other" content added to an ItemGroup. | |
| Role | text | Optional | The Role for the referenced ItemDef. | |
| RoleCodeListOID | oidref | Optional | Reference to a CodeList that defines the allowable values of Role for the Study. | The RoleCodelistOID must match the OID attribute for a CodeList within the Study/MetaDataVersion. |
| CollectionExceptionConditionOID | oidref | Optional | Reference to a ConditionDef | The CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion. |
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