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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rules
ItemOIDoidrefRequiredReference to the ItemDef.Must match the OID atttribute for an ItemDef in the Study/MetaDataVersion.
Mandatory(Yes | No)RequiredIndicator 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.
OrderNumberintegerOptionalIndicates the order in which this ItemRef 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.

KeySequenceintegerOptionalIndicates 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.

IsNonStandard(Yes)Optional

A non-standard variable is one that is not defined in the SDTMIG or the underlying SDTM model of a standard referenced within the ODM document.

Permitted for any ItemRef that represents a non-standard variable in an SDTM or SEND dataset when the ODM Context attribute value is "Other"

Is not used with an ItemRef that represents a value level metadata for an SDTMIG SUPPQUAL dataset

Has no meaning for ADaM, so shall not be used for ADaM variables


HasNoData(Yes)Conditional
  • Used to indicate that an ItemRef that represent a dataset's variable has no data. Note that variables refer to both standard and non-standard/ supplemental qualifiers variables (/ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef or /ODM/Study/MetaDataVersion/ValueListDef/ItemRef). 
A comment must be included to explain why no data is present for dataset's variables that were planned for use in the study.
MethodOIDoidrefOptionalReference to a MethodDef.The MethodOID value must match the OID attribute for a MethodDef in this Study/MetaDataVersion.
UnitsItemOID
oidrefOptional

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)OptionalIndicates 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.
There may only be one ItemRef within the ItemGroupDef with Repeat="Yes".

Other(Yes)OptionalIndicates that the Item represents "other" content added to an ItemGroup.
RoletextOptionalThe Role for the referenced ItemDef.
RoleCodeListOIDoidrefOptionalReference 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.
CollectionExceptionConditionOIDoidrefOptionalReference to a ConditionDefThe CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion.

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