ItemRef Attributes

Must match the OID attribute for an ItemDef in the Study/MetaDataVersion.

The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate ItemOID values.

Indicator of whether this ItemGroup must appear in the study clinical data for each subject per the study protocol.

The Mandatory flag indicates that the clinical data for an instance of the containing element would be incomplete without an instance of this type of item.

When the value is Yes, the data for each subject in the study must include an ItemData element with this ItemOID.

ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.

SDTM and CDASH Core designations. 

Reference the appropriate specifications for more a complete description. Example: CDASH: HR, R/C, O; SDTM: Req, Exp, Perm.

Indicates the order in which this ItemRef appears in Metadata displays or data entry applications.

The OrderNumbers provide an ordering on the Items (within a containing element) for use whenever a list of Items is presented to a user. They do not imply anything about event scheduling, time ordering, or data correctness.

OrderNumber must be a positive integer.

The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate OrderNumber values.

KeySequence must be a positive integer.

The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate KeySequence values.

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

• 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). 

Reference to a sibling ItemRef element that represents the unit specification for this ItemRef (defines the associated units variable).

Prefill value or a default value for a field that is automatically populated.

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".

The Role for the referenced ItemDef.

The Role attribute provides a single role name describing the use of this data item.

If the Role is defined by a standard terminology, RoleCodeListOID may be used to reference a CodeList that defines the full set roles from which the Role attribute value is to be taken.

This attribute should not be present unless the Role attribute is defined.

The RoleCodelistOID must match the OID attribute for a CodeList within the Study/MetaDataVersion.

If Role is defined, RoleCodeListOID is still optional.