ItemRef

A reference to an ItemDef as it occurs within a specific ItemGroupDef. The list of ItemRefs identifies the types of items that are allowed to occur within this type of item group.

Element Name	ItemRef
Parent Element(s)	ValueListDef ItemGroupDef
Element XPath(s)	/ODM/Study/MetaDataVersion/ValueListDef/ItemRef /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef
Element Textual Value	None
Attributes	ItemOID, KeySequence, IsNonStandard, HasNoData, MethodOID, UnitsItemOID, Repeat, Other, Role, RoleCodeListOID, OrderNumber, Mandatory, CollectionExceptionConditionOID, Core, PreSpecifiedValue
Child Elements	(Origin, WhereClauseRef)
Usage/Business Rules	Business Rule(s): For each ItemDef in a MetaDataVersion element there must be at least one ItemRef where the ItemRef/@ItemOID attribute matches ItemDef/@OID attribute. Other Information: The "Other" attribute is also used in the CodeListItem element.

Attribute	Schema Datatype or Enumeration	Usage	Definition	Business Rule(s)
ItemOID	oidref	Required	Reference to the ItemDef.	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.
Mandatory	(Yes \| No)	Required	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. ODM clinical data files that are incomplete in this sense may be considered incomplete for study review and analysis purposes.	When the value is "Yes", the data for each subject in the study must include an ItemData element with this ItemOID.
Core	(HR \| O \| R/C \| Cond \| Exp \| Perm \| Req)	Optional	CDASH, ADaM, SDTM, and SEND Core designations.	Reference the appropriate specifications for complete requirements. Example: CDASH: "HR", "R/C", "O"; SDTM: "Req", "Exp", "Perm".
OrderNumber	positiveInteger	Optional	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.	The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate OrderNumber values.
KeySequence	positiveInteger	Optional	Indicates that this item is a key for the enclosing element. It also provides an ordering for the keys.	The ItemRefs within an ItemGroupDef or ValueListDef 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.
MethodOID	oidref	Optional	Reference to a MethodDef used to derive the value of this item.	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 (defines the associated units variable).	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.
PreSpecifiedValue	text	Optional	Prefill value or a default value for a field that is automatically populated.
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. There may only be one ItemRef within the ItemGroupDef with Repeat="Yes".
Other	(Yes)	Optional	Flag to indicate that the Item represents "other" content added to an ItemGroup.
Role	text	Optional	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 must not be present unless the Role attribute is defined.
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. If Role is defined, RoleCodeListOID is still optional.
CollectionExceptionConditionOID	oidref	Optional	Reference to a ConditionDef that defines the circumstances under which collection of the Item may be omitted.	The CollectionExceptionConditionOID value must match the OID attribute for a ConditionDef in this Study/MetaDataVersion.

Example: ItemRef with ConditionDef

This example illustrates a data-collection instrument designed to collect data for an item IsPregnant for an item group InclusionCriteria, omitted for male subjects. The referenced ConditionDef would be defined as illustrated below. When the FormalExpression evaluates to True, the Item with OID IG.ISPREG need not be collected.

ItemRef with ConditionDef

            <ItemGroupDef OID="INCLUSION" Name="Inclusion Criteria" Repeating="No" Type="Section">
                <ItemRef ItemOID="ID.GENDER" Mandatory="Yes">
                    <Origin Type="Collected" Source="Sponsor"></Origin>
                </ItemRef>
                <ItemRef ItemOID="ID.ISPREG" Mandatory="Yes" CollectionExceptionConditionOID="CECID.ISMALE"/>
                <Origin Type="Collected" Source="Sponsor">
                    <SourceItems>
                        <SourceItem>
                            <Resource Type="ODM" Name="ItemDef" Label="Gender">
                                <Selection Path="../../ItemDef[@OID='ID.GENDER']/@Value"></Selection>
                            </Resource>
                        </SourceItem>
                    </SourceItems>
                </Origin>
            </ItemGroupDef>
            ...

            <ConditionDef OID="CECID.ISMALE" Name="Subject's gender is Male">
                <Description>
                    <TranslatedText xml:lang="en" Type="text/plain">Do not collect data for Male subjects</TranslatedText>
                </Description>
                <MethodSignature>
                    <Parameter Name="Gender" DataType="text"/>
                    <ReturnValue Name="IsMale" DataType="boolean"/>
                </MethodSignature>
                <FormalExpression Context="PL/SQL">
                    <Code>IsMale = (Gender := 'Male')</Code>
                </FormalExpression>
            </ConditionDef>



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