Clinical data corresponding to an ItemGroupRef defined in the active MetaDataVersion. 

Element NameItemGroupData
Parent ElementsClinicalData, ReferenceData, StudyEventData
Element XPath(s)

/ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData

/ODM/ReferenceData/ItemGroupData

/ODM/ClinicalData/ItemGroupData 

Element Textual ValueNone
AttributesItemGroupOID, ItemGroupRepeatKey, TransactionType, ItemGroupDataSeq
Child Elements(ItemGroupData*, ItemData*)+, AuditRecord?, Signature?, Annotation*, Query*)
Usage/Business Rules
  • Other Information:
    • The ItemGroupOID and ItemGroupRepeatKey attributes are used together to identify a particular item group. This pair of values uniquely identifies an ItemGroup within the containing StudyEvent.
    • The model supports nested and repeating item groups.

AttributeSchema Type or Enumeration ValuesUsageDefinitionBusiness Rule(s)
ItemGroupOIDoidrefRequiredReference to an ItemGroupDef for the MetaDataVersion identified in the ClinicalData element.
  • The values of ItemGroupOID must be unique within the parent element.
ItemGroupRepeatKeyrepeatKey

Conditional

  • Required when the Repeating attribute for the ItemGroupDef element is "Yes".
A key used to distinguish between repeats of the same type of item group.
  • The values of ItemGroupRepeatKey must be unique within the parent element.
  • The ItemGroupRepeatKey is present only if the ItemGroupDef is repeating.
  • For /ODM/ReferenceData/ItemGroupData, the ItemGroupOID and ItemGroupRepeatKey pair must be unique.
TransactionTypeInsert | Update | Remove | Upsert | Context

Conditional

  • Required when the FileType attribute for the ODM element is Transactional.
The TransactionType attribute need not be present in a Snapshot document.
ItemGroupDataSeqpositiveInteger

Conditional

  • Required when the parent element is ReferenceData or ClinicalData, the ItemGroupDataSeq.

Unique sequence # for each ItemGroupData child element (record) in the container element.

The ItemGroupDataSeq attribute doesn’t have any other meaning than the sequence in which the items are saved and exchanged for each ItemGroupDef. It is equivalent to the observation # in a dataset.

  • ItemGroupDataSeq may only be used when ItemGroupData is a direct child of either ClinicalData or ReferenceData and the ItemGroupData represents a row in a dataset.
  • The ItemGroupDataSeq and ItemGroupRepeatKey attributes are mutually exclusive.



Example

Multiple Selection Using Nested ItemGroupDefs
<?xml version="1.0" encoding="UTF-8"?> 
<ODM xmlns="http://www.cdisc.org/ns/odm/v2.0" FileOID="MyStudy_1" FileType="Snapshot" CreationDateTime="2019-03-11T17:33:17">  
    <Study OID="MyStudy" StudyName="My Study">
        <MetaDataVersion OID="MDV.MyStudy.001" Name="Study MyStudy 001, Data Definitions V-1">
			<ItemGroupDef OID="ODM.IG.DM" Name="Demographics" Repeating="No" Type="Section">
                <ItemRef ItemOID="IT.DM.BRTHYR" Mandatory="Yes"/>
                <ItemRef ItemOID="IT.DM.BRTHMO" Mandatory="Yes"/>
                <ItemRef ItemOID="IT.DM.BRTHDY" Mandatory="Yes"/>
                <ItemRef ItemOID="IT.DM.SEX" Mandatory="Yes"/>
                <ItemRef ItemOID="IT.DM.ETHNIC" Mandatory="Yes"/>
                <ItemGroupRef ItemGroupOID="ODM.IG.RACE" Mandatory="Yes" />
                <ItemGroupRef ItemGroupOID="ODM.IG.RACEOTH" Mandatory="No"/>
            </ItemGroupDef>
            <ItemGroupDef OID="ODM.IG.RACE" Name="Race" Repeating="Static" Type="Section">
                <ItemRef ItemOID="IT.DM.RACE" Mandatory="Yes" />
            </ItemGroupDef>
            <ItemGroupDef OID="ODM.IG.RACEOTH" Name="Race Other(s)" Repeating="Simple" RepeatingLimit="2" Type="Section">
                <ItemRef ItemOID="IT.DM.RACEOTH" Mandatory="No" Repeat="Yes"/>
            </ItemGroupDef>
            <ItemDef OID="IT.DM.RACE" Name="RACE" DataType="text" Length="41">
                <Description>
                    <TranslatedText xml:lang="en" Type="text/plain">Race</TranslatedText>
                </Description>
                <Question>
                    <TranslatedText xml:lang="en" Type="text/plain">Race (Select all that apply)</TranslatedText>
                </Question>
                <CodeListRef CodeListOID="CL.RACE"/>
            </ItemDef>
            <ItemDef OID="IT.DM.RACEOTH" Name="RACEOTH" DataType="text" Length="41">
                <Description>
                    <TranslatedText xml:lang="en" Type="text/plain">Race Other</TranslatedText>
                </Description>
                <Question>
                    <TranslatedText xml:lang="en" Type="text/plain">Other Race (Include maximum two other values not
                        listed under RACE)</TranslatedText>
                </Question>
            </ItemDef>
        </MetaDataVersion>
    </Study>
    <!-- Clinical Data -->
    <ClinicalData StudyOID="MyStudy" MetaDataVersionOID="MDV.MyStudy.001">
		<!-- Usually, the ItemGroupData is embedded within SubjectData-StudyEventData-(ItemGroupData).
			This is however omitted here for clarity -->
        <ItemGroupData ItemGroupOID="IG.DM" ItemGroupDataSeq="2">
            <ItemData ItemOID="IT.STUDYID">
                <Value>CDISC01</Value>
            </ItemData>
            <ItemData ItemOID="IT.DM.DOMAIN">
                <Value>DM</Value>
            </ItemData>
            <ItemData ItemOID="IT.USUBJID">
                <Value>CDISC01.100014</Value>
            </ItemData>
            <ItemData ItemOID="IT.DM.SUBJID">
                <Value>100014</Value>
            </ItemData>
            <ItemData ItemOID="IT.DM.SITEID">
                <Value>100</Value>
            </ItemData>
            <ItemData ItemOID="IT.DM.BRTHDTC">
                <Value>1936-11-01</Value>
            </ItemData>
            <ItemData ItemOID="IT.DM.AGE">
                <Value>66</Value>
            </ItemData>
            <ItemData ItemOID="IT.DM.AGEU">
                <Value>YEARS</Value>
            </ItemData>
            <ItemData ItemOID="IT.DM.SEX">
                <Value>F</Value>
            </ItemData>
            <ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="1">
                <ItemData ItemOID="IT.DM.RACE">
                    <Value>NATIVE HAWAIIAN</Value>
                </ItemData>
            </ItemGroupData>
            <ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="2">
                <ItemData ItemOID="IT.DM.RACE">
                    <Value>ASIAN</Value>
                </ItemData>
            </ItemGroupData>
            <ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="3">
                <ItemData ItemOID="IT.DM.RACE">
                    <Value>WHITE</Value>
                </ItemData>
            </ItemGroupData>
            <ItemGroupData ItemGroupOID="ODM.IG.RACEOTH" ItemGroupRepeatKey="1">
                <ItemData ItemOID="IT.DM.RACEOTH">
                    <Value>Other free text Race value"</Value>
                </ItemData>
            </ItemGroupData>
            <ItemGroupData ItemGroupOID="ODM.IG.RACEOTH" ItemGroupRepeatKey="2">
                <ItemData ItemOID="IT.DM.RACEOTH">
                    <Value>Another free text Race value</Value>
                </ItemData>
            </ItemGroupData>
        </ItemGroupData>
    </ClinicalData>
</ODM>

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