ItemGroupDef

An ItemGroupDef describes a type of variable or field grouping that can occur within a study.

Element Name	ItemGroupDef
Parent Elements	MetaDataVersion
Element XPath(s)	/ODM/Study/MetaDataVersion/ItemGroupDef
Element Textual Value	None
Attributes	OID, Name, Repeating, IsReferenceData, Structure, ArchiveLocationID, DatasetName, Domain, Type, Purpose, StandardOID, IsNonStandard, HasNoData, CommentOID
Child Elements	(Description?, Class?, (ItemGroupRef?, ItemRef?)+, Coding, WorkflowRef?, Origin, Alias*, Leaf?)
Usage/Business Rules	Business Rule(s): There must be an ItemGroupDef element for each unique ItemGroupOID attribute value in the study. Other Information: ODM v2.0 introduces nested ItemGroups. ItemGroupRef elements may be added to ItemGroupDef to create hierarchical data structures of arbitrary depth. Nested ItemGroupDefs can be used for enhanced re-usability of ItemGroups. They can also be used to represent semantic relationships between items, items that share common behaviors such as skip logic, or items that are displayed or collected together. The Coding child element allows to associate semantics within the group. For example, a LOINC panel code in the case that the ItemGroup represents a laboratory panel. The WorkflowRef child element allows to reference a workflow definition (WorkflowDef) for navigation within the ItemGroup, for example, when the ItemGroup represents a form or questionnaire (or part of it) where there is a workflow between the items or groups of items.

Attribute	Schema Datatype or Enumeration	Usage	Definition	Business Rule(s)
OID	oid	Required	Unique identifier for the ItemGroupDef element.	The OID attribute value must be unique within the Study/MetaDataVersion.
Name	name	Required	Human readable name for the ItemGroupDef.	The Name attribute must be unique within set of ItemGroupDef elements within a Study/MetadataVersion.
Repeating	(No \| Simple \| Dynamic \| Static)	Required	The Repeating attribute indicates that the ItemGroup may occur repeatedly within the containing element. Simple - the ItemGroup repeats within the containing element and is not bound in any way. Note: It is equivalent to the ODM v1.3.2 case where Repeating="Yes". Dynamic - ItemGroupData repeats based on values in a codelist. There may be multiple occurrences for some codelist items. Static - ItemGroupData repeats based on values in a codelist. Only one occurrence may happen for each codelist item.	For cases where Repeating is set to Dynamic or Static, one ItemRef within the ItemGroup must include the Repeat="Yes" attribute to indicate that that specific ItemRef references the codelist that establishes the Repeating behavior. If IsReferenceData is "Yes", the ItemGroup can occur only within a ReferenceData element. If IsReferenceData is "No", the ItemGroup can occur only within a ClinicalData element.
RepeatingLimit	positiveInteger	Optional	Maximum number of repeats.	RepeatingLimit can only be used when Repeating="Simple".
IsReferenceData	(Yes \| No)	Optional	Specifies whether this ItemGroupDef is used for non-subject data.	Data content for ItemGroupDef elements where the IsReferenceData attribute is "Yes" is under the /ODM/ReferenceData element.
Structure	text	Optional	Description of the level of detail represented by individual records in the ItemGroup
ArchiveLocationID	oidref	Optional	Reference to the unique ID of a leaf element that provides the actual location and file name of the data file.	If provided, the value must match the leaf ID attribute of the leaf child element.
DatasetName	name	Optional	Name of a file containing the ItemGroupData for this ItemGroupDef. The name applies to the object itself rather then providing a mapping to a different object.	Could have constraints on individual ODM extensions, such as Define-XML or associated CDISC Metadata Guidelines. For example, DatasetName could be defined as sasName (see Section 2.14, Data Formats) in Define-XML or associated CDISC Metadata Guidelines.
Domain	text	Optional	Identifies the scope or CDISC SDTMIG/SENDIG Domain of the ItemGroup data. The domain applies to the object itself rather then providing a mapping to a different object.	Usage requirements are based on the applicable CDISC Standard. Could have constraints on individual ODM extensions, such as Define-XML or associated CDISC Metadata Guidelines.
Type	(Form \| Section \| Dataset \| Concept)	Required	identifies the type of data structure the ItemGroup represents. Form - a CRF for data collection. Note, ItemGroupDef Type="Form" replaces the ODM v1.x FormDef element. Section - a section within a CRF. Dataset - tabulation, analysis or operational datasets. Concept - defines a biomedical concept.	Type is an extensible attribute. Type="Section" can only be used when the ItemGroup has a top-level ancestor ItemGroup that has Type="Form".
Purpose	text	Optional	Purpose of the ItemGroup.	Usage requirements are based on the applicable CDISC Standard. Could have constraints on individual ODM extensions, such as Define-XML or associated CDISC Metadata Guidelines.
StandardOID	oidref	Optional	Reference to a Standard element.	Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards.
IsNonStandard	Yes	Conditional	Required for ADaM, SDTM, or SEND if StandardOID is not provided.	Must not be provided when StandardOID is provided.
HasNoData	Yes	Optional	Used to indicate that an ItemGroupDef has no data. May be used at sponsor's discretion or if required by a regulatory authority	A comment must be included to explain why no data are present for datasets that were planned for use in the study.
CommentOID	oidref	Optional	Reference to a CommentDef with sponsor provided information related to this ItemGroupDef. It allows annotations to the ItemGroup.	Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion.

Example

This example shows a minimal nested ItemGroupDef of type Form.

Simple ItemGroupDef

<ItemGroupDef OID="ODM.IG.LB" Name="LAB Measurements" Repeating="No" Type="Form">
	<Description>
      <TranslatedText xml:lang="en" Type="text/plain">Laboratory Tests Results Form</TranslatedText>
    </Description>
    <ItemRef ItemOID="ODM.IT.LB.LBDTC" Mandatory="Yes" OrderNumber="1"/>
    <ItemGroupRef ItemGroupOID="ODM.IG.LB.WBC" Mandatory="Yes" MethodOID="ODM.MT.LB.LBORRES" OrderNumber="2"/>
    <ItemRef ItemOID="ODM.IT.LB.ALB.LBORRES" Mandatory="Yes" OrderNumber="3"/>
    <ItemRef ItemOID="ODM.IT.LB.ALB.LBORRESU" Mandatory="Yes" OrderNumber="4"/>
    <ItemRef ItemOID="ODM.IT.LB.GLUC.LBORRES" Mandatory="Yes" OrderNumber="5"/>
    <ItemRef ItemOID="ODM.IT.LB.GLUC.LBORRESU" Mandatory="Yes" OrderNumber="6"/>
</ItemGroupDef>
<!-- To indicate that WBC value (ODM.IT.LB.WBC.LBORRES) and WBC unit (ODM.IT.LB.WBC.LBORRESU) 
belong together, they can be put into one ItemGroupDef, which can then be within another ItemGroupDef -->             
<ItemGroupDef OID="ODM.IG.LB.WBC" Name="WBC Lab Results with Unit" Repeating="No" Type="Form">
    <ItemRef ItemOID="ODM.IT.LB.WBC.LBORRES" Mandatory="Yes" OrderNumber="1"/>
    <ItemRef ItemOID="ODM.IT.LB.WBC.LBORRESU" Mandatory="Yes" OrderNumber="2"/>               
    <Coding Code="26464-8" System="http://loinc.org" SystemName="LOINC" SystemVersion="2.61" Label="loinc_code"/>
</ItemGroupDef>

Example

An example of Static and Simple Repeating ItemGroupDef elements.

Repeating ItemGroupDef

<ItemGroupDef OID="ODM.IG.DM" Name="Demographics" Repeating="No" Type="Form">
    <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" Repeating="Yes"/>
</ItemGroupDef>

<ItemGroupDef OID="ODM.IG.RACEOTH" Name="Race Other(s)" Repeating="Simple" RepeatingLimit="2" Type="Section">
    <ItemRef ItemOID="IT.DM.RACEOTH" Mandatory="No" Repeating="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 (maximum two other values not listed under RACE)</TranslatedText>
    </Question>
</ItemDef>

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ItemGroupDef