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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier for the ItemGroupDef element.The OID attribute value must be unique within the Study/MetaDataVersion.
NamenameRequiredHuman 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

Characterizes the collection or occurrence of this ItemGroup.

Simple - ItemGroupData repeats are expected and may be unbounded.

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 occur for each codelist item.


RepeatingLimitpositiveIntegerOptionalMaximum number of repeats.RepeatingLimit may only be used when Repeating="Simple".
IsReferenceData(Yes | No)OptionalSpecifies 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.
StructuretextOptionalDescription of the level of detail represented by individual records in the ItemGroup
ArchiveLocationIDoidrefOptionalReference to the unique ID of a def:leaf that provides the actual location and file name of the data file.
  • If provided, this should match the leaf:id attribute of the def:leaf child element
  • If not provided, the root dataset file name is expected to be the same as the Name attribute.
DatasetNamenameOptionalName of a file containing the ItemGroupData for this ItemGroupDef.
DomaintextOptionalIdentifies the scope or CDISC SDTMIG/SENDIG Domain of the ItemGroup data.
Type(Form | Section | Dataset | Concept)Required

Indicates the function of this ItemGroup.

Form - a CRF for data collection.

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".

PurposetextOptionalRole of this ItemGroup. 
StandardOIDoidrefOptionalReference to a Standard element.Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards.
IsNonStandardYesConditionalRequired for ADaM, SDTM, or SEND if StandardOID is not provided.Should not be provided when StandardOID is provided.
HasNoDataYesOptionalUsed to indicate that an ItemGroupDef has no data. May be used at sponsor's discretion or if required by a regulatory authorityA comment must be included to explain why no data are present for datasets that were planned for use in the study.

CommentOID

oidrefOptionalReference to a CommentDef with sponsor provided information related to this ItemGroupDef,Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion.



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