You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 15 Next »

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 | Dataset | Concept)Optional

Indicates the function of this ItemGroup.

Form - data collection.

Dataset - tabulation, analysis or operational datasets.

Concept - defines a biomedical concept.

Type is an extensible attribute.
PurposetextOptionalRole of this ItemGroup. 
CommentOID ODM2DEV-64 - Getting issue details... STATUS 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.
StandardOIDoidrefOptionalReference to a Standard element.Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards.



  • No labels