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changes.mady.by.user Marcelina Hungria

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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
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

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.
RepeatingLimitpositiveIntegerOptionalMaximum number of repeats.
  • RepeatingLimit can 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
ArchiveLocationIDoidrefOptional

Reference to the unique ID of a

def:

leaf element that provides the actual location and file name of the data file.

  • If provided,
this should
  • the value must match the leaf ID attribute of the 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. 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.
DomaintextOptionalIdentifies 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".
PurposetextOptionalPurpose 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.
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.
  • Must 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 authority
  • A comment must be included to explain why no data are present for datasets that were planned for use in the study.

CommentOID

oidrefOptional

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.