Class: ItemGroupDef

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

URI: odm:ItemGroupDef

erDiagram
ItemGroupDef {
    oid OID  
    nameType name  
    ItemGroupRepeatingType repeating  
    positiveInteger repeatingLimit  
    YesOrNo isReferenceData  
    text structure  
    nameType datasetName  
    text domain  
    ItemGroupTypeType type  
    text purpose  
    YesOnly isNonStandard  
    YesOnly hasNoData  
}
ItemRef {
    positiveInteger keySequence  
    YesOnly isNonStandard  
    YesOnly hasNoData  
    YesOnly repeat  
    YesOnly other  
    text role  
    CoreType core  
    text preSpecifiedValue  
    positiveInteger orderNumber  
    YesOrNo mandatory  
}
WhereClauseRef {

}
Origin {
    OriginType type  
    OriginSource source  
}
ConditionDef {
    oid OID  
    nameType name  
}
CodeList {
    oid OID  
    nameType name  
    CLDataType dataType  
    YesOnly isNonStandard  
}
ItemDef {
    oid OID  
    nameType name  
    DataType dataType  
    positiveInteger length  
    text displayFormat  
    text variableSet  
}
MethodDef {
    oid OID  
    nameType name  
    MethodType type  
}
ItemGroupRef {
    positiveInteger orderNumber  
    YesOrNo mandatory  
}
Leaf {
    oid ID  
    uriorcurie href  
}
Title {
    text content  
}
Alias {
    text context  
    text name  
}
WorkflowRef {

}
WorkflowDef {
    oid OID  
    nameType name  
}
Coding {
    text code  
    uriorcurie system  
    text systemName  
    text systemVersion  
    text label  
    uriorcurie href  
    uriorcurie ref  
    text commentOID  
}
Class {
    ItemGroupClass name  
}
SubClass {
    ItemGroupSubClass name  
    ItemGroupClassSubClass parentClass  
}
Description {

}
TranslatedText {
    languageType language  
    text type  
    contentType content  
}
CommentDef {
    oid OID  
}
DocumentRef {
    oid leafID  
}
Standard {
    oid OID  
    StandardName name  
    StandardType type  
    StandardPublishingSet publishingSet  
    text version  
    StandardStatus status  
}

ItemGroupDef ||--|o Leaf : "archiveLocationID"
ItemGroupDef ||--|o Standard : "standardOID"
ItemGroupDef ||--|o CommentDef : "commentOID"
ItemGroupDef ||--|o Description : "description"
ItemGroupDef ||--|o Class : "itemGroupClass"
ItemGroupDef ||--}o Coding : "coding"
ItemGroupDef ||--|o WorkflowRef : "workflowRef"
ItemGroupDef ||--}o Origin : "origin"
ItemGroupDef ||--}o Alias : "alias"
ItemGroupDef ||--|o Leaf : "leaf"
ItemGroupDef ||--}o ItemGroupRef : "itemGroupRef"
ItemGroupDef ||--}o ItemRef : "itemRef"
ItemRef ||--|| ItemDef : "itemOID"
ItemRef ||--|o MethodDef : "methodOID"
ItemRef ||--|o ItemDef : "unitsItemOID"
ItemRef ||--|o CodeList : "roleCodeListOID"
ItemRef ||--|o ConditionDef : "collectionExceptionConditionOID"
ItemRef ||--}o Origin : "origin"
ItemRef ||--}o WhereClauseRef : "whereClauseRef"
WhereClauseRef ||--|| WhereClauseDef : "whereClauseOID"
Origin ||--|o Description : "description"
Origin ||--|o SourceItems : "sourceItems"
Origin ||--}o Coding : "coding"
Origin ||--}o DocumentRef : "documentRef"
ConditionDef ||--|o CommentDef : "commentOID"
ConditionDef ||--|o Description : "description"
ConditionDef ||--|o MethodSignature : "methodSignature"
ConditionDef ||--}o FormalExpression : "formalExpression"
ConditionDef ||--}o Alias : "alias"
CodeList ||--|o CommentDef : "commentOID"
CodeList ||--|o Standard : "standardOID"
CodeList ||--|o Description : "description"
CodeList ||--}o CodeListItem : "codeListItem"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Alias : "alias"
ItemDef ||--|o CommentDef : "commentOID"
ItemDef ||--|o Description : "description"
ItemDef ||--|o Definition : "definition"
ItemDef ||--|o Question : "question"
ItemDef ||--|o Prompt : "prompt"
ItemDef ||--|o CRFCompletionInstructions : "cRFCompletionInstructions"
ItemDef ||--|o ImplementationNotes : "implementationNotes"
ItemDef ||--|o CDISCNotes : "cDISCNotes"
ItemDef ||--}o RangeCheck : "rangeCheck"
ItemDef ||--|o CodeListRef : "codeListRef"
ItemDef ||--|o ValueListRef : "valueListRef"
ItemDef ||--}o Coding : "coding"
ItemDef ||--}o Alias : "alias"
MethodDef ||--|o CommentDef : "commentOID"
MethodDef ||--|o Description : "description"
MethodDef ||--|o MethodSignature : "methodSignature"
MethodDef ||--}o FormalExpression : "formalExpression"
MethodDef ||--}o Alias : "alias"
MethodDef ||--}o DocumentRef : "documentRef"
ItemGroupRef ||--|| ItemGroupDef : "itemGroupOID"
ItemGroupRef ||--|o MethodDef : "methodOID"
ItemGroupRef ||--|o ConditionDef : "collectionExceptionConditionOID"
Leaf ||--|o Title : "title"
WorkflowRef ||--|| WorkflowDef : "workflowOID"
WorkflowDef ||--|o Description : "description"
WorkflowDef ||--|o WorkflowStart : "workflowStart"
WorkflowDef ||--}o WorkflowEnd : "workflowEnd"
WorkflowDef ||--}o Transition : "transition"
WorkflowDef ||--}o Branching : "branching"
Class ||--}o SubClass : "subClass"
Description ||--}o TranslatedText : "translatedText"
CommentDef ||--|o Description : "description"
CommentDef ||--}o DocumentRef : "documentRef"
DocumentRef ||--}o PDFPageRef : "pDFPageRef"
Standard ||--|o CommentDef : "commentOID"

Slots

Name Cardinality* and Range Description Inheritance
OID 1..1
oid		 Unique identifier for the ItemGroupDef element. direct
name 1..1
nameType		 Human readable name for the ItemGroupDef. direct
repeating 1..1
ItemGroupRepeatingType		 The Repeating attribute indicates that the ItemGroup may occur repeatedly wit... direct
repeatingLimit 0..1
positiveInteger		 Maximum number of repeats. direct
isReferenceData 0..1
YesOrNo		 Specifies whether this ItemGroupDef is used for non-subject data. direct
structure 0..1
text		 Description of the level of detail represented by individual records in the I... direct
archiveLocationID 0..1
Leaf		 Reference to the unique ID of a leaf element that provides the actual locatio... direct
datasetName 0..1
nameType		 Name of a file containing the ItemGroupData for this ItemGroupDef. The name a... direct
domain 0..1
text		 Identifies the scope or CDISC SDTMIG/SENDIG Domain of the ItemGroup data. The... direct
type 1..1
ItemGroupTypeType		 identifies the type of data structure the ItemGroup represents. Form - a CRF ... direct
purpose 0..1
text		 Purpose of the ItemGroup. direct
standardOID 0..1
Standard		 Reference to a Standard element. direct
isNonStandard 0..1
YesOnly		 Required for ADaM, SDTM, or SEND if StandardOID is not provided. direct
hasNoData 0..1
YesOnly		 Used to indicate that an ItemGroupDef has no data. May be used at sponsor's d... direct
commentOID 0..1
CommentDef		 Reference to a CommentDef with sponsor provided information related to this I... direct
description 0..1
Description		 Description reference: A free-text description of the containing metadata com... direct
itemGroupClass 0..1
Class		 Class reference: The Class element identifies which predefined Class within t... direct
coding 0..*
Coding		 Coding reference: Coding references a symbol from a defined code system. It u... direct
workflowRef 0..1
WorkflowRef		 WorkflowRef reference: The WorkflowRef references a workflow definition direct
origin 0..*
Origin		 Origin reference: Origin defines the source metadata, where applicable, for O... direct
alias 0..*
Alias		 Alias reference: An Alias provides an additional name for an element. The Con... direct
leaf 0..1
Leaf		 Leaf reference: Contains the XLink information referenced by DocumentRef or A... direct
itemGroupRef 0..*
ItemGroupRef		 ItemGroupRef reference: ItemGroupRef references an ItemGroupDef as it occurs ... direct
itemRef 0..*
ItemRef		 ItemRef reference: A reference to an ItemDef as it occurs within a specific I... direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
MetaDataVersion itemGroupDef range ItemGroupDef
ItemGroupRef itemGroupOID range ItemGroupDef
SourceItem itemGroupOID range ItemGroupDef
ItemGroupData itemGroupOID range ItemGroupDef
KeySet itemGroupOID range ItemGroupDef

See Also

Identifier and Mapping Information

Schema Source

  • from schema: http://www.cdisc.org/ns/odm/v2.0

Mappings

Mapping Type Mapped Value
self odm:ItemGroupDef
native odm:ItemGroupDef

LinkML Source

Direct

name: ItemGroupDef
description: An ItemGroupDef describes a type of variable or field grouping that can
  occur within a study.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/ItemGroupDef
rank: 1000
slots:
- OID
- name
- repeating
- repeatingLimit
- isReferenceData
- structure
- archiveLocationID
- datasetName
- domain
- type
- purpose
- standardOID
- isNonStandard
- hasNoData
- commentOID
- description
- itemGroupClass
- coding
- workflowRef
- origin
- alias
- leaf
- itemGroupRef
- itemRef
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the ItemGroupDef element.
    comments:
    - 'Required

      range: oid

      The OID attribute value must be unique within the Study/MetaDataVersion.'
    identifier: true
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: Human readable name for the ItemGroupDef.
    comments:
    - 'Required

      range: name

      The Name attribute must be unique within set of ItemGroupDef elements within
      a Study/MetadataVersion.'
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  repeating:
    name: repeating
    description: '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.'
    comments:
    - 'Required

      enum values: (No | Simple | Dynamic | Static)

      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.'
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    range: ItemGroupRepeatingType
    required: true
  repeatingLimit:
    name: repeatingLimit
    description: Maximum number of repeats.
    comments:
    - 'Optional

      range: positiveInteger

      RepeatingLimit can only be used when Repeating="Simple".'
    domain_of:
    - ItemGroupDef
    range: positiveInteger
  isReferenceData:
    name: isReferenceData
    description: Specifies whether this ItemGroupDef is used for non-subject data.
    comments:
    - 'Optional

      enum values: (Yes | No)

      Data content for ItemGroupDef elements where the IsReferenceData attribute is
      "Yes" is under the /ODM/ReferenceData element.'
    domain_of:
    - ItemGroupDef
    range: YesOrNo
  structure:
    name: structure
    description: Description of the level of detail represented by individual records
      in the ItemGroup
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ItemGroupDef
    range: text
  archiveLocationID:
    name: archiveLocationID
    description: Reference to the unique ID of a leaf element that provides the actual
      location and file name of the data file.
    comments:
    - 'Optional

      range: oidref

      If provided, the value must match the leaf ID attribute of the leaf child element.'
    domain_of:
    - ItemGroupDef
    range: Leaf
  datasetName:
    name: datasetName
    description: 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.
    comments:
    - 'Optional

      range: name

      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_of:
    - ItemGroupDef
    range: nameType
  domain:
    name: domain
    description: 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.
    comments:
    - 'Optional

      range: text

      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.'
    domain_of:
    - ItemGroupDef
    range: text
  type:
    name: type
    description: 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.
    comments:
    - 'Required

      enum values: (Form | Section | Dataset | 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".'
    domain_of:
    - TranslatedText
    - PDFPageRef
    - Standard
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - Resource
    - MethodDef
    - StudyEndPoint
    - TransitionTimingConstraint
    - RelativeTimingConstraint
    - Branching
    - Organization
    - Query
    range: ItemGroupTypeType
    required: true
  purpose:
    name: purpose
    description: Purpose of the ItemGroup.
    comments:
    - 'Optional

      range: text

      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.'
    domain_of:
    - ItemGroupDef
    range: text
  standardOID:
    name: standardOID
    description: Reference to a Standard element.
    comments:
    - 'Optional

      range: oidref

      Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards.'
    domain_of:
    - ItemGroupDef
    - CodeList
    range: Standard
  isNonStandard:
    name: isNonStandard
    description: Required for ADaM, SDTM, or SEND if StandardOID is not provided.
    comments:
    - 'Conditional

      range: Yes

      Must not be provided when StandardOID is provided.'
    domain_of:
    - ItemGroupDef
    - ItemRef
    - CodeList
    range: YesOnly
  hasNoData:
    name: hasNoData
    description: Used to indicate that an ItemGroupDef has no data. May be used at
      sponsor's discretion or if required by a regulatory authority
    comments:
    - 'Optional

      range: Yes

      A comment must be included to explain why no data are present for datasets that
      were planned for use in the study.'
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: YesOnly
  commentOID:
    name: commentOID
    description: Reference to a CommentDef with sponsor provided information related
      to this ItemGroupDef. It allows annotations to the ItemGroup.
    comments:
    - 'Optional

      range: oidref

      Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion.'
    domain_of:
    - MetaDataVersion
    - Standard
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Coding
    range: CommentDef
  description:
    name: description
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  itemGroupClass:
    name: itemGroupClass
    domain_of:
    - ItemGroupDef
    range: Class
    maximum_cardinality: 1
  coding:
    name: coding
    multivalued: true
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - SourceItems
    - SourceItem
    - ItemDef
    - CodeList
    - CodeListItem
    - StudyIndication
    - StudyIntervention
    - StudyTargetPopulation
    - StudyParameter
    - ParameterValue
    - Criterion
    - Annotation
    range: Coding
    inlined: true
    inlined_as_list: true
  workflowRef:
    name: workflowRef
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Protocol
    - StudyStructure
    - Arm
    range: WorkflowRef
    maximum_cardinality: 1
  origin:
    name: origin
    multivalued: true
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: Origin
    inlined: true
    inlined_as_list: true
  alias:
    name: alias
    multivalued: true
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Protocol
    range: Alias
    inlined: true
    inlined_as_list: true
  leaf:
    name: leaf
    domain_of:
    - MetaDataVersion
    - ItemGroupDef
    range: Leaf
    maximum_cardinality: 1
  itemGroupRef:
    name: itemGroupRef
    multivalued: true
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    range: ItemGroupRef
    inlined: true
    inlined_as_list: true
  itemRef:
    name: itemRef
    multivalued: true
    domain_of:
    - ValueListDef
    - ItemGroupDef
    range: ItemRef
    inlined: true
    inlined_as_list: true
class_uri: odm:ItemGroupDef

Induced

name: ItemGroupDef
description: An ItemGroupDef describes a type of variable or field grouping that can
  occur within a study.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/ItemGroupDef
rank: 1000
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the ItemGroupDef element.
    comments:
    - 'Required

      range: oid

      The OID attribute value must be unique within the Study/MetaDataVersion.'
    identifier: true
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: Human readable name for the ItemGroupDef.
    comments:
    - 'Required

      range: name

      The Name attribute must be unique within set of ItemGroupDef elements within
      a Study/MetadataVersion.'
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  repeating:
    name: repeating
    description: '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.'
    comments:
    - 'Required

      enum values: (No | Simple | Dynamic | Static)

      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.'
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    range: ItemGroupRepeatingType
    required: true
  repeatingLimit:
    name: repeatingLimit
    description: Maximum number of repeats.
    comments:
    - 'Optional

      range: positiveInteger

      RepeatingLimit can only be used when Repeating="Simple".'
    domain_of:
    - ItemGroupDef
    range: positiveInteger
  isReferenceData:
    name: isReferenceData
    description: Specifies whether this ItemGroupDef is used for non-subject data.
    comments:
    - 'Optional

      enum values: (Yes | No)

      Data content for ItemGroupDef elements where the IsReferenceData attribute is
      "Yes" is under the /ODM/ReferenceData element.'
    domain_of:
    - ItemGroupDef
    range: YesOrNo
  structure:
    name: structure
    description: Description of the level of detail represented by individual records
      in the ItemGroup
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ItemGroupDef
    range: text
  archiveLocationID:
    name: archiveLocationID
    description: Reference to the unique ID of a leaf element that provides the actual
      location and file name of the data file.
    comments:
    - 'Optional

      range: oidref

      If provided, the value must match the leaf ID attribute of the leaf child element.'
    domain_of:
    - ItemGroupDef
    range: Leaf
  datasetName:
    name: datasetName
    description: 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.
    comments:
    - 'Optional

      range: name

      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_of:
    - ItemGroupDef
    range: nameType
  domain:
    name: domain
    description: 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.
    comments:
    - 'Optional

      range: text

      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.'
    domain_of:
    - ItemGroupDef
    range: text
  type:
    name: type
    description: 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.
    comments:
    - 'Required

      enum values: (Form | Section | Dataset | 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".'
    domain_of:
    - TranslatedText
    - PDFPageRef
    - Standard
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - Resource
    - MethodDef
    - StudyEndPoint
    - TransitionTimingConstraint
    - RelativeTimingConstraint
    - Branching
    - Organization
    - Query
    range: ItemGroupTypeType
    required: true
  purpose:
    name: purpose
    description: Purpose of the ItemGroup.
    comments:
    - 'Optional

      range: text

      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.'
    domain_of:
    - ItemGroupDef
    range: text
  standardOID:
    name: standardOID
    description: Reference to a Standard element.
    comments:
    - 'Optional

      range: oidref

      Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards.'
    domain_of:
    - ItemGroupDef
    - CodeList
    range: Standard
  isNonStandard:
    name: isNonStandard
    description: Required for ADaM, SDTM, or SEND if StandardOID is not provided.
    comments:
    - 'Conditional

      range: Yes

      Must not be provided when StandardOID is provided.'
    domain_of:
    - ItemGroupDef
    - ItemRef
    - CodeList
    range: YesOnly
  hasNoData:
    name: hasNoData
    description: Used to indicate that an ItemGroupDef has no data. May be used at
      sponsor's discretion or if required by a regulatory authority
    comments:
    - 'Optional

      range: Yes

      A comment must be included to explain why no data are present for datasets that
      were planned for use in the study.'
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: YesOnly
  commentOID:
    name: commentOID
    description: Reference to a CommentDef with sponsor provided information related
      to this ItemGroupDef. It allows annotations to the ItemGroup.
    comments:
    - 'Optional

      range: oidref

      Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion.'
    domain_of:
    - MetaDataVersion
    - Standard
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Coding
    range: CommentDef
  description:
    name: description
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  itemGroupClass:
    name: itemGroupClass
    domain_of:
    - ItemGroupDef
    range: Class
    maximum_cardinality: 1
  coding:
    name: coding
    multivalued: true
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - SourceItems
    - SourceItem
    - ItemDef
    - CodeList
    - CodeListItem
    - StudyIndication
    - StudyIntervention
    - StudyTargetPopulation
    - StudyParameter
    - ParameterValue
    - Criterion
    - Annotation
    range: Coding
    inlined: true
    inlined_as_list: true
  workflowRef:
    name: workflowRef
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Protocol
    - StudyStructure
    - Arm
    range: WorkflowRef
    maximum_cardinality: 1
  origin:
    name: origin
    multivalued: true
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: Origin
    inlined: true
    inlined_as_list: true
  alias:
    name: alias
    multivalued: true
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Protocol
    range: Alias
    inlined: true
    inlined_as_list: true
  leaf:
    name: leaf
    domain_of:
    - MetaDataVersion
    - ItemGroupDef
    range: Leaf
    maximum_cardinality: 1
  itemGroupRef:
    name: itemGroupRef
    multivalued: true
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    range: ItemGroupRef
    inlined: true
    inlined_as_list: true
  itemRef:
    name: itemRef
    multivalued: true
    domain_of:
    - ValueListDef
    - ItemGroupDef
    range: ItemRef
    inlined: true
    inlined_as_list: true
attributes:
  OID:
    name: OID
    description: Unique identifier for the ItemGroupDef element.
    comments:
    - 'Required

      range: oid

      The OID attribute value must be unique within the Study/MetaDataVersion.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: OID
    owner: ItemGroupDef
    domain_of:
    - Study
    - MetaDataVersion
    - Standard
    - ValueListDef
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - MethodDef
    - ConditionDef
    - CommentDef
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyParameter
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - User
    - Organization
    - Location
    - SignatureDef
    - Query
    range: oid
    required: true
  name:
    name: name
    description: Human readable name for the ItemGroupDef.
    comments:
    - 'Required

      range: name

      The Name attribute must be unique within set of ItemGroupDef elements within
      a Study/MetadataVersion.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: name
    owner: ItemGroupDef
    domain_of:
    - Alias
    - MetaDataVersion
    - Standard
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Class
    - SubClass
    - SourceItem
    - Resource
    - ItemDef
    - CodeList
    - MethodDef
    - Parameter
    - ReturnValue
    - ConditionDef
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - Arm
    - Epoch
    - StudyTiming
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Transition
    - Branching
    - Criterion
    - Organization
    - Location
    - Query
    range: nameType
    required: true
  repeating:
    name: repeating
    description: '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.'
    comments:
    - 'Required

      enum values: (No | Simple | Dynamic | Static)

      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.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: repeating
    owner: ItemGroupDef
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    range: ItemGroupRepeatingType
    required: true
  repeatingLimit:
    name: repeatingLimit
    description: Maximum number of repeats.
    comments:
    - 'Optional

      range: positiveInteger

      RepeatingLimit can only be used when Repeating="Simple".'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: repeatingLimit
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: positiveInteger
  isReferenceData:
    name: isReferenceData
    description: Specifies whether this ItemGroupDef is used for non-subject data.
    comments:
    - 'Optional

      enum values: (Yes | No)

      Data content for ItemGroupDef elements where the IsReferenceData attribute is
      "Yes" is under the /ODM/ReferenceData element.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: isReferenceData
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: YesOrNo
  structure:
    name: structure
    description: Description of the level of detail represented by individual records
      in the ItemGroup
    comments:
    - 'Optional

      range: text'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: structure
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: text
  archiveLocationID:
    name: archiveLocationID
    description: Reference to the unique ID of a leaf element that provides the actual
      location and file name of the data file.
    comments:
    - 'Optional

      range: oidref

      If provided, the value must match the leaf ID attribute of the leaf child element.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: archiveLocationID
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: Leaf
  datasetName:
    name: datasetName
    description: 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.
    comments:
    - 'Optional

      range: name

      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.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: datasetName
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: nameType
  domain:
    name: domain
    description: 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.
    comments:
    - 'Optional

      range: text

      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.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: domain
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: text
  type:
    name: type
    description: 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.
    comments:
    - 'Required

      enum values: (Form | Section | Dataset | 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".'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: type
    owner: ItemGroupDef
    domain_of:
    - TranslatedText
    - PDFPageRef
    - Standard
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - Resource
    - MethodDef
    - StudyEndPoint
    - TransitionTimingConstraint
    - RelativeTimingConstraint
    - Branching
    - Organization
    - Query
    range: ItemGroupTypeType
    required: true
  purpose:
    name: purpose
    description: Purpose of the ItemGroup.
    comments:
    - 'Optional

      range: text

      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.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: purpose
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: text
  standardOID:
    name: standardOID
    description: Reference to a Standard element.
    comments:
    - 'Optional

      range: oidref

      Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: standardOID
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    - CodeList
    range: Standard
  isNonStandard:
    name: isNonStandard
    description: Required for ADaM, SDTM, or SEND if StandardOID is not provided.
    comments:
    - 'Conditional

      range: Yes

      Must not be provided when StandardOID is provided.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: isNonStandard
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    - ItemRef
    - CodeList
    range: YesOnly
  hasNoData:
    name: hasNoData
    description: Used to indicate that an ItemGroupDef has no data. May be used at
      sponsor's discretion or if required by a regulatory authority
    comments:
    - 'Optional

      range: Yes

      A comment must be included to explain why no data are present for datasets that
      were planned for use in the study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: hasNoData
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: YesOnly
  commentOID:
    name: commentOID
    description: Reference to a CommentDef with sponsor provided information related
      to this ItemGroupDef. It allows annotations to the ItemGroup.
    comments:
    - 'Optional

      range: oidref

      Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: commentOID
    owner: ItemGroupDef
    domain_of:
    - MetaDataVersion
    - Standard
    - WhereClauseDef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Coding
    range: CommentDef
  description:
    name: description
    description: 'Description reference: A free-text description of the containing
      metadata component, unless restricted by Business Rules.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: description
    owner: ItemGroupDef
    domain_of:
    - Study
    - MetaDataVersion
    - ValueListDef
    - StudyEventGroupRef
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - CommentDef
    - Protocol
    - StudyStructure
    - TrialPhase
    - StudyIndication
    - StudyIntervention
    - StudyObjective
    - StudyEndPoint
    - StudyTargetPopulation
    - StudyEstimand
    - IntercurrentEvent
    - SummaryMeasure
    - Arm
    - Epoch
    - TransitionTimingConstraint
    - AbsoluteTimingConstraint
    - RelativeTimingConstraint
    - DurationTimingConstraint
    - WorkflowDef
    - Criterion
    - Organization
    - Location
    - ODMFileMetadata
    range: Description
    maximum_cardinality: 1
  itemGroupClass:
    name: itemGroupClass
    description: 'Class reference: The Class element identifies which predefined Class
      within the model applies to the definition of the dataset.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: itemGroupClass
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    range: Class
    maximum_cardinality: 1
  coding:
    name: coding
    description: 'Coding reference: Coding references a symbol from a defined code
      system. It uses a code defined in a terminology system to associate semantics
      with a given term, codelist, variable, or group of variables. The presence of
      a Coding element associates a meaning to its parent element. Including multiple
      Coding elements for a given parent indicates synonymous meanings provided by
      different code systems or code system versions.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: coding
    owner: ItemGroupDef
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - SourceItems
    - SourceItem
    - ItemDef
    - CodeList
    - CodeListItem
    - StudyIndication
    - StudyIntervention
    - StudyTargetPopulation
    - StudyParameter
    - ParameterValue
    - Criterion
    - Annotation
    range: Coding
    inlined: true
    inlined_as_list: true
  workflowRef:
    name: workflowRef
    description: 'WorkflowRef reference: The WorkflowRef references a workflow definition'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: workflowRef
    owner: ItemGroupDef
    domain_of:
    - StudyEventGroupDef
    - StudyEventDef
    - ItemGroupDef
    - Protocol
    - StudyStructure
    - Arm
    range: WorkflowRef
    maximum_cardinality: 1
  origin:
    name: origin
    description: 'Origin reference: Origin defines the source metadata, where applicable,
      for ODM ItemRefs or ItemGroupRefs. Origin as a child element replaces the Origin
      attribute in ODM v1.3 that exists for the ItemDef and ItemGroupDef elements.The
      Origin element is based on the def:Origin element in Define-XML v2.1 with the
      Trace-XML v1.0 extension.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: origin
    owner: ItemGroupDef
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: Origin
    inlined: true
    inlined_as_list: true
  alias:
    name: alias
    description: 'Alias reference: An Alias provides an additional name for an element.
      The Context attribute specifies the application domain in which this additional
      name is relevant.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: alias
    owner: ItemGroupDef
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    - ItemDef
    - CodeList
    - CodeListItem
    - MethodDef
    - ConditionDef
    - Protocol
    range: Alias
    inlined: true
    inlined_as_list: true
  leaf:
    name: leaf
    description: 'Leaf reference: Contains the XLink information referenced by DocumentRef
      or ArchiveLocationID'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: leaf
    owner: ItemGroupDef
    domain_of:
    - MetaDataVersion
    - ItemGroupDef
    range: Leaf
    maximum_cardinality: 1
  itemGroupRef:
    name: itemGroupRef
    description: 'ItemGroupRef reference: ItemGroupRef references an ItemGroupDef
      as it occurs within a specific StudyEventDef or ItemGroupDef. The list of ItemGroupRefs
      identifies the types of item groups that are allowed to occur within this type
      of studyevent or (nested) item group. The ItemGroupRefs within a single StudyEventDef
      or ItemGroupDef must not have duplicate ItemGroupOID or OrderNumber attribute
      values.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: itemGroupRef
    owner: ItemGroupDef
    domain_of:
    - StudyEventDef
    - ItemGroupDef
    range: ItemGroupRef
    inlined: true
    inlined_as_list: true
  itemRef:
    name: itemRef
    description: 'ItemRef reference: A reference to an ItemDef as it occurs within
      a specific ItemGroupDef. The list of ItemRefs identifies the types of items
      that are allowed to occur within this type of item group.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: itemRef
    owner: ItemGroupDef
    domain_of:
    - ValueListDef
    - ItemGroupDef
    range: ItemRef
    inlined: true
    inlined_as_list: true
class_uri: odm:ItemGroupDef