Class: ItemRef

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.

URI: odm:ItemRef

erDiagram
ItemRef {
    positiveInteger keySequence  
    YesOnly isNonStandard  
    YesOnly hasNoData  
    YesOnly repeat  
    YesOnly other  
    text role  
    CoreType core  
    text preSpecifiedValue  
    positiveInteger orderNumber  
    YesOrNo mandatory  
}
WhereClauseRef {

}
WhereClauseDef {
    oid OID  
}
Origin {
    OriginType type  
    OriginSource source  
}
DocumentRef {
    oid leafID  
}
Coding {
    text code  
    uriorcurie system  
    text systemName  
    text systemVersion  
    text label  
    uriorcurie href  
    uriorcurie ref  
    text commentOID  
}
SourceItems {

}
Description {

}
ConditionDef {
    oid OID  
    nameType name  
}
Alias {
    text context  
    text name  
}
FormalExpression {
    text context  
}
MethodSignature {

}
CommentDef {
    oid OID  
}
CodeList {
    oid OID  
    nameType name  
    CLDataType dataType  
    YesOnly isNonStandard  
}
CodeListItem {
    valueType codedValue  
    decimal rank  
    YesOnly other  
    positiveInteger orderNumber  
    YesOnly extendedValue  
}
Standard {
    oid OID  
    StandardName name  
    StandardType type  
    StandardPublishingSet publishingSet  
    text version  
    StandardStatus status  
}
ItemDef {
    oid OID  
    nameType name  
    DataType dataType  
    positiveInteger length  
    text displayFormat  
    text variableSet  
}
ValueListRef {

}
CodeListRef {

}
RangeCheck {
    Comparator comparator  
    SoftOrHard softHard  
}
CDISCNotes {

}
ImplementationNotes {

}
CRFCompletionInstructions {

}
Prompt {

}
Question {

}
Definition {

}
MethodDef {
    oid OID  
    nameType name  
    MethodType type  
}

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"
WhereClauseDef ||--|o CommentDef : "commentOID"
WhereClauseDef ||--}o RangeCheck : "rangeCheck"
Origin ||--|o Description : "description"
Origin ||--|o SourceItems : "sourceItems"
Origin ||--}o Coding : "coding"
Origin ||--}o DocumentRef : "documentRef"
DocumentRef ||--}o PDFPageRef : "pDFPageRef"
SourceItems ||--}o SourceItem : "sourceItem"
SourceItems ||--}o Coding : "coding"
Description ||--}o TranslatedText : "translatedText"
ConditionDef ||--|o CommentDef : "commentOID"
ConditionDef ||--|o Description : "description"
ConditionDef ||--|o MethodSignature : "methodSignature"
ConditionDef ||--}o FormalExpression : "formalExpression"
ConditionDef ||--}o Alias : "alias"
FormalExpression ||--|o Code : "code"
FormalExpression ||--|o ExternalCodeLib : "externalCodeLib"
MethodSignature ||--}o Parameter : "parameter"
MethodSignature ||--}o ReturnValue : "returnValue"
CommentDef ||--|o Description : "description"
CommentDef ||--}o DocumentRef : "documentRef"
CodeList ||--|o CommentDef : "commentOID"
CodeList ||--|o Standard : "standardOID"
CodeList ||--|o Description : "description"
CodeList ||--}o CodeListItem : "codeListItem"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Alias : "alias"
CodeListItem ||--|o CommentDef : "commentOID"
CodeListItem ||--|o Description : "description"
CodeListItem ||--|o Decode : "decode"
CodeListItem ||--}o Coding : "coding"
CodeListItem ||--}o Alias : "alias"
Standard ||--|o CommentDef : "commentOID"
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"
ValueListRef ||--|| ValueListDef : "valueListOID"
CodeListRef ||--|| CodeList : "codeListOID"
RangeCheck ||--|o ItemDef : "itemOID"
RangeCheck ||--|o ErrorMessage : "errorMessage"
RangeCheck ||--|o MethodSignature : "methodSignature"
RangeCheck ||--}o FormalExpression : "formalExpression"
RangeCheck ||--}o CheckValue : "checkValue"
CDISCNotes ||--}o TranslatedText : "translatedText"
ImplementationNotes ||--}o TranslatedText : "translatedText"
CRFCompletionInstructions ||--}o TranslatedText : "translatedText"
Prompt ||--}o TranslatedText : "translatedText"
Question ||--}o TranslatedText : "translatedText"
Definition ||--}o TranslatedText : "translatedText"
MethodDef ||--|o CommentDef : "commentOID"
MethodDef ||--|o Description : "description"
MethodDef ||--|o MethodSignature : "methodSignature"
MethodDef ||--}o FormalExpression : "formalExpression"
MethodDef ||--}o Alias : "alias"
MethodDef ||--}o DocumentRef : "documentRef"

Slots

Name Cardinality* and Range Description Inheritance
itemOID 1..1
ItemDef		 Reference to the ItemDef . direct
keySequence 0..1
positiveInteger		 Indicates that this item is a key for the enclosing element. It also provides... direct
isNonStandard 0..1
YesOnly		 A non-standard variable is one that is not defined in the SDTMIG or the under... direct
hasNoData 0..1
YesOnly		 Used to indicate that an ItemRef that represent a dataset's variable has no d... direct
methodOID 0..1
MethodDef		 Reference to a MethodDef used to derive the value of this item. direct
unitsItemOID 0..1
ItemDef		 Reference to a sibling ItemRef element that represents the unit specification... direct
repeat 0..1
YesOnly		 Indicates that the item serves as the item over which repeats are to be perfo... direct
other 0..1
YesOnly		 Flag to indicate that the Item represents "other" content added to an ItemGro... direct
role 0..1
text		 The Role for the referenced ItemDef. The Role attribute provides a single rol... direct
roleCodeListOID 0..1
CodeList		 Reference to a CodeList that defines the allowable values of Role for the Stu... direct
core 0..1
CoreType		 CDASH, ADaM, SDTM, and SEND Core designations. direct
preSpecifiedValue 0..1
text		 Prefill value or a default value for a field that is automatically populated. direct
orderNumber 0..1
positiveInteger		 Indicates the order in which this ItemRef appears in Metadata displays or dat... direct
mandatory 1..1
YesOrNo		 Indicator of whether this ItemGroup must appear in the study clinical data fo... direct
collectionExceptionConditionOID 0..1
ConditionDef		 Reference to a ConditionDef that defines the circumstances under which collec... direct
origin 0..*
Origin		 Origin reference: Origin defines the source metadata, where applicable, for O... direct
whereClauseRef 0..*
WhereClauseRef		 WhereClauseRef reference: The WhereClauseRef references the WhereClauseDef el... direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
ValueListDef itemRef range ItemRef
ItemGroupDef itemRef range ItemRef

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:ItemRef
native odm:ItemRef

LinkML Source

Direct

name: ItemRef
description: 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
see_also:
- https://wiki.cdisc.org/display/PUB/ItemRef
rank: 1000
slots:
- itemOID
- keySequence
- isNonStandard
- hasNoData
- methodOID
- unitsItemOID
- repeat
- other
- role
- roleCodeListOID
- core
- preSpecifiedValue
- orderNumber
- mandatory
- collectionExceptionConditionOID
- origin
- whereClauseRef
slot_usage:
  itemOID:
    name: itemOID
    description: Reference to the ItemDef .
    comments:
    - 'Required

      range: oidref

      Must match the OID attribute for an ItemDef in the Study/MetaDataVersion. The
      ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate ItemOID
      values.'
    domain_of:
    - ItemRef
    - SourceItem
    - RangeCheck
    - ItemData
    - KeySet
    range: ItemDef
    required: true
  keySequence:
    name: keySequence
    description: Indicates that this item is a key for the enclosing element. It also
      provides an ordering for the keys.
    comments:
    - 'Optional

      range: positiveInteger

      The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate
      KeySequence values.'
    domain_of:
    - ItemRef
    range: positiveInteger
  isNonStandard:
    name: isNonStandard
    description: A non-standard variable is one that is not defined in the SDTMIG
      or the underlying SDTM model of a standard referenced within the ODM document.
      Permitted for any ItemRef that represents a non-standard variable in an SDTM
      or SEND dataset when the ODM Context attribute value is "Other" Is not used
      with an ItemRef that represents a value level metadata for an SDTMIG SUPPQUAL
      dataset Has no meaning for ADaM, so shall not be used for ADaM variables
    comments:
    - 'Optional

      range: (Yes)'
    domain_of:
    - ItemGroupDef
    - ItemRef
    - CodeList
    range: YesOnly
  hasNoData:
    name: hasNoData
    description: Used to indicate that an ItemRef that represent a dataset's variable
      has no data. Note that variables refer to both standard and non-standard/ supplemental
      qualifiers variables (/ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef or /ODM/Study/MetaDataVersion/ValueListDef/ItemRef).
    comments:
    - 'Conditional

      range: (Yes)

      A comment must be included to explain why no data is present for dataset''s
      variables that were planned for use in the study.'
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: YesOnly
  methodOID:
    name: methodOID
    description: Reference to a MethodDef used to derive the value of this item.
    comments:
    - 'Optional

      range: oidref

      The MethodOID value must match the OID attribute for a MethodDef in this Study/MetaDataVersion.'
    domain_of:
    - ItemGroupRef
    - ItemRef
    - TransitionTimingConstraint
    range: MethodDef
  unitsItemOID:
    name: unitsItemOID
    description: Reference to a sibling ItemRef element that represents the unit specification
      for this ItemRef (defines the associated units variable).
    comments:
    - 'Optional

      range: oidref

      The sibling ItemRef element will have ItemOID=UnitsItemOID and the UnitsItemOID
      value must match the OID attribute for the ItemDef that defines the units for
      this Item.'
    domain_of:
    - ItemRef
    range: ItemDef
  repeat:
    name: repeat
    description: Indicates that the item serves as the item over which repeats are
      to be performed.
    comments:
    - 'Optional

      range: (Yes)

      The corresponding ItemDef must have an associated CodeList containing the items
      over which the repeat is to be performed. There may only be one ItemRef within
      the ItemGroupDef with Repeat="Yes".'
    domain_of:
    - ItemRef
    range: YesOnly
  other:
    name: other
    description: Flag to indicate that the Item represents "other" content added to
      an ItemGroup.
    comments:
    - 'Optional

      range: (Yes)'
    domain_of:
    - ItemRef
    - CodeListItem
    range: YesOnly
  role:
    name: role
    description: The Role for the referenced ItemDef. The Role attribute provides
      a single role name describing the use of this data item. If the Role is defined
      by a standard terminology, RoleCodeListOID may be used to reference a CodeList
      that defines the full set roles from which the Role attribute value is to be
      taken.
    comments:
    - 'Optional

      range: text

      This attribute must not be present unless the Role attribute is defined.'
    domain_of:
    - ItemRef
    - Organization
    - Location
    range: text
  roleCodeListOID:
    name: roleCodeListOID
    description: Reference to a CodeList that defines the allowable values of Role
      for the Study.
    comments:
    - 'Optional

      range: oidref

      The RoleCodelistOID must match the OID attribute for a CodeList within the Study/MetaDataVersion.
      If Role is defined, RoleCodeListOID is still optional.'
    domain_of:
    - ItemRef
    range: CodeList
  core:
    name: core
    description: CDASH, ADaM, SDTM, and SEND Core designations.
    comments:
    - 'Optional

      enum values: (HR | O | R/C | Cond | Exp | Perm | Req)

      Reference the appropriate specifications for complete requirements. Example:
      CDASH: "HR", "R/C", "O"; SDTM: "Req", "Exp", "Perm".'
    domain_of:
    - ItemRef
    range: CoreType
  preSpecifiedValue:
    name: preSpecifiedValue
    description: Prefill value or a default value for a field that is automatically
      populated.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ItemRef
    range: text
  orderNumber:
    name: orderNumber
    description: Indicates the order in which this ItemRef appears in Metadata displays
      or data entry applications. The OrderNumbers provide an ordering on the Items
      (within a containing element) for use whenever a list of Items is presented
      to a user. They do not imply anything about event scheduling, time ordering,
      or data correctness.
    comments:
    - 'Optional

      range: positiveInteger

      The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate
      OrderNumber values.'
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    - CodeListItem
    - Parameter
    - ReturnValue
    - StudyEndPointRef
    range: positiveInteger
  mandatory:
    name: mandatory
    description: Indicator of whether this ItemGroup must appear in the study clinical
      data for each subject per the study protocol. The Mandatory flag indicates that
      the clinical data for an instance of the containing element would be incomplete
      without an instance of this type of item. ODM clinical data files that are incomplete
      in this sense may be considered incomplete for study review and analysis purposes.
    comments:
    - 'Required

      enum values: (Yes | No)

      When the value is "Yes", the data for each subject in the study must include
      an ItemData element with this ItemOID.'
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    range: YesOrNo
    required: true
  collectionExceptionConditionOID:
    name: collectionExceptionConditionOID
    description: Reference to a ConditionDef that defines the circumstances under
      which collection of the Item may be omitted.
    comments:
    - 'Optional

      range: oidref

      The CollectionExceptionConditionOID value must match the OID attribute for a
      ConditionDef in this Study/MetaDataVersion.'
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    range: ConditionDef
  origin:
    name: origin
    multivalued: true
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: Origin
    inlined: true
    inlined_as_list: true
  whereClauseRef:
    name: whereClauseRef
    multivalued: true
    domain_of:
    - ItemRef
    range: WhereClauseRef
    inlined: true
    inlined_as_list: true
class_uri: odm:ItemRef

Induced

name: ItemRef
description: 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
see_also:
- https://wiki.cdisc.org/display/PUB/ItemRef
rank: 1000
slot_usage:
  itemOID:
    name: itemOID
    description: Reference to the ItemDef .
    comments:
    - 'Required

      range: oidref

      Must match the OID attribute for an ItemDef in the Study/MetaDataVersion. The
      ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate ItemOID
      values.'
    domain_of:
    - ItemRef
    - SourceItem
    - RangeCheck
    - ItemData
    - KeySet
    range: ItemDef
    required: true
  keySequence:
    name: keySequence
    description: Indicates that this item is a key for the enclosing element. It also
      provides an ordering for the keys.
    comments:
    - 'Optional

      range: positiveInteger

      The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate
      KeySequence values.'
    domain_of:
    - ItemRef
    range: positiveInteger
  isNonStandard:
    name: isNonStandard
    description: A non-standard variable is one that is not defined in the SDTMIG
      or the underlying SDTM model of a standard referenced within the ODM document.
      Permitted for any ItemRef that represents a non-standard variable in an SDTM
      or SEND dataset when the ODM Context attribute value is "Other" Is not used
      with an ItemRef that represents a value level metadata for an SDTMIG SUPPQUAL
      dataset Has no meaning for ADaM, so shall not be used for ADaM variables
    comments:
    - 'Optional

      range: (Yes)'
    domain_of:
    - ItemGroupDef
    - ItemRef
    - CodeList
    range: YesOnly
  hasNoData:
    name: hasNoData
    description: Used to indicate that an ItemRef that represent a dataset's variable
      has no data. Note that variables refer to both standard and non-standard/ supplemental
      qualifiers variables (/ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef or /ODM/Study/MetaDataVersion/ValueListDef/ItemRef).
    comments:
    - 'Conditional

      range: (Yes)

      A comment must be included to explain why no data is present for dataset''s
      variables that were planned for use in the study.'
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: YesOnly
  methodOID:
    name: methodOID
    description: Reference to a MethodDef used to derive the value of this item.
    comments:
    - 'Optional

      range: oidref

      The MethodOID value must match the OID attribute for a MethodDef in this Study/MetaDataVersion.'
    domain_of:
    - ItemGroupRef
    - ItemRef
    - TransitionTimingConstraint
    range: MethodDef
  unitsItemOID:
    name: unitsItemOID
    description: Reference to a sibling ItemRef element that represents the unit specification
      for this ItemRef (defines the associated units variable).
    comments:
    - 'Optional

      range: oidref

      The sibling ItemRef element will have ItemOID=UnitsItemOID and the UnitsItemOID
      value must match the OID attribute for the ItemDef that defines the units for
      this Item.'
    domain_of:
    - ItemRef
    range: ItemDef
  repeat:
    name: repeat
    description: Indicates that the item serves as the item over which repeats are
      to be performed.
    comments:
    - 'Optional

      range: (Yes)

      The corresponding ItemDef must have an associated CodeList containing the items
      over which the repeat is to be performed. There may only be one ItemRef within
      the ItemGroupDef with Repeat="Yes".'
    domain_of:
    - ItemRef
    range: YesOnly
  other:
    name: other
    description: Flag to indicate that the Item represents "other" content added to
      an ItemGroup.
    comments:
    - 'Optional

      range: (Yes)'
    domain_of:
    - ItemRef
    - CodeListItem
    range: YesOnly
  role:
    name: role
    description: The Role for the referenced ItemDef. The Role attribute provides
      a single role name describing the use of this data item. If the Role is defined
      by a standard terminology, RoleCodeListOID may be used to reference a CodeList
      that defines the full set roles from which the Role attribute value is to be
      taken.
    comments:
    - 'Optional

      range: text

      This attribute must not be present unless the Role attribute is defined.'
    domain_of:
    - ItemRef
    - Organization
    - Location
    range: text
  roleCodeListOID:
    name: roleCodeListOID
    description: Reference to a CodeList that defines the allowable values of Role
      for the Study.
    comments:
    - 'Optional

      range: oidref

      The RoleCodelistOID must match the OID attribute for a CodeList within the Study/MetaDataVersion.
      If Role is defined, RoleCodeListOID is still optional.'
    domain_of:
    - ItemRef
    range: CodeList
  core:
    name: core
    description: CDASH, ADaM, SDTM, and SEND Core designations.
    comments:
    - 'Optional

      enum values: (HR | O | R/C | Cond | Exp | Perm | Req)

      Reference the appropriate specifications for complete requirements. Example:
      CDASH: "HR", "R/C", "O"; SDTM: "Req", "Exp", "Perm".'
    domain_of:
    - ItemRef
    range: CoreType
  preSpecifiedValue:
    name: preSpecifiedValue
    description: Prefill value or a default value for a field that is automatically
      populated.
    comments:
    - 'Optional

      range: text'
    domain_of:
    - ItemRef
    range: text
  orderNumber:
    name: orderNumber
    description: Indicates the order in which this ItemRef appears in Metadata displays
      or data entry applications. The OrderNumbers provide an ordering on the Items
      (within a containing element) for use whenever a list of Items is presented
      to a user. They do not imply anything about event scheduling, time ordering,
      or data correctness.
    comments:
    - 'Optional

      range: positiveInteger

      The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate
      OrderNumber values.'
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    - CodeListItem
    - Parameter
    - ReturnValue
    - StudyEndPointRef
    range: positiveInteger
  mandatory:
    name: mandatory
    description: Indicator of whether this ItemGroup must appear in the study clinical
      data for each subject per the study protocol. The Mandatory flag indicates that
      the clinical data for an instance of the containing element would be incomplete
      without an instance of this type of item. ODM clinical data files that are incomplete
      in this sense may be considered incomplete for study review and analysis purposes.
    comments:
    - 'Required

      enum values: (Yes | No)

      When the value is "Yes", the data for each subject in the study must include
      an ItemData element with this ItemOID.'
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    range: YesOrNo
    required: true
  collectionExceptionConditionOID:
    name: collectionExceptionConditionOID
    description: Reference to a ConditionDef that defines the circumstances under
      which collection of the Item may be omitted.
    comments:
    - 'Optional

      range: oidref

      The CollectionExceptionConditionOID value must match the OID attribute for a
      ConditionDef in this Study/MetaDataVersion.'
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    range: ConditionDef
  origin:
    name: origin
    multivalued: true
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: Origin
    inlined: true
    inlined_as_list: true
  whereClauseRef:
    name: whereClauseRef
    multivalued: true
    domain_of:
    - ItemRef
    range: WhereClauseRef
    inlined: true
    inlined_as_list: true
attributes:
  itemOID:
    name: itemOID
    description: Reference to the ItemDef .
    comments:
    - 'Required

      range: oidref

      Must match the OID attribute for an ItemDef in the Study/MetaDataVersion. The
      ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate ItemOID
      values.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: itemOID
    owner: ItemRef
    domain_of:
    - ItemRef
    - SourceItem
    - RangeCheck
    - ItemData
    - KeySet
    range: ItemDef
    required: true
  keySequence:
    name: keySequence
    description: Indicates that this item is a key for the enclosing element. It also
      provides an ordering for the keys.
    comments:
    - 'Optional

      range: positiveInteger

      The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate
      KeySequence values.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: keySequence
    owner: ItemRef
    domain_of:
    - ItemRef
    range: positiveInteger
  isNonStandard:
    name: isNonStandard
    description: A non-standard variable is one that is not defined in the SDTMIG
      or the underlying SDTM model of a standard referenced within the ODM document.
      Permitted for any ItemRef that represents a non-standard variable in an SDTM
      or SEND dataset when the ODM Context attribute value is "Other" Is not used
      with an ItemRef that represents a value level metadata for an SDTMIG SUPPQUAL
      dataset Has no meaning for ADaM, so shall not be used for ADaM variables
    comments:
    - 'Optional

      range: (Yes)'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: isNonStandard
    owner: ItemRef
    domain_of:
    - ItemGroupDef
    - ItemRef
    - CodeList
    range: YesOnly
  hasNoData:
    name: hasNoData
    description: Used to indicate that an ItemRef that represent a dataset's variable
      has no data. Note that variables refer to both standard and non-standard/ supplemental
      qualifiers variables (/ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef or /ODM/Study/MetaDataVersion/ValueListDef/ItemRef).
    comments:
    - 'Conditional

      range: (Yes)

      A comment must be included to explain why no data is present for dataset''s
      variables that were planned for use in the study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: hasNoData
    owner: ItemRef
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: YesOnly
  methodOID:
    name: methodOID
    description: Reference to a MethodDef used to derive the value of this item.
    comments:
    - 'Optional

      range: oidref

      The MethodOID value must match the OID attribute for a MethodDef in this Study/MetaDataVersion.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: methodOID
    owner: ItemRef
    domain_of:
    - ItemGroupRef
    - ItemRef
    - TransitionTimingConstraint
    range: MethodDef
  unitsItemOID:
    name: unitsItemOID
    description: Reference to a sibling ItemRef element that represents the unit specification
      for this ItemRef (defines the associated units variable).
    comments:
    - 'Optional

      range: oidref

      The sibling ItemRef element will have ItemOID=UnitsItemOID and the UnitsItemOID
      value must match the OID attribute for the ItemDef that defines the units for
      this Item.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: unitsItemOID
    owner: ItemRef
    domain_of:
    - ItemRef
    range: ItemDef
  repeat:
    name: repeat
    description: Indicates that the item serves as the item over which repeats are
      to be performed.
    comments:
    - 'Optional

      range: (Yes)

      The corresponding ItemDef must have an associated CodeList containing the items
      over which the repeat is to be performed. There may only be one ItemRef within
      the ItemGroupDef with Repeat="Yes".'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: repeat
    owner: ItemRef
    domain_of:
    - ItemRef
    range: YesOnly
  other:
    name: other
    description: Flag to indicate that the Item represents "other" content added to
      an ItemGroup.
    comments:
    - 'Optional

      range: (Yes)'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: other
    owner: ItemRef
    domain_of:
    - ItemRef
    - CodeListItem
    range: YesOnly
  role:
    name: role
    description: The Role for the referenced ItemDef. The Role attribute provides
      a single role name describing the use of this data item. If the Role is defined
      by a standard terminology, RoleCodeListOID may be used to reference a CodeList
      that defines the full set roles from which the Role attribute value is to be
      taken.
    comments:
    - 'Optional

      range: text

      This attribute must not be present unless the Role attribute is defined.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: role
    owner: ItemRef
    domain_of:
    - ItemRef
    - Organization
    - Location
    range: text
  roleCodeListOID:
    name: roleCodeListOID
    description: Reference to a CodeList that defines the allowable values of Role
      for the Study.
    comments:
    - 'Optional

      range: oidref

      The RoleCodelistOID must match the OID attribute for a CodeList within the Study/MetaDataVersion.
      If Role is defined, RoleCodeListOID is still optional.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: roleCodeListOID
    owner: ItemRef
    domain_of:
    - ItemRef
    range: CodeList
  core:
    name: core
    description: CDASH, ADaM, SDTM, and SEND Core designations.
    comments:
    - 'Optional

      enum values: (HR | O | R/C | Cond | Exp | Perm | Req)

      Reference the appropriate specifications for complete requirements. Example:
      CDASH: "HR", "R/C", "O"; SDTM: "Req", "Exp", "Perm".'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: core
    owner: ItemRef
    domain_of:
    - ItemRef
    range: CoreType
  preSpecifiedValue:
    name: preSpecifiedValue
    description: Prefill value or a default value for a field that is automatically
      populated.
    comments:
    - 'Optional

      range: text'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: preSpecifiedValue
    owner: ItemRef
    domain_of:
    - ItemRef
    range: text
  orderNumber:
    name: orderNumber
    description: Indicates the order in which this ItemRef appears in Metadata displays
      or data entry applications. The OrderNumbers provide an ordering on the Items
      (within a containing element) for use whenever a list of Items is presented
      to a user. They do not imply anything about event scheduling, time ordering,
      or data correctness.
    comments:
    - 'Optional

      range: positiveInteger

      The ItemRefs within an ItemGroupDef or ValueListDef must not have duplicate
      OrderNumber values.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: orderNumber
    owner: ItemRef
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    - CodeListItem
    - Parameter
    - ReturnValue
    - StudyEndPointRef
    range: positiveInteger
  mandatory:
    name: mandatory
    description: Indicator of whether this ItemGroup must appear in the study clinical
      data for each subject per the study protocol. The Mandatory flag indicates that
      the clinical data for an instance of the containing element would be incomplete
      without an instance of this type of item. ODM clinical data files that are incomplete
      in this sense may be considered incomplete for study review and analysis purposes.
    comments:
    - 'Required

      enum values: (Yes | No)

      When the value is "Yes", the data for each subject in the study must include
      an ItemData element with this ItemOID.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: mandatory
    owner: ItemRef
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    range: YesOrNo
    required: true
  collectionExceptionConditionOID:
    name: collectionExceptionConditionOID
    description: Reference to a ConditionDef that defines the circumstances under
      which collection of the Item may be omitted.
    comments:
    - 'Optional

      range: oidref

      The CollectionExceptionConditionOID value must match the OID attribute for a
      ConditionDef in this Study/MetaDataVersion.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: collectionExceptionConditionOID
    owner: ItemRef
    domain_of:
    - StudyEventGroupRef
    - StudyEventRef
    - ItemGroupRef
    - ItemRef
    range: ConditionDef
  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: ItemRef
    domain_of:
    - ItemGroupDef
    - ItemRef
    range: Origin
    inlined: true
    inlined_as_list: true
  whereClauseRef:
    name: whereClauseRef
    description: 'WhereClauseRef reference: The WhereClauseRef references the WhereClauseDef
      element that describes the conditions under which the variable values are defined
      by the referenced ItemDef.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: whereClauseRef
    owner: ItemRef
    domain_of:
    - ItemRef
    range: WhereClauseRef
    inlined: true
    inlined_as_list: true
class_uri: odm:ItemRef