Class: Item
A data element that represents a specific piece of information within a defined context, with data type, constraints, and derivation methods
URI: odm:class/Item
erDiagram
Item {
DataType dataType
integer length
string role
boolean hasNoData
string crfCompletionInstructions
string cdiscNotes
string implementationNotes
string preSpecifiedValue
integer decimalDigits
string displayFormat
integer significantDigits
string OID
string uuid
string name
string description
string label
stringList aliases
boolean mandatory
string purpose
datetime lastUpdated
string owner
string wasDerivedFrom
}
Comment {
string text
string OID
string uuid
string name
string description
string label
stringList aliases
}
Coding {
string code
string decode
string codeSystem
string codeSystemVersion
AliasPredicate aliasType
}
DocumentReference {
string title
string leafID
integerList pages
string relationship
string version
string href
string OID
string uuid
string name
string description
string label
stringList aliases
}
Condition {
string implementsCondition
LogicalOperator operator
string OID
string uuid
string name
string description
string label
stringList aliases
boolean mandatory
string purpose
datetime lastUpdated
string owner
string wasDerivedFrom
}
FormalExpression {
string context
string expression
string returnType
string OID
string uuid
string name
string description
string label
stringList aliases
}
RangeCheck {
Comparator comparator
stringList checkValues
string item
SoftHard softHard
LogicalOperator operator
}
CodeList {
DataType dataType
string formatName
string version
string href
string OID
string uuid
string name
string description
string label
stringList aliases
boolean mandatory
string purpose
datetime lastUpdated
string owner
string wasDerivedFrom
}
Resource {
string resourceType
string attribute
string version
string href
string OID
string uuid
string name
string description
string label
stringList aliases
}
CodeListItem {
string codedValue
string decode
string description
stringList aliases
decimal weight
boolean other
}
ConceptProperty {
integer minOccurs
integer maxOccurs
string OID
string uuid
string name
string description
string label
stringList aliases
boolean mandatory
string purpose
datetime lastUpdated
string owner
string wasDerivedFrom
}
Origin {
OriginType type
OriginSource source
}
SourceItem {
stringList resource
}
WhereClause {
string OID
string uuid
string name
string description
string label
stringList aliases
}
Method {
MethodType type
string OID
string uuid
string name
string description
string label
stringList aliases
boolean mandatory
string purpose
datetime lastUpdated
string owner
string wasDerivedFrom
}
Item ||--|o CodeList : "codeList"
Item ||--|o Method : "method"
Item ||--}o RangeCheck : "rangeChecks"
Item ||--}o WhereClause : "whereClauses"
Item ||--|o Origin : "origin"
Item ||--|o ConceptProperty : "conceptProperty"
Item ||--|o CodeList : "roleCodeList"
Item ||--|o Condition : "collectionExceptionCondition"
Item ||--}o Coding : "coding"
Item ||--}o Comment : "comments"
Item ||--}o Comment : "siteOrSponsorComments"
Comment ||--}o DocumentReference : "documents"
Comment ||--}o Coding : "coding"
DocumentReference ||--}o Coding : "coding"
Condition ||--}o RangeCheck : "rangeChecks"
Condition ||--}o FormalExpression : "formalExpression"
Condition ||--}o Condition : "conditions"
Condition ||--}o Coding : "coding"
Condition ||--}o Comment : "comments"
Condition ||--}o Comment : "siteOrSponsorComments"
FormalExpression ||--}o Parameter : "parameters"
FormalExpression ||--|o ReturnValue : "returnValue"
FormalExpression ||--}o Resource : "externalCodeLibs"
FormalExpression ||--}o Coding : "coding"
RangeCheck ||--}o FormalExpression : "formalExpression"
CodeList ||--}o CodeListItem : "codeListItems"
CodeList ||--|o Resource : "externalCodeList"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Comment : "comments"
CodeList ||--}o Comment : "siteOrSponsorComments"
Resource ||--}o FormalExpression : "selection"
Resource ||--}o Coding : "coding"
CodeListItem ||--|o Coding : "coding"
ConceptProperty ||--|o CodeList : "codeList"
ConceptProperty ||--}o Coding : "coding"
ConceptProperty ||--}o Comment : "comments"
ConceptProperty ||--}o Comment : "siteOrSponsorComments"
Origin ||--}o SourceItem : "sourceItems"
Origin ||--|o DocumentReference : "document"
SourceItem ||--|o Item : "item"
SourceItem ||--|o DocumentReference : "document"
SourceItem ||--}o Coding : "coding"
WhereClause ||--}o Condition : "conditions"
WhereClause ||--}o Coding : "coding"
Method ||--}o FormalExpression : "formalExpressions"
Method ||--|o DocumentReference : "document"
Method ||--}o Coding : "coding"
Method ||--}o Comment : "comments"
Method ||--}o Comment : "siteOrSponsorComments"
Inheritance
Slots
Name | Cardinality and Range | Description | Inheritance |
---|---|---|---|
dataType | 1 DataType |
The data type of the item. | direct |
length | 0..1 Integer |
The maximum length of the data item in characters. | direct |
codeList | 0..1 CodeList |
Reference to the CodeList that constrains the item values. | direct |
method | 0..1 Method |
Reference to the Method element that describes how to derive this item's value. | direct |
rangeChecks | * RangeCheck |
Range checks applied to this item (e.g. edit checks, CORE rules) | direct |
whereClauses | * WhereClause |
References to different situations that define when this item applies. Multiple whereClauses are combined with OR logic: the item applies if ANY referenced WhereClause matches. Within each WhereClause, conditions are combined with AND logic: all conditions must be true. Example: whereClause: ["WC.SYSBP", "WC.DIABP"] means the item applies when (all conditions in WC.SYSBP are true) OR (all conditions in WC.DIABP are true). |
direct |
origin | 0..1 Origin |
The origin of the data | direct |
conceptProperty | 0..1 ConceptProperty |
Reference to a abstract concept property that this item is a specialization / instance of. | direct |
role | 0..1 String or String or TranslatedText |
Identifies the role of the item within the containing context, taken from the roleCodeList | IsODMItem |
roleCodeList | 0..1 CodeList |
Reference to the CodeList that defines the roles for this item | IsODMItem |
hasNoData | 0..1 Boolean |
Set to Yes if this is a manifest and there is no data for this item | IsODMItem |
crfCompletionInstructions | 0..1 String or String or TranslatedText |
CRFCompletionInstructions reference: Instructions for the clinical site on how to enter collected information on the CRF | IsODMItem |
cdiscNotes | 0..1 String or String or TranslatedText |
CDISCNotes reference: Explanatory text for the variable | IsODMItem |
implementationNotes | 0..1 String or String or TranslatedText |
ImplementationNotes reference: Further information, such as rationale and implementation instructions, on how to implement the CRF data collection fields | IsODMItem |
collectionExceptionCondition | 0..1 Condition |
Condition that defines when collection may be exempted | IsODMItem |
preSpecifiedValue | 0..1 String or String or TranslatedText |
Prefill value or a default value for a field that is automatically populated. | IsODMItem |
decimalDigits | 0..1 Integer |
For decimal values, the number of digits after the decimal point | Formatted |
displayFormat | 0..1 String |
A display format for the item | Formatted |
significantDigits | 0..1 Integer |
For numeric values, the number of significant digits | Formatted |
OID | 1 String |
Local identifier within this study/context. Use CDISC OID format for regulatory submissions, or simple strings for internal use. | Identifiable |
uuid | 0..1 String |
Universal unique identifier | Identifiable |
name | 0..1 String |
Short name or identifier, used for field names | Labelled |
description | 0..1 String or String or TranslatedText |
Detailed description, shown in tooltips | Labelled |
coding | * Coding |
Semantic tags for this element | Labelled |
label | 0..1 String or String or TranslatedText |
Human-readable label, shown in UIs | Labelled |
aliases | * String or String or TranslatedText |
Alternative name or identifier | Labelled |
mandatory | 0..1 Boolean |
Is this element required? | Governed |
comments | * Comment |
Comment on the element, such as a rationale for its inclusion or exclusion | Governed |
siteOrSponsorComments | * Comment |
Comment on the element, such as a rationale for its inclusion or exclusion | Governed |
purpose | 0..1 String or String or TranslatedText |
Purpose or rationale for this data element | Governed |
lastUpdated | 0..1 Datetime |
When the resource was last updated | Governed |
owner | 0..1 String or User or Organization or String |
Party responsible for this element | Governed |
wasDerivedFrom | 0..1 String or Item or ItemGroup or MetaDataVersion or CodeList or ReifiedConcept or ConceptProperty or Condition or Method or NominalOccurrence or Dataflow or CubeComponent or DataProduct or ProvisionAgreement |
Reference to another item that this item implements or extends, e.g. a template Item definition. | Governed |
Usages
Identifier and Mapping Information
Schema Source
- from schema: https://cdisc.org/define-json
Mappings
Mapping Type | Mapped Value |
---|---|
self | odm:Item |
native | odm:Item |
narrow | fhir:StructureDefinition/variable, fhir:Questionnaire/item, qb:ComponentProperty, omop:Field, omop:DerivedColumn |
related | usdm:BiomedicalConceptProperty, usdm:DerivationConceptProperty, usdm:AnalysisConceptProperty, fhir:ElementDefinition, qb:Measure, qb:Attribute, sdmx:Concept, sdmx:Component, sdmx:Representation, osb:sdtm_variable, osb:specimen, osb:unit_dimension, osb:std_unit |
close | odm:ItemRef, odm:ItemDef, qb:ComponentSpecification, sdmx:DataAttribute, sdmx:MetadataAttribute |
LinkML Source
Direct
name: Item
description: A data element that represents a specific piece of information within
a defined context, with data type, constraints, and derivation methods
from_schema: https://cdisc.org/define-json
close_mappings:
- odm:ItemRef
- odm:ItemDef
- qb:ComponentSpecification
- sdmx:DataAttribute
- sdmx:MetadataAttribute
related_mappings:
- usdm:BiomedicalConceptProperty
- usdm:DerivationConceptProperty
- usdm:AnalysisConceptProperty
- fhir:ElementDefinition
- qb:Measure
- qb:Attribute
- sdmx:Concept
- sdmx:Component
- sdmx:Representation
- osb:sdtm_variable
- osb:specimen
- osb:unit_dimension
- osb:std_unit
narrow_mappings:
- fhir:StructureDefinition/variable
- fhir:Questionnaire/item
- qb:ComponentProperty
- omop:Field
- omop:DerivedColumn
is_a: GovernedElement
mixins:
- IsODMItem
- Formatted
attributes:
dataType:
name: dataType
description: The data type of the item.
from_schema: https://cdisc.org/define-json
rank: 1000
domain_of:
- Item
- CodeList
- Parameter
- ReturnValue
range: DataType
required: true
length:
name: length
description: The maximum length of the data item in characters.
from_schema: https://cdisc.org/define-json
rank: 1000
domain_of:
- Item
range: integer
codeList:
name: codeList
description: Reference to the CodeList that constrains the item values.
from_schema: https://cdisc.org/define-json
rank: 1000
domain_of:
- Item
- ConceptProperty
- Parameter
range: CodeList
method:
name: method
description: Reference to the Method element that describes how to derive this
item's value.
from_schema: https://cdisc.org/define-json
rank: 1000
domain_of:
- Item
range: Method
rangeChecks:
name: rangeChecks
description: Range checks applied to this item (e.g. edit checks, CORE rules)
from_schema: https://cdisc.org/define-json
rank: 1000
domain_of:
- Item
- Condition
range: RangeCheck
multivalued: true
inlined: true
inlined_as_list: true
whereClauses:
name: whereClauses
description: 'References to different situations that define when this item applies.
Multiple whereClauses are combined with OR logic: the item applies if ANY referenced
WhereClause matches.
Within each WhereClause, conditions are combined with AND logic: all conditions
must be true.
Example: whereClause: ["WC.SYSBP", "WC.DIABP"] means the item applies when
(all conditions in WC.SYSBP are true) OR (all conditions in WC.DIABP are true).
'
from_schema: https://cdisc.org/define-json
close_mappings:
- fhir:StructureDefinition/context
domain_of:
- MetaDataVersion
- Item
- ItemGroup
range: WhereClause
multivalued: true
inlined: false
origin:
name: origin
description: The origin of the data
from_schema: https://cdisc.org/define-json
rank: 1000
domain_of:
- Item
range: Origin
inlined: true
conceptProperty:
name: conceptProperty
description: Reference to a abstract concept property that this item is a specialization
/ instance of.
from_schema: https://cdisc.org/define-json
rank: 1000
domain_of:
- Item
- Parameter
range: ConceptProperty
Induced
name: Item
description: A data element that represents a specific piece of information within
a defined context, with data type, constraints, and derivation methods
from_schema: https://cdisc.org/define-json
close_mappings:
- odm:ItemRef
- odm:ItemDef
- qb:ComponentSpecification
- sdmx:DataAttribute
- sdmx:MetadataAttribute
related_mappings:
- usdm:BiomedicalConceptProperty
- usdm:DerivationConceptProperty
- usdm:AnalysisConceptProperty
- fhir:ElementDefinition
- qb:Measure
- qb:Attribute
- sdmx:Concept
- sdmx:Component
- sdmx:Representation
- osb:sdtm_variable
- osb:specimen
- osb:unit_dimension
- osb:std_unit
narrow_mappings:
- fhir:StructureDefinition/variable
- fhir:Questionnaire/item
- qb:ComponentProperty
- omop:Field
- omop:DerivedColumn
is_a: GovernedElement
mixins:
- IsODMItem
- Formatted
attributes:
dataType:
name: dataType
description: The data type of the item.
from_schema: https://cdisc.org/define-json
rank: 1000
alias: dataType
owner: Item
domain_of:
- Item
- CodeList
- Parameter
- ReturnValue
range: DataType
required: true
length:
name: length
description: The maximum length of the data item in characters.
from_schema: https://cdisc.org/define-json
rank: 1000
alias: length
owner: Item
domain_of:
- Item
range: integer
codeList:
name: codeList
description: Reference to the CodeList that constrains the item values.
from_schema: https://cdisc.org/define-json
rank: 1000
alias: codeList
owner: Item
domain_of:
- Item
- ConceptProperty
- Parameter
range: CodeList
method:
name: method
description: Reference to the Method element that describes how to derive this
item's value.
from_schema: https://cdisc.org/define-json
rank: 1000
alias: method
owner: Item
domain_of:
- Item
range: Method
rangeChecks:
name: rangeChecks
description: Range checks applied to this item (e.g. edit checks, CORE rules)
from_schema: https://cdisc.org/define-json
rank: 1000
alias: rangeChecks
owner: Item
domain_of:
- Item
- Condition
range: RangeCheck
multivalued: true
inlined: true
inlined_as_list: true
whereClauses:
name: whereClauses
description: 'References to different situations that define when this item applies.
Multiple whereClauses are combined with OR logic: the item applies if ANY referenced
WhereClause matches.
Within each WhereClause, conditions are combined with AND logic: all conditions
must be true.
Example: whereClause: ["WC.SYSBP", "WC.DIABP"] means the item applies when
(all conditions in WC.SYSBP are true) OR (all conditions in WC.DIABP are true).
'
from_schema: https://cdisc.org/define-json
close_mappings:
- fhir:StructureDefinition/context
alias: whereClauses
owner: Item
domain_of:
- MetaDataVersion
- Item
- ItemGroup
range: WhereClause
multivalued: true
inlined: false
origin:
name: origin
description: The origin of the data
from_schema: https://cdisc.org/define-json
rank: 1000
alias: origin
owner: Item
domain_of:
- Item
range: Origin
inlined: true
conceptProperty:
name: conceptProperty
description: Reference to a abstract concept property that this item is a specialization
/ instance of.
from_schema: https://cdisc.org/define-json
rank: 1000
alias: conceptProperty
owner: Item
domain_of:
- Item
- Parameter
range: ConceptProperty
role:
name: role
description: Identifies the role of the item within the containing context, taken
from the roleCodeList
from_schema: https://cdisc.org/define-json
rank: 1000
alias: role
owner: Item
domain_of:
- IsODMItem
- Organization
- CubeComponent
range: string
any_of:
- range: string
- range: TranslatedText
roleCodeList:
name: roleCodeList
description: Reference to the CodeList that defines the roles for this item
from_schema: https://cdisc.org/define-json
rank: 1000
alias: roleCodeList
owner: Item
domain_of:
- IsODMItem
range: CodeList
hasNoData:
name: hasNoData
description: Set to Yes if this is a manifest and there is no data for this item
from_schema: https://cdisc.org/define-json
rank: 1000
alias: hasNoData
owner: Item
domain_of:
- IsODMItem
range: boolean
crfCompletionInstructions:
name: crfCompletionInstructions
description: 'CRFCompletionInstructions reference: Instructions for the clinical
site on how to enter collected information on the CRF'
from_schema: https://cdisc.org/define-json
rank: 1000
alias: crfCompletionInstructions
owner: Item
domain_of:
- IsODMItem
range: string
any_of:
- range: string
- range: TranslatedText
cdiscNotes:
name: cdiscNotes
description: 'CDISCNotes reference: Explanatory text for the variable'
from_schema: https://cdisc.org/define-json
rank: 1000
alias: cdiscNotes
owner: Item
domain_of:
- IsODMItem
range: string
any_of:
- range: string
- range: TranslatedText
implementationNotes:
name: implementationNotes
description: 'ImplementationNotes reference: Further information, such as rationale
and implementation instructions, on how to implement the CRF data collection
fields'
from_schema: https://cdisc.org/define-json
rank: 1000
alias: implementationNotes
owner: Item
domain_of:
- IsODMItem
range: string
any_of:
- range: string
- range: TranslatedText
collectionExceptionCondition:
name: collectionExceptionCondition
description: Condition that defines when collection may be exempted
from_schema: https://cdisc.org/define-json
rank: 1000
alias: collectionExceptionCondition
owner: Item
domain_of:
- IsODMItem
range: Condition
preSpecifiedValue:
name: preSpecifiedValue
description: Prefill value or a default value for a field that is automatically
populated.
from_schema: https://cdisc.org/define-json
rank: 1000
alias: preSpecifiedValue
owner: Item
domain_of:
- IsODMItem
range: string
any_of:
- range: string
- range: TranslatedText
decimalDigits:
name: decimalDigits
description: For decimal values, the number of digits after the decimal point
from_schema: https://cdisc.org/define-json
rank: 1000
alias: decimalDigits
owner: Item
domain_of:
- Formatted
range: integer
displayFormat:
name: displayFormat
description: A display format for the item
from_schema: https://cdisc.org/define-json
rank: 1000
alias: displayFormat
owner: Item
domain_of:
- Formatted
range: string
significantDigits:
name: significantDigits
description: For numeric values, the number of significant digits
from_schema: https://cdisc.org/define-json
rank: 1000
alias: significantDigits
owner: Item
domain_of:
- Formatted
range: integer
OID:
name: OID
description: Local identifier within this study/context. Use CDISC OID format
for regulatory submissions, or simple strings for internal use.
from_schema: https://cdisc.org/define-json
rank: 1000
identifier: true
alias: OID
owner: Item
domain_of:
- Identifiable
range: string
required: true
pattern: ^[A-Za-z][A-Za-z0-9._-]*$
uuid:
name: uuid
description: Universal unique identifier
from_schema: https://cdisc.org/define-json
rank: 1000
alias: uuid
owner: Item
domain_of:
- Identifiable
range: string
name:
name: name
description: Short name or identifier, used for field names
from_schema: https://cdisc.org/define-json
rank: 1000
alias: name
owner: Item
domain_of:
- Labelled
- Standard
range: string
description:
name: description
description: Detailed description, shown in tooltips
from_schema: https://cdisc.org/define-json
rank: 1000
alias: description
owner: Item
domain_of:
- Labelled
- CodeListItem
range: string
any_of:
- range: string
- range: TranslatedText
coding:
name: coding
description: Semantic tags for this element
from_schema: https://cdisc.org/define-json
rank: 1000
alias: coding
owner: Item
domain_of:
- Labelled
- CodeListItem
- SourceItem
range: Coding
multivalued: true
inlined: true
inlined_as_list: true
label:
name: label
description: Human-readable label, shown in UIs
from_schema: https://cdisc.org/define-json
exact_mappings:
- skos:prefLabel
rank: 1000
alias: label
owner: Item
domain_of:
- Labelled
range: string
any_of:
- range: string
- range: TranslatedText
aliases:
name: aliases
description: Alternative name or identifier
from_schema: https://cdisc.org/define-json
exact_mappings:
- skos:altLabel
rank: 1000
alias: aliases
owner: Item
domain_of:
- Labelled
- CodeListItem
range: string
multivalued: true
inlined: true
inlined_as_list: true
any_of:
- range: string
- range: TranslatedText
mandatory:
name: mandatory
description: Is this element required?
from_schema: https://cdisc.org/define-json
rank: 1000
alias: mandatory
owner: Item
domain_of:
- Governed
range: boolean
comments:
name: comments
description: Comment on the element, such as a rationale for its inclusion or
exclusion
from_schema: https://cdisc.org/define-json
rank: 1000
alias: comments
owner: Item
domain_of:
- Governed
range: Comment
multivalued: true
inlined: false
siteOrSponsorComments:
name: siteOrSponsorComments
description: Comment on the element, such as a rationale for its inclusion or
exclusion
from_schema: https://cdisc.org/define-json
rank: 1000
alias: siteOrSponsorComments
owner: Item
domain_of:
- Governed
range: Comment
multivalued: true
inlined: false
purpose:
name: purpose
description: Purpose or rationale for this data element
from_schema: https://cdisc.org/define-json
rank: 1000
alias: purpose
owner: Item
domain_of:
- Governed
range: string
any_of:
- range: string
- range: TranslatedText
lastUpdated:
name: lastUpdated
description: When the resource was last updated
from_schema: https://cdisc.org/define-json
rank: 1000
alias: lastUpdated
owner: Item
domain_of:
- Governed
range: datetime
owner:
name: owner
description: Party responsible for this element
from_schema: https://cdisc.org/define-json
narrow_mappings:
- prov:wasAttributedTo
- prov:wasAssociatedBy
rank: 1000
alias: owner
owner: Item
domain_of:
- Governed
range: string
any_of:
- range: User
- range: Organization
- range: string
wasDerivedFrom:
name: wasDerivedFrom
description: Reference to another item that this item implements or extends, e.g.
a template Item definition.
from_schema: https://cdisc.org/define-json
exact_mappings:
- prov:wasDerivedFrom
rank: 1000
alias: wasDerivedFrom
owner: Item
domain_of:
- Governed
range: string
any_of:
- range: Item
- range: ItemGroup
- range: MetaDataVersion
- range: CodeList
- range: ReifiedConcept
- range: ConceptProperty
- range: Condition
- range: Method
- range: NominalOccurrence
- range: Dataflow
- range: CubeComponent
- range: DataProduct
- range: ProvisionAgreement