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](https://cdisc.org/odm2/class/Item)
[DataType](../enums/DataType.md) | The data type of the item. | direct | | [length](../slots/length.md) | 0..1
[Integer](../types/Integer.md) | The maximum length of the data item in characters. | direct | | [codeList](../slots/codeList.md) | 0..1
[CodeList](../classes/CodeList.md) | Reference to the CodeList that constrains the item values. | direct | | [method](../slots/method.md) | 0..1
[Method](../classes/Method.md) | Reference to the Method element that describes how to derive this item's value. | direct | | [rangeChecks](../slots/rangeChecks.md) | *
[RangeCheck](../classes/RangeCheck.md) | Range checks applied to this item (e.g. edit checks, CORE rules) | direct | | [applicableWhen](../slots/applicableWhen.md) | *
[WhereClause](../classes/WhereClause.md) | 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](../slots/origin.md) | 0..1
[Origin](../classes/Origin.md) | The origin of the data | direct | | [conceptProperty](../slots/conceptProperty.md) | 0..1
[ConceptProperty](../classes/ConceptProperty.md) | Reference to a abstract concept property that this item is a specialization / instance of. | direct | | [role](../slots/role.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Identifies the role of the item within the containing context, taken from the roleCodeList | [IsODMItem](../classes/IsODMItem.md) | | [roleCodeList](../slots/roleCodeList.md) | 0..1
[CodeList](../classes/CodeList.md) | Reference to the CodeList that defines the roles for this item | [IsODMItem](../classes/IsODMItem.md) | | [hasNoData](../slots/hasNoData.md) | 0..1
[Boolean](../types/Boolean.md) | True if this is a manifest and there is no data for this item | [IsODMItem](../classes/IsODMItem.md) | | [crfCompletionInstructions](../slots/crfCompletionInstructions.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | CRFCompletionInstructions reference: Instructions for the clinical site on how to enter collected information on the CRF | [IsODMItem](../classes/IsODMItem.md) | | [cdiscNotes](../slots/cdiscNotes.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | CDISCNotes reference: Explanatory text for the variable | [IsODMItem](../classes/IsODMItem.md) | | [implementationNotes](../slots/implementationNotes.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | ImplementationNotes reference: Further information, such as rationale and implementation instructions, on how to implement the CRF data collection fields | [IsODMItem](../classes/IsODMItem.md) | | [collectionExceptionCondition](../slots/collectionExceptionCondition.md) | 0..1
[Condition](../classes/Condition.md) | Condition that defines when collection may be exempted | [IsODMItem](../classes/IsODMItem.md) | | [preSpecifiedValue](../slots/preSpecifiedValue.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Prefill value or a default value for a field that is automatically populated. | [IsODMItem](../classes/IsODMItem.md) | | [decimalDigits](../slots/decimalDigits.md) | 0..1
[Integer](../types/Integer.md) | For decimal values, the number of digits after the decimal point | [Formatted](../classes/Formatted.md) | | [displayFormat](../slots/displayFormat.md) | 0..1
[String](../types/String.md) | A display format for the item | [Formatted](../classes/Formatted.md) | | [significantDigits](../slots/significantDigits.md) | 0..1
[Integer](../types/Integer.md) | For numeric values, the number of significant digits | [Formatted](../classes/Formatted.md) | | [OID](../slots/OID.md) | 1
[String](../types/String.md) | Local identifier within this study/context. Use CDISC OID format for regulatory submissions, or simple strings for internal use. | [Identifiable](../classes/Identifiable.md) | | [uuid](../slots/uuid.md) | 0..1
[String](../types/String.md) | Universal unique identifier | [Identifiable](../classes/Identifiable.md) | | [name](../slots/name.md) | 0..1
[String](../types/String.md) | Short name or identifier, used for field names | [Labelled](../classes/Labelled.md) | | [description](../slots/description.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Detailed description, shown in tooltips | [Labelled](../classes/Labelled.md) | | [coding](../slots/coding.md) | *
[Coding](../classes/Coding.md) | Semantic tags for this element | [Labelled](../classes/Labelled.md) | | [label](../slots/label.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Human-readable label, shown in UIs | [Labelled](../classes/Labelled.md) | | [aliases](../slots/aliases.md) | *
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Alternative name or identifier | [Labelled](../classes/Labelled.md) | | [mandatory](../slots/mandatory.md) | 0..1
[Boolean](../types/Boolean.md) | Is this element required? | [Governed](../classes/Governed.md) | | [comments](../slots/comments.md) | *
[Comment](../classes/Comment.md) | Comment on the element, such as a rationale for its inclusion or exclusion | [Governed](../classes/Governed.md) | | [siteOrSponsorComments](../slots/siteOrSponsorComments.md) | *
[SiteOrSponsorComment](../classes/SiteOrSponsorComment.md) | Comment on the element, such as a rationale for its inclusion or exclusion | [Governed](../classes/Governed.md) | | [purpose](../slots/purpose.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Purpose or rationale for this data element | [Governed](../classes/Governed.md) | | [lastUpdated](../slots/lastUpdated.md) | 0..1
[Datetime](../types/Datetime.md) | When the resource was last updated | [Governed](../classes/Governed.md) | | [owner](../slots/owner.md) | 0..1
[String](../types/String.md) or
[User](../classes/User.md) or
[Organization](../classes/Organization.md) | Party responsible for this element | [Governed](../classes/Governed.md) | | [wasDerivedFrom](../slots/wasDerivedFrom.md) | 0..1
[String](../types/String.md) or
[Item](../classes/Item.md) or
[ItemGroup](../classes/ItemGroup.md) or
[MetaDataVersion](../classes/MetaDataVersion.md) or
[CodeList](../classes/CodeList.md) or
[ReifiedConcept](../classes/ReifiedConcept.md) or
[ConceptProperty](../classes/ConceptProperty.md) or
[Condition](../classes/Condition.md) or
[Method](../classes/Method.md) or
[NominalOccurrence](../classes/NominalOccurrence.md) or
[Dataflow](../classes/Dataflow.md) or
[CubeComponent](../classes/CubeComponent.md) or
[DataProduct](../classes/DataProduct.md) or
[ProvisionAgreement](../classes/ProvisionAgreement.md) | Reference to another item that this item implements or extends, e.g. a template Item definition. | [Governed](../classes/Governed.md) | ## Usages | used by | used in | type | used | | --- | --- | --- | --- | | [GovernedElement](../classes/GovernedElement.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Governed](../classes/Governed.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [MetaDataVersion](../classes/MetaDataVersion.md) | [items](../slots/items.md) | range | [Item](../classes/Item.md) | | [MetaDataVersion](../classes/MetaDataVersion.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Item](../classes/Item.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ItemGroup](../classes/ItemGroup.md) | [items](../slots/items.md) | range | [Item](../classes/Item.md) | | [ItemGroup](../classes/ItemGroup.md) | [keySequence](../slots/keySequence.md) | range | [Item](../classes/Item.md) | | [ItemGroup](../classes/ItemGroup.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [CodeList](../classes/CodeList.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Comment](../classes/Comment.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ReifiedConcept](../classes/ReifiedConcept.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ConceptProperty](../classes/ConceptProperty.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [WhereClause](../classes/WhereClause.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Condition](../classes/Condition.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [RangeCheck](../classes/RangeCheck.md) | [item](../slots/item.md) | any_of[range] | [Item](../classes/Item.md) | | [Method](../classes/Method.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [SourceItem](../classes/SourceItem.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [Parameter](../classes/Parameter.md) | [items](../slots/items.md) | any_of[range] | [Item](../classes/Item.md) | | [SiteOrSponsorComment](../classes/SiteOrSponsorComment.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [NominalOccurrence](../classes/NominalOccurrence.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [DataStructureDefinition](../classes/DataStructureDefinition.md) | [items](../slots/items.md) | range | [Item](../classes/Item.md) | | [DataStructureDefinition](../classes/DataStructureDefinition.md) | [keySequence](../slots/keySequence.md) | range | [Item](../classes/Item.md) | | [DataStructureDefinition](../classes/DataStructureDefinition.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Dataflow](../classes/Dataflow.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [CubeComponent](../classes/CubeComponent.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [CubeComponent](../classes/CubeComponent.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Measure](../classes/Measure.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [Measure](../classes/Measure.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Dimension](../classes/Dimension.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [Dimension](../classes/Dimension.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [DataAttribute](../classes/DataAttribute.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [DataAttribute](../classes/DataAttribute.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ObservationRelationship](../classes/ObservationRelationship.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [DataProduct](../classes/DataProduct.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ProvisionAgreement](../classes/ProvisionAgreement.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Analysis](../classes/Analysis.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Display](../classes/Display.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | ## Identifier and Mapping Information ### Schema Source * from schema: https://cdisc.org/dds ## 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
### Induced
erDiagram
CodeList {
string formatName
DataType dataType
string name
string description
string OID
stringList aliases
string href
boolean isNonStandard
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string version
string wasDerivedFrom
}
CodeListItem {
string description
string codedValue
string decode
boolean other
decimal weight
stringList aliases
}
Coding {
AliasPredicate aliasType
string code
string codeSystem
string codeSystemVersion
string decode
}
Comment {
string text
string name
string description
string OID
stringList aliases
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string wasDerivedFrom
}
ConceptProperty {
integer maxOccurs
integer minOccurs
string name
string description
string OID
stringList aliases
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string wasDerivedFrom
}
Condition {
string implementsCondition
LogicalOperator operator
string name
string description
string OID
stringList aliases
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string wasDerivedFrom
}
DocumentReference {
string leafID
integerList pages
string relationship
string title
string name
string description
string OID
stringList aliases
string href
string label
string uuid
string version
}
FormalExpression {
string expression
string returnType
string context
string name
string description
string OID
stringList aliases
string label
string uuid
}
Item {
DataType dataType
integer length
string name
string description
string OID
stringList aliases
string cdiscNotes
string crfCompletionInstructions
integer decimalDigits
string displayFormat
boolean hasNoData
string implementationNotes
string label
datetime lastUpdated
boolean mandatory
string owner
string preSpecifiedValue
string purpose
string role
integer significantDigits
string uuid
string wasDerivedFrom
}
Method {
MethodType type
string name
string description
string OID
stringList aliases
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string wasDerivedFrom
}
Origin {
OriginSource source
OriginType type
}
RangeCheck {
stringList checkValues
Comparator comparator
string item
SoftHard softHard
LogicalOperator operator
}
ReifiedConcept {
string name
string description
string OID
stringList aliases
string href
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string version
string wasDerivedFrom
}
Resource {
string attribute
string resourceType
string name
string description
string OID
stringList aliases
string href
string label
string uuid
string version
}
SiteOrSponsorComment {
OriginSource sourceType
string source
string text
string name
string description
string OID
stringList aliases
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string wasDerivedFrom
}
SourceItem {
stringList resource
}
Standard {
PublishingSet publishingSet
StandardStatus status
StandardType type
string version
StandardName name
string description
string OID
stringList aliases
string label
string uuid
}
WhereClause {
string name
string description
string OID
stringList aliases
string label
datetime lastUpdated
boolean mandatory
string owner
string purpose
string uuid
string wasDerivedFrom
}
CodeList ||--|o Resource : "externalCodeList"
CodeList ||--|o Standard : "standard"
CodeList ||--}o CodeListItem : "codeListItems"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Comment : "comments"
CodeList ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
CodeListItem ||--|o Coding : "coding"
Comment ||--}o Coding : "coding"
Comment ||--}o Comment : "comments"
Comment ||--}o DocumentReference : "documents"
Comment ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
ConceptProperty ||--|o CodeList : "codeList"
ConceptProperty ||--}o Coding : "coding"
ConceptProperty ||--}o Comment : "comments"
ConceptProperty ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
Condition ||--}o Coding : "coding"
Condition ||--}o Comment : "comments"
Condition ||--}o Condition : "conditions"
Condition ||--}o FormalExpression : "expressions"
Condition ||--}o RangeCheck : "rangeChecks"
Condition ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
DocumentReference ||--}o Coding : "coding"
FormalExpression ||--|o ReturnValue : "returnValue"
FormalExpression ||--}o Coding : "coding"
FormalExpression ||--}o Parameter : "parameters"
FormalExpression ||--}o Resource : "externalCodeLibs"
Item ||--|o CodeList : "codeList, roleCodeList"
Item ||--|o ConceptProperty : "conceptProperty"
Item ||--|o Condition : "collectionExceptionCondition"
Item ||--|o Method : "method"
Item ||--|o Origin : "origin"
Item ||--}o Coding : "coding"
Item ||--}o Comment : "comments"
Item ||--}o RangeCheck : "rangeChecks"
Item ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
Item ||--}o WhereClause : "applicableWhen"
Method ||--|o ReifiedConcept : "implementsConcept"
Method ||--}o Coding : "coding"
Method ||--}o Comment : "comments"
Method ||--}o DocumentReference : "documents"
Method ||--}o FormalExpression : "expressions"
Method ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
Origin ||--}o DocumentReference : "documents"
Origin ||--}o SourceItem : "sourceItems"
RangeCheck ||--}o FormalExpression : "expressions"
ReifiedConcept ||--}o Coding : "coding"
ReifiedConcept ||--}o Comment : "comments"
ReifiedConcept ||--}o ConceptProperty : "properties"
ReifiedConcept ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
Resource ||--}o Coding : "coding"
Resource ||--}o FormalExpression : "selection"
SiteOrSponsorComment ||--}o Coding : "coding"
SiteOrSponsorComment ||--}o Comment : "comments"
SiteOrSponsorComment ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
SourceItem ||--|o Item : "item"
SourceItem ||--}o Coding : "coding"
SourceItem ||--}o DocumentReference : "document"
Standard ||--}o Coding : "coding"
WhereClause ||--}o Coding : "coding"
WhereClause ||--}o Comment : "comments"
WhereClause ||--}o Condition : "conditions"
WhereClause ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
## Inheritance
* [GovernedElement](../classes/GovernedElement.md) [ [Identifiable](../classes/Identifiable.md) [Labelled](../classes/Labelled.md) [Governed](../classes/Governed.md)]
* **Item** [ [IsODMItem](../classes/IsODMItem.md) [Formatted](../classes/Formatted.md)]
## Slots
| Name | Cardinality and Range | Description | Inheritance |
| --- | --- | --- | --- |
| [dataType](../slots/dataType.md) | 1 [DataType](../enums/DataType.md) | The data type of the item. | direct | | [length](../slots/length.md) | 0..1
[Integer](../types/Integer.md) | The maximum length of the data item in characters. | direct | | [codeList](../slots/codeList.md) | 0..1
[CodeList](../classes/CodeList.md) | Reference to the CodeList that constrains the item values. | direct | | [method](../slots/method.md) | 0..1
[Method](../classes/Method.md) | Reference to the Method element that describes how to derive this item's value. | direct | | [rangeChecks](../slots/rangeChecks.md) | *
[RangeCheck](../classes/RangeCheck.md) | Range checks applied to this item (e.g. edit checks, CORE rules) | direct | | [applicableWhen](../slots/applicableWhen.md) | *
[WhereClause](../classes/WhereClause.md) | 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](../slots/origin.md) | 0..1
[Origin](../classes/Origin.md) | The origin of the data | direct | | [conceptProperty](../slots/conceptProperty.md) | 0..1
[ConceptProperty](../classes/ConceptProperty.md) | Reference to a abstract concept property that this item is a specialization / instance of. | direct | | [role](../slots/role.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Identifies the role of the item within the containing context, taken from the roleCodeList | [IsODMItem](../classes/IsODMItem.md) | | [roleCodeList](../slots/roleCodeList.md) | 0..1
[CodeList](../classes/CodeList.md) | Reference to the CodeList that defines the roles for this item | [IsODMItem](../classes/IsODMItem.md) | | [hasNoData](../slots/hasNoData.md) | 0..1
[Boolean](../types/Boolean.md) | True if this is a manifest and there is no data for this item | [IsODMItem](../classes/IsODMItem.md) | | [crfCompletionInstructions](../slots/crfCompletionInstructions.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | CRFCompletionInstructions reference: Instructions for the clinical site on how to enter collected information on the CRF | [IsODMItem](../classes/IsODMItem.md) | | [cdiscNotes](../slots/cdiscNotes.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | CDISCNotes reference: Explanatory text for the variable | [IsODMItem](../classes/IsODMItem.md) | | [implementationNotes](../slots/implementationNotes.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | ImplementationNotes reference: Further information, such as rationale and implementation instructions, on how to implement the CRF data collection fields | [IsODMItem](../classes/IsODMItem.md) | | [collectionExceptionCondition](../slots/collectionExceptionCondition.md) | 0..1
[Condition](../classes/Condition.md) | Condition that defines when collection may be exempted | [IsODMItem](../classes/IsODMItem.md) | | [preSpecifiedValue](../slots/preSpecifiedValue.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Prefill value or a default value for a field that is automatically populated. | [IsODMItem](../classes/IsODMItem.md) | | [decimalDigits](../slots/decimalDigits.md) | 0..1
[Integer](../types/Integer.md) | For decimal values, the number of digits after the decimal point | [Formatted](../classes/Formatted.md) | | [displayFormat](../slots/displayFormat.md) | 0..1
[String](../types/String.md) | A display format for the item | [Formatted](../classes/Formatted.md) | | [significantDigits](../slots/significantDigits.md) | 0..1
[Integer](../types/Integer.md) | For numeric values, the number of significant digits | [Formatted](../classes/Formatted.md) | | [OID](../slots/OID.md) | 1
[String](../types/String.md) | Local identifier within this study/context. Use CDISC OID format for regulatory submissions, or simple strings for internal use. | [Identifiable](../classes/Identifiable.md) | | [uuid](../slots/uuid.md) | 0..1
[String](../types/String.md) | Universal unique identifier | [Identifiable](../classes/Identifiable.md) | | [name](../slots/name.md) | 0..1
[String](../types/String.md) | Short name or identifier, used for field names | [Labelled](../classes/Labelled.md) | | [description](../slots/description.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Detailed description, shown in tooltips | [Labelled](../classes/Labelled.md) | | [coding](../slots/coding.md) | *
[Coding](../classes/Coding.md) | Semantic tags for this element | [Labelled](../classes/Labelled.md) | | [label](../slots/label.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Human-readable label, shown in UIs | [Labelled](../classes/Labelled.md) | | [aliases](../slots/aliases.md) | *
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Alternative name or identifier | [Labelled](../classes/Labelled.md) | | [mandatory](../slots/mandatory.md) | 0..1
[Boolean](../types/Boolean.md) | Is this element required? | [Governed](../classes/Governed.md) | | [comments](../slots/comments.md) | *
[Comment](../classes/Comment.md) | Comment on the element, such as a rationale for its inclusion or exclusion | [Governed](../classes/Governed.md) | | [siteOrSponsorComments](../slots/siteOrSponsorComments.md) | *
[SiteOrSponsorComment](../classes/SiteOrSponsorComment.md) | Comment on the element, such as a rationale for its inclusion or exclusion | [Governed](../classes/Governed.md) | | [purpose](../slots/purpose.md) | 0..1
[String](../types/String.md) or
[TranslatedText](../classes/TranslatedText.md) | Purpose or rationale for this data element | [Governed](../classes/Governed.md) | | [lastUpdated](../slots/lastUpdated.md) | 0..1
[Datetime](../types/Datetime.md) | When the resource was last updated | [Governed](../classes/Governed.md) | | [owner](../slots/owner.md) | 0..1
[String](../types/String.md) or
[User](../classes/User.md) or
[Organization](../classes/Organization.md) | Party responsible for this element | [Governed](../classes/Governed.md) | | [wasDerivedFrom](../slots/wasDerivedFrom.md) | 0..1
[String](../types/String.md) or
[Item](../classes/Item.md) or
[ItemGroup](../classes/ItemGroup.md) or
[MetaDataVersion](../classes/MetaDataVersion.md) or
[CodeList](../classes/CodeList.md) or
[ReifiedConcept](../classes/ReifiedConcept.md) or
[ConceptProperty](../classes/ConceptProperty.md) or
[Condition](../classes/Condition.md) or
[Method](../classes/Method.md) or
[NominalOccurrence](../classes/NominalOccurrence.md) or
[Dataflow](../classes/Dataflow.md) or
[CubeComponent](../classes/CubeComponent.md) or
[DataProduct](../classes/DataProduct.md) or
[ProvisionAgreement](../classes/ProvisionAgreement.md) | Reference to another item that this item implements or extends, e.g. a template Item definition. | [Governed](../classes/Governed.md) | ## Usages | used by | used in | type | used | | --- | --- | --- | --- | | [GovernedElement](../classes/GovernedElement.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Governed](../classes/Governed.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [MetaDataVersion](../classes/MetaDataVersion.md) | [items](../slots/items.md) | range | [Item](../classes/Item.md) | | [MetaDataVersion](../classes/MetaDataVersion.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Item](../classes/Item.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ItemGroup](../classes/ItemGroup.md) | [items](../slots/items.md) | range | [Item](../classes/Item.md) | | [ItemGroup](../classes/ItemGroup.md) | [keySequence](../slots/keySequence.md) | range | [Item](../classes/Item.md) | | [ItemGroup](../classes/ItemGroup.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [CodeList](../classes/CodeList.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Comment](../classes/Comment.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ReifiedConcept](../classes/ReifiedConcept.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ConceptProperty](../classes/ConceptProperty.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [WhereClause](../classes/WhereClause.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Condition](../classes/Condition.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [RangeCheck](../classes/RangeCheck.md) | [item](../slots/item.md) | any_of[range] | [Item](../classes/Item.md) | | [Method](../classes/Method.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [SourceItem](../classes/SourceItem.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [Parameter](../classes/Parameter.md) | [items](../slots/items.md) | any_of[range] | [Item](../classes/Item.md) | | [SiteOrSponsorComment](../classes/SiteOrSponsorComment.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [NominalOccurrence](../classes/NominalOccurrence.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [DataStructureDefinition](../classes/DataStructureDefinition.md) | [items](../slots/items.md) | range | [Item](../classes/Item.md) | | [DataStructureDefinition](../classes/DataStructureDefinition.md) | [keySequence](../slots/keySequence.md) | range | [Item](../classes/Item.md) | | [DataStructureDefinition](../classes/DataStructureDefinition.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Dataflow](../classes/Dataflow.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [CubeComponent](../classes/CubeComponent.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [CubeComponent](../classes/CubeComponent.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Measure](../classes/Measure.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [Measure](../classes/Measure.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Dimension](../classes/Dimension.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [Dimension](../classes/Dimension.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [DataAttribute](../classes/DataAttribute.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [DataAttribute](../classes/DataAttribute.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ObservationRelationship](../classes/ObservationRelationship.md) | [item](../slots/item.md) | range | [Item](../classes/Item.md) | | [DataProduct](../classes/DataProduct.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [ProvisionAgreement](../classes/ProvisionAgreement.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Analysis](../classes/Analysis.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | | [Display](../classes/Display.md) | [wasDerivedFrom](../slots/wasDerivedFrom.md) | any_of[range] | [Item](../classes/Item.md) | ## Identifier and Mapping Information ### Schema Source * from schema: https://cdisc.org/dds ## 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/dds
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/dds
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/dds
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/dds
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/dds
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/dds
rank: 1000
domain_of:
- Item
- Condition
range: RangeCheck
multivalued: true
inlined: true
inlined_as_list: true
applicableWhen:
name: applicableWhen
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/dds
close_mappings:
- fhir:StructureDefinition/context
rank: 1000
domain_of:
- Item
- ItemGroup
- Parameter
- Analysis
range: WhereClause
multivalued: true
inlined: false
origin:
name: origin
description: The origin of the data
from_schema: https://cdisc.org/dds
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/dds
rank: 1000
domain_of:
- Item
- Parameter
range: ConceptProperty
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/dds
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
owner: Item
domain_of:
- Item
- Condition
range: RangeCheck
multivalued: true
inlined: true
inlined_as_list: true
applicableWhen:
name: applicableWhen
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/dds
close_mappings:
- fhir:StructureDefinition/context
rank: 1000
owner: Item
domain_of:
- Item
- ItemGroup
- Parameter
- Analysis
range: WhereClause
multivalued: true
inlined: false
origin:
name: origin
description: The origin of the data
from_schema: https://cdisc.org/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
owner: Item
domain_of:
- IsODMItem
range: CodeList
hasNoData:
name: hasNoData
description: True if this is a manifest and there is no data for this item
from_schema: https://cdisc.org/dds
rank: 1000
owner: Item
domain_of:
- IsODMItem
- ItemGroup
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
owner: Item
domain_of:
- Formatted
range: integer
displayFormat:
name: displayFormat
description: A display format for the item
from_schema: https://cdisc.org/dds
rank: 1000
owner: Item
domain_of:
- Formatted
range: string
significantDigits:
name: significantDigits
description: For numeric values, the number of significant digits
from_schema: https://cdisc.org/dds
rank: 1000
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/dds
rank: 1000
identifier: true
owner: Item
domain_of:
- Identifiable
range: string
required: true
uuid:
name: uuid
description: Universal unique identifier
from_schema: https://cdisc.org/dds
rank: 1000
owner: Item
domain_of:
- Identifiable
range: string
name:
name: name
description: Short name or identifier, used for field names
from_schema: https://cdisc.org/dds
rank: 1000
owner: Item
domain_of:
- Labelled
- DefClass
- SubClass
- Standard
range: string
description:
name: description
description: Detailed description, shown in tooltips
from_schema: https://cdisc.org/dds
rank: 1000
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/dds
rank: 1000
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/dds
exact_mappings:
- skos:prefLabel
rank: 1000
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/dds
exact_mappings:
- skos:altLabel
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
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/dds
rank: 1000
owner: Item
domain_of:
- Governed
range: SiteOrSponsorComment
multivalued: true
inlined: false
purpose:
name: purpose
description: Purpose or rationale for this data element
from_schema: https://cdisc.org/dds
rank: 1000
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/dds
rank: 1000
owner: Item
domain_of:
- Governed
range: datetime
owner:
name: owner
description: Party responsible for this element
from_schema: https://cdisc.org/dds
narrow_mappings:
- prov:wasAttributedTo
- prov:wasAssociatedBy
rank: 1000
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/dds
exact_mappings:
- prov:wasDerivedFrom
rank: 1000
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