Class: ItemDef
An ItemDef describes a type of item that can occur within a study. Item properties include name, datatype, range, or codelist restrictions, and several other properties.
URI: odm:ItemDef
erDiagram
ItemDef {
oid OID
nameType name
DataType dataType
positiveInteger length
text displayFormat
text variableSet
}
Alias {
text context
text name
}
Coding {
text code
uriorcurie system
text systemName
text systemVersion
text label
uriorcurie href
uriorcurie ref
text commentOID
}
ValueListRef {
}
ValueListDef {
oid OID
}
CodeListRef {
}
CodeList {
oid OID
nameType name
CLDataType dataType
YesOnly isNonStandard
}
RangeCheck {
Comparator comparator
SoftOrHard softHard
}
CheckValue {
valueType content
}
FormalExpression {
text context
}
MethodSignature {
}
ErrorMessage {
}
CDISCNotes {
}
TranslatedText {
languageType language
text type
contentType content
}
ImplementationNotes {
}
CRFCompletionInstructions {
}
Prompt {
}
Question {
}
Definition {
}
Description {
}
CommentDef {
oid OID
}
DocumentRef {
oid leafID
}
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"
ValueListDef ||--|o Description : "description"
ValueListDef ||--}o ItemRef : "itemRef"
CodeListRef ||--|| CodeList : "codeListOID"
CodeList ||--|o CommentDef : "commentOID"
CodeList ||--|o Standard : "standardOID"
CodeList ||--|o Description : "description"
CodeList ||--}o CodeListItem : "codeListItem"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Alias : "alias"
RangeCheck ||--|o ItemDef : "itemOID"
RangeCheck ||--|o ErrorMessage : "errorMessage"
RangeCheck ||--|o MethodSignature : "methodSignature"
RangeCheck ||--}o FormalExpression : "formalExpression"
RangeCheck ||--}o CheckValue : "checkValue"
FormalExpression ||--|o Code : "code"
FormalExpression ||--|o ExternalCodeLib : "externalCodeLib"
MethodSignature ||--}o Parameter : "parameter"
MethodSignature ||--}o ReturnValue : "returnValue"
ErrorMessage ||--}o TranslatedText : "translatedText"
CDISCNotes ||--}o TranslatedText : "translatedText"
ImplementationNotes ||--}o TranslatedText : "translatedText"
CRFCompletionInstructions ||--}o TranslatedText : "translatedText"
Prompt ||--}o TranslatedText : "translatedText"
Question ||--}o TranslatedText : "translatedText"
Definition ||--}o TranslatedText : "translatedText"
Description ||--}o TranslatedText : "translatedText"
CommentDef ||--|o Description : "description"
CommentDef ||--}o DocumentRef : "documentRef"
DocumentRef ||--}o PDFPageRef : "pDFPageRef"
Slots
Name | Cardinality* and Range | Description | Inheritance |
---|---|---|---|
OID | 1..1 oid |
Unique identifier for the ItemDef element. | direct |
name | 1..1 nameType |
Human readable name for the ItemDef. | direct |
dataType | 1..1 DataType |
Specification of the allowable values and the intended use of the correspondi... | direct |
length | 0..1 positiveInteger |
Specifies the number of characters allowed for the ItemData/Value when it is ... | direct |
displayFormat | 0..1 text |
Display format supports data visualization of numeric float and date values. | direct |
variableSet | 0..1 text |
ADaM variable set, e.g. Dose, Analysis Parameter, Treatment Timing. | direct |
commentOID | 0..1 CommentDef |
Reference to a CommentDef with sponsor provided information related to this I... | direct |
description | 0..1 Description |
Description reference: A free-text description of the containing metadata com... | direct |
definition | 0..1 Definition |
A free-text definition of the parameter | direct |
question | 0..1 Question |
Question reference: A label shown to a human user when prompted to provide da... | direct |
prompt | 0..1 Prompt |
Prompt reference: A prompt text shown to a human user when prompted to provid... | direct |
cRFCompletionInstructions | 0..1 CRFCompletionInstructions |
CRFCompletionInstructions reference: Instructions for the clinical site on ho... | direct |
implementationNotes | 0..1 ImplementationNotes |
ImplementationNotes reference: Further information, such as rationale and imp... | direct |
cDISCNotes | 0..1 CDISCNotes |
CDISCNotes reference: Explanatory text for the variable. | direct |
rangeCheck | 0..* RangeCheck |
RangeCheck reference: A RangeCheck defines a constraint on the value of the e... | direct |
codeListRef | 0..1 CodeListRef |
CodeListRef reference: A reference to a CodeList definition. | direct |
valueListRef | 0..1 ValueListRef |
ValueListRef reference: The ValueListRef element is the OID of the ValueListD... | direct |
coding | 0..* Coding |
Coding reference: Coding references a symbol from a defined code system. It u... | direct |
alias | 0..* Alias |
Alias reference: An Alias provides an additional name for an element. The Con... | direct |
* See LinkML documentation for cardinality definitions.
Usages
used by | used in | type | used |
---|---|---|---|
MetaDataVersion | itemDef | range | ItemDef |
ItemRef | itemOID | range | ItemDef |
ItemRef | unitsItemOID | range | ItemDef |
SourceItem | itemOID | range | ItemDef |
RangeCheck | itemOID | range | ItemDef |
ItemData | itemOID | range | ItemDef |
KeySet | itemOID | range | ItemDef |
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:ItemDef |
native | odm:ItemDef |
LinkML Source
Direct
name: ItemDef
description: An ItemDef describes a type of item that can occur within a study. Item
properties include name, datatype, range, or codelist restrictions, and several
other properties.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/ItemDef
rank: 1000
slots:
- OID
- name
- dataType
- length
- displayFormat
- variableSet
- commentOID
- description
- definition
- question
- prompt
- cRFCompletionInstructions
- implementationNotes
- cDISCNotes
- rangeCheck
- codeListRef
- valueListRef
- coding
- alias
slot_usage:
OID:
name: OID
description: Unique identifier for the ItemDef element.
comments:
- 'Required
range: oid'
identifier: true
domain_of:
- Study
- MetaDataVersion
- Standard
- ValueListDef
- WhereClauseDef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- MethodDef
- ConditionDef
- CommentDef
- StudyIndication
- StudyIntervention
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- Arm
- Epoch
- StudyParameter
- StudyTiming
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Transition
- Branching
- Criterion
- User
- Organization
- Location
- SignatureDef
- Query
range: oid
required: true
name:
name: name
description: Human readable name for the ItemDef.
comments:
- 'Required
range: name'
domain_of:
- Alias
- MetaDataVersion
- Standard
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Class
- SubClass
- SourceItem
- Resource
- ItemDef
- CodeList
- MethodDef
- Parameter
- ReturnValue
- ConditionDef
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- Arm
- Epoch
- StudyTiming
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Transition
- Branching
- Criterion
- Organization
- Location
- Query
range: nameType
required: true
dataType:
name: dataType
description: Specification of the allowable values and the intended use of the
corresponding value elements.
comments:
- 'Required
enum values: (text | integer | decimal | float | double | date | time | datetime
| string | boolean | double | hexBinary | base64Binary | hexFloat | base64Float
| partialDate | partialTime | partialDatetime | durationDatetime | intervalDatetime
| incompleteDatetime | incompleteDate | incompleteTime | URI )'
domain_of:
- ItemDef
- CodeList
- Parameter
- ReturnValue
range: DataType
required: true
length:
name: length
description: Specifies the number of characters allowed for the ItemData/Value
when it is represented as a text.
comments:
- 'Optional
range: positiveInteger'
domain_of:
- ItemDef
range: positiveInteger
displayFormat:
name: displayFormat
description: Display format supports data visualization of numeric float and date
values.
comments:
- 'Optional
range: text'
domain_of:
- ItemDef
range: text
variableSet:
name: variableSet
description: ADaM variable set, e.g. Dose, Analysis Parameter, Treatment Timing.
comments:
- 'Optional
range: text'
domain_of:
- ItemDef
range: text
commentOID:
name: commentOID
description: Reference to a CommentDef with sponsor provided information related
to this ItemDef,
comments:
- 'Optional
range: oidref'
domain_of:
- MetaDataVersion
- Standard
- WhereClauseDef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- Coding
range: CommentDef
description:
name: description
domain_of:
- Study
- MetaDataVersion
- ValueListDef
- StudyEventGroupRef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Origin
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- CommentDef
- Protocol
- StudyStructure
- TrialPhase
- StudyIndication
- StudyIntervention
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- IntercurrentEvent
- SummaryMeasure
- Arm
- Epoch
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Criterion
- Organization
- Location
- ODMFileMetadata
range: Description
maximum_cardinality: 1
definition:
name: definition
domain_of:
- ItemDef
- Parameter
- ReturnValue
range: Definition
maximum_cardinality: 1
question:
name: question
domain_of:
- ItemDef
range: Question
maximum_cardinality: 1
prompt:
name: prompt
domain_of:
- ItemDef
range: Prompt
maximum_cardinality: 1
cRFCompletionInstructions:
name: cRFCompletionInstructions
domain_of:
- ItemDef
range: CRFCompletionInstructions
maximum_cardinality: 1
implementationNotes:
name: implementationNotes
domain_of:
- ItemDef
range: ImplementationNotes
maximum_cardinality: 1
cDISCNotes:
name: cDISCNotes
domain_of:
- ItemDef
range: CDISCNotes
maximum_cardinality: 1
rangeCheck:
name: rangeCheck
multivalued: true
domain_of:
- WhereClauseDef
- ItemDef
range: RangeCheck
inlined: true
inlined_as_list: true
codeListRef:
name: codeListRef
domain_of:
- ItemDef
range: CodeListRef
maximum_cardinality: 1
valueListRef:
name: valueListRef
domain_of:
- ItemDef
range: ValueListRef
maximum_cardinality: 1
coding:
name: coding
multivalued: true
domain_of:
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Origin
- SourceItems
- SourceItem
- ItemDef
- CodeList
- CodeListItem
- StudyIndication
- StudyIntervention
- StudyTargetPopulation
- StudyParameter
- ParameterValue
- Criterion
- Annotation
range: Coding
inlined: true
inlined_as_list: true
alias:
name: alias
multivalued: true
domain_of:
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- Protocol
range: Alias
inlined: true
inlined_as_list: true
class_uri: odm:ItemDef
Induced
name: ItemDef
description: An ItemDef describes a type of item that can occur within a study. Item
properties include name, datatype, range, or codelist restrictions, and several
other properties.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/ItemDef
rank: 1000
slot_usage:
OID:
name: OID
description: Unique identifier for the ItemDef element.
comments:
- 'Required
range: oid'
identifier: true
domain_of:
- Study
- MetaDataVersion
- Standard
- ValueListDef
- WhereClauseDef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- MethodDef
- ConditionDef
- CommentDef
- StudyIndication
- StudyIntervention
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- Arm
- Epoch
- StudyParameter
- StudyTiming
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Transition
- Branching
- Criterion
- User
- Organization
- Location
- SignatureDef
- Query
range: oid
required: true
name:
name: name
description: Human readable name for the ItemDef.
comments:
- 'Required
range: name'
domain_of:
- Alias
- MetaDataVersion
- Standard
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Class
- SubClass
- SourceItem
- Resource
- ItemDef
- CodeList
- MethodDef
- Parameter
- ReturnValue
- ConditionDef
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- Arm
- Epoch
- StudyTiming
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Transition
- Branching
- Criterion
- Organization
- Location
- Query
range: nameType
required: true
dataType:
name: dataType
description: Specification of the allowable values and the intended use of the
corresponding value elements.
comments:
- 'Required
enum values: (text | integer | decimal | float | double | date | time | datetime
| string | boolean | double | hexBinary | base64Binary | hexFloat | base64Float
| partialDate | partialTime | partialDatetime | durationDatetime | intervalDatetime
| incompleteDatetime | incompleteDate | incompleteTime | URI )'
domain_of:
- ItemDef
- CodeList
- Parameter
- ReturnValue
range: DataType
required: true
length:
name: length
description: Specifies the number of characters allowed for the ItemData/Value
when it is represented as a text.
comments:
- 'Optional
range: positiveInteger'
domain_of:
- ItemDef
range: positiveInteger
displayFormat:
name: displayFormat
description: Display format supports data visualization of numeric float and date
values.
comments:
- 'Optional
range: text'
domain_of:
- ItemDef
range: text
variableSet:
name: variableSet
description: ADaM variable set, e.g. Dose, Analysis Parameter, Treatment Timing.
comments:
- 'Optional
range: text'
domain_of:
- ItemDef
range: text
commentOID:
name: commentOID
description: Reference to a CommentDef with sponsor provided information related
to this ItemDef,
comments:
- 'Optional
range: oidref'
domain_of:
- MetaDataVersion
- Standard
- WhereClauseDef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- Coding
range: CommentDef
description:
name: description
domain_of:
- Study
- MetaDataVersion
- ValueListDef
- StudyEventGroupRef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Origin
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- CommentDef
- Protocol
- StudyStructure
- TrialPhase
- StudyIndication
- StudyIntervention
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- IntercurrentEvent
- SummaryMeasure
- Arm
- Epoch
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Criterion
- Organization
- Location
- ODMFileMetadata
range: Description
maximum_cardinality: 1
definition:
name: definition
domain_of:
- ItemDef
- Parameter
- ReturnValue
range: Definition
maximum_cardinality: 1
question:
name: question
domain_of:
- ItemDef
range: Question
maximum_cardinality: 1
prompt:
name: prompt
domain_of:
- ItemDef
range: Prompt
maximum_cardinality: 1
cRFCompletionInstructions:
name: cRFCompletionInstructions
domain_of:
- ItemDef
range: CRFCompletionInstructions
maximum_cardinality: 1
implementationNotes:
name: implementationNotes
domain_of:
- ItemDef
range: ImplementationNotes
maximum_cardinality: 1
cDISCNotes:
name: cDISCNotes
domain_of:
- ItemDef
range: CDISCNotes
maximum_cardinality: 1
rangeCheck:
name: rangeCheck
multivalued: true
domain_of:
- WhereClauseDef
- ItemDef
range: RangeCheck
inlined: true
inlined_as_list: true
codeListRef:
name: codeListRef
domain_of:
- ItemDef
range: CodeListRef
maximum_cardinality: 1
valueListRef:
name: valueListRef
domain_of:
- ItemDef
range: ValueListRef
maximum_cardinality: 1
coding:
name: coding
multivalued: true
domain_of:
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Origin
- SourceItems
- SourceItem
- ItemDef
- CodeList
- CodeListItem
- StudyIndication
- StudyIntervention
- StudyTargetPopulation
- StudyParameter
- ParameterValue
- Criterion
- Annotation
range: Coding
inlined: true
inlined_as_list: true
alias:
name: alias
multivalued: true
domain_of:
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- Protocol
range: Alias
inlined: true
inlined_as_list: true
attributes:
OID:
name: OID
description: Unique identifier for the ItemDef element.
comments:
- 'Required
range: oid'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
identifier: true
alias: OID
owner: ItemDef
domain_of:
- Study
- MetaDataVersion
- Standard
- ValueListDef
- WhereClauseDef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- MethodDef
- ConditionDef
- CommentDef
- StudyIndication
- StudyIntervention
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- Arm
- Epoch
- StudyParameter
- StudyTiming
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Transition
- Branching
- Criterion
- User
- Organization
- Location
- SignatureDef
- Query
range: oid
required: true
name:
name: name
description: Human readable name for the ItemDef.
comments:
- 'Required
range: name'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: name
owner: ItemDef
domain_of:
- Alias
- MetaDataVersion
- Standard
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Class
- SubClass
- SourceItem
- Resource
- ItemDef
- CodeList
- MethodDef
- Parameter
- ReturnValue
- ConditionDef
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- Arm
- Epoch
- StudyTiming
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Transition
- Branching
- Criterion
- Organization
- Location
- Query
range: nameType
required: true
dataType:
name: dataType
description: Specification of the allowable values and the intended use of the
corresponding value elements.
comments:
- 'Required
enum values: (text | integer | decimal | float | double | date | time | datetime
| string | boolean | double | hexBinary | base64Binary | hexFloat | base64Float
| partialDate | partialTime | partialDatetime | durationDatetime | intervalDatetime
| incompleteDatetime | incompleteDate | incompleteTime | URI )'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: dataType
owner: ItemDef
domain_of:
- ItemDef
- CodeList
- Parameter
- ReturnValue
range: DataType
required: true
length:
name: length
description: Specifies the number of characters allowed for the ItemData/Value
when it is represented as a text.
comments:
- 'Optional
range: positiveInteger'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: length
owner: ItemDef
domain_of:
- ItemDef
range: positiveInteger
displayFormat:
name: displayFormat
description: Display format supports data visualization of numeric float and date
values.
comments:
- 'Optional
range: text'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: displayFormat
owner: ItemDef
domain_of:
- ItemDef
range: text
variableSet:
name: variableSet
description: ADaM variable set, e.g. Dose, Analysis Parameter, Treatment Timing.
comments:
- 'Optional
range: text'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: variableSet
owner: ItemDef
domain_of:
- ItemDef
range: text
commentOID:
name: commentOID
description: Reference to a CommentDef with sponsor provided information related
to this ItemDef,
comments:
- 'Optional
range: oidref'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: commentOID
owner: ItemDef
domain_of:
- MetaDataVersion
- Standard
- WhereClauseDef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- Coding
range: CommentDef
description:
name: description
description: 'Description reference: A free-text description of the containing
metadata component, unless restricted by Business Rules.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: description
owner: ItemDef
domain_of:
- Study
- MetaDataVersion
- ValueListDef
- StudyEventGroupRef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Origin
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- CommentDef
- Protocol
- StudyStructure
- TrialPhase
- StudyIndication
- StudyIntervention
- StudyObjective
- StudyEndPoint
- StudyTargetPopulation
- StudyEstimand
- IntercurrentEvent
- SummaryMeasure
- Arm
- Epoch
- TransitionTimingConstraint
- AbsoluteTimingConstraint
- RelativeTimingConstraint
- DurationTimingConstraint
- WorkflowDef
- Criterion
- Organization
- Location
- ODMFileMetadata
range: Description
maximum_cardinality: 1
definition:
name: definition
description: A free-text definition of the parameter
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: definition
owner: ItemDef
domain_of:
- ItemDef
- Parameter
- ReturnValue
range: Definition
maximum_cardinality: 1
question:
name: question
description: 'Question reference: A label shown to a human user when prompted
to provide data for an item on paper or on a screen.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: question
owner: ItemDef
domain_of:
- ItemDef
range: Question
maximum_cardinality: 1
prompt:
name: prompt
description: 'Prompt reference: A prompt text shown to a human user when prompted
to provide data for an item on paper or on a screen. The Prompt is a short version
of the question.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: prompt
owner: ItemDef
domain_of:
- ItemDef
range: Prompt
maximum_cardinality: 1
cRFCompletionInstructions:
name: cRFCompletionInstructions
description: 'CRFCompletionInstructions reference: Instructions for the clinical
site on how to enter collected information on the CRF.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: cRFCompletionInstructions
owner: ItemDef
domain_of:
- ItemDef
range: CRFCompletionInstructions
maximum_cardinality: 1
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: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: implementationNotes
owner: ItemDef
domain_of:
- ItemDef
range: ImplementationNotes
maximum_cardinality: 1
cDISCNotes:
name: cDISCNotes
description: 'CDISCNotes reference: Explanatory text for the variable.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: cDISCNotes
owner: ItemDef
domain_of:
- ItemDef
range: CDISCNotes
maximum_cardinality: 1
rangeCheck:
name: rangeCheck
description: 'RangeCheck reference: A RangeCheck defines a constraint on the value
of the enclosing item. It represents an expression that evaluates to True when
the ItemData value is valid or False when the ItemData value is invalid. The
expression is specified using either Comparator and CheckValue or using FormalExpressions.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
multivalued: true
alias: rangeCheck
owner: ItemDef
domain_of:
- WhereClauseDef
- ItemDef
range: RangeCheck
inlined: true
inlined_as_list: true
codeListRef:
name: codeListRef
description: 'CodeListRef reference: A reference to a CodeList definition.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: codeListRef
owner: ItemDef
domain_of:
- ItemDef
range: CodeListRef
maximum_cardinality: 1
valueListRef:
name: valueListRef
description: 'ValueListRef reference: The ValueListRef element is the OID of the
ValueListDef that contains the valuelist definition associated with the variable.
If value-level metadata is required for a variable, a ValueListRef element should
be provided as a child element on the ItemDef for the variable definition.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
alias: valueListRef
owner: ItemDef
domain_of:
- ItemDef
range: ValueListRef
maximum_cardinality: 1
coding:
name: coding
description: 'Coding reference: Coding references a symbol from a defined code
system. It uses a code defined in a terminology system to associate semantics
with a given term, codelist, variable, or group of variables. The presence of
a Coding element associates a meaning to its parent element. Including multiple
Coding elements for a given parent indicates synonymous meanings provided by
different code systems or code system versions.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
multivalued: true
alias: coding
owner: ItemDef
domain_of:
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- Origin
- SourceItems
- SourceItem
- ItemDef
- CodeList
- CodeListItem
- StudyIndication
- StudyIntervention
- StudyTargetPopulation
- StudyParameter
- ParameterValue
- Criterion
- Annotation
range: Coding
inlined: true
inlined_as_list: true
alias:
name: alias
description: 'Alias reference: An Alias provides an additional name for an element.
The Context attribute specifies the application domain in which this additional
name is relevant.'
from_schema: http://www.cdisc.org/ns/odm/v2.0
rank: 1000
multivalued: true
alias: alias
owner: ItemDef
domain_of:
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- CodeListItem
- MethodDef
- ConditionDef
- Protocol
range: Alias
inlined: true
inlined_as_list: true
class_uri: odm:ItemDef