Class: IsODMItem
A mixin that provides additional attributes for CDISC Operational Data Model items, including roles, completion instructions, and implementation notes
URI: odm:class/IsODMItem
erDiagram
IsODMItem {
string role
boolean hasNoData
string crfCompletionInstructions
string cdiscNotes
string implementationNotes
string preSpecifiedValue
}
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
}
SiteOrSponsorComment {
string text
OriginSource sourceType
string source
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
boolean mandatory
string purpose
datetime lastUpdated
string owner
string wasDerivedFrom
}
Coding {
string code
string decode
string codeSystem
string codeSystemVersion
AliasPredicate aliasType
}
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
boolean isNonStandard
string OID
string uuid
string name
string description
string label
stringList aliases
boolean mandatory
string purpose
datetime lastUpdated
string owner
string wasDerivedFrom
}
Standard {
StandardName name
StandardType type
PublishingSet publishingSet
string version
StandardStatus status
string OID
string uuid
string description
string label
stringList aliases
}
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
}
IsODMItem ||--|o CodeList : "roleCodeList"
IsODMItem ||--|o Condition : "collectionExceptionCondition"
Condition ||--}o RangeCheck : "rangeChecks"
Condition ||--}o FormalExpression : "expressions"
Condition ||--}o Condition : "conditions"
Condition ||--}o Coding : "coding"
Condition ||--}o Comment : "comments"
Condition ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
SiteOrSponsorComment ||--}o Coding : "coding"
SiteOrSponsorComment ||--}o Comment : "comments"
SiteOrSponsorComment ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
Comment ||--}o DocumentReference : "documents"
Comment ||--}o Coding : "coding"
Comment ||--}o Comment : "comments"
Comment ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
FormalExpression ||--}o Parameter : "parameters"
FormalExpression ||--|o ReturnValue : "returnValue"
FormalExpression ||--}o Resource : "externalCodeLibs"
FormalExpression ||--}o Coding : "coding"
RangeCheck ||--}o FormalExpression : "expressions"
CodeList ||--}o CodeListItem : "codeListItems"
CodeList ||--|o Resource : "externalCodeList"
CodeList ||--|o Standard : "standard"
CodeList ||--}o Coding : "coding"
CodeList ||--}o Comment : "comments"
CodeList ||--}o SiteOrSponsorComment : "siteOrSponsorComments"
Standard ||--}o Coding : "coding"
Resource ||--}o FormalExpression : "selection"
Resource ||--}o Coding : "coding"
CodeListItem ||--|o Coding : "coding"
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| role | 0..1 String or String or TranslatedText |
Identifies the role of the item within the containing context, taken from the roleCodeList | direct |
| roleCodeList | 0..1 CodeList |
Reference to the CodeList that defines the roles for this item | direct |
| hasNoData | 0..1 Boolean |
True if this is a manifest and there is no data for this item | direct |
| crfCompletionInstructions | 0..1 String or String or TranslatedText |
CRFCompletionInstructions reference: Instructions for the clinical site on how to enter collected information on the CRF | direct |
| cdiscNotes | 0..1 String or String or TranslatedText |
CDISCNotes reference: Explanatory text for the variable | direct |
| 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 | direct |
| collectionExceptionCondition | 0..1 Condition |
Condition that defines when collection may be exempted | direct |
| preSpecifiedValue | 0..1 String or String or TranslatedText |
Prefill value or a default value for a field that is automatically populated. | direct |
Mixin Usage
| mixed into | description |
|---|---|
| Item | A data element that represents a specific piece of information within a defined context, with data type, constraints, and derivation methods |
Identifier and Mapping Information
Schema Source
- from schema: https://cdisc.org/define-json
Mappings
| Mapping Type | Mapped Value |
|---|---|
| self | odm:IsODMItem |
| native | odm:IsODMItem |
LinkML Source
Direct
name: IsODMItem
description: A mixin that provides additional attributes for CDISC Operational Data
Model items, including roles, completion instructions, and implementation notes
from_schema: https://cdisc.org/define-json
mixin: true
attributes:
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
domain_of:
- IsODMItem
- Organization
- CubeComponent
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
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/define-json
rank: 1000
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/define-json
rank: 1000
domain_of:
- IsODMItem
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
domain_of:
- IsODMItem
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
domain_of:
- IsODMItem
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
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
domain_of:
- IsODMItem
any_of:
- range: string
- range: TranslatedText
Induced
name: IsODMItem
description: A mixin that provides additional attributes for CDISC Operational Data
Model items, including roles, completion instructions, and implementation notes
from_schema: https://cdisc.org/define-json
mixin: true
attributes:
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: IsODMItem
domain_of:
- IsODMItem
- Organization
- CubeComponent
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: IsODMItem
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/define-json
rank: 1000
alias: hasNoData
owner: IsODMItem
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/define-json
rank: 1000
alias: crfCompletionInstructions
owner: IsODMItem
domain_of:
- IsODMItem
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: IsODMItem
domain_of:
- IsODMItem
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: IsODMItem
domain_of:
- IsODMItem
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: IsODMItem
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: IsODMItem
domain_of:
- IsODMItem
any_of:
- range: string
- range: TranslatedText