Class: StudyParameter

A StudyParameter defines a study design parameter for which the value or values are delivered in the ParameterValue child element or elements.

URI: odm:StudyParameter

erDiagram
StudyParameter {
    oid OID  
    nameType term  
    nameType shortName  
}
Coding {
    text code  
    uriorcurie system  
    text systemName  
    text systemVersion  
    text label  
    uriorcurie href  
    uriorcurie ref  
    text commentOID  
}
ParameterValue {
    text value  
}

StudyParameter ||--|o ParameterValue : "parameterValue"
StudyParameter ||--}o Coding : "coding"
ParameterValue ||--}o Coding : "coding"

Slots

Name Cardinality* and Range Description Inheritance
OID 1..1
oid		 Unique identifier for StudyParameter. Note a StudyParameter can be referenced... direct
term 1..1
nameType		 Longer name. Provides the full name of the parameter. direct
shortName 0..1
nameType		 Short name or code for the parameter. direct
parameterValue 0..1
ParameterValue		 ParameterValue reference: This element contains the value of the study parame... direct
coding 0..*
Coding		 Coding reference: Coding references a symbol from a defined code system. It u... direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
StudySummary studyParameter range StudyParameter

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:StudyParameter
native odm:StudyParameter

LinkML Source

Direct

name: StudyParameter
description: A StudyParameter defines a study design parameter for which the value
  or values are delivered in the ParameterValue child element or elements.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyParameter
rank: 1000
slots:
- OID
- term
- shortName
- parameterValue
- coding
slot_usage:
  OID:
    name: OID
    description: Unique identifier for StudyParameter. Note a StudyParameter can be
      referenced from other elements.
    comments:
    - 'Required

      range: oid

      Must be unique within the Protocol.'
    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
  term:
    name: term
    description: Longer name. Provides the full name of the parameter.
    comments:
    - 'Required

      range: name

      For the CDISC end-to-end use case, when the study parameter will be included
      in the SDTM Trial Summary (TS) domain dataset, the Term will be taken from the
      CDISC Controlled Terminology "TSPARM" (C67152) codelist Note the term may include
      white space.'
    domain_of:
    - StudyParameter
    range: nameType
    required: true
  shortName:
    name: shortName
    description: Short name or code for the parameter.
    comments:
    - 'Required

      range: name

      Must not include white space. For the CDISC end-to-end use case, when the study
      parameter will be included in the SDTM TS domain dataset, the ShortName will
      be taken from the CDISC Controlled Terminology "TSPARMCD" (C66738) codelist
      and the value of ShortName will be limited to 8 characters.'
    domain_of:
    - StudyParameter
    range: nameType
  parameterValue:
    name: parameterValue
    domain_of:
    - StudyParameter
    range: ParameterValue
    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
class_uri: odm:StudyParameter

Induced

name: StudyParameter
description: A StudyParameter defines a study design parameter for which the value
  or values are delivered in the ParameterValue child element or elements.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyParameter
rank: 1000
slot_usage:
  OID:
    name: OID
    description: Unique identifier for StudyParameter. Note a StudyParameter can be
      referenced from other elements.
    comments:
    - 'Required

      range: oid

      Must be unique within the Protocol.'
    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
  term:
    name: term
    description: Longer name. Provides the full name of the parameter.
    comments:
    - 'Required

      range: name

      For the CDISC end-to-end use case, when the study parameter will be included
      in the SDTM Trial Summary (TS) domain dataset, the Term will be taken from the
      CDISC Controlled Terminology "TSPARM" (C67152) codelist Note the term may include
      white space.'
    domain_of:
    - StudyParameter
    range: nameType
    required: true
  shortName:
    name: shortName
    description: Short name or code for the parameter.
    comments:
    - 'Required

      range: name

      Must not include white space. For the CDISC end-to-end use case, when the study
      parameter will be included in the SDTM TS domain dataset, the ShortName will
      be taken from the CDISC Controlled Terminology "TSPARMCD" (C66738) codelist
      and the value of ShortName will be limited to 8 characters.'
    domain_of:
    - StudyParameter
    range: nameType
  parameterValue:
    name: parameterValue
    domain_of:
    - StudyParameter
    range: ParameterValue
    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
attributes:
  OID:
    name: OID
    description: Unique identifier for StudyParameter. Note a StudyParameter can be
      referenced from other elements.
    comments:
    - 'Required

      range: oid

      Must be unique within the Protocol.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: OID
    owner: StudyParameter
    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
  term:
    name: term
    description: Longer name. Provides the full name of the parameter.
    comments:
    - 'Required

      range: name

      For the CDISC end-to-end use case, when the study parameter will be included
      in the SDTM Trial Summary (TS) domain dataset, the Term will be taken from the
      CDISC Controlled Terminology "TSPARM" (C67152) codelist Note the term may include
      white space.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: term
    owner: StudyParameter
    domain_of:
    - StudyParameter
    range: nameType
    required: true
  shortName:
    name: shortName
    description: Short name or code for the parameter.
    comments:
    - 'Required

      range: name

      Must not include white space. For the CDISC end-to-end use case, when the study
      parameter will be included in the SDTM TS domain dataset, the ShortName will
      be taken from the CDISC Controlled Terminology "TSPARMCD" (C66738) codelist
      and the value of ShortName will be limited to 8 characters.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: shortName
    owner: StudyParameter
    domain_of:
    - StudyParameter
    range: nameType
  parameterValue:
    name: parameterValue
    description: 'ParameterValue reference: This element contains the value of the
      study parameter as text content.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: parameterValue
    owner: StudyParameter
    domain_of:
    - StudyParameter
    range: ParameterValue
    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: StudyParameter
    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
class_uri: odm:StudyParameter