Class: StudyEndPoint

A study end point reflects an outcome measure of interest that is statistically analyzed to address a particular research question for the study. It typically specifies the type of assessments made; the timing of those assessments; the assessment tools used; and other details, as applicable, such as how multiple assessments within an individual are to be combined.

URI: odm:StudyEndPoint

erDiagram
StudyEndPoint {
    oid OID  
    nameType name  
    StudyEndPointType type  
    StudyEstimandLevel level  
}
FormalExpression {
    text context  
}
ExternalCodeLib {
    nameType library  
    nameType method  
    text version  
    text ref  
    uriorcurie href  
}
Code {
    text content  
}
Description {

}
TranslatedText {
    languageType language  
    text type  
    contentType content  
}

StudyEndPoint ||--|o Description : "description"
StudyEndPoint ||--}o FormalExpression : "formalExpression"
FormalExpression ||--|o Code : "code"
FormalExpression ||--|o ExternalCodeLib : "externalCodeLib"
Description ||--}o TranslatedText : "translatedText"

Slots

Name Cardinality* and Range Description Inheritance
OID 1..1
oid		 Unique identifier for the StudyEndPoint element direct
name 1..1
nameType		 Human readable identifier for the StudyEndPoint element. direct
type 0..1
StudyEndPointType		 The type of end point. Simple: measures the change of a single outcome that i... direct
level 0..1
StudyEstimandLevel		 Level for the Study Endpoint. Primary endpoint(s) are typically efficacy meas... direct
description 0..1
Description		 Description reference: A free-text description of the containing metadata com... direct
formalExpression 0..*
FormalExpression		 FormalExpression reference: A FormalExpression used within a ConditionDef or ... direct

* See LinkML documentation for cardinality definitions.

Usages

used by used in type used
StudyEndPointRef studyEndPointOID range StudyEndPoint
StudyEndPoints studyEndPoint range StudyEndPoint

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:StudyEndPoint
native odm:StudyEndPoint

LinkML Source

Direct

name: StudyEndPoint
description: A study end point reflects an outcome measure of interest that is statistically
  analyzed to address a particular research question for the study. It typically specifies
  the type of assessments made; the timing of those assessments; the assessment tools
  used; and other details, as applicable, such as how multiple assessments within
  an individual are to be combined.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyEndPoint
rank: 1000
slots:
- OID
- name
- type
- level
- description
- formalExpression
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the StudyEndPoint element
    comments:
    - 'Required

      range: oid

      The OID attribute for the StudyEndPoint must be unique within the study.'
    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 identifier for the StudyEndPoint element.
    comments:
    - 'Required

      range: name

      The Name must be unique within the set of StudyEndPoints elements for the study.'
    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
  type:
    name: type
    description: 'The type of end point. Simple: measures the change of a single outcome
      that is meaningful in the context of the disease being studied. Humane: the
      point at which pain and/or distress is terminated, minimized, or reduced. Surrogate:
      a measure of effect of a specific treatment that may correlate with a real clinical
      endpoint but does not necessarily have a guaranteed relationship (e.g., a biomarker).
      Combined: end point that is a combination of several measures. Example: A heart
      attack study may report the incidence of the combined endpoint of chest pain,
      myocardial infarction, or death.'
    comments:
    - 'Optional

      enum values: (Simple | Humane | Surrogate | Composite)'
    domain_of:
    - TranslatedText
    - PDFPageRef
    - Standard
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - Resource
    - MethodDef
    - StudyEndPoint
    - TransitionTimingConstraint
    - RelativeTimingConstraint
    - Branching
    - Organization
    - Query
    range: StudyEndPointType
  level:
    name: level
    description: Level for the Study Endpoint. Primary endpoint(s) are typically efficacy
      measures that address the main research question [1] Secondary endpoints are
      generally not sufficient to influence decision-making alone, but may support
      the claim of efficacy by demonstrating additional effects or by supporting a
      causal mechanism. [2] Exploratory endpoints (where nominated) typically capture
      outcomes that occur less frequently or which may be useful for exploring novel
      hypotheses. [1]
    comments:
    - 'Optional

      enum values: (Primary | Secondary | Exploratory)

      These are defined in concordance with the ICH M11 Clinical electronic Structured
      Harmonised Protocol Specification'
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyEstimandLevel
  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
  formalExpression:
    name: formalExpression
    multivalued: true
    domain_of:
    - RangeCheck
    - MethodDef
    - ConditionDef
    - StudyEndPoint
    - StudyTargetPopulation
    range: FormalExpression
    inlined: true
    inlined_as_list: true
class_uri: odm:StudyEndPoint

Induced

name: StudyEndPoint
description: A study end point reflects an outcome measure of interest that is statistically
  analyzed to address a particular research question for the study. It typically specifies
  the type of assessments made; the timing of those assessments; the assessment tools
  used; and other details, as applicable, such as how multiple assessments within
  an individual are to be combined.
from_schema: http://www.cdisc.org/ns/odm/v2.0
see_also:
- https://wiki.cdisc.org/display/PUB/StudyEndPoint
rank: 1000
slot_usage:
  OID:
    name: OID
    description: Unique identifier for the StudyEndPoint element
    comments:
    - 'Required

      range: oid

      The OID attribute for the StudyEndPoint must be unique within the study.'
    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 identifier for the StudyEndPoint element.
    comments:
    - 'Required

      range: name

      The Name must be unique within the set of StudyEndPoints elements for the study.'
    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
  type:
    name: type
    description: 'The type of end point. Simple: measures the change of a single outcome
      that is meaningful in the context of the disease being studied. Humane: the
      point at which pain and/or distress is terminated, minimized, or reduced. Surrogate:
      a measure of effect of a specific treatment that may correlate with a real clinical
      endpoint but does not necessarily have a guaranteed relationship (e.g., a biomarker).
      Combined: end point that is a combination of several measures. Example: A heart
      attack study may report the incidence of the combined endpoint of chest pain,
      myocardial infarction, or death.'
    comments:
    - 'Optional

      enum values: (Simple | Humane | Surrogate | Composite)'
    domain_of:
    - TranslatedText
    - PDFPageRef
    - Standard
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - Resource
    - MethodDef
    - StudyEndPoint
    - TransitionTimingConstraint
    - RelativeTimingConstraint
    - Branching
    - Organization
    - Query
    range: StudyEndPointType
  level:
    name: level
    description: Level for the Study Endpoint. Primary endpoint(s) are typically efficacy
      measures that address the main research question [1] Secondary endpoints are
      generally not sufficient to influence decision-making alone, but may support
      the claim of efficacy by demonstrating additional effects or by supporting a
      causal mechanism. [2] Exploratory endpoints (where nominated) typically capture
      outcomes that occur less frequently or which may be useful for exploring novel
      hypotheses. [1]
    comments:
    - 'Optional

      enum values: (Primary | Secondary | Exploratory)

      These are defined in concordance with the ICH M11 Clinical electronic Structured
      Harmonised Protocol Specification'
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyEstimandLevel
  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
  formalExpression:
    name: formalExpression
    multivalued: true
    domain_of:
    - RangeCheck
    - MethodDef
    - ConditionDef
    - StudyEndPoint
    - StudyTargetPopulation
    range: FormalExpression
    inlined: true
    inlined_as_list: true
attributes:
  OID:
    name: OID
    description: Unique identifier for the StudyEndPoint element
    comments:
    - 'Required

      range: oid

      The OID attribute for the StudyEndPoint must be unique within the study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    identifier: true
    alias: OID
    owner: StudyEndPoint
    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 identifier for the StudyEndPoint element.
    comments:
    - 'Required

      range: name

      The Name must be unique within the set of StudyEndPoints elements for the study.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: name
    owner: StudyEndPoint
    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
  type:
    name: type
    description: 'The type of end point. Simple: measures the change of a single outcome
      that is meaningful in the context of the disease being studied. Humane: the
      point at which pain and/or distress is terminated, minimized, or reduced. Surrogate:
      a measure of effect of a specific treatment that may correlate with a real clinical
      endpoint but does not necessarily have a guaranteed relationship (e.g., a biomarker).
      Combined: end point that is a combination of several measures. Example: A heart
      attack study may report the incidence of the combined endpoint of chest pain,
      myocardial infarction, or death.'
    comments:
    - 'Optional

      enum values: (Simple | Humane | Surrogate | Composite)'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: type
    owner: StudyEndPoint
    domain_of:
    - TranslatedText
    - PDFPageRef
    - Standard
    - StudyEventDef
    - ItemGroupDef
    - Origin
    - Resource
    - MethodDef
    - StudyEndPoint
    - TransitionTimingConstraint
    - RelativeTimingConstraint
    - Branching
    - Organization
    - Query
    range: StudyEndPointType
  level:
    name: level
    description: Level for the Study Endpoint. Primary endpoint(s) are typically efficacy
      measures that address the main research question [1] Secondary endpoints are
      generally not sufficient to influence decision-making alone, but may support
      the claim of efficacy by demonstrating additional effects or by supporting a
      causal mechanism. [2] Exploratory endpoints (where nominated) typically capture
      outcomes that occur less frequently or which may be useful for exploring novel
      hypotheses. [1]
    comments:
    - 'Optional

      enum values: (Primary | Secondary | Exploratory)

      These are defined in concordance with the ICH M11 Clinical electronic Structured
      Harmonised Protocol Specification'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    alias: level
    owner: StudyEndPoint
    domain_of:
    - StudyObjective
    - StudyEndPoint
    - StudyEstimand
    range: StudyEstimandLevel
  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: StudyEndPoint
    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
  formalExpression:
    name: formalExpression
    description: 'FormalExpression reference: A FormalExpression used within a ConditionDef
      or a RangeCheck must evaluate to True or False. A FormalExpression referenced
      within a MethodDef having Type Imputation, Computation, or Transpose must evaluate
      to the correct DataType for an Item that may be imputed or computed using the
      Method. A FormalExpression gets parameter and return value definitions from
      the MethodSignature element. The data types in the MethodSignature parameters
      and return values must match the corresponding data types in the FormalExpression.'
    from_schema: http://www.cdisc.org/ns/odm/v2.0
    rank: 1000
    multivalued: true
    alias: formalExpression
    owner: StudyEndPoint
    domain_of:
    - RangeCheck
    - MethodDef
    - ConditionDef
    - StudyEndPoint
    - StudyTargetPopulation
    range: FormalExpression
    inlined: true
    inlined_as_list: true
class_uri: odm:StudyEndPoint