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Class: Clinical Trial (ClinicalTrial)

Information specific to clinical trials

URI: include:ClinicalTrial

classDiagram class ClinicalTrial click ClinicalTrial href "../ClinicalTrial/" ClinicalTrial : armAllocation ClinicalTrial --> "1" EnumArmAllocation : armAllocation click EnumArmAllocation href "../EnumArmAllocation/" ClinicalTrial : armInformation ClinicalTrial : clinicalStudyDesign ClinicalTrial --> "1" EnumClinicalStudyDesign : clinicalStudyDesign click EnumClinicalStudyDesign href "../EnumClinicalStudyDesign/" ClinicalTrial : intervention ClinicalTrial : interventionAssignmentStrategy ClinicalTrial --> "1" EnumInterventionAssignmentStrategy : interventionAssignmentStrategy click EnumInterventionAssignmentStrategy href "../EnumInterventionAssignmentStrategy/" ClinicalTrial : interventionType ClinicalTrial --> "1" EnumInterventionType : interventionType click EnumInterventionType href "../EnumInterventionType/" ClinicalTrial : nctId ClinicalTrial : otherOutcomeMeasure ClinicalTrial : primaryOutcomeMeasure ClinicalTrial : primaryPurpose ClinicalTrial --> "1" EnumPrimaryPurpose : primaryPurpose click EnumPrimaryPurpose href "../EnumPrimaryPurpose/" ClinicalTrial : secondaryOutcomeMeasure ClinicalTrial : studyCode ClinicalTrial --> "1" Study : studyCode click Study href "../Study/" ClinicalTrial : trialPhase ClinicalTrial --> "1" EnumTrialPhase : trialPhase click EnumTrialPhase href "../EnumTrialPhase/"

Slots

Name Cardinality and Range Description Inheritance
studyCode 1
Study
Unique identifier for the study (generally a short acronym) direct
nctId 1
String
The unique identification code given to each clinical study upon registration... direct
clinicalStudyDesign 1
EnumClinicalStudyDesign
The nature of the investigation or investigational use for which clinical stu... direct
trialPhase 1
EnumTrialPhase
For a clinical trial of a drug product (including a biological product), the ... direct
primaryPurpose 1
EnumPrimaryPurpose
The main objective of the intervention(s) being evaluated by the clinical tri... direct
interventionType 1
EnumInterventionType
For each intervention studied in the clinical study, the general type of inte... direct
intervention 1..*
String
For interventional studies, specify the intervention(s) associated with each ... direct
armInformation 1..*
String
For interventional studies, a description of each arm of the clinical trial t... direct
armAllocation 1
EnumArmAllocation
The method by which participants are assigned to arms in a clinical trial direct
interventionAssignmentStrategy 1
EnumInterventionAssignmentStrategy
In an interventional study, the strategy for assigning interventions to parti... direct
primaryOutcomeMeasure 1..*
String
A description of each primary outcome measure (title, description, and time p... direct
secondaryOutcomeMeasure 1..*
String
A description of each secondary outcome measure (title, description, and time... direct
otherOutcomeMeasure 1..*
String
A description of other outcome measures (title, description, and time point/d... direct

Identifier and Mapping Information

Schema Source

  • from schema: https://w3id.org/include

Mappings

Mapping Type Mapped Value
self include:ClinicalTrial
native include:ClinicalTrial

LinkML Source

Direct

name: ClinicalTrial
definition_uri: include:ClinicalTrial
description: Information specific to clinical trials
title: Clinical Trial
from_schema: https://w3id.org/include
slots:
- studyCode
- nctId
- clinicalStudyDesign
- trialPhase
- primaryPurpose
- interventionType
- intervention
- armInformation
- armAllocation
- interventionAssignmentStrategy
- primaryOutcomeMeasure
- secondaryOutcomeMeasure
- otherOutcomeMeasure
slot_usage:
  studyCode:
    name: studyCode
    range: Study

Induced

name: ClinicalTrial
definition_uri: include:ClinicalTrial
description: Information specific to clinical trials
title: Clinical Trial
from_schema: https://w3id.org/include
slot_usage:
  studyCode:
    name: studyCode
    range: Study
attributes:
  studyCode:
    name: studyCode
    definition_uri: include:studyCode
    description: Unique identifier for the study (generally a short acronym)
    title: Study Code
    from_schema: https://w3id.org/include
    rank: 1000
    alias: studyCode
    owner: ClinicalTrial
    domain_of:
    - Study
    - ClinicalTrial
    - Dataset
    - DatasetManifest
    - ParticipantSampleDataFileManifest
    - Participant
    - Condition
    - Biospecimen
    - DataFile
    range: Study
    required: true
  nctId:
    name: nctId
    definition_uri: include:nctId
    description: The unique identification code given to each clinical study upon
      registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit
      number. Also known as ClinicalTrials.gov Identifier
    title: NCT ID
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov NCT Number
    rank: 1000
    alias: nctId
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: string
    required: true
    multivalued: false
  clinicalStudyDesign:
    name: clinicalStudyDesign
    definition_uri: include:clinicalStudyDesign
    description: The nature of the investigation or investigational use for which
      clinical study information is being submitted. Select one.
    title: Clinical Study Design
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Study Type
    rank: 1000
    alias: clinicalStudyDesign
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: enum_clinicalStudyDesign
    required: true
    multivalued: false
  trialPhase:
    name: trialPhase
    definition_uri: include:trialPhase
    description: For a clinical trial of a drug product (including a biological product),
      the numerical phase of such clinical trial. Select only one.
    title: Trial Phase
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Study Phase
    rank: 1000
    alias: trialPhase
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: enum_trialPhase
    required: true
    multivalued: false
  primaryPurpose:
    name: primaryPurpose
    definition_uri: include:primaryPurpose
    description: The main objective of the intervention(s) being evaluated by the
      clinical trial. Select one.
    title: Primary Purpose
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Primary Purpose
    rank: 1000
    alias: primaryPurpose
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: enum_primaryPurpose
    required: true
    multivalued: false
  interventionType:
    name: interventionType
    definition_uri: include:interventionType
    description: For each intervention studied in the clinical study, the general
      type of intervention. Select one.
    title: Intervention Type
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Intervention Type
    rank: 1000
    alias: interventionType
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: enum_interventionType
    required: true
    multivalued: false
  intervention:
    name: intervention
    definition_uri: include:intervention
    description: For interventional studies, specify the intervention(s) associated
      with each arm or group; at least one intervention must be specified for interventional
      studies. Use non-proprietary names where available. Multiple values should be
      pipe-separated. For observational studies, specify the intervention(s)/exposure(s)
      of interest, if any.
    title: Intervention
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Intervention
    rank: 1000
    alias: intervention
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: string
    required: true
    multivalued: true
  armInformation:
    name: armInformation
    definition_uri: include:armInformation
    description: For interventional studies, a description of each arm of the clinical
      trial that indicates its role in the clinical trial (e.g. Experimental, Active
      Comparator, Placebo Comparator, Sham Comparator; No Intervention; Other); provides
      an informative title; and, if necessary, additional descriptive information
      (including which interventions are administered in each arm) to differentiate
      each arm from other arms in the clinical trial. Multiple values should be pipe-separated.
      For observational studies, specify the predefined participant groups (cohorts)
      to be studied, e.g. those with or without a condition/exposure.
    title: Arm Information
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Study Arms
    rank: 1000
    alias: armInformation
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: string
    required: true
    multivalued: true
  armAllocation:
    name: armAllocation
    definition_uri: include:armAllocation
    description: The method by which participants are assigned to arms in a clinical
      trial.
    title: Arm Allocation
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Allocation
    rank: 1000
    alias: armAllocation
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: enum_armAllocation
    required: true
    multivalued: false
  interventionAssignmentStrategy:
    name: interventionAssignmentStrategy
    definition_uri: include:interventionAssignmentStrategy
    description: In an interventional study, the strategy for assigning interventions
      to participants.
    title: Intervention Assignment Strategy
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Interventional Study Model
    rank: 1000
    alias: interventionAssignmentStrategy
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: enum_interventionAssignmentStrategy
    required: true
    multivalued: false
  primaryOutcomeMeasure:
    name: primaryOutcomeMeasure
    definition_uri: include:primaryOutcomeMeasure
    description: A description of each primary outcome measure (title, description,
      and time point/duration of assessment). Multiple values should be pipe-separated.
    title: Primary Outcome Measure
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Primary Outcome Measures
    rank: 1000
    alias: primaryOutcomeMeasure
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: string
    required: true
    multivalued: true
  secondaryOutcomeMeasure:
    name: secondaryOutcomeMeasure
    definition_uri: include:secondaryOutcomeMeasure
    description: A description of each secondary outcome measure (title, description,
      and time point/duration of assessment). Multiple values should be pipe-separated.
    title: Secondary Outcome Measure
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Secondary Outcome Measures
    rank: 1000
    alias: secondaryOutcomeMeasure
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: string
    required: true
    multivalued: true
  otherOutcomeMeasure:
    name: otherOutcomeMeasure
    definition_uri: include:otherOutcomeMeasure
    description: A description of other outcome measures (title, description, and
      time point/duration of assessment). Multiple values should be pipe-separated.
    title: Other Outcome Measure
    from_schema: https://w3id.org/include
    aliases:
    - clinicaltrials.gov Other Outcome Measures
    rank: 1000
    alias: otherOutcomeMeasure
    owner: ClinicalTrial
    domain_of:
    - ClinicalTrial
    range: string
    required: true
    multivalued: true