Class: Clinical Trial (ClinicalTrial)
Information specific to clinical trials
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