Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
ResearchStudy | TU | DomainResource | Investigation to increase healthcare-related patient-independent knowledge
Элементы, определённые в родительском элементе: id, meta, implicitRules, language, text, contained, extension, modifierExtension |
|
identifier | Σ | 0..* | Identifier | Business Identifier for study
|
title | Σ | 0..1 | string | Name for this study |
protocol | Σ | 0..* | Reference( PlanDefinition) | Steps followed in executing study
|
partOf | Σ | 0..* | Reference( ResearchStudy) | Part of larger study
|
status | ?! Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
ResearchStudyStatus ( Required) |
primaryPurposeType | Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType ( Extensible) |
phase | Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase ( Example) |
category | Σ | 0..* | CodeableConcept | Classifications for the study
|
focus | Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study
|
condition | Σ | 0..* | CodeableConcept | Condition being studied
Condition/Problem/Diagnosis Codes ( Example) |
contact | Σ | 0..* | ContactDetail | Contact details for the study
|
relatedArtifact | 0..* | RelatedArtifact | References and dependencies
|
|
keyword | Σ | 0..* | CodeableConcept | Used to search for the study
|
location | Σ | 0..* | CodeableConcept | Geographic region(s) for study
Jurisdiction ( Extensible) |
description | 0..1 | markdown | What this is study doing | |
enrollment | Σ | 0..* | Reference( Group) | Inclusion & exclusion criteria
|
period | Σ | 0..1 | Period | When the study began and ended |
sponsor | Σ | 0..1 | Reference( Organization) | Organization that initiates and is legally responsible for the study |
principalInvestigator | Σ | 0..1 | Reference( Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study |
site | Σ | 0..* | Reference( Location) | Facility where study activities are conducted
|
reasonStopped | Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped ( Example) |
note | 0..* | Annotation | Comments made about the study
|
|
arm | 0..* | BackboneElement | Defined path through the study for a subject
|
|
name | 1..1 | string | Label for study arm | |
type | 0..1 | CodeableConcept | Categorization of study arm | |
description | 0..1 | string | Short explanation of study path | |
objective | 0..* | BackboneElement | A goal for the study
|
|
name | 0..1 | string | Label for the objective | |
type | 0..1 | CodeableConcept | primary | secondary | exploratory
ResearchStudyObjectiveType ( Preferred) |
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Documentation for this format |