Extensions for Using Data Elements from FHIR R5 in FHIR R4B - Downloaded Version null See the Directory of published versions
| Official URL: http://hl7.org/fhir/5.0/StructureDefinition/profile-ResearchStudy | Version: 0.1.0 | |||
| Standards status: Trial-use | Maturity Level: 0 | Computable Name: Profile_R5_ResearchStudy_R4B | ||
This cross-version profile allows R5 ResearchStudy content to be represented via FHIR R4B ResearchStudy resources.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.3.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | ResearchStudy.implicitRules, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | ResearchStudy(4.3.0) | Investigation to increase healthcare-related patient-independent knowledge | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
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0..* | Resource | Contained, inline Resources Constraints: dom-r4b | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | uri | R5: Canonical identifier for this study resource (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url Constraints: ext-1 | |||||
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0..1 | string | R5: The business version for the study record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version Constraints: ext-1 | |||||
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0..1 | string | R5: Name for this study (computer friendly) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name Constraints: ext-1 | |||||
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0..* | (Complex) | R5: Additional names for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label Constraints: ext-1 | |||||
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0..1 | dateTime | R5: Date the resource last changed (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date Constraints: ext-1 | |||||
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0..* | CodeableConcept | R5: Classifications of the study design characteristics (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics. Constraints: ext-1 | |||||
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0..1 | markdown | R5: Brief text explaining the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary Constraints: ext-1 | |||||
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0..* | CodeableConcept | R5: Classification for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc. Constraints: ext-1 | |||||
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0..* | (Complex) | R5: Sponsors, collaborators, and other parties (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty Constraints: ext-1 | |||||
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0..* | (Complex) | R5: Status of study with time for that status (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus Constraints: ext-1 | |||||
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0..1 | unsignedInt | R5: Estimated total number of participants to be enrolled (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber Constraints: ext-1 | |||||
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0..1 | unsignedInt | R5: Actual total number of participants enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber Constraints: ext-1 | |||||
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0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) | R5: Group of participants who were enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup Constraints: ext-1 | |||||
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0..* | (Complex) | R5: A variable measured during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure Constraints: ext-1 | |||||
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0..* | Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) | R5: Link to results generated during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result Constraints: ext-1 | |||||
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?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
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Σ | 0..* | Identifier | Business Identifier for study | ||||
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Σ | 0..1 | string | Name for this study | ||||
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Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
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Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
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?!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 Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
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0..1 | string | xml:id (or equivalent in JSON) | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | code | R5: draft | active | retired | unknown additional codes URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. Constraints: ext-1 | |||||
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0..1 | code | Primitive value for code | |||||
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Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study. | ||||
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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 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | ||||
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Σ | 0..* | CodeableConcept | Classifications for the study Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
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Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..* | CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0) | Medication | Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0) | MedicinalProductDefinition | Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0) | SubstanceDefinition | Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) | R5: focus additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus Binding: R5ResearchStudyFocusTypeForR4B (0.1.0) (example): Common codes of research study focus Constraints: ext-1 | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
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Σ | 0..* | ContactDetail | Contact details for the study | ||||
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0..* | RelatedArtifact | References and dependencies | |||||
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Σ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | ||||
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Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
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0..1 | markdown | What this is study doing | |||||
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Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | Reference(Resource) | R5: Inclusion and exclusion criteria additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1 | |||||
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible) | ||||
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Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
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Σ | 0..1 | string | Text alternative for the resource | ||||
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Σ | 0..1 | Period | When the study began and ended | ||||
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Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
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Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
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Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | Reference(Resource) | R5: site URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1 | |||||
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible) | ||||
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Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
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Σ | 0..1 | string | Text alternative for the resource | ||||
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Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
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0..* | Annotation | Comments made about the study | |||||
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0..* | BackboneElement | Defined path through the study for a subject | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | id | R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId Constraints: ext-1 | |||||
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0..* | Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) | R5: Interventions or exposures in this comparisonGroup or cohort (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure Constraints: ext-1 | |||||
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0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) | R5: Group of participants who were enrolled in study comparisonGroup (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup Constraints: ext-1 | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
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1..1 | string | Label for study arm | |||||
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0..1 | CodeableConcept | Categorization of study arm | |||||
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0..1 | string | Short explanation of study path | |||||
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0..* | BackboneElement | A goal for the study | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | markdown | R5: Description of the objective (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description Constraints: ext-1 | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
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0..1 | string | Label for the objective | |||||
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0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | preferred | Common Languages | 📍4.3.0 | FHIR Std. |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.3.0 | FHIR Std. |
| ResearchStudy.primaryPurposeType | Base | extensible | ResearchStudyPrimaryPurposeType | 📍4.3.0 | FHIR Std. |
| ResearchStudy.phase | Base | example | ResearchStudyPhase | 📍4.3.0 | FHIR Std. |
| ResearchStudy.category | Base | example | Not State | Unknown | |
| ResearchStudy.focus | Base | example | Not State | Unknown | |
| ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍4.3.0 | FHIR Std. |
| ResearchStudy.keyword | Base | example | Not State | Unknown | |
| ResearchStudy.location | Base | extensible | Jurisdiction | 📍4.3.0 | FHIR Std. |
| ResearchStudy.enrollment.type | Base | extensible | ResourceType | 📍4.3.0 | FHIR Std. |
| ResearchStudy.site.type | Base | extensible | ResourceType | 📍4.3.0 | FHIR Std. |
| ResearchStudy.reasonStopped | Base | example | ResearchStudyReasonStopped | 📍4.3.0 | FHIR Std. |
| ResearchStudy.objective.type | Base | preferred | ResearchStudyObjectiveType | 📍4.3.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| dom-r4b | warning | ResearchStudy.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems |
($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
|
| ele-1 | error | ResearchStudy.meta, ResearchStudy.implicitRules, ResearchStudy.language, ResearchStudy.text, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.identifier, ResearchStudy.title, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.primaryPurposeType, ResearchStudy.phase, ResearchStudy.category, ResearchStudy.focus, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.focus.coding, ResearchStudy.focus.text, ResearchStudy.condition, ResearchStudy.contact, ResearchStudy.relatedArtifact, ResearchStudy.keyword, ResearchStudy.location, ResearchStudy.description, ResearchStudy.enrollment, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.enrollment.reference, ResearchStudy.enrollment.type, ResearchStudy.enrollment.identifier, ResearchStudy.enrollment.display, ResearchStudy.period, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.site.reference, ResearchStudy.site.type, ResearchStudy.site.identifier, ResearchStudy.site.display, ResearchStudy.reasonStopped, ResearchStudy.note, ResearchStudy.arm, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.arm.name, ResearchStudy.arm.type, ResearchStudy.arm.description, ResearchStudy.objective, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension, ResearchStudy.objective.name, ResearchStudy.objective.type | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Summary
Extensions
This structure refers to these extensions:
Maturity: 0
Key Elements View
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.3.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | ResearchStudy.implicitRules, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
This structure is derived from ResearchStudy
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
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0..* | ResearchStudy(4.3.0) | Investigation to increase healthcare-related patient-independent knowledge | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): IETF language tag
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
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0..* | Resource | Contained, inline Resources Constraints: dom-r4b | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | uri | R5: Canonical identifier for this study resource (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url Constraints: ext-1 | |||||
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0..1 | string | R5: The business version for the study record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version Constraints: ext-1 | |||||
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0..1 | string | R5: Name for this study (computer friendly) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name Constraints: ext-1 | |||||
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0..* | (Complex) | R5: Additional names for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label Constraints: ext-1 | |||||
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0..1 | dateTime | R5: Date the resource last changed (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date Constraints: ext-1 | |||||
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0..* | CodeableConcept | R5: Classifications of the study design characteristics (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign Binding: R5StudyDesignForR4B (0.1.0) (preferred): This is a set of terms for study design characteristics. Constraints: ext-1 | |||||
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0..1 | markdown | R5: Brief text explaining the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary Constraints: ext-1 | |||||
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0..* | CodeableConcept | R5: Classification for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier Binding: R5ResearchStudyClassifiersForR4B (0.1.0) (example): desc. Constraints: ext-1 | |||||
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0..* | (Complex) | R5: Sponsors, collaborators, and other parties (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty Constraints: ext-1 | |||||
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0..* | (Complex) | R5: Status of study with time for that status (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus Constraints: ext-1 | |||||
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0..1 | unsignedInt | R5: Estimated total number of participants to be enrolled (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber Constraints: ext-1 | |||||
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0..1 | unsignedInt | R5: Actual total number of participants enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber Constraints: ext-1 | |||||
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0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) | R5: Group of participants who were enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup Constraints: ext-1 | |||||
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0..* | (Complex) | R5: A variable measured during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure Constraints: ext-1 | |||||
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0..* | Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0) | EvidenceReport | Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0) | Citation | Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0) | DiagnosticReport) | R5: Link to results generated during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result Constraints: ext-1 | |||||
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?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
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Σ | 0..* | Identifier | Business Identifier for study | ||||
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Σ | 0..1 | string | Name for this study | ||||
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Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
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Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
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?!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 Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
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0..1 | string | xml:id (or equivalent in JSON) | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | code | R5: draft | active | retired | unknown additional codes URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. Constraints: ext-1 | |||||
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0..1 | code | Primitive value for code | |||||
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Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study. | ||||
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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 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | ||||
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Σ | 0..* | CodeableConcept | Classifications for the study Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
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Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..* | CodeableReference(Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0) | Medication | Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0) | MedicinalProductDefinition | Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0) | SubstanceDefinition | Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) | R5: focus additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus Binding: R5ResearchStudyFocusTypeForR4B (0.1.0) (example): Common codes of research study focus Constraints: ext-1 | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
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Σ | 0..* | ContactDetail | Contact details for the study | ||||
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0..* | RelatedArtifact | References and dependencies | |||||
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Σ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | ||||
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Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
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0..1 | markdown | What this is study doing | |||||
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Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | Reference(Resource) | R5: Inclusion and exclusion criteria additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1 | |||||
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible) | ||||
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Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
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Σ | 0..1 | string | Text alternative for the resource | ||||
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Σ | 0..1 | Period | When the study began and ended | ||||
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Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
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Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
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Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | Reference(Resource) | R5: site URL: http://hl7.org/fhir/StructureDefinition/alternate-reference Constraints: ext-1 | |||||
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ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
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Σ | 0..1 | uri | Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible) | ||||
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Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
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Σ | 0..1 | string | Text alternative for the resource | ||||
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Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
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0..* | Annotation | Comments made about the study | |||||
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0..* | BackboneElement | Defined path through the study for a subject | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | id | R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId Constraints: ext-1 | |||||
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0..* | Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0) | EvidenceVariable) | R5: Interventions or exposures in this comparisonGroup or cohort (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure Constraints: ext-1 | |||||
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0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0) | Group) | R5: Group of participants who were enrolled in study comparisonGroup (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup Constraints: ext-1 | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
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1..1 | string | Label for study arm | |||||
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0..1 | CodeableConcept | Categorization of study arm | |||||
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0..1 | string | Short explanation of study path | |||||
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0..* | BackboneElement | A goal for the study | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
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0..1 | markdown | R5: Description of the objective (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description Constraints: ext-1 | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
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0..1 | string | Label for the objective | |||||
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0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | preferred | Common Languages | 📍4.3.0 | FHIR Std. |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.3.0 | FHIR Std. |
| ResearchStudy.primaryPurposeType | Base | extensible | ResearchStudyPrimaryPurposeType | 📍4.3.0 | FHIR Std. |
| ResearchStudy.phase | Base | example | ResearchStudyPhase | 📍4.3.0 | FHIR Std. |
| ResearchStudy.category | Base | example | Not State | Unknown | |
| ResearchStudy.focus | Base | example | Not State | Unknown | |
| ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍4.3.0 | FHIR Std. |
| ResearchStudy.keyword | Base | example | Not State | Unknown | |
| ResearchStudy.location | Base | extensible | Jurisdiction | 📍4.3.0 | FHIR Std. |
| ResearchStudy.enrollment.type | Base | extensible | ResourceType | 📍4.3.0 | FHIR Std. |
| ResearchStudy.site.type | Base | extensible | ResourceType | 📍4.3.0 | FHIR Std. |
| ResearchStudy.reasonStopped | Base | example | ResearchStudyReasonStopped | 📍4.3.0 | FHIR Std. |
| ResearchStudy.objective.type | Base | preferred | ResearchStudyObjectiveType | 📍4.3.0 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| dom-r4b | warning | ResearchStudy.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems |
($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
|
| ele-1 | error | ResearchStudy.meta, ResearchStudy.implicitRules, ResearchStudy.language, ResearchStudy.text, ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.identifier, ResearchStudy.title, ResearchStudy.protocol, ResearchStudy.partOf, ResearchStudy.status, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.primaryPurposeType, ResearchStudy.phase, ResearchStudy.category, ResearchStudy.focus, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.focus.coding, ResearchStudy.focus.text, ResearchStudy.condition, ResearchStudy.contact, ResearchStudy.relatedArtifact, ResearchStudy.keyword, ResearchStudy.location, ResearchStudy.description, ResearchStudy.enrollment, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.enrollment.reference, ResearchStudy.enrollment.type, ResearchStudy.enrollment.identifier, ResearchStudy.enrollment.display, ResearchStudy.period, ResearchStudy.sponsor, ResearchStudy.principalInvestigator, ResearchStudy.site, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.site.reference, ResearchStudy.site.type, ResearchStudy.site.identifier, ResearchStudy.site.display, ResearchStudy.reasonStopped, ResearchStudy.note, ResearchStudy.arm, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.arm.name, ResearchStudy.arm.type, ResearchStudy.arm.description, ResearchStudy.objective, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension, ResearchStudy.objective.name, ResearchStudy.objective.type | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | ResearchStudy.extension, ResearchStudy.extension:url, ResearchStudy.extension:version, ResearchStudy.extension:name, ResearchStudy.extension:label, ResearchStudy.extension:date, ResearchStudy.extension:studyDesign, ResearchStudy.extension:descriptionSummary, ResearchStudy.extension:classifier, ResearchStudy.extension:associatedParty, ResearchStudy.extension:progressStatus, ResearchStudy.extension:targetNumber, ResearchStudy.extension:actualNumber, ResearchStudy.extension:actualGroup, ResearchStudy.extension:outcomeMeasure, ResearchStudy.extension:result, ResearchStudy.modifierExtension, ResearchStudy.status.extension, ResearchStudy.status.extension:status, ResearchStudy.focus.extension, ResearchStudy.focus.extension:focus, ResearchStudy.enrollment.extension, ResearchStudy.enrollment.extension:eligibility, ResearchStudy.site.extension, ResearchStudy.site.extension:site, ResearchStudy.arm.extension, ResearchStudy.arm.extension:linkId, ResearchStudy.arm.extension:intendedExposure, ResearchStudy.arm.extension:observedGroup, ResearchStudy.arm.modifierExtension, ResearchStudy.objective.extension, ResearchStudy.objective.extension:description, ResearchStudy.objective.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Summary
Extensions
This structure refers to these extensions:
Maturity: 0
Other representations of profile: CSV, Excel, Schematron