Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

• Content
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Resource Profile: SystematicReview

Profile of ResearchStudy for Evidence Based Medicine IG. The SystematicReview Profile is used for a scientific study based on a protocol that includes search and selection of eligible studies, study quality assessment, data extraction, and synthesis.

Usage:

• Examples for this Resource Profile: NMA_Diabetes

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
searchStrategy		0..*	Reference(SearchStrategy)	Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy
systematicReviewEligibilityCriteria		0..1	Reference(SystematicReviewEligibilityCriteria)	Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria
numberOfStudiesIdentified		0..1	unsignedInt	Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified
numberOfStudiesIncluded		0..1	unsignedInt	Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included
includedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study
excludedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study
resultAsComposition		0..*	Reference(Composition)	Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition
studyRegistration		0..*	base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta	Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
phase		0..0
recruitment		0..0
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
searchStrategy		0..*	Reference(SearchStrategy)	Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
systematicReviewEligibilityCriteria		0..1	Reference(SystematicReviewEligibilityCriteria)	Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
numberOfStudiesIdentified		0..1	unsignedInt	Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
numberOfStudiesIncluded		0..1	unsignedInt	Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
includedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
excludedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
resultAsComposition		0..*	Reference(Composition)	Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
studyRegistration		0..*	base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta	Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').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	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
searchStrategy		0..*	Reference(SearchStrategy)	Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy
systematicReviewEligibilityCriteria		0..1	Reference(SystematicReviewEligibilityCriteria)	Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria
numberOfStudiesIdentified		0..1	unsignedInt	Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified
numberOfStudiesIncluded		0..1	unsignedInt	Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included
includedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study
excludedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study
resultAsComposition		0..*	Reference(Composition)	Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition
studyRegistration		0..*	base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta	Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url		0..1	uri	Canonical identifier for this study resource
identifier	Σ	0..*	Identifier	Business Identifier for study
version		0..1	string	The business version for the study record
name		0..1	string	Name for this study (computer friendly)
title	Σ	0..1	string	Human readable name of the study
label		0..*	BackboneElement	Additional names for the study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: TitleType (extensible): desc.
value		0..1	string	The name
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
relatedArtifact		0..*	RelatedArtifact	References, URLs, and attachments
date		0..1	dateTime	Date the resource last changed
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
studyDesign	Σ	0..*	CodeableConcept	Classifications of the study design characteristics Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
focus		0..*	CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable)	Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Common codes of research study focus
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery.
region	Σ	0..*	CodeableConcept	Geographic area for the study Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
descriptionSummary		0..1	markdown	Brief text explaining the study
description		0..1	markdown	Detailed narrative of the study
period	Σ	0..1	Period	When the study began and ended
site	Σ	0..*	Reference(Location | ResearchStudy | Organization)	Facility where study activities are conducted
note		0..*	Annotation	Comments made about the study
classifier		0..*	CodeableConcept	Classification for the study Binding: ResearchStudyClassifiers (example): desc.
associatedParty		0..*	BackboneElement	Sponsors, collaborators, and other parties
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Name of associated party
role		1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc.
period		0..*	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
progressStatus		0..*	BackboneElement	Status of study with time for that status
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
state		1..1	CodeableConcept	Label for status or state (e.g. recruitment status) Binding: ResearchStudyStatus (extensible): defn.
actual		0..1	boolean	Actual if true else anticipated
period		0..1	Period	Date range
whyStopped	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.
comparisonGroup		0..*	BackboneElement	Defined path through the study for a subject
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
linkId		0..1	id	Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
name		1..1	string	Label for study comparisonGroup
type		0..1	CodeableConcept	Categorization of study comparisonGroup Binding: ResearchStudyArmType (extensible): desc.
description		0..1	markdown	Short explanation of study path
intendedExposure		0..*	Reference(EvidenceVariable)	Interventions or exposures in this comparisonGroup or cohort
observedGroup		0..1	Reference(Group)	Group of participants who were enrolled in study comparisonGroup
objective		0..*	BackboneElement	A goal for the study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
description		0..1	markdown	Description of the objective
outcomeMeasure		0..*	BackboneElement	A variable measured during the study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Label for the outcome
type		0..*	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn.
description		0..1	markdown	Description of the outcome
reference		0..1	Reference(EvidenceVariable)	Structured outcome definition
result	Σ	0..*	Reference(Citation | Composition | DiagnosticReport)	Link to results generated during the study
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2 from the FHIR Standard
ResearchStudy.label.type	extensible	TitleType http://hl7.org/fhir/ValueSet/title-type from the FHIR Standard
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
ResearchStudy.primaryPurposeType	preferred	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.studyDesign	preferred	StudyDesign http://hl7.org/fhir/ValueSet/study-design from the FHIR Standard
ResearchStudy.focus	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type from the FHIR Standard
ResearchStudy.condition	example	ConditionProblemDiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.region	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.classifier	example	ResearchStudyClassifiers http://hl7.org/fhir/ValueSet/research-study-classifiers from the FHIR Standard
ResearchStudy.associatedParty.role	extensible	ResearchStudyPartyRole http://hl7.org/fhir/ValueSet/research-study-party-role from the FHIR Standard
ResearchStudy.associatedParty.classifier	example	ResearchStudyPartyOrgType http://hl7.org/fhir/ValueSet/research-study-party-organization-type from the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status from the FHIR Standard
ResearchStudy.whyStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard
ResearchStudy.comparisonGroup.type	extensible	ResearchStudyArmType http://hl7.org/fhir/ValueSet/research-study-arm-type from the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard
ResearchStudy.outcomeMeasure.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').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	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from ResearchStudy

Summary

Prohibited: 2 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/StructureDefinition/artifact-author
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition
• http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration

Maturity: 1

Differential View

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
searchStrategy		0..*	Reference(SearchStrategy)	Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy
systematicReviewEligibilityCriteria		0..1	Reference(SystematicReviewEligibilityCriteria)	Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria
numberOfStudiesIdentified		0..1	unsignedInt	Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified
numberOfStudiesIncluded		0..1	unsignedInt	Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included
includedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study
excludedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study
resultAsComposition		0..*	Reference(Composition)	Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition
studyRegistration		0..*	base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta	Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
phase		0..0
recruitment		0..0
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: 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 dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created ele-1: All FHIR elements must have a @value or children
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
searchStrategy		0..*	Reference(SearchStrategy)	Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
systematicReviewEligibilityCriteria		0..1	Reference(SystematicReviewEligibilityCriteria)	Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
numberOfStudiesIdentified		0..1	unsignedInt	Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
numberOfStudiesIncluded		0..1	unsignedInt	Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
includedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
excludedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
resultAsComposition		0..*	Reference(Composition)	Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
studyRegistration		0..*	base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta	Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').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	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
author		0..*	ContactDetail	Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author
searchStrategy		0..*	Reference(SearchStrategy)	Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy
systematicReviewEligibilityCriteria		0..1	Reference(SystematicReviewEligibilityCriteria)	Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria
numberOfStudiesIdentified		0..1	unsignedInt	Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified
numberOfStudiesIncluded		0..1	unsignedInt	Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included
includedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study
excludedStudy		0..*	Reference(Citation | Composition | ResearchStudy)	Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study
resultAsComposition		0..*	Reference(Composition)	Link to results generated by the study. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition
studyRegistration		0..*	base64Binary, boolean, canonical(), code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference(), Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference(), SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta	Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url		0..1	uri	Canonical identifier for this study resource
identifier	Σ	0..*	Identifier	Business Identifier for study
version		0..1	string	The business version for the study record
name		0..1	string	Name for this study (computer friendly)
title	Σ	0..1	string	Human readable name of the study
label		0..*	BackboneElement	Additional names for the study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type		0..1	CodeableConcept	primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: TitleType (extensible): desc.
value		0..1	string	The name
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
relatedArtifact		0..*	RelatedArtifact	References, URLs, and attachments
date		0..1	dateTime	Date the resource last changed
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
studyDesign	Σ	0..*	CodeableConcept	Classifications of the study design characteristics Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
focus		0..*	CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable)	Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Common codes of research study focus
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery.
region	Σ	0..*	CodeableConcept	Geographic area for the study Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
descriptionSummary		0..1	markdown	Brief text explaining the study
description		0..1	markdown	Detailed narrative of the study
period	Σ	0..1	Period	When the study began and ended
site	Σ	0..*	Reference(Location | ResearchStudy | Organization)	Facility where study activities are conducted
note		0..*	Annotation	Comments made about the study
classifier		0..*	CodeableConcept	Classification for the study Binding: ResearchStudyClassifiers (example): desc.
associatedParty		0..*	BackboneElement	Sponsors, collaborators, and other parties
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Name of associated party
role		1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc.
period		0..*	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
progressStatus		0..*	BackboneElement	Status of study with time for that status
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
state		1..1	CodeableConcept	Label for status or state (e.g. recruitment status) Binding: ResearchStudyStatus (extensible): defn.
actual		0..1	boolean	Actual if true else anticipated
period		0..1	Period	Date range
whyStopped	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.
comparisonGroup		0..*	BackboneElement	Defined path through the study for a subject
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
linkId		0..1	id	Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
name		1..1	string	Label for study comparisonGroup
type		0..1	CodeableConcept	Categorization of study comparisonGroup Binding: ResearchStudyArmType (extensible): desc.
description		0..1	markdown	Short explanation of study path
intendedExposure		0..*	Reference(EvidenceVariable)	Interventions or exposures in this comparisonGroup or cohort
observedGroup		0..1	Reference(Group)	Group of participants who were enrolled in study comparisonGroup
objective		0..*	BackboneElement	A goal for the study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
description		0..1	markdown	Description of the objective
outcomeMeasure		0..*	BackboneElement	A variable measured during the study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		0..1	string	Label for the outcome
type		0..*	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn.
description		0..1	markdown	Description of the outcome
reference		0..1	Reference(EvidenceVariable)	Structured outcome definition
result	Σ	0..*	Reference(Citation | Composition | DiagnosticReport)	Link to results generated during the study
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2 from the FHIR Standard
ResearchStudy.label.type	extensible	TitleType http://hl7.org/fhir/ValueSet/title-type from the FHIR Standard
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2 from the FHIR Standard
ResearchStudy.primaryPurposeType	preferred	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.studyDesign	preferred	StudyDesign http://hl7.org/fhir/ValueSet/study-design from the FHIR Standard
ResearchStudy.focus	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type from the FHIR Standard
ResearchStudy.condition	example	ConditionProblemDiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.region	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.classifier	example	ResearchStudyClassifiers http://hl7.org/fhir/ValueSet/research-study-classifiers from the FHIR Standard
ResearchStudy.associatedParty.role	extensible	ResearchStudyPartyRole http://hl7.org/fhir/ValueSet/research-study-party-role from the FHIR Standard
ResearchStudy.associatedParty.classifier	example	ResearchStudyPartyOrgType http://hl7.org/fhir/ValueSet/research-study-party-organization-type from the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status from the FHIR Standard
ResearchStudy.whyStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard
ResearchStudy.comparisonGroup.type	extensible	ResearchStudyArmType http://hl7.org/fhir/ValueSet/research-study-arm-type from the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard
ResearchStudy.outcomeMeasure.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').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	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from ResearchStudy

Summary

Prohibited: 2 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/StructureDefinition/artifact-author
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study
• http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-result-as-composition
• http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration

Maturity: 1

Other representations of profile: CSV, Excel, Schematron