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Resource Profile: Genomics Research Study

Base profile that defines Research Study returned from GenomOncology's API suite.

Usage:

• This Resource Profile is not used by any profiles in this Implementation Guide

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
variant-assessed		0..*	Reference(Genomics Variant)	Variants Assessed URL: http://fhir.genomoncology.io/StructureDefinition/variants-assessed
distance-to-nearest-recruiting-location		0..1	Quantity	Distance To Nearest Recruiting Location URL: http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
variant-assessed		0..*	Reference(Genomics Variant)	Variants Assessed URL: http://fhir.genomoncology.io/StructureDefinition/variants-assessed ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
distance-to-nearest-recruiting-location		0..1	Quantity	Distance To Nearest Recruiting Location URL: http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 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().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(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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
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
variant-assessed		0..*	Reference(Genomics Variant)	Variants Assessed URL: http://fhir.genomoncology.io/StructureDefinition/variants-assessed
distance-to-nearest-recruiting-location		0..1	Quantity	Distance To Nearest Recruiting Location URL: http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for study
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	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.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 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.
category	Σ	0..*	CodeableConcept	Classifications for the study Binding Description (No ValueSet): (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions.
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery.
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner | PractitionerRole)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note		0..*	Annotation	Comments made about the study
arm		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
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	example	ResearchStudyPhase http://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard
ResearchStudy.category	example
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard
ResearchStudy.objective.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().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(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

Extensions

This structure refers to these extensions:

• http://fhir.genomoncology.io/StructureDefinition/variants-assessed
• http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location

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
variant-assessed		0..*	Reference(Genomics Variant)	Variants Assessed URL: http://fhir.genomoncology.io/StructureDefinition/variants-assessed
distance-to-nearest-recruiting-location		0..1	Quantity	Distance To Nearest Recruiting Location URL: http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
variant-assessed		0..*	Reference(Genomics Variant)	Variants Assessed URL: http://fhir.genomoncology.io/StructureDefinition/variants-assessed ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
distance-to-nearest-recruiting-location		0..1	Quantity	Distance To Nearest Recruiting Location URL: http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 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().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(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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
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
variant-assessed		0..*	Reference(Genomics Variant)	Variants Assessed URL: http://fhir.genomoncology.io/StructureDefinition/variants-assessed
distance-to-nearest-recruiting-location		0..1	Quantity	Distance To Nearest Recruiting Location URL: http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for study
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	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.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 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.
category	Σ	0..*	CodeableConcept	Classifications for the study Binding Description (No ValueSet): (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding Description (No ValueSet): (example): Codes for medications, devices and other interventions.
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding Description (No ValueSet): (example): Words associated with the study that may be useful in discovery.
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner | PractitionerRole)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note		0..*	Annotation	Comments made about the study
arm		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
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	example	ResearchStudyPhase http://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard
ResearchStudy.category	example
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard
ResearchStudy.objective.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().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(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

Extensions

This structure refers to these extensions:

• http://fhir.genomoncology.io/StructureDefinition/variants-assessed
• http://fhir.genomoncology.io/StructureDefinition/distance-to-nearest-recruiting-location

Other representations of profile: CSV, Excel, Schematron