CQDG_FHIR_IG - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: Ferlab.bio StructureDefinition/cqdg-study

A research study in CQDG

Usage:

• Examples for this Resource Profile: ResearchStudy/ResearchStudyExample

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		4..*	Extension	Extension Slice: Unordered, Open by value:url
population		0..1	Coding	Ferlab.bio Extension/population-info URL: https://fhir.cqdg.ca/StructureDefinition/population-info
accessLimitations		0..1	Coding	Ferlab.bio Extension/access-limitations URL: https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
accessRequirements		0..*	Coding	Ferlab.bio Extension/access-requirement URL: https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
dataset		0..*	(Complex)	Ferlab.bio Extension/dataset URL: https://fhir.cqdg.ca/StructureDefinition/dataset
dataCategory		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
extension		0..0
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-category (required)
studyDesign		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
extension		0..0
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/study-design (required)
dataCollectionMethod		1..*	(Complex)	Ferlab.bio Extension/data-collection-method URL: https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
extension		0..0
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-collection-method (required)
restricted		1..1	boolean	Restricted URL: https://fhir.cqdg.ca/StructureDefinition/Restricted
researchStudyExpectedContent		0..1	(Complex)	Ferlab.bio Extension/expectedStudyContent URL: https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent
Slices for identifier		1..*	Identifier	Business Identifier for study Slice: Unordered, Open At End by value:system
identifier:CQDG_ID		1..1	Identifier	Business Identifier for study
system		1..1	uri	The namespace for the identifier value Required Pattern: https://fhir.cqdg.ca/fhir/ResearchStudy
category		0..1	CodeableConcept	Classifications for the study
coding		0..1	Coding	Code defined by a terminology system
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ResearchStudy.extension:dataCategory.value[x]:valueCodeableConcept	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCodeableConcept	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCodeableConcept	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		4..*	Extension	Extension Slice: Unordered, Open by value:url
population		0..1	Coding	Ferlab.bio Extension/population-info URL: https://fhir.cqdg.ca/StructureDefinition/population-info
accessLimitations		0..1	Coding	Ferlab.bio Extension/access-limitations URL: https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
accessRequirements		0..*	Coding	Ferlab.bio Extension/access-requirement URL: https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
dataset		0..*	(Complex)	Ferlab.bio Extension/dataset URL: https://fhir.cqdg.ca/StructureDefinition/dataset
dataCategory		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-category (required)
value[x]:valueCoding		0..1	Coding	Value of extension
studyDesign		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/study-design (required)
value[x]:valueCoding		0..1	Coding	Value of extension
dataCollectionMethod		1..*	(Complex)	Ferlab.bio Extension/data-collection-method URL: https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-collection-method (required)
value[x]:valueCoding		0..1	Coding	Value of extension
restricted		1..1	boolean	Restricted URL: https://fhir.cqdg.ca/StructureDefinition/Restricted
researchStudyExpectedContent		0..1	(Complex)	Ferlab.bio Extension/expectedStudyContent URL: https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Business Identifier for study Slice: Unordered, Open At End by value:system
identifier:CQDG_ID	Σ	1..1	Identifier	Business Identifier for study
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: https://fhir.cqdg.ca/fhir/ResearchStudy
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.
category	Σ	0..1	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.
coding	Σ	0..1	Coding	Code defined by a terminology system
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.extension:dataCategory.value[x]:valueCodeableConcept	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCodeableConcept	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCodeableConcept	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG
ResearchStudy.identifier:CQDG_ID.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.category	example

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		4..*	Extension	Extension Slice: Unordered, Open by value:url
population		0..1	Coding	Ferlab.bio Extension/population-info URL: https://fhir.cqdg.ca/StructureDefinition/population-info
accessLimitations		0..1	Coding	Ferlab.bio Extension/access-limitations URL: https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
accessRequirements		0..*	Coding	Ferlab.bio Extension/access-requirement URL: https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
dataset		0..*	(Complex)	Ferlab.bio Extension/dataset URL: https://fhir.cqdg.ca/StructureDefinition/dataset
dataCategory		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-category (required)
value[x]:valueCoding		0..1	Coding	Value of extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system Binding: Ferlab.bio ValueSet/data-category (required)
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
studyDesign		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/study-design (required)
value[x]:valueCoding		0..1	Coding	Value of extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system Binding: Ferlab.bio ValueSet/study-design (required)
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
dataCollectionMethod		1..*	(Complex)	Ferlab.bio Extension/data-collection-method URL: https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-collection-method (required)
value[x]:valueCoding		0..1	Coding	Value of extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system Binding: Ferlab.bio ValueSet/data-collection-method (required)
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
restricted		1..1	boolean	Restricted URL: https://fhir.cqdg.ca/StructureDefinition/Restricted
researchStudyExpectedContent		0..1	(Complex)	Ferlab.bio Extension/expectedStudyContent URL: https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Business Identifier for study Slice: Unordered, Open At End by value:system
identifier:CQDG_ID	Σ	1..1	Identifier	Business Identifier for study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: https://fhir.cqdg.ca/fhir/ResearchStudy
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
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..1	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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
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 Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ResearchStudy.extension:dataCategory.value[x]:valueCodeableConcept	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:dataCategory.value[x]:valueCoding.code	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCodeableConcept	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCoding.code	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCodeableConcept	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCoding.code	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG
ResearchStudy.identifier:CQDG_ID.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:CQDG_ID.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
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

Mandatory: 7 elements
Prohibited: 3 elements

Extensions

This structure refers to these extensions:

• https://fhir.cqdg.ca/StructureDefinition/population-info
• https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
• https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
• https://fhir.cqdg.ca/StructureDefinition/dataset
• https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
• https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
• https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
• https://fhir.cqdg.ca/StructureDefinition/Restricted
• https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ResearchStudy.identifier (Open at End)

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		4..*	Extension	Extension Slice: Unordered, Open by value:url
population		0..1	Coding	Ferlab.bio Extension/population-info URL: https://fhir.cqdg.ca/StructureDefinition/population-info
accessLimitations		0..1	Coding	Ferlab.bio Extension/access-limitations URL: https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
accessRequirements		0..*	Coding	Ferlab.bio Extension/access-requirement URL: https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
dataset		0..*	(Complex)	Ferlab.bio Extension/dataset URL: https://fhir.cqdg.ca/StructureDefinition/dataset
dataCategory		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
extension		0..0
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-category (required)
studyDesign		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
extension		0..0
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/study-design (required)
dataCollectionMethod		1..*	(Complex)	Ferlab.bio Extension/data-collection-method URL: https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
extension		0..0
Slices for value[x]				Content/Rules for all slices
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-collection-method (required)
restricted		1..1	boolean	Restricted URL: https://fhir.cqdg.ca/StructureDefinition/Restricted
researchStudyExpectedContent		0..1	(Complex)	Ferlab.bio Extension/expectedStudyContent URL: https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent
Slices for identifier		1..*	Identifier	Business Identifier for study Slice: Unordered, Open At End by value:system
identifier:CQDG_ID		1..1	Identifier	Business Identifier for study
system		1..1	uri	The namespace for the identifier value Required Pattern: https://fhir.cqdg.ca/fhir/ResearchStudy
category		0..1	CodeableConcept	Classifications for the study
coding		0..1	Coding	Code defined by a terminology system
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ResearchStudy.extension:dataCategory.value[x]:valueCodeableConcept	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCodeableConcept	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCodeableConcept	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		4..*	Extension	Extension Slice: Unordered, Open by value:url
population		0..1	Coding	Ferlab.bio Extension/population-info URL: https://fhir.cqdg.ca/StructureDefinition/population-info
accessLimitations		0..1	Coding	Ferlab.bio Extension/access-limitations URL: https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
accessRequirements		0..*	Coding	Ferlab.bio Extension/access-requirement URL: https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
dataset		0..*	(Complex)	Ferlab.bio Extension/dataset URL: https://fhir.cqdg.ca/StructureDefinition/dataset
dataCategory		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-category (required)
value[x]:valueCoding		0..1	Coding	Value of extension
studyDesign		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/study-design (required)
value[x]:valueCoding		0..1	Coding	Value of extension
dataCollectionMethod		1..*	(Complex)	Ferlab.bio Extension/data-collection-method URL: https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-collection-method (required)
value[x]:valueCoding		0..1	Coding	Value of extension
restricted		1..1	boolean	Restricted URL: https://fhir.cqdg.ca/StructureDefinition/Restricted
researchStudyExpectedContent		0..1	(Complex)	Ferlab.bio Extension/expectedStudyContent URL: https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Business Identifier for study Slice: Unordered, Open At End by value:system
identifier:CQDG_ID	Σ	1..1	Identifier	Business Identifier for study
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: https://fhir.cqdg.ca/fhir/ResearchStudy
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.
category	Σ	0..1	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.
coding	Σ	0..1	Coding	Code defined by a terminology system
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.extension:dataCategory.value[x]:valueCodeableConcept	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCodeableConcept	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCodeableConcept	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG
ResearchStudy.identifier:CQDG_ID.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.category	example

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		4..*	Extension	Extension Slice: Unordered, Open by value:url
population		0..1	Coding	Ferlab.bio Extension/population-info URL: https://fhir.cqdg.ca/StructureDefinition/population-info
accessLimitations		0..1	Coding	Ferlab.bio Extension/access-limitations URL: https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
accessRequirements		0..*	Coding	Ferlab.bio Extension/access-requirement URL: https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
dataset		0..*	(Complex)	Ferlab.bio Extension/dataset URL: https://fhir.cqdg.ca/StructureDefinition/dataset
dataCategory		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-category (required)
value[x]:valueCoding		0..1	Coding	Value of extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system Binding: Ferlab.bio ValueSet/data-category (required)
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
studyDesign		1..*	(Complex)	Ferlab.bio Extension/data-category URL: https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/study-design (required)
value[x]:valueCoding		0..1	Coding	Value of extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system Binding: Ferlab.bio ValueSet/study-design (required)
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
dataCollectionMethod		1..*	(Complex)	Ferlab.bio Extension/data-collection-method URL: https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension"
Slices for value[x]		0..1		Value of extension Slice: Unordered, Closed by type:$this
valueBase64Binary			base64Binary
valueBoolean			boolean
valueCanonical			canonical(Any)
valueCode			code
valueDate			date
valueDateTime			dateTime
valueDecimal			decimal
valueId			id
valueInstant			instant
valueInteger			integer
valueMarkdown			markdown
valueOid			oid
valuePositiveInt			positiveInt
valueString			string
valueTime			time
valueUnsignedInt			unsignedInt
valueUri			uri
valueUrl			url
valueUuid			uuid
valueAddress			Address
valueAge			Age
valueAnnotation			Annotation
valueAttachment			Attachment
valueCodeableConcept			CodeableConcept
valueCoding			Coding
valueContactPoint			ContactPoint
valueCount			Count
valueDistance			Distance
valueDuration			Duration
valueHumanName			HumanName
valueIdentifier			Identifier
valueMoney			Money
valuePeriod			Period
valueQuantity			Quantity
valueRange			Range
valueRatio			Ratio
valueReference			Reference(Any)
valueSampledData			SampledData
valueSignature			Signature
valueTiming			Timing
valueContactDetail			ContactDetail
valueContributor			Contributor
valueDataRequirement			DataRequirement
valueExpression			Expression
valueParameterDefinition			ParameterDefinition
valueRelatedArtifact			RelatedArtifact
valueTriggerDefinition			TriggerDefinition
valueUsageContext			UsageContext
valueDosage			Dosage
valueMeta			Meta
value[x]:valueCodeableConcept		0..1	CodeableConcept	Value of extension Binding: Ferlab.bio ValueSet/data-collection-method (required)
value[x]:valueCoding		0..1	Coding	Value of extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	0..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	0..1	code	Symbol in syntax defined by the system Binding: Ferlab.bio ValueSet/data-collection-method (required)
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
restricted		1..1	boolean	Restricted URL: https://fhir.cqdg.ca/StructureDefinition/Restricted
researchStudyExpectedContent		0..1	(Complex)	Ferlab.bio Extension/expectedStudyContent URL: https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	Σ	1..*	Identifier	Business Identifier for study Slice: Unordered, Open At End by value:system
identifier:CQDG_ID	Σ	1..1	Identifier	Business Identifier for study
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Required Pattern: https://fhir.cqdg.ca/fhir/ResearchStudy
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
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..1	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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..1	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
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 Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ResearchStudy.extension:dataCategory.value[x]:valueCodeableConcept	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:dataCategory.value[x]:valueCoding.code	required	DataCategoryVS (a valid code from Ferlab.bio CodeSystem/data-category) https://fhir.cqdg.ca/ValueSet/data-category-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCodeableConcept	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:studyDesign.value[x]:valueCoding.code	required	StudyDesignVS (a valid code from Ferlab.bio CodeSystem/study-design) https://fhir.cqdg.ca/ValueSet/study-design-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCodeableConcept	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG
ResearchStudy.extension:dataCollectionMethod.value[x]:valueCoding.code	required	DataCollectionMethodVS (a valid code from Ferlab.bio CodeSystem/data-collection-method) https://fhir.cqdg.ca/ValueSet/data-collection-method-vs from this IG
ResearchStudy.identifier:CQDG_ID.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchStudy.identifier:CQDG_ID.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
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

Mandatory: 7 elements
Prohibited: 3 elements

Extensions

This structure refers to these extensions:

• https://fhir.cqdg.ca/StructureDefinition/population-info
• https://fhir.cqdg.ca/StructureDefinition/AccessLimitations
• https://fhir.cqdg.ca/StructureDefinition/AccessRequirements
• https://fhir.cqdg.ca/StructureDefinition/dataset
• https://fhir.cqdg.ca/StructureDefinition/DataCategoryExtension
• https://fhir.cqdg.ca/StructureDefinition/StudyDesignExtension
• https://fhir.cqdg.ca/StructureDefinition/DataCollectionMethodExtension
• https://fhir.cqdg.ca/StructureDefinition/Restricted
• https://fhir.cqdg.ca/StructureDefinition/ResearchStudy/ExpectedContent

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ResearchStudy.identifier (Open at End)