Extensions for Using Data Elements from FHIR R4 in FHIR R4B - Downloaded Version null See the Directory of published versions

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Resource Profile: Profile_R4_ResearchSubject_R4B

This cross-version profile allows R4 ResearchSubject content to be represented via FHIR R4B ResearchSubject resources.

Usages:

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

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
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Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject(4.3.0)	Physical entity which is the primary unit of interest in the study
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
status	?!Σ	1..1	code	candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
study	Σ	1..1	Reference(ResearchStudy)	Study subject is part of
individual	Σ	1..1	Reference(Patient)	Who is part of study
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.3.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	ResearchSubject	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	ResearchSubject	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ResearchSubject	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	ResearchSubject	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	ResearchSubject	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ResearchSubject.implicitRules, ResearchSubject.modifierExtension, ResearchSubject.status, ResearchSubject.study, ResearchSubject.individual	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	ResearchSubject.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from ResearchSubject

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject(4.3.0)	Physical entity which is the primary unit of interest in the study
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject(4.3.0)	Physical entity which is the primary unit of interest in the study
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): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources Constraints: dom-r4b
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..*	Identifier	Business Identifier for research subject in a study
status	?!Σ	1..1	code	candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
period	Σ	0..1	Period	Start and end of participation
study	Σ	1..1	Reference(ResearchStudy)	Study subject is part of
individual	Σ	1..1	Reference(Patient)	Who is part of study
assignedArm		0..1	string	What path should be followed
actualArm		0..1	string	What path was followed
consent		0..1	Reference(Consent)	Agreement to participate in study
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.language	Base	preferred	Common Languages	📍4.3.0	FHIR Std.
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.3.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	ResearchSubject	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	ResearchSubject	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ResearchSubject	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	ResearchSubject	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	ResearchSubject	A resource should have narrative for robust management	text.`div`.exists()
dom-r4b	warning	ResearchSubject.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems	($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1	error	ResearchSubject.meta, ResearchSubject.implicitRules, ResearchSubject.language, ResearchSubject.text, ResearchSubject.extension, ResearchSubject.modifierExtension, ResearchSubject.identifier, ResearchSubject.status, ResearchSubject.period, ResearchSubject.study, ResearchSubject.individual, ResearchSubject.assignedArm, ResearchSubject.actualArm, ResearchSubject.consent	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	ResearchSubject.extension, ResearchSubject.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from ResearchSubject

Summary

Maturity: 0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject(4.3.0)	Physical entity which is the primary unit of interest in the study
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
status	?!Σ	1..1	code	candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
study	Σ	1..1	Reference(ResearchStudy)	Study subject is part of
individual	Σ	1..1	Reference(Patient)	Who is part of study
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.3.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	ResearchSubject	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	ResearchSubject	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ResearchSubject	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	ResearchSubject	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	ResearchSubject	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ResearchSubject.implicitRules, ResearchSubject.modifierExtension, ResearchSubject.status, ResearchSubject.study, ResearchSubject.individual	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	ResearchSubject.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Differential View

This structure is derived from ResearchSubject

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject(4.3.0)	Physical entity which is the primary unit of interest in the study
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject(4.3.0)	Physical entity which is the primary unit of interest in the study
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): IETF language tag Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources Constraints: dom-r4b
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..*	Identifier	Business Identifier for research subject in a study
status	?!Σ	1..1	code	candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
period	Σ	0..1	Period	Start and end of participation
study	Σ	1..1	Reference(ResearchStudy)	Study subject is part of
individual	Σ	1..1	Reference(Patient)	Who is part of study
assignedArm		0..1	string	What path should be followed
actualArm		0..1	string	What path was followed
consent		0..1	Reference(Consent)	Agreement to participate in study
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.language	Base	preferred	Common Languages	📍4.3.0	FHIR Std.
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.3.0	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	ResearchSubject	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	ResearchSubject	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ResearchSubject	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	ResearchSubject	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	ResearchSubject	A resource should have narrative for robust management	text.`div`.exists()
dom-r4b	warning	ResearchSubject.contained	Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems	($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)
ele-1	error	ResearchSubject.meta, ResearchSubject.implicitRules, ResearchSubject.language, ResearchSubject.text, ResearchSubject.extension, ResearchSubject.modifierExtension, ResearchSubject.identifier, ResearchSubject.status, ResearchSubject.period, ResearchSubject.study, ResearchSubject.individual, ResearchSubject.assignedArm, ResearchSubject.actualArm, ResearchSubject.consent	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	ResearchSubject.extension, ResearchSubject.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()

This structure is derived from ResearchSubject

Summary

Maturity: 0

Other representations of profile: CSV, Excel, Schematron