NCPI FHIR Implementation Guide v2 - 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: NCPI Study Participant

Research Study

Usage:

• Examples for this Resource Profile: ResearchSubject/gregor-example-participantstudy

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
• All

Name	Flags	Card.	Type	Description & Constraints
ResearchSubject		0..*	ResearchSubject	Physical entity which is the primary unit of interest in the study 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
extension:access-policy		0..*	Reference(NCPI Research Access Policy)	The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy ele-1: All FHIR elements must have a @value or children unless an empty Parameters resource 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	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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. ele-1: All FHIR elements must have a @value or children
study	Σ	1..1	Reference(ResearchStudy)	The Research Study this participant has a relationship with ele-1: All FHIR elements must have a @value or children
individual	Σ	1..1	Reference(NCPI Participant)	The participant we are describing ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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	**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 ResearchSubject

Name	Flags	Card.	Type	Description & Constraints
ResearchSubject		0..*	ResearchSubject	Physical entity which is the primary unit of interest in the study
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:access-policy		0..*	Reference(NCPI Research Access Policy)	The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
study		1..1	Reference(ResearchStudy)	The Research Study this participant has a relationship with
individual		1..1	Reference(NCPI Participant)	The participant we are describing
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ResearchSubject		0..*	ResearchSubject	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
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:access-policy		0..*	Reference(NCPI Research Access Policy)	The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
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)	The Research Study this participant has a relationship with
individual	Σ	1..1	Reference(NCPI Participant)	The participant we are describing
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	Conformance	ValueSet	URI
ResearchSubject.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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	**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 ResearchSubject

Summary

Structures

This structure refers to these other structures:

• NCPI Participant (https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/ncpi-participant)

Extensions

This structure refers to these extensions:

• https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ResearchSubject		0..*	ResearchSubject	Physical entity which is the primary unit of interest in the study 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
extension:access-policy		0..*	Reference(NCPI Research Access Policy)	The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy ele-1: All FHIR elements must have a @value or children unless an empty Parameters resource 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	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. ele-1: All FHIR elements must have a @value or children
study	Σ	1..1	Reference(ResearchStudy)	The Research Study this participant has a relationship with ele-1: All FHIR elements must have a @value or children
individual	Σ	1..1	Reference(NCPI Participant)	The participant we are describing ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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	**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()

Differential View

This structure is derived from ResearchSubject

Name	Flags	Card.	Type	Description & Constraints
ResearchSubject		0..*	ResearchSubject	Physical entity which is the primary unit of interest in the study
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:access-policy		0..*	Reference(NCPI Research Access Policy)	The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
study		1..1	Reference(ResearchStudy)	The Research Study this participant has a relationship with
individual		1..1	Reference(NCPI Participant)	The participant we are describing
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ResearchSubject		0..*	ResearchSubject	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
contained		0..*	Resource	Contained, inline Resources dom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:access-policy		0..*	Reference(NCPI Research Access Policy)	The Access Policy that may apply to this participant's data from this study. Not canonical, ie, one must rely on the row level AP. URL: https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
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)	The Research Study this participant has a relationship with
individual	Σ	1..1	Reference(NCPI Participant)	The participant we are describing
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	Conformance	ValueSet	URI
ResearchSubject.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.3.0 from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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	**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 ResearchSubject

Summary

Structures

This structure refers to these other structures:

• NCPI Participant (https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/ncpi-participant)

Extensions

This structure refers to these extensions:

• https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/access-policy

Other representations of profile: CSV, Excel, Schematron