Key Guidelines

In situations where a person participates in multiple studies that have participant data scoped in an exclusive way within one or more projects, we have a Person entity. It is functionally a “group” of Participants that are all describing one “actual” person. This is especially to support situations where access policies about that participant might be conflicting and cases where the data itself about the participant might conflict but cannot be adjudicated by the repository.

Added Profile Restrictions

In order to ensure that our resources are interoperable across studies, we have employed a number of restrictions that should make consuming Patient resources more consistent.

• ID should be a globally unique identifier associated with the person. This practice is intended to make constructing queries for the same person compatible across different servers (such as QA vs PROD) but also to make the resource URLs more meaningful.

Recommended Practices

Unique participant identifiers are essential to joining the information about a single entity's (i.e., person's) involvement in multiple research studies.

FHIR Mappings

The following fields from the shared data model are to be mapped into the NCPI Participant as shown below:

Study Participation

The conventional FHIR mechanism to link Patient resources to a ResearchStudy is through the use of a ResearchSubject resource. Let's use GREGoR data as an example: NCPI Person "PS_000" which represents the "actual" person participating in a study is linked to a specific research study via NCPI Participant, "GSS123456". In this case, GSS123456 is connected to PS_000 by link.target and if PS_000 participanted in another study, their other unique NCPI Participant ID could be similarly linked. NCPI Study Participant connects NCPI Research Study, relevant Access Policies, and an NCPI Participant into a single profile while NCPI Study Group contains a list of Study Participants.

For further information, see the Participant, Research Study, and Person examples:

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Person		0..*	Person	A generic person record
id	Σ	0..1	id	Unique participant identifier
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
active	?!Σ	0..1	boolean	This person's record is in active use
link		1..*	BackboneElement	Link to a resource that concerns the same actual person
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
target		1..1	Reference(NCPI Participant)	The participant we are describing
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Person	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Person	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	Person	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	Person	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Person	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 Person

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Person		0..*	Person	A generic person record
id		0..1	id	Unique participant identifier
link		1..*	BackboneElement	Link to a resource that concerns the same actual person
target		1..1	Reference(NCPI Participant)	The participant we are describing
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Person		0..*	Person	A generic person record
id	Σ	0..1	id	Unique participant identifier
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier		0..*	Identifier	A human identifier for this person
name	Σ	0..*	HumanName	A name associated with the person
telecom	Σ	0..*	ContactPoint	A contact detail for the person
gender	Σ	0..1	code	male | female | other | unknown Binding: AdministrativeGender (required): The gender of a person used for administrative purposes.
birthDate	Σ	0..1	date	The date on which the person was born
address		0..*	Address	One or more addresses for the person
photo		0..1	Attachment	Image of the person
managingOrganization	Σ	0..1	Reference(Organization)	The organization that is the custodian of the person record
active	?!Σ	0..1	boolean	This person's record is in active use
link		1..*	BackboneElement	Link to a resource that concerns the same actual person
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
target		1..1	Reference(NCPI Participant)	The participant we are describing
assurance		0..1	code	level1 | level2 | level3 | level4 Binding: IdentityAssuranceLevel (required): The level of confidence that this link represents the same actual person, based on NIST Authentication Levels.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Person.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Person.gender	Base	required	AdministrativeGender	📍4.0.1	FHIR Std.
Person.link.assurance	Base	required	IdentityAssuranceLevel	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Person	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Person	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	Person	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	Person	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Person	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()

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Person		0..*	Person	A generic person record
id	Σ	0..1	id	Unique participant identifier
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
active	?!Σ	0..1	boolean	This person's record is in active use
link		1..*	BackboneElement	Link to a resource that concerns the same actual person
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
target		1..1	Reference(NCPI Participant)	The participant we are describing
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Person	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Person	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	Person	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	Person	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Person	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 Person

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Person		0..*	Person	A generic person record
id		0..1	id	Unique participant identifier
link		1..*	BackboneElement	Link to a resource that concerns the same actual person
target		1..1	Reference(NCPI Participant)	The participant we are describing
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Person		0..*	Person	A generic person record
id	Σ	0..1	id	Unique participant identifier
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier		0..*	Identifier	A human identifier for this person
name	Σ	0..*	HumanName	A name associated with the person
telecom	Σ	0..*	ContactPoint	A contact detail for the person
gender	Σ	0..1	code	male | female | other | unknown Binding: AdministrativeGender (required): The gender of a person used for administrative purposes.
birthDate	Σ	0..1	date	The date on which the person was born
address		0..*	Address	One or more addresses for the person
photo		0..1	Attachment	Image of the person
managingOrganization	Σ	0..1	Reference(Organization)	The organization that is the custodian of the person record
active	?!Σ	0..1	boolean	This person's record is in active use
link		1..*	BackboneElement	Link to a resource that concerns the same actual person
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
target		1..1	Reference(NCPI Participant)	The participant we are describing
assurance		0..1	code	level1 | level2 | level3 | level4 Binding: IdentityAssuranceLevel (required): The level of confidence that this link represents the same actual person, based on NIST Authentication Levels.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Person.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Person.gender	Base	required	AdministrativeGender	📍4.0.1	FHIR Std.
Person.link.assurance	Base	required	IdentityAssuranceLevel	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Person	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Person	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	Person	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	Person	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Person	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 Person

Summary

Mandatory: 1 element

Structures

This structure refers to these other structures:

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