MII_IG_Person - Local Development build (v2025.0.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• XML
• JSON
• TTL

Resource Profile: MII PR Person Proband

Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative.

Usage:

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

Formal Views of Profile Content

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

• 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-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated 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-6: A resource should have narrative for robust management dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
id	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource ele-1: All FHIR elements must have a @value or children
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to ele-1: All FHIR elements must have a @value or children
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
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored 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
Slices for identifier	SΣ	1..*	Identifier	Business Identifier for research subject in a study Slice: Unordered, Open by pattern:$this ele-1: All FHIR elements must have a @value or children
identifier:subjectIdentificationCode	SΣ	1..1	Identifier	Business Identifier for research subject in a study ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
type		1..1	CodeableConcept	Description of identifier Fixed Value: (complex)
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ANON
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children
type	SΣ	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. ele-1: All FHIR elements must have a @value or children
system	SΣ	1..1	uri	The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
status	?!SΣ	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
period	SΣC	1..1	Period	Start and end of participation ele-1: All FHIR elements must have a @value or children per-1: If present, start SHALL have a lower value than end
start	SΣC	1..1	dateTime	Starting time with inclusive boundary ele-1: All FHIR elements must have a @value or children
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing ele-1: All FHIR elements must have a @value or children
study	SΣC	1..1	Reference(ResearchStudy)	Study subject is part of ele-1: All FHIR elements must have a @value or children ref-1: SHALL have a contained resource if a local reference is provided
individual	SΣC	1..1	Reference(Patient)	Who is part of study ele-1: All FHIR elements must have a @value or children ref-1: SHALL have a contained resource if a local reference is provided
consent	SC	1..1	Reference(Consent)	Agreement to participate in study ele-1: All FHIR elements must have a @value or children ref-1: SHALL have a contained resource if a local reference is provided
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchSubject.identifier:subjectIdentificationCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchSubject.identifier:subjectIdentificationCode.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1 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 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	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** elements	Must have either extensions or value[x], not both : extension.exists() != value.exists()
per-1	error	ResearchSubject.period	If present, start SHALL have a lower value than end : start.hasValue().not() or end.hasValue().not() or (start <= end)
ref-1	error	ResearchSubject.study, ResearchSubject.individual, ResearchSubject.consent	SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

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
id	S	0..1	id	Logical id of this artifact
meta	S	0..1	Meta	Metadata about the resource
profile	S	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
Slices for identifier	S	1..*	Identifier	Business Identifier for research subject in a study Slice: Unordered, Open by pattern:$this
identifier:subjectIdentificationCode	S	1..1	Identifier	Business Identifier for research subject in a study Required Pattern: At least the following
type		1..1	CodeableConcept	Description of identifier Fixed Value: (complex)
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ANON
type	S	0..1	CodeableConcept	Description of identifier
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
status	S	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
period	S	1..1	Period	Start and end of participation
start	S	1..1	dateTime	Starting time with inclusive boundary
end	S	0..1	dateTime	End time with inclusive boundary, if not ongoing
study	S	1..1	Reference(ResearchStudy)	Study subject is part of
individual	S	1..1	Reference(Patient)	Who is part of study
consent	S	1..1	Reference(Consent)	Agreement to participate in study
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	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	SΣ	1..*	Identifier	Business Identifier for research subject in a study Slice: Unordered, Open by pattern:$this
identifier:subjectIdentificationCode	SΣ	1..1	Identifier	Business Identifier for research subject in a study Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		1..1	CodeableConcept	Description of identifier Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ANON
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
system		0..1	uri	The namespace for the identifier value
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
id		0..1	string	Unique id for inter-element referencing
extension	N	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	SΣ	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	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
status	?!SΣ	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	SΣC	1..1	Period	Start and end of participation per-1: If present, start SHALL have a lower value than end
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
study	SΣC	1..1	Reference(ResearchStudy)	Study subject is part of ref-1: SHALL have a contained resource if a local reference is provided
individual	SΣC	1..1	Reference(Patient)	Who is part of study ref-1: SHALL have a contained resource if a local reference is provided
assignedArm		0..1	string	What path should be followed
actualArm		0..1	string	What path was followed
consent	SC	1..1	Reference(Consent)	Agreement to participate in study ref-1: SHALL have a contained resource if a local reference is provided
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchSubject.meta.security	extensible	All Security Labels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
ResearchSubject.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
ResearchSubject.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
ResearchSubject.identifier:subjectIdentificationCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchSubject.identifier:subjectIdentificationCode.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1 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 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	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** elements	Must have either extensions or value[x], not both : extension.exists() != value.exists()
per-1	error	ResearchSubject.identifier:subjectIdentificationCode.period, ResearchSubject.period	If present, start SHALL have a lower value than end : start.hasValue().not() or end.hasValue().not() or (start <= end)
ref-1	error	ResearchSubject.identifier:subjectIdentificationCode.assigner, ResearchSubject.study, ResearchSubject.individual, ResearchSubject.consent	SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

This structure is derived from ResearchSubject

Summary

Mandatory: 7 elements
Must-Support: 15 elements

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ResearchSubject.identifier

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-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated 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-6: A resource should have narrative for robust management dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
id	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource ele-1: All FHIR elements must have a @value or children
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to ele-1: All FHIR elements must have a @value or children
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
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored 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
Slices for identifier	SΣ	1..*	Identifier	Business Identifier for research subject in a study Slice: Unordered, Open by pattern:$this ele-1: All FHIR elements must have a @value or children
identifier:subjectIdentificationCode	SΣ	1..1	Identifier	Business Identifier for research subject in a study ele-1: All FHIR elements must have a @value or children Required Pattern: At least the following
type		1..1	CodeableConcept	Description of identifier Fixed Value: (complex)
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ANON
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . ele-1: All FHIR elements must have a @value or children
type	SΣ	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. ele-1: All FHIR elements must have a @value or children
system	SΣ	1..1	uri	The namespace for the identifier value ele-1: All FHIR elements must have a @value or children Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique ele-1: All FHIR elements must have a @value or children Example General: 123456
status	?!SΣ	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
period	SΣC	1..1	Period	Start and end of participation ele-1: All FHIR elements must have a @value or children per-1: If present, start SHALL have a lower value than end
start	SΣC	1..1	dateTime	Starting time with inclusive boundary ele-1: All FHIR elements must have a @value or children
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing ele-1: All FHIR elements must have a @value or children
study	SΣC	1..1	Reference(ResearchStudy)	Study subject is part of ele-1: All FHIR elements must have a @value or children ref-1: SHALL have a contained resource if a local reference is provided
individual	SΣC	1..1	Reference(Patient)	Who is part of study ele-1: All FHIR elements must have a @value or children ref-1: SHALL have a contained resource if a local reference is provided
consent	SC	1..1	Reference(Consent)	Agreement to participate in study ele-1: All FHIR elements must have a @value or children ref-1: SHALL have a contained resource if a local reference is provided
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchSubject.identifier:subjectIdentificationCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchSubject.identifier:subjectIdentificationCode.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1 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 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	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** elements	Must have either extensions or value[x], not both : extension.exists() != value.exists()
per-1	error	ResearchSubject.period	If present, start SHALL have a lower value than end : start.hasValue().not() or end.hasValue().not() or (start <= end)
ref-1	error	ResearchSubject.study, ResearchSubject.individual, ResearchSubject.consent	SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

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
id	S	0..1	id	Logical id of this artifact
meta	S	0..1	Meta	Metadata about the resource
profile	S	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
Slices for identifier	S	1..*	Identifier	Business Identifier for research subject in a study Slice: Unordered, Open by pattern:$this
identifier:subjectIdentificationCode	S	1..1	Identifier	Business Identifier for research subject in a study Required Pattern: At least the following
type		1..1	CodeableConcept	Description of identifier Fixed Value: (complex)
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ANON
type	S	0..1	CodeableConcept	Description of identifier
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
status	S	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
period	S	1..1	Period	Start and end of participation
start	S	1..1	dateTime	Starting time with inclusive boundary
end	S	0..1	dateTime	End time with inclusive boundary, if not ongoing
study	S	1..1	Reference(ResearchStudy)	Study subject is part of
individual	S	1..1	Reference(Patient)	Who is part of study
consent	S	1..1	Reference(Consent)	Agreement to participate in study
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	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	Σ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	SΣ	1..*	Identifier	Business Identifier for research subject in a study Slice: Unordered, Open by pattern:$this
identifier:subjectIdentificationCode	SΣ	1..1	Identifier	Business Identifier for research subject in a study Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
use		0..1	code	usual | official | temp | secondary | old (If known)
type		1..1	CodeableConcept	Description of identifier Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/v2-0203
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: ANON
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
system		0..1	uri	The namespace for the identifier value
value		0..1	string	The value that is unique
period		0..1	Period	Time period when id is/was valid for use
assigner		0..1	Reference(Organization)	Organization that issued id (may be just text)
id		0..1	string	Unique id for inter-element referencing
extension	N	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	SΣ	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	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
status	?!SΣ	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	SΣC	1..1	Period	Start and end of participation per-1: If present, start SHALL have a lower value than end
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
study	SΣC	1..1	Reference(ResearchStudy)	Study subject is part of ref-1: SHALL have a contained resource if a local reference is provided
individual	SΣC	1..1	Reference(Patient)	Who is part of study ref-1: SHALL have a contained resource if a local reference is provided
assignedArm		0..1	string	What path should be followed
actualArm		0..1	string	What path was followed
consent	SC	1..1	Reference(Consent)	Agreement to participate in study ref-1: SHALL have a contained resource if a local reference is provided
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchSubject.meta.security	extensible	All Security Labels http://hl7.org/fhir/ValueSet/security-labels from the FHIR Standard
ResearchSubject.meta.tag	example	CommonTags http://hl7.org/fhir/ValueSet/common-tags from the FHIR Standard
ResearchSubject.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
ResearchSubject.identifier:subjectIdentificationCode.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
ResearchSubject.identifier:subjectIdentificationCode.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
ResearchSubject.status	required	ResearchSubjectStatus http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1 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 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	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** elements	Must have either extensions or value[x], not both : extension.exists() != value.exists()
per-1	error	ResearchSubject.identifier:subjectIdentificationCode.period, ResearchSubject.period	If present, start SHALL have a lower value than end : start.hasValue().not() or end.hasValue().not() or (start <= end)
ref-1	error	ResearchSubject.identifier:subjectIdentificationCode.assigner, ResearchSubject.study, ResearchSubject.individual, ResearchSubject.consent	SHALL have a contained resource if a local reference is provided : reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

This structure is derived from ResearchSubject

Summary

Mandatory: 7 elements
Must-Support: 15 elements

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of ResearchSubject.identifier

Other representations of profile: CSV, Excel, Schematron