This page is part of the MII Implementation Guide Medizinisches Forschungsvorhaben (v2027.0.0-ballot: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

• Inhalt
• Detaillierte Beschreibungen
• Mappings
• Beispiele
• XML
• JSON

Ressourcenprofil: MII PR Studie Proband

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

Usages:

• Refer to this Profile: MII PR Studie Studieneinschluss Anfrage
• Examples for this Profile: ResearchSubject/mii-exa-studie-proband
• CapabilityStatements using this Profile: MII CPS Metadata Studie

You can also check for usages in the FHIR IG Statistics

Formale Ansichten des Profilinhalts

Beschreibung von Profilen, Differentials, Snapshots und deren Repräsentationen.

• Schlüsselelemente-Tabelle
• Differential-Tabelle
• Snapshot-Tabelle
• Statistiken/Referenzen
• Alle

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	1..*	Identifier	Identifier des Probanden. 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
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)
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. 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	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
status	?!SΣ	1..1	code	Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
period	SΣ	1..1	Period	Anfang und Ende der Teilnahme
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
study	SΣ	1..1	Reference(ResearchStudy)	Studie, der der Proband angehört
individual	SΣ	1..1	Reference(Patient)	Wer an der Studie teilnimmt.
consent	S	1..1	Reference(Consent)	Einverständnis zur Studienteilnahme
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.identifier:subjectIdentificationCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.0.1	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 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** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Diese Struktur ist abgeleitet von ResearchSubject

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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	Identifier des Probanden. 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	S	0..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
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	Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen
period	S	1..1	Period	Anfang und Ende der Teilnahme
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)	Studie, der der Proband angehört
individual	S	1..1	Reference(Patient)	Wer an der Studie teilnimmt.
consent	S	1..1	Reference(Consent)	Einverständnis zur Studienteilnahme
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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		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 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
Slices for identifier	SΣ	1..*	Identifier	Identifier des Probanden. 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 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. 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	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	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)
status	?!SΣ	1..1	code	Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
period	SΣ	1..1	Period	Anfang und Ende der Teilnahme
id		0..1	string	Unique id for inter-element referencing
extension		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	SΣ	1..1	Reference(ResearchStudy)	Studie, der der Proband angehört
individual	SΣ	1..1	Reference(Patient)	Wer an der Studie teilnimmt.
assignedArm		0..1	string	What path should be followed
actualArm		0..1	string	What path was followed
consent	S	1..1	Reference(Consent)	Einverständnis zur Studienteilnahme
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.meta.​security	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
ResearchSubject.meta.​tag	Base	example	Common Tags	📍4.0.1	FHIR Std.
ResearchSubject.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.0.1	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 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** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Diese Struktur ist abgeleitet von 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

Schlüsselelemente-Ansicht

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	1..*	Identifier	Identifier des Probanden. 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
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)
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. 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	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
status	?!SΣ	1..1	code	Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
period	SΣ	1..1	Period	Anfang und Ende der Teilnahme
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
study	SΣ	1..1	Reference(ResearchStudy)	Studie, der der Proband angehört
individual	SΣ	1..1	Reference(Patient)	Wer an der Studie teilnimmt.
consent	S	1..1	Reference(Consent)	Einverständnis zur Studienteilnahme
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.identifier:subjectIdentificationCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.0.1	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 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** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Differential-Ansicht

Diese Struktur ist abgeleitet von ResearchSubject

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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	Identifier des Probanden. 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	S	0..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
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	Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen
period	S	1..1	Period	Anfang und Ende der Teilnahme
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)	Studie, der der Proband angehört
individual	S	1..1	Reference(Patient)	Wer an der Studie teilnimmt.
consent	S	1..1	Reference(Consent)	Einverständnis zur Studienteilnahme
Documentation for this format

Snapshot-AnsichtView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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		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 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
Slices for identifier	SΣ	1..*	Identifier	Identifier des Probanden. 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 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. 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	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	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)
status	?!SΣ	1..1	code	Kandidat | geeignet | Nachverfolgung | ungeeignet | nicht registriert | außer Studie | in Studie | Studienintervention in Studie | Studienbeobachtung in Studie | ausstehend in Studie | potenzieller Kandidat | Screening | zurückgezogen Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study.
period	SΣ	1..1	Period	Anfang und Ende der Teilnahme
id		0..1	string	Unique id for inter-element referencing
extension		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	SΣ	1..1	Reference(ResearchStudy)	Studie, der der Proband angehört
individual	SΣ	1..1	Reference(Patient)	Wer an der Studie teilnimmt.
assignedArm		0..1	string	What path should be followed
actualArm		0..1	string	What path was followed
consent	S	1..1	Reference(Consent)	Einverständnis zur Studienteilnahme
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchSubject.meta.​security	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
ResearchSubject.meta.​tag	Base	example	Common Tags	📍4.0.1	FHIR Std.
ResearchSubject.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchSubject.identifier:subjectIdentificationCode.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
ResearchSubject.status	Base	required	ResearchSubjectStatus	📍4.0.1	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 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** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()

Diese Struktur ist abgeleitet von 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

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