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

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Resource Profile: MII PR Studie Studie

This profile describes a study within the Medical Informatics Initiative.

Usages:

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

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:Label	S	0..*	(Complex)	MII EX Studie Backport Label URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
extension:AssociatedParty	S	0..*	(Complex)	MII EX Studie Backport AssociatedParty URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
extension:Ethikvotum	S	0..*	(Complex)	MII EX Studie Ethikvotum URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
extension:Studienregister	S	0..*	Reference(Library)	MII EX Studie Studienregister URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
extension:Eligibility	S	0..1	Reference(Group | EvidenceVariable)	MII EX Studie Eligibility URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
extension:Akronym	S	0..1	string	MII EX Studie Akronym URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
extension:Rekrutierung	S	0..1	(Complex)	MII EX Studie Rekrutierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
extension:Finanzierung	S	0..*	string	MII EX Studie Finanzierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business Identifier for study.
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..1	string	The value that is unique Example General: 123456
title	SΣ	0..1	string	Name for this study.
partOf	SΣ	0..*	Reference(ResearchStudy)	Part of larger study.
status	?!SΣ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
category	SΣ	0..*	CodeableConcept	Classifications for the study. Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions.
text	SΣ	0..1	string	Plain text representation of the concept
keyword	SΣ	0..*	CodeableConcept	Used to search for the study. Binding Description: (example): Words associated with the study that may be useful in discovery.
text	SΣ	0..1	string	Plain text representation of the concept
arm	S	0..*	BackboneElement	Defined path through the study for a subject.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	Label for study arm
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchStudy.status	Base	required	ResearchStudyStatus	📍4.0.1	FHIR Std.
ResearchStudy.category	Base	example		Not State	Unknown
ResearchStudy.focus	Base	example		Not State	Unknown
ResearchStudy.keyword	Base	example		Not State	Unknown

Constraints

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:Label	S	0..*	(Complex)	MII EX Studie Backport Label URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
extension:AssociatedParty	S	0..*	(Complex)	MII EX Studie Backport AssociatedParty URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
extension:Ethikvotum	S	0..*	(Complex)	MII EX Studie Ethikvotum URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
extension:Studienregister	S	0..*	Reference(Library)	MII EX Studie Studienregister URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
extension:Eligibility	S	0..1	Reference(Group | EvidenceVariable)	MII EX Studie Eligibility URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
extension:Akronym	S	0..1	string	MII EX Studie Akronym URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
extension:Rekrutierung	S	0..1	(Complex)	MII EX Studie Rekrutierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
extension:Finanzierung	S	0..*	string	MII EX Studie Finanzierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
identifier	S	0..*	Identifier	Business Identifier for study.
system	S	0..1	uri	The namespace for the identifier value
value	S	0..1	string	The value that is unique
title	S	0..1	string	Name for this study.
partOf	S	0..*	Reference(ResearchStudy)	Part of larger study.
status	S	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
category	S	0..*	CodeableConcept	Classifications for the study.
focus	S	0..*	CodeableConcept	Drugs, devices, etc. under study
text	S	0..1	string	Plain text representation of the concept
keyword	S	0..*	CodeableConcept	Used to search for the study.
text	S	0..1	string	Plain text representation of the concept
arm	S	0..*	BackboneElement	Defined path through the study for a subject.
name	S	1..1	string	Label for study arm
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
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): 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
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:Label	S	0..*	(Complex)	MII EX Studie Backport Label URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
extension:AssociatedParty	S	0..*	(Complex)	MII EX Studie Backport AssociatedParty URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
extension:Ethikvotum	S	0..*	(Complex)	MII EX Studie Ethikvotum URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
extension:Studienregister	S	0..*	Reference(Library)	MII EX Studie Studienregister URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
extension:Eligibility	S	0..1	Reference(Group | EvidenceVariable)	MII EX Studie Eligibility URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
extension:Akronym	S	0..1	string	MII EX Studie Akronym URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
extension:Rekrutierung	S	0..1	(Complex)	MII EX Studie Rekrutierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
extension:Finanzierung	S	0..*	string	MII EX Studie Finanzierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business Identifier for study.
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	Σ	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	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..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)
title	SΣ	0..1	string	Name for this study.
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	SΣ	0..*	Reference(ResearchStudy)	Part of larger study.
status	?!SΣ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category	SΣ	0..*	CodeableConcept	Classifications for the study. Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	SΣ	0..*	CodeableConcept	Used to search for the study. Binding Description: (example): Words associated with the study that may be useful in discovery.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner | PractitionerRole)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note		0..*	Annotation	Comments made about the study
arm	S	0..*	BackboneElement	Defined path through the study for a subject.
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
name	S	1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
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
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
ResearchStudy.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchStudy.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
ResearchStudy.status	Base	required	ResearchStudyStatus	📍4.0.1	FHIR Std.
ResearchStudy.primaryPurposeType	Base	extensible	ResearchStudyPrimaryPurposeType	📍4.0.1	FHIR Std.
ResearchStudy.phase	Base	example	ResearchStudyPhase	📍4.0.1	FHIR Std.
ResearchStudy.category	Base	example		Not State	Unknown
ResearchStudy.focus	Base	example		Not State	Unknown
ResearchStudy.condition	Base	example	Condition/Problem/Diagnosis Codes	📍4.0.1	FHIR Std.
ResearchStudy.keyword	Base	example		Not State	Unknown
ResearchStudy.location	Base	extensible	Jurisdiction	📍4.0.1	FHIR Std.
ResearchStudy.reasonStopped	Base	example	ResearchStudyReasonStopped	📍4.0.1	FHIR Std.
ResearchStudy.objective.​type	Base	preferred	ResearchStudyObjectiveType	📍4.0.1	FHIR Std.

Constraints

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

Summary

Must-Support: 22 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:Label	S	0..*	(Complex)	MII EX Studie Backport Label URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
extension:AssociatedParty	S	0..*	(Complex)	MII EX Studie Backport AssociatedParty URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
extension:Ethikvotum	S	0..*	(Complex)	MII EX Studie Ethikvotum URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
extension:Studienregister	S	0..*	Reference(Library)	MII EX Studie Studienregister URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
extension:Eligibility	S	0..1	Reference(Group | EvidenceVariable)	MII EX Studie Eligibility URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
extension:Akronym	S	0..1	string	MII EX Studie Akronym URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
extension:Rekrutierung	S	0..1	(Complex)	MII EX Studie Rekrutierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
extension:Finanzierung	S	0..*	string	MII EX Studie Finanzierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business Identifier for study.
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..1	string	The value that is unique Example General: 123456
title	SΣ	0..1	string	Name for this study.
partOf	SΣ	0..*	Reference(ResearchStudy)	Part of larger study.
status	?!SΣ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
category	SΣ	0..*	CodeableConcept	Classifications for the study. Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions.
text	SΣ	0..1	string	Plain text representation of the concept
keyword	SΣ	0..*	CodeableConcept	Used to search for the study. Binding Description: (example): Words associated with the study that may be useful in discovery.
text	SΣ	0..1	string	Plain text representation of the concept
arm	S	0..*	BackboneElement	Defined path through the study for a subject.
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	Label for study arm
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchStudy.status	Base	required	ResearchStudyStatus	📍4.0.1	FHIR Std.
ResearchStudy.category	Base	example		Not State	Unknown
ResearchStudy.focus	Base	example		Not State	Unknown
ResearchStudy.keyword	Base	example		Not State	Unknown

Constraints

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:Label	S	0..*	(Complex)	MII EX Studie Backport Label URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
extension:AssociatedParty	S	0..*	(Complex)	MII EX Studie Backport AssociatedParty URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
extension:Ethikvotum	S	0..*	(Complex)	MII EX Studie Ethikvotum URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
extension:Studienregister	S	0..*	Reference(Library)	MII EX Studie Studienregister URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
extension:Eligibility	S	0..1	Reference(Group | EvidenceVariable)	MII EX Studie Eligibility URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
extension:Akronym	S	0..1	string	MII EX Studie Akronym URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
extension:Rekrutierung	S	0..1	(Complex)	MII EX Studie Rekrutierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
extension:Finanzierung	S	0..*	string	MII EX Studie Finanzierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
identifier	S	0..*	Identifier	Business Identifier for study.
system	S	0..1	uri	The namespace for the identifier value
value	S	0..1	string	The value that is unique
title	S	0..1	string	Name for this study.
partOf	S	0..*	Reference(ResearchStudy)	Part of larger study.
status	S	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
category	S	0..*	CodeableConcept	Classifications for the study.
focus	S	0..*	CodeableConcept	Drugs, devices, etc. under study
text	S	0..1	string	Plain text representation of the concept
keyword	S	0..*	CodeableConcept	Used to search for the study.
text	S	0..1	string	Plain text representation of the concept
arm	S	0..*	BackboneElement	Defined path through the study for a subject.
name	S	1..1	string	Label for study arm
Documentation for this format

Snapshot ViewView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
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): 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
Slices for extension	S	0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:Label	S	0..*	(Complex)	MII EX Studie Backport Label URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
extension:AssociatedParty	S	0..*	(Complex)	MII EX Studie Backport AssociatedParty URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
extension:Ethikvotum	S	0..*	(Complex)	MII EX Studie Ethikvotum URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
extension:Studienregister	S	0..*	Reference(Library)	MII EX Studie Studienregister URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
extension:Eligibility	S	0..1	Reference(Group | EvidenceVariable)	MII EX Studie Eligibility URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
extension:Akronym	S	0..1	string	MII EX Studie Akronym URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
extension:Rekrutierung	S	0..1	(Complex)	MII EX Studie Rekrutierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
extension:Finanzierung	S	0..*	string	MII EX Studie Finanzierung URL: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	0..*	Identifier	Business Identifier for study.
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	Σ	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	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	0..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)
title	SΣ	0..1	string	Name for this study.
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	SΣ	0..*	Reference(ResearchStudy)	Part of larger study.
status	?!SΣ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category	SΣ	0..*	CodeableConcept	Classifications for the study. Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	SΣ	0..*	CodeableConcept	Used to search for the study. Binding Description: (example): Words associated with the study that may be useful in discovery.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	SΣ	0..1	string	Plain text representation of the concept
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner | PractitionerRole)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
reasonStopped	Σ	0..1	CodeableConcept	accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
note		0..*	Annotation	Comments made about the study
arm	S	0..*	BackboneElement	Defined path through the study for a subject.
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
name	S	1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
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
name		0..1	string	Label for the objective
type		0..1	CodeableConcept	primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
ResearchStudy.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
ResearchStudy.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
ResearchStudy.status	Base	required	ResearchStudyStatus	📍4.0.1	FHIR Std.
ResearchStudy.primaryPurposeType	Base	extensible	ResearchStudyPrimaryPurposeType	📍4.0.1	FHIR Std.
ResearchStudy.phase	Base	example	ResearchStudyPhase	📍4.0.1	FHIR Std.
ResearchStudy.category	Base	example		Not State	Unknown
ResearchStudy.focus	Base	example		Not State	Unknown
ResearchStudy.condition	Base	example	Condition/Problem/Diagnosis Codes	📍4.0.1	FHIR Std.
ResearchStudy.keyword	Base	example		Not State	Unknown
ResearchStudy.location	Base	extensible	Jurisdiction	📍4.0.1	FHIR Std.
ResearchStudy.reasonStopped	Base	example	ResearchStudyReasonStopped	📍4.0.1	FHIR Std.
ResearchStudy.objective.​type	Base	preferred	ResearchStudyObjectiveType	📍4.0.1	FHIR Std.

Constraints

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

Summary

Must-Support: 22 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label
• http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung
• https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung

Other representations of profile: CSV, Excel, Schematron