German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: Profile Clinical Study

Profile to describe a clinical study in which a patient takes part.

Usage:

• Examples for this Resource Profile: ResearchStudy/ExampleStudyNapkonCovidom and ResearchStudy/ExampleStudyRAAINBOW

Formal Views of Profile Content

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

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

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for identifier	S	0..*	Identifier	Business Identifier for study Slice: Unordered, Open by pattern:$this
identifier:eudraCT		0..1	Identifier	Eudra CT Number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.clinicaltrialsregister.eu
system	S	1..1	uri	The namespace for the identifier value Required Pattern: https://www.clinicaltrialsregister.eu
value	S	1..1	string	The value that is unique
identifier:NCT		0..1	Identifier	NCT number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://clinicaltrials.gov
system	S	1..1	uri	The namespace for the identifier value Required Pattern: http://clinicaltrials.gov
value	S	1..1	string	The value that is unique
identifier:PMID		0..1	Identifier	Pubmed ID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
system	S	1..1	uri	The namespace for the identifier value Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
value	S	1..1	string	The value that is unique
identifier:DOI		0..1	Identifier	Digital Object Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://doi.org
system	S	1..1	uri	The namespace for the identifier value Required Pattern: https://doi.org
value	S	1..1	string	The value that is unique
identifier:URI		0..1	Identifier	Uniform Resource Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:ietf:rfc:3986
system	S	1..1	uri	The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value	S	1..1	string	The value that is unique
identifier:DRKS		0..1	Identifier	Deusches Register Klinischer Studien Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.drks.de
system	S	1..1	uri	The namespace for the identifier value Required Pattern: https://www.drks.de
value	S	1..1	string	The value that is unique
title	S	0..1	string	Name for this 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
primaryPurposeType	S	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
phase		1..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 (required)
Slices for category	S	1..*	CodeableConcept	Classifications for the study Slice: Unordered, Open by pattern:$this
category:studyCategory	S	1..1	CodeableConcept	Classifications for the study Binding: ValueSet Studienkategorien NCIt (required)
category:studyDesign	S	0..*	CodeableConcept	Classifications for the study Binding: ValueSet Studiendesign NCIt (required)
category:typeOfBlinding	S	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Blinding NCIt (required)
category:typeOfRandomization	S	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Randomization NCIt (required)
focus	S	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: ValueSet Study Focus NCIt (extensible)
arm	S	0..*	BackboneElement	Defined path through the study for a subject
type	S	0..1	CodeableConcept	Categorization of study arm Binding: ValueSet Type of Study Arm NCIt (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ResearchStudy.phase	required	ResearchStudyPhase
ResearchStudy.category:studyCategory	required	VS_Studienkategorien_NCIT
ResearchStudy.category:studyDesign	required	VS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlinding	required	VS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomization	required	VS_TypeOfRandomization_NCIT
ResearchStudy.focus	extensible	VS_StudyFocus_NCIT
ResearchStudy.arm.type	required	VS_TypeOfStudyArm_NCIT

Name	Flags	Card.	Type	Description & Constraints
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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	0..*	Identifier	Business Identifier for study Slice: Unordered, Open by pattern:$this
identifier:eudraCT	Σ	0..1	Identifier	Eudra CT Number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.clinicaltrialsregister.eu
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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.clinicaltrialsregister.eu
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:NCT	Σ	0..1	Identifier	NCT number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://clinicaltrials.gov
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	1..1	uri	The namespace for the identifier value Required Pattern: http://clinicaltrials.gov
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:PMID	Σ	0..1	Identifier	Pubmed ID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
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	1..1	uri	The namespace for the identifier value Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:DOI	Σ	0..1	Identifier	Digital Object Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://doi.org
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	1..1	uri	The namespace for the identifier value Required Pattern: https://doi.org
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:URI	Σ	0..1	Identifier	Uniform Resource Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:ietf:rfc:3986
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	1..1	uri	The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:DRKS	Σ	0..1	Identifier	Deusches Register Klinischer Studien Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.drks.de
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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.drks.de
value	SΣ	1..1	string	The value that is unique Example General: 123456
title	SΣ	0..1	string	Name for this 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	SΣ	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	1..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 (required)
Slices for category	SΣ	1..*	CodeableConcept	Classifications for the study Slice: Unordered, Open by pattern:$this Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
category:studyCategory	SΣ	1..1	CodeableConcept	Classifications for the study Binding: ValueSet Studienkategorien NCIt (required)
category:studyDesign	SΣ	0..*	CodeableConcept	Classifications for the study Binding: ValueSet Studiendesign NCIt (required)
category:typeOfBlinding	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Blinding NCIt (required)
category:typeOfRandomization	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Randomization NCIt (required)
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: ValueSet Study Focus NCIt (extensible)
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		1..1	string	Label for study arm
type	S	0..1	CodeableConcept	Categorization of study arm Binding: ValueSet Type of Study Arm NCIt (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ResearchStudy.identifier:eudraCT.use	required	IdentifierUse
ResearchStudy.identifier:NCT.use	required	IdentifierUse
ResearchStudy.identifier:PMID.use	required	IdentifierUse
ResearchStudy.identifier:DOI.use	required	IdentifierUse
ResearchStudy.identifier:URI.use	required	IdentifierUse
ResearchStudy.identifier:DRKS.use	required	IdentifierUse
ResearchStudy.status	required	ResearchStudyStatus
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType
ResearchStudy.phase	required	ResearchStudyPhase
ResearchStudy.category	example
ResearchStudy.category:studyCategory	required	VS_Studienkategorien_NCIT
ResearchStudy.category:studyDesign	required	VS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlinding	required	VS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomization	required	VS_TypeOfRandomization_NCIT
ResearchStudy.focus	extensible	VS_StudyFocus_NCIT
ResearchStudy.arm.type	required	VS_TypeOfStudyArm_NCIT

Constraints

Id	Grade	Path(s)	Details	Requirements
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
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
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	0..*	Identifier	Business Identifier for study Slice: Unordered, Open by pattern:$this
identifier:eudraCT	Σ	0..1	Identifier	Eudra CT Number 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.clinicaltrialsregister.eu
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		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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.clinicaltrialsregister.eu
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)
identifier:NCT	Σ	0..1	Identifier	NCT number 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: http://clinicaltrials.gov
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		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	1..1	uri	The namespace for the identifier value Required Pattern: http://clinicaltrials.gov
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)
identifier:PMID	Σ	0..1	Identifier	Pubmed ID 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
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		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	1..1	uri	The namespace for the identifier value Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
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)
identifier:DOI	Σ	0..1	Identifier	Digital Object Identifier 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://doi.org
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		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	1..1	uri	The namespace for the identifier value Required Pattern: https://doi.org
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)
identifier:URI	Σ	0..1	Identifier	Uniform Resource Identifier 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:ietf:rfc:3986
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		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	1..1	uri	The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
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)
identifier:DRKS	Σ	0..1	Identifier	Deusches Register Klinischer Studien 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.drks.de
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		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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.drks.de
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)
title	SΣ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	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	SΣ	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	1..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 (required)
Slices for category	SΣ	1..*	CodeableConcept	Classifications for the study Slice: Unordered, Open by pattern:$this Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
category:studyCategory	SΣ	1..1	CodeableConcept	Classifications for the study Binding: ValueSet Studienkategorien NCIt (required)
category:studyDesign	SΣ	0..*	CodeableConcept	Classifications for the study Binding: ValueSet Studiendesign NCIt (required)
category:typeOfBlinding	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Blinding NCIt (required)
category:typeOfRandomization	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Randomization NCIt (required)
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: ValueSet Study Focus NCIt (extensible)
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	Σ	0..*	CodeableConcept	Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
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		1..1	string	Label for study arm
type	S	0..1	CodeableConcept	Categorization of study arm Binding: ValueSet Type of Study Arm NCIt (required)
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	Conformance	ValueSet
ResearchStudy.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
ResearchStudy.identifier:eudraCT.use	required	IdentifierUse
ResearchStudy.identifier:eudraCT.type	extensible	Identifier Type Codes
ResearchStudy.identifier:NCT.use	required	IdentifierUse
ResearchStudy.identifier:NCT.type	extensible	Identifier Type Codes
ResearchStudy.identifier:PMID.use	required	IdentifierUse
ResearchStudy.identifier:PMID.type	extensible	Identifier Type Codes
ResearchStudy.identifier:DOI.use	required	IdentifierUse
ResearchStudy.identifier:DOI.type	extensible	Identifier Type Codes
ResearchStudy.identifier:URI.use	required	IdentifierUse
ResearchStudy.identifier:URI.type	extensible	Identifier Type Codes
ResearchStudy.identifier:DRKS.use	required	IdentifierUse
ResearchStudy.identifier:DRKS.type	extensible	Identifier Type Codes
ResearchStudy.status	required	ResearchStudyStatus
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType
ResearchStudy.phase	required	ResearchStudyPhase
ResearchStudy.category	example
ResearchStudy.category:studyCategory	required	VS_Studienkategorien_NCIT
ResearchStudy.category:studyDesign	required	VS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlinding	required	VS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomization	required	VS_TypeOfRandomization_NCIT
ResearchStudy.focus	extensible	VS_StudyFocus_NCIT
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped
ResearchStudy.arm.type	required	VS_TypeOfStudyArm_NCIT
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

This structure is derived from ResearchStudy

Summary

Mandatory: 3 elements (12 nested mandatory elements)
Must-Support: 24 elements

Slices

This structure defines the following Slices:

• The element ResearchStudy.identifier is sliced based on the value of pattern:$this
• The element ResearchStudy.category is sliced based on the value of pattern:$this

Differential View

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for identifier	S	0..*	Identifier	Business Identifier for study Slice: Unordered, Open by pattern:$this
identifier:eudraCT		0..1	Identifier	Eudra CT Number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.clinicaltrialsregister.eu
system	S	1..1	uri	The namespace for the identifier value Required Pattern: https://www.clinicaltrialsregister.eu
value	S	1..1	string	The value that is unique
identifier:NCT		0..1	Identifier	NCT number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://clinicaltrials.gov
system	S	1..1	uri	The namespace for the identifier value Required Pattern: http://clinicaltrials.gov
value	S	1..1	string	The value that is unique
identifier:PMID		0..1	Identifier	Pubmed ID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
system	S	1..1	uri	The namespace for the identifier value Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
value	S	1..1	string	The value that is unique
identifier:DOI		0..1	Identifier	Digital Object Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://doi.org
system	S	1..1	uri	The namespace for the identifier value Required Pattern: https://doi.org
value	S	1..1	string	The value that is unique
identifier:URI		0..1	Identifier	Uniform Resource Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:ietf:rfc:3986
system	S	1..1	uri	The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value	S	1..1	string	The value that is unique
identifier:DRKS		0..1	Identifier	Deusches Register Klinischer Studien Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.drks.de
system	S	1..1	uri	The namespace for the identifier value Required Pattern: https://www.drks.de
value	S	1..1	string	The value that is unique
title	S	0..1	string	Name for this 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
primaryPurposeType	S	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
phase		1..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 (required)
Slices for category	S	1..*	CodeableConcept	Classifications for the study Slice: Unordered, Open by pattern:$this
category:studyCategory	S	1..1	CodeableConcept	Classifications for the study Binding: ValueSet Studienkategorien NCIt (required)
category:studyDesign	S	0..*	CodeableConcept	Classifications for the study Binding: ValueSet Studiendesign NCIt (required)
category:typeOfBlinding	S	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Blinding NCIt (required)
category:typeOfRandomization	S	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Randomization NCIt (required)
focus	S	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: ValueSet Study Focus NCIt (extensible)
arm	S	0..*	BackboneElement	Defined path through the study for a subject
type	S	0..1	CodeableConcept	Categorization of study arm Binding: ValueSet Type of Study Arm NCIt (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
ResearchStudy.phase	required	ResearchStudyPhase
ResearchStudy.category:studyCategory	required	VS_Studienkategorien_NCIT
ResearchStudy.category:studyDesign	required	VS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlinding	required	VS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomization	required	VS_TypeOfRandomization_NCIT
ResearchStudy.focus	extensible	VS_StudyFocus_NCIT
ResearchStudy.arm.type	required	VS_TypeOfStudyArm_NCIT

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
Slices for identifier	SΣ	0..*	Identifier	Business Identifier for study Slice: Unordered, Open by pattern:$this
identifier:eudraCT	Σ	0..1	Identifier	Eudra CT Number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.clinicaltrialsregister.eu
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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.clinicaltrialsregister.eu
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:NCT	Σ	0..1	Identifier	NCT number Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://clinicaltrials.gov
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	1..1	uri	The namespace for the identifier value Required Pattern: http://clinicaltrials.gov
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:PMID	Σ	0..1	Identifier	Pubmed ID Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
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	1..1	uri	The namespace for the identifier value Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:DOI	Σ	0..1	Identifier	Digital Object Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://doi.org
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	1..1	uri	The namespace for the identifier value Required Pattern: https://doi.org
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:URI	Σ	0..1	Identifier	Uniform Resource Identifier Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:ietf:rfc:3986
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	1..1	uri	The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value	SΣ	1..1	string	The value that is unique Example General: 123456
identifier:DRKS	Σ	0..1	Identifier	Deusches Register Klinischer Studien Required Pattern: At least the following
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.drks.de
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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.drks.de
value	SΣ	1..1	string	The value that is unique Example General: 123456
title	SΣ	0..1	string	Name for this 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	SΣ	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	1..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 (required)
Slices for category	SΣ	1..*	CodeableConcept	Classifications for the study Slice: Unordered, Open by pattern:$this Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
category:studyCategory	SΣ	1..1	CodeableConcept	Classifications for the study Binding: ValueSet Studienkategorien NCIt (required)
category:studyDesign	SΣ	0..*	CodeableConcept	Classifications for the study Binding: ValueSet Studiendesign NCIt (required)
category:typeOfBlinding	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Blinding NCIt (required)
category:typeOfRandomization	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Randomization NCIt (required)
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: ValueSet Study Focus NCIt (extensible)
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		1..1	string	Label for study arm
type	S	0..1	CodeableConcept	Categorization of study arm Binding: ValueSet Type of Study Arm NCIt (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
ResearchStudy.identifier:eudraCT.use	required	IdentifierUse
ResearchStudy.identifier:NCT.use	required	IdentifierUse
ResearchStudy.identifier:PMID.use	required	IdentifierUse
ResearchStudy.identifier:DOI.use	required	IdentifierUse
ResearchStudy.identifier:URI.use	required	IdentifierUse
ResearchStudy.identifier:DRKS.use	required	IdentifierUse
ResearchStudy.status	required	ResearchStudyStatus
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType
ResearchStudy.phase	required	ResearchStudyPhase
ResearchStudy.category	example
ResearchStudy.category:studyCategory	required	VS_Studienkategorien_NCIT
ResearchStudy.category:studyDesign	required	VS_Studiendesign_NCIT
ResearchStudy.category:typeOfBlinding	required	VS_TypeOfBlinding_NCIT
ResearchStudy.category:typeOfRandomization	required	VS_TypeOfRandomization_NCIT
ResearchStudy.focus	extensible	VS_StudyFocus_NCIT
ResearchStudy.arm.type	required	VS_TypeOfStudyArm_NCIT

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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
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	0..*	Identifier	Business Identifier for study Slice: Unordered, Open by pattern:$this
identifier:eudraCT	Σ	0..1	Identifier	Eudra CT Number 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.clinicaltrialsregister.eu
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		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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.clinicaltrialsregister.eu
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)
identifier:NCT	Σ	0..1	Identifier	NCT number 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: http://clinicaltrials.gov
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		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	1..1	uri	The namespace for the identifier value Required Pattern: http://clinicaltrials.gov
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)
identifier:PMID	Σ	0..1	Identifier	Pubmed ID 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: http://www.ncbi.nlm.nih.gov/pubmed
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		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	1..1	uri	The namespace for the identifier value Required Pattern: http://www.ncbi.nlm.nih.gov/pubmed
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)
identifier:DOI	Σ	0..1	Identifier	Digital Object Identifier 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://doi.org
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		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	1..1	uri	The namespace for the identifier value Required Pattern: https://doi.org
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)
identifier:URI	Σ	0..1	Identifier	Uniform Resource Identifier 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: urn:ietf:rfc:3986
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		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	1..1	uri	The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
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)
identifier:DRKS	Σ	0..1	Identifier	Deusches Register Klinischer Studien 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		0..1	CodeableConcept	Description of identifier
system		1..1	uri	The namespace for the identifier value Fixed Value: https://www.drks.de
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		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	1..1	uri	The namespace for the identifier value Required Pattern: https://www.drks.de
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)
title	SΣ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	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	SΣ	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	1..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 (required)
Slices for category	SΣ	1..*	CodeableConcept	Classifications for the study Slice: Unordered, Open by pattern:$this Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
category:studyCategory	SΣ	1..1	CodeableConcept	Classifications for the study Binding: ValueSet Studienkategorien NCIt (required)
category:studyDesign	SΣ	0..*	CodeableConcept	Classifications for the study Binding: ValueSet Studiendesign NCIt (required)
category:typeOfBlinding	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Blinding NCIt (required)
category:typeOfRandomization	SΣ	0..1	CodeableConcept	Classifications for the study Binding: ValueSet Type of Randomization NCIt (required)
focus	SΣ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: ValueSet Study Focus NCIt (extensible)
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	Σ	0..*	CodeableConcept	Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
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		1..1	string	Label for study arm
type	S	0..1	CodeableConcept	Categorization of study arm Binding: ValueSet Type of Study Arm NCIt (required)
description		0..1	string	Short explanation of study path