Care Coordination Management, published by Helex OÜ. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/helexlab/ig-ccm/ and changes regularly. See the Directory of published versions

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Resource Profile: Ccm Research Study

A localized profile of ResearchStudy for use in Estonian clinical research settings.

Usages:

• Examples for this Profile: ResearchStudy/ccm-research-study-example

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    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
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:location		0..*	Coding	ADS ADR-ID extension URL: https://fhir.ee/base/StructureDefinition/ee-ads-adr-id Binding: ADS AdrId (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Business Identifier for study
title	SΣ	1..1	string	Human readable name of the study
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
associatedParty	S	0..*	BackboneElement	Sponsors, collaborators, and other parties
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	Name of associated party
role	S	1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc.
period	S	1..1	Period	When active in the role
party	S	1..1	Reference(Practitioner)	Individual or organization associated with study (use practitionerRole to specify their organisation)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard
ResearchStudy.associatedParty.role	extensible	ResearchStudyPartyRole http://hl7.org/fhir/ValueSet/research-study-party-role From the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status From the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:location		0..*	Coding	ADS ADR-ID extension URL: https://fhir.ee/base/StructureDefinition/ee-ads-adr-id Binding: ADS AdrId (required)
identifier	S	1..*	Identifier	Business Identifier for study
title	S	1..1	string	Human readable name of the study
label		0..0
protocol		0..0
partOf		0..0
relatedArtifact		0..0
primaryPurposeType		0..0
phase		0..0
studyDesign		0..0
focus		0..0
condition		0..0
keyword		0..0
region		0..0
descriptionSummary		0..0
description		0..0
period		0..0
site		0..0
note		0..0
classifier		0..0
associatedParty	S	0..*	BackboneElement	Sponsors, collaborators, and other parties
name	S	1..1	string	Name of associated party
role	S	1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
period	S	1..1	Period	When active in the role
party	S	1..1	Reference(Practitioner)	Individual or organization associated with study (use practitionerRole to specify their organisation)
progressStatus		0..0
whyStopped		0..0
recruitment		0..0
comparisonGroup		0..0
objective		0..0
outcomeMeasure		0..0
result		0..0
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
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		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:location		0..*	Coding	ADS ADR-ID extension URL: https://fhir.ee/base/StructureDefinition/ee-ads-adr-id Binding: ADS AdrId (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url		0..1	uri	Canonical identifier for this study resource
identifier	SΣ	1..*	Identifier	Business Identifier for study
version		0..1	string	The business version for the study record
name		0..1	string	Name for this study (computer friendly)
title	SΣ	1..1	string	Human readable name of the study
date		0..1	dateTime	Date the resource last changed
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
associatedParty	S	0..*	BackboneElement	Sponsors, collaborators, and other parties
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	Name of associated party
role	S	1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc.
period	S	1..1	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party	S	1..1	Reference(Practitioner)	Individual or organization associated with study (use practitionerRole to specify their organisation)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
ResearchStudy.label.type	extensible	TitleType http://hl7.org/fhir/ValueSet/title-type From the FHIR Standard
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard
ResearchStudy.associatedParty.role	extensible	ResearchStudyPartyRole http://hl7.org/fhir/ValueSet/research-study-party-role From the FHIR Standard
ResearchStudy.associatedParty.classifier	example	ResearchStudyPartyOrgType http://hl7.org/fhir/ValueSet/research-study-party-organization-type From the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status From the FHIR Standard
ResearchStudy.comparisonGroup.type	extensible	ResearchStudyArmType http://hl7.org/fhir/ValueSet/research-study-arm-type From the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard
ResearchStudy.outcomeMeasure.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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: 2 elements(3 nested mandatory elements)
Must-Support: 7 elements
Prohibited: 24 elements

Extensions

This structure refers to these extensions:

• https://fhir.ee/base/StructureDefinition/ee-ads-adr-id

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
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:location		0..*	Coding	ADS ADR-ID extension URL: https://fhir.ee/base/StructureDefinition/ee-ads-adr-id Binding: ADS AdrId (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Business Identifier for study
title	SΣ	1..1	string	Human readable name of the study
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
associatedParty	S	0..*	BackboneElement	Sponsors, collaborators, and other parties
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name	S	1..1	string	Name of associated party
role	S	1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc.
period	S	1..1	Period	When active in the role
party	S	1..1	Reference(Practitioner)	Individual or organization associated with study (use practitionerRole to specify their organisation)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard
ResearchStudy.associatedParty.role	extensible	ResearchStudyPartyRole http://hl7.org/fhir/ValueSet/research-study-party-role From the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status From the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:location		0..*	Coding	ADS ADR-ID extension URL: https://fhir.ee/base/StructureDefinition/ee-ads-adr-id Binding: ADS AdrId (required)
identifier	S	1..*	Identifier	Business Identifier for study
title	S	1..1	string	Human readable name of the study
label		0..0
protocol		0..0
partOf		0..0
relatedArtifact		0..0
primaryPurposeType		0..0
phase		0..0
studyDesign		0..0
focus		0..0
condition		0..0
keyword		0..0
region		0..0
descriptionSummary		0..0
description		0..0
period		0..0
site		0..0
note		0..0
classifier		0..0
associatedParty	S	0..*	BackboneElement	Sponsors, collaborators, and other parties
name	S	1..1	string	Name of associated party
role	S	1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
period	S	1..1	Period	When active in the role
party	S	1..1	Reference(Practitioner)	Individual or organization associated with study (use practitionerRole to specify their organisation)
progressStatus		0..0
whyStopped		0..0
recruitment		0..0
comparisonGroup		0..0
objective		0..0
outcomeMeasure		0..0
result		0..0
Documentation for this format

Snapshot View

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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
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		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:location		0..*	Coding	ADS ADR-ID extension URL: https://fhir.ee/base/StructureDefinition/ee-ads-adr-id Binding: ADS AdrId (required)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url		0..1	uri	Canonical identifier for this study resource
identifier	SΣ	1..*	Identifier	Business Identifier for study
version		0..1	string	The business version for the study record
name		0..1	string	Name for this study (computer friendly)
title	SΣ	1..1	string	Human readable name of the study
date		0..1	dateTime	Date the resource last changed
status	?!Σ	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
associatedParty	S	0..*	BackboneElement	Sponsors, collaborators, and other parties
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	Name of associated party
role	S	1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair Binding: ResearchStudyPartyRole (extensible): desc.
period	S	1..1	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party	S	1..1	Reference(Practitioner)	Individual or organization associated with study (use practitionerRole to specify their organisation)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard
ResearchStudy.label.type	extensible	TitleType http://hl7.org/fhir/ValueSet/title-type From the FHIR Standard
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|5.0.0 From the FHIR Standard
ResearchStudy.associatedParty.role	extensible	ResearchStudyPartyRole http://hl7.org/fhir/ValueSet/research-study-party-role From the FHIR Standard
ResearchStudy.associatedParty.classifier	example	ResearchStudyPartyOrgType http://hl7.org/fhir/ValueSet/research-study-party-organization-type From the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status From the FHIR Standard
ResearchStudy.comparisonGroup.type	extensible	ResearchStudyArmType http://hl7.org/fhir/ValueSet/research-study-arm-type From the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard
ResearchStudy.outcomeMeasure.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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: 2 elements(3 nested mandatory elements)
Must-Support: 7 elements
Prohibited: 24 elements

Extensions

This structure refers to these extensions:

• https://fhir.ee/base/StructureDefinition/ee-ads-adr-id

Other representations of profile: CSV, Excel, Schematron