Care Coordination Management
0.0.1 - ci-build Estonia (EST)

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

Resource Profile: ResearchStudyCcm

Official URL: http://helex.org/ig/ccm/StructureDefinition/research-study-ccm Version: 0.0.1
Draft as of 2025-12-05 Computable Name: ResearchStudyCcm

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

Usages:

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.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... identifier SΣ 1..* Identifier Business Identifier for study
... title SΣ 1..1 string Name ResearchStudy (in Lithuanian)
.... Slices for extension 0..* Extension Name ResearchStudy (in English)
Slice: Unordered, Open by value:url
..... extension:translation S 0..* (Complex) Language Translation (Localization)
URL: http://hl7.org/fhir/StructureDefinition/translation
... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible Research Study Party Role 📍5.0.0 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍5.0.0 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().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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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 Name ResearchStudy (in Lithuanian)
.... Slices for extension 0..* Extension Name ResearchStudy (in English)
Slice: Unordered, Open by value:url
..... extension:translation S 0..* (Complex) Language Translation (Localization)
URL: http://hl7.org/fhir/StructureDefinition/translation
... label 0..0 Additional names for the study
... protocol 0..0 Steps followed in executing study
... partOf 0..0 Part of larger study
... relatedArtifact 0..0 References, URLs, and attachments
... primaryPurposeType 0..0 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... phase 0..0 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
... studyDesign 0..0 Classifications of the study design characteristics
... focus 0..0 Drugs, devices, etc. under study
... condition 0..0 Condition being studied
... keyword 0..0 Used to search for the study
... region 0..0 Geographic area for the study
... descriptionSummary 0..0 Brief text explaining the study
... description 0..0 Detailed narrative of the study
... period 0..0 When the study began and ended
... site 0..0 Facility where study activities are conducted
... note 0..0 Comments made about the study
... classifier 0..0 Classification for the study
... 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 Status of study with time for that status
... whyStopped 0..0 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
... recruitment 0..0 Target or actual group of participants enrolled in study
... comparisonGroup 0..0 Defined path through the study for a subject
... objective 0..0 A goal for the study
... outcomeMeasure 0..0 A variable measured during the study
... result 0..0 Link to results generated during the study

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... 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 Name ResearchStudy (in Lithuanian)
.... id 0..1 string xml:id (or equivalent in JSON)
.... Slices for extension 0..* Extension Name ResearchStudy (in English)
Slice: Unordered, Open by value:url
..... extension:translation S 0..* (Complex) Language Translation (Localization)
URL: http://hl7.org/fhir/StructureDefinition/translation
.... value 0..1 string Primitive value for string
Max Length:1048576
... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base required All Languages 📍5.0.0 FHIR Std.
ResearchStudy.label.​type Base extensible Title Type 📍5.0.0 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible Research Study Party Role 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​classifier Base example Research Study Party Organization Type 📍5.0.0 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍5.0.0 FHIR Std.
ResearchStudy.comparisonGroup.​type Base extensible Research Study Arm Type 📍5.0.0 FHIR Std.
ResearchStudy.objective.​type Base preferred Research Study Objective Type 📍5.0.0 FHIR Std.
ResearchStudy.outcomeMeasure.​type Base preferred Research Study Objective Type 📍5.0.0 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().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: 8 elements
Prohibited: 24 elements

Extensions

This structure refers to these extensions:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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)
... identifier SΣ 1..* Identifier Business Identifier for study
... title SΣ 1..1 string Name ResearchStudy (in Lithuanian)
.... Slices for extension 0..* Extension Name ResearchStudy (in English)
Slice: Unordered, Open by value:url
..... extension:translation S 0..* (Complex) Language Translation (Localization)
URL: http://hl7.org/fhir/StructureDefinition/translation
... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible Research Study Party Role 📍5.0.0 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍5.0.0 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().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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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 Name ResearchStudy (in Lithuanian)
.... Slices for extension 0..* Extension Name ResearchStudy (in English)
Slice: Unordered, Open by value:url
..... extension:translation S 0..* (Complex) Language Translation (Localization)
URL: http://hl7.org/fhir/StructureDefinition/translation
... label 0..0 Additional names for the study
... protocol 0..0 Steps followed in executing study
... partOf 0..0 Part of larger study
... relatedArtifact 0..0 References, URLs, and attachments
... primaryPurposeType 0..0 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... phase 0..0 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
... studyDesign 0..0 Classifications of the study design characteristics
... focus 0..0 Drugs, devices, etc. under study
... condition 0..0 Condition being studied
... keyword 0..0 Used to search for the study
... region 0..0 Geographic area for the study
... descriptionSummary 0..0 Brief text explaining the study
... description 0..0 Detailed narrative of the study
... period 0..0 When the study began and ended
... site 0..0 Facility where study activities are conducted
... note 0..0 Comments made about the study
... classifier 0..0 Classification for the study
... 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 Status of study with time for that status
... whyStopped 0..0 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
... recruitment 0..0 Target or actual group of participants enrolled in study
... comparisonGroup 0..0 Defined path through the study for a subject
... objective 0..0 A goal for the study
... outcomeMeasure 0..0 A variable measured during the study
... result 0..0 Link to results generated during the study

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
... 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 Name ResearchStudy (in Lithuanian)
.... id 0..1 string xml:id (or equivalent in JSON)
.... Slices for extension 0..* Extension Name ResearchStudy (in English)
Slice: Unordered, Open by value:url
..... extension:translation S 0..* (Complex) Language Translation (Localization)
URL: http://hl7.org/fhir/StructureDefinition/translation
.... value 0..1 string Primitive value for string
Max Length:1048576
... 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)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base required All Languages 📍5.0.0 FHIR Std.
ResearchStudy.label.​type Base extensible Title Type 📍5.0.0 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible Research Study Party Role 📍5.0.0 FHIR Std.
ResearchStudy.associatedParty.​classifier Base example Research Study Party Organization Type 📍5.0.0 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍5.0.0 FHIR Std.
ResearchStudy.comparisonGroup.​type Base extensible Research Study Arm Type 📍5.0.0 FHIR Std.
ResearchStudy.objective.​type Base preferred Research Study Objective Type 📍5.0.0 FHIR Std.
ResearchStudy.outcomeMeasure.​type Base preferred Research Study Objective Type 📍5.0.0 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().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: 8 elements
Prohibited: 24 elements

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron