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: ResearchSubjectCcm

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

CCM ResearchSubject profile linking a patient with a ResearchStudy and tracking lifecycle via progress entries.

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
.. ResearchSubject 0..* ResearchSubject Participant or object which is the recipient of investigative activities in a study
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... progress S 0..* BackboneElement Subject status
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type S 1..1 CodeableConcept state | milestone
Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 0..1 uri Identity of the terminology system
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: state
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... subjectState S 1..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectState (required)
.... startDate S 1..1 dateTime State change date
.... endDate S 0..1 dateTime State change date
... period SΣ 1..1 Period Start and end of participation
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudyCcm) Study subject is part of
... subject SΣ 1..1 Reference(PatientCcm) Who or what is part of study
... consent S 0..* Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchSubject.progress.​type Base example Research Subject State Type 📍5.0.0 FHIR Std.
ResearchSubject.progress.​subjectState Base required Research Subject State 📦5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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 ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchSubject

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Participant or object which is the recipient of investigative activities in a study
... identifier S 0..* Identifier Business Identifier for research subject in a study
... status S 1..1 code draft | active | retired | unknown
... progress S 0..* BackboneElement Subject status
.... type S 1..1 CodeableConcept state | milestone
Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: state
.... subjectState S 1..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectState (required)
.... milestone 0..0 SignedUp | Screened | Randomized
.... reason 0..0 State change reason
.... startDate S 1..1 dateTime State change date
.... endDate S 0..1 dateTime State change date
.... start S 1..1 dateTime Starting time with inclusive boundary
.... end S 0..1 dateTime End time with inclusive boundary, if not ongoing
... study S 1..1 Reference(ResearchStudyCcm) Study subject is part of
... subject S 1..1 Reference(PatientCcm) Who or what is part of study
... assignedComparisonGroup 0..0 What path should be followed
... actualComparisonGroup 0..0 What path was followed
... consent S 0..* Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ResearchSubject.progress.​subjectState Base required Research Subject State 📦5.0.0 FHIR Std.
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Participant or object which is the recipient of investigative activities in a study
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Business Identifier for research subject in a study
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... progress S 0..* BackboneElement Subject status
.... 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
.... type S 1..1 CodeableConcept state | milestone
Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 0..1 uri Identity of the terminology system
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: state
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... subjectState S 1..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectState (required)
.... startDate S 1..1 dateTime State change date
.... endDate S 0..1 dateTime State change date
... period SΣ 1..1 Period Start and end of participation
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudyCcm) Study subject is part of
... subject SΣ 1..1 Reference(PatientCcm) Who or what is part of study
... consent S 0..* Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.language Base required All Languages 📍5.0.0 FHIR Std.
ResearchSubject.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchSubject.progress.​type Base example Research Subject State Type 📍5.0.0 FHIR Std.
ResearchSubject.progress.​subjectState Base required Research Subject State 📦5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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 ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchSubject

Summary

Mandatory: 2 elements(3 nested mandatory elements)
Must-Support: 13 elements
Prohibited: 4 elements

Structures

This structure refers to these other structures:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Participant or object which is the recipient of investigative activities in a study
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... progress S 0..* BackboneElement Subject status
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type S 1..1 CodeableConcept state | milestone
Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 0..1 uri Identity of the terminology system
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: state
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... subjectState S 1..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectState (required)
.... startDate S 1..1 dateTime State change date
.... endDate S 0..1 dateTime State change date
... period SΣ 1..1 Period Start and end of participation
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudyCcm) Study subject is part of
... subject SΣ 1..1 Reference(PatientCcm) Who or what is part of study
... consent S 0..* Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchSubject.progress.​type Base example Research Subject State Type 📍5.0.0 FHIR Std.
ResearchSubject.progress.​subjectState Base required Research Subject State 📦5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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 ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from ResearchSubject

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Participant or object which is the recipient of investigative activities in a study
... identifier S 0..* Identifier Business Identifier for research subject in a study
... status S 1..1 code draft | active | retired | unknown
... progress S 0..* BackboneElement Subject status
.... type S 1..1 CodeableConcept state | milestone
Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: state
.... subjectState S 1..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectState (required)
.... milestone 0..0 SignedUp | Screened | Randomized
.... reason 0..0 State change reason
.... startDate S 1..1 dateTime State change date
.... endDate S 0..1 dateTime State change date
.... start S 1..1 dateTime Starting time with inclusive boundary
.... end S 0..1 dateTime End time with inclusive boundary, if not ongoing
... study S 1..1 Reference(ResearchStudyCcm) Study subject is part of
... subject S 1..1 Reference(PatientCcm) Who or what is part of study
... assignedComparisonGroup 0..0 What path should be followed
... actualComparisonGroup 0..0 What path was followed
... consent S 0..* Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ResearchSubject.progress.​subjectState Base required Research Subject State 📦5.0.0 FHIR Std.

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchSubject 0..* ResearchSubject Participant or object which is the recipient of investigative activities in a study
... 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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..* Identifier Business Identifier for research subject in a study
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... progress S 0..* BackboneElement Subject status
.... 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
.... type S 1..1 CodeableConcept state | milestone
Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
Required Pattern: At least the following
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (Complex)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... system 0..1 uri Identity of the terminology system
...... version 0..1 string Version of the system - if relevant
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: state
...... display 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... subjectState S 1..1 CodeableConcept candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
Binding: ResearchSubjectState (required)
.... startDate S 1..1 dateTime State change date
.... endDate S 0..1 dateTime State change date
... period SΣ 1..1 Period Start and end of participation
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... start SΣC 1..1 dateTime Starting time with inclusive boundary
.... end SΣC 0..1 dateTime End time with inclusive boundary, if not ongoing
... study SΣ 1..1 Reference(ResearchStudyCcm) Study subject is part of
... subject SΣ 1..1 Reference(PatientCcm) Who or what is part of study
... consent S 0..* Reference(Consent) Agreement to participate in study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchSubject.language Base required All Languages 📍5.0.0 FHIR Std.
ResearchSubject.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchSubject.progress.​type Base example Research Subject State Type 📍5.0.0 FHIR Std.
ResearchSubject.progress.​subjectState Base required Research Subject State 📦5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchSubject If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchSubject If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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 ResearchSubject If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchSubject If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchSubject A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

This structure is derived from ResearchSubject

Summary

Mandatory: 2 elements(3 nested mandatory elements)
Must-Support: 13 elements
Prohibited: 4 elements

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron