Healthy Route Implementation Guide
0.1.0 - ci-build

Healthy Route Implementation Guide, published by Savannah Informatics. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/savannahghi/healthy-route-ig/ and changes regularly. See the Directory of published versions

Resource Profile: Healthy Route Study Participation

Official URL: https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-subject Version: 0.1.0
Draft as of 2026-09-04 Computable Name: HRResearchSubject

One participant's enrolment onto one country's protocol, and the consent that permitted it.

Joins a participant to a protocol and to the permission that allowed them to be enrolled. It is the resource that answers whether a given person was in the study at a given time, which is distinct from whether the study holds data about them.

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 Screening, enrolment and withdrawal
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... subjectState S 0..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| on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn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): Indicates the progression of a study subject through a study.
... period SΣ 0..1 Period Period of participation
... study SΣ 1..1 Reference(Healthy Route Study) Study subject is part of
... subject SΣ 1..1 Reference(Healthy Route Patient) Who or what is part of study
... actualComparisonGroup S 0..1 id Case or control
... consent S 1..* Reference(Healthy Route 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.​subjectState Base required Research Subject State 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

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 Enrolment identifier, where the site issues one separately
... status S 1..1 code draft | active | retired | unknown
... progress S 0..* BackboneElement Screening, enrolment and withdrawal
.... subjectState S 0..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
... study S 1..1 Reference(Healthy Route Study) Study subject is part of
... subject S 1..1 Reference(Healthy Route Patient) Who or what is part of study
... actualComparisonGroup S 0..1 id Case or control
... consent S 1..* Reference(Healthy Route Consent) Agreement to participate in study

doco Documentation for this format
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 Enrolment identifier, where the site issues one separately
... 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 Screening, enrolment and withdrawal
.... 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 0..1 CodeableConcept state | milestone
Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
.... subjectState S 0..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): Indicates the progression of a study subject through a study.
.... milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
Binding: ResearchSubjectMilestone (example): Indicates the progression of a study subject through the study milestones.
.... reason 0..1 CodeableConcept State change reason
Binding: StateChangeReason (example): Indicates why the state of the subject changed.
.... startDate 0..1 dateTime State change date
.... endDate 0..1 dateTime State change date
... period SΣ 0..1 Period Period of participation
... study SΣ 1..1 Reference(Healthy Route Study) Study subject is part of
... subject SΣ 1..1 Reference(Healthy Route Patient) Who or what is part of study
... assignedComparisonGroup 0..1 id What path should be followed
... actualComparisonGroup S 0..1 id Case or control
... consent S 1..* Reference(Healthy Route 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.
ResearchSubject.progress.​milestone Base example Research Subject Milestone 📍5.0.0 FHIR Std.
ResearchSubject.progress.​reason Base example StateChangeReason 📦2.0.0 THO v7.3

Constraints

Id Grade Path(s) Description Expression

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 Screening, enrolment and withdrawal
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... subjectState S 0..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): Indicates the progression of a study subject through a study.
... period SΣ 0..1 Period Period of participation
... study SΣ 1..1 Reference(Healthy Route Study) Study subject is part of
... subject SΣ 1..1 Reference(Healthy Route Patient) Who or what is part of study
... actualComparisonGroup S 0..1 id Case or control
... consent S 1..* Reference(Healthy Route 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.​subjectState Base required Research Subject State 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression

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 Enrolment identifier, where the site issues one separately
... status S 1..1 code draft | active | retired | unknown
... progress S 0..* BackboneElement Screening, enrolment and withdrawal
.... subjectState S 0..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
... study S 1..1 Reference(Healthy Route Study) Study subject is part of
... subject S 1..1 Reference(Healthy Route Patient) Who or what is part of study
... actualComparisonGroup S 0..1 id Case or control
... consent S 1..* Reference(Healthy Route Consent) Agreement to participate in study

doco Documentation for this format

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 Enrolment identifier, where the site issues one separately
... 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 Screening, enrolment and withdrawal
.... 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 0..1 CodeableConcept state | milestone
Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
.... subjectState S 0..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): Indicates the progression of a study subject through a study.
.... milestone 0..1 CodeableConcept SignedUp | Screened | Randomized
Binding: ResearchSubjectMilestone (example): Indicates the progression of a study subject through the study milestones.
.... reason 0..1 CodeableConcept State change reason
Binding: StateChangeReason (example): Indicates why the state of the subject changed.
.... startDate 0..1 dateTime State change date
.... endDate 0..1 dateTime State change date
... period SΣ 0..1 Period Period of participation
... study SΣ 1..1 Reference(Healthy Route Study) Study subject is part of
... subject SΣ 1..1 Reference(Healthy Route Patient) Who or what is part of study
... assignedComparisonGroup 0..1 id What path should be followed
... actualComparisonGroup S 0..1 id Case or control
... consent S 1..* Reference(Healthy Route 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.
ResearchSubject.progress.​milestone Base example Research Subject Milestone 📍5.0.0 FHIR Std.
ResearchSubject.progress.​reason Base example StateChangeReason 📦2.0.0 THO v7.3

Constraints

Id Grade Path(s) Description Expression

 

Other representations of profile: CSV, Excel, Schematron