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

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Resource Profile: Healthy Route Study Participation

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:

• Examples for this Profile: ResearchSubject/ExampleParticipationScreenFailure

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
ResearchSubject		0..*	ResearchSubject	Participant or object which is the recipient of investigative activities in a study
ResearchSubject.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
ResearchSubject.contained		0..*	Resource	Contained, inline Resources
ResearchSubject.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored
ResearchSubject.identifier	S This element must be supported. Σ This element is included in summaries.	0..*	Identifier	Enrolment identifier, where the site issues one separately
ResearchSubject.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
ResearchSubject.progress	S This element must be supported.	0..*	BackboneElement	Screening, enrolment and withdrawal
ResearchSubject.progress.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
ResearchSubject.progress.subjectState	S This element must be supported.	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.
ResearchSubject.period	S This element must be supported. Σ This element is included in summaries.	0..1	Period	Period of participation
ResearchSubject.study	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Study)	Study subject is part of
ResearchSubject.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Patient)	Who or what is part of study
ResearchSubject.actualComparisonGroup	S This element must be supported.	0..1	id	Case or control
ResearchSubject.consent	S This element must be supported.	1..*	Reference(Healthy Route Consent)	Agreement to participate in study
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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject	Participant or object which is the recipient of investigative activities in a study
ResearchSubject.identifier	S This element must be supported.	0..*	Identifier	Enrolment identifier, where the site issues one separately
ResearchSubject.status	S This element must be supported.	1..1	code	draft | active | retired | unknown
ResearchSubject.progress	S This element must be supported.	0..*	BackboneElement	Screening, enrolment and withdrawal
ResearchSubject.progress.subjectState	S This element must be supported.	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
ResearchSubject.period	S This element must be supported.	0..1	Period	Period of participation
ResearchSubject.study	S This element must be supported.	1..1	Reference(Healthy Route Study)	Study subject is part of
ResearchSubject.subject	S This element must be supported.	1..1	Reference(Healthy Route Patient)	Who or what is part of study
ResearchSubject.actualComparisonGroup	S This element must be supported.	0..1	id	Case or control
ResearchSubject.consent	S This element must be supported.	1..*	Reference(Healthy Route Consent)	Agreement to participate in study
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject	Participant or object which is the recipient of investigative activities in a study
ResearchSubject.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
ResearchSubject.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
ResearchSubject.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
ResearchSubject.language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
ResearchSubject.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
ResearchSubject.contained		0..*	Resource	Contained, inline Resources
ResearchSubject.extension		0..*	Extension	Additional content defined by implementations
ResearchSubject.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored
ResearchSubject.identifier	S This element must be supported. Σ This element is included in summaries.	0..*	Identifier	Enrolment identifier, where the site issues one separately
ResearchSubject.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
ResearchSubject.progress	S This element must be supported.	0..*	BackboneElement	Screening, enrolment and withdrawal
ResearchSubject.progress.id		0..1	string	Unique id for inter-element referencing
ResearchSubject.progress.extension		0..*	Extension	Additional content defined by implementations
ResearchSubject.progress.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
ResearchSubject.progress.type		0..1	CodeableConcept	state | milestone Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
ResearchSubject.progress.subjectState	S This element must be supported.	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.
ResearchSubject.progress.milestone		0..1	CodeableConcept	SignedUp | Screened | Randomized Binding: ResearchSubjectMilestone (example): Indicates the progression of a study subject through the study milestones.
ResearchSubject.progress.reason		0..1	CodeableConcept	State change reason Binding: StateChangeReason (example): Indicates why the state of the subject changed.
ResearchSubject.progress.startDate		0..1	dateTime	State change date
ResearchSubject.progress.endDate		0..1	dateTime	State change date
ResearchSubject.period	S This element must be supported. Σ This element is included in summaries.	0..1	Period	Period of participation
ResearchSubject.study	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Study)	Study subject is part of
ResearchSubject.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Patient)	Who or what is part of study
ResearchSubject.assignedComparisonGroup		0..1	id	What path should be followed
ResearchSubject.actualComparisonGroup	S This element must be supported.	0..1	id	Case or control
ResearchSubject.consent	S This element must be supported.	1..*	Reference(Healthy Route Consent)	Agreement to participate in study
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 v7.4

Constraints

Id

Grade

Path(s)

Description

Expression

This structure is derived from ResearchSubject

Summary

Mandatory: 1 element
Must-Support: 9 elements

Structures

This structure refers to these other structures:

• Healthy Route Study (https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-study)
• Healthy Route Patient (https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-patient)
• Healthy Route Consent (https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-consent)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject	Participant or object which is the recipient of investigative activities in a study
ResearchSubject.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
ResearchSubject.contained		0..*	Resource	Contained, inline Resources
ResearchSubject.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored
ResearchSubject.identifier	S This element must be supported. Σ This element is included in summaries.	0..*	Identifier	Enrolment identifier, where the site issues one separately
ResearchSubject.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
ResearchSubject.progress	S This element must be supported.	0..*	BackboneElement	Screening, enrolment and withdrawal
ResearchSubject.progress.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
ResearchSubject.progress.subjectState	S This element must be supported.	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.
ResearchSubject.period	S This element must be supported. Σ This element is included in summaries.	0..1	Period	Period of participation
ResearchSubject.study	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Study)	Study subject is part of
ResearchSubject.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Patient)	Who or what is part of study
ResearchSubject.actualComparisonGroup	S This element must be supported.	0..1	id	Case or control
ResearchSubject.consent	S This element must be supported.	1..*	Reference(Healthy Route Consent)	Agreement to participate in study
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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject	Participant or object which is the recipient of investigative activities in a study
ResearchSubject.identifier	S This element must be supported.	0..*	Identifier	Enrolment identifier, where the site issues one separately
ResearchSubject.status	S This element must be supported.	1..1	code	draft | active | retired | unknown
ResearchSubject.progress	S This element must be supported.	0..*	BackboneElement	Screening, enrolment and withdrawal
ResearchSubject.progress.subjectState	S This element must be supported.	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
ResearchSubject.period	S This element must be supported.	0..1	Period	Period of participation
ResearchSubject.study	S This element must be supported.	1..1	Reference(Healthy Route Study)	Study subject is part of
ResearchSubject.subject	S This element must be supported.	1..1	Reference(Healthy Route Patient)	Who or what is part of study
ResearchSubject.actualComparisonGroup	S This element must be supported.	0..1	id	Case or control
ResearchSubject.consent	S This element must be supported.	1..*	Reference(Healthy Route Consent)	Agreement to participate in study
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchSubject		0..*	ResearchSubject	Participant or object which is the recipient of investigative activities in a study
ResearchSubject.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
ResearchSubject.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
ResearchSubject.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
ResearchSubject.language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
ResearchSubject.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
ResearchSubject.contained		0..*	Resource	Contained, inline Resources
ResearchSubject.extension		0..*	Extension	Additional content defined by implementations
ResearchSubject.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored
ResearchSubject.identifier	S This element must be supported. Σ This element is included in summaries.	0..*	Identifier	Enrolment identifier, where the site issues one separately
ResearchSubject.status	?! This element is a modifier element. S This element must be supported. Σ This element is included in summaries.	1..1	code	draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
ResearchSubject.progress	S This element must be supported.	0..*	BackboneElement	Screening, enrolment and withdrawal
ResearchSubject.progress.id		0..1	string	Unique id for inter-element referencing
ResearchSubject.progress.extension		0..*	Extension	Additional content defined by implementations
ResearchSubject.progress.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
ResearchSubject.progress.type		0..1	CodeableConcept	state | milestone Binding: ResearchSubjectStateType (example): Identifies the kind of state being refered to.
ResearchSubject.progress.subjectState	S This element must be supported.	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.
ResearchSubject.progress.milestone		0..1	CodeableConcept	SignedUp | Screened | Randomized Binding: ResearchSubjectMilestone (example): Indicates the progression of a study subject through the study milestones.
ResearchSubject.progress.reason		0..1	CodeableConcept	State change reason Binding: StateChangeReason (example): Indicates why the state of the subject changed.
ResearchSubject.progress.startDate		0..1	dateTime	State change date
ResearchSubject.progress.endDate		0..1	dateTime	State change date
ResearchSubject.period	S This element must be supported. Σ This element is included in summaries.	0..1	Period	Period of participation
ResearchSubject.study	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Study)	Study subject is part of
ResearchSubject.subject	S This element must be supported. Σ This element is included in summaries.	1..1	Reference(Healthy Route Patient)	Who or what is part of study
ResearchSubject.assignedComparisonGroup		0..1	id	What path should be followed
ResearchSubject.actualComparisonGroup	S This element must be supported.	0..1	id	Case or control
ResearchSubject.consent	S This element must be supported.	1..*	Reference(Healthy Route Consent)	Agreement to participate in study
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 v7.4

Constraints

Id

Grade

Path(s)

Description

Expression

This structure is derived from ResearchSubject

Summary

Mandatory: 1 element
Must-Support: 9 elements

Structures

This structure refers to these other structures:

• Healthy Route Study (https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-research-study)
• Healthy Route Patient (https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-patient)
• Healthy Route Consent (https://fhir.savannahghi.org/ig/healthy-route/StructureDefinition/hr-consent)

Other representations of profile: CSV, Excel, Schematron