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

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

A country's approved protocol, and the parties, sites and targets it names.

Carries the variation between participating countries as instance data. A consumer reading this resource can establish which protocol version a participant was enrolled under, who sponsored it, which sites recruited for it and what it set out to measure, without holding a copy of the protocol document.

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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... version S 1..1 string Protocol version
... title SΣ 1..1 string Human readable name of the study
... protocol SΣ 0..* Reference(PlanDefinition) Steps followed in executing 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.
... primaryPurposeType SΣ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
... studyDesign SΣ 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
... region SΣ 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... description S 0..1 markdown Detailed narrative of the study
... period SΣ 0..1 Period Recruitment period
... site SΣ 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
... associatedParty S 1..* BackboneElement Sponsors, collaborators, and other parties
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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.
.... party S 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus S 0..* BackboneElement Whether recruitment is open
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
... recruitment SΣ 1..1 BackboneElement Target or actual group of participants enrolled in study
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... targetNumber S 1..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber S 0..1 unsignedInt Actual total number of participants enrolled in study
... objective S 0..* BackboneElement A goal for the study
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... outcomeMeasure S 0..* BackboneElement A variable measured during the study
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍5.0.0 FHIR Std.
ResearchStudy.studyDesign Base preferred Study Design 📍5.0.0 FHIR Std.
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍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

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... identifier S 1..* Identifier Protocol number
... version S 1..1 string Protocol version
... title S 1..1 string Human readable name of the study
... status S 1..1 code draft | active | retired | unknown
... primaryPurposeType S 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... studyDesign S 0..* CodeableConcept Classifications of the study design characteristics
... region S 1..* CodeableConcept Country the protocol was approved for
... description S 0..1 markdown Detailed narrative of the study
... period S 0..1 Period Recruitment period
... site S 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
... associatedParty S 1..* BackboneElement Sponsors, collaborators, and other parties
.... 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
.... party S 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus S 0..* BackboneElement Whether recruitment is open
... recruitment S 1..1 BackboneElement Target or actual group of participants enrolled in study
.... targetNumber S 1..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber S 0..1 unsignedInt Actual total number of participants enrolled in study
... objective S 0..* BackboneElement A goal for the study
... outcomeMeasure S 0..* BackboneElement A variable measured 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
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier SΣ 1..* Identifier Protocol number
... version S 1..1 string Protocol version
... name 0..1 string Name for this study (computer friendly)
... title SΣ 1..1 string Human readable name of the study
... label 0..* BackboneElement Additional names for the study
.... 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 primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Binding: TitleType (extensible): desc.
.... value 0..1 string The name
... protocol SΣ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf Σ 0..* Reference(ResearchStudy) Part of larger study
... relatedArtifact 0..* RelatedArtifact References, URLs, and attachments
... date 0..1 dateTime Date the resource last changed
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... primaryPurposeType SΣ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
... studyDesign SΣ 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
... focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Common codes of research study focus
... condition Σ 0..* CodeableConcept Condition being studied
Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding Description: (example): Words associated with the study that may be useful in discovery.
... region SΣ 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... descriptionSummary 0..1 markdown Brief text explaining the study
... description S 0..1 markdown Detailed narrative of the study
... period SΣ 0..1 Period Recruitment period
... site SΣ 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
... note 0..* Annotation Comments made about the study
... classifier 0..* CodeableConcept Classification for the study
Binding: ResearchStudyClassifiers (example): desc.
... associatedParty S 1..* 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 0..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 0..* 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 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus S 0..* BackboneElement Whether recruitment is open
.... 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
.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
.... actual 0..1 boolean Actual if true else anticipated
.... period 0..1 Period Date range
... whyStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
... recruitment SΣ 1..1 BackboneElement Target or actual group of participants enrolled in study
.... 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
.... targetNumber S 1..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber S 0..1 unsignedInt Actual total number of participants enrolled in study
.... eligibility 0..1 Reference(Group | EvidenceVariable) Inclusion and exclusion criteria
.... actualGroup Σ 0..1 Reference(Group) Group of participants who were enrolled in study
... comparisonGroup 0..* BackboneElement Defined path through the study for a subject
.... 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
.... linkId 0..1 id Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
.... name 1..1 string Label for study comparisonGroup
.... type 0..1 CodeableConcept Categorization of study comparisonGroup
Binding: ResearchStudyArmType (extensible): desc.
.... description 0..1 markdown Short explanation of study path
.... intendedExposure 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort
.... observedGroup 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup
... objective S 0..* BackboneElement A goal for the study
.... 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 0..1 string Label for the objective
.... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
.... description 0..1 markdown Description of the objective
... outcomeMeasure S 0..* BackboneElement A variable measured during the study
.... 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 0..1 string Label for the outcome
.... type 0..* CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): defn.
.... description 0..1 markdown Description of the outcome
.... reference 0..1 Reference(EvidenceVariable) Structured outcome definition
... result Σ 0..* Reference(EvidenceReport | Citation | DiagnosticReport) Link to results generated during the study

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.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍5.0.0 FHIR Std.
ResearchStudy.phase Base example Research Study Phase 📍5.0.0 FHIR Std.
ResearchStudy.studyDesign Base preferred Study Design 📍5.0.0 FHIR Std.
ResearchStudy.focus Base example Research Study Focus Type 📍5.0.0 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍5.0.0 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.
ResearchStudy.classifier Base example Research Study Classifiers 📍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.whyStopped Base example Research Study Reason Stopped 📍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

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
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... version S 1..1 string Protocol version
... title SΣ 1..1 string Human readable name of the study
... protocol SΣ 0..* Reference(PlanDefinition) Steps followed in executing 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.
... primaryPurposeType SΣ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
... studyDesign SΣ 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
... region SΣ 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... description S 0..1 markdown Detailed narrative of the study
... period SΣ 0..1 Period Recruitment period
... site SΣ 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
... associatedParty S 1..* BackboneElement Sponsors, collaborators, and other parties
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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.
.... party S 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus S 0..* BackboneElement Whether recruitment is open
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
... recruitment SΣ 1..1 BackboneElement Target or actual group of participants enrolled in study
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... targetNumber S 1..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber S 0..1 unsignedInt Actual total number of participants enrolled in study
... objective S 0..* BackboneElement A goal for the study
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
... outcomeMeasure S 0..* BackboneElement A variable measured during the study
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍5.0.0 FHIR Std.
ResearchStudy.studyDesign Base preferred Study Design 📍5.0.0 FHIR Std.
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍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

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... identifier S 1..* Identifier Protocol number
... version S 1..1 string Protocol version
... title S 1..1 string Human readable name of the study
... status S 1..1 code draft | active | retired | unknown
... primaryPurposeType S 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
... studyDesign S 0..* CodeableConcept Classifications of the study design characteristics
... region S 1..* CodeableConcept Country the protocol was approved for
... description S 0..1 markdown Detailed narrative of the study
... period S 0..1 Period Recruitment period
... site S 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
... associatedParty S 1..* BackboneElement Sponsors, collaborators, and other parties
.... 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
.... party S 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus S 0..* BackboneElement Whether recruitment is open
... recruitment S 1..1 BackboneElement Target or actual group of participants enrolled in study
.... targetNumber S 1..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber S 0..1 unsignedInt Actual total number of participants enrolled in study
... objective S 0..* BackboneElement A goal for the study
... outcomeMeasure S 0..* BackboneElement A variable measured 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
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier SΣ 1..* Identifier Protocol number
... version S 1..1 string Protocol version
... name 0..1 string Name for this study (computer friendly)
... title SΣ 1..1 string Human readable name of the study
... label 0..* BackboneElement Additional names for the study
.... 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 primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Binding: TitleType (extensible): desc.
.... value 0..1 string The name
... protocol SΣ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf Σ 0..* Reference(ResearchStudy) Part of larger study
... relatedArtifact 0..* RelatedArtifact References, URLs, and attachments
... date 0..1 dateTime Date the resource last changed
... status ?!SΣ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... primaryPurposeType SΣ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
... studyDesign SΣ 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
... focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Common codes of research study focus
... condition Σ 0..* CodeableConcept Condition being studied
Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding Description: (example): Words associated with the study that may be useful in discovery.
... region SΣ 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
... descriptionSummary 0..1 markdown Brief text explaining the study
... description S 0..1 markdown Detailed narrative of the study
... period SΣ 0..1 Period Recruitment period
... site SΣ 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
... note 0..* Annotation Comments made about the study
... classifier 0..* CodeableConcept Classification for the study
Binding: ResearchStudyClassifiers (example): desc.
... associatedParty S 1..* 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 0..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 0..* 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 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus S 0..* BackboneElement Whether recruitment is open
.... 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
.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
.... actual 0..1 boolean Actual if true else anticipated
.... period 0..1 Period Date range
... whyStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
... recruitment SΣ 1..1 BackboneElement Target or actual group of participants enrolled in study
.... 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
.... targetNumber S 1..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber S 0..1 unsignedInt Actual total number of participants enrolled in study
.... eligibility 0..1 Reference(Group | EvidenceVariable) Inclusion and exclusion criteria
.... actualGroup Σ 0..1 Reference(Group) Group of participants who were enrolled in study
... comparisonGroup 0..* BackboneElement Defined path through the study for a subject
.... 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
.... linkId 0..1 id Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
.... name 1..1 string Label for study comparisonGroup
.... type 0..1 CodeableConcept Categorization of study comparisonGroup
Binding: ResearchStudyArmType (extensible): desc.
.... description 0..1 markdown Short explanation of study path
.... intendedExposure 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort
.... observedGroup 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup
... objective S 0..* BackboneElement A goal for the study
.... 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 0..1 string Label for the objective
.... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
.... description 0..1 markdown Description of the objective
... outcomeMeasure S 0..* BackboneElement A variable measured during the study
.... 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 0..1 string Label for the outcome
.... type 0..* CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): defn.
.... description 0..1 markdown Description of the outcome
.... reference 0..1 Reference(EvidenceVariable) Structured outcome definition
... result Σ 0..* Reference(EvidenceReport | Citation | DiagnosticReport) Link to results generated during the study

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.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍5.0.0 FHIR Std.
ResearchStudy.phase Base example Research Study Phase 📍5.0.0 FHIR Std.
ResearchStudy.studyDesign Base preferred Study Design 📍5.0.0 FHIR Std.
ResearchStudy.focus Base example Research Study Focus Type 📍5.0.0 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍5.0.0 FHIR Std.
ResearchStudy.keyword Base example Not State Unknown
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.
ResearchStudy.classifier Base example Research Study Classifiers 📍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.whyStopped Base example Research Study Reason Stopped 📍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

 

Other representations of profile: CSV, Excel, Schematron