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 2026-10-11 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: doco
ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
ResearchStudy.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
ResearchStudy.contained 0..* Resource Contained, inline Resources
ResearchStudy.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored
ResearchStudy.identifier This element must be supported. This element is included in summaries. 1..* Identifier Protocol number
ResearchStudy.version This element must be supported. 1..1 string Protocol version
ResearchStudy.title This element must be supported. This element is included in summaries. 1..1 string Human readable name of the study
ResearchStudy.protocol This element must be supported. This element is included in summaries. 0..* Reference(PlanDefinition) Steps followed in executing study
ResearchStudy.status This element is a modifier element. This element must be supported. 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.
ResearchStudy.primaryPurposeType This element must be supported. This element is included in summaries. 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.
ResearchStudy.studyDesign This element must be supported. This element is included in summaries. 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
ResearchStudy.region This element must be supported. This element is included in summaries. 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
ResearchStudy.description This element must be supported. 0..1 markdown Detailed narrative of the study
ResearchStudy.period This element must be supported. This element is included in summaries. 0..1 Period Recruitment period
ResearchStudy.site This element must be supported. This element is included in summaries. 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
ResearchStudy.associatedParty This element must be supported. 1..* BackboneElement Sponsors, collaborators, and other parties
ResearchStudy.associatedParty.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.associatedParty.role This element must be supported. 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.
ResearchStudy.associatedParty.party This element must be supported. 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
ResearchStudy.progressStatus This element must be supported. 0..* BackboneElement Whether recruitment is open
ResearchStudy.progressStatus.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.progressStatus.state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
ResearchStudy.recruitment This element must be supported. This element is included in summaries. 1..1 BackboneElement Target or actual group of participants enrolled in study
ResearchStudy.recruitment.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.recruitment.targetNumber This element must be supported. 1..1 unsignedInt Estimated total number of participants to be enrolled
ResearchStudy.recruitment.actualNumber This element must be supported. 0..1 unsignedInt Actual total number of participants enrolled in study
ResearchStudy.objective This element must be supported. 0..* BackboneElement A goal for the study
ResearchStudy.objective.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.outcomeMeasure This element must be supported. 0..* BackboneElement A variable measured during the study
ResearchStudy.outcomeMeasure.modifierExtension This element is a modifier element. This element is included in summaries. 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: doco
ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
ResearchStudy.identifier This element must be supported. 1..* Identifier Protocol number
ResearchStudy.version This element must be supported. 1..1 string Protocol version
ResearchStudy.title This element must be supported. 1..1 string Human readable name of the study
ResearchStudy.status This element must be supported. 1..1 code draft | active | retired | unknown
ResearchStudy.primaryPurposeType This element must be supported. 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudy.studyDesign This element must be supported. 0..* CodeableConcept Classifications of the study design characteristics
ResearchStudy.region This element must be supported. 1..* CodeableConcept Country the protocol was approved for
ResearchStudy.description This element must be supported. 0..1 markdown Detailed narrative of the study
ResearchStudy.period This element must be supported. 0..1 Period Recruitment period
ResearchStudy.site This element must be supported. 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
ResearchStudy.associatedParty This element must be supported. 1..* BackboneElement Sponsors, collaborators, and other parties
ResearchStudy.associatedParty.role This element must be supported. 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
ResearchStudy.associatedParty.party This element must be supported. 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
ResearchStudy.progressStatus This element must be supported. 0..* BackboneElement Whether recruitment is open
ResearchStudy.recruitment This element must be supported. 1..1 BackboneElement Target or actual group of participants enrolled in study
ResearchStudy.recruitment.targetNumber This element must be supported. 1..1 unsignedInt Estimated total number of participants to be enrolled
ResearchStudy.recruitment.actualNumber This element must be supported. 0..1 unsignedInt Actual total number of participants enrolled in study
ResearchStudy.objective This element must be supported. 0..* BackboneElement A goal for the study
ResearchStudy.outcomeMeasure This element must be supported. 0..* BackboneElement A variable measured during the study

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: doco
ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
ResearchStudy.id This element is included in summaries. 0..1 id Logical id of this artifact
ResearchStudy.meta This element is included in summaries. 0..1 Meta Metadata about the resource
ResearchStudy.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
ResearchStudy.language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
ResearchStudy.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
ResearchStudy.contained 0..* Resource Contained, inline Resources
ResearchStudy.extension 0..* Extension Additional content defined by implementations
ResearchStudy.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored
ResearchStudy.url 0..1 uri Canonical identifier for this study resource
ResearchStudy.identifier This element must be supported. This element is included in summaries. 1..* Identifier Protocol number
ResearchStudy.version This element must be supported. 1..1 string Protocol version
ResearchStudy.name 0..1 string Name for this study (computer friendly)
ResearchStudy.title This element must be supported. This element is included in summaries. 1..1 string Human readable name of the study
ResearchStudy.label 0..* BackboneElement Additional names for the study
ResearchStudy.label.id 0..1 string Unique id for inter-element referencing
ResearchStudy.label.extension 0..* Extension Additional content defined by implementations
ResearchStudy.label.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.label.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.
ResearchStudy.label.value 0..1 string The name
ResearchStudy.protocol This element must be supported. This element is included in summaries. 0..* Reference(PlanDefinition) Steps followed in executing study
ResearchStudy.partOf This element is included in summaries. 0..* Reference(ResearchStudy) Part of larger study
ResearchStudy.relatedArtifact 0..* RelatedArtifact References, URLs, and attachments
ResearchStudy.date 0..1 dateTime Date the resource last changed
ResearchStudy.status This element is a modifier element. This element must be supported. 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.
ResearchStudy.primaryPurposeType This element must be supported. This element is included in summaries. 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.
ResearchStudy.phase This element is included in summaries. 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.
ResearchStudy.studyDesign This element must be supported. This element is included in summaries. 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
ResearchStudy.focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Common codes of research study focus
ResearchStudy.condition This element is included in summaries. 0..* CodeableConcept Condition being studied
Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
ResearchStudy.keyword This element is included in summaries. 0..* CodeableConcept Used to search for the study
Binding Description: (example): Words associated with the study that may be useful in discovery.
ResearchStudy.region This element must be supported. This element is included in summaries. 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
ResearchStudy.descriptionSummary 0..1 markdown Brief text explaining the study
ResearchStudy.description This element must be supported. 0..1 markdown Detailed narrative of the study
ResearchStudy.period This element must be supported. This element is included in summaries. 0..1 Period Recruitment period
ResearchStudy.site This element must be supported. This element is included in summaries. 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
ResearchStudy.note 0..* Annotation Comments made about the study
ResearchStudy.classifier 0..* CodeableConcept Classification for the study
Binding: ResearchStudyClassifiers (example): desc.
ResearchStudy.associatedParty This element must be supported. 1..* BackboneElement Sponsors, collaborators, and other parties
ResearchStudy.associatedParty.id 0..1 string Unique id for inter-element referencing
ResearchStudy.associatedParty.extension 0..* Extension Additional content defined by implementations
ResearchStudy.associatedParty.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.associatedParty.name 0..1 string Name of associated party
ResearchStudy.associatedParty.role This element must be supported. 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.
ResearchStudy.associatedParty.period 0..* Period When active in the role
ResearchStudy.associatedParty.classifier 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry
Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
ResearchStudy.associatedParty.party This element must be supported. 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
ResearchStudy.progressStatus This element must be supported. 0..* BackboneElement Whether recruitment is open
ResearchStudy.progressStatus.id 0..1 string Unique id for inter-element referencing
ResearchStudy.progressStatus.extension 0..* Extension Additional content defined by implementations
ResearchStudy.progressStatus.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.progressStatus.state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
ResearchStudy.progressStatus.actual 0..1 boolean Actual if true else anticipated
ResearchStudy.progressStatus.period 0..1 Period Date range
ResearchStudy.whyStopped This element is included in summaries. 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.
ResearchStudy.recruitment This element must be supported. This element is included in summaries. 1..1 BackboneElement Target or actual group of participants enrolled in study
ResearchStudy.recruitment.id 0..1 string Unique id for inter-element referencing
ResearchStudy.recruitment.extension 0..* Extension Additional content defined by implementations
ResearchStudy.recruitment.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.recruitment.targetNumber This element must be supported. 1..1 unsignedInt Estimated total number of participants to be enrolled
ResearchStudy.recruitment.actualNumber This element must be supported. 0..1 unsignedInt Actual total number of participants enrolled in study
ResearchStudy.recruitment.eligibility 0..1 Reference(Group | EvidenceVariable) Inclusion and exclusion criteria
ResearchStudy.recruitment.actualGroup This element is included in summaries. 0..1 Reference(Group) Group of participants who were enrolled in study
ResearchStudy.comparisonGroup 0..* BackboneElement Defined path through the study for a subject
ResearchStudy.comparisonGroup.id 0..1 string Unique id for inter-element referencing
ResearchStudy.comparisonGroup.extension 0..* Extension Additional content defined by implementations
ResearchStudy.comparisonGroup.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.comparisonGroup.linkId 0..1 id Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
ResearchStudy.comparisonGroup.name 1..1 string Label for study comparisonGroup
ResearchStudy.comparisonGroup.type 0..1 CodeableConcept Categorization of study comparisonGroup
Binding: ResearchStudyArmType (extensible): desc.
ResearchStudy.comparisonGroup.description 0..1 markdown Short explanation of study path
ResearchStudy.comparisonGroup.intendedExposure 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort
ResearchStudy.comparisonGroup.observedGroup 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup
ResearchStudy.objective This element must be supported. 0..* BackboneElement A goal for the study
ResearchStudy.objective.id 0..1 string Unique id for inter-element referencing
ResearchStudy.objective.extension 0..* Extension Additional content defined by implementations
ResearchStudy.objective.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.objective.name 0..1 string Label for the objective
ResearchStudy.objective.type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
ResearchStudy.objective.description 0..1 markdown Description of the objective
ResearchStudy.outcomeMeasure This element must be supported. 0..* BackboneElement A variable measured during the study
ResearchStudy.outcomeMeasure.id 0..1 string Unique id for inter-element referencing
ResearchStudy.outcomeMeasure.extension 0..* Extension Additional content defined by implementations
ResearchStudy.outcomeMeasure.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.outcomeMeasure.name 0..1 string Label for the outcome
ResearchStudy.outcomeMeasure.type 0..* CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): defn.
ResearchStudy.outcomeMeasure.description 0..1 markdown Description of the outcome
ResearchStudy.outcomeMeasure.reference 0..1 Reference(EvidenceVariable) Structured outcome definition
ResearchStudy.result This element is included in summaries. 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: doco
ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
ResearchStudy.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
ResearchStudy.contained 0..* Resource Contained, inline Resources
ResearchStudy.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored
ResearchStudy.identifier This element must be supported. This element is included in summaries. 1..* Identifier Protocol number
ResearchStudy.version This element must be supported. 1..1 string Protocol version
ResearchStudy.title This element must be supported. This element is included in summaries. 1..1 string Human readable name of the study
ResearchStudy.protocol This element must be supported. This element is included in summaries. 0..* Reference(PlanDefinition) Steps followed in executing study
ResearchStudy.status This element is a modifier element. This element must be supported. 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.
ResearchStudy.primaryPurposeType This element must be supported. This element is included in summaries. 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.
ResearchStudy.studyDesign This element must be supported. This element is included in summaries. 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
ResearchStudy.region This element must be supported. This element is included in summaries. 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
ResearchStudy.description This element must be supported. 0..1 markdown Detailed narrative of the study
ResearchStudy.period This element must be supported. This element is included in summaries. 0..1 Period Recruitment period
ResearchStudy.site This element must be supported. This element is included in summaries. 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
ResearchStudy.associatedParty This element must be supported. 1..* BackboneElement Sponsors, collaborators, and other parties
ResearchStudy.associatedParty.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.associatedParty.role This element must be supported. 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.
ResearchStudy.associatedParty.party This element must be supported. 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
ResearchStudy.progressStatus This element must be supported. 0..* BackboneElement Whether recruitment is open
ResearchStudy.progressStatus.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.progressStatus.state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
ResearchStudy.recruitment This element must be supported. This element is included in summaries. 1..1 BackboneElement Target or actual group of participants enrolled in study
ResearchStudy.recruitment.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.recruitment.targetNumber This element must be supported. 1..1 unsignedInt Estimated total number of participants to be enrolled
ResearchStudy.recruitment.actualNumber This element must be supported. 0..1 unsignedInt Actual total number of participants enrolled in study
ResearchStudy.objective This element must be supported. 0..* BackboneElement A goal for the study
ResearchStudy.objective.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.outcomeMeasure This element must be supported. 0..* BackboneElement A variable measured during the study
ResearchStudy.outcomeMeasure.modifierExtension This element is a modifier element. This element is included in summaries. 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: doco
ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
ResearchStudy.identifier This element must be supported. 1..* Identifier Protocol number
ResearchStudy.version This element must be supported. 1..1 string Protocol version
ResearchStudy.title This element must be supported. 1..1 string Human readable name of the study
ResearchStudy.protocol This element must be supported. 0..* Reference(PlanDefinition) Steps followed in executing study
ResearchStudy.status This element must be supported. 1..1 code draft | active | retired | unknown
ResearchStudy.primaryPurposeType This element must be supported. 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudy.studyDesign This element must be supported. 0..* CodeableConcept Classifications of the study design characteristics
ResearchStudy.region This element must be supported. 1..* CodeableConcept Country the protocol was approved for
ResearchStudy.description This element must be supported. 0..1 markdown Detailed narrative of the study
ResearchStudy.period This element must be supported. 0..1 Period Recruitment period
ResearchStudy.site This element must be supported. 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
ResearchStudy.associatedParty This element must be supported. 1..* BackboneElement Sponsors, collaborators, and other parties
ResearchStudy.associatedParty.role This element must be supported. 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
ResearchStudy.associatedParty.party This element must be supported. 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
ResearchStudy.progressStatus This element must be supported. 0..* BackboneElement Whether recruitment is open
ResearchStudy.recruitment This element must be supported. 1..1 BackboneElement Target or actual group of participants enrolled in study
ResearchStudy.recruitment.targetNumber This element must be supported. 1..1 unsignedInt Estimated total number of participants to be enrolled
ResearchStudy.recruitment.actualNumber This element must be supported. 0..1 unsignedInt Actual total number of participants enrolled in study
ResearchStudy.objective This element must be supported. 0..* BackboneElement A goal for the study
ResearchStudy.outcomeMeasure This element must be supported. 0..* BackboneElement A variable measured during the study

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: doco
ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
ResearchStudy.id This element is included in summaries. 0..1 id Logical id of this artifact
ResearchStudy.meta This element is included in summaries. 0..1 Meta Metadata about the resource
ResearchStudy.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created
ResearchStudy.language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
ResearchStudy.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
ResearchStudy.contained 0..* Resource Contained, inline Resources
ResearchStudy.extension 0..* Extension Additional content defined by implementations
ResearchStudy.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored
ResearchStudy.url 0..1 uri Canonical identifier for this study resource
ResearchStudy.identifier This element must be supported. This element is included in summaries. 1..* Identifier Protocol number
ResearchStudy.version This element must be supported. 1..1 string Protocol version
ResearchStudy.name 0..1 string Name for this study (computer friendly)
ResearchStudy.title This element must be supported. This element is included in summaries. 1..1 string Human readable name of the study
ResearchStudy.label 0..* BackboneElement Additional names for the study
ResearchStudy.label.id 0..1 string Unique id for inter-element referencing
ResearchStudy.label.extension 0..* Extension Additional content defined by implementations
ResearchStudy.label.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.label.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.
ResearchStudy.label.value 0..1 string The name
ResearchStudy.protocol This element must be supported. This element is included in summaries. 0..* Reference(PlanDefinition) Steps followed in executing study
ResearchStudy.partOf This element is included in summaries. 0..* Reference(ResearchStudy) Part of larger study
ResearchStudy.relatedArtifact 0..* RelatedArtifact References, URLs, and attachments
ResearchStudy.date 0..1 dateTime Date the resource last changed
ResearchStudy.status This element is a modifier element. This element must be supported. 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.
ResearchStudy.primaryPurposeType This element must be supported. This element is included in summaries. 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.
ResearchStudy.phase This element is included in summaries. 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.
ResearchStudy.studyDesign This element must be supported. This element is included in summaries. 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (preferred): This is a set of terms for study design characteristics.
ResearchStudy.focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Common codes of research study focus
ResearchStudy.condition This element is included in summaries. 0..* CodeableConcept Condition being studied
Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
ResearchStudy.keyword This element is included in summaries. 0..* CodeableConcept Used to search for the study
Binding Description: (example): Words associated with the study that may be useful in discovery.
ResearchStudy.region This element must be supported. This element is included in summaries. 1..* CodeableConcept Country the protocol was approved for
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
ResearchStudy.descriptionSummary 0..1 markdown Brief text explaining the study
ResearchStudy.description This element must be supported. 0..1 markdown Detailed narrative of the study
ResearchStudy.period This element must be supported. This element is included in summaries. 0..1 Period Recruitment period
ResearchStudy.site This element must be supported. This element is included in summaries. 1..* Reference(Healthy Route Organization | Healthy Route Location) Facility where study activities are conducted
ResearchStudy.note 0..* Annotation Comments made about the study
ResearchStudy.classifier 0..* CodeableConcept Classification for the study
Binding: ResearchStudyClassifiers (example): desc.
ResearchStudy.associatedParty This element must be supported. 1..* BackboneElement Sponsors, collaborators, and other parties
ResearchStudy.associatedParty.id 0..1 string Unique id for inter-element referencing
ResearchStudy.associatedParty.extension 0..* Extension Additional content defined by implementations
ResearchStudy.associatedParty.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.associatedParty.name 0..1 string Name of associated party
ResearchStudy.associatedParty.role This element must be supported. 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.
ResearchStudy.associatedParty.period 0..* Period When active in the role
ResearchStudy.associatedParty.classifier 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry
Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
ResearchStudy.associatedParty.party This element must be supported. 0..1 Reference(Healthy Route Practitioner | Healthy Route Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
ResearchStudy.progressStatus This element must be supported. 0..* BackboneElement Whether recruitment is open
ResearchStudy.progressStatus.id 0..1 string Unique id for inter-element referencing
ResearchStudy.progressStatus.extension 0..* Extension Additional content defined by implementations
ResearchStudy.progressStatus.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.progressStatus.state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
ResearchStudy.progressStatus.actual 0..1 boolean Actual if true else anticipated
ResearchStudy.progressStatus.period 0..1 Period Date range
ResearchStudy.whyStopped This element is included in summaries. 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.
ResearchStudy.recruitment This element must be supported. This element is included in summaries. 1..1 BackboneElement Target or actual group of participants enrolled in study
ResearchStudy.recruitment.id 0..1 string Unique id for inter-element referencing
ResearchStudy.recruitment.extension 0..* Extension Additional content defined by implementations
ResearchStudy.recruitment.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.recruitment.targetNumber This element must be supported. 1..1 unsignedInt Estimated total number of participants to be enrolled
ResearchStudy.recruitment.actualNumber This element must be supported. 0..1 unsignedInt Actual total number of participants enrolled in study
ResearchStudy.recruitment.eligibility 0..1 Reference(Group | EvidenceVariable) Inclusion and exclusion criteria
ResearchStudy.recruitment.actualGroup This element is included in summaries. 0..1 Reference(Group) Group of participants who were enrolled in study
ResearchStudy.comparisonGroup 0..* BackboneElement Defined path through the study for a subject
ResearchStudy.comparisonGroup.id 0..1 string Unique id for inter-element referencing
ResearchStudy.comparisonGroup.extension 0..* Extension Additional content defined by implementations
ResearchStudy.comparisonGroup.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.comparisonGroup.linkId 0..1 id Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
ResearchStudy.comparisonGroup.name 1..1 string Label for study comparisonGroup
ResearchStudy.comparisonGroup.type 0..1 CodeableConcept Categorization of study comparisonGroup
Binding: ResearchStudyArmType (extensible): desc.
ResearchStudy.comparisonGroup.description 0..1 markdown Short explanation of study path
ResearchStudy.comparisonGroup.intendedExposure 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort
ResearchStudy.comparisonGroup.observedGroup 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup
ResearchStudy.objective This element must be supported. 0..* BackboneElement A goal for the study
ResearchStudy.objective.id 0..1 string Unique id for inter-element referencing
ResearchStudy.objective.extension 0..* Extension Additional content defined by implementations
ResearchStudy.objective.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.objective.name 0..1 string Label for the objective
ResearchStudy.objective.type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
ResearchStudy.objective.description 0..1 markdown Description of the objective
ResearchStudy.outcomeMeasure This element must be supported. 0..* BackboneElement A variable measured during the study
ResearchStudy.outcomeMeasure.id 0..1 string Unique id for inter-element referencing
ResearchStudy.outcomeMeasure.extension 0..* Extension Additional content defined by implementations
ResearchStudy.outcomeMeasure.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized
ResearchStudy.outcomeMeasure.name 0..1 string Label for the outcome
ResearchStudy.outcomeMeasure.type 0..* CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): defn.
ResearchStudy.outcomeMeasure.description 0..1 markdown Description of the outcome
ResearchStudy.outcomeMeasure.reference 0..1 Reference(EvidenceVariable) Structured outcome definition
ResearchStudy.result This element is included in summaries. 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

 

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