Notificación FACEDRA basada en FHIR® R5 |
0.1.1 - ci-build International flag

Notificación FACEDRA basada en FHIR® R5 | - Local Development build (v0.1.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Estudio de Investigacion FACEDRA ( Experimental )

Official URL: https://hl7.comisca.org/fhir/StructureDefinition/estudio-investigacion-facedra Version: 0.1.1
Standards status: Informative Computable Name: EstudioInvestigacionFACEDRA

Copyright/Legal: Derechos de autor (c) 2026, Consejo de Ministros de Salud de Centroamérica y República Dominicana (COMISCA). Este trabajo se distribuye bajo la licencia CC0-1.0, lo que permite su uso sin restricciones, incluso para fines comerciales. HL7®, FHIR® y el logotipo FHIR (diseño de llama) son marcas registradas de Health Level Seven International. Su uso no implica respaldo por parte de HL7. El contenido normativo de FHIR es © HL7.org 2011+. Todos los derechos reservados.

Perfil del recurso ResearchStudy para representar notificaciones FACEDRA de tipo estudio, segun el modelo funcional definido en la hoja ResearchStudy.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... name 1..1 string Nombre del estudio
... title Σ 0..1 string Titulo formal del estudio
... status ?!Σ 1..1 code Estado del estudio
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... region Σ 0..* CodeableConcept Pais o paises del estudio
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
.... coding Σ 1..* Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... identifier 0..1 Identifier Identificador del estudio
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... name 1..1 string Nombre del estudio
... title 0..1 string Titulo formal del estudio
... region 0..* CodeableConcept Pais o paises del estudio
.... coding 1..* Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system

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 Σ 0..1 Identifier Identificador del estudio
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... version 0..1 string The business version for the study record
... name 1..1 string Nombre del estudio
... title Σ 0..1 string Titulo formal del estudio
... 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 Σ 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 ?!Σ 1..1 code Estado del estudio
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... primaryPurposeType Σ 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 Σ 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 Σ 0..* CodeableConcept Pais o paises del estudio
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..* Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... descriptionSummary 0..1 markdown Brief text explaining the study
... description 0..1 markdown Detailed narrative of the study
... period Σ 0..1 Period When the study began and ended
... site Σ 0..* Reference(Location | ResearchStudy | Organization) 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 0..* 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 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 0..1 Reference(Practitioner | PractitionerRole | Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus 0..* BackboneElement Status of study with time for that status
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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 Σ 0..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 0..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber 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 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 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.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
ResearchStudy.identifier.​type Base extensible Identifier Type Codes 📍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
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 1 element(5 nested mandatory elements)

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
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
... name 1..1 string Nombre del estudio
... title Σ 0..1 string Titulo formal del estudio
... status ?!Σ 1..1 code Estado del estudio
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... region Σ 0..* CodeableConcept Pais o paises del estudio
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
.... coding Σ 1..* Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍5.0.0 FHIR Std.
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
... identifier 0..1 Identifier Identificador del estudio
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... name 1..1 string Nombre del estudio
... title 0..1 string Titulo formal del estudio
... region 0..* CodeableConcept Pais o paises del estudio
.... coding 1..* Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system

doco Documentation for this format

Snapshot ViewView

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 Σ 0..1 Identifier Identificador del estudio
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
.... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 1..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... version 0..1 string The business version for the study record
... name 1..1 string Nombre del estudio
... title Σ 0..1 string Titulo formal del estudio
... 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 Σ 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 ?!Σ 1..1 code Estado del estudio
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... primaryPurposeType Σ 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 Σ 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 Σ 0..* CodeableConcept Pais o paises del estudio
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..* Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... descriptionSummary 0..1 markdown Brief text explaining the study
... description 0..1 markdown Detailed narrative of the study
... period Σ 0..1 Period When the study began and ended
... site Σ 0..* Reference(Location | ResearchStudy | Organization) 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 0..* 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 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 0..1 Reference(Practitioner | PractitionerRole | Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus 0..* BackboneElement Status of study with time for that status
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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 Σ 0..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 0..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber 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 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 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.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
ResearchStudy.identifier.​type Base extensible Identifier Type Codes 📍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
dom-2 error ResearchStudy If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error ResearchStudy If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error ResearchStudy If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice ResearchStudy A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Summary

Mandatory: 1 element(5 nested mandatory elements)

 

Other representations of profile: CSV, Excel, Schematron