Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Resource Profile: M11ResearchStudy

Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-research-study Version: 2.0.0-ballot
Standards status: Draft Maturity Level: 1 Computable Name: M11ResearchStudy
Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.54

Profile of ResearchStudy for Evidence Based Medicine IG. The M11ResearchStudy Profile is used to add extensions for use with an M11 Report.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: 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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
.... author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... confidentialityStatement 0..1 string Sponsor Confidentiality Statement, if applicable.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... saeReportingMethod 0..1 string Method for reporting Serious Adverse Events.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... studyAmendment 0..1 (Complex) An amendment to a study protocol
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... title Σ 0..1 string Human readable name of the study
ele-1: All FHIR elements must have a @value or children
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.


ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
.... confidentialityStatement 0..1 string Sponsor Confidentiality Statement, if applicable.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement
.... saeReportingMethod 0..1 string Method for reporting Serious Adverse Events.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method
.... studyAmendment 0..1 (Complex) An amendment to a study protocol
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
... version 0..1 string The business version for the study record
... name 0..1 string Name for this study (computer friendly)
... title Σ 0..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 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 draft | active | retired | unknown
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 (No ValueSet): (example): Words associated with the study that may be useful in discovery.


... region Σ 0..* CodeableConcept Geographic area for the study
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... 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
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... estimand 0..* (Complex) An outcome measure described with the estimand framework
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand
.... 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(Citation | Composition | DiagnosticReport) Link to results generated during the study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2
from the FHIR Standard
ResearchStudy.label.typeextensibleTitleType
http://hl7.org/fhir/ValueSet/title-type
from the FHIR Standard
ResearchStudy.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2
from the FHIR Standard
ResearchStudy.primaryPurposeTypepreferredResearchStudyPrimaryPurposeType
http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
from the FHIR Standard
ResearchStudy.phaseexampleResearchStudyPhase
http://hl7.org/fhir/ValueSet/research-study-phase
from the FHIR Standard
ResearchStudy.studyDesignpreferredStudyDesign
http://hl7.org/fhir/ValueSet/study-design
from the FHIR Standard
ResearchStudy.focusexampleResearchStudyFocusType
http://hl7.org/fhir/ValueSet/research-study-focus-type
from the FHIR Standard
ResearchStudy.conditionexampleConditionProblemDiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
ResearchStudy.keywordexample
ResearchStudy.regionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ResearchStudy.classifierexampleResearchStudyClassifiers
http://hl7.org/fhir/ValueSet/research-study-classifiers
from the FHIR Standard
ResearchStudy.associatedParty.roleextensibleResearchStudyPartyRole
http://hl7.org/fhir/ValueSet/research-study-party-role
from the FHIR Standard
ResearchStudy.associatedParty.classifierexampleResearchStudyPartyOrgType
http://hl7.org/fhir/ValueSet/research-study-party-organization-type
from the FHIR Standard
ResearchStudy.progressStatus.stateextensibleResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status
from the FHIR Standard
ResearchStudy.whyStoppedexampleResearchStudyReasonStopped
http://hl7.org/fhir/ValueSet/research-study-reason-stopped
from the FHIR Standard
ResearchStudy.comparisonGroup.typeextensibleResearchStudyArmType
http://hl7.org/fhir/ValueSet/research-study-arm-type
from the FHIR Standard
ResearchStudy.objective.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard
ResearchStudy.outcomeMeasure.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from ResearchStudy

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: 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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
.... author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... confidentialityStatement 0..1 string Sponsor Confidentiality Statement, if applicable.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... saeReportingMethod 0..1 string Method for reporting Serious Adverse Events.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... studyAmendment 0..1 (Complex) An amendment to a study protocol
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... title Σ 0..1 string Human readable name of the study
ele-1: All FHIR elements must have a @value or children
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.


ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
.... confidentialityStatement 0..1 string Sponsor Confidentiality Statement, if applicable.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement
.... saeReportingMethod 0..1 string Method for reporting Serious Adverse Events.
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method
.... studyAmendment 0..1 (Complex) An amendment to a study protocol
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
... version 0..1 string The business version for the study record
... name 0..1 string Name for this study (computer friendly)
... title Σ 0..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 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 draft | active | retired | unknown
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 (No ValueSet): (example): Words associated with the study that may be useful in discovery.


... region Σ 0..* CodeableConcept Geographic area for the study
Binding: JurisdictionValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... 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
.... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
..... estimand 0..* (Complex) An outcome measure described with the estimand framework
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand
.... 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(Citation | Composition | DiagnosticReport) Link to results generated during the study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2
from the FHIR Standard
ResearchStudy.label.typeextensibleTitleType
http://hl7.org/fhir/ValueSet/title-type
from the FHIR Standard
ResearchStudy.statusrequiredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2
from the FHIR Standard
ResearchStudy.primaryPurposeTypepreferredResearchStudyPrimaryPurposeType
http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
from the FHIR Standard
ResearchStudy.phaseexampleResearchStudyPhase
http://hl7.org/fhir/ValueSet/research-study-phase
from the FHIR Standard
ResearchStudy.studyDesignpreferredStudyDesign
http://hl7.org/fhir/ValueSet/study-design
from the FHIR Standard
ResearchStudy.focusexampleResearchStudyFocusType
http://hl7.org/fhir/ValueSet/research-study-focus-type
from the FHIR Standard
ResearchStudy.conditionexampleConditionProblemDiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
ResearchStudy.keywordexample
ResearchStudy.regionextensibleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ResearchStudy.classifierexampleResearchStudyClassifiers
http://hl7.org/fhir/ValueSet/research-study-classifiers
from the FHIR Standard
ResearchStudy.associatedParty.roleextensibleResearchStudyPartyRole
http://hl7.org/fhir/ValueSet/research-study-party-role
from the FHIR Standard
ResearchStudy.associatedParty.classifierexampleResearchStudyPartyOrgType
http://hl7.org/fhir/ValueSet/research-study-party-organization-type
from the FHIR Standard
ResearchStudy.progressStatus.stateextensibleResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status
from the FHIR Standard
ResearchStudy.whyStoppedexampleResearchStudyReasonStopped
http://hl7.org/fhir/ValueSet/research-study-reason-stopped
from the FHIR Standard
ResearchStudy.comparisonGroup.typeextensibleResearchStudyArmType
http://hl7.org/fhir/ValueSet/research-study-arm-type
from the FHIR Standard
ResearchStudy.objective.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard
ResearchStudy.outcomeMeasure.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorResearchStudyIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorResearchStudyIf 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-4errorResearchStudyIf 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-5errorResearchStudyIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceResearchStudyA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel, Schematron