IL Core Implementation Guide
0.18.0 - draft Israel flag

This page is part of the IL-Core IG (v0.18.0: draft-1 Draft) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: ILCore ResearchStudy Profile

Official URL: http://fhir.health.gov.il/StructureDefinition/il-core-research-study Version: 0.18.0
Standards status: Trial-use Maturity Level: 1 Computable Name: ILCoreResearchStudy

Israel Core proposed constraints and extensions on the ResearchStudy Resource

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 ILCoreResearchStudy Profile
... protocol 0..* Reference(ILCore PlanDefinition Profile) Steps followed in executing study
... partOf 0..* Reference(ILCore ResearchStudy Profile) Part of larger study
... enrollment 0..* Reference(ILCore Group Profile) Inclusion & exclusion criteria
... principalInvestigator 0..1 Reference(ILCore Practitioner Profile | ILCore PractitionerRole Profile) Researcher who oversees multiple aspects of the study
... site 0..* Reference(ILCore Location Profile) Facility where study activities are conducted

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy ILCoreResearchStudy Profile
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... protocol Σ 0..* Reference(ILCore PlanDefinition Profile) Steps followed in executing study
... status ?!Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... enrollment Σ 0..* Reference(ILCore Group Profile) Inclusion & exclusion criteria
... sponsor Σ 0..1 Reference(ILCore Organization Profile) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(ILCore Practitioner Profile | ILCore PractitionerRole Profile) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(ILCore Location Profile) Facility where study activities are conducted

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy ILCoreResearchStudy Profile
... 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: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for study
... title Σ 0..1 string Name for this study
... protocol Σ 0..* Reference(ILCore PlanDefinition Profile) Steps followed in executing study
... partOf Σ 0..* Reference(ILCore ResearchStudy Profile) Part of larger study
... status ?!Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): 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.

... category Σ 0..* CodeableConcept Classifications for the study
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


... focus Σ 0..* CodeableConcept Drugs, devices, etc. under study
Binding: (unbound) (example): Codes for medications, devices and other interventions.


... condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ 0..* ContactDetail Contact details for the study
... relatedArtifact 0..* RelatedArtifact References and dependencies
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ 0..* CodeableConcept Geographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1 markdown What this is study doing
... enrollment Σ 0..* Reference(ILCore Group Profile) Inclusion & exclusion criteria
... period Σ 0..1 Period When the study began and ended
... sponsor Σ 0..1 Reference(ILCore Organization Profile) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(ILCore Practitioner Profile | ILCore PractitionerRole Profile) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(ILCore Location Profile) Facility where study activities are conducted
... reasonStopped 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.

... note 0..* Annotation Comments made about the study
... arm 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
.... name 1..1 string Label for study arm
.... type 0..1 CodeableConcept Categorization of study arm
.... description 0..1 string Short explanation of study path
... 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
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.categoryexample
ResearchStudy.focusexample
ResearchStudy.conditionexampleCondition/Problem/DiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
ResearchStudy.keywordexample
ResearchStudy.locationextensibleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ResearchStudy.reasonStoppedexampleResearchStudyReasonStopped
http://hl7.org/fhir/ValueSet/research-study-reason-stopped
from the FHIR Standard
ResearchStudy.objective.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard

Differential View

This structure is derived from ResearchStudy

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy ILCoreResearchStudy Profile
... protocol 0..* Reference(ILCore PlanDefinition Profile) Steps followed in executing study
... partOf 0..* Reference(ILCore ResearchStudy Profile) Part of larger study
... enrollment 0..* Reference(ILCore Group Profile) Inclusion & exclusion criteria
... principalInvestigator 0..1 Reference(ILCore Practitioner Profile | ILCore PractitionerRole Profile) Researcher who oversees multiple aspects of the study
... site 0..* Reference(ILCore Location Profile) Facility where study activities are conducted

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy ILCoreResearchStudy Profile
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... protocol Σ 0..* Reference(ILCore PlanDefinition Profile) Steps followed in executing study
... status ?!Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... enrollment Σ 0..* Reference(ILCore Group Profile) Inclusion & exclusion criteria
... sponsor Σ 0..1 Reference(ILCore Organization Profile) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(ILCore Practitioner Profile | ILCore PractitionerRole Profile) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(ILCore Location Profile) Facility where study activities are conducted

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy 0..* ResearchStudy ILCoreResearchStudy Profile
... 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: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for study
... title Σ 0..1 string Name for this study
... protocol Σ 0..* Reference(ILCore PlanDefinition Profile) Steps followed in executing study
... partOf Σ 0..* Reference(ILCore ResearchStudy Profile) Part of larger study
... status ?!Σ 1..1 code active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.

... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (extensible): 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.

... category Σ 0..* CodeableConcept Classifications for the study
Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.


... focus Σ 0..* CodeableConcept Drugs, devices, etc. under study
Binding: (unbound) (example): Codes for medications, devices and other interventions.


... condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.


... contact Σ 0..* ContactDetail Contact details for the study
... relatedArtifact 0..* RelatedArtifact References and dependencies
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding: (unbound) (example): Words associated with the study that may be useful in discovery.


... location Σ 0..* CodeableConcept Geographic region(s) for study
Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.


... description 0..1 markdown What this is study doing
... enrollment Σ 0..* Reference(ILCore Group Profile) Inclusion & exclusion criteria
... period Σ 0..1 Period When the study began and ended
... sponsor Σ 0..1 Reference(ILCore Organization Profile) Organization that initiates and is legally responsible for the study
... principalInvestigator Σ 0..1 Reference(ILCore Practitioner Profile | ILCore PractitionerRole Profile) Researcher who oversees multiple aspects of the study
... site Σ 0..* Reference(ILCore Location Profile) Facility where study activities are conducted
... reasonStopped 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.

... note 0..* Annotation Comments made about the study
... arm 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
.... name 1..1 string Label for study arm
.... type 0..1 CodeableConcept Categorization of study arm
.... description 0..1 string Short explanation of study path
... 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.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
ResearchStudy.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
ResearchStudy.statusrequiredResearchStudyStatus
http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
from the FHIR Standard
ResearchStudy.primaryPurposeTypeextensibleResearchStudyPrimaryPurposeType
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.categoryexample
ResearchStudy.focusexample
ResearchStudy.conditionexampleCondition/Problem/DiagnosisCodes
http://hl7.org/fhir/ValueSet/condition-code
from the FHIR Standard
ResearchStudy.keywordexample
ResearchStudy.locationextensibleJurisdiction ValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
ResearchStudy.reasonStoppedexampleResearchStudyReasonStopped
http://hl7.org/fhir/ValueSet/research-study-reason-stopped
from the FHIR Standard
ResearchStudy.objective.typepreferredResearchStudyObjectiveType
http://hl7.org/fhir/ValueSet/research-study-objective-type
from the FHIR Standard

 

Other representations of profile: CSV, Excel, Schematron