IL Core Implementation Guide
0.18.0 - draft
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
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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 | |
sponsor | 0..1 | Reference(ILCore Organization Profile) | Organization that initiates and is legally responsible for the study | |
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 | |
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 |
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completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. |
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 |
Documentation for this format |
Path | Conformance | ValueSet | URI |
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard |
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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. | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard | ||||
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard | ||||
ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard | ||||
ResearchStudy.category | example | |||||
ResearchStudy.focus | example | |||||
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard | ||||
ResearchStudy.keyword | example | |||||
ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | ||||
ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard | ||||
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard |
This structure is derived from ResearchStudy
Summary
Structures
This structure refers to these other structures:
Maturity: 1
Differential View
This structure is derived from ResearchStudy
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 | |
sponsor | 0..1 | Reference(ILCore Organization Profile) | Organization that initiates and is legally responsible for the study | |
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 | |
Documentation for this format |
Key Elements View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
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 |
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. |
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 |
Documentation for this format |
Path | Conformance | ValueSet | URI |
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints | ||||
---|---|---|---|---|---|---|---|---|
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.
| |||||
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. | |||||
Documentation for this format |
Path | Conformance | ValueSet | URI | |||
ResearchStudy.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languages from the FHIR Standard | ||||
ResearchStudy.status | required | ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard | ||||
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard | ||||
ResearchStudy.phase | example | ResearchStudyPhasehttp://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard | ||||
ResearchStudy.category | example | |||||
ResearchStudy.focus | example | |||||
ResearchStudy.condition | example | Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard | ||||
ResearchStudy.keyword | example | |||||
ResearchStudy.location | extensible | Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard | ||||
ResearchStudy.reasonStopped | example | ResearchStudyReasonStoppedhttp://hl7.org/fhir/ValueSet/research-study-reason-stopped from the FHIR Standard | ||||
ResearchStudy.objective.type | preferred | ResearchStudyObjectiveTypehttp://hl7.org/fhir/ValueSet/research-study-objective-type from the FHIR Standard |
This structure is derived from ResearchStudy
Summary
Structures
This structure refers to these other structures:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron