Extensions for Using Data Elements from FHIR R5 in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R5 in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R5 in FHIR STU3 - Downloaded Version null See the Directory of published versions
| Official URL: http://hl7.org/fhir/5.0/StructureDefinition/profile-ResearchStudy | Version: 0.1.0 | |||
| Standards status: Trial-use | Maturity Level: 0 | Computable Name: Profile_R5_ResearchStudy_R3 | ||
This cross-version profile allows R5 ResearchStudy content to be represented via FHIR STU3 ResearchStudy resources.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required |
ResearchStudyStatus
|
📍3.0.2 | tx.fhir.org |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| 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 |
contained.where(('#'+id in %resource.descendants().reference).not()).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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints Filter:   | ||||
|---|---|---|---|---|---|---|---|---|
  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: Common Languages (extensible): A human language.
| |||||
| 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 | |||||
  Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
   extension:url |
0..1 | uri | R5: Canonical identifier for this study resource (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url | |||||
| extension:version |
0..1 | string | R5: The business version for the study record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version | |||||
| extension:name |
0..1 | string | R5: Name for this study (computer friendly) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name | |||||
| extension:label |
0..* | (Complex) | R5: Additional names for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label | |||||
| extension:date |
0..1 | dateTime | R5: Date the resource last changed (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date | |||||
| extension:primaryPurposeType |
0..1 | CodeableConcept | R5: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType Binding: R5ResearchStudyPrimPurpTypeForR3 (0.1.0) (preferred): Codes for the main intent of the study. | |||||
| extension:phase |
0..1 | CodeableConcept | R5: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.phase Binding: R5ResearchStudyPhaseForR3 (0.1.0) (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | |||||
| extension:studyDesign |
0..* | CodeableConcept | R5: Classifications of the study design characteristics (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign Binding: R5StudyDesignForR3 (0.1.0) (preferred): This is a set of terms for study design characteristics. | |||||
| extension:condition |
0..* | CodeableConcept | R5: Condition being studied (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.condition | |||||
| extension:descriptionSummary |
0..1 | markdown | R5: Brief text explaining the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary | |||||
| extension:classifier |
0..* | CodeableConcept | R5: Classification for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier Binding: R5ResearchStudyClassifiersForR3 (0.1.0) (example): desc. | |||||
| extension:associatedParty |
0..* | (Complex) | R5: Sponsors, collaborators, and other parties (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty | |||||
| extension:progressStatus |
0..* | (Complex) | R5: Status of study with time for that status (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus | |||||
| extension:targetNumber |
0..1 | unsignedInt | R5: Estimated total number of participants to be enrolled (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber | |||||
| extension:actualNumber |
0..1 | unsignedInt | R5: Actual total number of participants enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber | |||||
| extension:actualGroup |
0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR STU3(0.1.0) | Group) | R5: Group of participants who were enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup | |||||
| extension:objective |
0..* | (Complex) | R5: A goal for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective | |||||
| extension:outcomeMeasure |
0..* | (Complex) | R5: A variable measured during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure | |||||
 extension:result |
0..* | Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR STU3(0.1.0) | Basic | Cross-version Profile for R5.Citation for use in FHIR STU3(0.1.0) | Basic | Cross-version Profile for R5.DiagnosticReport for use in FHIR STU3(0.1.0) | DiagnosticReport) | R5: Link to results generated during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result | |||||
 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(PlanDefinition) | Steps followed in executing study | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:protocol |
0..* | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: protocol additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
 display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:partOf |
0..* | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: partOf additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| status |
?!Σ | 1..1 | code | draft | in-progress | suspended | stopped | completed | entered-in-error Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:status |
0..1 | code | R5: draft | active | retired | unknown additional codes URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | |||||
| value |
0..1 | code | Primitive value for code | |||||
| category |
Σ | 0..* | CodeableConcept | Classifications for the study Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| focus |
Σ | 0..* | CodeableConcept | Drugs, devices, conditions, etc. under study Binding Description: (example): Codes for medications, devices, conditions and other interventions | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:focus |
0..* | (Complex) | R5: Drugs, devices, etc. under study additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus | |||||
| coding |
Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text |
Σ | 0..1 | string | Plain text representation of the concept | ||||
| 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 Description: (example): Words associated with the study that may be useful in discovery | ||||
| jurisdiction |
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(Group) | Inclusion & exclusion criteria | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:eligibility |
0..1 | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: Inclusion and exclusion criteria additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner) | The individual responsible for the study | ||||
| site |
Σ | 0..* | Reference(Location) | Location involved in study execution | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:site |
0..* | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: Facility where study activities are conducted URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| reasonStopped |
Σ | 0..1 | CodeableConcept | Reason for terminating study early | ||||
| note |
0..* | Annotation | Comments made about the event | |||||
 arm |
0..* | BackboneElement | Defined path through the study for a subject | |||||
 id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:linkId |
0..1 | id | R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId | |||||
| extension:intendedExposure |
0..* | Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR STU3(0.1.0) | Basic) | R5: Interventions or exposures in this comparisonGroup or cohort (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure | |||||
| extension:observedGroup |
0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR STU3(0.1.0) | Group) | R5: Group of participants who were enrolled in study comparisonGroup (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| name |
1..1 | string | Label for study arm | |||||
| code |
0..1 | CodeableConcept | Categorization of study arm | |||||
| description |
0..1 | string | Short explanation of study path | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | extensible |
Common Languages
|
📍3.0.2 | tx.fhir.org |
| ResearchStudy.status | Base | required |
ResearchStudyStatus
|
📍3.0.2 | tx.fhir.org |
| ResearchStudy.category | Base | example | Not State | Unknown | |
| ResearchStudy.focus | Base | example | Not State | Unknown | |
| ResearchStudy.keyword | Base | example | Not State | Unknown | |
| ResearchStudy.jurisdiction | Base | extensible | Jurisdiction ValueSet | 📍3.0.2 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| 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 |
contained.where(('#'+id in %resource.descendants().reference).not()).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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Summary
Extensions
This structure refers to these extensions:
Maturity: 0
Key Elements View
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required |
ResearchStudyStatus
|
📍3.0.2 | tx.fhir.org |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| 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 |
contained.where(('#'+id in %resource.descendants().reference).not()).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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
This structure is derived from ResearchStudy
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| 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: Common Languages (extensible): A human language.
| |||||
| 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 | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:url |
0..1 | uri | R5: Canonical identifier for this study resource (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url | |||||
| extension:version |
0..1 | string | R5: The business version for the study record (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version | |||||
| extension:name |
0..1 | string | R5: Name for this study (computer friendly) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name | |||||
| extension:label |
0..* | (Complex) | R5: Additional names for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label | |||||
| extension:date |
0..1 | dateTime | R5: Date the resource last changed (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date | |||||
| extension:primaryPurposeType |
0..1 | CodeableConcept | R5: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType Binding: R5ResearchStudyPrimPurpTypeForR3 (0.1.0) (preferred): Codes for the main intent of the study. | |||||
| extension:phase |
0..1 | CodeableConcept | R5: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.phase Binding: R5ResearchStudyPhaseForR3 (0.1.0) (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | |||||
| extension:studyDesign |
0..* | CodeableConcept | R5: Classifications of the study design characteristics (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign Binding: R5StudyDesignForR3 (0.1.0) (preferred): This is a set of terms for study design characteristics. | |||||
| extension:condition |
0..* | CodeableConcept | R5: Condition being studied (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.condition | |||||
| extension:descriptionSummary |
0..1 | markdown | R5: Brief text explaining the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary | |||||
| extension:classifier |
0..* | CodeableConcept | R5: Classification for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier Binding: R5ResearchStudyClassifiersForR3 (0.1.0) (example): desc. | |||||
| extension:associatedParty |
0..* | (Complex) | R5: Sponsors, collaborators, and other parties (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty | |||||
| extension:progressStatus |
0..* | (Complex) | R5: Status of study with time for that status (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus | |||||
| extension:targetNumber |
0..1 | unsignedInt | R5: Estimated total number of participants to be enrolled (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber | |||||
| extension:actualNumber |
0..1 | unsignedInt | R5: Actual total number of participants enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber | |||||
| extension:actualGroup |
0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR STU3(0.1.0) | Group) | R5: Group of participants who were enrolled in study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup | |||||
| extension:objective |
0..* | (Complex) | R5: A goal for the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective | |||||
| extension:outcomeMeasure |
0..* | (Complex) | R5: A variable measured during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure | |||||
| extension:result |
0..* | Reference(Cross-version Profile for R5.EvidenceReport for use in FHIR STU3(0.1.0) | Basic | Cross-version Profile for R5.Citation for use in FHIR STU3(0.1.0) | Basic | Cross-version Profile for R5.DiagnosticReport for use in FHIR STU3(0.1.0) | DiagnosticReport) | R5: Link to results generated during the study (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result | |||||
| 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(PlanDefinition) | Steps followed in executing study | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:protocol |
0..* | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: protocol additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:partOf |
0..* | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: partOf additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| status |
?!Σ | 1..1 | code | draft | in-progress | suspended | stopped | completed | entered-in-error Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:status |
0..1 | code | R5: draft | active | retired | unknown additional codes URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | |||||
| value |
0..1 | code | Primitive value for code | |||||
| category |
Σ | 0..* | CodeableConcept | Classifications for the study Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| focus |
Σ | 0..* | CodeableConcept | Drugs, devices, conditions, etc. under study Binding Description: (example): Codes for medications, devices, conditions and other interventions | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:focus |
0..* | (Complex) | R5: Drugs, devices, etc. under study additional types URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus | |||||
| coding |
Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text |
Σ | 0..1 | string | Plain text representation of the concept | ||||
| 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 Description: (example): Words associated with the study that may be useful in discovery | ||||
| jurisdiction |
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(Group) | Inclusion & exclusion criteria | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:eligibility |
0..1 | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: Inclusion and exclusion criteria additional types URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner) | The individual responsible for the study | ||||
| site |
Σ | 0..* | Reference(Location) | Location involved in study execution | ||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:site |
0..* | ?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]] | R5: Facility where study activities are conducted URL: http://hl7.org/fhir/StructureDefinition/alternate-reference | |||||
| reference |
ΣC | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| identifier |
Σ | 0..1 | Identifier | Logical reference, when literal reference is not known | ||||
| display |
Σ | 0..1 | string | Text alternative for the resource | ||||
| reasonStopped |
Σ | 0..1 | CodeableConcept | Reason for terminating study early | ||||
| note |
0..* | Annotation | Comments made about the event | |||||
| arm |
0..* | BackboneElement | Defined path through the study for a subject | |||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:linkId |
0..1 | id | R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId | |||||
| extension:intendedExposure |
0..* | Reference(Cross-version Profile for R5.EvidenceVariable for use in FHIR STU3(0.1.0) | Basic) | R5: Interventions or exposures in this comparisonGroup or cohort (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure | |||||
| extension:observedGroup |
0..1 | Reference(Cross-version Profile for R5.Group for use in FHIR STU3(0.1.0) | Group) | R5: Group of participants who were enrolled in study comparisonGroup (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| name |
1..1 | string | Label for study arm | |||||
| code |
0..1 | CodeableConcept | Categorization of study arm | |||||
| description |
0..1 | string | Short explanation of study path | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | extensible |
Common Languages
|
📍3.0.2 | tx.fhir.org |
| ResearchStudy.status | Base | required |
ResearchStudyStatus
|
📍3.0.2 | tx.fhir.org |
| ResearchStudy.category | Base | example | Not State | Unknown | |
| ResearchStudy.focus | Base | example | Not State | Unknown | |
| ResearchStudy.keyword | Base | example | Not State | Unknown | |
| ResearchStudy.jurisdiction | Base | extensible | Jurisdiction ValueSet | 📍3.0.2 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-1 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain any narrative |
contained.text.empty()
|
| 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 |
contained.where(('#'+id in %resource.descendants().reference).not()).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()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() | (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Summary
Extensions
This structure refers to these extensions:
Maturity: 0
Other representations of profile: CSV, Excel, Schematron
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r5.r3#0.1.0 based on FHIR 3.0.2. Generated 2026-03-20
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change
