Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3
World
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 1.0.0-ballot3 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
| Official URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/study-registry-record | Version: 1.0.0-ballot3 | ||||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: StudyRegistryRecord | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.139 | |||||
Profile of ResearchStudy for Evidence Based Medicine IG. The StudyRegistryRecord Profile is used for a scientific study record in a research study registry, such as ClinicalTrials.gov or the European Union Clinical Trial Information System (EU CTIS).
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.classifier | Base | preferred | ResearchStudy Classifier Value Set | 📦1.0.0-ballot3 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
This structure is derived from ResearchStudy
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.classifier | Base | preferred | ResearchStudy Classifier Value Set | 📦1.0.0-ballot3 | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter:  | ||||
|---|---|---|---|---|---|---|---|---|
  ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
  id |
0..1 | id | Logical id of this artifact | |||||
 meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
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
| |||||
| 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 | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
   extension:publicationStatus |
0..1 | CodeableConcept | Publication status URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status Binding: Cited Artifact Status Type (preferred) | |||||
| extension:author |
0..* | ContactDetail | Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author | |||||
| extension:studyRegistration |
0..* | (Complex) | Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration | |||||
 extension:isLowInterventionTrial |
0..1 | boolean | Is a low intervention clinical trial. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-is-low-intervention-trial | |||||
 modifierExtension |
0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | |||||
| url |
0..1 | uri | Canonical identifier for this study resource | |||||
| identifier |
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 |
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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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: Title Type (preferred): desc. | |||||
| value |
0..1 | string | The name | |||||
 language |
0..1 | code | Used to express the specific language Binding: AllLanguages (required): IETF language tag for a human language
| |||||
 protocol |
0..* | Reference(PlanDefinition) | Steps followed in executing study | |||||
| partOf |
0..* | Reference(ResearchStudy) | Part of larger study | |||||
| citeAs |
0..1 | markdown | How to cite this ResearchStudy | |||||
| relatesTo |
0..* | BackboneElement | Relationships to other Resources | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension:quotation |
0..1 | markdown | Quoted portion from related artifact URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation | |||||
| extension:classifier |
0..1 | CodeableConcept | A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| type |
1..1 | CodeableConcept | documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. | |||||
  target[x] |
1..1 | The artifact that is related to this ResearchStudy | ||||||
 targetUri |
uri | |||||||
| targetAttachment |
Attachment | |||||||
| targetCanonical |
canonical(Resource) | |||||||
| targetReference |
Reference(Resource) | |||||||
| targetMarkdown |
markdown | |||||||
| date |
0..1 | dateTime | Date the resource last changed | |||||
| status |
1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | |||||
| purposeType |
0..* | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPurposeType (preferred): Codes for the main intent of the study. | |||||
| phase |
0..1 | CodeableConcept | Classifier used for clinical trials Binding: ResearchStudyPhase (preferred): Classifiers of clinical trial progression for human use. | |||||
| studyDesign |
0..* | CodeableConcept | Classifications of the study design characteristics Binding: Study Design (preferred): This is a set of terms for study design characteristics. | |||||
| focus |
0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus | |||||
| condition |
0..* | CodeableConcept | Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis. | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension:isRareDisease |
0..1 | boolean | Is a rare disease URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-is-rare-disease | |||||
| coding |
0..* | Coding | Code defined by a terminology system | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:translation |
0..* | (Complex) | Language Translation (Localization) URL: http://hl7.org/fhir/StructureDefinition/translation | |||||
| value |
0..1 | string | Primitive value for string Max Length:1048576 | |||||
| keyword |
0..* | CodeableConcept | Used to search for the study Binding: ResearchStudyFocusType (example): Some example codes. | |||||
| region |
0..* | CodeableConcept | Geographic area for the study Binding: Jurisdiction ValueSet (preferred): 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 |
0..1 | Period | When the study began and ended | |||||
| site |
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: ResearchStudy Classifier Value Set (preferred) | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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-chair | irb | data-monitoring Binding: Research Study Party Role (preferred): This is a ResearchStudy's party role. | |||||
| 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 | Dates for status changes for the conduct of the study, or study registry and administrative actions | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| state |
1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: Research Study Status (preferred): Codes that convey the current status of the research study. | |||||
| actual |
0..1 | boolean | Actual if true else anticipated | |||||
| period |
0..1 | Period | Date range | |||||
| whyStopped |
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 |
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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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) | Inclusion and exclusion criteria | |||||
| actualGroup |
0..1 | Reference(Group) | Group of participants who were enrolled in study | |||||
| description |
0..1 | markdown | Description of the recruitment | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| targetNumber |
0..1 | unsignedInt | Estimated total number of participants to be enrolled in the comparison group | |||||
| actualNumber |
0..1 | unsignedInt | Actual total number of participants enrolled in the comparison group | |||||
| eligibility |
0..1 | Reference(Group) | Inclusion and exclusion criteria for the comparison group | |||||
| observedGroup |
0..1 | Reference(Group) | Group of participants who were enrolled in the comparison group | |||||
| name |
0..1 | string | A simple label for the comparison Group | |||||
| description |
0..1 | markdown | Description of the comparison Group | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| name |
0..1 | string | Label for the outcome measure | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn. | |||||
| description |
0..1 | markdown | Description of the outcome measure | |||||
| endpoint |
1..1 | Reference(EvidenceVariable) | Definition of the outcome measure | |||||
| population |
0..1 | Reference(Group) | Population for this estimand | |||||
| intervention |
0..1 | Reference(Group) | Comparison group of interest | |||||
| comparator |
0..1 | Reference(Group) | Comparison group for comparison | |||||
| summaryMeasure |
0..1 | CodeableConcept | Statistical measure for treatment effect estimate Binding: Statistic Type (example): The type of a statistic, e.g. relative risk or mean. | |||||
| endpointAnalysisPlan |
0..1 | Reference(Evidence) | Statistical analysis plan for a single endpoint | |||||
| eventHandling |
0..* | BackboneElement | Handling of intercurrent event | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| event |
0..1 | CodeableConcept | The event | |||||
| group |
0..1 | CodeableConcept | The group that is affected by this event handling | |||||
| handling |
0..1 | CodeableConcept | How the data is handled | |||||
| description |
0..1 | markdown | Text summary of event handling | |||||
| result |
0..* | Reference(Composition | DiagnosticReport | DocumentReference | Evidence) | Link to results generated during the study | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | required | All Languages | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.label.type | Base | preferred | Title Type | 📦1.0.0 | THO v7.5 |
| ResearchStudy.label.language | Base | required | All Languages | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.relatesTo.type | Base | extensible | Artifact Relationship Type | 📦1.0.0 | THO v7.5 |
| ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.purposeType | Base | preferred | ResearchStudyPurposeType | 📦2.0.0 | THO v7.5 |
| ResearchStudy.phase | Base | preferred | ResearchStudyPhase | 📦2.0.0 | THO v7.5 |
| ResearchStudy.studyDesign | Base | preferred | Study Design | 📦1.0.0 | THO v7.5 |
| ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.keyword | Base | example | Research Study Focus Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.region | Base | preferred | Jurisdiction ValueSet | 📦1.0.0 | THO v7.5 |
| ResearchStudy.classifier | Base | preferred | ResearchStudy Classifier Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.associatedParty.role | Base | preferred | Research Study Party Role | 📦1.0.0 | THO v7.5 |
| ResearchStudy.associatedParty.classifier | Base | example | Research Study Party Organization Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.progressStatus.state | Base | preferred | Research Study Status | 📦1.0.0 | THO v7.5 |
| ResearchStudy.whyStopped | Base | example | ResearchStudyReasonStopped | 📦2.0.0 | THO v7.5 |
| ResearchStudy.objective.type | Base | preferred | ResearchStudyObjectiveType | 📦2.0.0 | THO v7.5 |
| ResearchStudy.objective.outcomeMeasure.type | Base | preferred | ResearchStudyObjectiveType | 📦2.0.0 | THO v7.5 |
| ResearchStudy.objective.outcomeMeasure.summaryMeasure | Base | example | Statistic Type | 📦2.0.0 | THO v7.5 |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Summary
Extensions
This structure refers to these extensions:
Maturity: 1
Key Elements View
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.classifier | Base | preferred | ResearchStudy Classifier Value Set | 📦1.0.0-ballot3 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
Differential View
This structure is derived from ResearchStudy
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.classifier | Base | preferred | ResearchStudy Classifier Value Set | 📦1.0.0-ballot3 | This IG |
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
| id |
0..1 | id | Logical id of this artifact | |||||
| meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
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
| |||||
| 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 | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension:publicationStatus |
0..1 | CodeableConcept | Publication status URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status Binding: Cited Artifact Status Type (preferred) | |||||
| extension:author |
0..* | ContactDetail | Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author | |||||
| extension:studyRegistration |
0..* | (Complex) | Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration | |||||
| extension:isLowInterventionTrial |
0..1 | boolean | Is a low intervention clinical trial. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-is-low-intervention-trial | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | |||||
| url |
0..1 | uri | Canonical identifier for this study resource | |||||
| identifier |
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 |
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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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: Title Type (preferred): desc. | |||||
| value |
0..1 | string | The name | |||||
| language |
0..1 | code | Used to express the specific language Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| protocol |
0..* | Reference(PlanDefinition) | Steps followed in executing study | |||||
| partOf |
0..* | Reference(ResearchStudy) | Part of larger study | |||||
| citeAs |
0..1 | markdown | How to cite this ResearchStudy | |||||
| relatesTo |
0..* | BackboneElement | Relationships to other Resources | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension:quotation |
0..1 | markdown | Quoted portion from related artifact URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation | |||||
| extension:classifier |
0..1 | CodeableConcept | A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| type |
1..1 | CodeableConcept | documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. | |||||
| target[x] |
1..1 | The artifact that is related to this ResearchStudy | ||||||
| targetUri |
uri | |||||||
| targetAttachment |
Attachment | |||||||
| targetCanonical |
canonical(Resource) | |||||||
| targetReference |
Reference(Resource) | |||||||
| targetMarkdown |
markdown | |||||||
| date |
0..1 | dateTime | Date the resource last changed | |||||
| status |
1..1 | code | draft | active | retired | unknown Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource. | |||||
| purposeType |
0..* | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPurposeType (preferred): Codes for the main intent of the study. | |||||
| phase |
0..1 | CodeableConcept | Classifier used for clinical trials Binding: ResearchStudyPhase (preferred): Classifiers of clinical trial progression for human use. | |||||
| studyDesign |
0..* | CodeableConcept | Classifications of the study design characteristics Binding: Study Design (preferred): This is a set of terms for study design characteristics. | |||||
| focus |
0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus | |||||
| condition |
0..* | CodeableConcept | Condition being studied Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis. | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| extension:isRareDisease |
0..1 | boolean | Is a rare disease URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-is-rare-disease | |||||
| coding |
0..* | Coding | Code defined by a terminology system | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| id |
0..1 | string | xml:id (or equivalent in JSON) | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| extension:translation |
0..* | (Complex) | Language Translation (Localization) URL: http://hl7.org/fhir/StructureDefinition/translation | |||||
| value |
0..1 | string | Primitive value for string Max Length:1048576 | |||||
| keyword |
0..* | CodeableConcept | Used to search for the study Binding: ResearchStudyFocusType (example): Some example codes. | |||||
| region |
0..* | CodeableConcept | Geographic area for the study Binding: Jurisdiction ValueSet (preferred): 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 |
0..1 | Period | When the study began and ended | |||||
| site |
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: ResearchStudy Classifier Value Set (preferred) | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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-chair | irb | data-monitoring Binding: Research Study Party Role (preferred): This is a ResearchStudy's party role. | |||||
| 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 | Dates for status changes for the conduct of the study, or study registry and administrative actions | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| state |
1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: Research Study Status (preferred): Codes that convey the current status of the research study. | |||||
| actual |
0..1 | boolean | Actual if true else anticipated | |||||
| period |
0..1 | Period | Date range | |||||
| whyStopped |
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 |
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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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) | Inclusion and exclusion criteria | |||||
| actualGroup |
0..1 | Reference(Group) | Group of participants who were enrolled in study | |||||
| description |
0..1 | markdown | Description of the recruitment | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| targetNumber |
0..1 | unsignedInt | Estimated total number of participants to be enrolled in the comparison group | |||||
| actualNumber |
0..1 | unsignedInt | Actual total number of participants enrolled in the comparison group | |||||
| eligibility |
0..1 | Reference(Group) | Inclusion and exclusion criteria for the comparison group | |||||
| observedGroup |
0..1 | Reference(Group) | Group of participants who were enrolled in the comparison group | |||||
| name |
0..1 | string | A simple label for the comparison Group | |||||
| description |
0..1 | markdown | Description of the comparison Group | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| 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 Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| name |
0..1 | string | Label for the outcome measure | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): defn. | |||||
| description |
0..1 | markdown | Description of the outcome measure | |||||
| endpoint |
1..1 | Reference(EvidenceVariable) | Definition of the outcome measure | |||||
| population |
0..1 | Reference(Group) | Population for this estimand | |||||
| intervention |
0..1 | Reference(Group) | Comparison group of interest | |||||
| comparator |
0..1 | Reference(Group) | Comparison group for comparison | |||||
| summaryMeasure |
0..1 | CodeableConcept | Statistical measure for treatment effect estimate Binding: Statistic Type (example): The type of a statistic, e.g. relative risk or mean. | |||||
| endpointAnalysisPlan |
0..1 | Reference(Evidence) | Statistical analysis plan for a single endpoint | |||||
| eventHandling |
0..* | BackboneElement | Handling of intercurrent event | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||
| event |
0..1 | CodeableConcept | The event | |||||
| group |
0..1 | CodeableConcept | The group that is affected by this event handling | |||||
| handling |
0..1 | CodeableConcept | How the data is handled | |||||
| description |
0..1 | markdown | Text summary of event handling | |||||
| result |
0..* | Reference(Composition | DiagnosticReport | DocumentReference | Evidence) | Link to results generated during the study | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | required | All Languages | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.label.type | Base | preferred | Title Type | 📦1.0.0 | THO v7.5 |
| ResearchStudy.label.language | Base | required | All Languages | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.relatesTo.type | Base | extensible | Artifact Relationship Type | 📦1.0.0 | THO v7.5 |
| ResearchStudy.status | Base | required | PublicationStatus | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.purposeType | Base | preferred | ResearchStudyPurposeType | 📦2.0.0 | THO v7.5 |
| ResearchStudy.phase | Base | preferred | ResearchStudyPhase | 📦2.0.0 | THO v7.5 |
| ResearchStudy.studyDesign | Base | preferred | Study Design | 📦1.0.0 | THO v7.5 |
| ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.keyword | Base | example | Research Study Focus Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.region | Base | preferred | Jurisdiction ValueSet | 📦1.0.0 | THO v7.5 |
| ResearchStudy.classifier | Base | preferred | ResearchStudy Classifier Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.associatedParty.role | Base | preferred | Research Study Party Role | 📦1.0.0 | THO v7.5 |
| ResearchStudy.associatedParty.classifier | Base | example | Research Study Party Organization Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.progressStatus.state | Base | preferred | Research Study Status | 📦1.0.0 | THO v7.5 |
| ResearchStudy.whyStopped | Base | example | ResearchStudyReasonStopped | 📦2.0.0 | THO v7.5 |
| ResearchStudy.objective.type | Base | preferred | ResearchStudyObjectiveType | 📦2.0.0 | THO v7.5 |
| ResearchStudy.objective.outcomeMeasure.type | Base | preferred | ResearchStudyObjectiveType | 📦2.0.0 | THO v7.5 |
| ResearchStudy.objective.outcomeMeasure.summaryMeasure | Base | example | Statistic Type | 📦2.0.0 | THO v7.5 |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Summary
Extensions
This structure refers to these extensions:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-snapshot1.
Generated
2026-11-05
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