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/m11-research-study | Version: 1.0.0-ballot3 | ||||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: M11ResearchStudy | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.44.42.58 | |||||
Profile of ResearchStudy for Evidence Based Medicine IG. The M11ResearchStudy Profile is used to report data specified in the ICH M11 Harmonised Guideline CeSHarP. The instance in the Evidence Based Medicine on FHIR IG is a copy of the instance in the HL7 Vulcan Clinical Study Protocol IG, modified for technical support within the Evidence Based Medicine on FHIR IG because the coordination (dependencies) between the IGs cannot be technically established prior to publication of FHIR R6.
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.phase | Base | required | ICH M11 Trial Phase Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.classifier | Base | preferred | ICH M11 Amendment Details Statement 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 StudyDesign
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.identifier.type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.classifier | Base | preferred | ICH M11 Amendment Details Statement Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.associatedParty.role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot3 | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter:  | ||||
|---|---|---|---|---|---|---|---|---|
  ResearchStudy |
0..* | StudyDesign | 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:confidentialityStatement |
0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement | |||||
| extension:saeReportingMethod |
0..1 | string | Method for reporting Serious Adverse Events. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method | |||||
| extension:studyAmendment |
0..1 | (Complex) | An amendment to a study protocol URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment | |||||
| extension:versionDate |
0..1 | date | Protocol version date URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-version-date | |||||
| extension:approval |
0..1 | (Complex) | Approval and sign off URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-approval | |||||
 extension:m11Amendment |
0..1 | (Complex) | An amendment to a study protocol URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment | |||||
 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 | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| use |
0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | |||||
| type |
0..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type Value Set (extensible) | |||||
| system |
0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | |||||
| value |
C | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period |
0..1 | Period | Time period when id is/was valid for use | |||||
  assigner |
0..1 | Reference(Organization) | Organization that issued id (may be just text) | |||||
| 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: ICH M11 Trial Phase Value Set (required) | |||||
| 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. | |||||
| 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: ICH M11 Amendment Details Statement 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: UDP Party Role Type Value Set (extensible) | |||||
| 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.identifier.use | Base | required | IdentifierUse | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.identifier.type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot3 | This IG |
| 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 | required | ICH M11 Trial Phase Value Set | 📦1.0.0-ballot3 | This IG |
| 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 | ICH M11 Amendment Details Statement Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.associatedParty.role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot3 | This IG |
| 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())
|
This structure is derived from StudyDesign
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.phase | Base | required | ICH M11 Trial Phase Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.focus | Base | example | Research Study Focus Type | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.classifier | Base | preferred | ICH M11 Amendment Details Statement 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 StudyDesign
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.identifier.type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.phase | Base | required | ICH M11 Trial Phase Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.classifier | Base | preferred | ICH M11 Amendment Details Statement Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.associatedParty.role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot3 | This IG |
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy |
0..* | StudyDesign | 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:confidentialityStatement |
0..1 | string | Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement | |||||
| extension:saeReportingMethod |
0..1 | string | Method for reporting Serious Adverse Events. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method | |||||
| extension:studyAmendment |
0..1 | (Complex) | An amendment to a study protocol URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment | |||||
| extension:versionDate |
0..1 | date | Protocol version date URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-version-date | |||||
| extension:approval |
0..1 | (Complex) | Approval and sign off URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-approval | |||||
| extension:m11Amendment |
0..1 | (Complex) | An amendment to a study protocol URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-protocol-amendment | |||||
| 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 | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| use |
0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | |||||
| type |
0..1 | CodeableConcept | Description of identifier Binding: UDP Identifier Type Value Set (extensible) | |||||
| system |
0..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | |||||
| value |
C | 0..1 | string | The value that is unique Example General: 123456 | ||||
| period |
0..1 | Period | Time period when id is/was valid for use | |||||
| assigner |
0..1 | Reference(Organization) | Organization that issued id (may be just text) | |||||
| 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: ICH M11 Trial Phase Value Set (required) | |||||
| 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. | |||||
| 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: ICH M11 Amendment Details Statement 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: UDP Party Role Type Value Set (extensible) | |||||
| 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.identifier.use | Base | required | IdentifierUse | 📍6.0.0-snapshot1 | FHIR Std. |
| ResearchStudy.identifier.type | Base | extensible | UDP Identifier Type Value Set | 📦1.0.0-ballot3 | This IG |
| 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 | required | ICH M11 Trial Phase Value Set | 📦1.0.0-ballot3 | This IG |
| 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 | ICH M11 Amendment Details Statement Value Set | 📦1.0.0-ballot3 | This IG |
| ResearchStudy.associatedParty.role | Base | extensible | UDP Party Role Type Value Set | 📦1.0.0-ballot3 | This IG |
| 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())
|
This structure is derived from StudyDesign
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
Links: Table of Contents |
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