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

Resource Profile: M11ResearchStudy

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

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* StudyDesign Investigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension Content/Rules for all slices
.... 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
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... phase Σ 0..1 CodeableConcept Classifier used for clinical trials
Binding: ICH M11 Trial Phase Value Set (required)
... focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Some example codes of research study focus
... classifier 0..* CodeableConcept Classification for the study
Binding: ICH M11 Amendment Details Statement Value Set (preferred)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot5 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-ballot5 FHIR Std.
ResearchStudy.classifier Base preferred ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG

Constraints

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())

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* StudyDesign Investigation to increase healthcare-related patient-independent knowledge
... Slices for extension Content/Rules for all slices
.... 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
... identifier
.... type 0..1 CodeableConcept Description of identifier
Binding: UDP Identifier Type Value Set (extensible)
... phase 0..1 CodeableConcept Classifier used for clinical trials
Binding: ICH M11 Trial Phase Value Set (required)
... classifier 0..* CodeableConcept Classification for the study
Binding: ICH M11 Amendment Details Statement Value Set (preferred)
... associatedParty
.... 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)

doco Documentation for this format

Terminology Bindings (Differential)

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
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* StudyDesign 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 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 ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: UDP Identifier Type Value Set (extensible)
.... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 0..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 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 Σ 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 ?!Σ 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
Additional BindingsPurpose
CommonLanguages Starter
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf Σ 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 ?!Σ 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 ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... purposeType Σ 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 Σ 0..1 CodeableConcept Classifier used for clinical trials
Binding: ICH M11 Trial Phase Value Set (required)
... studyDesign Σ 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 Σ 0..* CodeableConcept Condition being studied
Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding: ResearchStudyFocusType (example): Some example codes.
... region Σ 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 Σ 0..1 Period When the study began and ended
... site Σ 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 ?!Σ 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 ?!Σ 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 Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
... recruitment Σ 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 ?!Σ 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 Σ 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 ?!Σ 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 ?!Σ 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 ?!Σ 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 ?!Σ 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 Σ 0..* Reference(Composition | DiagnosticReport | DocumentReference | Evidence) Link to results generated during the study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base required All Languages 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.identifier.​use Base required IdentifierUse 📍6.0.0-ballot5 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 v7.4
ResearchStudy.label.​language Base required All Languages 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.relatesTo.​type Base extensible Artifact Relationship Type 📦1.0.0 THO v7.4
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.purposeType Base preferred ResearchStudyPurposeType 📦2.0.0 THO v7.4
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 v7.4
ResearchStudy.focus Base example Research Study Focus Type 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.keyword Base example Research Study Focus Type 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.region Base preferred Jurisdiction ValueSet 📦1.0.0 THO v7.4
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-ballot5 FHIR Std.
ResearchStudy.progressStatus.​state Base preferred Research Study Status 📦1.0.0 THO v7.4
ResearchStudy.whyStopped Base example ResearchStudyReasonStopped 📦2.0.0 THO v7.4
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📦2.0.0 THO v7.4
ResearchStudy.objective.​outcomeMeasure.type Base preferred ResearchStudyObjectiveType 📦2.0.0 THO v7.4
ResearchStudy.objective.​outcomeMeasure.summaryMeasure Base example Statistic Type 📦2.0.0 THO v7.4

Constraints

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())

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* StudyDesign Investigation to increase healthcare-related patient-independent knowledge
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension Content/Rules for all slices
.... 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
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... phase Σ 0..1 CodeableConcept Classifier used for clinical trials
Binding: ICH M11 Trial Phase Value Set (required)
... focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) Drugs, devices, etc. under study
Binding: ResearchStudyFocusType (example): Some example codes of research study focus
... classifier 0..* CodeableConcept Classification for the study
Binding: ICH M11 Amendment Details Statement Value Set (preferred)

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot5 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-ballot5 FHIR Std.
ResearchStudy.classifier Base preferred ICH M11 Amendment Details Statement Value Set 📦1.0.0-ballot3 This IG

Constraints

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* StudyDesign Investigation to increase healthcare-related patient-independent knowledge
... Slices for extension Content/Rules for all slices
.... 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
... identifier
.... type 0..1 CodeableConcept Description of identifier
Binding: UDP Identifier Type Value Set (extensible)
... phase 0..1 CodeableConcept Classifier used for clinical trials
Binding: ICH M11 Trial Phase Value Set (required)
... classifier 0..* CodeableConcept Classification for the study
Binding: ICH M11 Amendment Details Statement Value Set (preferred)
... associatedParty
.... 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)

doco Documentation for this format

Terminology Bindings (Differential)

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. ResearchStudy 0..* StudyDesign 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: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 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 ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
.... type Σ 0..1 CodeableConcept Description of identifier
Binding: UDP Identifier Type Value Set (extensible)
.... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
.... value ΣC 0..1 string The value that is unique
Example General: 123456
.... period Σ 0..1 Period Time period when id is/was valid for use
.... assigner Σ 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 Σ 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 ?!Σ 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
Additional BindingsPurpose
CommonLanguages Starter
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study
... partOf Σ 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 ?!Σ 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 ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (required): Codes that convey the current publication status of the research study resource.
... purposeType Σ 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 Σ 0..1 CodeableConcept Classifier used for clinical trials
Binding: ICH M11 Trial Phase Value Set (required)
... studyDesign Σ 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 Σ 0..* CodeableConcept Condition being studied
Binding: ConditionProblemDiagnosisCodes (example): Identification of the condition or diagnosis.
... keyword Σ 0..* CodeableConcept Used to search for the study
Binding: ResearchStudyFocusType (example): Some example codes.
... region Σ 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 Σ 0..1 Period When the study began and ended
... site Σ 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 ?!Σ 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 ?!Σ 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 Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely.
... recruitment Σ 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 ?!Σ 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 Σ 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 ?!Σ 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 ?!Σ 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 ?!Σ 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 ?!Σ 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 Σ 0..* Reference(Composition | DiagnosticReport | DocumentReference | Evidence) Link to results generated during the study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.language Base required All Languages 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.identifier.​use Base required IdentifierUse 📍6.0.0-ballot5 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 v7.4
ResearchStudy.label.​language Base required All Languages 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.relatesTo.​type Base extensible Artifact Relationship Type 📦1.0.0 THO v7.4
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.purposeType Base preferred ResearchStudyPurposeType 📦2.0.0 THO v7.4
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 v7.4
ResearchStudy.focus Base example Research Study Focus Type 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.keyword Base example Research Study Focus Type 📍6.0.0-ballot5 FHIR Std.
ResearchStudy.region Base preferred Jurisdiction ValueSet 📦1.0.0 THO v7.4
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-ballot5 FHIR Std.
ResearchStudy.progressStatus.​state Base preferred Research Study Status 📦1.0.0 THO v7.4
ResearchStudy.whyStopped Base example ResearchStudyReasonStopped 📦2.0.0 THO v7.4
ResearchStudy.objective.​type Base preferred ResearchStudyObjectiveType 📦2.0.0 THO v7.4
ResearchStudy.objective.​outcomeMeasure.type Base preferred ResearchStudyObjectiveType 📦2.0.0 THO v7.4
ResearchStudy.objective.​outcomeMeasure.summaryMeasure Base example Statistic Type 📦2.0.0 THO v7.4

Constraints

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())

 

Other representations of profile: CSV, Excel, Schematron