Clinical Study Protocol (Vulcan UDP)
1.0.1-ballot2 - STU 1 - Ballot International flag

Clinical Study Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Resource Profile: M11 Research Study

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile Version: 1.0.1-ballot2
Standards status: Trial-use Draft as of 2025-11-26 Maturity Level: 1 Computable Name: M11_ResearchStudyProfile

Constraint of ResearchStudy to M11 Guidance An instance of this profile represents a single version of the protocol definition. Previous amendments are represented by further instances of ResearchStudy linked through the relatedArtifact attribute.

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:author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
.... extension:RelatesToWithQuotation 0..* (Complex) Related artifact with quoted portion
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
.... 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:narrative 0..* Reference(Research Study Narratives) Narrative Elements
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
.... extension:amendment 0..1 (Complex) Amendment to a protocol - from EBM
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/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: M11 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.phase Base required M11 Phase Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.focus Base example Research Study Focus Type 📍6.0.0-ballot3 FHIR Std.

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())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

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:narrative 0..* Reference(Research Study Narratives) Narrative Elements
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
.... extension:amendment 0..1 (Complex) Amendment to a protocol - from EBM
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/protocol-amendment
... identifier
.... type ?! 1..1 CodeableConcept Description of identifier
Binding: M11 Identifier Type Value Set (extensible)
..... coding
...... code 1..1 code Symbol in syntax defined by the system
... label
.... 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: CDISC DDF Study Title Type Value Set (extensible)
.... type 1..1 code documentation | justification | 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 | specification-of | created-with | cite-as | summarizes
... phase 0..1 CodeableConcept Classifier used for clinical trials
Binding: M11 Phase Value Set (required)
... focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) Drugs, devices, etc. under study
... associatedParty
.... role 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
Binding: NCI Study Role Value Set (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ResearchStudy.identifier.​type Base extensible M11 Identifier Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.label.​type Base extensible CDISC DDF Study Title Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.phase Base required M11 Phase Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.associatedParty.​role Base extensible NCI Study Role Value Set 📦1.0.1-ballot2 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 Extension
Slice: Unordered, Open by value:url
.... extension:author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
.... extension:RelatesToWithQuotation 0..* (Complex) Related artifact with quoted portion
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
.... 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:narrative 0..* Reference(Research Study Narratives) Narrative Elements
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
.... extension:amendment 0..1 (Complex) Amendment to a protocol - from EBM
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/protocol-amendment
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
.... id 0..1 id 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 1..1 CodeableConcept Description of identifier
Binding: M11 Identifier Type Value Set (extensible)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system 0..1 uri Identity of the terminology system
...... version 0..1 string Version of the system - if relevant
...... code C 1..1 code Symbol in syntax defined by the system
...... display C 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... 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 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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: CDISC DDF Study Title Type Value Set (extensible)
.... value 0..1 string The name
... 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
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 code documentation | justification | 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 | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): 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.
... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept Classifier used for clinical trials
Binding: M11 Phase Value Set (required)
... studyDesign Σ 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (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: JurisdictionValueSet (extensible): 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: ResearchStudyClassifiers (example): desc.
... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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
Binding: NCI Study Role 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 Status of study with time for that status
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
.... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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
... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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
... objective 0..* BackboneElement A goal for the study
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 0..1 string Label for the objective
.... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
.... 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
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... 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: StatisticType (example): The type of a statistic, e.g. relative risk or mean.
..... 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
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... 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(Citation | Composition | DiagnosticReport | 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-ballot3 FHIR Std.
ResearchStudy.identifier.​use Base required IdentifierUse 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.identifier.​type Base extensible M11 Identifier Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.label.​type Base extensible CDISC DDF Study Title Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.relatesTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.phase Base required M11 Phase Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.studyDesign Base preferred Study Design 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.focus Base example Research Study Focus Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.keyword Base example Research Study Focus Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.classifier Base example Research Study Classifiers 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible NCI Study Role Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.associatedParty.​classifier Base example Research Study Party Organization Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.whyStopped Base example Research Study Reason Stopped 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.objective.​type Base preferred Research Study Objective Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.objective.​outcomeMeasure.type Base preferred Research Study Objective Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.objective.​outcomeMeasure.summaryMeasure Base example Statistic Type 📍6.0.0-ballot3 FHIR Std.

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())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

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:author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
.... extension:RelatesToWithQuotation 0..* (Complex) Related artifact with quoted portion
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
.... 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:narrative 0..* Reference(Research Study Narratives) Narrative Elements
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
.... extension:amendment 0..1 (Complex) Amendment to a protocol - from EBM
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/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: M11 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

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.phase Base required M11 Phase Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.focus Base example Research Study Focus Type 📍6.0.0-ballot3 FHIR Std.

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())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

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:narrative 0..* Reference(Research Study Narratives) Narrative Elements
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
.... extension:amendment 0..1 (Complex) Amendment to a protocol - from EBM
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/protocol-amendment
... identifier
.... type ?! 1..1 CodeableConcept Description of identifier
Binding: M11 Identifier Type Value Set (extensible)
..... coding
...... code 1..1 code Symbol in syntax defined by the system
... label
.... 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: CDISC DDF Study Title Type Value Set (extensible)
.... type 1..1 code documentation | justification | 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 | specification-of | created-with | cite-as | summarizes
... phase 0..1 CodeableConcept Classifier used for clinical trials
Binding: M11 Phase Value Set (required)
... focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) Drugs, devices, etc. under study
... associatedParty
.... role 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
Binding: NCI Study Role Value Set (extensible)

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
ResearchStudy.identifier.​type Base extensible M11 Identifier Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.label.​type Base extensible CDISC DDF Study Title Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.phase Base required M11 Phase Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.associatedParty.​role Base extensible NCI Study Role Value Set 📦1.0.1-ballot2 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 Extension
Slice: Unordered, Open by value:url
.... extension:author 0..* ContactDetail Who authored the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-author
.... extension:RelatesToWithQuotation 0..* (Complex) Related artifact with quoted portion
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation
.... 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:narrative 0..* Reference(Research Study Narratives) Narrative Elements
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
.... extension:amendment 0..1 (Complex) Amendment to a protocol - from EBM
URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/protocol-amendment
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study
.... id 0..1 id 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 1..1 CodeableConcept Description of identifier
Binding: M11 Identifier Type Value Set (extensible)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding 0..* Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system 0..1 uri Identity of the terminology system
...... version 0..1 string Version of the system - if relevant
...... code C 1..1 code Symbol in syntax defined by the system
...... display C 0..1 string Representation defined by the system
...... userSelected 0..1 boolean If this coding was chosen directly by the user
..... text 0..1 string Plain text representation of the concept
.... 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 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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: CDISC DDF Study Title Type Value Set (extensible)
.... value 0..1 string The name
... 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
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 code documentation | justification | 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 | specification-of | created-with | cite-as | summarizes
Binding: ArtifactRelationshipType (required): 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.
... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: ResearchStudyPrimaryPurposeType (preferred): Codes for the main intent of the study.
... phase Σ 0..1 CodeableConcept Classifier used for clinical trials
Binding: M11 Phase Value Set (required)
... studyDesign Σ 0..* CodeableConcept Classifications of the study design characteristics
Binding: StudyDesign (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: JurisdictionValueSet (extensible): 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: ResearchStudyClassifiers (example): desc.
... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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
Binding: NCI Study Role 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 Status of study with time for that status
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: ResearchStudyStatus (extensible): defn.
.... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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
... 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... 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
... objective 0..* BackboneElement A goal for the study
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 0..1 string Label for the objective
.... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective.
.... 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
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... 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: StatisticType (example): The type of a statistic, e.g. relative risk or mean.
..... 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
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... 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(Citation | Composition | DiagnosticReport | 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-ballot3 FHIR Std.
ResearchStudy.identifier.​use Base required IdentifierUse 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.identifier.​type Base extensible M11 Identifier Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.label.​type Base extensible CDISC DDF Study Title Type Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.relatesTo.​type Base required Artifact Relationship Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.status Base required PublicationStatus 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.primaryPurposeType Base preferred Research Study Primary Purpose Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.phase Base required M11 Phase Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.studyDesign Base preferred Study Design 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.focus Base example Research Study Focus Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.condition Base example Condition/Problem/Diagnosis Codes 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.keyword Base example Research Study Focus Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.region Base extensible Jurisdiction ValueSet 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.classifier Base example Research Study Classifiers 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.associatedParty.​role Base extensible NCI Study Role Value Set 📦1.0.1-ballot2 This IG
ResearchStudy.associatedParty.​classifier Base example Research Study Party Organization Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.progressStatus.​state Base extensible Research Study Status 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.whyStopped Base example Research Study Reason Stopped 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.objective.​type Base preferred Research Study Objective Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.objective.​outcomeMeasure.type Base preferred Research Study Objective Type 📍6.0.0-ballot3 FHIR Std.
ResearchStudy.objective.​outcomeMeasure.summaryMeasure Base example Statistic Type 📍6.0.0-ballot3 FHIR Std.

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())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

 

Other representations of profile: CSV, Excel, Schematron