Pharmaceutical Research 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 1.0.0-ballot 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

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Resource Profile: M11 Research Study

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:

• Examples for this Profile: ResearchStudy/IGBJ-ResearchStudy

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
extension:amendment		0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.phase	required	M11PhaseVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs From this IG
ResearchStudy.focus	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ResearchStudy	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ResearchStudy	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ResearchStudy	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from StudyDesign

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
extension:amendment		0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/pharmaceutical-research-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)
relatesTo
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)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ResearchStudy.identifier.type	extensible	M11IdentifierType_VS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-identifier-type-vs From this IG
ResearchStudy.label.type	extensible	DDFStudyTitleTypeVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/ddf-study-title-type-vs From this IG
ResearchStudy.phase	required	M11PhaseVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs From this IG
ResearchStudy.associatedParty.role	extensible	NCIStudyRoleVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/nci-study-role-vs From this IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Bindings Purpose 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/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
extension:amendment		0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/pharmaceutical-research-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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.identifier.type	extensible	M11IdentifierType_VS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-identifier-type-vs From this IG
ResearchStudy.label.type	extensible	DDFStudyTitleTypeVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/ddf-study-title-type-vs From this IG
ResearchStudy.relatesTo.type	required	ArtifactRelationshipType http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.primaryPurposeType	preferred	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type From the FHIR Standard
ResearchStudy.phase	required	M11PhaseVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs From this IG
ResearchStudy.studyDesign	preferred	StudyDesign http://hl7.org/fhir/ValueSet/study-design From the FHIR Standard
ResearchStudy.focus	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type From the FHIR Standard
ResearchStudy.condition	example	ConditionProblemDiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code From the FHIR Standard
ResearchStudy.keyword	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type From the FHIR Standard
ResearchStudy.region	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction From the FHIR Standard
ResearchStudy.classifier	example	ResearchStudyClassifiers http://hl7.org/fhir/ValueSet/research-study-classifiers From the FHIR Standard
ResearchStudy.associatedParty.role	extensible	NCIStudyRoleVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/nci-study-role-vs From this IG
ResearchStudy.associatedParty.classifier	example	ResearchStudyPartyOrgType http://hl7.org/fhir/ValueSet/research-study-party-organization-type From the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status From the FHIR Standard
ResearchStudy.whyStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped From the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard
ResearchStudy.objective.outcomeMeasure.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard
ResearchStudy.objective.outcomeMeasure.summaryMeasure	example	StatisticType http://hl7.org/fhir/ValueSet/statistic-type From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ResearchStudy	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ResearchStudy	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ResearchStudy	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from StudyDesign

Summary

Mandatory: 0 element(2 nested mandatory elements)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
• http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment

Maturity: 1

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
extension:amendment		0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.phase	required	M11PhaseVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs From this IG
ResearchStudy.focus	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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

This structure is derived from StudyDesign

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
extension:amendment		0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/pharmaceutical-research-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)
relatesTo
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)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
ResearchStudy.identifier.type	extensible	M11IdentifierType_VS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-identifier-type-vs From this IG
ResearchStudy.label.type	extensible	DDFStudyTitleTypeVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/ddf-study-title-type-vs From this IG
ResearchStudy.phase	required	M11PhaseVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs From this IG
ResearchStudy.associatedParty.role	extensible	NCIStudyRoleVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/nci-study-role-vs From this IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
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 Bindings Purpose 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/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
extension:amendment		0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/pharmaceutical-research-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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.identifier.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.identifier.type	extensible	M11IdentifierType_VS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-identifier-type-vs From this IG
ResearchStudy.label.type	extensible	DDFStudyTitleTypeVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/ddf-study-title-type-vs From this IG
ResearchStudy.relatesTo.type	required	ArtifactRelationshipType http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.status	required	PublicationStatus http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3 From the FHIR Standard
ResearchStudy.primaryPurposeType	preferred	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type From the FHIR Standard
ResearchStudy.phase	required	M11PhaseVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs From this IG
ResearchStudy.studyDesign	preferred	StudyDesign http://hl7.org/fhir/ValueSet/study-design From the FHIR Standard
ResearchStudy.focus	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type From the FHIR Standard
ResearchStudy.condition	example	ConditionProblemDiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code From the FHIR Standard
ResearchStudy.keyword	example	ResearchStudyFocusType http://hl7.org/fhir/ValueSet/research-study-focus-type From the FHIR Standard
ResearchStudy.region	extensible	JurisdictionValueSet http://hl7.org/fhir/ValueSet/jurisdiction From the FHIR Standard
ResearchStudy.classifier	example	ResearchStudyClassifiers http://hl7.org/fhir/ValueSet/research-study-classifiers From the FHIR Standard
ResearchStudy.associatedParty.role	extensible	NCIStudyRoleVS http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/nci-study-role-vs From this IG
ResearchStudy.associatedParty.classifier	example	ResearchStudyPartyOrgType http://hl7.org/fhir/ValueSet/research-study-party-organization-type From the FHIR Standard
ResearchStudy.progressStatus.state	extensible	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status From the FHIR Standard
ResearchStudy.whyStopped	example	ResearchStudyReasonStopped http://hl7.org/fhir/ValueSet/research-study-reason-stopped From the FHIR Standard
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard
ResearchStudy.objective.outcomeMeasure.type	preferred	ResearchStudyObjectiveType http://hl7.org/fhir/ValueSet/research-study-objective-type From the FHIR Standard
ResearchStudy.objective.outcomeMeasure.summaryMeasure	example	StatisticType http://hl7.org/fhir/ValueSet/statistic-type From the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	ResearchStudy	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	ResearchStudy	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	ResearchStudy	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	ResearchStudy	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from StudyDesign

Summary

Mandatory: 0 element(2 nested mandatory elements)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
• http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment

Maturity: 1

Other representations of profile: CSV, Excel, Schematron