Clinical Study Protocol, 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-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

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Resource Profile: M11 Research Study Profile

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 relatesTo attribute.

Usages:

• Examples for this Profile: ResearchStudy/Exemplar-ResearchStudy-001, ResearchStudy/Exemplar-ResearchStudy-Current-Amendment, ResearchStudy/JPMA0001-eng, ResearchStudy/JPMA0001-jpn... Show 4 more, ResearchStudy/ResearchStudy-Composition-Section-Per-Section-001, ResearchStudy/ResearchStudy-Narrative-Comp-Per-M11-001, ResearchStudy/ResearchStudy-Narrative-Complex-001 and ResearchStudy/ResearchStudy-Single-Composition-001

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy	C	0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:narrative	S	0..*	Reference(Research Study Narratives)	Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment	S	0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement		0..1	string	Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval	SC	0..1	(Complex)	Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study	S	1..1	(Complex)	Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Business Identifier for study
use	?!	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	S	1..1	CodeableConcept	Description of identifier Binding: UDP Identifier Type Value Set (extensible)
title	SΣ	0..1	string	Human readable name of the study
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	SΣ	0..1	CodeableConcept	Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
focus		0..*	CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition)	Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus
associatedParty		0..*	BackboneElement	Sponsors, collaborators, and other parties
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
reference	SC	0..1	string	Literal reference, Relative, internal or absolute URL
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.identifier.​use	Base	required	IdentifierUse	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.identifier.​type	Base	extensible	UDP Identifier Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.status	Base	required	PublicationStatus	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.phase	Base	required	ICH M11 Trial Phase Value Set Terminology	📦1.0.0-ballot2	This IG
ResearchStudy.focus	Base	example	Research Study Focus Type	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.associatedParty.​role	Base	extensible	UDP Party Role Type Value Set	📦1.0.0-ballot2	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
date-required	warning	ResearchStudy.extension:approval	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
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()
identifier-required	error	ResearchStudy	The identifier MUST be populated with at least a Sponsor identifier	identifier.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy	C	0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:narrative	S	0..*	Reference(Research Study Narratives)	Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment	S	0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement		0..1	string	Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval	S	0..1	(Complex)	Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
extension:m11-research-study	S	1..1	(Complex)	Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
identifier	S	1..*	Identifier	Business Identifier for study
type	?!S	1..1	CodeableConcept	Description of identifier Binding: UDP Identifier Type Value Set (extensible)
coding
code		1..1	code	Symbol in syntax defined by the system
title	S	0..1	string	Human readable name of the study
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: UDP 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	S	0..1	CodeableConcept	Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (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: UDP Party Role Type Value Set (extensible)
party
reference	S	0..1	string	Literal reference, Relative, internal or absolute URL
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.identifier.​type	Base	extensible	UDP Identifier Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.label.​type	Base	extensible	UDP Study Title Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.phase	Base	required	ICH M11 Trial Phase Value Set Terminology	📦1.0.0-ballot2	This IG
ResearchStudy.associatedParty.​role	Base	extensible	UDP Party Role Type Value Set	📦1.0.0-ballot2	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
identifier-required	error	ResearchStudy	The identifier MUST be populated with at least a Sponsor identifier	identifier.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy	C	0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
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		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:narrative	S	0..*	Reference(Research Study Narratives)	Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment	S	0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement		0..1	string	Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval	SC	0..1	(Complex)	Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study	S	1..1	(Complex)	Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url		0..1	uri	Canonical identifier for this study resource
identifier	SΣ	1..*	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	S	1..1	CodeableConcept	Description of identifier Binding: UDP 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	SΣ	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: UDP 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	SΣ	0..1	CodeableConcept	Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (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: UDP Party Role Type Value Set (extensible)
period		0..*	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SC	0..1	string	Literal reference, Relative, internal or absolute URL
type		0..1	uri	Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	C	0..1	Identifier	Logical reference, when literal reference is not known
display	C	0..1	string	Text alternative for the resource
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	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	UDP Identifier Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.label.​type	Base	extensible	UDP Study Title Type Value Set	📦1.0.0-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	ICH M11 Trial Phase Value Set Terminology	📦1.0.0-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	UDP Party Role Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.associatedParty.​classifier	Base	example	Research Study Party Organization Type	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.associatedParty.​party.type	Base	extensible	Resource Types	📍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
date-required	warning	ResearchStudy.extension:approval	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
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()
identifier-required	error	ResearchStudy	The identifier MUST be populated with at least a Sponsor identifier	identifier.exists()

Summary

Mandatory: 4 elements(1 nested mandatory element)
Must-Support: 9 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study

Maturity: 2

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy	C	0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:narrative	S	0..*	Reference(Research Study Narratives)	Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment	S	0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement		0..1	string	Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval	SC	0..1	(Complex)	Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study	S	1..1	(Complex)	Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Business Identifier for study
use	?!	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	S	1..1	CodeableConcept	Description of identifier Binding: UDP Identifier Type Value Set (extensible)
title	SΣ	0..1	string	Human readable name of the study
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	SΣ	0..1	CodeableConcept	Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (required)
focus		0..*	CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition)	Drugs, devices, etc. under study Binding: ResearchStudyFocusType (example): Some example codes of research study focus
associatedParty		0..*	BackboneElement	Sponsors, collaborators, and other parties
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb Binding: UDP Party Role Type Value Set (extensible)
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
reference	SC	0..1	string	Literal reference, Relative, internal or absolute URL
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.identifier.​use	Base	required	IdentifierUse	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.identifier.​type	Base	extensible	UDP Identifier Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.status	Base	required	PublicationStatus	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.phase	Base	required	ICH M11 Trial Phase Value Set Terminology	📦1.0.0-ballot2	This IG
ResearchStudy.focus	Base	example	Research Study Focus Type	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.associatedParty.​role	Base	extensible	UDP Party Role Type Value Set	📦1.0.0-ballot2	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
date-required	warning	ResearchStudy.extension:approval	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
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()
identifier-required	error	ResearchStudy	The identifier MUST be populated with at least a Sponsor identifier	identifier.exists()

Differential View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy	C	0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:narrative	S	0..*	Reference(Research Study Narratives)	Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment	S	0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement		0..1	string	Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval	S	0..1	(Complex)	Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
extension:m11-research-study	S	1..1	(Complex)	Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
identifier	S	1..*	Identifier	Business Identifier for study
type	?!S	1..1	CodeableConcept	Description of identifier Binding: UDP Identifier Type Value Set (extensible)
coding
code		1..1	code	Symbol in syntax defined by the system
title	S	0..1	string	Human readable name of the study
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: UDP 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	S	0..1	CodeableConcept	Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (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: UDP Party Role Type Value Set (extensible)
party
reference	S	0..1	string	Literal reference, Relative, internal or absolute URL
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
ResearchStudy.identifier.​type	Base	extensible	UDP Identifier Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.label.​type	Base	extensible	UDP Study Title Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.phase	Base	required	ICH M11 Trial Phase Value Set Terminology	📦1.0.0-ballot2	This IG
ResearchStudy.associatedParty.​role	Base	extensible	UDP Party Role Type Value Set	📦1.0.0-ballot2	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
identifier-required	error	ResearchStudy	The identifier MUST be populated with at least a Sponsor identifier	identifier.exists()

Snapshot ViewView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
ResearchStudy	C	0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge Constraints: identifier-required
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		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:narrative	S	0..*	Reference(Research Study Narratives)	Narrative Elements URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
extension:amendment	S	0..1	(Complex)	Amendment to a protocol - from EBM URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
extension:confidentialityStatement		0..1	string	Sponsor Confidentiality Statement, if applicable. URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
extension:approval	SC	0..1	(Complex)	Sign-off details URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval Constraints: date-required
extension:m11-research-study	S	1..1	(Complex)	Additional concepts for M11 URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
url		0..1	uri	Canonical identifier for this study resource
identifier	SΣ	1..*	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	S	1..1	CodeableConcept	Description of identifier Binding: UDP 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	SΣ	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: UDP 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	SΣ	0..1	CodeableConcept	Classifier used for clinical trials Binding: ICH M11 Trial Phase Value Set Terminology (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: UDP Party Role Type Value Set (extensible)
period		0..*	Period	When active in the role
classifier		0..*	CodeableConcept	nih | fda | government | nonprofit | academic | industry Binding: ResearchStudyPartyOrgType (example): A characterization or type of the entity.
party		0..1	Reference(Practitioner | PractitionerRole | Organization)	Individual or organization associated with study (use practitionerRole to specify their organisation)
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SC	0..1	string	Literal reference, Relative, internal or absolute URL
type		0..1	uri	Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	C	0..1	Identifier	Logical reference, when literal reference is not known
display	C	0..1	string	Text alternative for the resource
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	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	UDP Identifier Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.label.​type	Base	extensible	UDP Study Title Type Value Set	📦1.0.0-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	ICH M11 Trial Phase Value Set Terminology	📦1.0.0-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	UDP Party Role Type Value Set	📦1.0.0-ballot2	This IG
ResearchStudy.associatedParty.​classifier	Base	example	Research Study Party Organization Type	📍6.0.0-ballot3	FHIR Std.
ResearchStudy.associatedParty.​party.type	Base	extensible	Resource Types	📍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
date-required	warning	ResearchStudy.extension:approval	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
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()
identifier-required	error	ResearchStudy	The identifier MUST be populated with at least a Sponsor identifier	identifier.exists()

Summary

Mandatory: 4 elements(1 nested mandatory element)
Must-Support: 9 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
• http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study

Maturity: 2

Other representations of profile: CSV, Excel, Schematron