FHIR Osiris Implementation Guide - Local Development build (v2.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: Oncology Clinical Trial

Oncology clinical trial used to associate a Onco Patient to a Clinical Trial

Usage:

• Refer to this Resource Profile: Clinical Trial Subject and Treatment

Formal Views of Profile Content

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

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

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
identifier		1..1	Identifier	EudraCT number of the clinical trial
title	S	1..1	string	Clinical trial name
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
identifier	Σ	1..1	Identifier	EudraCT number of the clinical trial
title	SΣ	1..1	string	Clinical trial name
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
identifier	Σ	1..1	Identifier	EudraCT number of the clinical trial
title	SΣ	1..1	string	Clinical trial name
protocol	ΣC	0..*	Reference(PlanDefinition)	Steps followed in executing study ref-1: SHALL have a contained resource if a local reference is provided
partOf	ΣC	0..*	Reference(ResearchStudy)	Part of larger study ref-1: SHALL have a contained resource if a local reference is provided
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category	Σ	0..*	CodeableConcept	Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	ΣC	0..*	Reference(Group)	Inclusion & exclusion criteria ref-1: SHALL have a contained resource if a local reference is provided
period	ΣC	0..1	Period	When the study began and ended per-1: If present, start SHALL have a lower value than end
sponsor	ΣC	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study ref-1: SHALL have a contained resource if a local reference is provided
principalInvestigator	ΣC	0..1	Reference(Practitioner | PractitionerRole)	Researcher who oversees multiple aspects of the study ref-1: SHALL have a contained resource if a local reference is provided
site	ΣC	0..*	Reference(Location)	Facility where study activities are conducted ref-1: SHALL have a contained resource if a local reference is provided
reasonStopped	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.
note		0..*	Annotation	Comments made about the study
arm		0..*	BackboneElement	Defined path through the study for a subject
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	example	ResearchStudyPhase http://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard
ResearchStudy.category	example
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.reasonStopped	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

This structure is derived from ResearchStudy

Summary

Mandatory: 2 elements
Must-Support: 1 element

Differential View

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
identifier		1..1	Identifier	EudraCT number of the clinical trial
title	S	1..1	string	Clinical trial name
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
identifier	Σ	1..1	Identifier	EudraCT number of the clinical trial
title	SΣ	1..1	string	Clinical trial name
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	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: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
identifier	Σ	1..1	Identifier	EudraCT number of the clinical trial
title	SΣ	1..1	string	Clinical trial name
protocol	ΣC	0..*	Reference(PlanDefinition)	Steps followed in executing study ref-1: SHALL have a contained resource if a local reference is provided
partOf	ΣC	0..*	Reference(ResearchStudy)	Part of larger study ref-1: SHALL have a contained resource if a local reference is provided
status	?!Σ	1..1	code	active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType	Σ	0..1	CodeableConcept	treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
phase	Σ	0..1	CodeableConcept	n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
category	Σ	0..*	CodeableConcept	Classifications for the study Binding: (unbound) (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.
focus	Σ	0..*	CodeableConcept	Drugs, devices, etc. under study Binding: (unbound) (example): Codes for medications, devices and other interventions.
condition	Σ	0..*	CodeableConcept	Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis.
contact	Σ	0..*	ContactDetail	Contact details for the study
relatedArtifact		0..*	RelatedArtifact	References and dependencies
keyword	Σ	0..*	CodeableConcept	Used to search for the study Binding: (unbound) (example): Words associated with the study that may be useful in discovery.
location	Σ	0..*	CodeableConcept	Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use.
description		0..1	markdown	What this is study doing
enrollment	ΣC	0..*	Reference(Group)	Inclusion & exclusion criteria ref-1: SHALL have a contained resource if a local reference is provided
period	ΣC	0..1	Period	When the study began and ended per-1: If present, start SHALL have a lower value than end
sponsor	ΣC	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study ref-1: SHALL have a contained resource if a local reference is provided
principalInvestigator	ΣC	0..1	Reference(Practitioner | PractitionerRole)	Researcher who oversees multiple aspects of the study ref-1: SHALL have a contained resource if a local reference is provided
site	ΣC	0..*	Reference(Location)	Facility where study activities are conducted ref-1: SHALL have a contained resource if a local reference is provided
reasonStopped	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.
note		0..*	Annotation	Comments made about the study
arm		0..*	BackboneElement	Defined path through the study for a subject
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
name		1..1	string	Label for study arm
type		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
objective		0..*	BackboneElement	A goal for the study
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
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.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
ResearchStudy.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
ResearchStudy.status	required	ResearchStudyStatus http://hl7.org/fhir/ValueSet/research-study-status|4.0.1 from the FHIR Standard
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType http://hl7.org/fhir/ValueSet/research-study-prim-purp-type from the FHIR Standard
ResearchStudy.phase	example	ResearchStudyPhase http://hl7.org/fhir/ValueSet/research-study-phase from the FHIR Standard
ResearchStudy.category	example
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes http://hl7.org/fhir/ValueSet/condition-code from the FHIR Standard
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet http://hl7.org/fhir/ValueSet/jurisdiction from the FHIR Standard
ResearchStudy.reasonStopped	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

This structure is derived from ResearchStudy

Summary

Mandatory: 2 elements
Must-Support: 1 element

Other representations of profile: CSV, Excel, Schematron