AGHA.FHIR.GENCLIPR\Genomics Clinical Picture Repository Research Study

Genomics Clinical Picture Repository Implementation Guide
0.1.0 - ci-build

Genomics Clinical Picture Repository Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions

Resource Profile: Genomics Clinical Picture Repository Research Study

Official URL: http://aehrc.github.io/genclipr-fhir-ig/StructureDefinition/GencliprResearchStudy				Version: 0.1.0
Active as of 2022-03-21				Computable Name: GencliprResearchStudy
Copyright/Legal: Australian Genomics

Captures information about a research study and groups encounters that where generated as part of the study.

Formal Views of Profile Content

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

Text Summary
Differential Table
Snapshot Table
Snapshot Table (Must Support)
All

This structure is derived from ResearchStudy

Summary

Mandatory: 1 element
Must-Support: 1 element

This structure is derived from ResearchStudy

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
identifier	S	1..*	Identifier	Business Identifier for study
type		0..1	CodeableConcept	Description of identifier Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://aehrc.github.io/genclipr-fhir-ig/CodeSystem/IdentifierType
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RSI
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
id	Σ	0..1	string	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) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Business Identifier for study
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual \| official \| temp \| secondary \| old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://aehrc.github.io/genclipr-fhir-ig/CodeSystem/IdentifierType
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RSI
display		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	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
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	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner \| PractitionerRole)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
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		0..*	Extension	Additional content defined by implementations
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		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.
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
identifier	Σ	1..*	Identifier	Business Identifier for study
Documentation for this format

This structure is derived from ResearchStudy

Summary

Mandatory: 1 element
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	S	1..*	Identifier	Business Identifier for study
type		0..1	CodeableConcept	Description of identifier Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://aehrc.github.io/genclipr-fhir-ig/CodeSystem/IdentifierType
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RSI
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy		0..*	ResearchStudy	Investigation to increase healthcare-related patient-independent knowledge
id	Σ	0..1	string	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) Max Binding: AllLanguages: A human language.
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	SΣ	1..*	Identifier	Business Identifier for study
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual \| official \| temp \| secondary \| old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://aehrc.github.io/genclipr-fhir-ig/CodeSystem/IdentifierType
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: RSI
display		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	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
title	Σ	0..1	string	Name for this study
protocol	Σ	0..*	Reference(PlanDefinition)	Steps followed in executing study
partOf	Σ	0..*	Reference(ResearchStudy)	Part of larger study
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	Σ	0..*	Reference(Group)	Inclusion & exclusion criteria
period	Σ	0..1	Period	When the study began and ended
sponsor	Σ	0..1	Reference(Organization)	Organization that initiates and is legally responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner \| PractitionerRole)	Researcher who oversees multiple aspects of the study
site	Σ	0..*	Reference(Location)	Facility where study activities are conducted
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		0..*	Extension	Additional content defined by implementations
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		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.
Documentation for this format

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

Path	Conformance	ValueSet / Code
ResearchStudy.language	preferred	CommonLanguages Max Binding: AllLanguages
ResearchStudy.identifier.use	required	IdentifierUse
ResearchStudy.identifier.type	extensible	Pattern: RSI
ResearchStudy.status	required	ResearchStudyStatus
ResearchStudy.primaryPurposeType	extensible	ResearchStudyPrimaryPurposeType
ResearchStudy.phase	example	ResearchStudyPhase
ResearchStudy.category	example
ResearchStudy.focus	example
ResearchStudy.condition	example	Condition/Problem/DiagnosisCodes
ResearchStudy.keyword	example
ResearchStudy.location	extensible	Jurisdiction ValueSet
ResearchStudy.reasonStopped	example	ResearchStudyReasonStopped
ResearchStudy.objective.type	preferred	ResearchStudyObjectiveType

Constraints

Id	Grade	Path	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 in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').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	ResearchStudy.meta	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.implicitRules	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.language	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.text	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ResearchStudy.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	ResearchStudy.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ResearchStudy.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	ResearchStudy.identifier	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.identifier.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ResearchStudy.identifier.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	ResearchStudy.identifier.use	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.identifier.type	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.identifier.system	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.identifier.value	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.identifier.period	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.identifier.assigner	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.title	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.protocol	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.partOf	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.status	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.primaryPurposeType	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.phase	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.category	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.focus	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.condition	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.contact	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.relatedArtifact	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.keyword	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.location	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.description	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.enrollment	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.period	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.sponsor	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.principalInvestigator	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.site	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.reasonStopped	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.note	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.arm	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.arm.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ResearchStudy.arm.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	ResearchStudy.arm.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ResearchStudy.arm.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	ResearchStudy.arm.name	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.arm.type	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.arm.description	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.objective	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.objective.extension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ResearchStudy.objective.extension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	ResearchStudy.objective.modifierExtension	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	ResearchStudy.objective.modifierExtension	Must have either extensions or value[x], not both : extension.exists() != value.exists()
ele-1	error	ResearchStudy.objective.name	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ele-1	error	ResearchStudy.objective.type	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())

IG © 2021+ The Australian e-Health Research Centre. Package agha.fhir.genclipr#0.1.0 based on FHIR 4.0.1. Generated 2022-03-21
Links: Table of Contents | QA Report