FHIR for FAIR - FHIR Implementation Guide
1.0.0 - STU 1

FHIR for FAIR - FHIR Implementation Guide, published by Health Level Seven International - SOA Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-for-fair/ and changes regularly. See the Directory of published versions

## Resource Profile: ResearchStudy [Study Level Medatata]

Official URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/ResearchStudy-uv-f4f | Version: 1.0.0
Active as of 2024-01-05 | Computable Name: ResearchStudyF4F

This profile defines how to use the ResearchStudy resource to convey metadata information for a FAIR collection of data at the study level realized by using HL7 FHIR

Usage:

- Examples for this Resource Profile: ResearchStudy/f4h-rs-2

### 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
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
copyright |  | 0..1 | markdown | Copyright URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
licenceAttachment |  | 0..1 | Attachment | Licence Terms as Attachment URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
licenceCodeable |  | 0..1 | CodeableConcept | Licence Terms as CodeableConcept URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
context |  | 0..* | UsageContext | Usage Context [ResearchStudy] URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
Slices for identifier |  | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:system
identifier:url |  | 0..* | Identifier | GUPRI (uri)
system |  | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value |  | 0..1 | string | uri
title |  | 0..1 | string | Name for this study.
status |  | 1..1 | code | The current state of the study.
primaryPurposeType |  | 0..1 | CodeableConcept | A classification of the intent of the study.
relatedArtifact |  | 0..* | RelatedArtifactF4F | Related artifacts for a knowledge resource
description |  | 0..1 | markdown | What this is study doing.
objective |  | 0..* | BackboneElement | A goal for the study.
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
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
copyright |  | 0..1 | markdown | Copyright URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
licenceAttachment |  | 0..1 | Attachment | Licence Terms as Attachment URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
licenceCodeable |  | 0..1 | CodeableConcept | Licence Terms as CodeableConcept URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
context |  | 0..* | UsageContext | Usage Context [ResearchStudy] URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:system
identifier:url | Σ | 0..* | Identifier | GUPRI (uri)
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
system | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value | Σ | 0..1 | string | uri Example General: 123456
title | Σ | 0..1 | string | Name for this study.
status | ?!Σ | 1..1 | code | The current state of the study. Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | Σ | 0..1 | CodeableConcept | A classification of the intent of the study. Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
relatedArtifact |  | 0..* | RelatedArtifactF4F | Related artifacts for a knowledge resource
description |  | 0..1 | markdown | What this is study doing.
objective |  | 0..* | BackboneElement | A goal for the study.
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.identifier:url.use | required | IdentifierUse
ResearchStudy.status | required | ResearchStudyStatus
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+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(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() |

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): IETF language tag
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
copyright |  | 0..1 | markdown | Copyright URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
licenceAttachment |  | 0..1 | Attachment | Licence Terms as Attachment URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
licenceCodeable |  | 0..1 | CodeableConcept | Licence Terms as CodeableConcept URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
context |  | 0..* | UsageContext | Usage Context [ResearchStudy] URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:system
identifier:url | Σ | 0..* | Identifier | GUPRI (uri)
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 | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible)
system | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value | Σ | 0..1 | string | uri 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 | The current state of the study. Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | Σ | 0..1 | CodeableConcept | A classification of the intent of the study. 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..* | RelatedArtifactF4F | Related artifacts for a knowledge resource
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

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
ResearchStudy.identifier:url.use | required | IdentifierUse
ResearchStudy.identifier:url.type | extensible | Identifier Type Codes
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(s) | Details | Requirements
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+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(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() |
dom-r4b | warning | ResearchStudy.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from ResearchStudy

Summary

Mandatory: 0 element (1 nested mandatory element)

Structures

This structure refers to these other structures:

- RelatedArtifact [FHIR for FAIR] (http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/RelatedArtifact-uv-f4f)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context

Slices

This structure defines the following Slices:

- The element ResearchStudy.identifier is sliced based on the value of value:system

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
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
copyright |  | 0..1 | markdown | Copyright URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
licenceAttachment |  | 0..1 | Attachment | Licence Terms as Attachment URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
licenceCodeable |  | 0..1 | CodeableConcept | Licence Terms as CodeableConcept URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
context |  | 0..* | UsageContext | Usage Context [ResearchStudy] URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
Slices for identifier |  | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:system
identifier:url |  | 0..* | Identifier | GUPRI (uri)
system |  | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value |  | 0..1 | string | uri
title |  | 0..1 | string | Name for this study.
status |  | 1..1 | code | The current state of the study.
primaryPurposeType |  | 0..1 | CodeableConcept | A classification of the intent of the study.
relatedArtifact |  | 0..* | RelatedArtifactF4F | Related artifacts for a knowledge resource
description |  | 0..1 | markdown | What this is study doing.
objective |  | 0..* | BackboneElement | A goal for the study.
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
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
copyright |  | 0..1 | markdown | Copyright URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
licenceAttachment |  | 0..1 | Attachment | Licence Terms as Attachment URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
licenceCodeable |  | 0..1 | CodeableConcept | Licence Terms as CodeableConcept URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
context |  | 0..* | UsageContext | Usage Context [ResearchStudy] URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:system
identifier:url | Σ | 0..* | Identifier | GUPRI (uri)
use | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
system | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value | Σ | 0..1 | string | uri Example General: 123456
title | Σ | 0..1 | string | Name for this study.
status | ?!Σ | 1..1 | code | The current state of the study. Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | Σ | 0..1 | CodeableConcept | A classification of the intent of the study. Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study.
relatedArtifact |  | 0..* | RelatedArtifactF4F | Related artifacts for a knowledge resource
description |  | 0..1 | markdown | What this is study doing.
objective |  | 0..* | BackboneElement | A goal for the study.
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.identifier:url.use | required | IdentifierUse
ResearchStudy.status | required | ResearchStudyStatus
ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType

#### Constraints

Id | Grade | Path(s) | Details | Requirements
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+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(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() |

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): IETF language tag
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
copyright |  | 0..1 | markdown | Copyright URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
licenceAttachment |  | 0..1 | Attachment | Licence Terms as Attachment URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
licenceCodeable |  | 0..1 | CodeableConcept | Licence Terms as CodeableConcept URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
context |  | 0..* | UsageContext | Usage Context [ResearchStudy] URL: http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
Slices for identifier | Σ | 0..* | Identifier | Business Identifier for study Slice: Unordered, Open by value:system
identifier:url | Σ | 0..* | Identifier | GUPRI (uri)
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 | ?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required)
type | Σ | 0..1 | CodeableConcept | Description of identifier Binding: Identifier Type Codes (extensible)
system | Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: urn:ietf:rfc:3986
value | Σ | 0..1 | string | uri 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 | The current state of the study. Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study.
primaryPurposeType | Σ | 0..1 | CodeableConcept | A classification of the intent of the study. 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..* | RelatedArtifactF4F | Related artifacts for a knowledge resource
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

#### Terminology Bindings

Path | Conformance | ValueSet
ResearchStudy.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
ResearchStudy.identifier:url.use | required | IdentifierUse
ResearchStudy.identifier:url.type | extensible | Identifier Type Codes
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(s) | Details | Requirements
dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where(((id.exists() and ('#'+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(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() |
dom-r4b | warning | ResearchStudy.contained | Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems : ($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic) |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from ResearchStudy

Summary

Mandatory: 0 element (1 nested mandatory element)

Structures

This structure refers to these other structures:

- RelatedArtifact [FHIR for FAIR] (http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/RelatedArtifact-uv-f4f)

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/copyright
- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceAttachment
- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/licenceCodeable
- http://hl7.org/fhir/uv/fhir-for-fair/StructureDefinition/researchStudy-context

Slices

This structure defines the following Slices:

- The element ResearchStudy.identifier is sliced based on the value of value:system

Other representations of profile: CSV, Excel, Schematron