FHIR for FAIR - FHIR Implementation Guide
1.0.0 - STU 1
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
| 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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from ResearchStudy
| 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 | ||||
| Path | Conformance | ValueSet |
| ResearchStudy.identifier:url.use | required | IdentifierUse |
| ResearchStudy.status | required | ResearchStudyStatus |
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType |
| 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
| |||||
| 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 | ||||||||
| Path | Conformance | ValueSet | ||||
| ResearchStudy.language | preferred | CommonLanguages
| ||||
| 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 |
| 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:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from ResearchStudy
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 | ||||
| Path | Conformance | ValueSet |
| ResearchStudy.identifier:url.use | required | IdentifierUse |
| ResearchStudy.status | required | ResearchStudyStatus |
| ResearchStudy.primaryPurposeType | extensible | ResearchStudyPrimaryPurposeType |
| 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
| |||||
| 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 | ||||||||
| Path | Conformance | ValueSet | ||||
| ResearchStudy.language | preferred | CommonLanguages
| ||||
| 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 |
| 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:
Extensions
This structure refers to these extensions:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ Health Level Seven International - SOA Work Group. Package hl7.fhir.uv.fhir-for-fair#1.0.0 based on FHIR 4.3.0. Generated 2024-01-05
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