Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

Adverse Event Clinical Research R4 Backport, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-backport-ig/ and changes regularly. See the Directory of published versions

## Extension: Suspect Entity

Official URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity | Version: 1.0.1
Standards status: Trial-use | Maturity Level: 2 | Computable Name: SuspectEntity

Describes the entity that is suspected to have caused the adverse event.

Context of Use

This extension may be used on the following element(s):

- Element ID AdverseEvent

Usage info

Usage:

- Use this Extension: Adverse Event Clinical Research
- Examples for this Extension: AdverseEvent/AdverseEventFromProcedureNotStudyDrug, AdverseEvent/ClinicalTrialSignificantAdverseEvent, AdverseEvent/NonSeriousAdverseEventResearchStudyMed, AdverseEvent/SeriousAdverseEventResearchStudy... Show 6 more, AdverseEvent/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a, AdverseEvent/adverse-event-compass-ex1b, AdverseEvent/adverse-event-compass-ex2, AdverseEvent/adverse-event-device-death and AdverseEvent/clinical-research-ae-example-medwatch-patient-report

### Formal Views of Extension Content

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

- Text Summary
- Differential Table
- Snapshot Table
- All

This structure is derived from Extension

Summary

Complex Extension: Describes the entity that is suspected to have caused the adverse event.

- instance: Reference: An Extension
- assessmentMethod: CodeableConcept: An Extension
- entityRelatedness: CodeableConcept: An Extension
- author: Reference: An Extension

Maturity: 2

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Suspect Entity
extension |  | 2..* | Extension | Extension
extension:instance |  | 1..1 | Extension | Refers to the specific entity that is suspected of causing the adverse event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "instance"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueReference |  | 0..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | Value of extension
extension:causality |  | 1..1 | Extension | Causality - information on the possible cause of the event
extension:assessmentMethod |  | 0..1 | Extension | Method of evaluating the relatedness of the suspected entity to the event.
extension |  | 0..0 |  |
url |  | 1..1 | uri | "assessmentMethod"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
extension:entityRelatedness |  | 0..1 | Extension | Result of the assessment regarding the relatedness of the suspected entity to the event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "entityRelatedness"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
extension:author |  | 0..1 | Extension | Author of the information on the possible cause of the event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "author"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueReference |  | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "causality"
value[x] |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
value[x] |  | 0..0 |  |
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Suspect Entity
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 2..* | Extension | Extension Slice: Unordered, Open by value:url
extension:instance |  | 1..1 | Extension | Refers to the specific entity that is suspected of causing the adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "instance"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueReference |  | 0..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | Value of extension
extension:causality |  | 1..1 | Extension | Causality - information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
extension:assessmentMethod |  | 0..1 | Extension | Method of evaluating the relatedness of the suspected entity to the event.
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "assessmentMethod"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
extension:entityRelatedness |  | 0..1 | Extension | Result of the assessment regarding the relatedness of the suspected entity to the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "entityRelatedness"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
extension:author |  | 0..1 | Extension | Author of the information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "author"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueReference |  | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "causality"
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
Documentation for this format

This structure is derived from Extension

Summary

Complex Extension: Describes the entity that is suspected to have caused the adverse event.

- instance: Reference: An Extension
- assessmentMethod: CodeableConcept: An Extension
- entityRelatedness: CodeableConcept: An Extension
- author: Reference: An Extension

Maturity: 2

Differential View

This structure is derived from Extension

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Suspect Entity
extension |  | 2..* | Extension | Extension
extension:instance |  | 1..1 | Extension | Refers to the specific entity that is suspected of causing the adverse event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "instance"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueReference |  | 0..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | Value of extension
extension:causality |  | 1..1 | Extension | Causality - information on the possible cause of the event
extension:assessmentMethod |  | 0..1 | Extension | Method of evaluating the relatedness of the suspected entity to the event.
extension |  | 0..0 |  |
url |  | 1..1 | uri | "assessmentMethod"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
extension:entityRelatedness |  | 0..1 | Extension | Result of the assessment regarding the relatedness of the suspected entity to the event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "entityRelatedness"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
extension:author |  | 0..1 | Extension | Author of the information on the possible cause of the event
extension |  | 0..0 |  |
url |  | 1..1 | uri | "author"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Open by type:$this
value[x]:valueReference |  | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "causality"
value[x] |  | 0..0 |  |
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
value[x] |  | 0..0 |  |
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
Extension |  | 0..* | Extension | Suspect Entity
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 2..* | Extension | Extension Slice: Unordered, Open by value:url
extension:instance |  | 1..1 | Extension | Refers to the specific entity that is suspected of causing the adverse event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "instance"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueReference |  | 0..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | Value of extension
extension:causality |  | 1..1 | Extension | Causality - information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
Slices for extension |  | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url
extension:assessmentMethod |  | 0..1 | Extension | Method of evaluating the relatedness of the suspected entity to the event.
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "assessmentMethod"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
extension:entityRelatedness |  | 0..1 | Extension | Result of the assessment regarding the relatedness of the suspected entity to the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "entityRelatedness"
Slices for value[x] |  | 0..1 | CodeableConcept | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueCodeableConcept |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Causality Relatedness (preferred)
extension:author |  | 0..1 | Extension | Author of the information on the possible cause of the event
id |  | 0..1 | string | Unique id for inter-element referencing
extension |  | 0..0 |  |
url |  | 1..1 | uri | "author"
Slices for value[x] |  | 0..1 | Reference() | Value of extension Slice: Unordered, Closed by type:$this
value[x]:valueReference |  | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Value of extension
url |  | 1..1 | uri | "causality"
url |  | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
Documentation for this format

Other representations of profile: CSV, Excel, Schematron

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConcept | preferred | AdverseEventCausalityMethod `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` from the FHIR Standard
Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConcept | preferred | AdverseEventClinicalResearchCausalityRelatedness `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness`

#### Constraints

Id | Grade | Path(s) | Details | Requirements
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() |