Adverse Event Clinical Research R4 Backport
1.0.1 - STU1
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
| 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):
Usage info
Usage:
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
Summary
Complex Extension: Describes the entity that is suspected to have caused the adverse event.
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.
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
| Path | Conformance | ValueSet | URI |
| Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConcept | preferred | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConcept | preferred | AdverseEventClinicalResearchCausalityRelatednesshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness |
| 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() |
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.ae-research-backport-ig#1.0.1 based on FHIR 4.0.1. Generated 2024-04-30
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