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/seriousness-criteria | Version: 1.0.1 | |||
Standards status: Trial-use | Maturity Level: 2 | Computable Name: SeriousnessCriteria |
Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
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
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Criteria reviewed in determining serious adverse event | |
extension | 2..* | Extension | Extension | |
extension:criterionCode | S | 1..1 | Extension | Action criteria usually associated with events that pose a threat to a patient's life or functioning |
extension | 0..0 | |||
url | 1..1 | uri | "criterionCode" | |
value[x] | 1..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Seriousness Criteria (extensible) | |
extension:criterionPresent | 1..1 | Extension | Presence or absence of the specified criteria | |
extension | 0..0 | |||
url | 1..1 | uri | "criterionPresent" | |
value[x] | 1..1 | boolean | Value of extension | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria" | |
value[x] | 0..0 | |||
Documentation for this format |
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Criteria reviewed in determining serious adverse event | |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 2..* | Extension | Extension Slice: Unordered, Open by value:url | |
extension:criterionCode | S | 1..1 | Extension | Action criteria usually associated with events that pose a threat to a patient's life or functioning |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "criterionCode" | |
value[x] | 1..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Seriousness Criteria (extensible) | |
extension:criterionPresent | 1..1 | Extension | Presence or absence of the specified criteria | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "criterionPresent" | |
value[x] | 1..1 | boolean | Value of extension | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria" | |
Documentation for this format |
This structure is derived from Extension
Summary
Complex Extension: Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
Maturity: 2
Differential View
This structure is derived from Extension
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Criteria reviewed in determining serious adverse event | |
extension | 2..* | Extension | Extension | |
extension:criterionCode | S | 1..1 | Extension | Action criteria usually associated with events that pose a threat to a patient's life or functioning |
extension | 0..0 | |||
url | 1..1 | uri | "criterionCode" | |
value[x] | 1..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Seriousness Criteria (extensible) | |
extension:criterionPresent | 1..1 | Extension | Presence or absence of the specified criteria | |
extension | 0..0 | |||
url | 1..1 | uri | "criterionPresent" | |
value[x] | 1..1 | boolean | Value of extension | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria" | |
value[x] | 0..0 | |||
Documentation for this format |
Snapshot View
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
Extension | 0..* | Extension | Criteria reviewed in determining serious adverse event | |
id | 0..1 | string | Unique id for inter-element referencing | |
Slices for extension | 2..* | Extension | Extension Slice: Unordered, Open by value:url | |
extension:criterionCode | S | 1..1 | Extension | Action criteria usually associated with events that pose a threat to a patient's life or functioning |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "criterionCode" | |
value[x] | 1..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Seriousness Criteria (extensible) | |
extension:criterionPresent | 1..1 | Extension | Presence or absence of the specified criteria | |
id | 0..1 | string | Unique id for inter-element referencing | |
extension | 0..0 | |||
url | 1..1 | uri | "criterionPresent" | |
value[x] | 1..1 | boolean | Value of extension | |
url | 1..1 | uri | "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria" | |
Documentation for this format |
Other representations of profile: CSV, Excel, Schematron
Path | Conformance | ValueSet | URI |
Extension.extension:criterionCode.value[x] | extensible | AdverseEventCRSerCrithttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria |
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() |