Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot
Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot
This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
| Page standards status: Trial-use | Maturity Level: 2 |
Definitions for the severity-or-grade extension.
Guidance on how to interpret the contents of this table can be found here.
| 1. Extension | |
| Definition | Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity. For cancer related trials, severity is represented as a grade. Optional Extension Element - found in all resources. |
| 2. Extension.extension | |
| Control | 0..0* |
| 3. Extension.url | |
| Fixed Value | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade |
| 4. Extension.value[x] | |
| Binding | The codes SHOULD be taken from AdverseEvent Severity or Grade Value SetFor codes, see (unbound) |
| Type | Choice of: , date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
Guidance on how to interpret the contents of this table can be found here.
| 1. Extension | |
| Definition | Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity. For cancer related trials, severity is represented as a grade. Optional Extension Element - found in all resources. |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
| 2. Extension.extension | |
| Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Control | 0..0* |
| Type | Extension |
| Summary | false |
| Alternate Names | extensions, user content |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
| 3. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Control | 1..1 |
| Type | uri |
| XML Representation | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Fixed Value | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade |
| 4. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from AdverseEvent Severity or Grade Value SetFor codes, see (unbound) |
| Type | Choice of: CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Summary | false |
| Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be found here.
| 1. Extension | |
| Definition | Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity. For cancer related trials, severity is represented as a grade. |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| 2. Extension.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Control | 0..1 |
| Type | string |
| XML Representation | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 3. Extension.extension | |
| Definition | An Extension |
| Control | 0..0 |
| Type | Extension |
| Summary | false |
| Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
| 4. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Control | 1..1 |
| Type | uri |
| XML Representation | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Fixed Value | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade |
| 5. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from AdverseEvent Severity or Grade Value Set |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Summary | false |
| Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |
IG © 2020+ HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups. Package hl7.fhir.uv.ae-research-backport-ig#1.0.0-ballot based on FHIR 4.0.1. Generated 2023-07-28
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