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 seriousness-criteria extension.
Guidance on how to interpret the contents of this table can be found here.
| 1. Extension | |
| Definition | TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events. Optional Extension Element - found in all resources. |
| 2. Extension.extension | |
| Control | 20..* |
| 3. Extension.extension:criterionCode | |
| SliceName | criterionCode |
| Control | 1..1 |
| Must Support | true |
| 4. Extension.extension:criterionCode.extension | |
| Control | 0..0 |
| 5. Extension.extension:criterionCode.url | |
| Control | 0..? |
| Fixed Value | criterionCode |
| 6. Extension.extension:criterionCode.value[x] | |
| Control | 1..? |
| Binding | The codes SHALL be taken from Adverse Event Seriousness Criteria; other codes may be used where these codes are not suitable |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| 7. Extension.extension:criterionPresent | |
| SliceName | criterionPresent |
| Control | 1..1 |
| 8. Extension.extension:criterionPresent.extension | |
| Control | 0..0 |
| 9. Extension.extension:criterionPresent.url | |
| Control | 0..? |
| Fixed Value | criterionPresent |
| 10. Extension.extension:criterionPresent.value[x] | |
| Control | 1..? |
| Type | boolean |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 11. Extension.url | |
| Fixed Value | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria |
| 12. Extension.value[x] | |
| Control | 0..01 |
| [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 | TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events. 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 | 20..* |
| 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.extension:criterionCode | |
| SliceName | criterionCode |
| 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 | 10..1* |
| Type | Extension |
| Must Support | true |
| 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()) |
| 4. Extension.extension:criterionCode.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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
| 5. Extension.extension:criterionCode.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 | criterionCode |
| 6. Extension.extension:criterionCode.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Control | 10..1 |
| Binding | The codes SHALL be taken from Adverse Event Seriousness Criteria; other codes may be used where these codes are not suitableFor 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())) |
| 7. Extension.extension:criterionPresent | |
| SliceName | criterionPresent |
| 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 | 10..1* |
| 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()) |
| 8. Extension.extension:criterionPresent.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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
| 9. Extension.extension:criterionPresent.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 | criterionPresent |
| 10. Extension.extension:criterionPresent.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Control | 10..1 |
| Type | Choice of: boolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, Signature, unsignedInt, time |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an 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())) |
| 11. 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/seriousness-criteria |
| 12. 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..01 |
| Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an 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())) |
Guidance on how to interpret the contents of this table can be found here.
| 1. Extension | |
| Definition | TBD - Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events. |
| 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 | 2..* |
| 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.extension:criterionCode | |
| SliceName | criterionCode |
| Definition | An Extension |
| Control | 1..1 |
| Type | Extension |
| Must Support | true |
| 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()) |
| 5. Extension.extension:criterionCode.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 |
| 6. Extension.extension:criterionCode.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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
| 7. Extension.extension:criterionCode.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 | criterionCode |
| 8. Extension.extension:criterionCode.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Control | 1..1 |
| Binding | The codes SHALL be taken from Adverse Event Seriousness Criteria; other codes may be used where these codes are not suitable |
| 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())) |
| 9. Extension.extension:criterionPresent | |
| SliceName | criterionPresent |
| Definition | An Extension |
| Control | 1..1 |
| 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()) |
| 10. Extension.extension:criterionPresent.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 |
| 11. Extension.extension:criterionPresent.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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
| 12. Extension.extension:criterionPresent.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 | criterionPresent |
| 13. Extension.extension:criterionPresent.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Control | 1..1 |
| Type | boolean |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an 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())) |
| 14. 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/seriousness-criteria |
| 15. 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..0 |
| Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an 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())) |
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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