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
| Page standards status: Trial-use | Maturity Level: 2 |
Definitions for the suspect-entity extension.
Guidance on how to interpret the contents of this table can be found here
| 0. Extension | |
| Definition | Describes the entity that is suspected to have caused the adverse event. |
| Short | Suspect Entity |
| 2. Extension.extension | |
| Control | 2..? |
| 4. Extension.extension:instance | |
| Slice Name | instance |
| Short | Refers to the specific entity that is suspected of causing the adverse event |
| Control | 1..1 |
| 6. Extension.extension:instance.extension | |
| Control | 0..0 |
| 8. Extension.extension:instance.url | |
| Fixed Value | instance |
| 10. Extension.extension:instance.value[x] | |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Slicing | This element introduces a set of slices on Extension.extension.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 12. Extension.extension:instance.value[x]:valueReference | |
| Slice Name | valueReference |
| Control | 0..1 |
| Type | Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy) |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| 14. Extension.extension:causality | |
| Slice Name | causality |
| Short | Causality - information on the possible cause of the event |
| Control | 1..1 |
| 16. Extension.extension:causality.extension:assessmentMethod | |
| Slice Name | assessmentMethod |
| Short | Method of evaluating the relatedness of the suspected entity to the event. |
| Control | 0..1 |
| 18. Extension.extension:causality.extension:assessmentMethod.extension | |
| Control | 0..0 |
| 20. Extension.extension:causality.extension:assessmentMethod.url | |
| Fixed Value | assessmentMethod |
| 22. Extension.extension:causality.extension:assessmentMethod.value[x] | |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 24. Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConcept | |
| Slice Name | valueCodeableConcept |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from AdverseEventCausalityMethod (preferred to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| 26. Extension.extension:causality.extension:entityRelatedness | |
| Slice Name | entityRelatedness |
| Short | Result of the assessment regarding the relatedness of the suspected entity to the event |
| Control | 0..1 |
| 28. Extension.extension:causality.extension:entityRelatedness.extension | |
| Control | 0..0 |
| 30. Extension.extension:causality.extension:entityRelatedness.url | |
| Fixed Value | entityRelatedness |
| 32. Extension.extension:causality.extension:entityRelatedness.value[x] | |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 34. Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConcept | |
| Slice Name | valueCodeableConcept |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from Adverse Event Clinical Research Causality Relatedness (preferred to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness) |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| 36. Extension.extension:causality.extension:author | |
| Slice Name | author |
| Short | Author of the information on the possible cause of the event |
| Control | 0..1 |
| 38. Extension.extension:causality.extension:author.extension | |
| Control | 0..0 |
| 40. Extension.extension:causality.extension:author.url | |
| Fixed Value | author |
| 42. Extension.extension:causality.extension:author.value[x] | |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 44. Extension.extension:causality.extension:author.value[x]:valueReference | |
| Slice Name | valueReference |
| Control | 0..1 |
| Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson, ResearchSubject) |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| 46. Extension.extension:causality.url | |
| Fixed Value | causality |
| 48. Extension.extension:causality.value[x] | |
| Control | 0..0 |
| 50. Extension.url | |
| Fixed Value | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity |
| 52. Extension.value[x] | |
| Control | 0..0 |
Guidance on how to interpret the contents of this table can be found here
| 0. Extension | |
| Definition | Describes the entity that is suspected to have caused the adverse event. Optional Extension Element - found in all resources. |
| Short | Suspect EntityOptional Extensions Element |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| Is Modifier | false |
| Invariants | 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())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. |
| Short | ExtensionAdditional content defined by implementations |
| 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. |
| Control | 20..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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:instance | |
| Slice Name | instance |
| Definition | An Extension |
| Short | Refers to the specific entity that is suspected of causing the adverse eventAdditional content defined by implementations |
| Control | 10..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 6. Extension.extension:instance.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. |
| Short | ExtensionAdditional content defined by implementations |
| 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. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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: |
| 8. Extension.extension:instance.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | instance |
| 10. Extension.extension:instance.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference, 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, 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 12. Extension.extension:instance.value[x]:valueReference | |
| Slice Name | valueReference |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy), 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, 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 14. Extension.extension:causality | |
| Slice Name | causality |
| Definition | An Extension |
| Short | Causality - information on the possible cause of the eventAdditional content defined by implementations |
| Control | 10..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 16. Extension.extension:causality.extension:assessmentMethod | |
| Slice Name | assessmentMethod |
| Definition | An Extension |
| Short | Method of evaluating the relatedness of the suspected entity to the event.Additional content defined by implementations |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 18. Extension.extension:causality.extension:assessmentMethod.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. |
| Short | ExtensionAdditional content defined by implementations |
| 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. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 20. Extension.extension:causality.extension:assessmentMethod.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | assessmentMethod |
| 22. Extension.extension:causality.extension:assessmentMethod.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 24. Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConcept | |
| Slice Name | valueCodeableConcept |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from For codes, see AdverseEventCausalityMethod (preferred to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. |
| Type | 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 26. Extension.extension:causality.extension:entityRelatedness | |
| Slice Name | entityRelatedness |
| Definition | An Extension |
| Short | Result of the assessment regarding the relatedness of the suspected entity to the eventAdditional content defined by implementations |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 28. Extension.extension:causality.extension:entityRelatedness.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. |
| Short | ExtensionAdditional content defined by implementations |
| 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. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 30. Extension.extension:causality.extension:entityRelatedness.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | entityRelatedness |
| 32. Extension.extension:causality.extension:entityRelatedness.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 34. Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConcept | |
| Slice Name | valueCodeableConcept |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from For codes, see Adverse Event Clinical Research Causality Relatedness (preferred to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness) |
| Type | 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 36. Extension.extension:causality.extension:author | |
| Slice Name | author |
| Definition | An Extension |
| Short | Author of the information on the possible cause of the eventAdditional content defined by implementations |
| Control | 0..1* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 38. Extension.extension:causality.extension:author.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. |
| Short | ExtensionAdditional content defined by implementations |
| 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. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 40. Extension.extension:causality.extension:author.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | author |
| 42. Extension.extension:causality.extension:author.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference, 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, 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 44. Extension.extension:causality.extension:author.value[x]:valueReference | |
| Slice Name | valueReference |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson, ResearchSubject), 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, 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] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. Extension.extension:causality.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | causality |
| 48. Extension.extension:causality.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| 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 |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 50. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity |
| 52. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| 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 |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | 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
| 0. Extension | |
| Definition | Describes the entity that is suspected to have caused the adverse event. |
| Short | Suspect Entity |
| Control | 0..* This element is affected by the following invariants: ele-1 |
| Is Modifier | false |
| Invariants | 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.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 4. Extension.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 2..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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: |
| 6. Extension.extension:instance | |
| Slice Name | instance |
| Definition | An Extension |
| Short | Refers to the specific entity that is suspected of causing the adverse event |
| Control | 1..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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:instance.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 10. Extension.extension:instance.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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:instance.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | instance |
| 14. Extension.extension:instance.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 16. Extension.extension:instance.value[x]:valueReference | |
| Slice Name | valueReference |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy) |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. Extension.extension:causality | |
| Slice Name | causality |
| Definition | An Extension |
| Short | Causality - information on the possible cause of the event |
| Control | 1..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 20. Extension.extension:causality.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 22. Extension.extension:causality.extension | |
| Definition | 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. |
| Short | Additional content defined by implementations |
| 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. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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: |
| 24. Extension.extension:causality.extension:assessmentMethod | |
| Slice Name | assessmentMethod |
| Definition | An Extension |
| Short | Method of evaluating the relatedness of the suspected entity to the event. |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 26. Extension.extension:causality.extension:assessmentMethod.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 28. Extension.extension:causality.extension:assessmentMethod.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 30. Extension.extension:causality.extension:assessmentMethod.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | assessmentMethod |
| 32. Extension.extension:causality.extension:assessmentMethod.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 34. Extension.extension:causality.extension:assessmentMethod.value[x]:valueCodeableConcept | |
| Slice Name | valueCodeableConcept |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from AdverseEventCausalityMethod (preferred to http://hl7.org/fhir/ValueSet/adverse-event-causality-method)Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 36. Extension.extension:causality.extension:entityRelatedness | |
| Slice Name | entityRelatedness |
| Definition | An Extension |
| Short | Result of the assessment regarding the relatedness of the suspected entity to the event |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 38. Extension.extension:causality.extension:entityRelatedness.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 40. Extension.extension:causality.extension:entityRelatedness.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 42. Extension.extension:causality.extension:entityRelatedness.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | entityRelatedness |
| 44. Extension.extension:causality.extension:entityRelatedness.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 46. Extension.extension:causality.extension:entityRelatedness.value[x]:valueCodeableConcept | |
| Slice Name | valueCodeableConcept |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Binding | The codes SHOULD be taken from Adverse Event Clinical Research Causality Relatedness (preferred to http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness) |
| Type | CodeableConcept |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 48. Extension.extension:causality.extension:author | |
| Slice Name | author |
| Definition | An Extension |
| Short | Author of the information on the possible cause of the event |
| Control | 0..1 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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()) |
| 50. Extension.extension:causality.extension:author.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 52. Extension.extension:causality.extension:author.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | 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.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: |
| 54. Extension.extension:causality.extension:author.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | author |
| 56. Extension.extension:causality.extension:author.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| Slicing | This element introduces a set of slices on Extension.extension.extension.value[x]. The slices are unordered and Closed, and can be differentiated using the following discriminators: |
| 58. Extension.extension:causality.extension:author.value[x]:valueReference | |
| Slice Name | valueReference |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| Control | 0..1 |
| Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson, ResearchSubject) |
| [x] Note | See Choice of Data Types for further information about how to use [x] |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 60. Extension.extension:causality.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | causality |
| 62. Extension.extension:causality.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| 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 |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 64. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| 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. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity |
| 66. Extension.value[x] | |
| Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Value of extension |
| 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 |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | 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. 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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