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

## Resource Profile: Adverse Event Clinical Research

Official URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research | Version: 1.0.1
Standards status: Trial-use | Maturity Level: 2 | Computable Name: AdverseEventClinicalResearch

Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications.

### Scope

The Clinical Research adverse event profile of AdverseEvent, is for the clinical research setting. Adverse events are tracked and evaluated as part of the clinical research process in a research study, as the occurrence of an adverse event may surface a potential confounder or a potential side-effect of the study treatment. In the research setting an adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects, potential adverse events are not reported (this is surfaced in the profile as a constraint of ‘actual’ for the value of ‘actuality’). Examples of adverse events include the administration of an incorrect drug or an incorrect dose of a drug causing an adverse reaction, the use of an implanted device that causes an infection, or a biologic used during a research study that causes unanticipated renal failure. These events are characterized by the need to capture cause and effect (although they might not be known at the time of the event), severity, and outcome.

### Use of data elements

The concepts modeled in each of these data elements include important distinctions and serve separate purposes in the context of a clinical trial. Specifically:

Severity and grade characterize the degree or intensity of an adverse event, but not necessarily the degree of impact on the subject or the subject’s health. For example, headache can be severe but not life-threatening, whereas even a less severe hemorrhage could be far more dangerous.

Seriousness criteria describe the medical significance of the event, and the risk to the subject’s life or their ability to function. Seriousness criteria also have very specific implications with regard to reporting to regulatory bodies for clinical trials. Clinical trial protocols commonly specify precise reporting requirements based on seriousness criteria.

The event element is used to specify what occurred to the subject. That is, the event itself that can be further characterized in its severity and its seriousness. While it is true that the event type includes values for death or mortality, in cases where a subject experiences another type of event, the model must provide a distinct structure to capture that information.

The adverse event outcome concept is required to capture whether events were or are ongoing. This information is a necessary component of evaluating clinical trials and may be needed for regulatory reporting. While in some particular cases certain adverse events may result in an outcome of death, creating coincidental overlap with information that may be captured elsewhere in the model, in many cases this structure is required to reflect information with a separate, distinct meaning.

The approach in the IG reflects our efforts to ensure that the model supports the core use cases required for data capture and reporting for clinical trials. The individuals and organizations creating and using clinical trial data are required to understand these use cases and their implications for populating the data structures defined in the IG; and in many cases the consequences for mishandling these data have regulatory implications.

Finally, please note that AdverseEvent.extension:seriousness-criteria and AdverseEvent.severity or AdverseEvent.extension:grade SHALL NOT be used to communicate that the patient has died. The value of "Death" used in these elements reflects the possibility of the event occurring.

### Note on identifiers

The FHIR identifier data element provides for a place to put a business identifier. It has a rich set of metadata that can be associated with the identifier such as assigner, namespace, valid period, use and type. Business identifiers such as the Investigational New Drug (IND#) can be represented. However, the use case will determine if the business identifier should be placed on the AdverseEvent Clinical Research Profile, or a more appropriate Resource. In the case of IND#, for example, the IND# should be placed on a Medication Resource data instance as one of the slices of Medication.identifier.

Usage:

- Examples for this Resource Profile: AdverseEvent/AdverseEventFromProcedureNotStudyDrug, AdverseEvent/ClinicalTrialSignificantAdverseEvent, AdverseEvent/NonSeriousAdverseEventResearchStudyMed, AdverseEvent/SeriousAdverseEventResearchStudy... Show 6 more, AdverseEvent/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a, AdverseEvent/adverse-event-compass-ex1b, AdverseEvent/adverse-event-compass-ex2, AdverseEvent/adverse-event-device-death and AdverseEvent/clinical-research-ae-example-medwatch-patient-report

### Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

- Differential Table
- Key Elements Table
- Snapshot Table
- Statistics/References
- All

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
research-subject-ref |  | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
caused-subject-to-discontinue-study |  | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
seriousness-criteria |  | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
ae-grade |  | 0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred)
expected-in-research-study |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
note |  | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
resolve-date |  | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
participant |  | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
resultingEffect |  | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
Slices for modifierExtension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:status | Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown Binding: (unbound) (required): Codes identifying the lifecycle stage of an event.
actuality |  | 1..1 | code | actual Required Pattern: actual
event |  | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event.
resultingCondition |  | 0..0 |  |
seriousness | S | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
outcome | S | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required)
suspectEntity |  | 0..0 |  |
subjectMedicalHistory |  | 0..0 |  |
referenceDocument |  | 0..0 |  |
study | S | 1..1 | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
AdverseEvent.modifierExtension:status [CanonicalType[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]] | required | ``
AdverseEvent.event | example | AdverseEventType `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs` from this IG
AdverseEvent.seriousness | required | AdverseEventSeriousness `http://terminology.hl7.org/ValueSet/adverse-event-seriousness`
AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomes `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes`

#### Constraints

Id | Grade | Path(s) | Details | Requirements
aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
research-subject-ref |  | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
caused-subject-to-discontinue-study |  | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
seriousness-criteria |  | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
ae-grade |  | 0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred)
expected-in-research-study |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
note |  | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
resolve-date |  | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
participant |  | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
resultingEffect |  | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:status | ?!Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown
actuality | ?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
event | Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event.
subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
seriousness | S Σ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
outcome | S Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required)
study | S Σ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
AdverseEvent.actuality | required | Pattern: actual `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.event | example | AdverseEventType `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs` from this IG
AdverseEvent.seriousness | required | AdverseEventSeriousness `http://terminology.hl7.org/ValueSet/adverse-event-seriousness`
AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomes `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes`

#### Constraints

Id | Grade | Path(s) | Details | Requirements
aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() |
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() |

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
research-subject-ref |  | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
caused-subject-to-discontinue-study |  | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
seriousness-criteria |  | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
ae-grade |  | 0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred)
expected-in-research-study |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
note |  | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
resolve-date |  | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
participant |  | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
resultingEffect |  | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:status | ?!Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown
identifier | Σ | 0..1 | Identifier | Business identifier for the event
actuality | ?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
category | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event | Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event.
subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of
date | Σ | 0..1 | dateTime | When the event occurred
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred
seriousness | S Σ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
outcome | S Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required)
recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event
study | S Σ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
AdverseEvent.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
`http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
AdverseEvent.actuality | required | Pattern: actual `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.category | extensible | AdverseEventCategory `http://hl7.org/fhir/ValueSet/adverse-event-category` from the FHIR Standard
AdverseEvent.event | example | AdverseEventType `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs` from this IG
AdverseEvent.seriousness | required | AdverseEventSeriousness `http://terminology.hl7.org/ValueSet/adverse-event-seriousness`
AdverseEvent.severity | required | AdverseEventSeverity `http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1` from the FHIR Standard
AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomes `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes`
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment `http://hl7.org/fhir/ValueSet/adverse-event-causality-assess` from the FHIR Standard
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() |
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() |

This structure is derived from AdverseEvent

Summary

Mandatory: 6 elements
Must-Support: 3 elements
Prohibited: 4 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status (Modifier)

Maturity: 2

Differential View

This structure is derived from AdverseEvent

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
research-subject-ref |  | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
caused-subject-to-discontinue-study |  | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
seriousness-criteria |  | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
ae-grade |  | 0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred)
expected-in-research-study |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
note |  | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
resolve-date |  | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
participant |  | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
resultingEffect |  | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
Slices for modifierExtension |  | 1..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:status | Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown Binding: (unbound) (required): Codes identifying the lifecycle stage of an event.
actuality |  | 1..1 | code | actual Required Pattern: actual
event |  | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event.
resultingCondition |  | 0..0 |  |
seriousness | S | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
outcome | S | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required)
suspectEntity |  | 0..0 |  |
subjectMedicalHistory |  | 0..0 |  |
referenceDocument |  | 0..0 |  |
study | S | 1..1 | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings (Differential)

Path | Conformance | ValueSet | URI
AdverseEvent.modifierExtension:status [CanonicalType[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]] | required | ``
AdverseEvent.event | example | AdverseEventType `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs` from this IG
AdverseEvent.seriousness | required | AdverseEventSeriousness `http://terminology.hl7.org/ValueSet/adverse-event-seriousness`
AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomes `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes`

#### Constraints

Id | Grade | Path(s) | Details | Requirements
aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |

Key Elements View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
research-subject-ref |  | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
caused-subject-to-discontinue-study |  | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
seriousness-criteria |  | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
ae-grade |  | 0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred)
expected-in-research-study |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
note |  | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
resolve-date |  | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
participant |  | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
resultingEffect |  | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:status | ?!Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown
actuality | ?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
event | Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event.
subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
seriousness | S Σ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
outcome | S Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required)
study | S Σ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
AdverseEvent.actuality | required | Pattern: actual `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.event | example | AdverseEventType `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs` from this IG
AdverseEvent.seriousness | required | AdverseEventSeriousness `http://terminology.hl7.org/ValueSet/adverse-event-seriousness`
AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomes `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes`

#### Constraints

Id | Grade | Path(s) | Details | Requirements
aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() |
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() |

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
id | Σ | 0..1 | id | Logical id of this artifact
meta | Σ | 0..1 | Meta | Metadata about the resource
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
language |  | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
Additional Bindings | Purpose
AllLanguages | Max Binding
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation
contained |  | 0..* | Resource | Contained, inline Resources
Slices for extension |  | 0..* | Extension | Extension Slice: Unordered, Open by value:url
research-subject-ref |  | 0..1 | Reference(ResearchSubject) | Research Subject record of subject URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
caused-subject-to-discontinue-study |  | 0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
seriousness-criteria |  | 0..* | (Complex) | Criteria reviewed in determining serious adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
ae-grade |  | 0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred)
expected-in-research-study |  | 0..1 | boolean | Considered likely or probable or anticipated in the research study URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
note |  | 0..* | Annotation | Comment on adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
resolve-date |  | 0..1 | dateTime | Adverse Event resolution date URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
suspect-entity | Σ | 0..* | (Complex) | A suspected agent causing the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
contributing-factor | Σ | 0..* | (Complex) | Contributing factors suspected to have increased the probability or severity of the adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
mitigating-action | Σ | 0..* | (Complex) | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
supporting-info | Σ | 0..* | (Complex) | Subject medical history or document relevant to this adverse event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
participant |  | 0..* | (Complex) | Who was involved in the adverse event or the potential adverse event and what they did URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
resultingEffect |  | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url
modifierExtension:status | ?!Σ | 1..1 | Status | in-progress | completed | entered-in-error | unknown
identifier | Σ | 0..1 | Identifier | Business identifier for the event
actuality | ?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
category | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event | Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEvent Type (example): Detailed type of event.
subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event
encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of
date | Σ | 0..1 | dateTime | When the event occurred
detected | Σ | 0..1 | dateTime | When the event was detected
recordedDate | Σ | 0..1 | dateTime | When the event was recorded
location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred
seriousness | S Σ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required)
severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
outcome | S Σ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required)
recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event
contributor | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event
study | S Σ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
AdverseEvent.language | preferred | CommonLanguages
Additional Bindings | Purpose
AllLanguages | Max Binding
`http://hl7.org/fhir/ValueSet/languages` from the FHIR Standard
AdverseEvent.actuality | required | Pattern: actual `http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1` from the FHIR Standard
AdverseEvent.category | extensible | AdverseEventCategory `http://hl7.org/fhir/ValueSet/adverse-event-category` from the FHIR Standard
AdverseEvent.event | example | AdverseEventType `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs` from this IG
AdverseEvent.seriousness | required | AdverseEventSeriousness `http://terminology.hl7.org/ValueSet/adverse-event-seriousness`
AdverseEvent.severity | required | AdverseEventSeverity `http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1` from the FHIR Standard
AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomes `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes`
AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessment `http://hl7.org/fhir/ValueSet/adverse-event-causality-assess` from the FHIR Standard
AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethod `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` from the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
aeClinRes-seriousness-1 | error | AdverseEvent | If seriousness is serious then must have at least one seriousness criterion. : (seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
dom-2 | error | AdverseEvent | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | AdverseEvent | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty() |
dom-4 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() |
dom-5 | error | AdverseEvent | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | AdverseEvent | A resource should have narrative for robust management : text.`div`.exists() |
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() |

This structure is derived from AdverseEvent

Summary

Mandatory: 6 elements
Must-Support: 3 elements
Prohibited: 4 elements

Extensions

This structure refers to these extensions:

- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
- http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status (Modifier)

Maturity: 2

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