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
| 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.
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.
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.
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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
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 | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.modifierExtension:status [CanonicalType[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]] | required | | |
| AdverseEvent.event | example | AdverseEventTypehttp://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vsfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://terminology.hl7.org/ValueSet/adverse-event-seriousness | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes |
| 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 |
SΣ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required) |
| outcome |
SΣ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required) |
| study |
SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | |
| AdverseEvent.event | example | AdverseEventTypehttp://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vsfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://terminology.hl7.org/ValueSet/adverse-event-seriousness | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes |
| 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.
| |||||
| 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 |
SΣ | 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 |
SΣ | 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 |
SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | ||||
| AdverseEvent.event | example | AdverseEventTypehttp://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vsfrom this IG | ||||
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://terminology.hl7.org/ValueSet/adverse-event-seriousness | ||||
| AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1from the FHIR Standard | ||||
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assessfrom the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard |
| 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:
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 | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.modifierExtension:status [CanonicalType[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]] | required | | |
| AdverseEvent.event | example | AdverseEventTypehttp://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vsfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://terminology.hl7.org/ValueSet/adverse-event-seriousness | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes |
| 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 |
SΣ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: AdverseEventSeriousness (required) |
| outcome |
SΣ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: Adverse Event Clinical Research Outcomes (required) |
| study |
SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | |
| AdverseEvent.event | example | AdverseEventTypehttp://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vsfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://terminology.hl7.org/ValueSet/adverse-event-seriousness | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes |
| 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.
| |||||
| 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 |
SΣ | 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 |
SΣ | 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 |
SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | ||||
| AdverseEvent.event | example | AdverseEventTypehttp://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vsfrom this IG | ||||
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://terminology.hl7.org/ValueSet/adverse-event-seriousness | ||||
| AdverseEvent.severity | required | AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1from the FHIR Standard | ||||
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | ||||
| AdverseEvent.suspectEntity.causality.assessment | example | AdverseEventCausalityAssessmenthttp://hl7.org/fhir/ValueSet/adverse-event-causality-assessfrom the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard |
| 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:
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
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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