Adverse Event Clinical Research
1.0.1 - STU1
Adverse Event Clinical Research
1.0.1 - STU1
Adverse Event Clinical Research, 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-ig/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research | Version: 1.0.1 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: AdverseEventClinicalResearch | ||
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.extension: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 | An event that may be related to unintended effects on a patient or research participant 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 | |
 caused-subject-to-discontinue-study |
0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria | |
| ae-severity |
0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) | |
| ae-grade |
0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred) | |
 actuality |
1..1 | code | actual Required Pattern: actual | |
| code |
1..1 | CodeableConcept | Event or incident that occurred or was averted | |
 occurrence[x] |
S | 0..1 | Period | When the event occurred |
| resultingEffect |
0..* | Reference(Condition | Observation) | Effect on the subject due to this event | |
| 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 | Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required) |
| study |
S | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in |
 suspectEntity |
||||
  causality |
S | 1..1 | BackboneElement | Information on the possible cause of the event |
 assessmentMethod |
0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. | |
 entityRelatedness |
0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Adverse Event Clinical Research Causality Relatedness (preferred) | |
| preventiveAction |
0..0 | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | preferred | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | preferred | AdverseEventClinicalResearchCausalityRelatednesshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness |
| 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-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-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent |
C | 0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant 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 |
| contained |
0..* | Resource | Contained, inline Resources | |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| caused-subject-to-discontinue-study |
0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria | |
| ae-severity |
0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) | |
| ae-grade |
0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred) | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. |
| actuality |
?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual |
| code |
Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. |
 subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject impacted by event |
| occurrence[x] |
SΣ | 0..1 | Period | When the event occurred |
| resultingEffect |
Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this 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 | Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required) |
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in |
| suspectEntity |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
 instance[x] |
Σ | 1..1 | Refers to the specific entity that caused the adverse event | |
| instanceCodeableConcept |
CodeableConcept | |||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
| causality |
SΣ | 1..1 | BackboneElement | Information on the possible cause of the event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessmentMethod |
Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. |
| entityRelatedness |
Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Adverse Event Clinical Research Causality Relatedness (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.code | example | AdverseEventTypehttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | preferred | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | preferred | AdverseEventClinicalResearchCausalityRelatednesshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom 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-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-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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 | An event that may be related to unintended effects on a patient or research participant 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: AllLanguages (required): IETF language tag for 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 | |||||
| caused-subject-to-discontinue-study |
0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria | |||||
| ae-severity |
0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) | |||||
| ae-grade |
0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred) | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business identifier for the event | ||||
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an 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 | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational. | ||||
| code |
Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. | ||||
| subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | ||||
| occurrence[x] |
SΣ | 0..1 | Period | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingEffect |
Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event | ||||
| 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) | ||||
| outcome |
SΣ | 1..1 | CodeableConcept | Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required) | ||||
| recorder |
Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event | ||||
| participant |
Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| function |
Σ | 0..1 | CodeableConcept | Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event. | ||||
| actor |
Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | ||||
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in | ||||
| expectedInResearchStudy |
0..1 | boolean | Considered likely or probable or anticipated in the research study | |||||
| suspectEntity |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance[x] |
Σ | 1..1 | Refers to the specific entity that caused the adverse event | |||||
| instanceCodeableConcept |
CodeableConcept | |||||||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||||||
| causality |
SΣ | 1..1 | BackboneElement | Information on the possible cause of the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessmentMethod |
Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. | ||||
| entityRelatedness |
Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Adverse Event Clinical Research Causality Relatedness (preferred) | ||||
| author |
Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | ||||
| contributingFactor |
Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| mitigatingAction |
Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. | |||||
| itemReference |
Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| supportingInfo |
Σ | 0..* | BackboneElement | Supporting information relevant to the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| note |
Σ | 0..* | Annotation | Comment on adverse event | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.category | example | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | |
| AdverseEvent.code | example | AdverseEventTypehttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | |
| AdverseEvent.participant.function | example | AdverseEventParticipantFunctionhttp://hl7.org/fhir/ValueSet/adverse-event-participant-functionfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | preferred | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | preferred | AdverseEventClinicalResearchCausalityRelatednesshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness | |
| AdverseEvent.contributingFactor.item[x] | example | AdverseEventContributingFactorhttp://hl7.org/fhir/ValueSet/adverse-event-contributing-factorfrom the FHIR Standard | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom the FHIR Standard | |
| AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingActionhttp://hl7.org/fhir/ValueSet/adverse-event-mitigating-actionfrom the FHIR Standard | |
| AdverseEvent.supportingInfo.item[x] | example | AdverseEventSupportingInforationhttp://hl7.org/fhir/ValueSet/adverse-event-supporting-infofrom 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-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-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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: 4 elements(1 nested mandatory element)
Must-Support: 5 elements
Prohibited: 1 element
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 | An event that may be related to unintended effects on a patient or research participant 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 | |
| caused-subject-to-discontinue-study |
0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria | |
| ae-severity |
0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) | |
| ae-grade |
0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred) | |
| actuality |
1..1 | code | actual Required Pattern: actual | |
| code |
1..1 | CodeableConcept | Event or incident that occurred or was averted | |
| occurrence[x] |
S | 0..1 | Period | When the event occurred |
| resultingEffect |
0..* | Reference(Condition | Observation) | Effect on the subject due to this event | |
| 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 | Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required) |
| study |
S | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in |
| suspectEntity |
||||
| causality |
S | 1..1 | BackboneElement | Information on the possible cause of the event |
| assessmentMethod |
0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. | |
| entityRelatedness |
0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Adverse Event Clinical Research Causality Relatedness (preferred) | |
| preventiveAction |
0..0 | |||
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | preferred | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | preferred | AdverseEventClinicalResearchCausalityRelatednesshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness |
| 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-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-ig/StructureDefinition/seriousness-criteria').exists().not() ) |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent |
C | 0..* | AdverseEvent | An event that may be related to unintended effects on a patient or research participant 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 |
| contained |
0..* | Resource | Contained, inline Resources | |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| caused-subject-to-discontinue-study |
0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria | |
| ae-severity |
0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) | |
| ae-grade |
0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred) | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event. |
| actuality |
?!Σ | 1..1 | code | actual Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual |
| code |
Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. |
| subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject impacted by event |
| occurrence[x] |
SΣ | 0..1 | Period | When the event occurred |
| resultingEffect |
Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this 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 | Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required) |
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in |
| suspectEntity |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance[x] |
Σ | 1..1 | Refers to the specific entity that caused the adverse event | |
| instanceCodeableConcept |
CodeableConcept | |||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||
| causality |
SΣ | 1..1 | BackboneElement | Information on the possible cause of the event |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessmentMethod |
Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. |
| entityRelatedness |
Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Adverse Event Clinical Research Causality Relatedness (preferred) |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.code | example | AdverseEventTypehttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | preferred | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | preferred | AdverseEventClinicalResearchCausalityRelatednesshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom 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-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-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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 | An event that may be related to unintended effects on a patient or research participant 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: AllLanguages (required): IETF language tag for 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 | |||||
| caused-subject-to-discontinue-study |
0..1 | boolean | Adverse event caused subject to discontinue the study URL: http://hl7.org/fhir/uv/ae-research-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-ig/StructureDefinition/seriousness-criteria | |||||
| ae-severity |
0..1 | CodeableConcept | The degree of something undesirable URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) | |||||
| ae-grade |
0..1 | CodeableConcept | The degree of something undesirable, used in oncology trials URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade Binding: Adverse Event Clinical Research Grades (preferred) | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business identifier for the event | ||||
| status |
?!Σ | 1..1 | code | in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an 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 | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational. | ||||
| code |
Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event. | ||||
| subject |
Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject) | Subject impacted by event | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | The Encounter associated with the start of the AdverseEvent | ||||
| occurrence[x] |
SΣ | 0..1 | Period | When the event occurred | ||||
| detected |
Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate |
Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingEffect |
Σ | 0..* | Reference(Condition | Observation) | Effect on the subject due to this event | ||||
| 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) | ||||
| outcome |
SΣ | 1..1 | CodeableConcept | Type of outcome from the adverse event Binding: Adverse Event Clinical Research Outcomes (required) | ||||
| recorder |
Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject) | Who recorded the adverse event | ||||
| participant |
Σ | 0..* | BackboneElement | Who was involved in the adverse event or the potential adverse event and what they did | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| function |
Σ | 0..1 | CodeableConcept | Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event. | ||||
| actor |
Σ | 1..1 | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject) | Who was involved in the adverse event or the potential adverse event | ||||
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Research study that the subject is enrolled in | ||||
| expectedInResearchStudy |
0..1 | boolean | Considered likely or probable or anticipated in the research study | |||||
| suspectEntity |
Σ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance[x] |
Σ | 1..1 | Refers to the specific entity that caused the adverse event | |||||
| instanceCodeableConcept |
CodeableConcept | |||||||
| instanceReference |
Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy) | |||||||
| causality |
SΣ | 1..1 | BackboneElement | Information on the possible cause of the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessmentMethod |
Σ | 0..1 | CodeableConcept | Method of evaluating the relatedness of the suspected entity to the event. Binding: AdverseEventCausalityMethod (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. | ||||
| entityRelatedness |
Σ | 0..1 | CodeableConcept | Result of the assessment regarding the relatedness of the suspected entity to the event Binding: Adverse Event Clinical Research Causality Relatedness (preferred) | ||||
| author |
Σ | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject) | Author of the information on the possible cause of the event | ||||
| contributingFactor |
Σ | 0..* | BackboneElement | Contributing factors suspected to have increased the probability or severity of the adverse event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Item suspected to have increased the probability or severity of the adverse event Binding: AdverseEventContributingFactor (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| mitigatingAction |
Σ | 0..* | BackboneElement | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm Binding: AdverseEventMitigatingAction (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm. | |||||
| itemReference |
Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| supportingInfo |
Σ | 0..* | BackboneElement | Supporting information relevant to the event | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item[x] |
Σ | 1..1 | Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event. | |||||
| itemReference |
Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse) | |||||||
| itemCodeableConcept |
CodeableConcept | |||||||
| note |
Σ | 0..* | Annotation | Comment on adverse event | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| AdverseEvent.status | required | AdverseEventStatushttp://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0from the FHIR Standard | |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0from the FHIR Standard | |
| AdverseEvent.category | example | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | |
| AdverseEvent.code | example | AdverseEventTypehttp://hl7.org/fhir/ValueSet/adverse-event-typefrom the FHIR Standard | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousnessfrom the FHIR Standard | |
| AdverseEvent.outcome | required | AdverseEventClinicalResearchOutcomeshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes | |
| AdverseEvent.participant.function | example | AdverseEventParticipantFunctionhttp://hl7.org/fhir/ValueSet/adverse-event-participant-functionfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.assessmentMethod | preferred | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.entityRelatedness | preferred | AdverseEventClinicalResearchCausalityRelatednesshttp://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness | |
| AdverseEvent.contributingFactor.item[x] | example | AdverseEventContributingFactorhttp://hl7.org/fhir/ValueSet/adverse-event-contributing-factorfrom the FHIR Standard | |
| AdverseEvent.preventiveAction.item[x] | example | AdverseEventPreventiveActionhttp://hl7.org/fhir/ValueSet/adverse-event-preventive-actionfrom the FHIR Standard | |
| AdverseEvent.mitigatingAction.item[x] | example | AdverseEventMitigatingActionhttp://hl7.org/fhir/ValueSet/adverse-event-mitigating-actionfrom the FHIR Standard | |
| AdverseEvent.supportingInfo.item[x] | example | AdverseEventSupportingInforationhttp://hl7.org/fhir/ValueSet/adverse-event-supporting-infofrom 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-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-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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: 4 elements(1 nested mandatory element)
Must-Support: 5 elements
Prohibited: 1 element
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-ig#1.0.1 based on FHIR 5.0.0. Generated 2024-04-30
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