abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| Left: | Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research) |
| Right: | Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0' vs '1.0.1' |
| Information | StructureDefinition.date | Values for date differ: '2024-04-17T12:50:34+00:00' vs '2024-04-30T21:05:30+00:00' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/AdverseEvent | ||
| copyright | |||
| date | 2024-04-17T12:50:34+00:00 | 2024-04-30T21:05:30+00:00 |
|
| description | Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications. | ||
| experimental | |||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
| jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 | ||
| kind | resource | ||
| name | AdverseEventClinicalResearch | ||
| publisher | HL7 International / Biomedical Research and Regulation | ||
| purpose | |||
| status | active | ||
| title | Adverse Event Clinical Research | ||
| type | AdverseEvent | ||
| url | http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research | ||
| version | 1.0.0 | 1.0.1 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 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. | 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 | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||||
 Slices for modifierExtension | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url | ?! | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | Σ | 0..1 | Identifier | Business identifier for the event | |||||||||
| actuality | ?!Σ | 1..1 | code | actual Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual | ?!Σ | 1..1 | code | actual Binding: ?? (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: ?? (extensible): Overall categorization of the event, e.g. product-related or situational. | 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: ?? (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: ?? (example): Detailed type of event. | Σ | 1..1 | CodeableConcept | Event or incident that occurred or was averted Binding: ?? (example): Detailed type of event. | |||||||||
| subject | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | Σ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | |||||||||
| encounter | Σ | 0..1 | Reference(Encounter) | Encounter created as part of | Σ | 0..1 | Reference(Encounter) | Encounter created as part of | |||||||||
| date | Σ | 0..1 | dateTime | When the event occurred | Σ | 0..1 | dateTime | When the event occurred | |||||||||
| detected | Σ | 0..1 | dateTime | When the event was detected | Σ | 0..1 | dateTime | When the event was detected | |||||||||
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded | Σ | 0..1 | dateTime | When the event was recorded | |||||||||
| resultingCondition | Σ | 0..0 | Σ | 0..0 | |||||||||||||
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | 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: ?? (required) | SΣ | 1..1 | CodeableConcept | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition Binding: ?? (required) | |||||||||
| severity | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (required): The severity of the adverse event itself, in direct relation to the subject. | Σ | 0..1 | CodeableConcept | mild | moderate | severe Binding: ?? (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: ?? (required) | SΣ | 1..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: ?? (required) | |||||||||
| recorder | Σ | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Who recorded the adverse event | 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 | Σ | 0..* | Reference(Practitioner | PractitionerRole | Device) | Who was involved in the adverse event or the potential adverse event | |||||||||
 suspectEntity | Σ | 0..0 | Σ | 0..0 | |||||||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| instance | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event | Σ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event | |||||||||
 causality | Σ | 0..* | BackboneElement | Information on the possible cause of the event | Σ | 0..* | BackboneElement | Information on the possible cause of the event | |||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| assessment | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. | Σ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: ?? (example): Codes for the assessment of whether the entity caused the event. | |||||||||
| productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | |||||||||
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | |||||||||
| method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: ?? (example): TODO. | |||||||||
| subjectMedicalHistory | Σ | 0..0 | Σ | 0..0 | |||||||||||||
| referenceDocument | Σ | 0..0 | Σ | 0..0 | |||||||||||||
| study | SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study | SΣ | 1..1 | Reference(ResearchStudy) | AdverseEvent.study | |||||||||
| Documentation for this format | |||||||||||||||||