Profile Comparison between http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research vs http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research

Left:Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research)
Right:Adverse Event Clinical Research (http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research)

Messages

ErrorStructureDefinition.versionValues for version differ: '1.0.0' vs '1.0.1'
InformationStructureDefinition.dateValues for date differ: '2024-04-15T17:39:57+00:00' vs '2024-04-30T20:32:38+00:00'

Metadata

NameValueComments
.abstractfalse
    .baseDefinitionhttp://hl7.org/fhir/StructureDefinition/AdverseEvent
      .copyright
        .date2024-04-15T17:39:57+00:002024-04-30T20:32:38+00:00
        • Values Differ
        .descriptionFoundational profile of AdverseEvent for Clinical Research communications.
          .experimental
            .fhirVersion5.0.0
              .jurisdiction
                ..jurisdiction[0]http://unstats.un.org/unsd/methods/m49/m49.htm#001
                  .kindresource
                    .nameAdverseEventClinicalResearch
                      .publisherHL7 International / Biomedical Research and Regulation
                        .purpose
                          .statusactive
                            .titleAdverse Event Clinical Research
                              .typeAdverseEvent
                                .urlhttp://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research
                                  .version1.0.01.0.1
                                  • Values Differ

                                  Structure

                                  NameL FlagsL Card.L TypeL Description & ConstraintsR FlagsR Card.R TypeR Description & ConstraintsCommentsdoco
                                  .. AdverseEvent C0..*AdverseEventAn 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.
                                  C0..*AdverseEventAn 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 Σ0..1idLogical id of this artifactΣ0..1idLogical id of this artifact
                                      ... meta Σ0..1MetaMetadata about the resourceΣ0..1MetaMetadata about the resource
                                        ... implicitRules ?!Σ0..1uriA set of rules under which this content was created?!Σ0..1uriA set of rules under which this content was created
                                          ... language 0..1codeLanguage of the resource content
                                          Binding: ?? (required): IETF language tag for a human language

                                          Additional BindingsPurpose
                                          ??Starter
                                          0..1codeLanguage of the resource content
                                          Binding: ?? (required): IETF language tag for a human language

                                          Additional BindingsPurpose
                                          ??Starter
                                            ... text 0..1NarrativeText summary of the resource, for human interpretation0..1NarrativeText summary of the resource, for human interpretation
                                              ... contained 0..*ResourceContained, inline Resources
                                              0..*ResourceContained, inline Resources
                                                ... Slices for extension 0..*ExtensionExtension
                                                Slice: Unordered, Open by value:url
                                                0..*ExtensionExtension
                                                Slice: Unordered, Open by value:url
                                                  ... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored
                                                  ?!Σ0..*ExtensionExtensions that cannot be ignored
                                                    ... identifier Σ0..*IdentifierBusiness identifier for the event
                                                    Σ0..*IdentifierBusiness identifier for the event
                                                      ... status ?!Σ1..1codein-progress | completed | entered-in-error | unknown
                                                      Binding: ?? (required): Codes identifying the lifecycle stage of an event.

                                                      ?!Σ1..1codein-progress | completed | entered-in-error | unknown
                                                      Binding: ?? (required): Codes identifying the lifecycle stage of an event.

                                                        ... actuality ?!Σ1..1codeactual
                                                        Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential.


                                                        Required Pattern: actual
                                                        ?!Σ1..1codeactual
                                                        Binding: ?? (required): Overall nature of the adverse event, e.g. real or potential.


                                                        Required Pattern: actual
                                                          ... category Σ0..*CodeableConceptwrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
                                                          Binding: ?? (example): Overall categorization of the event, e.g. product-related or situational.


                                                          Σ0..*CodeableConceptwrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
                                                          Binding: ?? (example): Overall categorization of the event, e.g. product-related or situational.


                                                            ... code Σ1..1CodeableConceptEvent or incident that occurred or was averted
                                                            Binding: ?? (example): Detailed type of event.

                                                            Σ1..1CodeableConceptEvent or incident that occurred or was averted
                                                            Binding: ?? (example): Detailed type of event.

                                                              ... subject Σ1..1Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)Subject impacted by eventΣ1..1Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)Subject impacted by event
                                                                ... encounter Σ0..1Reference(Encounter)The Encounter associated with the start of the AdverseEventΣ0..1Reference(Encounter)The Encounter associated with the start of the AdverseEvent
                                                                  ... occurrence[x] SΣ0..1PeriodWhen the event occurredSΣ0..1PeriodWhen the event occurred
                                                                    ... detected Σ0..1dateTimeWhen the event was detectedΣ0..1dateTimeWhen the event was detected
                                                                      ... recordedDate Σ0..1dateTimeWhen the event was recordedΣ0..1dateTimeWhen the event was recorded
                                                                        ... resultingEffect Σ0..*Reference(Condition | Observation)Effect on the subject due to this event
                                                                        Σ0..*Reference(Condition | Observation)Effect on the subject due to this event
                                                                          ... location Σ0..1Reference(Location)Location where adverse event occurredΣ0..1Reference(Location)Location where adverse event occurred
                                                                            ... seriousness SΣ1..1CodeableConceptInvestigator defined severity of the adverse event, in relation to the subject not the resulting condition
                                                                            Binding: ?? (required)
                                                                            SΣ1..1CodeableConceptInvestigator defined severity of the adverse event, in relation to the subject not the resulting condition
                                                                            Binding: ?? (required)
                                                                              ... outcome SΣ1..1CodeableConceptType of outcome from the adverse event
                                                                              Binding: ?? (required)
                                                                              SΣ1..1CodeableConceptType of outcome from the adverse event
                                                                              Binding: ?? (required)
                                                                                ... recorder Σ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)Who recorded the adverse eventΣ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)Who recorded the adverse event
                                                                                  ... participant Σ0..*BackboneElementWho was involved in the adverse event or the potential adverse event and what they did
                                                                                  Σ0..*BackboneElementWho was involved in the adverse event or the potential adverse event and what they did
                                                                                    .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                      .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                      0..*ExtensionAdditional content defined by implementations
                                                                                        .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                        ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                          .... function Σ0..1CodeableConceptType of involvement
                                                                                          Binding: ?? (example): Codes describing the type of involvement of the actor in the adverse event.

                                                                                          Σ0..1CodeableConceptType of involvement
                                                                                          Binding: ?? (example): Codes describing the type of involvement of the actor in the adverse event.

                                                                                            .... actor Σ1..1Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)Who was involved in the adverse event or the potential adverse eventΣ1..1Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)Who was involved in the adverse event or the potential adverse event
                                                                                              ... study SΣ1..1Reference(ResearchStudy)Research study that the subject is enrolled in
                                                                                              SΣ1..1Reference(ResearchStudy)Research study that the subject is enrolled in
                                                                                                ... expectedInResearchStudy 0..1booleanConsidered likely or probable or anticipated in the research study0..1booleanConsidered likely or probable or anticipated in the research study
                                                                                                  ... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
                                                                                                  Σ0..*BackboneElementThe suspected agent causing the adverse event
                                                                                                    .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                      .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                      0..*ExtensionAdditional content defined by implementations
                                                                                                        .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                        ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                          .... instance[x] Σ1..1CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)Refers to the specific entity that caused the adverse eventΣ1..1CodeableConcept, Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device | BiologicallyDerivedProduct | ResearchStudy)Refers to the specific entity that caused the adverse event
                                                                                                            .... causality SΣ1..1BackboneElementInformation on the possible cause of the eventSΣ1..1BackboneElementInformation on the possible cause of the event
                                                                                                              ..... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                ..... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                0..*ExtensionAdditional content defined by implementations
                                                                                                                  ..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                  ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                    ..... assessmentMethod Σ0..1CodeableConceptMethod of evaluating the relatedness of the suspected entity to the event.
                                                                                                                    Binding: ?? (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.

                                                                                                                    Σ0..1CodeableConceptMethod of evaluating the relatedness of the suspected entity to the event.
                                                                                                                    Binding: ?? (preferred): Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.

                                                                                                                      ..... entityRelatedness Σ0..1CodeableConceptResult of the assessment regarding the relatedness of the suspected entity to the event
                                                                                                                      Binding: ?? (preferred)
                                                                                                                      Σ0..1CodeableConceptResult of the assessment regarding the relatedness of the suspected entity to the event
                                                                                                                      Binding: ?? (preferred)
                                                                                                                        ..... author Σ0..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)Author of the information on the possible cause of the eventΣ0..1Reference(Practitioner | PractitionerRole | Patient | RelatedPerson | ResearchSubject)Author of the information on the possible cause of the event
                                                                                                                          ... contributingFactor Σ0..*BackboneElementContributing factors suspected to have increased the probability or severity of the adverse event
                                                                                                                          Σ0..*BackboneElementContributing factors suspected to have increased the probability or severity of the adverse event
                                                                                                                            .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                              .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                              0..*ExtensionAdditional content defined by implementations
                                                                                                                                .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                  .... item[x] Σ1..1Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement), CodeableConceptItem suspected to have increased the probability or severity of the adverse event
                                                                                                                                  Binding: ?? (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

                                                                                                                                  Σ1..1Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Device | DeviceUsage | DocumentReference | MedicationAdministration | MedicationStatement), CodeableConceptItem suspected to have increased the probability or severity of the adverse event
                                                                                                                                  Binding: ?? (example): Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.

                                                                                                                                    ... preventiveAction Σ0..0Σ0..0
                                                                                                                                      .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                        .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                        0..*ExtensionAdditional content defined by implementations
                                                                                                                                          .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                          ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                            .... item[x] Σ1..1Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConceptAction that contributed to avoiding the adverse event
                                                                                                                                            Binding: ?? (example): Codes describing the preventive actions that contributed to avoiding the adverse event.

                                                                                                                                            Σ1..1Reference(Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConceptAction that contributed to avoiding the adverse event
                                                                                                                                            Binding: ?? (example): Codes describing the preventive actions that contributed to avoiding the adverse event.

                                                                                                                                              ... mitigatingAction Σ0..*BackboneElementAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm
                                                                                                                                              Σ0..*BackboneElementAmeliorating actions taken after the adverse event occured in order to reduce the extent of harm
                                                                                                                                                .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                  .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                  0..*ExtensionAdditional content defined by implementations
                                                                                                                                                    .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                    ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                      .... item[x] Σ1..1Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConceptAmeliorating action taken after the adverse event occured in order to reduce the extent of harm
                                                                                                                                                      Binding: ?? (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.

                                                                                                                                                      Σ1..1Reference(Procedure | DocumentReference | MedicationAdministration | MedicationRequest), CodeableConceptAmeliorating action taken after the adverse event occured in order to reduce the extent of harm
                                                                                                                                                      Binding: ?? (example): Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.

                                                                                                                                                        ... supportingInfo Σ0..*BackboneElementSupporting information relevant to the event
                                                                                                                                                        Σ0..*BackboneElementSupporting information relevant to the event
                                                                                                                                                          .... id 0..1stringUnique id for inter-element referencing0..1stringUnique id for inter-element referencing
                                                                                                                                                            .... extension 0..*ExtensionAdditional content defined by implementations
                                                                                                                                                            0..*ExtensionAdditional content defined by implementations
                                                                                                                                                              .... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                              ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
                                                                                                                                                                .... item[x] Σ1..1Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse), CodeableConceptSubject medical history or document relevant to this adverse event
                                                                                                                                                                Binding: ?? (example): Codes describing the supporting information relevant to the event.

                                                                                                                                                                Σ1..1Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse), CodeableConceptSubject medical history or document relevant to this adverse event
                                                                                                                                                                Binding: ?? (example): Codes describing the supporting information relevant to the event.

                                                                                                                                                                  ... note Σ0..*AnnotationComment on adverse event
                                                                                                                                                                  Σ0..*AnnotationComment on adverse event

                                                                                                                                                                    doco Documentation for this format