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Merge pull request HL7#968 from bheale/master
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AdverseEvent Clinical Research Profile IG and AdverseEvent Clinical Research R4 BAckport Profile IG
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@lmckenzi
lmckenzi authored Mar 27, 2024
2 parents 755d33d + ac9100e commit 6785a52
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59 changes: 37 additions & 22 deletions xml/FHIR-ae-research-backport-ig.xml
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<?xml version="1.0" encoding="UTF-8"?>
<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/uv/ae-research-backport-ig/2023Sep" ciUrl="https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig" defaultVersion="1.0.0-ballot" defaultWorkgroup="brr" gitUrl="https://github.com/HL7/fhir-ae-research-backport-ig" url="http://hl7.org/fhir/uv/ae-research-backport-ig">
<version code="current" url="https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig"/>
<version code="1.0.0-ballot" url="http://hl7.org/fhir/uv/ae-research-backport-ig/2023Sep"/>
<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/uv/ae-research-backport-ig/2023Sep" ciUrl="http://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig" defaultVersion="1.0.0" defaultWorkgroup="brr" gitUrl="https://github.com/HL7/fhir-ae-research-backport-ig" url="http://hl7.org/fhir/uv/ae-research-backport-ig">
<version code="current" url="http://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig"/>
<version code="1.0.0" url="http://hl7.org/fhir/uv/ae-research-backport-ig/STU1"/>
<version code="1.0.0-ballot" deprecated="true" url="http://hl7.org/fhir/uv/ae-research-backport-ig/2023Sep"/>
<artifactPageExtension value="-definitions"/>
<artifactPageExtension value="-examples"/>
<artifactPageExtension value="-mappings"/>
<artifact id="Condition/AEHepaticFailureUseCase7" key="Condition-AEHepaticFailureUseCase7" name="AEHepaticFailureUseCase7"/>
<artifact id="Condition/AEHepaticFailureUseCase7complication" key="Condition-AEHepaticFailureUseCase7complication" name="AEHepaticFailureUseCase7complication"/>
<artifact id="Condition/AEHepaticFailure" key="Condition-AEHepaticFailure" name="AEHepaticFailure"/>
<artifact deprecated="true" id="Condition/AEHepaticFailureUseCase7" key="Condition-AEHepaticFailureUseCase7" name="AEHepaticFailureUseCase7"/>
<artifact deprecated="true" id="Condition/AEHepaticFailureUseCase7complication" key="Condition-AEHepaticFailureUseCase7complication" name="AEHepaticFailureUseCase7complication"/>
<artifact id="Condition/AEHepaticFailurecomplication" key="Condition-AEHepaticFailurecomplication" name="AEHepaticFailurecomplication"/>
<artifact id="StructureDefinition/AdverseEvent-clinical-research" key="StructureDefinition-AdverseEvent-clinical-research" name="Adverse Event Clinical Research"/>
<artifact id="ValueSet/adverse-event-outcome-clinical-research-vs" key="ValueSet-adverse-event-outcome-clinical-research-vs" name="Adverse Event Clinical Research Outcomes"/>
<artifact deprecated="true" id="ValueSet/adverse-event-outcome-clinical-research-vs" key="ValueSet-adverse-event-outcome-clinical-research-vs" name="Adverse Event Clinical Research Outcomes"/>
<artifact id="StructureDefinition/ae-grade" key="StructureDefinition-ae-grade" name="Adverse Event Grade"/>
<artifact id="ValueSet/adverse-event-participant-function-vs" key="ValueSet-adverse-event-participant-function-vs" name="Adverse Event Participant Functions"/>
<artifact id="ValueSet/adverse-event-seriousness-criteria-vs" key="ValueSet-adverse-event-seriousness-criteria-vs" name="Adverse Event Seriousness Criteria"/>
<artifact deprecated="true" id="ValueSet/adverse-event-seriousness-criteria-vs" key="ValueSet-adverse-event-seriousness-criteria-vs" name="Adverse Event Seriousness Criteria"/>
<artifact id="ValueSet/adverse-event-status-vs" key="ValueSet-adverse-event-status-vs" name="Adverse Event Status"/>
<artifact id="StructureDefinition/resolve-date" key="StructureDefinition-resolve-date" name="Adverse Event resolution date"/>
<artifact id="StructureDefinition/caused-subject-to-discontinue-study" key="StructureDefinition-caused-subject-to-discontinue-study" name="Adverse event caused subject to discontinue the study"/>
<artifact id="ValueSet/adverse-event-contributing-factor-vs" key="ValueSet-adverse-event-contributing-factor-vs" name="AdverseEvent Contributing Factor"/>
<artifact id="ValueSet/adverse-event-mitigating-action-vs" key="ValueSet-adverse-event-mitigating-action-vs" name="AdverseEvent Mitigating Action"/>
<artifact id="ValueSet/adverse-event-seriousness-non-only-vs" key="ValueSet-adverse-event-seriousness-non-only-vs" name="AdverseEvent Seriousness Non-serious Codes Only"/>
<artifact id="CodeSystem/adverse-event-severity-or-grade-cs" key="CodeSystem-adverse-event-severity-or-grade-cs" name="AdverseEvent Severity or Grade Codes"/>
<artifact id="ValueSet/adverse-event-severity-or-grade-vs" key="ValueSet-adverse-event-severity-or-grade-vs" name="AdverseEvent Severity or Grade Value Set"/>
<artifact deprecated="true" id="CodeSystem/adverse-event-severity-or-grade-cs" key="CodeSystem-adverse-event-severity-or-grade-cs" name="AdverseEvent Severity or Grade Codes"/>
<artifact deprecated="true" id="ValueSet/adverse-event-severity-or-grade-vs" key="ValueSet-adverse-event-severity-or-grade-vs" name="AdverseEvent Severity or Grade Value Set"/>
<artifact id="ValueSet/adverse-event-supporting-info" key="ValueSet-adverse-event-supporting-info" name="AdverseEvent Supporting Information"/>
<artifact id="ValueSet/adverse-event-type-vs" key="ValueSet-adverse-event-type-vs" name="AdverseEvent Type"/>
<artifact id="CapabilityStatement/base-level-server" key="CapabilityStatement-base-level-server" name="Base AdverseEvent Clinical Research Profile Capability Statement"/>
<artifact id="AdverseEvent/AdverseEventFromProcedureNotStudyDrug" key="AdverseEvent-AdverseEventFromProcedureNotStudyDrug" name="AdverseEventFromProcedureNotStudyDrug"/>
<artifact deprecated="true" id="CapabilityStatement/base-level-server" key="CapabilityStatement-base-level-server" name="Base AdverseEvent Clinical Research Profile Capability Statement"/>
<artifact id="ResearchStudy/BreastCancerTrial" key="ResearchStudy-BreastCancerTrial" name="Breast Cancer Trial"/>
<artifact id="ValueSet/adverse-event-causality-related-vs" key="ValueSet-adverse-event-causality-related-vs" name="Causality Relatedness values"/>
<artifact id="AdverseEvent/ClinicalResearchAdverseEventUseCase15" key="AdverseEvent-ClinicalResearchAdverseEventUseCase15" name="ClinicalResearchAdverseEventUseCase15"/>
<artifact id="AdverseEvent/ClinicalResearchAdverseEventUseCase16" key="AdverseEvent-ClinicalResearchAdverseEventUseCase16" name="ClinicalResearchAdverseEventUseCase16"/>
<artifact id="AdverseEvent/ClinicalResearchAdverseEventUseCase17" key="AdverseEvent-ClinicalResearchAdverseEventUseCase17" name="ClinicalResearchAdverseEventUseCase17"/>
<artifact id="AdverseEvent/ClinicalResearchAdverseEventUseCase7" key="AdverseEvent-ClinicalResearchAdverseEventUseCase7" name="ClinicalResearchAdverseEventUseCase7"/>
<artifact deprecated="true" id="ValueSet/adverse-event-causality-related-vs" key="ValueSet-adverse-event-causality-related-vs" name="Causality Relatedness values"/>
<artifact deprecated="true" id="AdverseEvent/ClinicalResearchAdverseEventUseCase15" key="AdverseEvent-ClinicalResearchAdverseEventUseCase15" name="ClinicalResearchAdverseEventUseCase15"/>
<artifact deprecated="true" id="AdverseEvent/ClinicalResearchAdverseEventUseCase16" key="AdverseEvent-ClinicalResearchAdverseEventUseCase16" name="ClinicalResearchAdverseEventUseCase16"/>
<artifact deprecated="true" id="AdverseEvent/ClinicalResearchAdverseEventUseCase17" key="AdverseEvent-ClinicalResearchAdverseEventUseCase17" name="ClinicalResearchAdverseEventUseCase17"/>
<artifact deprecated="true" id="AdverseEvent/ClinicalResearchAdverseEventUseCase7" key="AdverseEvent-ClinicalResearchAdverseEventUseCase7" name="ClinicalResearchAdverseEventUseCase7"/>
<artifact id="AdverseEvent/ClinicalTrialSignificantAdverseEvent" key="AdverseEvent-ClinicalTrialSignificantAdverseEvent" name="ClinicalTrialSignificantAdverseEvent"/>
<artifact id="Patient/ClinicalTrialSubject5" key="Patient-ClinicalTrialSubject5" name="ClinicalTrialSubject5"/>
<artifact id="StructureDefinition/contributing-factor" key="StructureDefinition-contributing-factor" name="Contributing Factor"/>
<artifact id="StructureDefinition/seriousness-criteria" key="StructureDefinition-seriousness-criteria" name="Criteria reviewed in determining serious adverse event"/>
<artifact id="Device/device-infuser" key="Device-device-infuser" name="Device - Infuser that exploded"/>
<artifact id="Patient/patient-slp" key="Patient-patient-slp" name="Example patient SLP"/>
<artifact id="StructureDefinition/expected-in-research-study" key="StructureDefinition-expected-in-research-study" name="Expected In Research Study"/>
<artifact id="CodeSystem/fda-add-seriousness-criteria-cs" key="CodeSystem-fda-add-seriousness-criteria-cs" name="FDA Additional Seriousness Criteria CodeSystem"/>
<artifact id="Condition/GIBleedUseCase15" key="Condition-GIBleedUseCase15" name="GIBleedUseCase15"/>
<artifact deprecated="true" id="CodeSystem/fda-add-seriousness-criteria-cs" key="CodeSystem-fda-add-seriousness-criteria-cs" name="FDA Additional Seriousness Criteria CodeSystem"/>
<artifact id="Condition/GIBleed" key="Condition-GIBleed" name="GIBleed"/>
<artifact deprecated="true" id="Condition/GIBleedUseCase15" key="Condition-GIBleedUseCase15" name="GIBleedUseCase15"/>
<artifact id="Observation/blood-pressure-janet" key="Observation-blood-pressure-janet" name="Janet Blood Pressure Observation"/>
<artifact id="Patient/JanetPatient" key="Patient-JanetPatient" name="Janet Patient"/>
<artifact id="MedicationStatement/example001" key="MedicationStatement-example001" name="Janet Tylenol PM med"/>
Expand All @@ -48,42 +56,49 @@
<artifact id="MedicationRequest/medicationrequest-for-study-medication-administration-ABC" key="MedicationRequest-medicationrequest-for-study-medication-administration-ABC" name="Medication Request for discontinued clinical trial medication ABC"/>
<artifact id="Medication/bresentrik" key="Medication-bresentrik" name="Medication is bresentrik"/>
<artifact id="StructureDefinition/mitigating-action" key="StructureDefinition-mitigating-action" name="Mitigating Action"/>
<artifact id="AdverseEvent/NonSeriousAdverseEventResearchStudyMed" key="AdverseEvent-NonSeriousAdverseEventResearchStudyMed" name="NonSeriousAdverseEventResearchStudyMed"/>
<artifact id="StructureDefinition/note" key="StructureDefinition-note" name="Note"/>
<artifact id="StructureDefinition/participant" key="StructureDefinition-participant" name="Participant"/>
<artifact id="Patient/patient-moumic" key="Patient-patient-moumic" name="Patient MOUMIC"/>
<artifact id="AdverseEvent/clinical-research-ae-example-medwatch-patient-report" key="AdverseEvent-clinical-research-ae-example-medwatch-patient-report" name="Patient reported AE during research study"/>
<artifact id="Condition/janetReported-condition" key="Condition-janetReported-condition" name="Problem"/>
<artifact id="Provenance/provenance-for-blood-pressure-janet" key="Provenance-provenance-for-blood-pressure-janet" name="Provenance for Janet Blood Pressure Observation"/>
<artifact id="Provenance/provenance-for-weight" key="Provenance-provenance-for-weight" name="Provenance for Janet weight Observation"/>
<artifact id="StructureDefinition/research-subject-ref" key="StructureDefinition-research-subject-ref" name="Research Subject record of subject"/>
<artifact id="StructureDefinition/resultingEffect" key="StructureDefinition-resultingEffect" name="Resulting Effect"/>
<artifact id="StructureDefinition/severity-or-grade" key="StructureDefinition-severity-or-grade" name="Severity Or Grade"/>
<artifact id="Patient/SCHJO" key="Patient-SCHJO" name="Serious Adverse Event"/>
<artifact id="AdverseEvent/SeriousAdverseEventResearchStudy" key="AdverseEvent-SeriousAdverseEventResearchStudy" name="SeriousAdverseEventResearchStudy"/>
<artifact deprecated="true" id="StructureDefinition/severity-or-grade" key="StructureDefinition-severity-or-grade" name="Severity Or Grade"/>
<artifact id="StructureDefinition/supporting-info" key="StructureDefinition-supporting-info" name="Supporting information relevant to the event"/>
<artifact id="StructureDefinition/suspect-entity" key="StructureDefinition-suspect-entity" name="Suspect Entity"/>
<artifact id="Patient/SCHJO" key="Patient-SCHJO" name="Use Case 1 - Serious Adverse Event"/>
<artifact id="Patient/patient-moumic" key="Patient-patient-moumic" name="Use Case 16 Patient MOUMIC"/>
<artifact id="AdverseEvent/clinical-research-ae-example-medwatch-patient-report" key="AdverseEvent-clinical-research-ae-example-medwatch-patient-report" name="Use case 6B - patient reported AE during research study"/>
<artifact id="Condition/janetReported-condition" key="Condition-janetReported-condition" name="Use case 6B - problem"/>
<artifact id="StructureDefinition/status" key="StructureDefinition-status" name="Workflow Status"/>
<artifact id="AdverseEvent/adverse-event-compass-ex1" key="AdverseEvent-adverse-event-compass-ex1" name="adverse-event-compass-ex1"/>
<artifact id="AdverseEvent/adverse-event-compass-ex1a" key="AdverseEvent-adverse-event-compass-ex1a" name="adverse-event-compass-ex1a"/>
<artifact id="AdverseEvent/adverse-event-compass-ex1b" key="AdverseEvent-adverse-event-compass-ex1b" name="adverse-event-compass-ex1b"/>
<artifact id="AdverseEvent/adverse-event-compass-ex2" key="AdverseEvent-adverse-event-compass-ex2" name="adverse-event-compass-ex2"/>
<artifact id="AdverseEvent/adverse-event-device-death" key="AdverseEvent-adverse-event-device-death" name="adverse-event-device-death"/>
<artifact id="Procedure/clinical-trial-acme-procedure" key="Procedure-clinical-trial-acme-procedure" name="clinical-trial-acme-procedure"/>
<artifact id="ResearchSubject/clinical-trial-acme-subject" key="ResearchSubject-clinical-trial-acme-subject" name="clinical-trial-acme-subject"/>
<artifact id="ResearchStudy/clinical-trial-example-compass" key="ResearchStudy-clinical-trial-example-compass" name="clinical-trial-example-compass"/>
<artifact id="ResearchSubject/clinical-trial-example-subject" key="ResearchSubject-clinical-trial-example-subject" name="clinical-trial-example-subject"/>
<artifact id="ResearchSubject/clinical-trial-example-subject1" key="ResearchSubject-clinical-trial-example-subject1" name="clinical-trial-example-subject1"/>
<artifact id="MedicationAdministration/medication-administration-contrast-dye" key="MedicationAdministration-medication-administration-contrast-dye" name="medication-administration-contrast-dye"/>
<artifact id="MedicationAdministration/medication-administration-forhives" key="MedicationAdministration-medication-administration-forhives" name="medication-administration-forhives"/>
<artifact id="MedicationAdministration/medication-administration-kadcyla" key="MedicationAdministration-medication-administration-kadcyla" name="medication-administration-kadcyla"/>
<artifact id="MedicationAdministration/medication-administration-kadcyla-reduced" key="MedicationAdministration-medication-administration-kadcyla-reduced" name="medication-administration-kadcyla-reduced"/>
<artifact id="MedicationAdministration/medication-administration-kadcyla1" key="MedicationAdministration-medication-administration-kadcyla1" name="medication-administration-kadcyla1"/>
<artifact id="MedicationAdministration/medication-administration-tucatinib" key="MedicationAdministration-medication-administration-tucatinib" name="medication-administration-tucatinib"/>
<artifact id="MedicationAdministration/medication-administration-tucatinib-reduced" key="MedicationAdministration-medication-administration-tucatinib-reduced" name="medication-administration-tucatinib-reduced"/>
<artifact id="MedicationAdministration/medication-administration-tylenol" key="MedicationAdministration-medication-administration-tylenol" name="medication-administration-tylenol"/>
<artifact id="Medication/medication-contrast-dye" key="Medication-medication-contrast-dye" name="medication-contrast-dye"/>
<artifact id="Medication/medication-forhives" key="Medication-medication-forhives" name="medication-forhives"/>
<artifact id="MedicationRequest/medication-request-example-kadcyla" key="MedicationRequest-medication-request-example-kadcyla" name="medication-request-example-kadcyla"/>
<artifact id="MedicationRequest/medication-request-example-kadcyla1" key="MedicationRequest-medication-request-example-kadcyla1" name="medication-request-example-kadcyla1"/>
<artifact id="MedicationRequest/medication-request-example-tucatinib" key="MedicationRequest-medication-request-example-tucatinib" name="medication-request-example-tucatinib"/>
<artifact id="MedicationRequest/medication-request-example-zofran" key="MedicationRequest-medication-request-example-zofran" name="medication-request-example-zofran"/>
<artifact id="Medication/medication-tylenol" key="Medication-medication-tylenol" name="medication-tylenol"/>
<artifact id="Patient/patient-example-kaitlyn-b" key="Patient-patient-example-kaitlyn-b" name="patient-example-kaitlyn-b"/>
<artifact id="Patient/patient-example-kaitlyn-b1" key="Patient-patient-example-kaitlyn-b1" name="patient-example-kaitlyn-b1"/>
<artifact id="Practitioner/practitioner-oncology-nurse-jane" key="Practitioner-practitioner-oncology-nurse-jane" name="practitioner-oncology-nurse-jane"/>
<artifact id="Practitioner/practitioner-owen-oncologist" key="Practitioner-practitioner-owen-oncologist" name="practitioner-owen-oncologist"/>
<artifact id="Procedure/procedure-upper-endoscopy" key="Procedure-procedure-upper-endoscopy" name="procedure-upper-endoscopy"/>
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