From bc44d0f8b729d852b8005056950a0930d3ad8a29 Mon Sep 17 00:00:00 2001
From: Bret Heale <bheale@users.noreply.github.com>
Date: Mon, 24 Jul 2023 00:28:18 -0600
Subject: [PATCH 1/3] Update FHIR-us-mcc.xml

updated for STU 1 ballot
---
 xml/FHIR-us-mcc.xml | 36 ++++++++++++++++++------------------
 1 file changed, 18 insertions(+), 18 deletions(-)

diff --git a/xml/FHIR-us-mcc.xml b/xml/FHIR-us-mcc.xml
index 5daaf3f2c..f3ca3670d 100644
--- a/xml/FHIR-us-mcc.xml
+++ b/xml/FHIR-us-mcc.xml
@@ -1,23 +1,22 @@
 <?xml version="1.0" encoding="UTF-8"?>
-<specification ballotUrl="http://hl7.org/fhir/us/mcc/2023Jan" gitUrl="https://github.com/HL7/mcc" url="http://hl7.org/fhir/us/mcc" ciUrl="http://build.fhir.org/ig/HL7/fhir-us-mcc" defaultWorkgroup="pc" defaultVersion="1.0.0-ballot"
-    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:noNamespaceSchemaLocation="../schemas/specification.xsd">
-
+<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/us/mcc/2023Sep-ballot" ciUrl="http://build.fhir.org/ig/HL7/fhir-us-mcc" defaultVersion="1.0.0-ballot2" defaultWorkgroup="" gitUrl="https://github.com/HL7/mcc" url="http://hl7.org/fhir/us/mcc">
 <version code="current" url="http://build.fhir.org/ig/HL7/fhir-us-mcc"/>
-<version code="1.0.0-ballot" url="http://hl7.org/fhir/us/mcc/2023Jan"/>
-<version code="1.0.0" url="http://hl7.org/fhir/us/mcc/2023Jan" deprecated="true" />
-
-	
+<version code="1.0.0-ballot2" url="http://hl7.org/fhir/us/mcc/2023Sep-ballot"/>
+<version code="1.0.0-ballot" deprecated="true" url="http://hl7.org/fhir/us/mcc/2023Jan"/>
+<version code="1.0.0" deprecated="true" url="http://hl7.org/fhir/us/mcc/2023Jan"/>
 <artifactPageExtension value="-definitions"/>
 <artifactPageExtension value="-examples"/>
 <artifactPageExtension value="-mappings"/>
 <artifact id="RelatedPerson/caregiver-of-noelle" key="RelatedPerson-caregiver-of-noelle" name="Caregiver Example"/>
+<artifact id="StructureDefinition/changePattern" key="StructureDefinition-changePattern" name="Change Pattern R5 backport"/>
+<artifact id="StructureDefinition/custodian" key="StructureDefinition-custodian" name="Custodian R5 backport"/>
 <artifact id="StructureDefinition/DocRefPACP" key="StructureDefinition-DocRefPACP" name="Document Reference to Patient's Personal Advance Care Plan (Advance Directive)"/>
 <artifact deprecated="true" id="Parameters/expansion-parameters-fhir-mcc-ig" key="Parameters-expansion-parameters-fhir-mcc-ig" name="Expansion Parameters - MCC SNOMED"/>
 <artifact id="Parameters/expansion-parameters-mcc" key="Parameters-expansion-parameters-mcc" name="Expansion Parameters SNOMED US Version"/>
 <artifact id="CareTeam/careteam-of-noelle" key="CareTeam-careteam-of-noelle" name="MCC Care Team Example"/>
+<artifact id="Observation/caregiver-feelings-condition-status" key="Observation-caregiver-feelings-condition-status" name="MCC Caregiver Feelings on Condition Observation example"/>
 <artifact id="Condition/ConditionCKD" key="Condition-ConditionCKD" name="MCC Chronic Condition - CKD Example"/>
-<artifact id="CapabilityStatement/mcc-client" key="CapabilityStatement-mcc-client" name="MCC Client CapabilityStatement"/>
-<artifact id="Observation/pulse-intensity-palpation" key="Observation-pulse-intensity-palpation" name="MCC Clinical Test Observation example"/>
+<artifact id="Observation/pulse-intensity-palpation" key="Observation-pulse-intensity-palpation" name="MCC Clinical Result Observation example"/>
 <artifact id="DiagnosticReport/BoneSurvey" key="DiagnosticReport-BoneSurvey" name="MCC Diagnostic Report and Note Example"/>
 <artifact id="DocumentReference/PACP" key="DocumentReference-PACP" name="MCC Document Reference to Advance Directives Example"/>
 <artifact id="FamilyMemberHistory/father" key="FamilyMemberHistory-father" name="MCC Family Member History Example - Father"/>
@@ -25,7 +24,6 @@
 <artifact id="Goal/WGT-loss" key="Goal-WGT-loss" name="MCC Goal Example - Weight Loss"/>
 <artifact id="Observation/bunMCC" key="Observation-bunMCC" name="MCC Lab Observation - BUN"/>
 <artifact id="MedicationRequest/MCCMedExample" key="MedicationRequest-MCCMedExample" name="MCC Medication Request Example"/>
-<artifact id="Observation/AHC-HRSN-item-example-68517-2" key="Observation-AHC-HRSN-item-example-68517-2" name="MCC Observation SDOH Assessment"/>
 <artifact id="Observation/caregiver-consideration-obs-example" key="Observation-caregiver-consideration-obs-example" name="MCC Observation of Caregiver considerations example"/>
 <artifact id="Patient/cc-pat-pnoelle" key="Patient-cc-pat-pnoelle" name="MCC Patient"/>
 <artifact id="Practitioner/practitionerMCC-1" key="Practitioner-practitionerMCC-1" name="MCC Practitioner - Nephrologist"/>
@@ -36,25 +34,28 @@
 <artifact id="PractitionerRole/PractitionerRoleMCC3" key="PractitionerRole-PractitionerRoleMCC3" name="MCC Practitioner - Primary Care Provider Role"/>
 <artifact id="Procedure/Dialysis" key="Procedure-Dialysis" name="MCC Procedure Example - Dialysis"/>
 <artifact id="QuestionnaireResponse/hunger-vital-sign-example" key="QuestionnaireResponse-hunger-vital-sign-example" name="MCC QuestionnaireResponse Example"/>
-<artifact id="CapabilityStatement/mcc-server" key="CapabilityStatement-mcc-server" name="MCC Server CapabilityStatement"/>
+<artifact id="Observation/AHC-HRSN-item-example-68517-2" key="Observation-AHC-HRSN-item-example-68517-2" name="MCC SDOH assessment example Observation"/>
 <artifact id="Observation/Symptom1" key="Observation-Symptom1" name="MCC Symptom Observation Example - Taste Sense Altered"/>
 <artifact id="StructureDefinition/MCCCareTeam" key="StructureDefinition-MCCCareTeam" name="MCCCareTeam"/>
+<artifact id="CapabilityStatement/mcc-client" key="CapabilityStatement-mcc-client" name="MCCClientCapabilityStatement"/>
+<artifact id="CapabilityStatement/mcc-server" key="CapabilityStatement-mcc-server" name="MCCServerCapabilityStatement"/>
 <artifact id="StructureDefinition/mccCarePlan" key="StructureDefinition-mccCarePlan" name="Multiple Chronic Care Condition Care Plan"/>
 <artifact id="CareTeam/MCCCareTeamexample" key="CareTeam-MCCCareTeamexample" name="Multiple Chronic Condition Care Plan Care Team"/>
 <artifact id="StructureDefinition/MCCCaregiverConsiderationsObservation" key="StructureDefinition-MCCCaregiverConsiderationsObservation" name="Multiple Chronic Condition Care Plan Caregiver Considerations Observation"/>
-<artifact id="StructureDefinition/MCCCaregiverOnCareTeam" key="StructureDefinition-MCCCaregiverOnCareTeam" name="Multiple Chronic Condition Care Plan Caregiver on Care Team"/>
+<artifact deprecated="true" id="StructureDefinition/MCCCaregiverOnCareTeam" key="StructureDefinition-MCCCaregiverOnCareTeam" name="Multiple Chronic Condition Care Plan Caregiver on Care Team"/>
 <artifact id="StructureDefinition/MCCChronicDisease" key="StructureDefinition-MCCChronicDisease" name="Multiple Chronic Condition Care Plan Chronic Disease Conditions"/>
 <artifact id="StructureDefinition/MCCImagingObservation" key="StructureDefinition-MCCImagingObservation" name="Multiple Chronic Condition Care Plan Clinical Imaging Observation"/>
 <artifact id="StructureDefinition/MCCClinicalImpression" key="StructureDefinition-MCCClinicalImpression" name="Multiple Chronic Condition Care Plan Clinical Impression"/>
 <artifact id="ClinicalImpression/clinical-impression-example" key="ClinicalImpression-clinical-impression-example" name="Multiple Chronic Condition Care Plan Clinical Impression Example"/>
-<artifact id="StructureDefinition/MCCClinicalTestObservation" key="StructureDefinition-MCCClinicalTestObservation" name="Multiple Chronic Condition Care Plan Clinical Test Observation"/>
+<artifact id="StructureDefinition/MCCClinicalResultObservation" key="StructureDefinition-MCCClinicalResultObservation" name="Multiple Chronic Condition Care Plan Clinical Result Observation"/>
+<artifact deprecated="true" id="StructureDefinition/MCCClinicalTestObservation" key="StructureDefinition-MCCClinicalTestObservation" name="Multiple Chronic Condition Care Plan Clinical Test Observation"/>
 <artifact id="StructureDefinition/MCCDiagnosticReportAndNote" key="StructureDefinition-MCCDiagnosticReportAndNote" name="Multiple Chronic Condition Care Plan Diagnostic Report and Note"/>
 <artifact id="CarePlan/MCCCarePlan" key="CarePlan-MCCCarePlan" name="Multiple Chronic Condition Care Plan Example"/>
 <artifact id="StructureDefinition/MCCFamilyHistory" key="StructureDefinition-MCCFamilyHistory" name="Multiple Chronic Condition Care Plan Family History"/>
 <artifact id="StructureDefinition/MCCGoal" key="StructureDefinition-MCCGoal" name="Multiple Chronic Condition Care Plan Goal"/>
 <artifact id="Observation/mcc-imaging-observation-example" key="Observation-mcc-imaging-observation-example" name="Multiple Chronic Condition Care Plan Imagining Observation Example"/>
 <artifact id="StructureDefinition/MCCImmunization" key="StructureDefinition-MCCImmunization" name="Multiple Chronic Condition Care Plan Immunization"/>
-<artifact id="Immunization/immunizarion-1" key="Immunization-immunizarion-1" name="Multiple Chronic Condition Care Plan Immunization Example"/>
+<artifact id="Immunization/immunization-1" key="Immunization-immunizarion-1" name="Multiple Chronic Condition Care Plan Immunization Example"/>
 <artifact id="StructureDefinition/MCCLaboratoryResultObservation" key="StructureDefinition-MCCLaboratoryResultObservation" name="Multiple Chronic Condition Care Plan Laboratory Result Observation"/>
 <artifact id="StructureDefinition/MCCMedicationRequest" key="StructureDefinition-MCCMedicationRequest" name="Multiple Chronic Condition Care Plan Medication Request"/>
 <artifact id="StructureDefinition/MCCNutritionOrder" key="StructureDefinition-MCCNutritionOrder" name="Multiple Chronic Condition Care Plan Nutrition Order"/>
@@ -67,12 +68,12 @@
 <artifact id="StructureDefinition/MCCSimpleObservation" key="StructureDefinition-MCCSimpleObservation" name="Multiple Chronic Condition Care Plan Simple Observation"/>
 <artifact id="Observation/simple-observation-example" key="Observation-simple-observation-example" name="Multiple Chronic Condition Care Plan Simple Observation Example"/>
 <artifact id="StructureDefinition/MCCSymptomObservation" key="StructureDefinition-MCCSymptomObservation" name="Multiple Chronic Condition Care Plan Symptom Observation"/>
-<artifact id="CareTeam/caregiveronteam-of-noelle" key="CareTeam-caregiveronteam-of-noelle" name="Multiple Chronic Condition Care Plan example of MCC CaregiverOnCareTeam"/>
-<artifact id="Observation/caregiver-feelings-condition-status" key="Observation-caregiver-feelings-condition-status" name="Multiple Chronic Condition Care Plan example of Observation of Caregiver feelings towards status of a patient's condition"/>
+<artifact deprecated="true" id="CareTeam/caregiveronteam-of-noelle" key="CareTeam-caregiveronteam-of-noelle" name="Multiple Chronic Condition Care Plan example of MCC CaregiverOnCareTeam"/>
 <artifact id="ServiceRequest/foodpantry-referral" key="ServiceRequest-foodpantry-referral" name="Multiple Chronic Condition Service Request - Food Pantry"/>
 <artifact id="Observation/MCCweight" key="Observation-MCCweight" name="US-Core MCC Weight Example"/>
 <page key="NA" name="(NA)"/>
 <page key="many" name="(many)"/>
+<page key="careplanAggregation" name="Alternatives for Transmitting/Collecting Aggregated Care Plans"/>
 <page key="artifacts" name="Artifacts Summary"/>
 <page key="capability_statements" name="Capability Statements"/>
 <page deprecated="true" key="conformance" name="Conformance"/>
@@ -95,11 +96,10 @@
 <page key="mcc_use_cases" name="MCC Use Cases"/>
 <page key="mcc_value_set_libraries_and_usage" name="MCC Value Set Libraries and Usage"/>
 <page key="note_on__include_and__revInclude" name="Note on _include and _revinclude"/>
-<page key="profiles_or_resources_directly_reused_in_this_guide" name="Profiles or Resources Directly Reused in this Guide"/>
+<page deprecated="true" key="profiles_or_resources_directly_reused_in_this_guide" name="Profiles or Resources Directly Reused in this Guide"/>
 <page key="questionnaire_response" name="Questionnaire Response"/>
 <page key="security" name="Security"/>
 <page key="structure_and_design_considerations" name="Structure and Design Considerations"/>
 <page key="toc" name="Table of Contents"/>
 <page key="us_core_general_requirements" name="US Core General Requirements"/>
 </specification>
-

From 3202218bfcae1165fcfe36be54c63692ca0bd8a7 Mon Sep 17 00:00:00 2001
From: Bret Heale <bheale@users.noreply.github.com>
Date: Mon, 24 Jul 2023 01:07:06 -0600
Subject: [PATCH 2/3] Update FHIR-us-mcc.xml

---
 xml/FHIR-us-mcc.xml | 7 +++++--
 1 file changed, 5 insertions(+), 2 deletions(-)

diff --git a/xml/FHIR-us-mcc.xml b/xml/FHIR-us-mcc.xml
index f3ca3670d..acb6d232c 100644
--- a/xml/FHIR-us-mcc.xml
+++ b/xml/FHIR-us-mcc.xml
@@ -1,5 +1,8 @@
 <?xml version="1.0" encoding="UTF-8"?>
-<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/us/mcc/2023Sep-ballot" ciUrl="http://build.fhir.org/ig/HL7/fhir-us-mcc" defaultVersion="1.0.0-ballot2" defaultWorkgroup="" gitUrl="https://github.com/HL7/mcc" url="http://hl7.org/fhir/us/mcc">
+
+<specification ballotUrl="http://hl7.org/fhir/us/mcc/2023Sep-ballot" gitUrl="https://github.com/HL7/mcc" url="http://hl7.org/fhir/us/mcc" ciUrl="http://build.fhir.org/ig/HL7/fhir-us-mcc" defaultWorkgroup="pc" defaultVersion="1.0.0-ballot2"
+    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:noNamespaceSchemaLocation="../schemas/specification.xsd">
+	
 <version code="current" url="http://build.fhir.org/ig/HL7/fhir-us-mcc"/>
 <version code="1.0.0-ballot2" url="http://hl7.org/fhir/us/mcc/2023Sep-ballot"/>
 <version code="1.0.0-ballot" deprecated="true" url="http://hl7.org/fhir/us/mcc/2023Jan"/>
@@ -102,4 +105,4 @@
 <page key="structure_and_design_considerations" name="Structure and Design Considerations"/>
 <page key="toc" name="Table of Contents"/>
 <page key="us_core_general_requirements" name="US Core General Requirements"/>
-</specification>
+</specification>
\ No newline at end of file

From 0c3a7cf8648dc573cb0827f1f584c00ee87d6cb7 Mon Sep 17 00:00:00 2001
From: Bret Heale <bheale@users.noreply.github.com>
Date: Mon, 24 Jul 2023 10:44:37 -0600
Subject: [PATCH 3/3] ae-research and ae-research-backport

---
 xml/FHIR-ae-research-backport-ig.xml | 110 +++++++++++++++++++++++++++
 xml/FHIR-ae-research-ig.xml          |  92 ++++++++++++++++++++++
 xml/SPECS-FHIR.xml                   |   2 +
 3 files changed, 204 insertions(+)
 create mode 100644 xml/FHIR-ae-research-backport-ig.xml
 create mode 100644 xml/FHIR-ae-research-ig.xml

diff --git a/xml/FHIR-ae-research-backport-ig.xml b/xml/FHIR-ae-research-backport-ig.xml
new file mode 100644
index 000000000..008796208
--- /dev/null
+++ b/xml/FHIR-ae-research-backport-ig.xml
@@ -0,0 +1,110 @@
+<?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-ballot" ciUrl="https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig" gitUrl="https://github.com/HL7/fhir-ae-research-backport-ig" defaultVersion="1.0.0-ballot" defaultWorkgroup="brr" 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-ballot"/>
+<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="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 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 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 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="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 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="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 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"/>
+<artifact id="MedicationStatement/example007" key="MedicationStatement-example007" name="Janet allergy med"/>
+<artifact id="MedicationStatement/example003" key="MedicationStatement-example003" name="Janet pill for water retention med not known"/>
+<artifact id="Observation/weight-janet" key="Observation-weight-janet" name="Janet weight Observation"/>
+<artifact id="MedicationAdministration/medicationAdministration-for-bresentrik" key="MedicationAdministration-medicationAdministration-for-bresentrik" name="Medication Administration for bresentrik"/>
+<artifact id="MedicationAdministration/medadmin0301" key="MedicationAdministration-medadmin0301" name="Medication Administration of Med0301"/>
+<artifact id="MedicationRequest/medicationrequest-for-bresentrik" key="MedicationRequest-medicationrequest-for-bresentrik" name="Medication Request for bresentrik"/>
+<artifact id="MedicationRequest/medicationrequest0301-discontinue" key="MedicationRequest-medicationrequest0301-discontinue" name="Medication Request for discontinued clinical trial medication 0301"/>
+<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="StructureDefinition/note" key="StructureDefinition-note" name="Note"/>
+<artifact id="StructureDefinition/participant" key="StructureDefinition-participant" name="Participant"/>
+<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="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="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="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-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-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="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"/>
+<artifact id="ResearchStudy/research-study-DISNEY" key="ResearchStudy-research-study-DISNEY" name="research-study-DISNEY"/>
+<artifact id="ResearchStudy/research-study-XYZ" key="ResearchStudy-research-study-XYZ" name="research-study-XYZ"/>
+<artifact id="ResearchStudy/research-study-acme" key="ResearchStudy-research-study-acme" name="research-study-acme"/>
+<artifact id="Medication/resstudy-medication-WBY" key="Medication-resstudy-medication-WBY" name="resstudy-medication-WBY"/>
+<artifact id="Medication/study-medication-ABC" key="Medication-study-medication-ABC" name="study-medication-ABC"/>
+<artifact id="Medication/study-medication-MMD" key="Medication-study-medication-MMD" name="study-medication-MMD"/>
+<artifact id="MedicationAdministration/study-medication-administration-ABC" key="MedicationAdministration-study-medication-administration-ABC" name="study-medication-administration-ABC"/>
+<artifact id="MedicationAdministration/study-medication-administration-MMD" key="MedicationAdministration-study-medication-administration-MMD" name="study-medication-administration-MMD"/>
+<artifact id="MedicationAdministration/study-medication-administration-WBY" key="MedicationAdministration-study-medication-administration-WBY" name="study-medication-administration-WBY"/>
+<page key="NA" name="(NA)"/>
+<page key="many" name="(many)"/>
+<page key="index" name="AdverseEvents for Clinical Research Home Page"/>
+<page key="artifacts" name="Artifacts Summary"/>
+<page key="background" name="Background and Workflow"/>
+<page key="exampleCancerClinicalTrial" name="Cancer Clinical Trial Example"/>
+<page key="changes" name="IG Change History"/>
+<page key="examples" name="Real World examples"/>
+<page key="security" name="Security Note"/>
+<page key="toc" name="Table of Contents"/>
+<page key="downloads" name="Useful Downloads"/>
+</specification>
\ No newline at end of file
diff --git a/xml/FHIR-ae-research-ig.xml b/xml/FHIR-ae-research-ig.xml
new file mode 100644
index 000000000..8f2a4e6cd
--- /dev/null
+++ b/xml/FHIR-ae-research-ig.xml
@@ -0,0 +1,92 @@
+<?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-ig/2023Sep-ballot" ciUrl="https://build.fhir.org/ig/HL7/fhir-ae-research-ig" gitUrl="https://github.com/HL7/fhir-ae-research-ig" defaultVersion="1.0.0-ballot" defaultWorkgroup="brr" url="http://hl7.org/fhir/uv/ae-research-ig">
+<version code="current" url="https://build.fhir.org/ig/HL7/fhir-ae-research-ig"/>
+<version code="1.0.0-ballot" url="http://hl7.org/fhir/uv/ae-research-ig/2023Sep-ballot"/>
+<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="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 id="ValueSet/adverse-event-seriousness-criteria-vs" key="ValueSet-adverse-event-seriousness-criteria-vs" name="Adverse Event Seriousness Criteria"/>
+<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="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 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 id="Patient/ClinicalTrialSubject5" key="Patient-ClinicalTrialSubject5" name="ClinicalTrialSubject5"/>
+<artifact id="StructureDefinition/seriousness-criteria" key="StructureDefinition-seriousness-criteria" name="Criteria reviewed in determining serious adverse event"/>
+<artifact id="Patient/patient-slp" key="Patient-patient-slp" name="Example patient SLP"/>
+<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 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"/>
+<artifact id="MedicationStatement/example007" key="MedicationStatement-example007" name="Janet allergy med"/>
+<artifact id="MedicationStatement/example003" key="MedicationStatement-example003" name="Janet pill for water retention med not known"/>
+<artifact id="Observation/weight-janet" key="Observation-weight-janet" name="Janet weight Observation"/>
+<artifact id="MedicationAdministration/medicationAdministration-for-bresentrik" key="MedicationAdministration-medicationAdministration-for-bresentrik" name="Medication Administration for bresentrik"/>
+<artifact id="MedicationAdministration/medadmin0301" key="MedicationAdministration-medadmin0301" name="Medication Administration of Med0301"/>
+<artifact id="MedicationRequest/medicationrequest-for-bresentrik" key="MedicationRequest-medicationrequest-for-bresentrik" name="Medication Request for bresentrik"/>
+<artifact id="MedicationRequest/medicationrequest0301-discontinue" key="MedicationRequest-medicationrequest0301-discontinue" name="Medication Request for discontinued clinical trial medication 0301"/>
+<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="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/severity-or-grade" key="StructureDefinition-severity-or-grade" name="Severity Or Grade"/>
+<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="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="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="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-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-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="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"/>
+<artifact id="ResearchStudy/research-study-DISNEY" key="ResearchStudy-research-study-DISNEY" name="research-study-DISNEY"/>
+<artifact id="ResearchStudy/research-study-XYZ" key="ResearchStudy-research-study-XYZ" name="research-study-XYZ"/>
+<artifact id="ResearchStudy/research-study-acme" key="ResearchStudy-research-study-acme" name="research-study-acme"/>
+<artifact id="Medication/resstudy-medication-WBY" key="Medication-resstudy-medication-WBY" name="resstudy-medication-WBY"/>
+<artifact id="Medication/study-medication-ABC" key="Medication-study-medication-ABC" name="study-medication-ABC"/>
+<artifact id="Medication/study-medication-MMD" key="Medication-study-medication-MMD" name="study-medication-MMD"/>
+<artifact id="MedicationAdministration/study-medication-administration-ABC" key="MedicationAdministration-study-medication-administration-ABC" name="study-medication-administration-ABC"/>
+<artifact id="MedicationAdministration/study-medication-administration-MMD" key="MedicationAdministration-study-medication-administration-MMD" name="study-medication-administration-MMD"/>
+<artifact id="MedicationAdministration/study-medication-administration-WBY" key="MedicationAdministration-study-medication-administration-WBY" name="study-medication-administration-WBY"/>
+<page key="NA" name="(NA)"/>
+<page key="many" name="(many)"/>
+<page key="index" name="AdverseEvents for Clinical Research Home Page"/>
+<page key="artifacts" name="Artifacts Summary"/>
+<page key="background" name="Background and Workflow"/>
+<page key="exampleCancerClinicalTrial" name="Cancer Clinical Trial Example"/>
+<page key="changes" name="IG Change History"/>
+<page key="examples" name="Real World examples"/>
+<page key="security" name="Security Note"/>
+<page key="toc" name="Table of Contents"/>
+<page key="downloads" name="Useful Downloads"/>
+</specification>
\ No newline at end of file
diff --git a/xml/SPECS-FHIR.xml b/xml/SPECS-FHIR.xml
index 6763e7796..f739e9033 100644
--- a/xml/SPECS-FHIR.xml
+++ b/xml/SPECS-FHIR.xml
@@ -138,4 +138,6 @@
   <specification key="us-mcc" name="Multiple Chronic Condition Care Plan" />
   <specification key="uv-emedicinal-product-info" name="Electronic Medicinal Product Information"/>
   <specification key="us-hsds" name="Human Services Directory" />  
+  <specification key="ae-research-ig" name="Adverse Event Clinical Research" />
+  <specification key="ae-research-backport-ig" name="Adverse Event Clinical Research R4 Backport"/>
 </specifications>