Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

Adverse Event Clinical Research R4 Backport, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-backport-ig/ and changes regularly. See the Directory of published versions

## Useful Downloads

Full Implementation Guide

The entire implementation guide (including the HTML files, definitions, validation information, etc.) may be downloaded here.

In addition there are format specific definitions files.

- XML
- JSON
- TTL

Examples: all the examples that are used in this Implementation Guide available for download:

- XML
- JSON
- TTl

Cross Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.uv.ae-research-backport-ig.r4) and R4B (hl7.fhir.uv.ae-research-backport-ig.r4b) are available.

Dependency Table

IG | Package | FHIR | Comment
--- | --- | --- | ---
Adverse Event Clinical Research R4 Backport | hl7.fhir.uv.ae-research-backport-ig#1.0.1 | R4 |
FHIR Extensions Pack | hl7.fhir.uv.extensions.r4#5.1.0 | R4 | Automatically added as a dependency - all IGs depend on the HL7 Extension Pack
HL7 Terminology (THO) | hl7.terminology#5.5.0 | R4 |
FHIR Extensions Pack | hl7.fhir.uv.extensions.r4#1.0.0 | R4 |

Package hl7.fhir.uv.extensions.r4#5.1.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sat, Apr 27, 2024 18:39+1000+10:00)

Package hl7.fhir.uv.extensions.r4#1.0.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sun, Mar 26, 2023 08:46+1100+11:00)

Globals Table

There are no Global profiles defined

IP Statements

This publication includes IP covered under the following statements.

- Please see https://www.meddra.org/legal-mentions . For information about special licensing, see https://www.meddra.org/subscription/special-licences
  Show Usage
  - Medical Dictionary for Regulatory Activities: AdverseEvent/AdverseEventFromProcedureNotStudyDrug, AdverseEvent/NonSeriousAdverseEventResearchStudyMed... Show 6 more, AdverseEvent/SeriousAdverseEventResearchStudy, AdverseEvent/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a, AdverseEvent/adverse-event-compass-ex1b, AdverseEvent/adverse-event-compass-ex2 and Condition/AEModeratehives
- The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
  Show Usage
  - Unified Code for Units of Measure (UCUM): MedicationAdministration/medadmin0301, MedicationAdministration/medication-administration-contrast-dye... Show 21 more, MedicationAdministration/medication-administration-forhives, MedicationAdministration/medication-administration-kadcyla, MedicationAdministration/medication-administration-kadcyla-reduced, MedicationAdministration/medication-administration-kadcyla1, MedicationAdministration/medication-administration-tucatinib, MedicationAdministration/medication-administration-tucatinib-reduced, MedicationAdministration/medication-administration-tylenol, MedicationAdministration/medicationAdministration-for-bresentrik, MedicationAdministration/study-medication-administration-ABC, MedicationAdministration/study-medication-administration-MMD, MedicationAdministration/study-medication-administration-WBY, MedicationRequest/medication-request-example-kadcyla, MedicationRequest/medication-request-example-kadcyla1, MedicationRequest/medication-request-example-tucatinib, MedicationRequest/medication-request-example-zofran, MedicationRequest/medicationrequest-for-bresentrik, MedicationRequest/medicationrequest-for-study-medication-administration-ABC, MedicationStatement/example001, MedicationStatement/example003, Observation/blood-pressure-janet and Observation/weight-janet
- These codes are excerpted from ASTM Standard, E1762-95(2013) - Standard Guide for Electronic Authentication of Health Care Information, Copyright by ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. Copies of this standard are available through the ASTM Web Site at www.astm.org.
  Show Usage
  - Signature Type Codes: MedicationAdministration/medadmin0301 and MedicationAdministration/medicationAdministration-for-bresentrik
- This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
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  - LOINC: Observation/blood-pressure-janet and Observation/weight-janet
- This material contains content that is copyright of SNOMED International. Implementers of these specifications must have the appropriate SNOMED CT Affiliate license - for more information contact https://www.snomed.org/get-snomed or info@snomed.org.
  Show Usage
  - SNOMED Clinical Terms® (SNOMED CT®): AdverseEvent/ClinicalTrialSignificantAdverseEvent, AdverseEvent/adverse-event-device-death... Show 42 more, AdverseEvent/clinical-research-ae-example-medwatch-patient-report, AdverseEventClinicalResearch, AdverseEventContributingFactor, AdverseEventMitigatingAction, AdverseEventSupportingInformation, AdverseEventType, Condition/AEHeadache, Condition/AEHepaticFailure, Condition/AEHepaticFailurecomplication, Condition/AEModeratehives, Condition/GIBleed, Condition/janetReported-condition, ContributingFactor, Medication/medication-contrast-dye, MedicationAdministration/medadmin0301, MedicationAdministration/medication-administration-contrast-dye, MedicationAdministration/medication-administration-forhives, MedicationAdministration/medication-administration-kadcyla, MedicationAdministration/medication-administration-kadcyla-reduced, MedicationAdministration/medication-administration-kadcyla1, MedicationAdministration/medication-administration-tucatinib, MedicationAdministration/medication-administration-tucatinib-reduced, MedicationAdministration/medication-administration-tylenol, MedicationAdministration/medicationAdministration-for-bresentrik, MedicationAdministration/study-medication-administration-ABC, MedicationAdministration/study-medication-administration-MMD, MedicationAdministration/study-medication-administration-WBY, MedicationRequest/medication-request-example-kadcyla, MedicationRequest/medication-request-example-kadcyla1, MedicationRequest/medication-request-example-tucatinib, MedicationRequest/medication-request-example-zofran, MedicationRequest/medicationrequest-for-bresentrik, MedicationRequest/medicationrequest-for-study-medication-administration-ABC, MedicationRequest/medicationrequest0301-discontinue, MedicationStatement/example001, MedicationStatement/example003, MedicationStatement/example007, MitigatingAction, Procedure/clinical-trial-acme-procedure, Procedure/procedure-upper-endoscopy, ResearchStudy/BreastCancerTrial and SupportingInfo
- This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license
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  - AdverseEventCategory: AdverseEvent/adverse-event-device-death
  - AdverseEventCausalityMethod: SuspectEntity
  - AdverseEventSeriousness: AdverseEvent/AdverseEventFromProcedureNotStudyDrug, AdverseEvent/ClinicalTrialSignificantAdverseEvent... Show 10 more, AdverseEvent/NonSeriousAdverseEventResearchStudyMed, AdverseEvent/SeriousAdverseEventResearchStudy, AdverseEvent/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a, AdverseEvent/adverse-event-compass-ex1b, AdverseEvent/adverse-event-compass-ex2, AdverseEvent/adverse-event-device-death, AdverseEvent/clinical-research-ae-example-medwatch-patient-report, AdverseEventClinicalResearch and AdverseEventSeriousnessNonOnly
  - AdverseEventSeverity: AdverseEvent/AdverseEventFromProcedureNotStudyDrug, AdverseEvent/ClinicalTrialSignificantAdverseEvent, AdverseEvent/NonSeriousAdverseEventResearchStudyMed and AdverseEvent/SeriousAdverseEventResearchStudy
  - Condition Clinical Status Codes: Condition/AEHeadache, Condition/AEHepaticFailure... Show 4 more, Condition/AEHepaticFailurecomplication, Condition/AEModeratehives, Condition/GIBleed and Condition/janetReported-condition
  - DoseAndRateType: MedicationRequest/medicationrequest-for-bresentrik, MedicationRequest/medicationrequest-for-study-medication-administration-ABC, MedicationStatement/example001 and MedicationStatement/example003
  - Observation Category Codes: Observation/blood-pressure-janet and Observation/weight-janet
  - Provenance participant type: Provenance/provenance-for-blood-pressure-janet and Provenance/provenance-for-weight
  - Reason Medication Given Codes: MedicationAdministration/medadmin0301 and MedicationAdministration/medicationAdministration-for-bresentrik
  - ResearchStudyPhase: ResearchStudy/BreastCancerTrial
  - ResearchStudyPrimaryPurposeType: ResearchStudy/BreastCancerTrial
  - contactRole2: Patient/JanetPatient
  - identifierType: Patient/JanetPatient, Patient/patient-example-kaitlyn-b, Patient/patient-example-kaitlyn-b1 and Patient/patient-slp
  - degreeLicenseCertificate: Practitioner/practitioner-oncology-nurse-jane and Practitioner/practitioner-owen-oncologist
- This material derives from the HL7 Terminology THO. THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license
  Show Usage
  - MaritalStatus: Patient/JanetPatient
  - ParticipationType: AdverseEvent/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a... Show 7 more, AdverseEvent/adverse-event-compass-ex1b, AdverseEvent/adverse-event-compass-ex2, AdverseEvent/adverse-event-device-death, AdverseEventParticipantFunction, MedicationAdministration/medadmin0301, MedicationAdministration/medicationAdministration-for-bresentrik and Participant
  - Orderable Drug Form: MedicationStatement/example001 and MedicationStatement/example003
- Using RxNorm codes of type SAB=RXNORM as this specification describes does not require a UMLS license. Access to the full set of RxNorm definitions, and/or additional use of other RxNorm structures and information requires a UMLS license. The use of RxNorm in this specification is pursuant to HL7's status as a licensee of the NLM UMLS. HL7's license does not convey the right to use RxNorm to any users of this specification; implementers must acquire a license to use RxNorm in their own right.
  Show Usage
  - RxNorm: Medication/medication-forhives, Medication/medication-tylenol... Show 14 more, Medication/resstudy-medication-WBY, Medication/study-medication-ABC, Medication/study-medication-MMD, MedicationAdministration/medication-administration-kadcyla, MedicationAdministration/medication-administration-kadcyla-reduced, MedicationAdministration/medication-administration-kadcyla1, MedicationAdministration/medication-administration-tucatinib, MedicationAdministration/medication-administration-tucatinib-reduced, MedicationRequest/medication-request-example-kadcyla, MedicationRequest/medication-request-example-kadcyla1, MedicationRequest/medication-request-example-tucatinib, MedicationRequest/medication-request-example-zofran, MedicationStatement/example001 and MedicationStatement/example007