This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, 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.
Examples: all the examples that are used in this Implementation Guide available for download:
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
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)
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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)
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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
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- 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
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- 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.
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- 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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- 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.
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- 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
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- 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.
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- 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