Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

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

Table of Contents

.. 0 Table of Contents
... 1 AdverseEvents for Clinical Research Home Page
... 2 Background and Workflow
... 3 Real World examples
.... 3.1 Cancer Clinical Trial Example
... 4 Security Note
... 5 Useful Downloads
... 6 IG Change History
... 7 Artifacts Summary
.... 7.1 Adverse Event Clinical Research
.... 7.2 Adverse Event Grade
.... 7.3 Adverse event caused subject to discontinue the study
.... 7.4 Contributing Factor
.... 7.5 Expected In Research Study
.... 7.6 Mitigating Action
.... 7.7 Note
.... 7.8 Participant
.... 7.9 Research Subject record of subject
.... 7.10 Adverse Event resolution date
.... 7.11 Resulting Effect
.... 7.12 Criteria reviewed in determining serious adverse event
.... 7.13 Workflow Status
.... 7.14 Supporting information relevant to the event
.... 7.15 Suspect Entity
.... 7.16 AdverseEvent Contributing Factor
.... 7.17 AdverseEvent Mitigating Action
.... 7.18 Adverse Event Participant Functions
.... 7.19 AdverseEvent Seriousness Non-serious Codes Only
.... 7.20 Adverse Event Status
.... 7.21 AdverseEvent Supporting Information
.... 7.22 AdverseEvent Type
.... 7.23 ClinicalTrialSignificantAdverseEvent
.... 7.24 Patient reported AE during research study
.... 7.25 adverse-event-compass-ex1
.... 7.26 adverse-event-compass-ex1a
.... 7.27 adverse-event-compass-ex1b
.... 7.28 adverse-event-compass-ex2
.... 7.29 AdverseEventFromProcedureNotStudyDrug
.... 7.30 SeriousAdverseEventResearchStudy
.... 7.31 NonSeriousAdverseEventResearchStudyMed
.... 7.32 adverse-event-device-death
.... 7.33 Serious Adverse Event
.... 7.34 ClinicalTrialSubject5
.... 7.35 AEHepaticFailure
.... 7.36 AEHepaticFailurecomplication
.... 7.37 Janet Patient
.... 7.38 Breast Cancer Trial
.... 7.39 Janet weight Observation
.... 7.40 Janet Blood Pressure Observation
.... 7.41 Janet Tylenol PM med
.... 7.42 Janet allergy med
.... 7.43 Janet pill for water retention med not known
.... 7.44 Medication Administration for bresentrik
.... 7.45 Medication is bresentrik
.... 7.46 Medication Request for bresentrik
.... 7.47 Medication Administration of Med0301
.... 7.48 Medication Request for discontinued clinical trial medication ABC
.... 7.49 Medication Request for discontinued clinical trial medication 0301
.... 7.50 Problem
.... 7.51 patient-example-kaitlyn-b
.... 7.52 practitioner-oncology-nurse-jane
.... 7.53 practitioner-owen-oncologist
.... 7.54 medication-request-example-kadcyla
.... 7.55 medication-request-example-tucatinib
.... 7.56 medication-administration-kadcyla
.... 7.57 medication-administration-tucatinib
.... 7.58 clinical-trial-example-compass
.... 7.59 clinical-trial-example-subject
.... 7.60 medication-administration-kadcyla-reduced
.... 7.61 medication-administration-tucatinib-reduced
.... 7.62 medication-request-example-zofran
.... 7.63 GIBleed
.... 7.64 research-study-XYZ
.... 7.65 study-medication-ABC
.... 7.66 study-medication-administration-ABC
.... 7.67 procedure-upper-endoscopy
.... 7.68 research-study-DISNEY
.... 7.69 study-medication-MMD
.... 7.70 study-medication-administration-MMD
.... 7.71 medication-tylenol
.... 7.72 medication-administration-tylenol
.... 7.73 research-study-acme
.... 7.74 clinical-trial-acme-subject
.... 7.75 clinical-trial-acme-procedure
.... 7.76 study-medication-administration-WBY
.... 7.77 medication-contrast-dye
.... 7.78 medication-administration-contrast-dye
.... 7.79 medication-forhives
.... 7.80 medication-administration-forhives
.... 7.81 AEModeratehives
.... 7.82 resstudy-medication-WBY
.... 7.83 Patient MOUMIC
.... 7.84 AEHeadache
.... 7.85 Example patient SLP
.... 7.86 Device - Infuser that exploded
.... 7.87 clinical-trial-example-subject1
.... 7.88 medication-administration-kadcyla1
.... 7.89 medication-request-example-kadcyla1
.... 7.90 patient-example-kaitlyn-b1