Adverse Event Clinical Research
1.0.1 - STU1 International flag

Adverse Event Clinical Research, 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-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 Severity
.... 7.4 Adverse event caused subject to discontinue the study
.... 7.5 Criteria reviewed in determining serious adverse event
.... 7.6 ClinicalTrialSignificantAdverseEvent
.... 7.7 Patient reported AE during research study
.... 7.8 adverse-event-compass-ex1
.... 7.9 adverse-event-compass-ex1a
.... 7.10 adverse-event-compass-ex1b
.... 7.11 adverse-event-compass-ex2
.... 7.12 AdverseEventFromProcedureNotStudyDrug
.... 7.13 SeriousAdverseEventResearchStudy
.... 7.14 NonSeriousAdverseEventResearchStudyMed
.... 7.15 adverse-event-device-death
.... 7.16 Serious Adverse Event
.... 7.17 ClinicalTrialSubject5
.... 7.18 AEHepaticFailure
.... 7.19 AEHepaticFailurecomplication
.... 7.20 Janet Patient
.... 7.21 Breast Cancer Trial
.... 7.22 Janet weight Observation
.... 7.23 Janet Blood Pressure Observation
.... 7.24 Janet Tylenol PM med
.... 7.25 Janet allergy med
.... 7.26 Janet pill for water retention med not known
.... 7.27 Medication Administration for bresentrik
.... 7.28 Medication is bresentrik
.... 7.29 Medication Request for bresentrik
.... 7.30 Medication Administration of Med0301
.... 7.31 Medication Request for discontinued clinical trial medication ABC
.... 7.32 Medication Request for discontinued clinical trial medication 0301
.... 7.33 Problem
.... 7.34 patient-example-kaitlyn-b
.... 7.35 practitioner-oncology-nurse-jane
.... 7.36 practitioner-owen-oncologist
.... 7.37 medication-request-example-kadcyla
.... 7.38 medication-request-example-tucatinib
.... 7.39 medication-administration-kadcyla
.... 7.40 medication-administration-tucatinib
.... 7.41 clinical-trial-example-compass
.... 7.42 clinical-trial-example-subject
.... 7.43 medication-administration-kadcyla-reduced
.... 7.44 medication-administration-tucatinib-reduced
.... 7.45 medication-request-example-zofran
.... 7.46 GIBleed
.... 7.47 research-study-XYZ
.... 7.48 study-medication-ABC
.... 7.49 study-medication-administration-ABC
.... 7.50 procedure-upper-endoscopy
.... 7.51 research-study-DISNEY
.... 7.52 study-medication-MMD
.... 7.53 study-medication-administration-MMD
.... 7.54 medication-tylenol
.... 7.55 medication-administration-tylenol
.... 7.56 research-study-acme
.... 7.57 clinical-trial-acme-subject
.... 7.58 clinical-trial-acme-procedure
.... 7.59 study-medication-administration-WBY
.... 7.60 medication-contrast-dye
.... 7.61 medication-administration-contrast-dye
.... 7.62 medication-forhives
.... 7.63 medication-administration-forhives
.... 7.64 AEModeratehives
.... 7.65 resstudy-medication-WBY
.... 7.66 Patient MOUMIC
.... 7.67 AEHeadache
.... 7.68 Example patient SLP
.... 7.69 Device - Infuser that exploded
.... 7.70 clinical-trial-example-subject1
.... 7.71 medication-administration-kadcyla1
.... 7.72 medication-request-example-kadcyla1
.... 7.73 patient-example-kaitlyn-b1