Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot International flag

This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, 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 Base AdverseEvent Clinical Research Profile Capability Statement
....7.2 Adverse Event Clinical Research
....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 Severity Or Grade
....7.14 Workflow Status
....7.15 Supporting information relevant to the event
....7.16 Suspect Entity
....7.17 Causality Relatedness values
....7.18 AdverseEvent Contributing Factor
....7.19 AdverseEvent Mitigating Action
....7.20 Adverse Event Clinical Research Outcomes
....7.21 Adverse Event Participant Functions
....7.22 Adverse Event Seriousness Criteria
....7.23 AdverseEvent Seriousness Non-serious Codes Only
....7.24 AdverseEvent Severity or Grade Value Set
....7.25 Adverse Event Status
....7.26 AdverseEvent Supporting Information
....7.27 AdverseEvent Type
....7.28 AdverseEvent Severity or Grade Codes
....7.29 FDA Additional Seriousness Criteria CodeSystem
....7.30 ClinicalResearchAdverseEventUseCase7
....7.31 Use case 6B - patient reported AE during research study
....7.32 adverse-event-compass-ex1
....7.33 adverse-event-compass-ex1a
....7.34 adverse-event-compass-ex1b
....7.35 adverse-event-compass-ex2
....7.36 ClinicalResearchAdverseEventUseCase17
....7.37 ClinicalResearchAdverseEventUseCase15
....7.38 ClinicalResearchAdverseEventUseCase16
....7.39 Use Case 1 - Serious Adverse Event
....7.40 ClinicalTrialSubject5
....7.41 AEHepaticFailureUseCase7
....7.42 AEHepaticFailureUseCase7complication
....7.43 Janet Patient
....7.44 Breast Cancer Trial
....7.45 Janet weight Observation
....7.46 Janet Blood Pressure Observation
....7.47 Janet Tylenol PM med
....7.48 Janet allergy med
....7.49 Janet pill for water retention med not known
....7.50 Medication Administration for bresentrik
....7.51 Medication is bresentrik
....7.52 Medication Request for bresentrik
....7.53 Medication Administration of Med0301
....7.54 Medication Request for discontinued clinical trial medication ABC
....7.55 Medication Request for discontinued clinical trial medication 0301
....7.56 Use case 6B - problem
....7.57 patient-example-kaitlyn-b
....7.58 practitioner-oncology-nurse-jane
....7.59 practitioner-owen-oncologist
....7.60 medication-request-example-kadcyla
....7.61 medication-request-example-tucatinib
....7.62 medication-administration-kadcyla
....7.63 medication-administration-tucatinib
....7.64 clinical-trial-example-compass
....7.65 clinical-trial-example-subject
....7.66 medication-administration-kadcyla-reduced
....7.67 medication-administration-tucatinib-reduced
....7.68 medication-request-example-zofran
....7.69 GIBleedUseCase15
....7.70 research-study-XYZ
....7.71 study-medication-ABC
....7.72 study-medication-administration-ABC
....7.73 procedure-upper-endoscopy
....7.74 research-study-DISNEY
....7.75 study-medication-MMD
....7.76 study-medication-administration-MMD
....7.77 medication-tylenol
....7.78 medication-administration-tylenol
....7.79 research-study-acme
....7.80 clinical-trial-acme-subject
....7.81 clinical-trial-acme-procedure
....7.82 study-medication-administration-WBY
....7.83 medication-contrast-dye
....7.84 medication-administration-contrast-dye
....7.85 medication-forhives
....7.86 medication-administration-forhives
....7.87 resstudy-medication-WBY
....7.88 Use Case 16 Patient MOUMIC
....7.89 Example patient SLP