Adverse Event Clinical Research
1.0.0-ballot - ballot International flag

This page is part of the Adverse Event Clinical Research (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR v5.0.0. . 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 Criteria reviewed in determining serious adverse event
....7.5 Severity Or Grade
....7.6 Causality Relatedness values
....7.7 Adverse Event Clinical Research Outcomes
....7.8 Adverse Event Seriousness Criteria
....7.9 AdverseEvent Severity or Grade Value Set
....7.10 AdverseEvent Severity or Grade Codes
....7.11 FDA Additional Seriousness Criteria CodeSystem
....7.12 ClinicalResearchAdverseEventUseCase7
....7.13 Use case 6B - patient reported AE during research study
....7.14 adverse-event-compass-ex1
....7.15 adverse-event-compass-ex1a
....7.16 adverse-event-compass-ex1b
....7.17 adverse-event-compass-ex2
....7.18 ClinicalResearchAdverseEventUseCase17
....7.19 ClinicalResearchAdverseEventUseCase15
....7.20 ClinicalResearchAdverseEventUseCase16
....7.21 Use Case 1 - Serious Adverse Event
....7.22 ClinicalTrialSubject5
....7.23 AEHepaticFailureUseCase7
....7.24 AEHepaticFailureUseCase7complication
....7.25 Janet Patient
....7.26 Breast Cancer Trial
....7.27 Janet weight Observation
....7.28 Janet Blood Pressure Observation
....7.29 Janet Tylenol PM med
....7.30 Janet allergy med
....7.31 Janet pill for water retention med not known
....7.32 Medication Administration for bresentrik
....7.33 Medication is bresentrik
....7.34 Medication Request for bresentrik
....7.35 Medication Administration of Med0301
....7.36 Medication Request for discontinued clinical trial medication ABC
....7.37 Medication Request for discontinued clinical trial medication 0301
....7.38 Use case 6B - problem
....7.39 patient-example-kaitlyn-b
....7.40 practitioner-oncology-nurse-jane
....7.41 practitioner-owen-oncologist
....7.42 medication-request-example-kadcyla
....7.43 medication-request-example-tucatinib
....7.44 medication-administration-kadcyla
....7.45 medication-administration-tucatinib
....7.46 clinical-trial-example-compass
....7.47 clinical-trial-example-subject
....7.48 medication-administration-kadcyla-reduced
....7.49 medication-administration-tucatinib-reduced
....7.50 medication-request-example-zofran
....7.51 GIBleedUseCase15
....7.52 research-study-XYZ
....7.53 study-medication-ABC
....7.54 study-medication-administration-ABC
....7.55 procedure-upper-endoscopy
....7.56 research-study-DISNEY
....7.57 study-medication-MMD
....7.58 study-medication-administration-MMD
....7.59 medication-tylenol
....7.60 medication-administration-tylenol
....7.61 research-study-acme
....7.62 clinical-trial-acme-subject
....7.63 clinical-trial-acme-procedure
....7.64 study-medication-administration-WBY
....7.65 medication-contrast-dye
....7.66 medication-administration-contrast-dye
....7.67 medication-forhives
....7.68 medication-administration-forhives
....7.69 resstudy-medication-WBY
....7.70 Use Case 16 Patient MOUMIC
....7.71 Example patient SLP