Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

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. For a full list of available versions, see the Directory of published versions

Example AdverseEvent: NonSeriousAdverseEventResearchStudyMed

Generated Narrative: AdverseEvent

Resource AdverseEvent "NonSeriousAdverseEventResearchStudyMed"

Profile: Adverse Event Clinical Research

Resulting Effect: Condition/AEHeadache: Mild Headache

Suspect Entity

url

instance

value: MedicationAdministration/study-medication-administration-MMD

url

causality

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-tylenol

Adverse event caused subject to discontinue the study: false

Expected In Research Study: true

Note: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not chnaged.

modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]

actuality: actual

event: Headache (Medical Dictionary for Regulatory Activities#10019211)

subject: Patient/patient-moumic " EXAMPLE"

date: 2022-02-01

seriousness: Non-serious (AdverseEventSeriousness#non-serious)

severity: Mild (AdverseEventSeverity#mild)

outcome: Not recovering/not resolved (NCI Thesaurus#C49494)

study: ResearchStudy/research-study-DISNEY