Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

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

## 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