Adverse Event Clinical Research
1.0.1 - STU1

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

## Example AdverseEvent: NonSeriousAdverseEventResearchStudyMed

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "NonSeriousAdverseEventResearchStudyMed"

Profile: Adverse Event Clinical Research

Adverse Event Severity: Mild (AdverseEventSeverity#mild)

Adverse event caused subject to discontinue the study: false

status: completed

actuality: actual

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

subject: Patient/patient-moumic " EXAMPLE"

occurrence: 2022-02-01 --> (ongoing)

resultingEffect: Condition/AEHeadache: Mild Headache

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

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

study: ResearchStudy/research-study-DISNEY

expectedInResearchStudy: true

> suspectEntity

> instance: MedicationAdministration/study-medication-administration-MMD

> ### Causalities

> - | EntityRelatedness
> * | Unlikely Related (NCI Thesaurus#C53257)

### MitigatingActions

- | Item[x]
* | MedicationAdministration/medication-administration-tylenol

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