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: ClinicalTrialSignificantAdverseEvent

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalTrialSignificantAdverseEvent"

Profile: Adverse Event Clinical Research

Resulting Effect: Condition/AEHepaticFailure

Resulting Effect: Condition/AEHepaticFailurecomplication

> Suspect Entity

> > url

> > `instance`

> value: MedicationAdministration/medadmin0301: Study Medication Use Case 7

> > url

> > `causality`

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Results In Persistent Or Significant Disability (NCI Thesaurus#C11338)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Requires Inpatient Hospitalization (NCI Thesaurus#C83052)

> > url

> > `criterionPresent`

> value: true

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Death Related to Adverse Event (NCI Thesaurus#C48275)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Is Life Threatening (NCI Thesaurus#C84266)

> > url

> > `criterionPresent`

> value: true

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Congenital Anomaly or Birth Defect (NCI Thesaurus#C83117)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Other Medically Important Condition (NCI Thesaurus#C82521)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Required Intervention to Prevent Permanent Impairment/damage (NCI Thesaurus#C201939)

> > url

> > `criterionPresent`

> value: true

> Mitigating Action

> > url

> > `item`

> value: MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued

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

actuality: actual

event: Serious reportable event associated with product or device (SNOMED CT#370901008)

subject: Patient/ClinicalTrialSubject5 " CLINICAL TRIAL"

detected: 1905-08-23

recordedDate: 1905-08-24

seriousness: Serious (AdverseEventSeriousness#serious)

severity: Severe (AdverseEventSeverity#severe)

outcome: Recovering/Resolving (NCI Thesaurus#C49496)

recorder: : Clinical Research Associate

study: : NCT1010101