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: Patient reported AE during research study

Generated Narrative: AdverseEvent

Resource AdverseEvent "clinical-research-ae-example-medwatch-patient-report"

Profile: Adverse Event Clinical Research

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionPresent`

> value: false

> > url

> > `criterionCode`

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

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

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

> > url

> > `criterionPresent`

> value: false

> 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: false

> 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

Note: A 64-year-old woman (Janet) is participating in a breast cancer clinical trial and taking an investigational drug. As part of her participation in the study, she was instructed to use a patient reported outcomes (ePRO) application to report an adverse event that resulted in any of the following: hospitalization, required help to prevent permanent harm, disability or health problem, birth defect, life-threatening, death, other serious/important medical incident (this list identifies the event as being serious events). The application is designed to capture data elements found on the 3500A Form. The Clinical Investigator (CI) receives a notification that Janet has an adverse event and reviews the event in Janet’s EHR system. The adverse event form is pre-populated from EHR data for the clinical investigator. The CI assesses causality for Janet’s adverse event and submits the serious adverse event to the sponsor. The sponsor reviews the received adverse event and performs its own causality assessment. Since this event is a Suspected Unexpected Serious Adverse Reaction (SUSAR) within FDA’s regulation. If the Suspected Unexpected Serious Adverse Reaction (SUSAR) was life threatening or death, it is submitted within 7 calendar days. Any other types of seriousness are submitted within 15 calendar days. (By Patient/JanetPatient @2023-04-12)

Resulting Effect: Condition/janetReported-condition

> Suspect Entity

> > url

> > `instance`

> value: Medication/bresentrik

> > url

> > `causality`

> Supporting information relevant to the event

> > url

> > `item`

> value: MedicationAdministration/medicationAdministration-for-bresentrik

> Suspect Entity

> > url

> > `instance`

> value: ResearchStudy/BreastCancerTrial

> > url

> > `causality`

> Supporting information relevant to the event

> > url

> > `item`

> value: Observation/weight-janet

> Supporting information relevant to the event

> > url

> > `item`

> value: Observation/blood-pressure-janet

> Supporting information relevant to the event

> > url

> > `item`

> value: MedicationStatement/example001

> Supporting information relevant to the event

> > url

> > `item`

> value: MedicationStatement/example007

> Supporting information relevant to the event

> > url

> > `item`

> value: MedicationStatement/example003

> 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/JanetPatient: Janet " CLINICAL TRIAL PATIENT"

date: 2023-04-10

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

recorder: Patient/JanetPatient " CLINICAL TRIAL PATIENT"

study: ResearchStudy/BreastCancerTrial