AE for Clinical Research

Background  (taken from IG)

The intent of this guide is to provide a profile on the FHIR AdverseEvent Resource suitable for Clinical Research.

A single Adverse Event (AE) may need to be reported in multiple ways. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events and Clinical Research adverse events provide important extensions, value-sets and examples for implementing AdverseEvent.

This guide, the Clinical Research adverse event implementation guide, is for the clinical research setting. In this setting, the event is tracked and evaluated as part of the clinical research process for the research study.

Scope

This FHIR IG enables the collection of adverse events in real-world data (RWD) sources such as electronic health records (EHR) and personal health records (PHR) that occur during clinical trials. It ensures the appropriate AE representation required to support clinical research trials within a regulated environment. As the AEs are collected in RWD sources, the data can be transmitted via FHIR to clinical trial management systems, regulatory agencies, sponsors, and clinical research organizations for further processing and reporting. When the AE for Clinical Research IG was constructed, the implementers were using FHIR R4. For this reason, two implementation guides were made: one for FHIR R5 and a backport for FHIR R4 to guide implementers on using R4 based on the FHIR IG in R5. The thought process was that this would aid implementers in using R4 and transitioning to R5 when the time comes.

Project Status

• ACTIVE  (Status Date: 09/2023 – In September 2023 ballot)

FHIR IG:

• https://build.fhir.org/ig/HL7/fhir-ae-research-ig/
• https://build.fhir.org/ig/HL7/fhir-ae-research-backport-ig/index.html
•  Jira dashboard - September 2023 ballot

IG Proposal: 

• Adverse Event Clinical Research
• Adverse Event Clinical Research R4 Backport
• Vulcan Adverse Event page

Zulip Chat Stream:

#Vulcan/AE>stream events

FHIR Resources

Last Updated: 12-September-2023

This Implementation Guide profiles the following FHIR resources