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Section 1c: FHIR®
Section 3: Implementation Guides

HL7 FHIR® R5 Implementation Guide: Adverse Event Clinical Research, Edition 1

DESCRIPTION

This guide provides a baseline profile on the FHIR AdverseEvent Resource suitable for Clinical Research. The profile serves as foundational specification to meet general needs in communicating serious and non-serious adverse events in clinical research. For example, to meet the need for regulatory submission requirements. This version is R5, there is also an R4 backport for convenience to those systems that cannot operate on FHIR R5.

 

See the specification at http://hl7.org/fhir/uv/ae-research-ig/STU1

ALTERNATIVE NAMES

HL7 FHIR® R5 Implementation Guide: Adverse Event Clinical Research, Edition 1 may also go by the following names or acronyms:

"HL7 FHIR® IG: Adverse Event Clinical Research, R1",Adverse Event Clinical Research Profile

BENEFITS

  • Provides a baseline profile on the FHIR AdverseEvent Resource suitable for Clinical Research adverse event reporting
  • Serves as foundational specification to meet general needs in communicating adverse events in clinical research
  • Enables an adverse event to be tracked and evaluated as part of the clinical research process for the research study as done in regulated clinical trials
  • Defines the data elements needed to support the workflow for collecting and reporting serious and non-serious AEs in clinical research to meet the need for regulatory submission requirements 
  • Supports electronic transmission of AE data via FHIR to sponsors, regulatory agencies, and clinical research organizations for further processing and reporting

IMPLEMENTATIONS/CASE STUDIES

  • Epic,
  • Advarra,
  • Flatiron Health

DEVELOPMENT BACKGROUND

The development of this IG was sponsored by the HL7 Vulcan Accelerator (https://confluence.hl7.org/display/VA/Adverse+Events). Participants included: Advarra, Clinical Data Interchange Standards Consortium (CDISC), Epic, U.S. Food and Drug Administration (FDA), Flatiron Health, Humanized Health Consulting, ELIMU, MITRE, PatientLink, Pfizer, TransCelerate Biopharma.

RELATED DOCUMENTS

HL7 FHIR® R5 Implementation Guide: Adverse Event Clinical Research, Edition 1

(Download)

STU DOCUMENTS

HL7 FHIR® R5 Implementation Guide: Adverse Event Clinical Research, Edition 1 See the standard at http://hl7.org/fhir/uv/ae-research-ig/STU1. Expiration Apr 2026

TOPIC

  • Regulated Studies

BALLOT TYPES

  • STU

STATUS DATE

2024-04-15

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

PRODUCT TYPES

  • Implementation Guide
  • Specification Errata

STAKEHOLDERS

  • EHR, PHR Vendors
  • HIS Vendors
  • Pharmaceutical Vendors
  • Regulatory Agency
  • Standards Development Organizations (SDOs)

FAMILY

  • FHIR

CURRENT STATE

  • Active

REALM

  • Universal