In clinical research, the accurate tracking and evaluation of adverse events (AEs) are crucial elements of the research process. The FHIR IG focuses on capturing adverse events in the clinical research setting, ensuring that essential data elements, such as cause-and-effect relationships, seriousness, severity, and outcomes, are appropriately documented. It addresses the need for multiple reporting formats depending on workflow patterns, offering extensions, value-sets, and examples tailored for clinical research contexts

This FHIR IG enables the collection of adverse events from real-world data (RWD) sources, including electronic health records (EHR) and personal health records (PHR) of patients enrolled in clinical trials. It facilitates the transmission of AE data to sponsors, regulatory agencies, and clinical research organizations for further processing and reporting. Whether in pre-market clinical trials or post-market surveillance, the IG supports the documentation and reporting of adverse events by various stakeholders, including healthcare providers, clinical investigators, patients, and medical product manufacturers.

Professionals involved in clinical research stand to benefit significantly from adopting the Vulcan Accelerator's FHIR IG. By adhering to standardized data representations and transmission protocols, they can streamline adverse event documentation, enhance data interoperability across systems, ensure compliance with regulatory requirements, and facilitate timely reporting to relevant stakeholders. This not only improves the efficiency and effectiveness of clinical research operations but also contributes to patient safety and regulatory compliance.

Implementing the FHIR IG empowers clinical investigators to document adverse events directly within EHR systems, facilitating seamless transmission to electronic data capture (EDC) systems for triage and onward reporting to sponsors and regulatory agencies. Patients can also report adverse events through electronic patient-reported outcomes (ePRO) systems, ensuring prompt inclusion in reporting processes. Moreover, the IG supports various use cases, including post-market surveillance and pre-market clinical trial reporting, thereby enhancing longitudinal safety surveillance and enabling clinical decision support actions within research settings.

The Vulcan Accelerator's FHIR IG offers a comprehensive and standardized approach to capturing and communicating adverse events in clinical research contexts. By leveraging FHIR standards and best practices, professionals can enhance data quality, interoperability, and regulatory compliance while advancing patient safety and research outcomes. Join us in adopting this innovative solution to transform the landscape of adverse event documentation and reporting in clinical research.