A Description of the Active Risk Identification and Analysis System of the U.S. Food and Drug Administration

This poster describes the Active Risk Identification and Analysis (ARIA) system, a major component of the U.S. Food and Drug Administration (FDA)’s Sentinel System. The Sentinel System, designed for postmarket medical product safety surveillance, includes the Sentinel Operations Center (SOC), Innovation Center (IC), and Community Building and Outreach Center (CBOC). The ARIA system, coordinated by the SOC, evaluates the use and safety of regulated medical products. Key features include the Sentinel Distributed Database (SDD), the Sentinel Common Data Model (SCDM), and pre-tested analytic tools. This poster was presented at the 2024 ISPE: 4th Annual African Regional Interest Group Meeting.