Surveillance Tools

A variety of automated tools for active safety surveillance have been developed for FDA’s use in Sentinel. These include routine querying tools such as summary tables, modular programs, and software toolkits that can be used quickly in a distributed data environment. Collectively, these tools support FDA’s Active Risk Identification and Analysis (ARIA) program.

For more information concerning ARIA and Sentinel surveillance tools, click on the links below.

Note that information obtained through Sentinel is intended to complement other types of data and information compiled by FDA scientists, such as adverse event reports, published study results, and clinical trials, which can be combined with Sentinel data and used by FDA to inform regulatory decisions regarding medical product safety. FDA may access the data available through Sentinel for a variety of reasons beyond assessing potential safety risks for a specific product (e.g., estimating the background rate of health outcomes, examining medical product use, and evaluating research methods).