Active Risk Identification and Analysis (ARIA) Overview

ARIA is a component of FDA’s Sentinel System that is used to conduct medical product safety surveillance. ARIA consists of:

Active Risk Identification and Analyses Conducted Since 2016

This graphic displays the total number of analyses conducted by FDA in ARIA since its launch in 2016. There are several types of analyses, including:

  • Summary table analyses
  • Level 1 analyses
  • Level 2 analyses

ARIA analyses by quarter

More technical information on these analyses are on the Routine Querying Tools section.  Results from these analyses are on the Assessments page, as they become available. Key regulatory outcomes for these analyses are on Completed ARIA Assessments & Impact.

Want to learn more about ARIA? Read about technical details of all Sentinel’s analytic tools that support ARIA.

ARIA uses parameterizable tools and a trusted multi-site distributed database. The data undergoes continuous quality checks and refreshes. With ARIA, safety analyses are conducted more efficiently—in a matter of months, rather than years. It also fulfills the mandate in the FDA Amendments Act of 2007.

FDA uses ARIA to conduct several types of analyses to monitor the safety of FDA approved medical products.

Level 1: Descriptive Analyses, Unadjusted Rates

Level 1 analyses characterize patterns of use of prescription medications or calculate rates of health outcomes of interest.

Levels 2 and 3: Adjusted Analyses with Sophisticated Confounding Control

Level 2 and 3 analyses are used to study whether an adverse effect is potentially related to a drug. It also estimates the size of that risk, if one is identified. Lastly, ARIA can also be used to detect new safety signals.

FDA uses ARIA to study signals that come from many sources, such as the FDA Adverse Event Reporting System (FAERS), observational studies, or clinical trials. To learn more, please refer to FDA’s Best Practices for Postmarket Safety Surveillance document.

signal identification in the Sentinel System

With ARIA, safety analyses happens more efficiently. It also fulfills the mandate in the FDA Amendments Act of 2007.

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