Welcome to Mini-Sentinel

Mini-Sentinel is a pilot project sponsored by the U.S. Food and Drug Administration (FDA) to create an active surveillance system - the Sentinel System - to monitor the safety of FDA-regulated medical products. Mini-Sentinel uses pre-existing electronic healthcare data from multiple sources. Collaborating Institutions provide access to data as well as scientific and organizational expertise.

Mini-Sentinel is part of the FDA’s Sentinel Initiative, which is exploring a variety of approaches for improving the Agency’s ability to quickly identify and assess safety issues.

The Mini-Sentinel pilot provides FDA the ability to:

  • Work through the “nuts and bolts” of designing safety assessments using multiple existing electronic healthcare data systems
  • Develop and evaluate scientific methods to increase the precision of active safety surveillance efforts
  • Identify and address barriers and challenges to building a practical, accurate, and timely system for active safety surveillance

Most Mini-Sentinel activities focus on assessments, methods, or data. Visit the following links to learn more about each type of activity:

  • Assessments - Medical product exposures, health outcomes, and links between them
  • Methods - Techniques for identifying, validating, and linking medical product exposures and health outcomes
  • Data - Mini-Sentinel Distributed Dataset and tools used to access the data