Sentinel

Sentinel is an active surveillance system sponsored by the U.S. Food and Drug Administration (FDA) to monitor the safety of regulated medical products using pre-existing electronic healthcare data from multiple sources. The Sentinel System is part of the FDA's Sentinel Initiative, a long-term effort to improve the FDA's ability to identify and access medical product safety issues.

The Sentinel Initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the performance of FDA-regulated medical products. The Initiative is the FDA's response to the Food and Drug Administration Amendments Act (FDAAA) requirement that the FDA work with public, academic, and private entities to develop a system to obtain information from existing electronic health care data from multiple sources to assess the safety of approved medical products. Sentinel's work focuses on drugs, vaccines, and other biologics (such as blood products).

Sentinel is growing quickly and invites interested candidates to contact us about training and employment opportunities.

 

Related Links

Sentinel Site

FDA's Sentinel Initiative 

 

Principal Investigator: Richard Platt, MD, MSc

Funder: Food and Drug Administration