FDA Sentinel Operations Center

Funding Information
  • United States Food and Drug Administration (FDA)
Leadership

Sengwee Darren Toh

Year
2008

Project Summary

The Harvard Pilgrim Health Care Institute brings 10 years of experience developing and operating the Sentinel System. We partner with over 60 technology, health care, and academic organizations across the nation on this important undertaking.

The Sentinel System is a national medical product safety surveillance system with one of the largest curated multi-site distributed databases dedicated to medical product safety in the world. The Sentinel System supports the FDA’s mission to protect public health and monitor the safety of FDA-regulated medical products.

An Innovative Safety Monitoring System

The FDA's 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 disparate sources to assess the safety of approved medical products.

The Sentinel System is part of the Sentinel Initiative. Within this system, we lead Sentinel Operations Center (SOC) and work closely with the FDA to assess the risks and benefits of marketed medical products.

  • Designing and conducting medical product utilization, safety, and effectiveness studies in close collaboration with FDA
  • Enhancing core data sources and evolving the Sentinel Common Data Model
  • Developing novel distributed analysis tools
  • Further improving capabilities in signal detection and other areas
  • Leading real-world-evidence demonstration projects

The Sentinel System also focuses on developing innovative methods to further advance Sentinel by: 

  • Improving capabilities of Sentinel by leveraging new data sources
  • Building tools needed to enable Sentinel queries to include electronic health record data
  • Enhancing real-world evidence capabilities through advanced analytics

Select Ongoing Projects

We've built a growing portfolio of projects in response to the FDA's evolving needs. Learn more about what we're working on.

Sentinel Data

A distributed approach to data that maintains patient privacy and data security.

Sentinel Tools

Publicly available standardized tools that enable faster and reproducible analyses in a multi-site setting.

The Active Risk Identification and Analysis (ARIA) system

Using state-of-the-art analysis tools and linked electronic health records (EHR) data to monitor the safety of medications.

PDUFA VII Pregnancy Demonstration Projects

Developing a framework describing how to optimally use data from different types of post-approval pregnancy safety studies.

PDUFA VII Negative Controls

Fulfilling a Prescription Drug User Fee Act (PDUFA) VII commitment.

ASPE - TMSIS

Making Medicaid data more accessible and interoperable to researchers using common data models and FHIR API (T-MSIS).

Sentinel System's Coronavirus (COVID-19) Activities

Engaging in numerous activities to protect and promote public health during, and beyond, the COVID-19 pandemic.

Sentinel Innovation Center

A test bed to identify, develop, and evaluate innovative methods to study drug safety and effectiveness using real-world data.

Disseminating Research

Sentinel is committed to publishing findings in journals and sharing information at relevant conferences. Over 245 scientific papers have been published since Sentinel's founding.

All Publications

Approximately 128.7M members are currently accruing new data in Sentinel. 

Sentinel: the Past 5 Years

24
Sponsor Notification letters supported
8
Labeling changes contributed to, 3 of which were class-wide
346
Safety concerns monitored
297
Work products posted