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Sentinel Structure

The Sentinel Initiative is lead by FDA in collaboration with its three centers, SOC, IC, CBOC


There are three distinct centers within the Sentinel Initiative:

  1. Community Building and Outreach Center (CBOC)
  2. Sentinel Innovation Center (IC)
  3. Sentinel Operations Center (SOC)

These centers collaborate to advance regulatory science using the Sentinel System. Each center operates independently and has a dedicated leadership team with dedicated staff. The three centers each carry out projects associated with the centers’ strategic objectives.

Deloitte Consulting, LLP leads CBOC. This center focuses on communication and collaboration by:

  • Deepening stakeholder involvement
  • Broadens awareness and access to Sentinel tools and data infrastructure

The primary functions of CBOC are to:

  • Catalyze breakthrough ideas in regulatory science through scientific challenges
  • Modernize the Sentinel website to enhance user experience and key functionalities  
  • Accelerate the use of the Sentinel Common Data Model for secondary purposes

Learn more about CBOC.

The IC is led by four Lead Hubs in collaboration with Harvard Pilgrim Health Care Institute: 

  • Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School
  • Duke Clinical Research Institute
  • Vanderbilt University Medical Center Department of Biomedical Informatics
  • Kaiser Permanente Washington Health Research Institute & University of Washington School of Public Health

This center focuses on developing innovative methods to further advance Sentinel. This includes exploring ways to extract and structure information from electronic health records. The primary functions of the Innovation Center are to:

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

Learn more about the IC.

Harvard Pilgrim leads the SOC and its Data Partners, using a distributed database. This center leverages organizational partnerships in the areas of:

  • Epidemiology
  • Clinical medicine
  • Pharmacy
  • Statistics
  • Health informatics
  • Data science (specifically, artificial intelligence tools like natural language processing and machine learning)
  • Network operations to support post market safety analyses.

The primary functions of the SOC are to:

  • Enhance core data sources and evolve the Sentinel Common Data Model 
  • Develop novel distributed analysis tools
  • Further enhance capabilities in signal detection and other areas
  • Lead Real World Evidence demonstration projects through FDA-Catalyst

Learn more about the SOC.