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Who Is Involved

The FDA leads the Sentinel System and Sentinel Initiative. In this capacity, the FDA:

  • Maintains decision-making authority and handles administering the Sentinel System contract
  • Establishes strategic priorities
  • Issues project requests
  • Reviews all work products

FDA Sentinel Leadership

Gerald Del Pan portrait photo
Gerald J. Dal Pan, MD, MHS
Director, CDER Office of Surveillance and Epidemiology
Robert Ball headshot photo
Robert Ball, MD, MPH
Deputy Director, CDER Office of Surveillance and Epidemiology
Professional headshot of Patricia "Trish" Bright
Patricia (“Trish”) Bright, PhD, MSPH
Associate Director for Sentinel, CDER Office of Surveillance and Epidemiology

Additional members of the FDA Sentinel Core Team:

  • Epidemiologist Team
    • Sarah Dutcher, PhD (Lead)
    • Jummai Apata, MBBS, DrPH
    • Jose J. Hernandez, RPh, MPH, MSc, PhD
    • Jamal T. Jones, PhD, MPH
    • Terrence (Terry) Lee, PhD., MPH
    • Fatma Shebl, MD, PhD, MS
    • Youjin Wang, PhD, RPh
  • Program Management Team
    • CAPT Jamila Mwidau, RN, MPH (Lead) 
    • Chanelle Jones, MHA, CPhT
    • Lucia Menegussi, BSN, MS, MSL

Sentinel generates evidence by partnering with various organizations such as: 

  • Academic medical centers
  • Healthcare systems
  • Health insurance companies

The following Data Partners have data in the Sentinel Common Data Model:

  1. Aetna, a CVS Health company 
  2. Carelon Research/Elevance Health
  3. Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)
  4. HealthPartners Institute
  5. Humana, Inc.
  6. Kaiser Permanente Colorado Institute for Health Research
  7. Kaiser Permanente Hawai'i, Center for Integrated Health Care Research
  8. Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc.
  9. Kaiser Permanente Northwest Center for Health Research
  10. Kaiser Permanente Washington Health Research Institute
  11. Marshfield Clinic Research Institute
  12. Optum
  13. Vanderbilt University Medical Center, Department of Health Policy (Tennessee Medicaid data)

Contributions from Sentinel Data Partners are coordinated through the Sentinel Operations Center (SOC). In this model:

  1. FDA submits a study design to SOC
  2. SOC distributes analytic code to applicable Sentinel Data Partners to run on their source data
  3. Sentinel Data Partners return de-identified data to SOC
  4. SOC aggregates data from Sentinel Data Partners, and delivers final results to FDA

Learn more about how Sentinel gets its data.

The Harvard Pilgrim Health Care Institute leads the Sentinel Operations Center. They partner with a broad range of Data and Academic Partners to answer FDA’s questions. Together, these Collaborating Institutions provide healthcare data and scientific, technical, and organizational expertise.

Below is a complete list of Collaborating Institutions.

  1. Aetna, a CVS Health company*
  2. Brigham and Women's Hospital: Division of Pharmacoepidemiology & Pharmacoeconomics in the Department of Medicine
  3. Carelon Research/Elevance Health*
  4. Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)*
  5. Harvard T.H. Chan School of Public Health
  6. HCA Healthcare
  7. Health Care Systems Research Network
  8. HealthVerity
  9. Humana, Inc.*
  10. Kaiser Permanente Center for Effectiveness and Safety Research
  11. Merative 
  12. Optum (OptumInsight Life Sciences Inc. and Optum Labs®)*
  13. TriNetX
  14. University of Florida College of Pharmacy: Department of Pharmaceutical Outcomes & Policy
  15. University of North Carolina Gillings School of Global Public Health: Center for Pharmacoepidemiology
  16. University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology
  17. Vanderbilt University Medical Center, Department of Health Policy (Tennesee Medicaid data)*

* Indicates Collaborating Institutions that are also Data Partners

Reagan-Udall Foundation for the Food and Drug Administration logo

The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) nonprofit. Congress created this nonprofit to advance regulatory science.

Innovation in Medical Evidence Development and Surveillance (IMEDS)

The Reagan-Udall Foundation has a private-public partnership called IMEDS. IMEDS gives private-sector entities access to a system based on the Sentinel Initiative. This system offers industry, academia, and researchers data that can help:

  • Check safety signals
  • Put in place post-market studies
  • Assess the impact of risk management actions

This is possible through select Data Partners and the Harvard Pilgrim Health Care Institute. Together, these two groups function as the Analytic Center. They help with the analyses of medical product safety evaluations.