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 In this section:

        Safety

FDA's Sentinel Initiative

                        
                FDA's Sentinel Initiative - Background
          FDA's Sentinel Initiative - Ongoing Projects Home
          Safety
          FDA's Sentinel InitiativeSafety FDA's Sentinel Initiative
  	
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***Transforming how we monitor the safety 
of FDA-regulated products***

Sentinel Initiative

Monitoring the safety of its regulated products is a major part of the FDA’s mission to protect public health. Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. In response to the FDA Amendments Act (FDAAA) of 2007, in May 2008 the FDA launched the Sentinel Initiative.

The first phase of this initiative was the Mini-Sentinel Pilot to inform the development of the Sentinel System. In September 2014, the FDA began transitioning from the Mini-Sentinel phase to the full Sentinel System, which officially launched in February 2016.  Over time, Sentinel has developed the largest multisite distributed database in the world dedicated to medical product safety. It is constantly growing and improving to meet FDA’s needs.

In September 2019, FDA announced Sentinel would expand to three distinct coordinating centers: Sentinel Operations Center, Innovation Center, and Community Building and Outreach Center.  The Operations Center will continue to leverage organizational partnerships in the areas of epidemiology, clinical medicine, pharmacy, statistics, health informatics, data science (specifically, artificial intelligence (natural language processing, machine learning)), and network operations to support postmarket safety analyses.  The Innovation Center will develop innovative methods to further advance Sentinel, including exploring novel ways to extract and structure information from electronic health records in the future.  The Community Building and Outreach Center’s will focus on communication and collaboration as well as deepening stakeholder involvement and broadening awareness, access, and use of Sentinel tools and data infrastructure.

This new design will enhance participation to a wider array of scientific expertise, translate new technologies from emerging fields such as data science and big data, create laboratories to develop new approaches to using electronic health records, and cultivate a robust scientific community to uncover novel ways to leverage the system’s core capabilities beyond drug safety.

The Sentinel Collaborators

Center
			CollaboratorSentinel Operations Center
			Lead: Harvard Pilgrim Health Care Institute
				Aetna, a CVS Health Company
				Brigham and Women’s Hospital
				Duke University School of Medicine: Department of Population Health Sciences (Medicare Fee-for-Service and Medicaid data)
				Harvard School of Public Health
				HCA Healthcare
				HealthCore/Elevance Health
				HealthPartners Institute
				Humana, Inc.
				Kaiser Permanente Colorado Institute for Health Research
				Kaiser Permanente Hawaii Center for Integrated Health Care Research
				Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc.
				Kaiser Permanente Northwest Center for Health Research
				Kaiser Permanente Washington Health Research Institute
				Marshfield Clinic Research Institute
				Merative
				Meyers Health Care Institute, a joint endeavor of UMass Chan Medical School, Reliant Medical Group, and Fallon Health
				Optum (OptumInsight Life Sciences Inc. and Optum Labs)
				Tennessee Medicaid
				TriNetX
				University of Florida
				University of Iowa
				University of North Carolina
				University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology
				Vanderbilt Medical Center, Department of Health Policy (Tennessee Medicaid data)Sentinel Innovation Center
			Lead Hubs
				Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School
					Duke University School of Medicine
					Kaiser Permanente Washington Health Research Institute with the University of Washington School of Public Health
					Vanderbilt University Medical Center Department of Biomedical Informatics
				Aetna, a CVS Health company
				Aetion, Inc.
				Amazon Web Services
				American Medical Informatics Association
				Columbia University
				ConcertoAI
				CorEvitas
				Doc.ai
				Duke Margolis Center for Health Policy
				Duke University
				Epic
				Evidation
				Harvard T.H. Chan School of Public Health
				HealthCore
				HealthVerity
				Humana, Inc.
				Kaiser Permanente Colorado Institute for Health Research
				Mass General Brigham
				Medical University of South Carolina
				Microsoft Healthcare NExT
				Microsoft Research
				Northeastern University
				Oak Ridge National Laboratory
				Observational Health Data Sciences and Informatics (OHDSI)
				Optum Labs
				Optum Life Sciences
				Penn State University
				Putnam Data Sciences
				PRACnet (Humana)
				Rutgers University: Center for Health Services Research
				Stanford University
				STAR Clinical Research Network
				TriNetX
				University of Alabama at Birmingham: Center for Outcomes and Effectiveness Research and Education
				University of California, Berkeley
				University of Illinois at Chicago: Department of Pharmacy Systems, Outcomes and Policy
				University of Iowa: Department of Epidemiology in the College of Public Health
				University of Florida College of Pharmacy: Department of Pharmaceutical Outcomes & Policy
				University of Michigan Medical School
				University of Pennsylvania School of Medicine: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics, Epidemiology and Informatics
				University of Pittsburgh School of Medicine: Department of Biomedical Informatics
				University of Tennessee
				University of Utah
				VeradigmSentinel Community Building and Outreach Center
			Lead: Deloitte Consulting
				Co-Lead: IQVIA
				NOVA Research
Sub-Topic Paragraphs
          Related LinksSentinel, FDA CDER’s active surveillance program
            Video: How Sentinel efficiently monitors safety of medical products on a massive scaleSentinel System Website
            Learn more about FDA's Sentinel System
          Related linksSentinel System Five-Year Strategy 2019-2023Framework for FDA’s Real-World Evidence ProgramFDA In Brief
            FDA announces a new Sentinel System contract, affirming its commitment to harnessing Real-World Data to improve the safety and effectiveness of drugs
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              Contact Us
        
      
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              SentinelInitiative@fda.hhs.gov
      
	
	301-796-2500
      
		
		
		
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		Food and Drug Administration
      

      Food and Drug Administration

	White Oak Campus 10903 New Hampshire AveSilver Spring, MD 20993United States

                                                                                  Content current as of:
      02/08/2023
                  
                   
Regulated Product(s)
		 DrugsFDA's Sentinel Initiative                
                          

                        FDA's Sentinel Initiative - Background
          FDA's Sentinel Initiative - Ongoing Projects
 
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