Sentinel Initiative is a set of efforts by U.S.
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) that tries to improve the ability to identify and evaluate safety of medicinal products.
It has several parts: Sentinel System, Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance Network (BloodSCAN).
Part of Sentinel Initiative is a surveillance program for biologics. It is called Biologics Effectiveness and Safety (BEST) Initiative.
Sentinel System
The Sentinel System uses pre-existing electronic healthcare data (including billing data). Part of the Sentinel System is a tool called Active Postmarket Risk Identification and Analysis (ARIA) system that was mandated in the U.S. Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007.
See also
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Health informatics
Health informatics combines communications, information technology (IT), and health care to enhance patient care and is at the forefront of the medical technological revolution. It can be viewed as a branch of engineering and applied science. ...
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Real world data
Real may refer to:
Currencies
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* Mexican real
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* Spanish colonial real
Nature and science
* Reality, the state of things as they exist, r ...
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Real world evidence
References
Food and Drug Administration
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