Sentinel Initiative

Sentinel Initiative is a set of efforts by U.S. Food and Drug Administration (FDA) that tries to improve the ability to identify and evaluate safety of medicinal products.[1][2]

It has several parts: Sentinel System,[3] Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance Network (BloodSCAN).[4]

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.[5]

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See also

References
  1. "Sentinel Initiative Website".
  2. Racoosin, Judith A.; Robb, Melissa A.; Sherman, Rachel E.; Woodcock, Janet (2012-01-03). "Chapter 30: FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals". In Strom, Brian L.; Kimmel, Stephen E.; Hennessy, Sean (eds.). Pharmacoepidemiology. Wiley-Blackwell. pp. 534–554. doi:10.1002/9781119959946.ch30. ISBN 9781119959946.
  3. Ball, R; Robb, M; Anderson, SA; Dal Pan, G (2016). "The FDA's sentinel initiative--A comprehensive approach to medical product surveillance". Clin Pharmacol Ther. 99 (3): 265–8. doi:10.1002/cpt.320. PMID 26667601.
  4. "Sentinel Description". FDA.
  5. "Background". FDA.


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