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词条 Sentinel Initiative
释义

  1. Sentinel System

  2. See also

  3. References

Sentinel Initiative is a set of efforts by U.S. Food and Drug Administration's (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]

See also

  • Real world data
  • Real world evidence
  • Health informatics
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References

1. ^{{cite web |title=Sentinel Initiative Website |url=https://www.sentinelinitiative.org}}
2. ^ {{cite book|url=http://doi.wiley.com/10.1002/9781119959946.ch30|title=Pharmacoepidemiology|last=Racoosin|first=Judith A.|last2=Robb|first2=Melissa A.|last3=Sherman|first3=Rachel E.|last4=Woodcock|first4=Janet|date=2012-01-03|work=Pharmacoepidemiology|publisher=Wiley-Blackwell|year=|isbn=9781119959946|editor-last=Strom|editor-first=Brian L.|location=|pages=534–554|language=en|chapter=Chapter 30: FDA's Sentinel Initiative: Active Surveillance to Identify Safety Signals|doi=10.1002/9781119959946.ch30|access-date=2019-03-29|editor2-last=Kimmel|editor2-first=Stephen E.|editor3-last=Hennessy|editor3-first=Sean}}
3. ^{{cite journal |title=The FDA's sentinel initiative--A comprehensive approach to medical product surveillance |pmid=26667601}}
4. ^{{cite web |title=Sentinel Description |url=https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm |publisher=FDA}}
5. ^{{cite web |title=Background |url=https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm149340.htm |publisher=FDA}}
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