# Sentinel Initiative

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**Sentinel Initiative** is a set of efforts by U.S. [Food and Drug Administration](/source/Food_and_Drug_Administration) (FDA) that tries to improve the ability to identify and evaluate safety of medicinal products.[1][2][3]

It has several parts: Sentinel System,[4] Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance Network (BloodSCAN).[5] Part of Sentinel Initiative is a surveillance program for biologics. It is called Biologics Effectiveness and Safety (BEST) Initiative.[6]

## 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.[7]

## See also

- [Health informatics](/source/Health_informatics)

- [Real world data](/source/Real_world_data)

- [Real world evidence](/source/Real_world_evidence)

## References

1. **[^](#cite_ref-sw_1-0)** ["Sentinel Initiative Website"](https://www.sentinelinitiative.org).

1. **[^](#cite_ref-pec13_2-0)** 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](/source/Doi_(identifier)):[10.1002/9781119959946.ch30](https://doi.org/10.1002%2F9781119959946.ch30). [ISBN](/source/ISBN_(identifier)) [9781119959946](https://en.wikipedia.org/wiki/Special:BookSources/9781119959946).

1. **[^](#cite_ref-3)** Desai, Rishi J.; Matheny, Michael E.; Johnson, Kevin; Marsolo, Keith; Curtis, Lesley H.; Nelson, Jennifer C.; Heagerty, Patrick J.; Maro, Judith; Brown, Jeffery; Toh, Sengwee; Nguyen, Michael (2021-12-20). ["Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework"](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8688411). *npj Digital Medicine*. **4** (1): 170. [doi](/source/Doi_(identifier)):[10.1038/s41746-021-00542-0](https://doi.org/10.1038%2Fs41746-021-00542-0). [ISSN](/source/ISSN_(identifier)) [2398-6352](https://search.worldcat.org/issn/2398-6352). [PMC](/source/PMC_(identifier)) [8688411](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8688411). [PMID](/source/PMID_(identifier)) [34931012](https://pubmed.ncbi.nlm.nih.gov/34931012). [S2CID](/source/S2CID_(identifier)) [245330913](https://api.semanticscholar.org/CorpusID:245330913).

1. **[^](#cite_ref-4)** 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](/source/Doi_(identifier)):[10.1002/cpt.320](https://doi.org/10.1002%2Fcpt.320). [PMID](/source/PMID_(identifier)) [26667601](https://pubmed.ncbi.nlm.nih.gov/26667601). [S2CID](/source/S2CID_(identifier)) [5129131](https://api.semanticscholar.org/CorpusID:5129131).

1. **[^](#cite_ref-main_5-0)** ["Sentinel Description"](https://web.archive.org/web/20100111235106/http://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm). FDA. Archived from [the original](https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm) on January 11, 2010.

1. **[^](#cite_ref-6)** ["The Biologics Effectiveness and Safety Initiative"](https://www.bestinitiative.org/). *BEST Initiative*.

1. **[^](#cite_ref-7)** ["Background"](https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm149340.htm). FDA. 4 February 2022.[*[dead link](https://en.wikipedia.org/wiki/Wikipedia:Link_rot)*]

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Adapted from the Wikipedia article [Sentinel Initiative](https://en.wikipedia.org/wiki/Sentinel_Initiative) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Sentinel_Initiative?action=history)). Available under [Creative Commons Attribution-ShareAlike 4.0 International](https://creativecommons.org/licenses/by-sa/4.0/). Changes may have been made.