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Design considerations, architecture, and use of the Mini-Sentinel distributed data system
Article first published online: 19 JAN 2012
DOI: 10.1002/pds.2336
Copyright © 2012 John Wiley & Sons, Ltd.
Issue
Pharmacoepidemiology and Drug Safety
Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program
Volume 21, Issue Supplement S1, pages 23–31, January 2012
Additional Information
How to Cite
Curtis, L. H., Weiner, M. G., Boudreau, D. M., Cooper, W. O., Daniel, G. W., Nair, V. P., Raebel, M. A., Beaulieu, N. U., Rosofsky, R., Woodworth, T. S. and Brown, J. S. (2012), Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidem. Drug Safe., 21: 23–31. doi: 10.1002/pds.2336
Publication History
- Issue published online: 19 JAN 2012
- Article first published online: 19 JAN 2012
REFERENCES
- 1Sliver Spring, MD: Food and Drug Administration, 2008. The Sentinel Initiative: national strategy for monitoring medical product safety. (http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf).
- 2, , , , , . Developing the Sentinel System—a national resource for evidence development. N Engl J Med 2011; 364(6): 498–499.
- 3About Mini-Sentinel. http://mini-sentinel.org/about_us/ [31 January 2011].
- 4, , , et al. Design of a National Distributed Health Data Network. Ann Intern Med 2009; 151: 341–344.
- 5, , , et al. Defining and Evaluating Possible Database Models to Implement the FDA Sentinel Initiative; U.S. Food and Drug Administration: FDA-2009-N-0192-0005.2009. Available at: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=090000648098c282 [Accessed February 2011].
- 6, , , et al. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study. Pharmacoepidemiol drug saf 2008; 17: 1226–1234.
- 7, , , , , . Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care. Med Care 2010; 48: S45–51.
- 8, , , . Defining and evaluating possible database models to implement the FDA Sentinel Initiative. FDA-2009-N-0192-0005. Available at http://www.regulations.gov/#!documentDetail;D = FDA-2009-N-0192-0005
- 9Vaccine Safety Datalink project. Website: www.cdc.gov/vaccinesafety/vsd [5 February 2011].
- 10National Vaccine Advisory Committee. Report on 2009 H1N1 Vaccine Safety Risk Assessment. Available at http://www.hhs.gov/nvpo/nvac/reports/2010vaccinesafetyreport.html [5 February 2011].
- 11HMO Research Network (HMORN). Website: www.hmoresearchnetwork.org/ [5 February 2011].
- 12Observational Medical Outcomes Partnership website: http://omop.fnih.org/ [5 February 2011].
- 13, , , et al. H1N1 Influenza Vaccine Safety in the Post-licensure Rapid Immunization Safety Monitoring (PRISM) Network. 48th Annual Meeting of the Infectious Diseases Society of America. Vancouver, British Columbia, Canada, 2010.
- 14, , , et al. The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program. Pharmacoepidemiol Drug Saf 2012; 21(S1): 12–17.
- 15, , . A policy framework for public health uses of electronic health data. Pharmacoepidemiol Drug Saf 2012; 21(S1): 18–22.
- 16FDA Sentinel Initiative reports. www.regulations.gov/search/Regs/home.html - docketDetail?R = FDA-2009-N-0192.
- 17, , , , . Risk for fractures with centrally acting muscle relaxants: an analysis of a national Medicare Advantage claim database. Ann Pharmacother 2010; 44: 1369–1375.
- 18, , , et al. Risks of congenital malformations and perinatal events among infants exposed to calcium channel and beta-blockers during pregnancy. Pharmacoepidemiol Drug Saf 2011; 20(2): 138–134. DOI: 10.1002/pds.2068
- 19, , , et al. Antidepressant medication use and risk of persistent pulmonary hypertension of the newborn. Pharmacoepidemiol Drug Saf 2009; 18(3): 246–252. PMID: 19148882.
- 20, (ed.). Pharmacoepidemiology, (4th edn). John Wiley & Sons, Ltd: West Sussex, England, 2005.
- 21, , , et al. for the Vaccine Safety Datalink Rapid Cycle Analysis Team. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care 2007; 45(10 Suppl 2): S89–95.
- 22, , , et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010; 153(9): 600–606.
- 23Informatics for Integrating Biology and the Bedside (i2b2). Website: www.i2b2.org
- 24Electronic Primary Care Research Network (ePCRN). Website: www.epcrn.bham.ac.uk
- 25Teradata. Website: www.teradata.com
- 26Mini-Sentinel Common Data Model V1.1. Available at http://www.mini-sentinel.org/work_products/Data_Activities/Mini-Sentinel_CommonDataModel_v1.1.pdf [11 August 2011].
- 27Mini-Sentinel Distributed Query Tool: Summary Table Descriptions. Available at http://www.mini-sentinel.org/work_products/Data_Activities/Mini-Sentinel_Query-Tool-Summary-Table-Description_v1.1x.pdf [12 August 2011].
- 28Mini-Sentinel Modular Programs. Available at http://www.mini-sentinel.org/data_activities/ [18 August 2011].