title: Design considerations, architecture, and use of the Mini-Sentinel distributed data system.
abstract: OBJECTIVE
  We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA.
  
  
  METHODS
  A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners. A review of existing common data models informed the process. Each participating organization designed a process to extract, transform, and load its source data, applying the common data model to create the Mini-Sentinel Distributed Database. Transformed data were characterized and evaluated using a series of programs developed centrally and executed locally by participating organizations. A secure communications portal was designed to facilitate queries of the Mini-Sentinel Distributed Database and transfer of confidential data, analytic tools were developed to facilitate rapid response to common questions, and distributed querying software was implemented to facilitate rapid querying of summary data.
  
  
  RESULTS
  As of July 2011, information on 99,260,976 health plan members was included in the Mini-Sentinel Distributed Database. The database includes 316,009,067 person-years of observation time, with members contributing, on average, 27.0 months of observation time. All data partners have successfully executed distributed code and returned findings to the Mini-Sentinel Operations Center.
  
  
  CONCLUSIONS
  This work demonstrates the feasibility of building a large, multiorganizational distributed data system in which organizations retain possession of their data that are used in an active surveillance system.
authors.affiliation: Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Lesley H
authors.initials: LH
authors.lastname: Curtis
authors.forename: Mark G
authors.initials: MG
authors.lastname: Weiner
authors.forename: Denise M
authors.initials: DM
authors.lastname: Boudreau
authors.forename: William O
authors.initials: WO
authors.lastname: Cooper
authors.forename: Gregory W
authors.initials: GW
authors.lastname: Daniel
authors.forename: Vinit P
authors.initials: VP
authors.lastname: Nair
authors.forename: Marsha A
authors.initials: MA
authors.lastname: Raebel
authors.forename: Nicolas U
authors.initials: NU
authors.lastname: Beaulieu
authors.forename: Robert
authors.initials: R
authors.lastname: Rosofsky
authors.forename: Tiffany S
authors.initials: TS
authors.lastname: Woodworth
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Brown
mesh_terms: D001688:Biological Products / Q000009:adverse effects; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies / Q000009:adverse effects; D005240:Feasibility Studies; D006801:Humans; D008962:Models, Theoretical; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D016730:Program Development; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products