title: The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program.
abstract: The US Food and Drug Administration's Mini-Sentinel pilot program is developing an organizational structure as well as principles and policies to govern its operations. These will inform the structure and function of the eventual Sentinel System. Mini-Sentinel is a collaboration that includes 25 participating institutions. We describe the program's current organizational structure and its major principles and policies. The organization includes a coordinating center with program leadership provided by a principal investigator; a planning board and subcommittees; an operations center; and data, methods, and protocol cores. Ad hoc workgroups are created as needed. A privacy panel advises about protection of individual health information. Principles and policies are intended to ensure that Mini-Sentinel conforms to the principles of fair information practices, protects the privacy of individual health information, maintains the security and integrity of data, assures the confidentiality of proprietary information, provides accurate and timely communications, prevents or manages conflicts of interest, and preserves respect for intellectual property rights.
authors.affiliation: Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 02215, USA. susan_forrow@harvardpilgrim.org
authors.forename: Susan
authors.initials: S
authors.lastname: Forrow
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Campion
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Herrinton
authors.forename: Vinit P
authors.initials: VP
authors.lastname: Nair
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Robb
authors.forename: Marcus
authors.initials: M
authors.lastname: Wilson
authors.forename: Richard
authors.initials: R
authors.lastname: Platt
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence; D003299:Cooperative Behavior; D006801:Humans; D018973:Intellectual Property; D016134:Organizational Policy; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D016730:Program Development / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration