| The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program. | |
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MedLine Citation:
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PMID: 22262588 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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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. Copyright © 2012 John Wiley & Sons, Ltd. |
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Authors:
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Susan Forrow; Daniel M Campion; Lisa J Herrinton; Vinit P Nair; Melissa A Robb; Marcus Wilson; Richard Platt |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Pharmacoepidemiology and drug safety Volume: 21 Suppl 1 ISSN: 1099-1557 ISO Abbreviation: Pharmacoepidemiol Drug Saf Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-01-20 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9208369 Medline TA: Pharmacoepidemiol Drug Saf Country: England |
Other Details:
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Languages: eng Pagination: 12-7 Citation Subset: IM |
Copyright Information:
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Copyright © 2012 John Wiley & Sons, Ltd. |
Affiliation:
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Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA. susan_forrow@harvardpilgrim.org. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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