The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program
Article first published online: 19 JAN 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program
Volume 21, Issue Supplement S1, pages 12–17, January 2012
How to Cite
Forrow, S., Campion, D. M., Herrinton, L. J., Nair, V. P., Robb, M. A., Wilson, M. and Platt, R. (2012), The organizational structure and governing principles of the Food and Drug Administration's Mini-Sentinel pilot program. Pharmacoepidem. Drug Safe., 21: 12–17. doi: 10.1002/pds.2242
- Issue published online: 19 JAN 2012
- Article first published online: 19 JAN 2012
- organizational structure;
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.