FDA engaged eHI to produce the report Developing a Governance and Operations Structure for the Sentinel Initiative in order to explore the range of governance and operational options available to Sentinel. The report's recommendations are based on various sources, including feedback received from the FDA-sponsored December 16, 2008 public meeting and docket submissions associated with that meeting, publicly available Sentinel-related documents and a review of initiatives similar to Sentinel. The report discusses what the public views as critical success factors for Sentinel's establishment, launch, and evolution, as well as approaches for FDA to consider in launching this collaborative effort (e.g., a government-run and controlled entity vs. a private-sector-run entity with government collaboration). General principles of good governance, roles and responsibilities of a governance entity, as well as potential funding sources and factors influencing an estimated annual operating budget are also examined. FDA welcomes your comments and proposals on this important report.
