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The US Food and Drug Administration plans to begin collecting information for its Sentinel Initiative, according to a Sept. 4 Federal Register announcement.
The US Food and Drug Administration plans to begin collecting information for its Sentinel Initiative, according to a Sept. 4 Federal Register announcement. The initiative, established in May 2008, focuses on enabling FDA to improve monitoring of drug performance after marketing approval by working with multiple healthcare data systems. The 2007 Food and Drug Administration Amendments Act calls for the agency to be able to access data from 25 million patients by July 2010, and from 100 million patients by July 2012, according to the announcement.
“The proposed system will enable queries of distributed data sources quickly and securely for relevant product-safety information,” says the announcement. “Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be included.”
The call for data, which will help FDA plan for this proposed system and for future work related to the Sentinel Initiative, has been submitted for approval to the Office for Management and Budget. The data sought includes the scope, content, structure, quality, and timeliness of data; patient population(s), duration of followup, and capture of care across all settings; availability, experience, and interest of investigators with knowledge of the data in using it for postmarket product-safety surveillance as well as plans for further data source enhancements; availability, experience, and interest of investigators with knowledge of the data in participating in a distributed data system; and barriers that exist to including each data source in the Sentinel Initiative.
The agency estimates that each respondent submitting the above information will spend about 24.5 hours doing so. FDA expects 250 respondents will participate in the survey.
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