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A tremendous amount of data about patients with a wide array of conditions currently resides in patient registries across the country. These data are being collected by researchers of many types to support epidemiological observations and paper publication. Increasingly the pharmaceutical industry is interested in using these data to support new product registrations, but the data were not generated with this use in mind. As a result they do not meet the standard of quality defined by the FDA, particularly with regard to 21 CFR Part 11. In order for the data to be included in a regulatory submission, the quality must be determined, and the organizations and personnel producing the data must be trained in the processes and procedures necessary to ensure that quality. This project will define the tools to be used to assess the quality of data in patient registries, and will define a training approach to be used to educate registry personnel in the methodologies necessary to produce data of regulatory quality.
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