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Get FDA Inspector Perspectives 2004-2024

: The Food and Drug Administration (FDA) has a crucial role in the oversight of clinical research. This article provides an overview of FDA’s Bioresearch Monitoring Program, with a focus on inspections of clinical investigators and sponsors. The responsibilities of clinical investigators and sponsors for conducting and monitoring clinical trials are outlined. Common deficiencies found during FDA inspections are discussed. Suggestions for preparing for a site inspection and conducting successf.

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