Update of FDA Clinical Investigator Inspection List

The US Food and Drug Administration (FDA) updates quarterly its Clinical Investigator Inspection List (CLIIL). The Clinical Investigator Inspection List contains names, addresses, and other information gathered from inspections of clinical investigators who have performed studies with investigational human drugs. The list contains information on investigators inspected since July 1977 whose inspection files have been closed with a final classification.  Please note that the current retention policy for paper files is ten years. Freedom of Information requests for documentation of inspections conducted over ten years ago may not be available.

The inspections were conducted as part of the Food and Drug Administration's Bioresearch Monitoring Program. This programme validates the quality of the clinical studies upon which drug approvals are based. It also assures that the rights and welfare of the human subjects in the studies have been protected.

Source: FDA Website

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