FDA Guidance: Inspection of Clinical Investigators, 6/10

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This document “Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators” was published in June, 2010 to provide information about FDA inspections of clinical investigators conducted under FDA’s Bioresearch Monitoring (BIMO) Program. This document supersedes FDA’s Information Sheet Guidance, “FDA Inspections of Clinical Investigators,” dated January 2006.

Section IV “How Are Clinical Investigator Inspections Conducted?” states that the FDA investigator may gather information to determine whether or not 21 CFR Part 11 requirements have been met for electronic study data and records.