The Food and Drug Administration (FDA) conducts site inspections of clinical investigators involved in FDA-regulated clinical trials to determine compliance with applicable regulations.  The UI HSO’s FDA Site Inspection Guide provides practical advice for Principal Investigators (PI) and research staff undergoing a FDA inspection.  This presentation will provide an overview of the guide, which outlines step-by-step pre-inspection preparations, recommended study team conduct during the inspection, potential post-inspection outcomes, and directions for post-inspection activities.

This session will be presented by the IRB Compliance Program from the Human Subjects Office: Elizabeth Jach, MA (IRB Compliance Manager); Michele Countryman, CIP (HSO Director); and Therese Barenz, CCRC, CIP (Senior Compliance and Education Specialist).

See the ICTS Page for more information.