Published on Human Subjects Office (https://hso.research.uiowa.edu)

Human Subjects Office releases new FDA Site Inspection Guidance [1]

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 Human Subjects Office (HSO) Compliance Staff has released the newly created FDA Site Inspection Guidance [2] to provide practical advice for Principal Investigators (PI) and research staff undergoing a FDA inspection.

Source URL: https://hso.research.uiowa.edu/human-subjects-office-releases-new-fda-site-inspection-guidance

Links:
[1] https://hso.research.uiowa.edu/human-subjects-office-releases-new-fda-site-inspection-guidance
[2] https://hso.research.uiowa.edu/fda-site-inspection-guidance