When a PI receives notice from the FDA about an upcoming site inspection, the FDA Site Inspection Guide provides guidance for what to do at these timepoints:

• Upon notification 
• Prior to, during and after the FDA inspection 

The FDA Inspection Guide also includes an example intake form and a list of questions that are often asked during a site inspection.

When the PI receives an FDA site inspection notice, notify the following:

• Research team
• Department Executive Officer (DEO)
• Clinic Director
• Human Subjects Office (irb-monitors@uiowa.edu)
• UI Health Care HIPAA Privacy Officer (compliance@healthcare.uiowa.edu)
• UI Health Care Pharmacy & Therapeutics Committee / Investigational Drug Service (IDS)
• Human Resources (to arrange access to the Electronic Medical Record)
• Study sponsor
• Contract Research Organization (CRO) or Coordinating Center (if applicable)