Inspections & Audits
The purpose of the Inspections and Audits stop is to perform any inspections or audits that might be required by the Regulatory Authority, IRB, or Trial Sponsor.
DCT-specific Considerations/Inputs
Per FDA Draft Guidance, the FDA will expect to have an identified location to review data collected by a Principal investigator. When a virtual PI is involved, a physical location for audit will still need to be identified.