Overview
When a Principal Investigator (PI) is notified of an upcoming FDA inspection, follow these steps to prepare for the Inspector's arrival.
Step1
Consider Logistics.
Scheduling
- Clear schedules (as much as possible) of key personnel (PI, CRC, the co-investigators most familiar with the study conduct)
- Designate a point-of-contact/note-taker who can be available all day throughout the inspection
- Plan attendees for daily debrief and recipients of daily email summaries during the inspection
Location
- Reserve separate space for the inspector that does not include research-related documentation
- Notify staff who work near the Inspector's designated space of the upcoming inspection dates
Step2
Perform a Document Review.
- Verify that the study binder external site (opens in a new window) is complete
- Strategically review study documents:
- Reports to IRB / FDA of protocol violations/incidents, unanticipated problems and corrective actions
- Adverse events
- Consent form signatures and versions
- Delegation log
- Drug / Device accountability logs
- Consult the IRB / Study Sponsor / Compliance with any questions or issues you anticipate.
Use the FDA Pre-Inspection Checklist to ensure all bases are covered.
Step3
Plan the Meeting.
- Schedule a coordination call with Compliance, IRB, and others as needed.
- Create a contact list for questions (study personnel, study sponsor, IRB coordinator, compliance, legal).