Preparing for the FDA Inspection

Scheduling

• Establish an inspection schedule early on with assistance from the inspector
• Clear schedules (as much as possible) of key personnel (PI, CRC, the co-investigators most familiar with the study conduct)
• 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

Personnel

• Identify the inspection host (preferably the PI) and designate a point-of-contact/note-taker who can be available all day throughout the inspection
• Create a contact list based on responsibilities 
• Prepare team to be able to address known issues (be on the same page) and who may speak based on roles

• Verify that the study binder external site (opens in a new window) is complete
• Perform quality review of all documents prior to sharing with inspector:
  • Reports to IRB / FDA  of protocol violations/incidents, unanticipated problems and corrective actions
  • Adverse events
  • Consent form signatures and versions
  • HIPAA signatures
  • 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. 

• Schedule a coordination call with the Office of Ethics and Compliance Regulatory Support Unit, IRB QIU, and others as needed.
  • Typically, the OEC Regulatory Support and IRB QIU will attend the entrance and exit inspection meetings in person or virtually.
• Create a contact list for questions (study personnel, study sponsor, IRB coordinator, compliance, legal).

See: UCSF Roles and Responsibilities for FDA Inspections