If you are conducting an IND or IDE trial, you should familiarize yourself with the applicable regulations that apply to proper conduct and maintenance of records for your trial.  These regulations can be found on the FDA’s website, or basic summaries can be found in previous JHM compliance monitoring presentations.

The best way to prepare for an FDA inspection is to conduct your research trial in compliance with all applicable regulations from the beginning of the trial.  If you have compliance questions, you should ask the sponsor or contact the OSHR compliance monitoring or regulatory team BEFORE you begin your trial, or as soon as you have questions, rather than waiting.

FDA inspections may be scheduled or unscheduled.  Notification of a possible inspection should be forwarded to the OSHR.  The compliance monitoring team is available to discuss inspection requirements and look over your records with you.

If the PI is not the sponsor-investigator of IND/IDE, notify the sponsor of the study.  Call the main IRB line, and ask to speak to a member of the regulatory team.  When you reach a member of the regulatory team, inform him/her that your site has been chosen for an FDA inspection.  The IRB regulatory team will assist you with the interview preparations for the FDA visit.