May 2025

Investigators conducting an Investigational New Drug (IND) or Investigational Device Exemption (IDE) trial are expected to be knowledgeable about the applicable regulations that establish the requirements for investigators and sponsors conducting FDA regulated research.  The general regulations can be found on the FDA’s website, and specific requirements for IND studies or investigational device studies.

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 and throughout its life-span. If you have compliance questions, you should ask the sponsor or contact the OSHR Compliance Monitoring Team or Compliance Associates BEFORE you begin your trial, or as soon as you have questions, rather than waiting. Additional resources are available from the Johns Hopkins Medicine Office of Clinical Trials IND/IDE Regulatory Program. 

FDA inspections may be scheduled or unscheduled. If you are the IND/IDE sponsor or sponsor-investigator, and you are notified of an impending inspection, please contact the OSHR Compliance Monitoring Team as soon as possible.

If you are the investigator, but not the sponsor-investigator of IND/IDE, notify the sponsor of the study. The sponsor will likely assist you in preparing for the inspection. Next, contact the Compliance Monitoring Team about the inspection.

In all cases of an upcoming inspection, it is required that investigators notify the Compliance Monitoring Team, as a representative will need to be present at the beginning of the inspection to review the Notice of Inspection and the ID/credentials of the FDA inspector. In addition, please note that the Compliance Monitoring Team is available to discuss inspection requirements and, if desired, look over your research records and FDA documentation with you to help prepare for the inspection. A Compliance Monitoring Team representative will help support the study team throughout the inspection and will participate in the inspection close-out.