Special thanks to all who attended our webinar “FDA & IRB Inspections: What Sites Need to Know”. We had some great questions from the audience during our Q&A session, which are answered below.
What does the inspector have to inform the staff before they leave after an audit?
Findings of the audit if there are any. Actions that may be taken with the investigation findings and possibility of getting a 483 or leaving a 483 report, if there are severe findings of noncompliance of FDA regulations.
Can you clarify, the FDA is not allow to view any other studies while on site?
Auditors will come for one specific trial. If there are findings of gross negligence, or proof of failures to adhere to FDA guidelines auditors can start to review more trials. My comment was that recruitment materials for other clinical trials not related to the one being audited should not be scattered around the office in view of inspectors. Nor should other study binders or materials be in view of the auditor.
FDF not completed by staff who left during or after study. How would you address this issue?
If you can call or email the person and remind them of the requirement they are still bound to, they will usually sign the paperwork. Electronic signed versions are legal documents.
Most FDA audits will occur after the study has been closed with the IRB (sometimes years later). Would you still notify your IRB?
You have to notify the CRO and Sponsor that you will be notifying the IRB and send copies of the notification. I am not sure what the procedures are for the IRB, but they will inform you of what procedures have to be taken.
Why would a study coordinator be fired and not the PI – ultimate oversight responsibility?
Although the responsibility is that of the PI, if there is gross negligence on the part of the study coordinator, the only choice the PI may have to rectify the situation is by firing the study coordinator in question and replacing that person with a more competent coordinator. A PI may do this during the FDA audit, to ensure they are trying to correct the situation and fix the problems that have occurred from “possible lack of oversight.” Not always the best way to deal with this, but it does happen.
If you missed it, the full webinar is available here on demand.