Sponsor-investigators have reporting responsibilities when adverse events occur in their study. In addition to submitting these events to their IRB, they must also submit in respect to the protocol’s data safety monitoring plan and to the FDA following FDA regulation 21 CFR 312.32(c) or 21 CFR 812.150(a)(1). Reporting of these events to the FDA are required for all IND/IDE holders.
When do you need to submit to the FDA?
Drugs/Biologics
Initial reporting: Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event. Unexpected fatal or life-threatening suspected adverse events must be reported to the FDA as soon as possible but no later than within 7 calendar days of first being notified of the event.
Follow-up reporting: Any relevant additional information obtained related to the initial report should be submitted as a Follow-up Safety Report and must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.
Adverse events that don’t meet these categories should be submitted with your annual report with a summary of all events that have occurred.
Devices
Initial reporting: Any unanticipated adverse event suspected to be caused/associated with a device must be reported to the FDA and the reviewing IRB within 10 working days of the event.
Follow up reporting: Any relevant additional information obtained related to the initial report should be submitted as a Follow-up Safety Report and must be reported to the FDA as soon as possible.
Adverse events that don’t meet these categories should be submitted with your annual report with a summary of all events that have occurred.
What needs to be submitted to the FDA?
- Cover letter
- Form 1571 (if an IND; not needed for IDE)
- Form 3500A (Don’t use Form 3500 or 3500B)
The IND/IDE should be submitted to the respective office in the FDA that monitors your IND/IDE: CDER, CBER or CDRH.
Useful resources
Contact us
Lauren Wallace, M.S., RAC-Drugs
Director of clinical research regulatory affairs
Division of Strategy and Regulatory Affairs
Elizabeth Kissell, MPH, CCRP
Clinical research monitor/FDA program administrator
Division of Strategy and Regulatory Affairs
