Prior to submitting any reports from the FDA, contact the IRBMED (763-4768) and/or the Health System Legal Office (764-2178). Also, provide the IRBMED with copies of all FDA correspondence, as noted below.
Use the ORIO form entitled “Report to or from an Oversight Entity” to report the following (click here to view a blank report):
- Within 7 calendar days of mailing any reports to the FDA, submit copies to the IRBMED.
- Within 7 calendar days of receiving any reports from the FDA, submit copies to the IRBMED.
- Within 7 calendar days of receiving from the sponsor/manufacturer/HDE holder any reports regarding urgent safety concerns or calling for changes in the use of the device, submit copies to the IRBMED.
- Within 7 calendar days of submitting to the sponsor/manufacturer/HDE holder any follow-up or other reports, submit copies to the IRBMED.
- When applying for approval of continuing review, submit to the IRBMED any routine reports to or from the sponsor/manufacturer that do not involve urgent safety concerns or call for changes in the use of the device.
Should you identify a breach of confidentiality, report it immediately to the UMHS Privacy Office (615-4759).
- Within 7 calendar days of identifying the breach, submit a report to the IRBMED. Use the ORIO form entitled “Protocol Deviation” (click here to view a blank report).
Web page created 2/7/2013