Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED. Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in conjunction with a protocol, investigatorship, or informed consent amendment. When those contexts don't apply, information should be reported as an ORIO in accordance with the guidelines below.
For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page.
**When notified of an Audit by a Federal Regulatory Agency (i.e., FDA, NIH, OHRP etc.), immediately call the Office of Regulatory Affairs (647-1576) and IRBMED (763‑4768) to inform each unit of the date of inspection. See below (Notification of Audit/Inspection/Inquiry).
** If an ORIO indicates notification of research subjects is necessary, IRBMED must review and approve materials prior to utilization.
Click on the headings below to expand.