For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page. Also see the University of Michigan Human Research Protection Program...

11/8/2021: This page has been archived. UMMS Regulatory Affairs maintains documentation regarding FDA Part 11 compliance at Data Integrity and Sharing (level-2 login required). The regulations in 21 CFR Part 11 set forth the criteria under which FDA...

Advertisements for recruiting potential research subjects can take many shapes. Examples include: flyers in a hospital hallway or on a student union bulletin board; newspaper, radio or television ads; direct mailings; electronic mail announcements;...

04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...

Click to review previous steps Step 1 Step 2 Refer to the IRB - approved documents for the specific study that includes a detailed plan for AE reporting . Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB , sponsor, IRB...

The table below presents instructions and guidance on informing IRBMED of reports to or from oversight bodies.

This table summarizes types of protocol deviations , exceptions, and violations that should be reported to IRBMED as ORIOs.

The Agency for Healthcare Research and Quality ( AHRQ ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of...