11/8/2021: This page has been archived.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04/23/2021: This page has been archived.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...