Guidance Jul 20, 2015 eResearch Regulatory Management (eRRM) eResearch Regulatory Management (eRRM) is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.
Guidance Apr 16, 2015 Unanticipated Problems Involving Risks to Subjects or Others 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...
Guidance Oct 17, 2011 Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED 04/23/2021: This page has been archived. Please refer to the more comprehensive pages: Certification Preparatory to Research Decedents De-identified Limited Data Sets
Guidance Jul 10, 2020 eResearch Cross-Reference Table These documents provide direction on consistency in application changes for the most common changes to the eResearch (IRB) application and the supporting materials. The "Table" indicates correspondences between all eResearch sections for certain...
