Guidance
Jun 7, 2021

Other Reportable Information or Occurrence (ORIO)

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...
Guidance
Jul 22, 2020

Study-Specific Adverse Event (AE) Reporting Plans

The IRBMED Standard Adverse Event (AE) Reporting Timetable is designed to accommodate a wide range of study designs and risk levels. These standard guidelines apply only to IRBMED reporting; they do not apply to reporting that may be required by...
Guidance
Jun 11, 2018

Adverse Event Reporting

Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. These guidelines apply only to IRBMED reporting. They do not apply to required...
Guidance
Aug 14, 2015

External Adverse Event (AE) Reporting

This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of non -UM investigators and non -UM IRBs , events about which the UM investigator receives a report, usually from the study sponsor...
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
Mar 12, 2012

Study-Specific AE Reporting

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...