Adverse Events and ORIOs

Overview

It is very important that you report adverse events and Other Reportable Information and Occurrences (ORIOs) according to the reporting requirements.

These resources provide information about what to report and when.


Links

IRBMED

Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting
An essential element of human subjects protection is identifying, analyzing the causes of, and responding appropriately to expected and unexpected adverse events as well as unanticipated problems involving risks to subjects or others. IRBMED provides several resources to help investigators identify and analyze the events and to formulate responses.

Other Reportable Information or Occurrence (ORIO)
IRBMED provides information about the types of ORIOs that are reportable to the IRBMED as well as an ORIO timetable.

ORIO Guidance
This page provides IRBMED guidance regarding other reportable information or occurrences (ORIOs).

Reporting Adverse Events (AEs)
This page provides IRBMED guidance regarding adverse event reporting, including step-by-step instructions on reporting procedures.

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 U-M investigator receives a report, usually from the study sponsor or oversight entity.

Office for Human Subjects Protections

How to Determine Whether a Problem is Unanticipated
This page provides OHRP’s expectations for what, when, and to whom adverse events need to be reported as unanticipated problems, given the requirements of the HHS regulations at 45 CFR part 46.

Unanticipated Problems Involving Risks and Adverse Events Guidance (2007)
On this page, OHRP provides regulatory requirements as well as recommendations regarding unanticipated problems involving risks and adverse events.

FDA

The following links provide information about FDA regulations regarding adverse events (AEs) and other reportable information and occurrences (ORIOs).

FDA 21CFR312.32 – IND Safety Reporting

FDA 21CRF312.64 (b) – Investigator Reports

Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs – Improving Human Subject Protection

FDA 21CRF812.150 – Investigational Device Exemptions – Subpart G Reports

What is a Serious Adverse Event?


Questions and Disclaimer

If you have questions about any of the resources on this page, please contact the sponsoring office directly. MICHR is not responsible for the content of these resources.

Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.

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