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Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting

Investigators and research staff are responsible for reporting information concerning the approved research to the IRB in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and...

Guidance

Jun 11, 2018

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

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...

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Guidance

Apr 12, 2013

Assent of Children in Research

The IRBMED has developed an assent template for researchers to use in developing an assent document appropriate for children ages 10 to 14. It is available here . Below are frequently asked questions about assent. More information is available here .

Guidance

Apr 17, 2012

Test Articles in Research

The term “test article” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...

Guidance

Oct 2, 2007

Study-Specific Adverse Event (AE) Reporting Plans

There are two types of studies for which the principal investigator should consider using a study-specific AE reporting plan in order to reduce or streamline the reporting burden on the study team: Sponsored studies that include a detailed AE...

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Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting

Other Reportable Information or Occurrence (ORIO)

Adverse Event Reporting

Most Viewed

Assent of Children in Research

Test Articles in Research

Study-Specific Adverse Event (AE) Reporting Plans

Medical School Office of Research