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

Jun 11, 2018 10:00 am

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 not implementing any changes to the research prior to IRB approval of the change via an amendment application ( when changes are necessary to eliminate apparent immediate hazards to the subject, implement the change and report by an ORIO and/or amendment submission within 7 calendar days after the action is taken). This includes all information with the potential to impact the risk or benefit assessments of the research.

Failure to follow these requirements may require the institution to take disciplinary actions, restrict research privileges, and report the non-compliance to government agencies and/or study sponsor.

See the site for adverse event definitions.