What type of adverse events should be reported and how?
• All adverse events should be reported, even those that do not appear to be related to the study. • Serious or Unexpected: Report to IRB/HSRC within 5 days; AE form (If serious, physician comment required) • Neither Serious nor Unexpected: Report to IRB/HSRC within 1 month; AE form (DOC) Can I do a study for more than a year? Submit a progress report (DOC) if a non-exempt project is to last longer than the approval period, which is typically 1 year. Submit 10 copies of the Progress Report to the Office of Research 2 months prior to the study s expiration. The study must be reviewed and re-approved by the IRB for research to continue. When is a study complete? Non-exempt studies are considered complete when data collection and data analysis are complete. Submit 1 copy of the Close Out Report (DOC) to the Office of Research 1 month after your study is complete. If you have additional questions, please contact: David Swain, PhD, IRB Chair (757) 683-6028 dswain@odu.
