Studies required to submit full continuing review forms must include a list of adverse events (AEs) with their CR submissions. The IRB asks that in addition to including dates of occurrence of AEs, these reports reflect the outcome of the AE, such as “ongoing,” or “resolved.” If the date of resolution is known, please include that information as well. This information helps the IRB assess whether the study’s risk/benefit ratio has changed over the past review period.
We have added a column to the IRB’s “Events and Deviations” template to capture this information. Remember to track these events as they happen, rather than trying to compile a list right before the CR report is due.