We know that, per IRB Policy 10.2, certain events need to be reported to the IRB right away. But how about all those other little incidents that don’t require immediate reporting, but instead are sent in with the study’s continuing review form? What does the IRB need to know about those?
We have a handy-dandy log available that greatly simplifies the collection and reporting of these events. Our Events and Deviations table is available on the IRB’s website, under Open Studies/Continuing Review. This spreadsheet guides you to record the information the IRB will want to know for the various events. While we don’t require a specific format for these reports, this sheet, we’ve found, is an easy way to compile the information the IRB will need.
One tip — please make it clear on the sheet you include with the CR which are the events and deviations that occurred in the approval period. Some investigators keep a single list throughout the entire study and submit the whole thing with each CR. That’s fine; just make sure it’s easy for the IRB to figure out which are the events that occurred during the most recent approval period.
A second, really big tip — Keep a running list of events throughout the year. Don’t wait until the last minute to try to compile a list right before your CR is due. Listing and tracking these events throughout the year has two big advantages — you’ll be more likely to notice any trends in events or deviations that may merit a protocol or process change, and you won’t have to drive yourself half crazy trying to pull everything together at the last minute.