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Following up on an audit at continuing review time

If your study has been audited during the most recent review period, you may have to do some additional reporting at your next continuing review (CR). Audits frequently find protocol deviations that the IRB asks you to report at CR.

Help us confirm that you are meeting this reporting requirement. To do so, in your deviation compilation, please note which deviations were related to an audit, and give us the audit finding number. An extra column noting something was part of “ORC audit, finding 5, bullet 1” would help us differentiate these deviations from any other reportable deviations. It may also prevent a contingency asking

And remember — keep a running tally of deviations throughout the year, rather than try to find and list them all right before continuing review. You can add your audit-related findings to the list right after you get the IRB letter asking you to report at CR. The IRB has a handy tracking tool on its website you can use to track events and deviations all year. Click on the “Events and Deviations Tables” link to find it.