A change in audit reviews

If you’ve ever been assigned an audit, you may have seen a form in CLARA called the assessment of noncompliance. IRB office staffers have been routinely completing that form as they prepare audits and audit responses for board review.

Well, like so many other things, that form dates from the “BC” (Before CLARA) era, and we think it has outlived its usefulness. Unlike its predecessor, CLARA makes it easy for office staff to write individual notes for each finding, and we find those notes to be more informative and easier to read than the one-size-fits-all form is. Therefore, IRB office staff will no longer complete the form and add it to the study file for audit reviews.

Please note we will continue to keep the form’s elements in mind as we review audits, and we will continue to write notes in CLARA addressing individual findings. The convened IRB also will continue making the same determinations regarding audits.