The IRB has simplified the process of submitting staff-only modifications. While these forms are still required to be submitted to ensure the study staff lists in CLARA are accurate, they will no longer be “acknowledged” by the IRB. Instead, when you sign off on the form, it will appear in CLARA with a “completed” status. No further action needs to be taken on the form.
Even though the IRB will no longer review these forms, please ensure they are submitted timely to ensure CLARA accurately documents your study staff. Please also ensure that you update the actual CLARA staff list and don’t just list the changes in text response. Failure to keep the CLARA staff list current may result in a noncompliance finding.