Change to the modification review process
Beginning January 3, 2017, ALL modifications submitted on studies with approved CLARA budgets will route through the Research Finance Team for review BEFORE they are sent to the IRB. What this means for investigators is that modification reviews and approvals may take a bit longer than they have in the past.
This new procedure pertains only to full modification forms, including those submitted in response to audits. It does NOT apply to staff-only modifications, which use a separate form. Reminder — PI changes require a full modification form and cannot be submitted on a staff-only modification.
Again, it is important to note that this review happens before, and completely independently of, the IRB’s review. So, if you submit a modification and are trying to find out about where it is in the review process, please start by checking its status in the History tab in CLARA. If the status shows that it is still in budget, please call the budget review staff directly and not the IRB, as the IRB office will not have received the modification yet and cannot help investigators with budget issues.
Please note that this change may lengthen the amount of time it takes to get modifications approved. Investigators facing a sponsor deadline for modification approval, or an approaching continuing review date, will want to keep that extra review time in mind when scheduling submissions.
If you have questions, please contact Cynthia Spinks, Research Finance Team Manager, at 501-526-4619 and email@example.com, or Jonathan Young, TRI Senior Project Manager, at 501-526-7984.