The different kinds of prereview

I’ve gone into CLARA, I’ve checked the “history” tab for my new submission that I completed a couple of days ago, and the tab shows the study is in prereview. So the IRB already has my study and I should be hearing from the IRB in a few days, correct?

Well, not exactly. CLARA is the submission system for used by several institutional offices overseeing research on campus, not just the IRB. In fact, the IRB is the last place most studies are sent after entry into CLARA. When the CLARA system shows a study is in “prereview,” the project is still in the process of being looked at by one of the offices that sees it before the IRB does. These can include the legal office, the Office of Research Regulatory Affairs, or budget and coverage. “ACH Prereview” is another possibility, which means the study is undergoing institutional review at Arkansas Children’s Hospital and hasn’t come to the IRB yet. Only when the History tab shows a study is in “IRB Prereview” has a project actually arrived at the IRB office.

Why is the IRB last in this process? The IRB must have final versions of study materials available for review, and the other prereviews can lead to changes in study documents. Only once those reviews are complete will the IRB look at a study.