
Mapping your submission landscape: how many IRBs, how many studies, how many deadlines
Teaches the regulatory coordinator to conduct a submission landscape assessment, cataloguing every active study, its IRB, its deadlines, and its current regulatory status to make the aggregate workload visible.
The invisible workload
Here is something I have observed consistently across sites of every size: the aggregate regulatory submission workload is almost always invisible to the people responsible for managing it. Each coordinator knows their own studies' deadlines. The principal investigator has a vague sense that "things are busy." The department administrator sees invoiced IRB fees but has no idea what they represent operationally. And the regulatory coordinator -- the person who should have the clearest view of the entire landscape -- often starts the job with no systematic way to see it.