We are submitting our final feasibility phase report to PCORI this week. We expect their review of the report to result in approval for full-scale.
We are about to submit the full scale central IRB application at Washington University. Sites are welcome to meet with their local IRB analyst to introduce the study with the current protocol and consent form, but there are no submission requirements yet.
For logistical purposes, we are scheduling pre-start up meetings with 5-6 sites at a time. We will be scheduling another set of meetings over the next 2 months.
