During pre-review of an initial application, IRB analysts will enter reviewer comments and send these to the study team to address. When the application is with the study team to address these pre-review comments, the study is in the “Issues Pending” state. Beginning March 26th, initial applications (only) that have been in the Issues Pending state for 45 days will now auto-route to Pre-submission, instead of being withdrawn by the IRB, thereby eliminating the need to submit a request to reactivate. Study teams will receive reminders at 15 and 30 days prior to the study being routed to Pre-submission and a deadline reached notification at day 45. This is only being implemented for the Non-Protocol-Based Application (nPBA), Protocol-Based Application (PBA), and Single IRB (sIRB) Application.
When in the pre-submission state, study teams can continue to work on the application and address IRB comments that have already been entered. When ready, study teams will resubmit the application. The IRB staff will then continue their review process. If significant changes have been made to the study design, re-review by scientific review committees may be appropriate.
Changes of Protocol in Issues Pending currently have 90 days prior to requiring reactivation. As of March 26th, this is being shortened to 45 days. Study teams will continue to receive email reminders.
**As of March 26th, any initial applications in Issues Pending for 45 days or longer will be automatically routed to pre-submission.**