Applications that are missing a significant amount of required information, as outlined in HRP-308, or ancillary approvals required for the pre-review process to be completed, may be sent back to pre-submission. This will allow the study team to continue to edit the application and supporting documents without delaying the review process and without the possibility of the study reaching a deadline and being auto-archived. These applications are identified by the IRB Analyst early in the pre-review process. The analyst will contact the study team and work to schedule a consult to discuss any outstanding issues.
Sending Applications Back to Pre-Submission
February 11, 2022