WORKSHEET External Reliance, Follow-On Submissions
This document is intended to be used as an aide for IRB Reliance Administrators on how to review follow-on submissions or additional information received after the initial authorization for external reliance is processed in Zipline (i.e., the application is in “Pending sIRB” state or beyond). It also addresses common issues with external study modifications and study updates
Change Notes
Add instructions for auditing Advarra studies; allow use of prepare and send letter function in Zipline for external modifications – 01.04.2024
Changes to instructions about modifying applications in Pending sIRB, finalizing updates, and completing data entry for external consent audits – 11.02.2023
Add information about process for requesting assistance from S&I Team – 03.02.2023
Newly implemented worksheet – 01.04.2023