4186 Single IRB and the CTSI: Liaison Model for the IRB Reliance Process

At study start-up, the sIRB PM can handle complicated communications among sites and the IRB at the same time the lead site is responsible for many other administrative tasks related to start-up. By absorbing the workload of IRB approval for multiple sites, the sIRB PM provides the lead site more capacity to handle other essential tasks. The sIRB PM translates new terminology and facilitates processes that are new for sites. IRB staff by allowing them to fulfill their duties of screening and review while leaving some of the reliance organization to the sIRBPM. Lead PI by allowing them to focus on conducting the research instead of the many administrative tasks required for single IRB review. Participating sites by having a liaison to enter their amendments and reportable events into an otherwise closed IRB software system. All parties by having the sIRB PM manage document organization, storage, and distribution study-wide. DISCUSSION/SIGNIFICANCE OF IMPACT: The CTSI sIRB PM role effectively shifts administrative work caused by the sIRB mandate by merging research coordinator experience with regulatory experience while building upon an existing strong relationship with the HRPP. Future focus is on process education, standardizing pricing structure, and ensuring sufficient budget support in grants.