2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. CENTRAL IRBs Developed by: U-MIC University of Michigan IRB Collaborative

4. Central IRBs 3 Developed by: U-MIC Central IRB single IRB that provides review for multiple sites independent (sometimes called commercial) o Chesapeake IRB o Western IRB o Schulman Associates IRB o Quorum Review o NCI CIRB institutional o university IRBs o hospital IRBs

5. Central IRBs 4 Developed by: U-MIC Ceding via agreement that delineates responsibilities between entities transfers IRB oversight only o Other regulatory oversight and workflows remain at UM. UM IRB relinquishes certain responsibilities. Central IRB assumes certain responsibilities. o IRB Authorization Agreement (institutional IRBs with FWAs) o Master Services Agreement (independent IRBs)

6. Central IRBs 5 Developed by: U-MIC Fees Independent IRBs charge fee. o usually paid by sponsor o Billing process varies based on Master Services Agreement. Institutional IRBs usually charge fee only for industry-sponsored research.

7. Central IRBs 6 Developed by: U-MIC Requesting use of central IRB eResearch Proposal Management (eRPM) o Create Clinical Trial Routing Form (CTRF). PAF application o Specify central IRB. eResearch Regulatory Management (eRRM) o Complete “Requesting Review by a Non-UM IRB” application (ceding application). reviewed by ancillary committees reviewed/acknowledged by UM IRB

8. Central IRBs 7 Developed by: U-MIC Project remains active in eResearch scheduled continuing review o to record key data elements about study conduct at UM  e.g., enrollment numbers amendments o changes in UM study team o change that may impact  ancillary committee’s review  decision to cede project adverse event/ORIO o related, serious AE at UM o UaP (UPIRSO) at UM o serious and/or continuing noncompliance determination regarding UM site o project placed on hold or suspended termination

9. Central IRBs 8 Developed by: U-MIC Central IRBs

10. THANK YOU. Brian Seabolt IRBMED 9 Developed by: U-MIC