To start the presentation, click on this button

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. Developed by: U-MIC 1 CENTRAL IRBs Developed by: U-MIC University of Michigan IRB Collaborative Central IRBs Central IRB single IRB that provides review for multiple sites independent (sometimes called commercial)

o o o o o Chesapeake IRB Western IRB Schulman Associates IRB Quorum Review NCI CIRB institutional o o university IRBs hospital IRBs

Developed by: U-MIC 3 Central IRBs 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 o IRB Authorization Agreement (institutional IRBs with FWAs) Master Services Agreement (independent IRBs) Developed by: U-MIC 4 Central IRBs Fees Independent IRBs charge fee. o

o usually paid by sponsor Billing process varies based on Master Services Agreement. Institutional IRBs usually charge fee only for industrysponsored research. Developed by: U-MIC 5 Central IRBs Requesting use of central IRB eResearch Proposal Management (eRPM) o

PAF application o Create Clinical Trial Routing Form (CTRF). Specify central IRB. eResearch Regulatory Management (eRRM) o Complete Requesting Review by a Non-UM IRB application (ceding application). Developed by:

U-MIC reviewed by ancillary committees reviewed/acknowledged by UM IRB 6 Central IRBs 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 committees review decision to cede project

adverse event/ORIO o o o o related, serious AE at UM UaP (UPIRSO) at UM serious and/or continuing noncompliance determination regarding UM site project placed on hold or suspended termination Developed by: U-MIC 7 Central IRBs

Central IRBs Developed by: U-MIC 8 THANK YOU. Brian Seabolt IRBMED Developed by: U-MIC 9