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.

DOCUMENT REVIEW AND FINALIZATION Developed by: U-MIC University of Michigan IRB Collaborative at scheduled continuing review

document review and finalization 3 Developed by: U-MIC review of supporting documents initial review scheduled continuing review (while documents are in use) recruitment after enrollment ends, IRB no longer reviews recruitment materials at SCR informed consent after subject interaction and intervention are concluded, IRB no longer reviews consent documents at SCR

document review and finalization 4 Developed by: U-MIC recruitment materials IRB reviews recruitment materials at SCR, if: enrollment ongoing eResearch renewal application section 1.1 eResearch renewal application section IRB updates documents’ approval and expiration dates If enrollment has permanently ended X-DO NOT USE_ IRB does not review recruitment materials at SCR

document review and finalization 5 Developed by: U-MIC informed consent documents IRB reviews consent documents at SCR, if: subject interaction/intervention ongoing or planned eResearch renewal application section 1.1 eResearch renewal application section IRB updates documents’ approval and expiration dates If further study activities are limited to follow-up X-DO NOT USE_ IRB does not review recruitment materials at SCR

document review and finalization 6 Developed by: U-MIC multisite trials coordinated by another site UM IRB does not review documents once they are no longer in use at UM coordinated by the University of Michigan UM IRB may continue to review documents even after they are no longer in use at UM depends on UM’s role as coordinating site

document review and finalization 7 Developed by: U-MIC IRB review of supporting documents at scheduled continuing review

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