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document review and finalization

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document review and finalization

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  1. 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

  2. document review and finalization at scheduled continuing review Developed by: U-MIC University of Michigan IRB Collaborative

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

  4. recruitment materials • IRB reviews recruitment materials at SCR, if: • enrollment ongoing • eResearch renewal application section 1.1 • eResearch renewal application section 1.1.1 • 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 Developed by: U-MIC

  5. 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 1.1.1 • 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 Developed by: U-MIC

  6. multisite trials document review and finalization • 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 coordinated by another site UM IRB does not review documents once they are no longer in use at UM Developed by: U-MIC

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

  8. Brian Seabolt IRBMED thank you. Developed by: U-MIC

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