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document review and finalization

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. at scheduled continuing review. review of supporting documents initial review

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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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