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Developed by:
U-MIC
1
DOCUMENT REVIEW AND
FINALIZATION
at scheduled continuing review
Developed by:
U-MIC
University of Michigan IRB Collaborative
document review and finalization
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
Developed by:
U-MIC
informed consent
•
after subject
interaction and
intervention are
concluded, IRB no
longer reviews consent
documents at SCR
3
document review and finalization
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
Developed by:
U-MIC
4
document review and finalization
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
Developed by:
U-MIC
5
document review and finalization
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
Developed by:
U-MIC
6
document review and finalization
IRB review of supporting
documents at scheduled
continuing review
Developed by:
U-MIC
7
THANK YOU.
Brian Seabolt
IRBMED
Developed by:
U-MIC
8