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Introduction to Reporting. The Report Form is used to submit problems, events, and information to the IRB for review. Examples of problems or events include the following:Unexpected, related adverse eventsDeviationsAdverse device effectsBreaches of confidentiality or privacyExamples of info
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1. Making Non-Compliance Determinations Gerald Treiman, IRB Chair
John Stillman, IRB Director
Maureen Brinkman, IRB Administrator
Ann Johnson, IRB Administrator
2. Introduction to Reporting The Report Form is used to submit problems, events, and information to the IRB for review.
Examples of problems or events include the following:
Unexpected, related adverse events
Deviations
Adverse device effects
Breaches of confidentiality or privacy
Examples of information include the following:
DSMB reports
New information about the study that does not require and amendment
Complaints from participants
Warning or determination letters
3. The Report Review Process There are 3 levels of review that may occur: Administrative review – conducted by Maureen Brinkman Starting point for all report forms EXCEPT adverse events Subcommittee review – conducted by Ingrid Nygaard, Chris Stock, or Dennis O’Rourke Starting point for adverse events Convened board review
