Making Non-Compliance Determinations

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