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New IRB Policies Reporting Unanticipated Problems & Adverse Events Data & Safety Monitoring

New IRB Policies Reporting Unanticipated Problems & Adverse Events Data & Safety Monitoring. Susan Burner Bankowski, M.S., J.D. Chair, OHSU IRB. Old Policy. Everything and the Kitchen Sink. Lacks Context and Meaning Results in waste of resources & arbitrary revisions to consent form.

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Arbitrary revisions - PowerPoint PPT Presentation

New IRB Policies Reporting Unanticipated Problems &amp; Adverse Events Data &amp; Safety Monitoring

New IRB Policies Reporting Unanticipated Problems & Adverse Events Data & Safety Monitoring