E02 - Research Plot Twists: Addressing and Expecting the Unexpected

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At first glance, the IRB’s most significant effort often seems to come during the initial review of a project—and ideally, everything proceeds smoothly from there. But research is dynamic, and unexpected challenges can arise. When they do, IRB review can become complex and demanding. This session will use discussion and case studies to provide practical guidance on handling protocol deviations, potential unanticipated problems, serious or continuing noncompliance, and other unforeseen issues that may emerge during a study.