Adverse Event and Information Reporting to the IRB: Policy Updates in Monitoring for Unanticipated Problems and Non-Comp - PowerPoint PPT Presentation


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OVERVIEW. A Discussion of Potential Risks in ResearchAdverse Event ReportingProtocol DeviationsFAQ. Risks in Research. The IRB reviews protocols in recognition of the fact that:Risks are inherent to clinical research, andEvery PI needs to have a plan to:Manage and mitigate the known risksCommunicate known risks to research subjects accurately.

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