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The Basics on Adverse Event Monitoring, Assessment and ...

Mary-Tara Roth, RN, MSN, MPH 1 The Basics on Adverse Event monitoring , Assessment and Reporting Overview of the Session Definitions Who regulates your study? Assessing AEs and UPs Reporting AEs and Ups The DSMP Case Examples (time permitting) 2 3 Why is this important? The 111 Criteria 45 CFR (OHRP) and 21 CRF (FDA) 4 Risks to subjects are minimized. Risks to subjects are reasonable in relation to benefits ( favorable risk benefit ratio). Selection of subjects is equitable. Informed consent process. Informed consent documentation. Adequate provision for monitoring the safety and data. Provisions to protect privacy/maintain confidentiality.

Relatedness/Causality Questions to ask in assessing causality are: • Is the AE a known reaction of the intervention? • Is the AE similar to other adverse events listed the investigator [s brochure or consent documents? • Has the AE occurred before in this study? • Is …

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