Course Description

During monitoring visits, one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA serves as the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post-marketing labeling. This includes causality, expectedness/unanticipated, and other important concepts. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

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Learning Objectives

• Define safety concepts and reporting requirements
• Recognize the importance of verifying the subject baseline history
• Determine when to start and stop monitoring AEs
• Apply a detailed presentation of the source document verification process of AEs
• Manage challenges in monitoring AEs
• Determine appropriate credentialing for site AE evaluation of event relationship
• Describe the impact of monitoring on future product labeling
• Discuss reporting trends

Who Should Attend

• Device and Drug Study Clinical Research Associates
• Contract Clinical Research Associates
• Clinical Research Associate Managers
• Project Managers

Instructor

Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.