During monitoring visits one of the most important and impacting activities that a CRA performs is the source document verification of Adverse Events (AEs). The CRA is 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. The safety regulatory and ICH definitions will be reviewed and applied to the monitoring process. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.
- 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
- Verify appropriate credentialing for site AE evaluation of event relationship
- Appreciate the impact of monitoring on future product labeling
- Discuss reporting trends
- Device and Drug Study CRAs
- Contract CRAs
- CRA Managers
- Project Managers
Jackie Stader, C.O.T., C.C.R.C.
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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.