Adverse Event Processes

This course provides a detailed review of the basics and fundamentals of safety reporting during clinical investigations prior to market approval. It outlines the entire process, using practical examples and flowcharts to illustrate each mechanism of the safety processes step-by-step.

This course covers the following topics:

• Objectives of safety reporting
• Definitions of the different classifications of adverse events and device deficiencies according to ISO 14155: 2011 principles
• Roles and responsibilities of the following parties: sponsors, monitors, investigators and their teams, critical event committees, and data monitoring boards
• Reporting obligations of each party
• Summary of the national differences in safety reporting, i.e. the US, Europe, and Japan
• Type of reports
• Examples and exercises  of common errors
• Case studies of several real-life situations and step-by-step guidance on what to do as a monitor or sponsor