Course Description

Adverse Event Processes

Course Description:

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

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Identify and categorize adverse events and device deficiencies
  • Classify, document, and report safety information during clinical investigations in compliance with international GCP requirements (ISO 14155: 2020) for medical devices
  • Take national differences into account

Who Should Enroll:

Monitors, clinical project managers and research associates, investigators, study coordinators, quality assurance associates and managers, regulatory and sales managers, marketing managers wanting to understand the general requirements of the safety reporting process, and clinical project managers from the pharmaceutical industry wanting to understand medical device adverse events, device deficiency definitions, and reporting requirements are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • Introduction to Good Clinical Practice (ID 42)
  • The Clinical Investigation Plan (ID 44)

Subject Matter Expert:
Danielle Giroud

77 min

Related resources:

Case studies:

Basic Account: € 218.00
Premium Account: € 163.00

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