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Premarketing Clinical Trial Safety


This module provides a framework and details around drug safety requirements for clinical trials for drugs in humans. It includes information about safety and ethical safeguards to protect human subjects in clinical trials including informed consent, institutional review boards and independent ethics committees, and data safety monitoring boards. Individual case reporting and aggregate reporting requirements are examined in detail. A case study with exercise questions provides real-world context and enables the learner to see how the concepts presented in the module apply in real life. Finally, the module will discuss risk assessment and the premarketing review of safety data in a marketing application.

The module takes an average of 4 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program.

"Excellent module! Well organized and explained. I loved the interactive elements in the module to entertain and reinforce learning!" 

-Previous Participant

Featured topics

  • Informed Consent
  • Institutional Review Boards and Ethics Committees
  • Data and Safety Monitoring Boards
  • Individual Case Reporting
  • Aggregate Reporting
  • Clinical Trial Safety Case Study Activity
  • Risk Assessment
  • Premarketing Review of Safety Data in a Marketing Application

Who should attend?

This module is designed for professionals involved in:

  • Drug safety and pharmacovigilance
  • Clinical research and development
  • Quality assurance and compliance
  • Regulatory affairs
  • Medical affairs
  • Marketing

Learning objectives

Upon completion of this module, learners should be able to:

  • Discuss the purpose of  informed consent in clinical trials
  • Identify the elements of informed consent in clinical trials
  • Define the roles of institutional review boards, ethics committees, and data and safety monitoring boards in clinical trials
  • Explain premarketing individual case reporting and aggregate reporting requirements
  • Discuss risk assessment in clinical trials
  • Explain the premarketing review of safety data in a marketing application

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