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This module is part of the DIA Drug Safety eLearning Program. The Premarketing Clinical Trial Safety module provides a framework and details around drug safety requirements for clinical trials for drugs in humans. This module provides information about safety and ethical safeguards in place to protect human subjects in clinical trials: informed consent, institutional review boards and ethics committees, and data safety monitoring boards. It will provide the details on individual case reporting and aggregate reporting requirements. Finally, the module will discuss risk assessment and the premarketing review of safety data in an application.

Featured topics

  • Informed Consent
  • Institutional Review Board and Ethics Committee
  • Data and Safety Monitoring Boards
  • Individual Case Reporting
  • Aggregate Reporting
  • Risk Assessment
  • Premarketing Review of Safety Data in an Application

Who should attend?

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

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 an application

This module takes an average of 4 hours to complete.

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