Drug Safety: Adverse Event Reporting

This course introduces the reasons for tracking adverse events and serious adverse events in clinical studies, the importance of reporting adverse events and serious adverse events, and the steps that should be taken when reporting an adverse event.

After completing this course, participants should be able to:

  • Describe the role of the sponsor organization
  • Describe the role of the responsible contact person
  • Explain an interventional clinical trial
  • Describe the elements of a valid SAE report
  • Indicate why adverse events are collected
  • Define and differentiate between adverse events, serious adverse events, adverse drug reactions, serious unexpected associated adverse events, and suspected unexpected serious adverse reactions
  • Outline the correct timeline for reporting serious adverse events
  • Discuss adverse event and serious adverse event follow-up information in clinical trials
  • Explain the correct sequence of information flow in the serious adverse event reporting process
  • Identify who is responsible for what and when in the serious adverse event collection and reporting process
  • Describe the roles and responsibilities in the adverse event handling process
  • Describe the activities for handling adverse events/serious adverse events at the study site
  • Discuss different terminologies used to report adverse events in clinical trials
  • Describe the Medical Dictionary for Regulatory Activities (MedDRA) and how the hierarchy of terms is applicable through all phases of the development cycle
  • Discuss the Common Terminology Criteria for Adverse Events (CTCAE v.3) as outlined by the National Cancer Institute (NCI)

Our e-courses are only available for group and corporate-wide licenses. Pricing is based on the estimated number of users. Please contact us to learn more about incorporating the GxP and Regulatory Series into your corporate training program. We can also develop custom training solutions to meet your specific training needs.