Begin a career in the rapidly expanding clinical research industry. In this seventh session of the series, we will examine adverse event reporting processes designed to ensure patient safety.
Upon completion of this course, you will be able to: differentiate between the types of adverse events (AE) and serious adverse events (SAE) encountered in clinical trials; explain AE reporting in the context of drug safety, regulations, implications for product labeling (e.g., boxed warnings), reporting requirements, and study discontinuation; discuss the implications of protocol deviations; and, examine the role of various clinical research professionals in ensuring timely AE reporting.
Attend only the sessions that interest you most, or register for all 12 sessions for the price of 10. Attend 10 sessions to receive a Professional Certificate of Completion in Clinical Research Foundations.