This module covers how to identify, assess, and report Serious Adverse Events (SAEs), outlining key criteria such as hospitalisation, death, life-threatening conditions, disability, and other medically important events.
This Rise module provides a clear, structured understanding of Serious Adverse Events (SAEs), a critical subset of AEs that must be reported to the sponsor immediately. Built with strong instructional design, it walks learners through how SAEs are identified, assessed, and managed in clinical trials. The module also explains the key criteria that define an SAE—such as hospitalisation, death, life-threatening conditions, significant disability, congenital anomalies, and other medically important events—ensuring clinical teams are equipped to recognise and report them accurately and compliantly.