Serious Adverse Events (SAEs): What it is and How to Handle

Overview: When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.

Serious adverse events are defined by the FDA as "Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death." Although this definition seems clear, there are words within the definition itself that have to be understood in order to ensure compliance. Who is the initial reporter? What is an adverse experience? Is an adverse experience different or the same as an adverse drug experience? How do you know if a more severe form as occurred? Is death the SAE or is the cause of death the SAE? 

This webinar will help sort out all these issues and get you to a better understanding of what needs to be reported to who. 

Why should you attend: Regulations and guidance can be overwhelming and seem conflicting when it comes to handling serious adverse events, it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) and what can be handled by the investigator as non-reporting of events that are considered reportable can lead to issues related to non-compliance.

Areas Covered in the Session:

• ICH guidelines and Good Clinical Practice (GCP)
• Department of Health and Human Services (DHHS) guidance
• Food and Drug Administration (FDA) guidance
• Definitions
• Potential effects on consent and the protocol
• Examples
• Links to useful resources