What are Serious Adverse Events and How do I Handle SAEs?

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.

Serious adverse events along with their cousins, adverse events, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood. This session will make a distinction between nomenclatures and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).

Areas Covered in the Seminar:

• ICH guidelines and Good Clinical Practice (GCP).
• Department of Health and Human Services (DHHS) guidance.
• Food and Drug Administration (FDA) guidance.
• Definitions of serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems.
• Potential effects on consent and the protocol.
• Examples of events that are considered reportable.
• Links to useful resources.