What is a serious adverse event (SAE)?

A serious adverse event (SAE) is defined as an occurrence that is life-threatening or requires hospitalization, among other criteria. This classification is important in clinical trials and research studies because it helps ensure participant safety and regulatory compliance. An SAE might include events that result in death, are life-threatening, require significant medical intervention, or lead to lasting disability.

This definition is grounded in rigorous safety monitoring processes essential for protecting participants in research studies. By identifying and reporting SAEs, researchers can take prompt actions to address safety concerns, ensuring that risks are mitigated, and that participant welfare is prioritized throughout the study. In contrast, minor events that do not require intervention or that represent routine side effects are not classified as serious adverse events, as they do not pose significant risks to participants. Additionally, events that occur simply during data collection do not inherently imply seriousness unless they meet specific criteria that suggest a substantial risk to the participant's health or well-being.