Introduction to Surgical Trials: Adverse Events Reporting and Data and Safety Monitoring
摘要
In surgical trials, safety monitoring should be prioritized during each stage of the study to ensure potential treatment benefits outweigh harms to patients. Many regulatory bodies require reporting of adverse events (AEs), serious adverse events (SAEs), and unanticipated problems (UAPs). The following chapter defines these terms in the context of surgical trials and provides recommendations for identifying, documenting, and reporting each. The role of internal and external safety monitoring throughout trials, including Data Monitoring Committees or Data and Safety Monitoring Boards, is also described.