关键词：临床试验；监测；数据库管理；委员会
摘 要：The objectives of this document are: 1) to determine the extent to which Data and Safety Monitoring Boards (DSMBs) met National Institutes of Health (NIH) guidance in carrying out their responsibilities to monitor trials and 2) to identify any challenges to DSMB effectiveness. Clinical trials test experimental drugs, devices, and treatments to determine whether they are safe and effective. DSMBs are advisory committees of experts responsible for reviewing ongoing trial data. They play a unique role in ensuring the safety of human subjects enrolled in trials. They also play a critical role in ensuring the merit of these trials. To carry out these functions, DSMBs must have direct access to unmasked data during the course of a trial, meaning that members know which subjects are in which treatment group--something the researchers and subjects themselves do not generally know. NIH requires DSMBs to monitor all Phase III multi-site trials that entail potential risk.