目的:分析及评价某院药物临床试验不良事件监控质量.方法:对照不良事件监控的质量评分标准,调查2007-2013年结题的Ⅱ~Ⅲ期项目中不良事件监控的质量得分及各要素的年均得分率.并对2007-2013年发生的15例严重不良事件(SAE)监控情况进行分析.结果:总体上,某院药物临床试验不良事件监控质量得分及各要素得分率均呈现逐年增长的趋势.2011年某院针对不良事件的监控实施展开全面整改工作,整改前存在的问题主要集中在:启动会培训缺失或不完整、实验检查类不良事件收集的遗漏、SAE获知的滞后性、SAE报告表原件的遗失、不良事件源文件记录的缺失或不完整.通过完善规章制度、建立应急预案、强化伦理审查力度、强化试验前不良事件的预防措施、加强机构办公室及科室的监控力度等措施,某院不良事件的监控质量显著提高.结论:加强临床试验机构对不良事件的监控作用,依靠临床试验各部门的共同努力,不断完善安全性监控体系,才能提高临床试验的质量和水平.

OBJECTIVE To investigate monitoring quality of adverse events in clinical trials in our hospital.METHODS Phase Ⅱ-Ⅲ clinical trials completed from 2007 to 2013 in our hospital were investigated to calculate annual average score and individual monitoring item score for adverse events by referring to quality scoring criteria for monitoring adverse events. The monitoring conditions of 15 cases of serious adverse events (SAE) were analyzed.RESULTS Generally, the monitoring quality score of adverse events in clinical trials in our hospital, as well as the score rate of individual monitoring items, presented the yearly increasing trend. In 2011, a comprehensive rectification work was carried out to improve monitoring quality of adverse events. Primary problems before rectification focused on missing/incomplete at the beginning of training, absent collection of adverse event with experimental investigations, hysteresis of SAE report, loss of original SAE report form, missing/incomplete source record of adverse events. By improving rules and regulations, developing emergency plan, strengthening ethical scrutiny, strengthening the monitoring management of organization office and departments, monitoring quality of adverse events in drug clinical trials of our hospital was obviously improved.CONCLUSION Quality and level of clinical trials can only be improved by strengthening monitoring of adverse events in the clinical trial institution, relying on joint efforts in different departments and persistent improvement of safety monitoring system.