药物临床试验管理系统在临床实践中的应用效果  

Application effect of drug clinical trial management system in clinical practice

作　　者：余敏 刘巧[2] 蔡学琪 尹年珍 王志华 张永东[1,2] YU Min;LIU Qiao;CAI Xue-qi;YIN Nian-zhen;WANG Zhi-hua;ZHANG Yong-dong(Institute of Hospital Management, University of South China, Chenzhou 423000;Drug Clinical Trial Institution,Chenzhou No.1 People's Hospital, Chenzhou 423000, China)

机构地区：[1]南华大学医院管理研究所,湖南郴州423000 [2]郴州市第一人民医院药物临床试验机构,湖南郴州423000

出　　处：《临床医学研究与实践》2019年第25期185-186,共2页Clinical Research and Practice

摘　　要：目的分析药物临床试验管理系统(CTMS)在临床实践中的应用效果。方法分析我院引进的药物临床试验GCP平台管理系统功能特点,比较我院CTMS使用前、后项目审核周期、年立项审核数目及伦理上会审查周期。结果使用CTMS后,项目审核周期显著缩短,年立项审核项目数明显增加,伦理上会审查周期明显缩短(P<0.05)。结论药物CTMS在临床实践中的应用效果显著,能够提高临床试验的管理效率,有利于保证试验结果的真实性和准确性。Objective To analyze the application effect of drug clinical trial management system (CTMS) in clinical practice. Methods The functional characteristics of GCP platform management system for clinical drug trials introduced by our hospital were analyzed, and review cycle of project, the number of annual project approval and cycle of ethical review before and after using CTMS in our hospital were compared. Results After using CTMS, the review cycle of project shortened significantly, and the number of annual project approval increased significantly, the cycle of ethical review shortened significantly (P<0.05). Conclusion Drug CTMS has a remarkable application effect in clinical practice. It can improve the management efficiency of clinical trials, and is conducive to ensure the authenticity and accuracy of trials results.

关 键 词：药物临床试验管理系统 项目审核 伦理审查 

分 类 号：R95[医药卫生—药学]