摘要
借助中医药多中心随机临床试验的实施,探寻建立高效可行的质量控制方法,为提高中医药临床试验过程管理的质量提供参考。通过召集专家论证与会议研讨,在试验实施之前明确质控的方法和操作流程,如健全质量控制体系,明确管理人员及职责,制定全面详尽的标准操作规程,加强对研究者的培训,通过定期召开数据安全监查会议、发挥电子数据库的质量监管作用、加强二级监查和国际联合监查等探索质控的措施。通过采取一系列合理可行的措施,创新了质控管理模式,加快了入组速度,使方案实施更加规范,提高了临床试验的透明度,取得了较好的质控效果。为今后中医药临床科研"国际化"和"创新"管理提供了依据。
The aim of the study was to explore the feasible and efficient methods of quality control and improve the quality of clinical trials of Chinese medicine through the implementation of a multi-center randomized trial. The method of quality control and operating procedure, which were laid out before the implementation, were drew up through administration decision and conference. The authors took a series of measures, such as perfecting the system of quality control, clearing management and responsibility, establishing comprehensive sop and emphasizing training, calling DSMB conferences, cultivating the supervising function of electronic database and strengthening site monitoring. The series of measures were used and the effect was well. Through applying reasonable measures, quality management was innovated, recruitment was accelerated, plans were operated more regularly and transparency of clinical trials was improved. The study is to provide reference for internationalized clinical research and new management style of Chinese medicine.
出处
《现代中医临床》
2014年第3期23-26,共4页
Modern Chinese Clinical Medicine
基金
国家中医临床研究基地业务建设科研专项(No.JDZX2012037
No.JDZX2012044)
中医药行业科研专项(No.201107005)
关键词
临床试验
中医药
质量控制
监查
标准操作规程
clinical trials
Chinese medicine
quality control
monitoring
standard operation procedure
