摘要
国家"十一五",863,973等项目的中医临床研究以多中心、地域广、研究样本量大为特点,为保证其科学性,必须进行严谨的质量控制。因中医临床研究不完全等同于新药临床试验,质量控制方法和内容则不能完全照搬药品临床试验管理规范(GCP)。在GCP基础上,总结了9个国家"十一五"科技支撑临床研究项目质量控制过程中应用的现场与远程交互的质量控制方法,并以研究时期为切入点,从研究初早期、研究实施期、研究结题前3期分别介绍了现场质量控制内容的侧重点及与远程质控的交互使用方法,以期为中医临床研究质量控制提供方法和思路。
Chinese medicine clinical research projects supported by the National Eleventh Five-Year Plan,the 863 Program,or the 973 Program are characterized by large samples,multi-center,wide area.In order to ensure its science,it is needed to strengthen quality control.Chinese medicine research is not exactly same as drug clinical trials.Therefore,the quality control can not be a copy of the contents of the Good Clinical Practices（GCP）.In this paper,remote-site interact quality control methods applied by nine national Eleventh Five-Year Plan supported clinical research projects were summed up based on GCP.It was focus on the research periods.On-site and the remote quality control interaction at the beginning,during the on-going,and just before the finish of the projects were described.
出处
《中国实验方剂学杂志》
CAS
北大核心
2011年第20期269-272,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
科学技术部国家"十一五"支撑计划项目(2006BAI0104212)
