国家科技支撑计划7个课题现场监查问题与建议

Suggestions on clinical trial quality control based on monitoring 7 projects of National Science and Technology Infrastructure Program

目的:加强多中心、大样本临床试验的质量控制和监查,以进一步提高临床研究质量。方法:以"十一五"国家科技支撑计划项目"重大疑难疾病中医药防治研究"的7个课题为例,说明了现场监查方法、常见问题,并提出建议。结果:课题总体研究质量优良,多数课题进展顺利。常见的问题包括病例报告表填写和修改不规范、研究药品管理有待加强、对合并用药记载不详细、研究数据上报不及时、一级和二级监查记录需要完善等。结论:建设过硬的研究团队非常重要;应慎重选择研究分中心,这对保证课题研究质量和进度至关重要;研究人员积极、认真、严谨的态度是关键;专家建议重视课题中期培训、进一步规范研究药品的管理、加强研究过程管理。

Objective：To enhance the quality control and monitoring of multi-central large sample clinical trails.Methods：Take 7 projects of National Science and Technology Infrastructure Program as examples to introduce the common problems and suggestions in quality monitoring.Results：Generally speaking,the quality is good,most projects of the program develop smoothly.The common problems are nonstandard filling and modification of CRF,deficiently description of drug combination,and slow electronic data report.In some unit,the management of research drug and quality monitoring recorder of basic level are weak.Conclusion：The organization and management of research team must be reinforced.The cooperative unit directly influences the progress and quality of clinical trial,so must be selected directly.The attitude to this study of cooperative unit and doctors is also very important.We should pay much attention to training and quality control during the research period,and improve the management of research drugs.