医疗机构临床试验质量控制标准实践研究

目的:建立机构内部的临床试验质量控制标准,规范临床试验质量控制工作.方法:根据质量控制实施阶段及侧重点,对质控进行分类;制定以项目启动质控细则及知情同意书、筛选入选表、研究者文件夹等单元模块质控细则,并依照已制定的质量控制标准实施质量控制.结果:制定以质控分类、质控标准细则、质控流程、质控问题判定为内容的临床试验质量控...

The Practice Rresearch on Clinical Trial Quality Control Standards

Objective:To establish internal clinical trial quality control(QC)standards and standardize clinical trial QC work.Methods:The QC standards were classified according to the implementation period and the key points of QC.The QC standards,including the project start-up rules,informed consent,screening list,researcher folder,etc.as the unit module QC rules,were formulated.And the implement of QC was in accordance with the established QC standards.Results:The clinical trial QC standards consisting of classification,standard rules,procedures,problem determination of QC were established.26 quality control inspections were carried out in accordance with the standards,and a total of 327 problems were found,of which 8 were main questions,87 were minor questions,and 232 were general questions,and no major problems were found.Conclusion:The established quality control standard of clinical trials has strong operability,can effectively standardize the quality control behavior of clinical trials,and has certain practical and reference value.