基于风险的药物临床试验方案偏离交互管理模式探讨

目的 探讨药物临床试验机构基于风险的药物临床试验方案偏离交互管理模式建立.方法 通过对国内外现行法规以及药物临床试验机构对于药物临床试验方案偏离管理现状梳理,对方案偏离定义、常见表现形式、发生主体、管理模式缺陷进行分析,提出利用基于风险、基于信息化、量化风险值进行伦理委员会办公室及机构办公室交互协作新型方案偏离管理模式...

Discussion on the interactive management mode of drug clinical trial protocol deviation based on risk

Objective To discuss the establishment of interactive management model from risk-based drug clinical trail’s protocol deviations(PD)in drug clinical trial institutions.Methods By sorting out the current domestic and international regulations and drug clinical trial institutions’management of protocol deviations,analyzing the definitions,common manifestations,occurrence parts,and management model defects of the trials,proposing to use risk-based,information-based,and quantitative risks value as a new scheme of interactive cooperation management model of PD between the ethics committee office and the drug clinical trial institution office.Results Establish a sustainable improvement plan of PD early warning management model under a risk-based information system.Conclusion The new management model reasonably solves the current shortage of human resources and resources in medical institutions.Actively establishes a dynamic quality management system under the risk model,strengthens the capacity building and management functions of drug clinical trial institutions,and make a contribute to the sustainable and healthy development of drug clinical trials.