药物临床试验机构的管理原则与要素

Management principles and elements of drug clinical trial institutions

药物临床试验机构的管理体系涉及医疗机构、药物临床试验机构办公室、临床专业科室和研究人员。医疗机构需建立药物临床试验的组织管理体系,相关职能部门依规对研究利益冲突、合同、财务、试验用药品、实验室、源文件、质量与培训等进行管理。药物临床试验机构办公室负责对临床试验项目的行政管理、质量管理、以及文件与信息管理。临床专业科室和研究人员应将受试者的权益、健康和安全作为临床试验的首要关注问题,遵循伦理委员会批准的方案开展研究。

The management system of drug clinical trial institutions involves the medical institu- tions, clinical trial institution office, clinical depart- ments and investigator. Medical institutions should establish management system for drug clinical trial, and the relevant functional departments to manage conflicts of interests in research, contracts, finance, investigational drugs, laboratory, source documents, quality, training and etc. Drug clinical trial institu- tion offiee is responsible for the administration,quality management, document and information management of clinical trial projects. Clinical departments and investigator conducting clinical trials should primarily pay attention to the rights, safety and well-being of subjects, and comply with the re- search protocol approved by Ethics Committee.