药物临床试验机构对临床试验项目质量控制工作的实践与思考

Practice and Reflection on the Quality Control of Clinical Trials in Drug Clinical Trial Institution

目的:梳理和分析临床试验机构对临床试验项目质量控制中发现的突出问题,探讨机构提高项目质量控制可采取的措施。方法:查阅和分析最新相关法律法规和指导原则,结合临床试验机构对试验项目质控工作及接受数据核查的实践经验,对临床试验中存在的突出问题做出梳理和分析。结果与结论:临床试验机构需提升对试验项目质量管理能力以顺应我国临床试验的发展与变革要求,可通过加强专职人员配备、结合质量控制标准操作规程的制定和切实执行和信息系统的建设等措施提高质控能力。

Objective: To sort out and analyze the prominent problems in the quality control of clinical trials and explore the feasible measures to improve quality control for clinical trial institutions. Methods: Consulting and analyzing the latest relevant laws,regulations and guidelines,and combining with our experience on the actual practice in the quality control and receiving data inspection from drug regulatory agency,we sorted out and analyzed the prominent problems in the quality control of clinical trials. Results and Conclusion: Clinical trial institutions need to improve the quality management ability to meet the requirements of development and reform of clinical trials in China. Strengthening the full-time staff,formulation and implementation of standard operating procedures( SOP) of quality control and the construction of information system are considered to be the effective methods to improve the quality control ability.