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随着新药临床试验科学性和规范性的加强,国内越来越多的药物临床试验机构相继建立和完善了各自的质量保证体系。“三级质控”的管理模式近年逐步推广并在临床试验质量控制方面发挥了巨大的作用。院内质控作为临床试验监督管理的重要形式,对保证临床试验质量更具有举足轻重的作用。笔者根据多年进行院内质控的经验,探讨了临床试验质量控制的关键点,并提出建议以供参考。
With the clinical trial of new drugs to enhance the scientific and normative, more and more domestic drug clinical trial institutions have established and improved their own quality assurance system. “Three quality control ” management model in recent years and gradually promote the clinical trial quality control has played a huge role. Hospital quality control as an important form of clinical trial supervision and management, to ensure the quality of clinical trials play a decisive role. The author based on years of experience in hospital quality control, discussed the key points of clinical trial quality control, and make recommendations for reference.