A Dissertation Submitted to Guangdong University of Technology
for the Master’s Degree of Business Administration
Optimization of Clinical Trial Quality Management in
company M
Candidate: Xie Dongni
Supervisor: Prof. Tao Yi
May 2022
School of Management
Guangdong University of Technology
Guangzhou, Guangdong, P. R. China, 510006
摘要
摘要
临床试验质量是新产品注册成功的关键，也是国家药品监督管理局检查的重点。
从每年国家局对申请注册的医疗器械临床试验的检查结果可以发现现阶段临床试验的
质量普遍存在较多问题。申办者作为临床试验的发起者和管理者，是临床试验质量和
数据可靠性的最终责任人。申办者对临床试验全过程的质量管理以及确保临床试验的
真实性和合规性上负有不可推卸的责任。本研究以 M公司为研究对象，运用了文献
分析、案例研究、PDCA循环法和访谈法，从申办者的视角探讨如何有效提高临床试
验的质量管理。通过调研发现 M公司目前在临床试验质量管理中存在的问题有试验
方案设计不合理、试验数据质量不高、试验如期完成率低、试验文件质量达标率低、
核查活动中的不合格率高等。从全面质量管理理论的五大因素着手对问题原因进行分
析，发现产生问题的原因集中在人、料、法、环四个方面，体现在组织管理存在弊
端、质量管理缺乏培训、缺乏对文件质量的管理、质量评审制度不完善、质量控制制
度不足、纠正预防措施不足和质量管理意识薄弱。结合约瑟夫朱兰的质量管理理论和
全面质量管理理论从人、料、法、环四个因素优化质量管理，包括调整组织机构、完
善培训体系、完善文件质量管理、完善质量评审制度、强化质量控制制度、优化纠正
预防措施、强化全员质量意识，同时阐述保障优化方案的保障措施和预期效果。
本文认为建立高效沟通的组织机构，同时强调项目经理在临床试验项目中的重要
作用可以为临床试验高效运行奠定基础；完善的培训体系可以保障质量管理人员的个
人能力，确保质量活动的切实执行；标准化的临床试验文件质量管理能够有效保证文
件的质量；完善的质量评审制度推动临床试验质量管理体系的不断优化改进，对关键
节点的评审可以保证临床试验关键阶段的质量，同时配合标准化、全流程的质量控制
手段和可执行的纠正预防措施，能够有效的保障对临床试验全过程的质量管理；通过
提升全员的质量意识，提高对质量管理的重视程度，为临床试验质量提供了多一层的
保障。通过以上优化手段实现申办者对临床试验进行全员参与、全面性、全过程的质
量管理。
关键词：医疗器械；临床试验；质量管理
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广东工业大学硕士专业学位论文
ABSTRACT
The quality of a clinical trial is crutial to new product registration, which is also the most
important section that the National Medical Products Administration focuses on. Besides, the
results of annual random inspection of the medical device clinical trials revealed that there
were still multiple quality management issues in the clinical trials. As the initiator and
management of a clinical trial, the sponsor is the ultimate responsible person for the quality
and reliability of clinical trial data. Sponsors have inescapable responsibilities for the quality
management of the whole process in a clinical trial, as well as ensuring the authenticity and
compliance of clinical trials. This study takes M company as the object and attempts to explore
how to effectively improve the quality management of clinical trials from the perspective of
sponsors via literature analysis, case study, PDCA cycle method and interview method. The
current problems inthe quality management of clinicaltrials in Company M include
unreasonal protocol designation, low quality of clnical data, low on-scheduled completion rate
of clinical trial, low quality of clinical essential documents, high unqualified rate in audit
activities. Based on the theory of Total Quality Management, the major factors affecting the
quality are the five aspects, this thesis analyses the reasons from the above five aspects and
the results are shortcomingof organization structure, insufficience trainingfor quality
management employee, lack of quality management for essential documents, imperfection of
quality evaluation system, insuffictience in quality control system, insuffictience in corrective
and preventive action management and week awareness of quality management. On the basis
of problem analysis, combined with the knowledge of Joseph M. Juran’s Quality management
theory and Total Quality Management theory, the study is going to optimize the organizational
structure and quality management system from four main factors, including adjusting the
organizationalstructure, improvingthetrainingsystem, improvingdocumentquality
management, improving the quality review system, strengthening the quality control system,
optimizing the corrective and preventive action requirements, expounding the guaranteed
measures and expected results, and strengthen the quality awareness of all employees.
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