| 摘要: |
| 目的 制定药物临床试验各环节的质量管理要点，探求科学、有效的质量管理办法，保证药物临床试验过程的规范、可控，提高药物临床试验的质量水平。方法 通过文献查找并结合临床实践，以方案设计、项目审批、团队组成、过程管理、资料管理等方面为切入点，分析药物临床试验实施前、中、后期的质量管理要点，探讨解决问题，提高项目质量的管理方法及措施，建立质量保证机制。结果 做好药物临床试验的质量管理，应重点做好方案审核、人员管理、过程管理、用药管理、不良事件管理等工作，充分发挥研究者、机构办公室与伦理委员会等多方的作用，立项前严格审核，过程中时刻监控，结束后层层把关，从细节抓起，共同监督。结论 药物临床试验检验着药品有效性和安全性两大基本属性，是新药上市的最后防线。只有做好质量管理工作，采取有效机制尽量避免试验各环节的失误，才能有效保证临床试验过程的规范性和真实性，切实保障受试者的权益。 |
| 关键词: 药物临床试验 质量控制 质量保证 质控员 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.15.023 |
| 分类号:R951 |
| 基金项目: |
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| Quality Management of Each Link in Clinical Trials of Drugs |
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YANG Min1, CHENG Guohua2
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1.Office of Drug Clinical Trial Institution, Shantou Central Hospital, Shantou 515031, China;2.School of Pharmacy, Jinan University, Guangzhou 510632, China
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| Abstract: |
| OBJECTIVE To formulate the key points of quality management in each link of drug clinical trials, searching for scientific and effective quality management methods to ensure that the drug clinical trial process is standardized and controllable, and finally improve the quality of drug clinical trials. METHODS Through literature search and combined with clinical practice, starting from program design, project approval, team composition, process management, data management and other aspects, and analyze the key points of quality management before, during and after the drug clinical trials and discuss the methods to solve problems and improve the project quality, then establish the quality assurance mechanism. RESULTS A good job in the quality management of drug clinical trials, should focus on the program review, personnel management, process management, medication management and adverse event management work. The investigators, institutional offices and ethics committees should be start with the details and work together to make the quality management better, such as examine the approve projects strictly, monitor the process timely and ending check strictly. CONCLUSION Drug clinical trials it's the last line of defense for new drugs application for that it inspects the two basic attribute of drug efficacy and safety. Only to do the quality management well and adopt an effective mechanism to avoid mistakes in each link of the test, can effectively ensure the clinical trial process standardized and authenticity, and protect the rights of subjects practically. |
| Key words: drug clinical trial quality control quality assurance quality controller |
