GCP 与临床试验质量管理.PDF

现代药物与临床 Drugs Clinic 第 28 卷 第 1 期 2013 年 1 月 • 63 • GCP 与临床试验质量管理 闫 妍，时 钢 天津市传染病医院，天津 300192 摘 要：通过研究天津市传染病医院在药物临床试验工作中具体实施《药物临床试验质量管理规范》（Good Clinical Practice, GCP ）的实际情况，探讨如何提高临床试验质量的具体措施。药品的安全、有效关乎人民的生命健康，因此药物临床试验的 科学性与真实性绝对不容质疑。做好药物临床试验工作必须保证试验质量，医院必须高度重视药物临床试验机构的发展，紧 紧把握工作重点，按照 GCP 及相关法律法规要求开展工作，建立完善且行之有效的管理体制，规范试验流程，加强对医护 人员的 GCP 培训及科研队伍建设，不断增强管理意识、提高药物临床试验质量。 关键词：GCP ；临床试验；质量管理 中图分类号：R951 文献标志码：A 文章编号：1674 - 5515(2013)01 - 0063 - 03 DOI :10.7501/j.issn.1674-5515.2013.01.018 GCP and quality management of clinical trial YAN Yan, SHI Gang Tianjin Infectious Disease Hospital, Tianjin 300192, China Abstract: To discuss how to improve the quality of clinical trials through the research on the implement of Good Clinical Practice (GCP) in the clinical trial in Tianjin Infectious Disease Hospital, Drug safety and efficacy are important for the health of human being, so there should be no doubt on the scientificity and truth of drug clinical trial. To make sure the drug clinical trial, test quality should be assured, hospital should attach the great importance to the drug clinical trial institution development, firmly grasp the work key, in accordance with the GCP and the requirements of relevant laws and regulations in order to carry out the work, build perfect and effective management system, make the test procedures standardized, strengthen the staff training and research, establish the GCP team building, continuously enhance the management consciousness, and improve the quality of drug used in clinical trial. Key words: GCP; clinical trial; quality management 药物临床试验是医院科研管理工作的重要组成 证药物临床试验过程的规范化，使其结果具有科学 [1] 部分。在新药研发过程中，临床试验是新药上市前 性、可靠性、准确性、完整性 。 必经的关键环节，同时也是药品监督管理部门进行