对加强药物临床试验院内质量管理的.pdfVIP

对加强药物临床试验院内质量管理的探讨 ＊ # 卢 芳 ，陈仲林，顾广羽，韩宝惠，李颖则，姜丽岩（上海市胸科医院，上海市 200030） 中图分类号 R95 文献标识码 C 文章编号 1001-0408（2011）45-4235-03 摘 要 目的：为切实提高药物临床试验数据的质量提供参考。方法：分析我国药物临床试验的质量管理现状，探讨我院药物临 床试验质量控制体系的建设情况并提出体会。结果与结论：我国药物临床试验的质量管理在机构和申办者2方面还存在诸多问 题。我院通过探索，建立了药物临床试验质量控制体系，通过采取专人负责、专项管理、定期检查、全程动态监控等措施，将质量管 理工作贯穿于整个药物临床试验过程中。在药物临床试验中，主要研究者保证投入足够的时间和精力、标准操作规程及时更新和 培训、规范原始文件的填写等是质量控制中比较重要的几个方面。 关键词 药物临床试验；质量管理；质量控制体系；医院 Study on the Improvement of Quality Management for Clinical Drug Trials in Hospital LU Fang ，CHEN Zhong-lin ，GU Guang-yu ，HAN Bao-hui ，LI Ying-ze ，JIANG Li-yan （Shanghai Chest Hospi- tal ，Shanghai 200030，China ） ABSTRACT OBJECTIVE ：To provide reference for the improvement of quality management of clinical drug trials data. METH- ODS ：The quality management of clinical drug trials in China was analyzed ，and the construction of quality control system of clini- cal drug trials in our hospital was investigated to provide experience. RESULTS CONCLUSIONS ：There are various problems about institution and bidder in the quality management of clinical drug trials in China. The quality control system of clinical drug tri- als in our hospital has been established. The quality management is carried out throughout clinical drug trials by being in charge of persons specially appointed ，special management ，regular checks ，whole dynamics monitoring ，etc. Important aspects of clinical drug trial are major researchers devoting enough time and energy ，standardizing and updating operation procedure and training ， standardizing the writing of original documents and so on. KEY WORDS Clinical drug trials ；Quality management ；Quality control system ；Hospital 划表中的学时数仅供参考），但至少应完成培训大纲及年度培 此，建立PIVAS 已经成为医院药学发展的方向之一。但自从 训计划要求的项目，并且有记录及考核