对加强药物临床试验院内质量管理的探讨

Study on the Improvement of Quality Management for Clinical Drug Trials in Hospital

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。

OBJECTIVE： To provide reference for the improvement of quality management of clinical drug trials data. METHODS： The quality management of clinical drug trials in China was analyzed, and the construction of quality control system of clinical 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 trials 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.