我院药物临床试验机构质量控制的操作程序分析.PDFVIP

我院药物临床试验机构质量控制的操作程序分析 刘琳娜＊，关 波，李诗草，张 甜，张 琰（第四军医大学唐都医院药物临床试验机构，西安 710038） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2014）21-1934-03 DOI 10.6039/j.issn.1001-0408.2014.21.05 摘 要 目的：为提高药物临床试验质量，建立有效的药物临床试验机构内部质量控制体系提供参考。方法：对我院药物临床试 验三级质控体系的建设情况进行了描述、分析，同时对质控的关键环节和具体做法进行了回顾与分析，并提出体会。结果与结论： 药物临床试验机构建立良好运行的质量控制体系有赖于申办方/合同研究组织、研究者以及机构三方的共同努力，三者缺一不可； 同时，以项目组为一级质控、专业组为二级质控、机构办公室为三级质控的三级质控体系作为临床试验质量监管的重要形式，能够 有效解决目前临床试验中存在的问题，提升药物临床试验的质量。 关键词 药物临床试验；机构；质量控制；三级质控体系 Operation Procedure Analysis for Quality Control Management of Clinical Trial Institution in Our Hospital LIU Lin-na，GUAN Bo，LI Shi-cao，ZHANG Tian，ZHANG Yan（Pharmaceutical Clinical Trial Institution，Tang- du Hospital，Fourth Military Medical University，Xi’an 710038，China） ABSTRACT OBJECTIVE：To provide reference for improving the quality of pharmaceutical clinical trials and establishing effec- tive internal quality control system of clinical trial institution. METHODS：The construction of tertiary quality control system was explained and analyzed. Furthermore，the key points and practical methods for quality control were reviewed and analyzed，and the experience was put forward. RESULTS CONCLUSIONS：The establishment and excellent operation of the quality control system of drug clinical trials depends on sponsor/CRO，investigator and the institution to work together. As an important form of quality control of clinical trials，tertiary quality control management mode，i.e. project team as first level of quality control，professional group as second level and institutions and office as third level，plays an important role on solving the problems in clinical trials and can elevate the quality of clinical trials. KEYWORDS Pharmaceutical clinical trials；Institution；Quality control；Tertiary quality control system 一个新药从研发到最终用于临床需要经过数个环节，包 1.1 项目的申办方/CRO