临床试验“三级质控”管理模式的实践与思考

Practice and thought for " tertiary quality control" management mode of clinical trails

新药临床试验质量是药品上市后安全有效的保障。加强新药临床试验监督管理,对提高新药临床试验质量具有重大意义。"三级质控"管理模式可有效解决目前新药临床试验监查中存在的问题,使药物临床试验质量得到进一步提高。

The quality control of new drug cilnical trial is the effective guaranty for the pharmaceutical safety and effective after available on market. Enhancing the inspection and quality control of new drug clinical trials provide the crucial importance to achieve a persistent profitable standard. ＂ tertiary quality control＂ management mode can effectively solve the problems meanwhile existing in the inspection of new drug clinical trial and simultaneously elevate the quality of clinical trials.