藥物臨床試驗(yàn)機(jī)構(gòu)是進(jìn)行藥物臨床試驗(yàn)的主要執(zhí)行單位，藥物臨床試驗(yàn)機(jī)構(gòu)的規(guī)范化管理及高效有序運(yùn)行對(duì)確保高質(zhì)量完成新藥的臨床試驗(yàn)具有重要作用。結(jié)合湖北省中醫(yī)院藥物臨床試驗(yàn)機(jī)構(gòu)建設(shè)情況、藥物臨床試驗(yàn)機(jī)構(gòu)資格認(rèn)定的準(zhǔn)備以及藥物臨床試驗(yàn)機(jī)構(gòu)日常管理的實(shí)際情況，試述如何保障藥物臨床試驗(yàn)機(jī)構(gòu)高效有序運(yùn)行，以期為國(guó)內(nèi)同行提供參考。

Drug clinical trial institutions are major drug clinical trial execution units, and the standardized management and the highly efficient and orderly operation of drug clinical trial institutions play an important role to complete the clinical trials of new drugs with high quality. Based on the construction of drug clinical trial institution in Hubei Provincial Hospital of Traditional Chinese Medicine, the accreditation preparation of drug clinical trial institution, and the daily management of drug clinical trial institution, the ensurance of the highly efficient and orderly operation of drug clinical trial institution was described, so as to provide the reference for the other drug clinical trial institution.