藥物臨床試驗機(jī)構(gòu)是進(jìn)行藥物臨床試驗的主要執(zhí)行單位，藥物臨床試驗機(jī)構(gòu)的規(guī)范化管理及高效有序運行對確保高質(zhì)量完成新藥的臨床試驗具有重要作用。結(jié)合湖北省中醫(yī)院藥物臨床試驗機(jī)構(gòu)建設(shè)情況、藥物臨床試驗機(jī)構(gòu)資格認(rèn)定的準(zhǔn)備以及藥物臨床試驗機(jī)構(gòu)日常管理的實際情況，試述如何保障藥物臨床試驗機(jī)構(gòu)高效有序運行，以期為國內(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.