[關(guān)鍵詞]
[摘要]
上海中醫(yī)藥大學(xué)附屬曙光醫(yī)院臨床試驗機(jī)構(gòu)在臨床試驗藥物中心化管理的建設(shè)中,適時推進(jìn)信息化管理系統(tǒng)的應(yīng)用,加強(qiáng)臨床試驗用藥物的規(guī)范化管理,不斷完善和健全試驗藥物管理流程上具有可操作性標(biāo)準(zhǔn)操作規(guī)程,提升臨床試驗整體管理水平,保證臨床試驗的質(zhì)量。通過介紹該院的經(jīng)驗,為建設(shè)試驗用藥物的規(guī)范化管理模式提供借鑒及參考依據(jù),對構(gòu)建規(guī)范化、科學(xué)化的臨床試驗用藥物中心化管理具有重要的現(xiàn)實意義。
[Key word]
[Abstract]
Under the construction of the centralized management in clinical testing facility by Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, they timely advance the application of information management systems, strengthen the standardization management of clinical trials using drugs, constantly improve and perfect test drug management process operable standard operating procedures, enhance the overall management of clinical trials, and ensure the quality of clinical trial. Through introducing this hospital's experience, they provide reference and reference basis to construct an experimental drugs' standardization of the management mode, to construct a standardized and scientific clinical trial with medicine centralized management with great importance.
[中圖分類號]
[基金項目]
上海市中醫(yī)藥事業(yè)發(fā)展三年行動計劃項目(ZY3-CCCX-2-1003)