本文選題：臨床試驗　切入點：臨床研究協(xié)調(diào)員　出處：《中國新藥與臨床雜志》2015年12期

【摘要】：臨床研究協(xié)調(diào)員(CRC)在完成高質(zhì)量的臨床試驗中所扮演的角色越來越受到國內(nèi)藥物臨床試驗機構(gòu)及藥物申辦者的廣泛關(guān)注。CRC作為臨床試驗過程中的一員,發(fā)揮著協(xié)調(diào)和管理項目的重要作用。本文結(jié)合作者的工作體會,對我國CRC的來源、認證、培訓(xùn)和管理等方面進行分析,為建立適合我國國情的CRC管理體系提供參考。
[Abstract]:Clinical Research Coordinator (CRC) played in clinical trials completed high quality in the role of more and more domestic drug clinical trial institution and the drug sponsor's attention.CRC as a member of the clinical trial process, plays an important role in the coordination and management of the project. This paper combined with the author's work experience, the source of China's CRC certification, training and management and other aspects of analysis, provide a reference for the establishment of China's CRC management system.

【作者單位】： 南京醫(yī)科大學(xué)附屬無錫第二醫(yī)院藥物臨床試驗機構(gòu)辦公室;
【分類號】：R952
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本文編號：1721985