摘要
该文对临床药物试验机构办公室加强药物临床试验规范化管理的重要性进行了探讨,结合机构办公室药物临床试验管理的现状,分析了机构办公室加强药物临床试验规范化管理的实践策略,加强人员管理,逐步完善制度标准建设,强化过程管理,提高机构办公室的药物临床试验规范化管理水平和效率。
The article discusses the importance of strengthening the standardized management of drug clinical trials in clnical drug trials institutional offices,combined with the current situation of drug clinical trial management in institutional offices.The practice strategies of institutional offices to strengthen the standardized management of drug clinical trials,strengthen personnel management,and gradually improve the construction of system standards,strengthen process management and improve the standardized management level and efficiency of drug clinical trials in institutional offices are analyzed.
作者
张潇怡
张清荣
ZHANG Xiaoyi;ZHANG Qingrong(Office of Clinical Drug Testing Institute,Affiliated Hospital of Nantong University,Nantong,Jiangsu Province,226001 China;Department of Burn and Plastic Surgery,Affiliated Hospital of Nantong University,Nantong,Jiangsu Province,226001 China)
出处
《中国卫生产业》
2021年第33期33-36,共4页
China Health Industry
关键词
临床药物试验机构
办公室
药物
临床试验
规范化
管理
Clinical drug trials institutions
Offices
Drug
Clinical trial
Standardization
Management