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药物临床试验机构是研究者安全、有效实施药物临床试验的重要保障。加强对药物临床试验机构的管理,对提高新药临床试验水平具有重大的意义。《药物临床试验机构资格认定办法(试行)》强调了药物临床试验机构的重要性和必要性。本文以我中心药物临床试验机构管理为例,结合传染病专科医院特点,从组织结构、人力资源、财务、资产和关键环节管理等方面探讨管理对策。
Drug clinical trial institutions is an important guarantee for researchers to carry out clinical trials of drugs safely and effectively. Strengthening the management of drug clinical trial institutions is of great significance to improving the clinical trial level of new drugs. The Measures for the Accreditation of Drug Clinical Trial Institutions (Trial) emphasize the importance and necessity of drug clinical trial institutions. This article takes the management of clinical trial institution of our center as an example, and discusses the management countermeasures from the aspects of organizational structure, human resources, finance, assets and key links in combination with the characteristics of infectious disease specialist hospitals.