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在非临床安全性评价中根据GLP建立和管理资料档案是很重要的一个方面。现从资料档案保存机构的硬件设施、档案管理中各方人员的职责、资料档案的管理程序和应注意问题4个方面介绍了资料档案管理的相关规定和经验。
The establishment and management of data files under GLP in non-clinical safety evaluation is a very important aspect. The relevant provisions and experiences of data archives management are introduced from the following four aspects: the hardware facilities of data archiving institutions, the responsibilities of personnel in archives management, the management procedures of data archives and the issues to be noted.