【摘要】 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。更多还原

【Abstract】 The archiving of records and materials generated during the course of a non-clinical health or environmental safety study is an important aspect of compliance with the Principles of Good Laboratory Practice(GLP).This article comprehensively reviews experience in respect of archive facilities,roles and responsibilities of related personalities,archiving procedure and attention.更多还原