美国卫生系统药师协会临床试验药物管理指南关键点介绍

Key Point Introduction to ASHP Guidelines for the Management of Investigational Drug Products

规范临床试验机构试验药物管理是提高受试者安全性、确保试验数据准确与完整性的重要保证。美国卫生系统药师协会于2018年出台了《临床试验药物管理指南》,对临床试验药物管理的6个关键环节,即临床试验药房的意义及管理模式、存储基础设施、人员管理、文件管理、过程管理、监查工作等作了详细规定。我国目前尚缺乏较全面的关于临床试验药物管理的相关规范,该文对该指南的关键内容进行详细解读和介绍,以期为我国临床试验药物管理提供参考和借鉴。

Standardizing the management of experimental drugs in clinical trial institutions is an important guarantee to improve the safety of subjects and ensure the accuracy and integrity of trial data.American Society of Health System Pharmacists(AHSP)issued the Guidelines for the Management of investigational drugs products in 2018,which detailed the six key links in the management of clinical trial drugs,namely,the significance and management mode of clinical trial pharmacies,storage infrastructure,personnel management,document management,process management,and supervision.At present,there is still a lack of comprehensive regulations on the management of investigational drugs products in China.In this paper,the key contents of the guidelines are interpreted and introduced in detail,so as to provide references for the management of investigational drugs products in China.