Ⅰ期临床试验用药物的规范化管理

通过介绍我院Ⅰ期临床试验研究室试验用药物管理制度和标准操作规程,为其他Ⅰ期药物临床试验机构提供参考。强调试验用药的科学管理是药物临床试验过程中重要环节,药品管理员及参与临床试验的研究人员在试验药物的接收、保存、发放、使用、回收、返还等各个环节中均应严格按照SOP规范执行操作,从而保证临床试验的质量,保障受试者的权益。

Standardized drug management in phase I clinical trial

This article was to give some advices on drug management for drug clinical trials by introducing investigational drug management system and standard operating procedures of phase I clinical trial center in our hospital. In order to ensure the quality of clinical trial and to protect rights of volunteers involved in clinical trial, the scientific investigational drug management, as a part of clinical trial, was of great importance. And all the drug administrators and researchers in clinical trials should operate strictly according to standard operation procedure during drug reception, storage, administration and recovery.