试验用体外诊断试剂规范化管理的探讨

摘要

This paper introduced the practice of Fuzhou Infectious Diseases Hospital in standardized management of in vitro diagnostic reagents for clinical trials including appointing reagents manager, providing special refrigerator for reagents storage, as well as the whole management process form reception, storage, obtainment, use and return of in vitro diagnostic reagents for clinical trials. These measures can ensure the clinical trials results scientific, accurate and reliable, and provide an important guarantee for the effectiveness and safety evaluation of in vitro diagnostic reagents for clinical trials.%为了保证临床试验结果科学、准确、可靠,本文阐述了我院临床试验专业组通过设置试剂管理员、配置试剂储存专用冰箱,以及对试验用体外诊断试剂的接收、储存、领取、使用和回收等各个环节进行规范化管理,为试验用体外诊断试剂的有效性和安全性评价提供重要保障.