药物临床试验质量控制创新管理模式探索

Exploration of innovative management system for quality control in drug clinical trials

药物临床试验是一个复杂的工程,其中间环节多、时间跨度长、过程繁琐、观察指标多、记录内容细致。为保障试验实施过程规范化、监管部门数据核查时可溯源,本文从试验药物、生物样品集中管理,现场管理组织(SMO)优选,SMO闭环质量抽查,项目全程管理,数据实时记录和质控,临床研究监查员系统性监查和质控前置预设等方面,介绍本机构持续改进所形成的一套符合临床试验质量实时质控的创新管理模式,旨在为广大药物临床试验机构加强临床试验质量控制,提高临床试验质量提供参考。

Clinical trial is a complicated project with many intermediate links,long time span,tedious processes,many observation indicators,and detailed records.In order to ensure the standardization and regulatory data verification traceable,this study introduced a set of innovative management mode,based on the centralized management of clinical trial drugs and biological samples,site management organization(SMO)optimization and elimination,SMO closed loop quality inspection,the project whole-process management,the data real-time recording and quality control,systematic inspection of clinical research associate,quality control pre-set,formed by the continuous improvement of our institution that conforms to the real-time quality control of clinical trials.The purpose of study is to provide reference for drug clinical trial institutions to strengthen clinical trial quality control and improve clinical trial quality.