中国循证医学杂志

中国循证医学杂志

促进我国临床试验数据管理规范化

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数据管理制度是影响临床试验质量的主要因素之一,数据管理制度设计包括指导委员会和数据管理委员会、数据采集、数据库、数据安全和监察、数据库锁定五个基本部分。本文介绍各部分的设计要点和方法,旨在帮助广大研究者了解临床试验数据管理制度,吁请广大研究者重视数据管理和了解管理制度的设计,帮助提高临床试验数据的管理水平。

Data management system is one of the major elements of quality of clinical trial. Development of data management system include a Steering Group and Data Safety and Monitoring Board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of five parts aims to help researchers to understand clinical trial data management system.

关键词: 临床试验数据; 数据管理; 规范化

Key words: Clinical trial data; Data management; Standardization

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