临床试验逻辑核查的分类及应用

Classification and application of logic check in clinical trail

临床试验数据的清理是临床试验过程中非常重要的环节,完整、清洁的数据才能用于统计分析。本文旨在讨论临床试验数据清理过程中数据核查计划的撰写及逻辑核查的分类等,并进一步讨论近年来临床试验数字化趋势对数据的采集及清理可能带来的影响。

Clinical trial data cleaning is very important in the process of clinical trials. Only integrated, cleaned data can be used for statistical analysis. The purpose of this paper is to discuss the compose of Data Verification Plan and the classification of logical verification in the process of data cleaning, and in further to discuss the possible influence on data collection and cleaning by the trend of clinical trial digitization in recent years.