确保数据质量

D. Coleman, J. Wiles
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引用次数: 0

摘要

一项典型的III期临床试验平均招募400名患者,每个患者有100个或更多的病例报告表(CRFs),每个报告表依次包含大约15个数据字段。简而言之,这代表了至少600,000次出错的机会!数据质量的目标是确保临床信息数据库准确地反映调查人员的观察、测量和实验室测试结果,统计学家从中做出关键决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Ensuring quality data
Defining Quality A typical Phase III clinical trial enrolls, on average, 400 patients – each having 100 or more Case Report Forms (CRFs), which in turn contain approximately 15 data fields each. In short, this represents at least 600,000 opportunities to make an error! The objective of data quality is to ensure that the database of clinical information, from which statisticians reach critical decisions, accurately reflects investigators’ observations, measurements and laboratory test results.
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