Quantifying Gains in Data Quality for Sampling Plans Used in Clinical Trial Monitoring

被引：0
作者：
Dennis W. King
Melynda Hazelwood
机构：
[1] STATKING Consulting,
[2] Inc.,undefined
来源：
Drug information journal : DIJ / Drug Information Association | 2003年 / 37卷
关键词：
Data quality; Data management; Quality assurance; Continuous sampling plans; Clinical monitoring;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Clinical study monitoring is the first level of quality assurance checks on clinical trials data. The clinical study monitor goes to the study site and compares the case report forms to the source documents. Because some clinical trials are very large, the monitor may not be able to do a 100% check of all case report forms versus their corresponding source document. This paper will examine three possible sampling plan scenarios for monitoring case report forms in large studies.
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页码：135 / 141
页数：6
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