Source Data Verification by Statistical Sampling
*Vlad Dragalin, Aptiv Solutions  Andrew Peter Grieve, Aptiv Solutions 

Keywords: SDV, acceptance sampling, outgoing quality, acceptable quality level

Statisticians have long been aware that 100% source data verification is unnecessary and wasteful of resources. AS a society we have nearly 100 years of experience in the use of statistical approaches to quality management and yet their use in monitoring data quality in clinical trials has been limited. In this talk I look at a particular implementation of a statistical approach to data quality and concentrate on the important aspect of data quality post-inspection.