Risk-based Centralized Monitoring of Clinical Trials: A Statistical Approach

Time

Tue, Jun 25 11:45AM
T 10

Title

Risk-based Centralized Monitoring of Clinical Trials: A Statistical Approach

Abstract Summary

In order to assess the site performances and data quality, a list of risk factors were identified. Based on these factors, statistical indices were derived for qualified site. These indices give quality scores to a site for a variety of study parameters, such as adverse events, protocol deviation, subject dropout, screen failure, time to subject randomization, query, query response time, data entry delay, visit duration, misrandomization, and study medication compliance. For site performance, a matrix was created based using these indices and a final score is derived from the matrix to assess site performance. In addition, data quality was also assessed by statistical monitoring of critical endpoints.

Poster Presenter

Peng Yang
MSc,
Associate Director, Statistical Programming and Data Managment,
Santen Incorporated
United States

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