A statistical approach to central monitoring of data quality in clinical trials

Venet, David; Doffagne, Erik; Burzykowski, Tomasz; Beckers, François; Tellier, Yves; Genevois-Marlin, Eric; Becker, Ursula; Bee, Valerie; Wilson, Veronique; Legrand, Catherine; Buyse, Marc

doi:10.1177/1740774512447898

A statistical approach to central monitoring of data quality in clinical trials

Venet, David

;

Doffagne, Erik

;

Burzykowski, Tomasz

;

Beckers, François

;

Buyse, Marc

;et.al.

(2012) Clinical Trials — Vol. 9, n° 6, p. 705-713 (2012)

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Authors

Venet, David
Author
Doffagne, Erik
Author
Burzykowski, Tomasz
Author
Beckers, François
Author
Legrand, CatherineUCLouvain
Author
Buyse, Marc
Author

Abstract

Central statistical monitoring can both optimize on-site monitoring and improve data quality and as such provides a cost-effective way of meeting regulatory requirements for clinical trials.

Affiliations

UCLouvainSSH/LIDAM/ISBA - Institut de Statistique, Biostatistique et Sciences Actuarielles

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Venet, D., Doffagne, E., Burzykowski, T., Beckers, F., Tellier, Y., Genevois-Marlin, E., Becker, U., Bee, V., Wilson, V., Legrand, C., & Buyse, M. (2012). A statistical approach to central monitoring of data quality in clinical trials. Clinical Trials, 9(6), 705-713. https://doi.org/10.1177/1740774512447898 (Original work published 2012)