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Understanding the Added Value of Action Limits for QTL Monitoring
Nathalie van Borrendam1, Annett Keller2, Leon Els3
1Integrated Data Analytics and Reporting, Johnson & Johnson, Graaf Engelbertlaan 75, 4837DS, Breda, Netherlands. nvanborr@its.jnj.com.
Abstract:
QTLs aim to ensure that the impact of risks on critical quality aspects of the trial remains within an acceptable range. Action limits can serve as an effective mechanism for the early detection of potential risks, emphasizing the importance of continuous, real-time data monitoring throughout the course of a clinical trial. A breach of an action limit constitutes an early warning of a potential negative impact on trial quality, which could subsequently affect statistical analyses. This paper presents practical examples to elucidate common characteristics of QTL parameters, thresholds, and their associated action limits.
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