Abstract
Background
TransCelerate’s model approach to risk-based monitoring (RBM) includes the application of the appropriate monitoring activities to enable both the early detection and timely resolution of issues. This article is a follow-up to part 1, published in the September 2014 issue with the same title.
Methods
The intent of this paper is to share information on what has been learned by various companies’ applications of central monitoring activities based on different RBM operating models. A library of risk indicators has been created, and this paper provides additional guidance on what has been learned in the application of these tools.
Results
The goal is to share the needs related to people, process, and technology as experienced by TransCelerate member companies.
Conclusions
One of the primary issue detection methods of central monitoring is the proactive identification of areas of focus through the use of risk indicators.
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Gough, J., Wilson, B., Zerola, M. et al. Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 2. Ther Innov Regul Sci 50, 8–14 (2016). https://doi.org/10.1177/2168479015618696
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DOI: https://doi.org/10.1177/2168479015618696