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Ther Innov Regul Sci ; 50(1): 8-14, 2016 Jan.
Article in English | MEDLINE | ID: mdl-30236019

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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