Monthly Archives

June 2016

Defining Clinical Trial Thresholds: Objective Vs Subjective?

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Defining Thresholds: Objective Vs Subjective?

Over the past few weeks, we’ve been discussing the thoughts of some of the leading experts in Risk-Based Monitoring, and we’ve really appreciated those of you who have got involved in the debates. The penultimate question we put to our partners centered around the complexity of defining subjective thresholds using Key Risk Indicators (KRIs) rather than (or in addition to) the objectivity of comparing one site against the others.…

Central Statistical Monitoring Should Support Key Risk Indicators

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As you may well know, much of the early work in Risk-Based Monitoring has focused on relatively simple Key Risk Indicators (KRIs) and traffic-light dashboards, which are easy to understand. However, there is now a growing requirement to complement this approach with a more sophisticated and comprehensive analysis of data using a Central Statistical Monitoring (CSM) methodology.…