Measure the Right Things at the Right Time: Design Key Risk Indicators and Key Performance Indicators that Provide Timely Insights During Study Conduct

This paper outlines an approach to and rationale for the best way to normalize metrics used as leading indicators to provide early signals of risk, such as with Key Risk Indicators, as part of Risk-Based Quality Management in implementation of ICH E6 (R2). How you define your measurements can allow you to see trends and outliers earlier as well as reduce the number of false positives! Download the paper to learn more.