G3+ Lab Abnormality Rate

Steps to Perform the Review

  1. In the KRI Report by Site and Country, toggle to the G3+ Lab Abnormality Rate results.

  2. Identify outliers.

For High Outliers

This indicates a potential safety risk or a data issue such as incorrect units causing the result to appear >= Grade 3. Consider the overall number of samples in the numerator and number of subjects impacted. If the number of samples is very low and is only impacting a single subject, escalation may not be warranted.

For Low Outliers

Consider if the site may be missing lab sample collections and thus have fewer samples making it less likely that G3+ abnormalities are observed. This could also indicate a less sick patient population for the site. Generally, low outliers in this KRI are unexpected.

G3+ Lab Abnormality Rate scatter plot