Risk Rating_Calculation Algorithm for the Occurrence (Actualization) Score

Occurrence at countries and study will be calculated from escalations of KRI at countries and study level and not from averaging of Occurrences at sites.

The Occurrence should be calculated at each level separately because it's possible that thresholds can be different at each level, as well as sample size, which is important for relative RIs (High/Low Rate of …).

For the occurrence calculation, we use a moving window of 4-8 weeks (depending on the study setting agreed to by the customer).


NOTE: If data import was missed for 1 day (for example) escalations of the KRI will be considered as low for this date.

Did this answer your question? Thanks for the feedback There was a problem submitting your feedback. Please try again later.

Still need help? Contact Us Contact Us