High Percentage of Subjects Unable to Switch Between Formulations


High Percentage of Subjects Who Cannot Switch Formulations Table
Type of indicator Risk
Risk Category Investigational Medicinal Product (IMP)
Golden KRI NO
Therapeutic Area General
IF Risk-Event Subjects are unable to switch to the second formulation of the investigational product as planned
DUE TO Risk Causes Poor health condition during hospitalization or insufficient cognitive ability at home to follow treatment instructions
THEN Risk Impact MAY RESULT Reduced study power and limited ability to compare treatment formulations effectively
Risk Indicator High Percentage of Subjects Unable to Switch Between Formulations
Metric Percentage of Subjects with Delayed or Failed Switch from Formulation 1 to Formulation 2
Unit %
What level should be measured Study, Country, Site
Purpose This KRI helps identify and address potential barriers affecting the transition between investigational product formulations. It supports understanding whether delays or failures are related to product characteristics, subject tolerability, or operational issues.
Description This KRI measures the proportion of subjects who encounter challenges or delays when switching between product formulations. A high percentage indicates a potential formulation or patient compliance issue.
Formula (Number of Subjects Who Failed or Were Delayed in Switching to Formulation 2 ÷ Number of Enrolled Subjects) × 100%
Suggested Thresholds - High 10%
Suggested Thresholds - Medium 5%
Associated Metric 1 Number of Enrolled Subjects
Associated Metric 2 Number of Subjects Who Failed or Were Delayed in Switching to Formulation 2
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