High Percentage of Subjects who can't switch from one formulation to another formulation

High Percentage of Subjects who can't switch from one formulation to another formulation (kri)
Type of indicator Risk
Risk Category IMP
Golden KRI NO
Therapeutic Area General
IF Risk-Event the switch to the formulation 2 of the investigational product is impossible
DUE TO Risk Causes the Subjects' poor condition in the hospital or insufficient cognitive status at home
THEN Risk Impact MAY RESULT a low study power
Risk Indicator High Percentage of Subjects who can't switch from one formulation to another formulation
Metric Percent of delayed switches from formulation 1 to formulation 2
Unit %
What level should be measured Study, Country, Site
Purpose Identify potential issues related to product formulation compatibility, Subject tolerance, or adverse reactions during the transition.
Description KRI measures the percentage of Subjects facing difficulties when switching between different product formulations.
Formula Calculate a number of Subjects who were not switched to formulation 2 in time (following a study protocol requirements) - number of Subjects experienced formulation switch failure, devide by a total number of Subjects, multiply by 100%.
Suggested Thresholds - High >10 %
Suggested Thresholds - Medium >5 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of Subjects experienced formulation switch failure
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