High Percentage of Subjects who can't switch from one formulation to another formulation
High Percentage of Subjects Who Can't Switch Formulations Table
High Percentage of Subjects Who Can't Switch Formulations
Type of indicator
Risk
Risk Category
IMP
Golden KRI
NO
Therapeutic Area
General
IF Risk-Event
The switch to 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 the number of Subjects who were not switched to formulation 2 in time (following study protocol requirements) - number of Subjects experienced formulation switch failure, divide by the 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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