Various reasons e.g., illness, change of mind, travel issues
THEN Risk Impact MAY RESULT
Concern about the validity of the study results
Risk Indicator
High percentage of drop outs
Metric
Percent of enrolled participants who have dropped out
Unit
%
What level should be measured
Study, Country, Site
Comments
Only participants who have passed screening and are enrolled are included in the assessment
Purpose
A proportion of trial participants is expected to drop out of the trial for various reasons. Assumptions on that proportion are made as part of the design of the study. If the actual proportion is much higher than expected this raises two concerns. First that there may not be enough data to draw a valid conclusion from the trial and second that participants are dropping out because of the investigational product. Monitoring drop out levels is therefore important.
Description
This KRI monitors the risk of a high level of participant drop outs at the site or for the study. It alarms if the percentage is higher than expected.
Formula
(Number of Dropouts)/(Number of Enrolled Subjects) x100. Use values from the same date.
Suggested Thresholds - High
>20%
Suggested Thresholds - Medium
>15%
Associated Metric 1
Number of Enrolled Subjects
Associated Metric 2
Number of Dropouts (all reasons)
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