High Percentage of DropOuts Due To Informed Consent Withdrawal

High Percentage of DropOuts Due To Informed Consent Withdrawal (kri)
Type of indicator Risk
Risk Category subject population
Golden KRI YES
Therapeutic Area General
IF Risk-Event a high number of Subjects withdraws their informed consent
DUE TO Risk Causes unknown reasons
THEN Risk Impact MAY RESULT an insufficient Subject participation and/or poor statistical significance
Risk Indicator High Percentage of DropOuts Due To Informed Consent Withdrawal
Metric Percent of DropOut due to IC withdrawn
Unit %
What level should be measured Study,Country,Site
Comments Screen failures must not been taken into account
Purpose DropOuts due to participants withdrawing informed consent are a subset of all DropOuts from the trial. A higher than expected level of DropOuts for this reason might indicate challenges with the administration practice of the investigational product and/or the side effects (whether or not these are reported as AEs).
Description This KRI monitors the risk of a high level of participant DropOuts due to pariticpants withdrawing consent. It alarms if the percentage of DropOuts out of those who have enrolled is too high.
Formula The metric calculates the percentage of the number of Subjects who DroppedOut of the study due to Withdrawal By Subject in the total number of enrolled subjects.
Suggested Thresholds - High >10 %
Suggested Thresholds - Medium >5 %
Associated Metric 1 Number of enrolled Subjects
Associated Metric 2 Number of DropOuts due to IC withdrawal
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