High Percentage of DropOuts Due To Informed Consent Withdrawal


High Percentage of Dropouts Due to Informed Consent Withdrawal
Type of indicator Risk
Risk Category Subject Population
Golden KRI YES
Therapeutic Area General
IF Risk-Event A higher than expected number of subjects withdraw their informed consent
DUE TO Risk Causes Unknown reasons
THEN Risk Impact MAY RESULT Concerns about the validity and interpretability of study results
Risk Indicator High Percentage of Dropouts Due to Informed Consent Withdrawal
Metric Percent of Enrolled Subjects Who Have Withdrawn Consent
Unit %
What level should be measured Study, Country, Site
Comments Only subjects who have passed screening and are enrolled are included in the calculation.
Purpose Subjects withdrawing consent are a subset of all dropouts from the study. A higher than expected rate of consent withdrawals might indicate issues with investigational product administration or tolerability, including side effects (whether or not reported as AEs).
Description This KRI monitors the risk of a high percentage of subjects withdrawing informed consent. It triggers an alert if the percentage exceeds expected levels.
Formula (Number of Dropouts Due to Withdrawn Informed Consent) / (Number of Randomized Subjects) × 100. Use values from the same date.
Suggested Thresholds - High 10%
Suggested Thresholds - Medium 5%
Associated Metric 1 Number of Randomized Subjects
Associated Metric 2 Number of Dropouts (Withdrawn Informed Consent)
Do you like the KRI description? Thanks for the feedback There was a problem submitting your feedback. Please try again later.