High Percentage of DropOuts Due To Informed Consent Withdrawal

High Percentage of Dropouts Due to Informed Consent Withdrawal Table

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	Concern about the validity of the study results
Risk Indicator	High percentage of drop outs 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Metric	Percent of enrolled subjects who have withdrawn consent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 participants who have passed screening and are enrolled are included in the calculation.
Purpose	Participants withdrawing consent are a subset of all drop outs from the study. A higher than expected level of participants withdrawing consent 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 participants withdrawing consent. It alarms if the percentage is higher than expected.
Formula	(Number of Dropouts due to Withdrawn Informed Consent)/(Number of Enrolled Subjects)x100. Use values from the same date.
Suggested Thresholds - High	>10 %
Suggested Thresholds - Medium	>5 %
Associated Metric 1	Number of Enrolled Subjects
Associated Metric 2	Number of Dropouts (Withdrawn Informed Consent)