High Percentage of PD in Informed Consent Form

High Percentage of PD in Informed Consent Form (kri)
Type of indicator Risk
Risk Category data collection procedures
Golden KRI YES
Therapeutic Area General
IF Risk-Event informed consent violations occur
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT GCP non-compliance
Risk Indicator High Percentage of PD in Informed Consent Form
Metric Percent of Informed Consent PD related to all Subjects in a Study
Unit %
What level should be measured Site
Purpose The informed consent process is a critical way that the safety, rights and well-being of trial participants is protected. This is a key requirement of GCP. A high rate of trial participants where there have been deviations form the protocol in this process would be significant concern that the safety, rights, and/or wellbeing was not being adequately protected.
Description KRI monitors the risk of a high level of participants being enrolled where there are protocol deviations relating to the informed consent process. It alarms if the percentage of those enrolled who have these deviations is high. Comments: the threshold is calculated for 100 subjects.
Formula Divide a value of metric Number of Subjects with PDs for ICF by a value of Number of Enrolled Subjects for the same date and multiply by 100%.
Suggested Thresholds - High < 0.09 %
Associated Metric 1 Number of PDs for IC
Associated Metric 2 Number of enrolled Subjects
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