High Percentage of Subjects with PDs in the Informed Consent Form

High Percentage of Subjects with PDs in the Informed Consent Form
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 such as inadequate training, oversight lapses, or procedural non-compliance
THEN Risk Impact MAY RESULT GCP non-compliance and potential compromise of subject rights, safety, or well-being
Risk Indicator High Percent of Subjects with PDs in the Informed Consent Form
Metric Percent of Subjects with PDs in the Informed Consent Form
Unit %
What level should be measured Site
Comments The threshold is calculated for every 100 enrolled subjects.
Purpose The informed consent process is essential for protecting subject safety, rights, and well-being, as required by GCP. A high rate of protocol deviations related to informed consent represents a significant compliance concern and may indicate inadequate site oversight or training.
Description This KRI monitors the proportion of enrolled subjects with protocol deviations related to the informed consent process. It triggers an alert when the percentage of affected subjects exceeds acceptable limits.
Formula (Number of Enrolled Subjects with PDs in Informed Consent) / (Number of Enrolled Subjects) × 100.
Suggested Thresholds - High 0.09%
Associated Metric 1 Number of Enrolled Subjects with PDs in Informed Consent
Associated Metric 2 Number of Enrolled Subjects
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