High Percentage of Subjects with PDs related to in/exclusion criteria (kri)

High Percentage of Subjects with PDs Related to In/Exclusion Criteria Table
Type of indicator Performance
Risk Category Organizational Experience
Golden KRI Yes
Therapeutic Area General
IF Risk-Event Subjects are randomized into the study despite not meeting inclusion or exclusion criteria
DUE TO Risk Causes Site non-adherence to protocol, errors in Subject medical history, or protocol complexity
THEN Risk Impact MAY RESULT Subject safety, rights, or well-being may be impacted. Data integrity could be compromised, and affected data might be unusable for statistical analysis.
Risk Indicator High Percentage of Subjects with Protocol Deviations Related to Inclusion/Exclusion Criteria
Metric Percentage of Subjects with One or More Protocol Deviations Related to Inclusion/Exclusion Criteria
Unit %
What level should be measured Study, Country, Site
Comments —
Purpose This KRI identifies potential systemic issues in the screening and enrollment process where Subjects are incorrectly enrolled. At the site level, it indicates possible significant compliance or training issues. At the study level, it signals challenges in applying inclusion/exclusion criteria and potential risks to data validity and overall study conclusions.
Description This KRI monitors the proportion of Subjects enrolled despite not meeting inclusion/exclusion criteria. It triggers an alert if the percentage exceeds the acceptable threshold.
Formula (Number of Randomized Subjects with at Least One Protocol Deviation Related to Inclusion/Exclusion Criteria ÷ Total Number of Randomized Subjects) × 100%
Suggested Thresholds - High 3%
Suggested Thresholds - Medium 2%
Associated Metric 1 Number of Randomized Subjects
Associated Metric 2 Number of Randomized Subjects with at Least One Protocol Deviation Related to Inclusion/Exclusion Criteria
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