High Percentage of Subjects with PDs of grading

Type of Indicator Performance
Risk Category Subject Population
Golden KRI No
Therapeutic Area Oncology
IF Risk Event Subjects with incorrect grading are enrolled
DUE TO Risk Causes Inaccurate histological assessment during screening and errors in enrollment processes
THEN Risk Impact May Result Subject safety, rights, and/or well-being may be impacted and/or data integrity may be compromised, potentially leading to inability to use subject data
Risk Indicator High percentage of subjects with protocol deviations related to grading
Metric Percentage of enrolled subjects with protocol deviations related to grading
Unit %
Measurement Level Study, Country, Site
Purpose To identify systemic issues in the grading process during screening so that corrective actions can be implemented to minimize recurrence and impact on future trial subjects and study data.
Description This KRI monitors the proportion of enrolled subjects with protocol deviations related to grading and triggers an alert if the percentage exceeds expected levels.
Formula (Number of subjects with one or more grading-related protocol deviations ÷ number of enrolled subjects) × 100
Suggested Threshold – High > 3%
Suggested Threshold – Medium > 2%
Associated Metric 1 Number of enrolled subjects
Associated Metric 2 Number of subjects with one or more grading-related protocol deviations
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