High Percentage of Subjects with PDs of staging


Type of Indicator Performance
Risk Category Subject Population
Golden KRI No
Therapeutic Area Oncology
IF Risk Event Subjects with incorrect staging are enrolled
DUE TO Risk Causes Inaccurate tumor, node, and metastasis (TNM) classification
THEN Risk Impact May Result Reduced survival outcomes for enrolled subjects
Risk Indicator High percentage of subjects with protocol deviations related to staging
Metric Percentage of subjects with protocol deviations related to staging
Unit %
Measurement Level Study, Country, Site
Purpose Ensure accuracy and reliability of disease staging processes, supporting valid study outcomes and appropriate subject management.
Description This KRI monitors the proportion of subjects with protocol deviations related to disease staging, highlighting the importance of consistent and accurate staging processes.
Formula (Number of subjects with staging-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 protocol deviations related to staging
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