High Percentage of Tumor Data Issues

High Percentage of Tumor Data Issues (kri)
Type of indicator Performance
Risk Category data collection procedures
Golden KRI NO
Therapeutic Area Oncology
IF Risk-Event the tumor data (progression, partial response, complete remission) is not clean
DUE TO Risk Causes various reasons
THEN Risk Impact MAY RESULT an extended study duration, unnecessary additional enrollment, and the treatment of Subjects with inadequate treatment options
Risk Indicator High Percentage of Tumor Data Issues
Metric Percent of Non-usable Tumor assessments
Unit %
What level should be measured Study, Country, Site, Subject
Purpose Optimize the accuracy and reliability of tumor data, supporting evidence-based clinical decisions, advancing oncology research, and improving Subject outcomes.
Description KRI monitors the occurrence of issues or discrepancies in the collection, documentation, or interpretation of tumor-related data, ensuring data accuracy for effective oncology research and Subject care.
Formula Devide a number of tumor data issues by a total number of tumor data entriestest, multiply by 100%.
Suggested Thresholds - High >10 %
Suggested Thresholds - Medium >5 %
Associated Metric 1 Number of tumor data issues
Associated Metric 2 Number of tumor data entriestest
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