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	Divide a number of tumor data issues by a total number of tumor data entries, 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 entries