| Type of indicator |
Performance |
| Risk Category |
Data Collection Procedures |
| Golden KRI |
NO |
| Therapeutic Area |
Oncology |
| IF Risk-Event |
Tumor data (e.g., progression, partial response, complete remission) are inaccurate, inconsistent, or incomplete |
| DUE TO Risk Causes |
Data entry errors, inconsistent documentation, unclear imaging results, or misinterpretation of tumor assessments |
| THEN Risk Impact MAY RESULT |
Extended study duration, unnecessary additional enrollment, and inappropriate treatment decisions for subjects |
| 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 |
Ensure the accuracy and reliability of tumor-related data to support evidence-based decisions, uphold oncology research quality, and enhance subject outcomes. |
| Description |
This KRI monitors the frequency of issues or discrepancies in tumor data collection, documentation, and interpretation. It helps ensure that tumor assessments are accurate, consistent, and usable for clinical and regulatory evaluation. |
| Formula |
(Number of Tumor Data Issues) / (Total Number of Tumor Data Entries) × 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 |
