High Percentage of Unblinding cases
High Percentage of Unblinding Cases
| Type of indicator |
Performance |
| Risk Category |
Blinding |
| Golden KRI |
NO |
| Therapeutic Area |
General |
| IF Risk-Event |
Unblinding of any party involved in the study conduct occurs |
| DUE TO Risk Causes |
Various reasons |
| THEN Risk Impact MAY RESULT |
Subject withdrawal or non-acceptance of the study data by health authorities |
| Risk Indicator |
High Percentage of Unblinding Cases |
| Metric |
Percent of Unblinding Cases |
| Unit |
% |
| What level should be measured |
Study, Country, Site |
| Purpose |
Safeguard the integrity and confidentiality of study data by minimizing the risk of unblinding. |
| Description |
This KRI monitors the risk of unblinding to ensure the integrity and confidentiality of study data are maintained. |
| Formula |
(Number of Unblinded Subjects) / (Number of Randomized Subjects) × 100. Use values from the same date. |
| Suggested Thresholds - High |
3% |
| Suggested Thresholds - Medium |
1% |
| Associated Metric 1 |
Number of Unblinded Subjects |
| Associated Metric 2 |
Number of Randomized Subjects |
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