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 |
a Subject withdrawn or the non-acceptance of the study data by health authorities |
| Risk Indicator |
High Percentage of Unblinding cases |
| Metric |
Percent of Unblinding cases |
| Percent |
% |
| What level should be measured |
Study, Country, Site |
| Comments |
|
| Purpose |
Safeguard the integrity and confidentiality of study data by minimizing the risk of unblinding |
| Description |
KRI monitors the risk of unblinding, ensuring data integrity and confidentiality. |
| Formula |
Count number of unblinded Subjects devide by total number of randomized Subjects |
| Suggested Thresholds - High |
>3 % |
| Suggested Thresholds - Medium |
>1 % |
| Associated Metric 2 |
Number of randomized Subjects |
| Associated Metric 1 |
Number of unblinded Subjects |
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