High Percentage of Incorrect Subject Randomization
High Percentage of Incorrect Subject Randomization
| Type of indicator | Risk |
|---|---|
| Risk Category | Technology |
| Golden KRI | NO |
| Therapeutic Area | General |
| IF Risk-Event | Improper randomization of Subjects by IXRS occurs |
| DUE TO Risk Causes | Various reasons |
| THEN Risk Impact MAY RESULT | Non-acceptance of the study by health authorities |
| Risk Indicator | High Percentage of Incorrect Subject Randomization |
| Metric | Percent of incorrectly randomized Subjects |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Comments | Require additional information from the customer: For each subject in isolation whether (s)he was incorrectly randomized. |
| Purpose | Ensure the accuracy and reliability of Subject randomization in clinical trials or research studies, thereby enhancing the validity of study findings and supporting evidence-based decision-making. KD COMMENT: I don't understand how this KRI works on an ongoing basis during the trial? How can you know if the randomization is correct or not after it has taken place and whilst the blind is in place (assuming a blinded trial)? Presumably it might not be a technology issue but a user error in entering data to the IXRS? I have seen this before. But it was only picked up after DB Lock. |
| Description | KRI monitors the occurrence of incorrect randomization assignments in clinical trials or research studies, ensuring the accuracy and integrity of subject randomization for reliable study outcomes and data analysis. |
| Formula | Find all Subjects who have errors in randomization (PD, randomization cross check, randomization logs), divide by total number of randomized Subjects, multiply by 100%. |
| Suggested Thresholds - High | >2 % |
| Suggested Thresholds - Medium | >0 % |
| Associated Metric 1 | Number of randomized Subjects |
| Associated Metric 2 | Number of Subjects with Randomization error |