High Percentage of DropOuts Due To Informed Consent Withdrawal
High Percentage of Dropouts Due to Informed Consent Withdrawal
| Type of indicator | Risk |
|---|---|
| Risk Category | Subject population |
| Golden KRI | Yes |
| Therapeutic Area | General |
| IF Risk-Event | A higher than expected number of Subjects withdraw their informed consent |
| DUE TO Risk Causes | Unknown reasons |
| THEN Risk Impact MAY RESULT | Concern about the validity of the study results |
| Risk Indicator | High percentage of drop outs due to informed consent withdrawal |
| Metric | Percent of enrolled subjects who have withdrawn consent |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Comments | Only participants who have passed screening and are enrolled are included in the calculation. |
| Purpose | Participants withdrawing consent are a subset of all drop outs from the study. A higher than expected level of participants withdrawing consent might indicate challenges with the administration practice of the investigational product and/or the side effects (whether or not these are reported as AEs). |
| Description | This KRI monitors the risk of a high level of participants withdrawing consent. It alarms if the percentage is higher than expected. |
| Formula | (Number of Dropouts due to Withdrawn Informed Consent)/(Number of Enrolled Subjects)x100. Use values from the same date. KEITH QUESTION: Why is this a golden KRI? Isn't this one that should be looked at if the number of drop outs overall is high? Why look at this in addition unless there is a known issue with the rate of drop outs overall? Also, suggest a change to the denominator to participant visits or participant weeks. |
| Suggested Thresholds - High | >10 % |
| Suggested Thresholds - Medium | >5 % |
| Associated Metric 1 | Number of Enrolled Subjects |
| Associated Metric 2 | Number of Dropouts (Withdrawn Informed Consent) |