Overrecruitment
Overrecruitment
| Type of indicator | Performance |
|---|---|
| Risk Category | Subject population |
| Golden KRI | No |
| Therapeutic Area | General |
| IF Risk-Event | A Site/Country/Study recruits more Subjects than statistically planned |
| DUE TO Risk Causes | A lack of control over the IXRS and the screening |
| THEN Risk Impact MAY RESULT | An unusual statistical analysis and difficulties in the interpretation |
| Risk Indicator | Overrecruitment |
| Metric | Percent of Overrecruited Subjects |
| Unit | % |
| What level should be measured | Study, Country, Site |
| Purpose | Maintain the integrity of clinical trials or research studies by ensuring that the number of enrolled participants aligns with planned targets and ethical considerations. KD COMMENT: This seems to be the "underrecruitment" KRI but with high thresholds. Why have two KRIs rather than one with two thresholds ("recruitment rate")? Seems to me to be unnecessary complexity. |
| Description | KRI monitors instances where the number of participants enrolled in a clinical trial or research study exceeds the predetermined target, ensuring adherence to enrollment plans and mitigating potential risks to participant safety and data quality. |
| Formula | Divide the actual number of enrolled Subjects by the planned number of Subjects for the same date and multiply by 100%. |
| Suggested Thresholds - High | >120 % |
| Suggested Thresholds - Medium | >110 % |
| Associated Metric 1 | Number of enrolled Subjects |
| Associated Metric 2 | Number of planned Subjects |