High Percentage of Start-Up Delays
| Type of indicator | Performance |
|---|---|
| Risk Category | Organizational Experience |
| Golden KRI | No |
| Therapeutic Area | General |
| IF Risk-Event | Start-up delays occur |
| DUE TO Risk Causes | Delays exceeding XXX days beyond the planned start-up timeline due to late contract signing, local ethics committee approval, clinical trial management processes, or investigational product availability |
| THEN Risk Impact MAY RESULT | Deviations from planned timelines and budgets, potentially delaying study initiation and participant recruitment |
| Risk Indicator | High Percentage of Start-Up Delays |
| Metric | Percentage of Sites with Start-Up Delays |
| Unit | % |
| What level should be measured | Study, Country |
| Purpose | To ensure timely initiation of clinical studies by monitoring start-up delays. Identifying and addressing start-up issues early supports efficient participant recruitment, adherence to study timelines, and optimal use of resources. |
| Description | This KRI tracks the percentage of sites experiencing delays during study start-up. It serves as an early warning indicator of potential operational inefficiencies and risks to study timelines. |
| Formula | For all sites planned to be activated as of the current date, calculate the delay between the planned and actual start-up dates. If a site started earlier than planned, count the delay as zero. Determine how many sites have a delay greater than XXX days, divide by the total number of sites planned to be launched by the current date, and multiply by 100%. |
| Suggested Thresholds - High | 20% |
| Suggested Thresholds - Medium | 10% |
| Associated Metric 1 | Number of Sites Planned to be Activated |
| Associated Metric 2 | Number of Activated Sites with Delays of XXX Days or More |