Table 1 Progression criteria
Criterion | Red (% complete) | Amber (% complete) | Green (% complete) |
|---|---|---|---|
Number of Sites opened | < 15 (75%) | > = 15 (75%) and < 20 | 20 (100%) |
Rate/site/month | < 0.9 (< 60%) | > = 0.9 (60%) and < 1.4 | 1.5 (100%) |
Number of participants recruited | < 144 (< 60%) | > = 144 (60%) and < 240 | 240 (100%) |
Allocation per protocol | < 90% | > = 90% and < 100% | 100% |
% FU (% of recruited) | < 50% | > = 50% and < 75% | 75% |