Impact of queries raised by research ethics committees (RECs) and trial phase (II, III, or IV) on time (days) needed from submission to approval, approval to reception, and submission to reception of the REC’s approval at the sponsor’s office on the full sample of approved applications (n = 183)
| Submission to approval | Approval to reception | Submission to reception | ||||
|---|---|---|---|---|---|---|
| Mean (SD), median, range | p Value | Mean (SD), median, range | p Value | Mean (SD), median, range | p Value | |
| NR, number of RECs; NAp, number of applications submitted for each trial phase; NS, not significant. | ||||||
| *p values marked for all between-phase comparisons. | ||||||
| Applications with queries raised n = 101 (NR = 41) | 63.5 (37.6), 54.5, 10–188 | 15.5 (25.8), 8, 0–195 | 79.1 (45.1), 69, 18–236 | |||
| Applications without queries n = 82 (NR = 21) | 47.1 (26.3), 40.5, 7–125 | 0.003 | 18.4 (17.6), 13.5, 0–75 | 0.022 | 65.2 (30.1), 61, 14–165 | NS |
| Trial phase | ||||||
| II | 57.4 (32.9), 49.5, 14–150 | 15.7 (15.5), 12.5, 0–68 | 73.2 (35.4), 61.5, 18–169 | |||
| NAp = 54 | ||||||
| III | 46.5 (25.9), 41, 7–125 | 0.009* | 16.2 (26.2), 8, 0–195 | NS | 62.8 (34.9), 56, 14–236 | 0.007* |
| NAp = 78 | ||||||
| IV | 67.9 (40.8), 61.5, 13–188 | 28.5 (40.3), 28.5 (0–57) | 86.6 (45.3), 83.5, 24–188 | |||
| NAp = 51 | ||||||