Table 4 Protocol deviations by site enrolment
Protocol deviation category | Total protocol deviations (N = 4074), (%a) | Protocol deviations at high enrolling sites (N = 1598), (%a) | Protocol deviations at low enrolling sites (N = 2476), (%a) |
|---|---|---|---|
Error in data/procedures | 545 (13.38%) | 316 (19.77%) | 229 (9.25%) |
Consent documentation errors | 172 (4.22%) | 147 (9.20%) | 25 (1.01%) |
Needless data collection/procedures | 130 (3.19%) | 72 (4.51%) | 58 (2.34%) |
Omitted data/procedure | 2815 (69.10%) | 1058 (66.21%) | 1757 (70.96%) |
Data for categorisation insufficient | 6 (0.15%) | 2 (0.13%) | 4 (0.16%) |
Use of materials not approved by Ethics Committee | 406 (9.97%) | 3 (0.19%) | 403 (16.28%) |