Table 3 ICF error items before and after intervention of ICF writing consultation
From: Continuous quality improvement: reducing informed consent form signing errors
Variable | Group | X2 | P | |
|---|---|---|---|---|
Before (N = 123) | After (N = 240) | |||
Signature error | ||||
The subjects did not add signatures next to the corrections made to signatures or dates on the ICF | 21 (17.1%) | 16 (6.7%) | 9.621 | 0.003 |
Multiple signatures in other fields | 5 (4.1%) | 19 (7.9%) | 1.954 | 0.187 |
ICF missing/missing signature | 6 (4.9%) | 10 (4.2%) | 0.098 | 0.790 |
Incorrect order of signatures | 7 (5.7%) | 8 (3.3%) | 1.141 | 0.281 |
Incorrect ICF version | 4 (3.3%) | 6 (2.5%) | 0.172 | 0.739 |
Correction tape used to correct signature | 1 (0.8%) | 3 (1.2%) | 0.143 | 1.000 |
Impersonated signature | 4 (3.3%) | 0 (0) | 7.892 | 0.013 |
Non-research-member signature | 2 (1.6%) | 1 (0.4%) | 1.451 | 0.266 |