Table 4 Factors associated with audit outcomes
Grading | p-value | ||||
|---|---|---|---|---|---|
Not a finding | Minor | Major | Critical | ||
Year | |||||
2013 | 12 (5.1) | 104 (44.1) | 91 (38.6) | 29 (12.3) | 0.813a |
2014 | 4 (13.8) | 11 (37.9) | 9 (31.0) | 5 (17.2) | |
2015 | 10 (11.6) | 30 (34.9) | 34 (39.5) | 12 (14.0) | |
2016 | 2 (3.7) | 27 (50.0) | 21 (38.9) | 4 (7.4) | |
2017 | 1 (1.8) | 26 (45.6) | 25 (43.9) | 5 (8.8) | |
Risk | |||||
Level 1 | 13 (4.9) | 105 (39.9) | 108 (41.1) | 37 (14.1) | 0.002a |
Level 2 | 12 (7.9) | 67 (44.1) | 58 (38.2) | 15 (9.9) | |
Level 3 | 4 (12.9) | 19 (61.3) | 7 (22.6) | 1 (3.2) | |
Level 4 | 0 (0) | 0 (0) | 1 (100) | 0 (0) | |
Undetermined* | 0 (0) | 7 (46.7) | 6 (40.0) | 2 (13.3) | |
Multicenter | |||||
Single center | 13 (4.63) | 108 (38.43) | 121 (43.06) | 39 (13.88) | < 0.0001a |
Domestic multicenter | 10 (6.17) | 83 (51.23) | 54 (33.33) | 15 (9.26) | |
International multicenter | 6 (31.58) | 7 (36.84) | 5 (26.32) | 1 (5.26) | |
Responsible entity | |||||
Investigator initiated | 28 (6.15) | 195 (42.86) | 177 (38.9) | 55 (12.09) | 0.6248b |
Sponsor initiated | 1 (14.28) | 3 (42.86) | 3 (42.86) | 0 (0) | |
Phase | |||||
Phase1, 1/2, 2, 2/3, 3, 4, PMS, medical-device | 11 (10.89) | 58 (57.43) | 28 (27.72) | 4 (3.96) | < 0.0001a |
Non-phase clinical research | 18 (4.99) | 140 (38.78) | 152 (42.11) | 51 (14.13) | |
Department | |||||
Clinical department I | 17 (9.5) | 86 (48.0) | 63 (35.2) | 13 (7.3) | 0.001a |
Clinical department II | 3 (6.7) | 18 (40.0) | 17 (37.8) | 7 (15.6) | |
Clinical department III | 5 (4.1) | 48 (39.0) | 48 (39.0) | 22 (17.9) | |
Supportive departments | 4 (4.0) | 42 (41.6) | 45 (44.6) | 10 (9.9) | |
Basic Science departments | 0 (0) | 4 (28.6) | 7 (50.0) | 3 (21.4) | |
Total | 29 (6.3) | 198 (42.9) | 180 (39.0) | 55 (11.9) | |