Table 5 Association of grade and five audit finding categories (N=462)
Categories | Grade | p-valuea | |||
|---|---|---|---|---|---|
Not a finding | Minor | Major | Critical | ||
Failure to maintain essential documents | 4(19.0) | 69(32.5) | 78(25.6) | 25(21.0) | 0.091 |
Inappropriateness of documents | 8(38.1) | 87(41.0) | 57(18.7) | 17(14.3) | <0.0001 |
Failure to obtain informed consent | 0(0.0) | 9(4.2) | 24(7.9) | 21(17.6) | 0.0001 |
Inappropriateness of informed consent form | 6(28.6) | 29(13.7) | 87(28.5) | 44(37.0) | <0.0001 |
Failure to protect participants’ personal information | 3(14.3) | 18(8.5) | 59(19.3) | 12(10.1) | 0.003 |