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Table 6 Results of routine audit after detection of non-compliance from screening audit

From: ‘Screening audit’ as a quality assurance tool in good clinical practice compliant research environments

Result from screening audit

Final IRB decision

Total

Critical (n=10)

Major (n=26)

Minor (n=22)

Critical, major

3 (17.6)

8 (47.1)

6 (35.3)

17 (100)

Non-responding

2 (16.6)

5 (41.7)

5 (41.7)

12 (100)

Total

5 (17.2)

13 (44.8)

11 (37.9)

29 (100)

  1. Values are presented as N (%); Routine audit was conducted on the protocols that the several non-compliances were found in the screening audit or the non-responded protocols