Table 1.
Interventional Review | Final Performance Evaluation | |||
---|---|---|---|---|
Compliant | Major Deviation | Minor Deviation | Total | |
Interventional review not done | 74 | 27 | 20 | 121 |
Modification(s) not required | 494 | 0 | 0 | 494 |
Modification(s) required and made | 354 | 0 | 0 | 354 |
Modification(s) required and NOT made | 8 | 31 | 45 | 84 |
Non-characterizable deviations* | 8 | 15 | 74 | 97 |
Deviations were not detected during pre- or on-treatment review, or interventional review and final review scores were not in agreement.