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Number of process errors theoretically detectable by each method
| The number of process errors detected by each method | ||||
|---|---|---|---|---|
| On-site | R2BM | DM | ||
| Critical process errors | Eligibility confirmation | 1 | 1 | 0 |
| Prohibited concomitant medication | 1 | 1 | 1 | |
| Non-critical process errors | Examinations related to other than the primary endpoint | 1 | 1 | 1 |
On-site on-site monitoring, R2BM remote risk-based monitoring, DM data review by the data manager
