STUDY-002
Sponsor · Phase · Indication
75C
Score Breakdown
Protocol Compliance
80
Data Integrity
72
Safety Reporting
70
Site Monitoring
78
Gap Findings (4)
| Rule ID | Description | Severity | ICH E6 Ref | Detected | |
|---|---|---|---|---|---|
| GCP-5.18.4e | Monitoring visit frequency below threshold | CRITICAL | ICH E6 5.18.4(e) | 2025-03-01 | |
| GCP-5.5.3b | IRB approval renewal overdue | CRITICAL | ICH E6 5.5.3(b) | 2025-02-10 | |
| GCP-8.2.3 | Missing investigator qualification records | MAJOR | ICH E6 8.2.3 | 2025-02-15 | |
| GCP-4.9.4 | Source document verification incomplete | MINOR | ICH E6 4.9.4 | 2025-01-20 |