Gap Explorer
10 findings · filtered by role scope
| Gap | Severity | Method | Owner | Status | Due |
|---|---|---|---|---|---|
Missing re-consent after Protocol Amendment 3 GAP-1042 · Informed Consent · STU-001 · SITE-014 | Critical | AI-assisted · 92% | Site | Open | 2026-08-06 |
Delegation log signatures out of date GAP-1043 · Delegation & Training · STU-001 · SITE-014 | Major | Rule-based | Site | In Remediation | 2026-07-30 |
SUSAR filed 9 days after awareness (target: 7) GAP-1051 · Safety Reporting · STU-002 | Critical | Rule-based | Sponsor | Pending Review | 2026-07-25 |
TMF index incomplete — Monitoring Visit Reports Q2 GAP-1058 · Documentation / TMF · STU-001 | Major | AI-assisted · 87% | CRO | Open | 2026-08-01 |
ICF version mismatch across sites GAP-1063 · Informed Consent · STU-002 | Critical | AI-assisted · 95% | Sponsor | Open | 2026-07-28 |
Investigator CV expired GAP-1071 · Delegation & Training · STU-002 · SITE-033 | Minor | Rule-based | Site | Open | 2026-08-15 |
Protocol deviation not logged within 24h GAP-1078 · Protocol Compliance · STU-002 · SITE-041 | Major | Rule-based | Site | Closed | 2026-07-05 |
DSUR filed 63 days after data lock (target: 60) GAP-1085 · Safety Reporting · STU-001 | Minor | Rule-based | Sponsor | Pending Review | 2026-08-10 |
E-signature meaning not captured GAP-1091 · Documentation / TMF · STU-005 | Major | Rule-based | CRO | Open | 2026-08-04 |
Site 014 trending toward high-risk GAP-1096 · Trial Management · STU-001 · SITE-014 | Major | AI-assisted · 81% | Sponsor | Open | 2026-08-02 |