Remediation Queue
7 actionable findings · start any to launch the guided wizard
Critical AI-assisted · 92%Site
Missing re-consent after Protocol Amendment 3
GAP-1042 · due 2026-08-06
Schedule re-consent visits within 10 days for the 12 identified subjects. Draft re-consent letter template attached, referencing amendment §2.4 language.
Major Rule-basedSite
Delegation log signatures out of date
GAP-1043 · due 2026-07-30
Re-issue delegation entries with corrected dates; PI to counter-sign. System will re-validate automatically.
Major AI-assisted · 87%CRO
TMF index incomplete — Monitoring Visit Reports Q2
GAP-1058 · due 2026-08-01
Meridian CRO to upload missing MVRs within 5 business days. Bulk-upload template attached.
Critical AI-assisted · 95%Sponsor
ICF version mismatch across sites
GAP-1063 · due 2026-07-28
Push ICF v2.3 to all sites; require read-receipt within 3 days. Pattern suggests training gap, not isolated site error.
Minor Rule-basedSite
Investigator CV expired
GAP-1071 · due 2026-08-15
Request updated CV; sub-I to sign and date. System will re-check on upload.
Major Rule-basedCRO
E-signature meaning not captured
GAP-1091 · due 2026-08-04
Re-sign with meaning field populated; update portal config to make field required.
Major AI-assisted · 81%Sponsor
Site 014 trending toward high-risk
GAP-1096 · due 2026-08-02
Trigger unscheduled monitoring visit; focus on ICF and delegation clusters. Historical pattern suggests coordinator turnover.