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CriticalSUSAR filed 9 days after awareness (target: 7)GAP-1051 · Safety Reporting Rule-based
SUSAR filed 9 days after awareness (target: 7)
GAP-1051 · Safety Reporting
Original gap
Sponsor SUSAR SR-2026-041 filed 2026-06-10; sponsor awareness 2026-06-01.
21 CFR 312.32(c)(1)(ii)EU CTR Art. 42
Submitted remediation
Document CAPA: root cause = weekend queue routing. Update SOP-SAF-004 §3 to require on-call escalation.
MinorDSUR filed 63 days after data lock (target: 60)GAP-1085 · Safety Reporting Rule-based
DSUR filed 63 days after data lock (target: 60)
GAP-1085 · Safety Reporting
Original gap
DSUR-2026-001 for ARCADIA-3 filed 2026-07-02; data lock 2026-04-30.
21 CFR 312.33ICH E2F
Submitted remediation
CAPA: schedule DSUR kickoff at data-lock + 30 days going forward.