Monitoring Visit Report
ATLAS-204 · Site 0117 — Northwell Health · Visit #7
Draft
Protocol
ATLAS-204
Site
0117 · Northwell
PI
Dr. J. Reyes, MD
Visit Type
Interim Monitoring
Visit Date
Apr 18, 2026
CRA
L. Brown
Source Data Verification
AI:Hit 100% SDV for subjects with open queries — 3 pending
AI:Auto-draft of 6 queries ready — review & dispatch
Findings & Action Items
F-001MAJORVISIT_WINDOWAI Detected
Subject 0117-0048 · V5 missed 7-day visit window
Root cause
Subject travel; no protocol-allowed deviation submitted at time of variance.
CAPA
Site to submit retroactive deviation form within 5 business days; PI to review visit window adherence training with coordinator.
F-002MAJORINFORMED_CONSENTAI Detected
ICF v4.2 re-consent overdue for 2 subjects enrolled pre-Mar 12
Root cause
Updated ICF approved Mar 12; site missed re-consent during continuing review window.
CAPA
Site to schedule re-consent visits within 14 days; document in subject files; submit to IRB at next continuing review.
F-003MINORDATA_ENTRY
4 minor transcription errors corrected on-site
Root cause
Manual data entry from source documents; lab values transposed in 3 cases, date format inconsistency in 1.
CAPA
Resolved during this visit. CRA to monitor data entry SOPs at next visit.
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