Protocol Deviations
Typed · severity-graded · AI-detection enabled
Open total
6
-2 vs last week
Critical open
1
action required
AI-detected
62%
of all deviations
Avg time-to-close
4.2d
industry: 18d
Minor
Major
Critical
AI-detected
Deviation Queue
Open first · critical pinned to top
DEV-1041
CRITICALDOSINGAI 94%
Subject 0117-0042 dosed outside protocol window — 3.2× delay
Site 0117 · 0117-0042·Detected Apr 22, 2026
OPEN
DEV-1042
MAJORINFORMED_CONSENTAI 91%
ICF v4.2 not re-signed for 2 subjects enrolled pre-Mar 12
Site 0117·Detected Apr 22, 2026
OPEN
DEV-1043
MAJORVISIT_WINDOWAI 88%
Visit 4 missed 7-day window — Subject 0203-0011
Site 0203 · 0203-0011·Detected Apr 19, 2026
OPEN
DEV-1044
MAJORPROHIBITED_MEDICATION
Concomitant strong CYP3A4 inducer reported · Subject 0341-0007
Site 0341 · 0341-0007·Detected Apr 18, 2026
IN REVIEW
DEV-1045
MINORDATA_ENTRY
CRF entry timestamp anomaly — manual override flagged
Site 0341·Detected Apr 17, 2026
OPEN
DEV-1046
MINORPROCEDUREAI 79%
Protocol-required vital signs not captured at V3
Site 0489 · 0489-0023·Detected Apr 15, 2026
IN REVIEW
DEV-1047
CRITICALINCLUSION_EXCLUSIONAI 96%
Enrolled subject does not meet eGFR criterion at screening
Site 0203 · 0203-0019·Detected Apr 14, 2026
CLOSED
DEV-1048
MINORDOCUMENTATION
Source document signature missing on 1 visit form
Site 0117·Detected Apr 12, 2026
CLOSED