Good morning
Portfolio overview · source: mock
Portfolio Compliance Index · Live
0.0/ 100
-0.8past 7 days · composite index
AI Coach
Critical deviation open at Site 0117. Subject 0117-0042 dosed outside protocol window.
signal · deviations · confidence 0.94
TodayLIVE
7 items ranked by lock-impact
Blockers
2
Est. time
40m
- BLOCKERMissing source· ~4 minUpload source for Visit 4 vital signsSubject 0203-0011 · Site 002Impact: Blocks SDV — 1 day·EHR mismatch · BP 142/88 in EDC, no source
- BLOCKERAE narrative· ~12 minWrite AE narrative for Grade 3 neutropeniaSubject 0117-A042 · Site 001 · onset Day 84Impact: Blocks DB lock — 2 days·EDC · AE form open since May 2
- HIGHSignature· ~5 minCountersign 3 monitoring reportsSites 001, 002, 003 · Visit 4 reportsImpact: TMF inspection-ready status: 88% → 92%·Reports filed by L. Brown · pending PI sign
- HIGHQuery· ~6 minResolve query: HbA1c value out of rangeSubject 0341-0007 · Site 003 · query #Q-1184Impact: Open >3 days — site responsiveness flag·AI flagged · range 4.0-14.0%, value entered 17.2%
- MEDIUMQuery· ~3 minResolve query: ConMed end date missingSubject 0489-0034 · Site 004Impact: Open 2 days·CDM query · field CONMED.endDate is null
- MEDIUMeDiary gap· ~8 minFollow up on missing eDiary entriesSubject 0117-A018 · 3 days missing · Site 001Impact: Compliance < 80% threshold·Patient app · last entry May 3, 02:14 ET
- LOWMissing source· ~2 minUpload signed ICF v4.2Subject 0203-0019 · enrolled May 5Impact: Cosmetic — already in TMF as scan·TMF audit · wet-ink original missing
Audit compliance
94%
WCAG-aligned trail
Expiring docs (30d)
3 of 87
review queue
Open critical devs
1
action required
IP accountability
91%
312 kits tracked
Recent Protocol Deviations
AI-flagged signals on top · last 30 days
CRITICALAI DetectedSite 0117 · DOSING
Subject 0117-0042 dosed outside protocol window
MAJORAI DetectedSite 0203 · VISIT_WINDOW
Visit 4 missed 7-day window — Subject 0203-0011
MINORSite 0341 · DATA_ENTRY
CRF entry timestamp anomaly
MAJORAI DetectedSite 0117 · INFORMED_CONSENT
ICF v4.2 not re-signed for 2 subjects
Expiring Documents
Within 30 days · regulatory risk
Form 1572 — Dr. M. Patel
FORM_1572 · Site 0203
Medical License — Dr. J. Reyes
MEDICAL_LICENSE · Site 0117
GCP Training — RN K. Williams
GCP_TRAINING · Site 0341
Site Compliance Snapshot
Composite of essential docs + deviation rate + IP accountability
88
Site 0117
Northwell Health
94
Site 0203
Memorial Sloan Kettering
79
Site 0341
MD Anderson
91
Site 0489
Cleveland Clinic