AOClinical Trial Site Readiness AgentRunning on Agentic OS · CT-2026-301
Tony Choi
Clinical Operations Lead

Site NJ-104 — Garden State Rheumatology Institute

Newark, NJ · Northeast · PI Dr. Alan Whitcomb · Coordinator Priya Raman

Activation PendingHigh61
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Activation Readiness

IRB / Ethics approvalPending
Regulatory documents8/10 complete
Investigator trainingComplete
Staff trainingComplete
ContractApproved
BudgetApproved
Planned activation2026-08-29 (in 8 days)

Enrollment

0of 30 patients (0%)
Enrollment rate0 patients / month
StatusNot started

Operations

Data entryNot Started
Open data queries0
Protocol deviations0
Outstanding tasks5
Last site activity2 days ago
Last monitoring visitNot yet visited

Agent Assessment

High
Risk score
61/100
Why am I seeing this?

NJ-104 was classified as High Risk because irb / ethics approval outstanding, planned activation in 8 days, 2 required regulatory documents missing.

Primary risk factors
  • IRB / Ethics approval outstanding+25 · Regulatory
    IRB status is "Pending" and required before activation.
    Source: Regulatory Document Repository
  • Planned activation in 8 days+20 · Timeline
    Planned activation 2026-08-29; site is not yet activated.
    Source: CTMS site activation record
  • 2 required regulatory documents missing+16 · Regulatory
    8/10 essential documents are on file.
    Source: Regulatory Document Repository
Recommended action

Contact Site Coordinator Priya Raman regarding the outstanding IRB approval and 2 missing regulatory documents.

Agent actions for this site

No actions prepared yet for NJ-104 in trial CT-2026-301.