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

Site TN-204 — Cumberland Arthritis Associates

Nashville, TN · Southeast · PI Dr. Peter Vance · Coordinator Alicia Monroe

On HoldHigh100
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Activation Readiness

IRB / Ethics approvalExpired
Regulatory documents6/10 complete
Investigator trainingIn Progress
Staff trainingNot Started
ContractPending
BudgetPending
Planned activation2026-05-11 (102 days overdue)

Enrollment

0of 20 patients (0%)
Enrollment rate0 patients / month
StatusNot started

Operations

Data entryNot Started
Open data queries0
Protocol deviations0
Outstanding tasks9
Last site activity27 days ago
Last monitoring visitNot yet visited

Agent Assessment

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

TN-204 was classified as High Risk because irb approval expired, 4 required regulatory documents missing, planned activation date has passed.

Primary risk factors
  • IRB approval expired+32 · Regulatory
    IRB record is "Expired" — the site cannot enroll patients in this state.
    Source: Regulatory Document Repository
  • 4 required regulatory documents missing+30 · Regulatory
    6/10 essential documents are on file.
    Source: Regulatory Document Repository
  • Planned activation date has passed+28 · Timeline
    Planned activation 2026-05-11; site is not yet activated.
    Source: CTMS site activation record
  • Site staff training not started+14 · Training
    Coordinator/staff protocol training is not complete.
    Source: Site Training Records (LMS)
  • Clinical trial agreement pending+12 · Regulatory
    Executed contract is required prior to activation.
    Source: CTMS contract record
  • No site activity for 27 days+12 · Engagement
    Site has not logged activity in CTMS recently.
    Source: CTMS activity log
  • Investigator training in progress+10 · Training
    Protocol training for the principal investigator is not complete.
    Source: Site Training Records (LMS)
  • Budget pending+8 · Regulatory
    Site budget approval is outstanding.
    Source: CTMS budget record
Recommended action

Contact Site Coordinator Alicia Monroe regarding the outstanding IRB approval and 4 missing regulatory documents.

Agent actions for this site

No actions prepared yet for TN-204 in trial CT-2026-301.