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

Site MI-303 — Motor City Autoimmune Institute

Detroit, MI · Midwest · PI Dr. Lucia Ferrante · Coordinator Devon Marsh

ActiveHigh79
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Activation Readiness

IRB / Ethics approvalApproved
Regulatory documents9/10 complete
Investigator trainingComplete
Staff trainingIn Progress
ContractApproved
BudgetApproved
Planned activationActivated 2026-05-26

Enrollment

4of 25 patients (16%)
Enrollment rate1.1 patients / month
StatusActive

Operations

Data entryOverdue
Open data queries21
Protocol deviations3
Outstanding tasks6
Last site activity12 days ago
Last monitoring visit71 days ago

Agent Assessment

High
Risk score
79/100
Why am I seeing this?

MI-303 was classified as High Risk because 21 open data queries, enrollment 16% of target vs ~50% expected, data entry overdue.

Primary risk factors
  • 21 open data queries+16 · Data Quality
    Data entry status is "Overdue".
    Source: EDC Query Log
  • Enrollment 16% of target vs ~50% expected+14 · Enrollment
    4/25 patients enrolled at 1.1/month after 3 months active.
    Source: Enrollment & Randomization Data (IWRS)
  • Data entry overdue+10 · Data Quality
    Case report form entry is beyond the protocol-defined window.
    Source: EDC Query Log
  • 1 required regulatory document missing+8 · Regulatory
    9/10 essential documents are on file.
    Source: Regulatory Document Repository
  • Activated 22 days behind plan+8 · Timeline
    Planned 2026-05-04, actual 2026-05-26.
    Source: CTMS site activation record
  • 3 protocol deviations+8 · Data Quality
    Deviation count above the study threshold of 1.
    Source: CTMS deviation log
  • Last monitoring visit 71 days ago+8 · Engagement
    Exceeds the 60-day monitoring interval for this study.
    Source: CTMS monitoring log
  • Site staff training in progress+7 · Training
    Coordinator/staff protocol training is not complete.
    Source: Site Training Records (LMS)
Recommended action

Create an operational task for query resolution and data entry catch-up at MI-303.

Agent actions for this site

Proposed Action
Create operational task — data query cleanup
HighApproved
Site
MI-303
Reason
21 open EDC queries and overdue data entry at MI-303.
Prepared content
Task: Coordinate query resolution sprint with Devon Marsh (Site Coordinator). Target: reduce open queries below 5 within 14 days.
Outcome: ResolvedOpen queries reduced 21 → 6 after site follow-up. Issue marked resolved by Clinical Ops.