Site CT-105 — Long Island Sound Rheumatic Care

Stamford, CT · Northeast · PI Dr. Owen Bradley · Coordinator Nina Cortez

Activation PendingMedium38
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Activation Readiness

IRB / Ethics approvalSubmitted
Regulatory documents9/10 complete
Investigator trainingComplete
Staff trainingIn Progress
ContractApproved
BudgetPending
Planned activation2026-09-14 (in 24 days)

Enrollment

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

Operations

Data entryNot Started
Open data queries0
Protocol deviations0
Outstanding tasks3
Last site activity4 days ago
Last monitoring visitNot yet visited

Agent Assessment

Medium
Risk score
38/100
Why am I seeing this?

CT-105 was classified as Medium Risk because irb / ethics approval outstanding, 1 required regulatory document missing, budget pending.

Primary risk factors
  • IRB / Ethics approval outstanding+15 · Regulatory
    IRB status is "Submitted" and required before activation.
    Source: Regulatory Document Repository
  • 1 required regulatory document missing+8 · Regulatory
    9/10 essential documents are on file.
    Source: Regulatory Document Repository
  • Budget pending+8 · Regulatory
    Site budget approval is outstanding.
    Source: CTMS budget record
  • Site staff training in progress+7 · Training
    Coordinator/staff protocol training is not complete.
    Source: Site Training Records (LMS)
Recommended action

Contact Site Coordinator Nina Cortez regarding the outstanding IRB approval and 1 missing regulatory document.

Agent actions for this site

No actions prepared yet for CT-105 in trial CT-2026-301.