Site CT-105 — Long Island Sound Rheumatic Care
Stamford, CT · Northeast · PI Dr. Owen Bradley · Coordinator Nina Cortez
Activation PendingMedium38
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
MediumRisk 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 · RegulatoryIRB status is "Submitted" and required before activation.Source: Regulatory Document Repository
- 1 required regulatory document missing+8 · Regulatory9/10 essential documents are on file.Source: Regulatory Document Repository
- Budget pending+8 · RegulatorySite budget approval is outstanding.Source: CTMS budget record
- Site staff training in progress+7 · TrainingCoordinator/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.