Site NY-102 — Hudson Valley Arthritis Center

Albany, NY · Northeast · PI Dr. Samuel Okonkwo · Coordinator Dana Reyes

ActiveMedium54

Activation Readiness

IRB / Ethics approvalApproved

Regulatory documents10/10 complete

Investigator trainingComplete

Staff trainingIn Progress

ContractApproved

BudgetApproved

Planned activationActivated 2026-04-08

7of 25 patients (28%)

Enrollment rate1.4 patients / month

StatusActive

Data entryLagging

Open data queries14

Protocol deviations2

Outstanding tasks4

Last site activity6 days ago

Last monitoring visit63 days ago

Medium

Risk score

54/100

Why am I seeing this?

NY-102 was classified as Medium Risk because enrollment 28% of target vs ~67% expected, 14 open data queries, activated 23 days behind plan.

Primary risk factors

Enrollment 28% of target vs ~67% expected+14 · Enrollment
7/25 patients enrolled at 1.4/month after 4 months active.
Source: Enrollment & Randomization Data (IWRS)
14 open data queries+9 · Data Quality
Data entry status is "Lagging".
Source: EDC Query Log
Activated 23 days behind plan+8 · Timeline
Planned 2026-03-16, actual 2026-04-08.
Source: CTMS site activation record
2 protocol deviations+8 · Data Quality
Deviation count above the study threshold of 1.
Source: CTMS deviation log
Last monitoring visit 63 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

Schedule an enrollment performance review with Dr. Samuel Okonkwo and agree a recruitment recovery plan.

Proposed Action

Schedule follow-up monitoring review

MediumApproved

Prepared content

Schedule a remote monitoring review with Dana Reyes for the week of 24 Aug 2026.

Outcome: Executed