Site MO-305 — Gateway Joint Health Research

St. Louis, MO · Midwest · PI Dr. Tanya Brooks · Coordinator Isaac Mendez

Activation PendingHigh100

Activation Readiness

IRB / Ethics approvalPending

Regulatory documents7/10 complete

Investigator trainingIn Progress

Staff trainingNot Started

ContractApproved

BudgetPending

Planned activation2026-08-27 (in 6 days)

0of 20 patients (0%)

Enrollment rate0 patients / month

StatusNot started

Data entryNot Started

Open data queries0

Protocol deviations0

Outstanding tasks7

Last site activity8 days ago

Last monitoring visitNot yet visited

High

Risk score

100/100

Why am I seeing this?

MO-305 was classified as High Risk because irb / ethics approval outstanding, 3 required regulatory documents missing, planned activation in 6 days.

Primary risk factors

IRB / Ethics approval outstanding+25 · Regulatory
IRB status is "Pending" and required before activation.
Source: Regulatory Document Repository
3 required regulatory documents missing+24 · Regulatory
7/10 essential documents are on file.
Source: Regulatory Document Repository
Planned activation in 6 days+20 · Timeline
Planned activation 2026-08-27; 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)
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 Isaac Mendez regarding the outstanding IRB approval and 3 missing regulatory documents.

No actions prepared yet for MO-305 in trial CT-2026-301.