OCR Industry Sponsors

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Office of Clinical Research

Site Activation Turn Around Times Target Current
Cycle time from draft budget to final budget
10 days
14 days
Cycle time from feasibility assessment to fully executed contract
30 days
45 days
Cycle time from fully executed contract to first enrollment
14 days
21 days
Cycle time from IRB submission to IRB approval
14 days
30 days
Facility & Staffing Target Current
Average PI years of experience
15 Years
15 Years
Certified Clinical Research Coordinators
5
2
Average research staff level of proficiency in EDC, IVRS, EMR, and CTMS
High
Mod
Percentage of studies that have used local lab & imaging successfully
100%
100%
Clinical Trials Summary Target Current
Number of Active Trials
50
30
Number of Departments involved in Research
10
8
% of clinical trials that concluded with target patient accrual
85
52
Number of Enrollment/Randomizations
1242
656

  • About 60 years of combined JPS PI research experience
  • About 30 years combined coordinator experience
  • Two ACRP certified research coordinators. Other coordinators eligible soon
  • ACRP certified clinical research manager
  • One Project Coordinator to interphase between clinical trials, data management and analytics
  • A pharmacy team with many years of research drug experience
  • One Sr. Business Intelligence Specialist to query EMR on potential patients for new studies
  • Grants Management team to facilitate federal, state and other research grants

  • Rapid access to Level I Trauma facility
  • CAP and CLIA certified lab – Onsite
  • Phlebotomy labs –
    • Availability of phlebotomy labs for blood draw
    • Five (5) phlebotomy certified coordinators
  • Dedicated research processing space with centrifuges and more
  • Imaging labs – Onsite CT scans, MRI, PET, bone scans and X-rays among others
  • Exam rooms – Availability of exam rooms to ensure privacy
  • Pharmacy – Research oriented pharmacist to help with compounding, infusions and other pharmacist related consults.
  • Technology
    • Software
      • Clinical Trial Management System (CTMS) – Allegro
      • UCM for contract management
      • Complion an eRegulatory document management tool
      • IRBnet for local IRB protocol submission and tracking
      • CITI for GCP and Biomedical research training
      • MedRegs
      • Statistical software (R and more)
    • High speed internet access
    • Research adaptive EMR via EPIC
  • Monitoring space for CRAs
  • Equipment
    • Defibrillators
    • ECG Machines
    • -20 degree freezer
    • -80 degree freezer
    • Back up generator
  • 24HR call - coordinator managed

Geographic Area:
JPS has a well-defined catchment area that encompasses Tarrant County, Texas, which is part of the Dallas-Fort Worth metropolitan area. Tarrant County is the third largest County in Texas with a population of 2.1 million people and an overall poverty of 13.5% [19, 20]. Tarrant County had the fifth highest population growth nationally between 2010 and 2019 (U.S. Census, March 26, 2020). In addition, the Dallas-Fort Worth-Arlington metropolitan area had the highest growth among U.S. metropolitan areas between 2010 and 2019.

Population Served/Pre-existing Strain:
JPS is a safety-net health system and serves vulnerable populations with barriers to healthcare including individuals who are low-income, uninsured, underinsured, racial/ethnic minorities, homeless, and have chronic health conditions. JPS Health Network provided care during 1.5 million patient encounters for 214,832 patients last year, of whom:

  • 68% of patients were aged 20 – 64 years.
  • 55% of patients were female; 45% were male.
  • 35% were Hispanic, 27% were non-Hispanic Black, 27% non-Hispanic White, 4% were Asian, and 7% were other racial/ethnic groups.
  • 27% were uninsured; 18% qualified for the JPS financial assistance program; 36% were on Medicaid, Medicare, or other government program; and 19% had private insurance.
  • JPS patients speak many languages, for which JPS has a Language Services department to provide interpreters.

AUDIT & MONITORING TEAM

The Research Integrity Team (RIT) within the Office of Clinical Research has been tasked with ensuring research compliance by continuous monitoring and routine or for-cause auditing activities. This extends to sponsored studies where high-quality consenting practices, timely documentation, complete regulatory submission or reporting and strict adherence to approved protocols are paramount.

  • Grant management
    • Identity funding opportunities
    • Assist with grant writing, e.g. statistical analysis plan
    • Power analysis/sample size determination
  • PI-initiated clinical trials
    • Statistical analysis plan
    • Power analysis/sample size determination
    • Randomization
    • Analytic results
  • Comprehensive statistical support
    • Study design
    • Protocol development
    • Data extraction from electronic medical record
    • Power analysis/sample size determination
    • Data analysis (e.g. modelling, prediction, testing)
  • Research dissemination
    • Manuscript writing
    • Poster creation
    • Abstract development
 

On September 19, 2023, Tarrant County Commissioners Court will adopt the Tarrant County Hospital District’s FY 24 proposed budget and tax rate. The Commissioners Court has proposed a tax rate of $0.1945 which is below the no-new-revenue rate and will collect less taxes than the previous tax year.