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March 2009 Research Study Members Training Session

The Bartter Research Unit (BRU) and the FIRST Program at the Bartter Center provide resources and support for research at the South Texas Veterans Health Care System. The BRU coordinates study procedures, maintains regulatory compliance, and ensures patient safety. The FIRST Program offers a wide range of services and resources, including inpatient and outpatient visits, skilled nursing services, data recording and documentation, laboratory testing, and more. Cost-sharing policies prioritize IIMS-supported studies and grants from federal agencies.

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March 2009 Research Study Members Training Session

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  1. March 2009 Research Study Members Training Session The Bartter Research Unit (BRU) as a Vehicle to Support Research at the South Texas Veterans Health Care System

  2. The FIRST Program…to support your research Frederic-Bartter Institutional Resource to Support Translation http://iims.uthscsa.edu/ FIRST- Outpatient Research Unit (FORU) Bartter Research Unit (BRU) CHART Center (pediatric unit)

  3. South Texas Veteran’s Health Care System (STVHCS) • Introducing the Bartter Center. • The new name of the old “GCRC” (physical Unit 7/A) • is officially the “Bartter Center”. • The Bartter Center actually is composed of two components: • The Bartter Research Unit (BRU) • the FIRST Program component located within • the Bartter Center at the VA-Hospital. • The Special Diagnostic Treatment Unit (SDTU) • a VA clinical unit to support specialty diagnostic • veteran’s health care needs within the hospital.

  4. The FIRST Program…to support your research Frederic-Bartter Institutional Resource to Support Translation Introducing the IIMS-FIRST Program Directors. IIMS-PCIR Director: Kenneth M. Hargreaves, DDS, Ph.D. FIRST Program Scientific Director: John D. Roache, Ph.D. FIRST Program Medical Director: John M. Erikson, M.D., Ph.D. FIRST Program Coordinator: Deborah Mote, MBA

  5. The FIRST Program…to support your research Frederic-Bartter Institutional Resource to Support Translation Bartter Research Unit (BRU) Deborah Mote – BRU Coordinator Sharyn Pryor, RN – VA Nurse Manager Mary Moore, RN – Assistant Nurse Manager John Erickson, MD – VA Medical Director

  6. The FIRST Program…to support your research Frederic-Bartter Institutional Resource to Support Translation Bartter Research Unit (BRU) Mission To create and maintain the resources to support the ethical conduct of research which will advance and support the translation of biomedical science to the improvement of Veteran’s Health Care.

  7. The FIRST Program…to support your research Frederic-Bartter Institutional Resource to Support Translation Bartter Research Unit (BRU) Objectives • To provide customer-friendly and competent facilities and staffing resources to support your research. • To assure investigators that study procedures are conducted according to the protocol and in full institutional and regulatory compliance. • To maintain procedures enabling the fidelity and safety monitoring ethically-required of investigators. • To protect the safety of patients, while advancing translational science through quality resource support.

  8. BRU Services, Resources • Inpatient Visits • Outpatient Visits We Cater to Special Needs. • Observation • Nurse Monitoring & Assessments • Skilled Nursing Services (ACLS) Dedicated Research Staff & Environment. • Study Technician Assistance • Data Recording & Source Documentation • Specimen Collection and Processing • Pharmacokinetic Sampling 24/7 & weekend hrs available • Laboratory Testing • ECG & physiological monitoring • Infusion pumps, cardiac monitoring, specialized equipment • Drug Administration (incl. Infusion) • Bionutritional Consultation & Food Services • Ultrasonography • DXA and Bone Mineral Density Scanning

  9. BRU Protocol Variance Log Study: IRB#: PI: The FIRST Program…to support your research Frederic-Bartter Institutional Resource to Support Translation

  10. Study: IRB#: PI: BRU: Visit Schedule of Study Procedures

  11. Study: IRB#: PI: BRU: Subject Enrollment Log

  12. The FIRST Program…to support your research Frederic-Bartter Institutional Resource to Support Translation IIMS – FIRST Program Cost-Sharing Policy • Priority Number • OverallDiscountDescription • < 100% IIMS supported studies • (either pilot studies or studies submitted by IIMS Clinical Scholars) • 2 < 75% grants and contracts from NIH or other Federal Agency • < 50% Exploratory or novel small pilot studies conducted to generate preliminary data • for subsequent NIH or other Federal grants and contracts • < 25% Private Foundation or selected Industry-sponsored • (private corporate funding source) studies • 0% Most Industry-sponsored studies • or any other studies which may strain FIRST Program resources

  13. VA Cost Sharing Policies?

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