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

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

3. 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. South Texas Veteran’s Health Care System (STVHCS)

4. 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 The FIRST Program …to support your research Frederic-Bartter Institutional Resource to Support Translation

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 John Erickson, MD – VA Medical Director Mary Moore, RN – Assistant Nurse Manager

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

9. For PI Review Only Date of VarianceDescription Visit # Staff Initials PI Initials PI review date PI notes (if needed) BRU Protocol Variance Log Study: IRB#:PI: Frederic-Bartter Institutional Resource to Support Translation The FIRST Program …to support your research

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

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

12. Priority Number Overall Discount Description 1 < 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 3 < 50% Exploratory or novel small pilot studies conducted to generate preliminary data for subsequent NIH or other Federal grants and contracts 4 < 25% Private Foundation or selected Industry-sponsored (private corporate funding source) studies 5 0% Most Industry-sponsored studies or any other studies which may strain FIRST Program resources IIMS – FIRST Program Cost-Sharing Policy The FIRST Program …to support your research Frederic-Bartter Institutional Resource to Support Translation

13. VA Cost Sharing Policies?