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.

Slides:

Advertisements

Similar presentations

The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.

Advertisements

Common/shared responsibilities between jobs.

Institutional Animal Care and Use Committee (IACUC)

The Joint Commission Chapter update: Waived Testing

0 EMS Stakeholders Meeting 2011 August 25, 2011 Bob Leopold EMS and Trauma Systems Program.

Nursing Research Opportunities in the USPHS CAPT. Victoria L. Anderson, RN, CRNP, MSN.

TEXAS SOUTHERN UNIVERSITY OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR DEPARTMENT OF RESEARCH ENHANCEMENT AND COMPLIANCE SERVICES.

1st Global QA Conference & 21st SQA Annual Meeting Falcon Consulting Group, LLC 1 Phase I Clinical Study Audits “A Deeper Scrutiny” Cheryl J. Priest, R.N.

TEXAS SOUTHERN UNIVERSITY INSTITUTIONAL ANIMAL CARE AND USE PROGRAM WORKSHOP OFFICE OF RESEARCH LINDA M. GARDINER, Ph.D. DIRECTOR RESEARCH ENHANCEMENT.

Good Clinical Practices Regulatory Guidelines for the Conduct of Clinical research Introduction to Research Pharmacy Services Javier Palacios, R.Ph. Sponsored.

Public and Private Interests in Animal Research LAT Chapter 1.

YALE MASTER SLIDE HERE Clinical Research Management – Is not just a handshake deal? Jamie Caldwell, MBA Director Office of Research Services for the Health.

Identification & Distinction of Clinical Trial Participant Charges Bethany Martell Office of Clinical Research Associate Director- Financial Operations.

Contact: For education: Kornelia Hathaway, Education & Training Manager, For.

University of Hawaii Clinical Research Center Louise Medina, R.N., M.H.A. Clinical Program Administrator.

Documentation of Human Subjects Research in the Patient’s Health Record Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas Veterans.

Clinical Research Center at a Glance Lynda Lane MS Administrative Director.

Career Research Power Point My Top Cluster  Health Science was my top cluster  My video link for this cluster is ( deos/CareerandClusterVideos/care.

Office of Research Oversight VHA Handbook VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Establishes procedures for determining whether.

Internal Auditing in Research: The QA Process Research Education Series February 14, 2011 Sarah Dutkevitch, RN, OCN, Clinical Research Nurse Specialist.

Coordinator University Clinical Research Pharmacy Investigational Drug Service (IDS) Marjorie Shaw Phillips, MS, RPh, FASHP Clinical Research Pharmacist.

Leadership in Psychology TERENCE M. KEANE, PH.D. Associate Chief of Staff for Research VA Boston Healthcare System Professor of Psychiatry & Psychology.

Lisa Denney, MPH HRPP Assistant Director Melanie Mace, MA HRPP Education and Training Coordinator Bill Woods, PhD CAPS Policy and Ethics Core November.

Memorial Hermann Healthcare System Clinical Integration & Disease Management Dan Wolterman April 15, 2010.

Component 2: The Culture of Health Care Unit 3: Health Care Settings— The Places Where Care Is Delivered Lecture 3 This material was developed by Oregon.

How Available is Healthcare Principles of Health Science.

International Research & Research Involving Children K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development.

Clinical Trials: How do I get started? OSP Brown Bag Session March 16, 2012 Ann J. Melvin MD, MPH Co-Director ITHS Regulatory Support and Bioethics Core.

Research and Development Protocol Submission and Continuing Review Processes Kimberly Summers, PharmD Assistant Chief for Clinical Research South Texas.

Diabetes Clinical and Translational Research: Rewards and Challenges Ruth S. Weinstock MD PhD Medical Director, Joslin Diabetes Center and Clinical Research.

Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Staffing and Training.

MGH Clinical Research Center Progress Report and Future Directions Kathy Hall, MS, ANP-BC, NE- BC Nurse Director, Clinical Research Center.

Role of the Oncology Research Team Carmen B. Jacobs, RN, OCN, CCRP.

Pre-Award Issues Related to Human Research and Animal Use March 15, 2013.

Healthcare Delivery System

Role of the Oncology Research Team Carmen B. Jacobs, BS, RN,OCN, CCRP U.T.M.D. Anderson Cancer Center Houston, Texas U.S.A.

Working with The Johns Hopkins University General Clinical Research Center (GCRC)

Ongoing Professional Practice Evaluation Joel T. Patterson, MD University of Texas Medical Branch.

Legal & Ethical Issues. Objectives At the completion of this session the participant will be able to: ◦ Describe the ethical principles associated with.

Building Clinical Infrastructure and Expert Support Michael Steinberg, MD, FACR ULAAC Disparity Project Centinela/Freeman Health System.

Cancer Centers In Clinical Trials Sandrine Marreaud Head of Medical Department.

Belinda Seto, Ph.D. Acting Deputy Director for Extramural Research National Institutes of Health Human Subjects Research Enhancements Awards Renaissance.

C T R C Clinical & Translational Research Center

OBSERVED IN ORO REVIEWS COMPLIANCE ISSUES: OBSERVED IN ORO REVIEWS David A. Weber, Ph.D., FACNP Acting Chief Officer Office of Research.

Office of Research Oversight VHA Handbook VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH Establishes standards and procedures for determining.

Healthcare Delivery System Foundation Standard Understand the healthcare delivery system (public, private, government and non-profit)

Regulations 201: Thorny Issues What is Research? Exempt and Expedited Reviews.

Why Write A Grant? Elaine M. Hylek, MD, MPH Professor of Medicine Associate Director, Education and Training Division BU CTSI Section of General Internal.

Limmer, First Responder: A Skills Approach, 7 th ed. © 2007 by Pearson Education, Inc. Upper Saddle River, NJ Chapter 1 Introduction to the EMS System.

Building a Research Core Road Map and Lessons Learned Scott A. LeMaire, MD Professor of Surgery and of Molecular Physiology and Biophysics Vice Chair for.

Paul Kelly Facility Research Compliance Officer for the Ralph H. Johnson VA Medical Center.

Office of Human Research Protection Georgia Health Sciences University.

Responsible Conduct of Animal Research at UTHSCH Meredith L. Moore, Ph.D. Assistant Director, IACUC Office

Conducting Research at Lincoln IRB/HRPP Policies, Procedures & Good Clinical Practices B Kanna MD, MPH, FACP Associate Program Director of Internal Medicine.

Sponsor Visits and Monitoring

The TJU Human Research Protection Program (HRPP): Part I – Which Entities/Offices are Involved ? J. Bruce Smith, MD, CIP.

IRB Presentation to the Pediatric Ethics Subcommittee of the FDA regarding “Gonadotropin Releasing Hormone (GnRH) Agonist Test in Disorders of Puberty”

BMED DEPARTMENT. what you want Do you know to be when you grow up?

Sponsor Visits and Monitoring Barbara Gallagher, RN Clinical Research Nurse Jefferson Clinical Research Institute.

CLINICAL TRIALS.

Introduction to Emergency Medical Care

Introduction to the Human Research Protections Office (HRPO)

Office of Animal Care Compliance (OACC)

Good Clinical Practice

Clinical Engineering Lecture (3).

South Carolina Clinical & Translational Research Institute (SCTR)

What is CICATS? The University of Connecticut, in partnership with regional hospitals, state agencies, and community health care organizations, has.

Cindy Murray NP Princess Margaret Cancer Centre

Optum’s Role in Mycare Ohio

11 iii. Define management and supervision roles and responsibilities

Presentation transcript:

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

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)

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)

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

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

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.

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.

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

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

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

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

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

VA Cost Sharing Policies?