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New Faculty Orientation September 21, 2010. Site Based Research at Duke. Mark Stacy, MD Associate Dean of Clinical Research Professor of Neurology. Site Based Research unit (SBR).

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new faculty orientation september 21 2010

New Faculty OrientationSeptember 21, 2010

Site Based Research at Duke

Mark Stacy, MDAssociate Dean of Clinical ResearchProfessor of Neurology

site based research unit sbr
Site Based Research unit (SBR)

Group of investigators and research staff in a given therapeutic area who conduct research involving human subjects

Oversees all clinical research that does not meet the federal regulatory requirement for exemption from IRB review where a Duke Medicine entity is the investigative site for research or a Duke faculty/staff member is responsible for a research activity that involves:

  • Direct interventions, observations, surveys or interactions with Duke patients
  • Use of biological specimens from Duke patients
  • Access to confidential, private information from Duke
site based research units sbr
Site-Based Research units (SBR)

The operating and business unit responsible for study:

  • Selection and evaluation
  • Execution and conduct
  • Quality
  • Integrity
  • Regulatory compliance
  • Financial management and performance
  • Resource allocation
  • Academic productivity
sbr alignment
SBR Alignment

Anesthesiology

Dermatology

Duke Clinical Research Unit

Family & Community Medicine

Heart Center

Medicine

OB/GYN

Oncology

Ophthalmology

Orthopaedics

Pediatrics

Primary care

Psychiatry

Radiology

School of Nursing

Surgery

organizational structure of sbrs
Organizational Structure of SBRs

Chancellor/Dean

Chairs/CSU Directors/Center Directors

SBR Director

SBR Faculty Advisory Board

Investigators

Research Practices Manager

Financial Practices Manager

Study Coordinators and Other Research Support Personnel

Department/Center Institute Business Manager

sbr director
SBR Director
  • Oversees the quality, financial performance, regulatory compliance, resource allocation and academic output of all clinical research studies conduced within the SBR
  • Directs the study selection process and ensures a balanced portfolio
  • Ensures the financial integrity and solvency of the SBR
sbr research practices manager
SBR Research Practices Manager
  • Supervises clinical research personnel, in many cases through a “dotted-line” type of arrangement
  • Facilitates assignment of staff across studies to manage peaks and valleys of workload and ensure adequate staffing, e.g., coverage of maternity leaves
  • Ensures appropriate orientation, training and oversight of CRCs
sbr financial practices manager
SBR Financial Practices Manager
  • Oversees budget preparation, including assisting with negotiating “out of scope” budget revisions and ensuring effort is charged to trials
  • Ensures appropriate financial management of clinical trials, including compliance with clinical trial billing processes and trial close-outs
  • Ensures accounts receivables are collected in a timely manner
  • Analyzes profitability and cash flow of individuals trials and the portfolio in aggregate
sbr advisory council
SBR Advisory Council
  • Comprised of SBR Directors, Practice Managers, Finance Managers, Central Administration and Research Support Areas Leadership
  • Serve as a unified voice and advocate for the clinical research community
  • Provide feedback regarding the needs of the clinical research community and the effectiveness of institutional research support services
  • Provide guidance to institutional leadership regarding priorities for improvement and investments in infrastructure resources
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