Site Based Research at Duke
New Faculty Orientation
September 21, 2010
Mark Stacy, MD
Associate Dean of Clinical Research
Professor of Neurology
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)
The operating and business unit responsible for
study:
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Selection and evaluation
Execution and conduct
Quality
Integrity
Regulatory compliance
Financial management and performance
Resource allocation
Academic productivity
SBR Alignment
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Anesthesiology
Dermatology
Duke Clinical Research Unit
Family & Community Medicine
Heart Center
Medicine
OB/GYN
Oncology
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Ophthalmology
Orthopaedics
Pediatrics
Primary care
Psychiatry
Radiology
School of Nursing
Surgery
Organizational Structure of SBRs
Chancellor/Dean
Chairs/CSU Directors/Center Directors
Department/Center Institute
Business Manager
SBR Director
SBR Faculty Advisory Board
Investigators
Research Practices Manager
Study Coordinators and
Other Research Support Personnel
Financial Practices Manager
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
• 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
• 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
• 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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Site-Based Research units (SBR)