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

Site Based Research unit (SBR) 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 Group of investigators and research staff in a given therapeutic area who conduct research involving human subjects

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 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

Department/Center Institute Business Manager Chairs/CSU Directors/Center Directors SBR Director Financial Practices ManagerInvestigators Chancellor/Dean Research Practices Manager Study Coordinators and Other Research Support Personnel SBR Faculty Advisory Board Organizational Structure of SBRs

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