The 2 nd Annual Quality in Clinical Research Conference wp.vcu.edu/qualitycr. April 28, 2017

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1 The 2 nd Annual Quality in Clinical Research Conference wp.vcu.edu/qualitycr April 28, 2017 The Jonah L. Larrick Center Virginia Commonwealth University MCV Campus 900 Turpin Street, Richmond, Virginia Presented by VCU Office of Research and Innovation VCU School of Medicine C. Kenneth and Dianne Wright Center for Clinical and Translational Research The VCU Massey Cancer Center The VCU Johnson Center for Critical Care and Pulmonary Research VCU Health Online registration is required. Visit go.vcu.edu/april28 (Best viewed using Google Chrome)

2 Schedule April 28, 2017 A.M. 8:00 Registration & Information Tables/Exhibits 8:30 Welcome & Announcements 8:40 Biomarkers and How to Study Them Arun Sanyal, MD Biomarkers are being increasingly developed and used to guide diagnosis, assess prognosis, make treatment decisions and assess responses to treatment across a wide range of diseases. This has brought the science of biomarker development and the regulatory underpinning of biomarker qualification into sharp focus as a key area of research for both routine clinical practice and Precision Medicine. In this lecture, the types of biomarkers and the regulatory milestones needed to establish specific biomarkers in specific contexts of use will be discussed. 9:55 Responsible Research: 2017 Frank Macrina, PhD This keynote will address the past, present and future of rigor and reproducibility in research. 11:15 Updates and Hot Topics Things are changing in clinical research both at the university and nationally. This session will highlight these changes. P.M. 12:00 Boxed Lunch Provided with Tables/Exhibits 12:00-4:30 Research for the Clinical Investigator Please see the separate agenda provided for this route. For the early clinical investigator, learn about the role clinical research plays in the discovery of new and better therapies and how the clinical investigator translates an idea into a protocol and a protocol into a clinical research study. VCU specific resources and policies will be highlighted. 1:00 Concurrent Afternoon Breakout Sessions #1 Session A: Beyond the Informed Consent Jennifer Economy, MSHA Enid A. Virago, PhD, CIP, CCRP This session provides an overview of real world issues facing the informed consent process. This presentation will explore the history of the informed consent, conducting the consent process, training of research staff, required documentation, and the future use of electronic consent systems. Session B: Billing Compliance Marga Johnson, MSHA, MBA Terri Rositch This session will review the rules surrounding clinical research billing from a compliance perspective, traces the path of a study participant bill through the health system, and explains the mechanisms in place that ensure the regulations governing clinical trial billing are being followed.

3 Session C: Sponsor-Investigator Investigational New Drug Applications (IND) or Investigational Device Exemptions (IDE) The speakers will explain the responsibilities of the faculty members holding an Investigational New Drug Applications (IND) or Investigational Device Exemptions (IDE) at VCU. Sponsor-Investigator responsibilities will be discussed including the regulations and guidelines to which the FDA expects the Clinical Investigator to adhere in their participation, review, and oversight of clinical investigations. 2:10 Concurrent Afternoon Breakout Sessions #2 Session D: Quality Enrollment: From Feasibility to Recruitment Rashmi Pershad, MPhil, CRA, CCRP Meagan D. Sok, MPH This session will cover the difficulties in evaluating clinical trial feasibility for possible patient populations, the best methods for overcoming these difficulties and successfully recruiting patients into studies including the importance of creating relationship with the subjects to ensure retention throughout the trial. Session E: Data Security Survival Guide 2017: How to Navigate the Complex Data Security and Compliance Landscape Dan Han, MBA, MS This session will provide its attendees with information on risks and challenges related to security and compliance of sensitive research information, and discuss technology tools and services provided by the University to help with the management of these risks. Session F: Case Studies for Clinical Research and Treatment Use of Drugs and Devices Case studies will be utilized to demonstrate key decision points in determining regulatory requirements of marketed and unmarketed drugs and devices in clinical research or in clinical care. 3:25 Concurrent Afternoon Breakout Sessions #3 Session G: Safety Reporting Amanda K. Garnett, RN, BSN, OCN This session will explore the assessment and reporting of adverse events according to FDA regulations and guidance. Discussions will include the significance of reporting and proper documentation of events. VCU policies will also be examined. Session H: Clinicaltrials.gov Alanda Perry Jones, MA, CCRP This session provides an overview of the reasons for registering studies and submitting results, the recent changes to ClinicalTrials.gov requirements, and the data submission and review process. New VCU policies and resources will also be discussed. Session I: Quality Monitoring Workshop If you are responsible for monitoring a study, responsible for assuring the quality of a study, or just want to know more about what it means to Be Audit Ready join for this hands on experience. No previous experience with auditing or monitoring is needed for attendance.

4 Research for the Clinical Investigator Afternoon Track P.M. For the early clinical investigator, learn about the role clinical research plays in the discovery of new and better therapies and how the clinical investigator translates an idea into a protocol and a protocol into a clinical research study. VCU specific resources and policies will be highlighted. 12:15 12:25 Introductions Mary Harmon, PhD Director of Clinical Research, VCUHS 12:25 1:10 Panel Discussion Shadab Siddiqui, MD -- Assistant Joelle Lemmons, MS, MHA, RN -- Nurse Manager, Clinical Research Services Unit Rashmi Pershad, M.Phil, CRA, CCRP -- Associate Director of Research Administration Arun Sanyal, MD -- Charles Caravati Division Chair, Internal Medicine Meghan Wright, MEd -- Human Research Subjects Protection Educator 1:10 1:30 The Importance of Clinical Research 1:30 1:40 Q&A Michael Donnenberg, MD VCU Senior Associate Dean for Research and Research Training Professor of Internal Medicine 1:40 2:00 Choosing a Project and a Mentor 2:00 2:10 Q&A Patrick Nana-Sinkam, MD, FCCP Chair, Division of Pulmonary Diseases and Critical Care Medicine 2:10 2:30 Clinical Research from Idea to Protocol 2:30 2:40 Q&A Francesco Celi, MD, MHSc Chair, Division of Endocrinology and Metabolism 2:40 3:00 Potential Barriers Encountered During the Research Process 3:00 3:10 Q&A Shadab Siddiqui, MD Assistant 3:10 3:30 Responsibilities of Principal Investigators 3:30 3:40 Q&A Richard Sterling, MD Chief, Section of Hepatology Medical Director, HIV-Liver Disease 3:40 4:00 Available Resources for Research at VCU 4:00 4:10 Q&A Arun Sanyal, MD Charles Caravati Division Chair, Internal Medicine 4:10 4:30 Wrap-up Lydia Klinger, CRA Director of Business Operations, C. Kenneth and Dianne Wright Center for Clinical & Translational Research

5 Conference Description The 2nd Annual Quality in Clinical Research Conference s goal is to increase the overall quality of clinical research at our institution by advancing VCU s vision to be a premier urban, public research university distinguished by providing quality research and discovery that advances knowledge, inspires creativity and improves human health. Morning keynotes on Biomarkers, Reproducibility in Research, and Hot Topics are followed by two tracks. For the early clinical investigator, the role that clinical research plays in the discovery of new and better therapies, translation of an idea into a protocol and a protocol into a clinical research study will be discussed. The second track includes breakout sessions highlighting federal regulation, university policy, and good clinical practice (GCP). Accreditation and Credit Physicians University Health Services Professional Education Programs (UHS-PEP) of Virginia Commonwealth University Health System is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. UHS-PEP designates this live activity for a maximum of 6.25 AMA PRA Category 1 Credits. Physicians should claim only credit commensurate with the extent of their participation in the activity. Nurses Continuing Education for Nurses: 6.3 Contact Hours. VCU Health is approved as a provider of continuing nursing education by the Virginia Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation. Continuing Education Units This continuing education activity meets the criteria of Virginia Commonwealth University and the Southern Association of Colleges and Schools 0.6 CEUs will be awarded and recorded with the University. Certificate of Attendance A certificate of attendance will be available to all participants that complete the post- conference evaluation. Learning Materials A free download of the course materials and presentations will be available to all registrants a week prior to the conference. The link for the download will be sent to you via the used for registration. Please download the materials prior to your arrival if desired, as no printed syllabus will be available at the meeting. Wifi will be available. Conference Location The Jonah L. Larrick Student Center is located on the medical campus of Virginia Commonwealth University at 900 Turpin St, Richmond, Virginia Conference Parking Those that have permits for the 8th Street Deck or have reciprocal privileges for the 8th Street Deck will have a space in the deck. Those that do not have a permit or reciprocal privileges for 8th Street Deck will need take a ticket. Questions and Information indide@vcuhealth.org Virginia Commonwealth University is an equal opportunity/affirmative action institution providing access to education and employment without regard to age, race, color, national origin, gender, religion, sexual orientation, veteran s status, political affiliation, or disability. If special accommodations are needed, please contact Beth Collins at estoddert@vcu.edu or (804)