Research Methodology, the Regulatory Process & Ethics
Presented jointly by the Vice President's Office for Research & Graduate Studies the School of Medicine
Location: JordanHallConferenceCenter Auditorium
- Light dinner will be provided
- Next page: see information regardingContinuing Medical Education (CME) credit and faculty disclosures
Agenda:
TimeTopicPresenter
5:00The Importance of Public Trust in the Research EnterpriseDavid Hudson
5:15Clinical Research Design OverviewJean Gaare Eby
5:45Delegation of Authority – AClinical Research Coordinator PerspectiveSandra Burks
6:15Dinner break
6:30The Role of the IRB in Clinical ResearchKaren Schwenzer
7:00Post-Approval Monitoring Program OverviewKaren Parks
7:15Post-Approval Monitoring Program: 2007 Findings/Lessons LearnedSarah Blackman
7:30Distinguishing Clinical Research from Medical CareRonald Turner
8:00Panel Q&A and Conclude
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Speakers:
David Hudson, PhD, Associate Vice President, Office of Research Graduate Studies
Jean Gaare Eby, ScD, IRB Educator, Office of Associate VP for Research & Graduate Studies
Sandra Burks, RN, BSN, CCRC, Associate Director, Surgical Therapeutic AdvancementCenter
Karen Schwenzer, MD, FCCM, Associate Professor of Anesthesiology, and Chair, IRB for Health Sciences Research
Karen Parks, BSN, RN, CCRP, Post Approval Compliance Monitor
Sarah Blackman, MPH, IRB Educator, Office of Associate VP for Research & Graduate Studies
Ronald Turner, MD, Professor of Pediatrics, and Associate Dean for Clinical Research
The University of Virginia School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
The University of Virginia School of Medicine designates this educational activity for a maximum of threeAMA PRA Category 1 Credit(s)TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.
The University of Virginia School of Medicine awards 0.1 CEU per contact hour to each non-physician participant who successfully completes this educational activity. The CEU (Continuing Education Unit) is a nationally recognized unit of measure for continuing education and training activities that meet specific educational planning requirements. The University of Virginia School of Medicine maintains a permanent record of participants who have been awarded CEUs.
Faculty Disclosure Information for Research Methodology, the RegulatoryProcess & Ethics
Dr. Ronald Turner has disclosed that he has a relevant financialrelationship as an independent contractor (research and clinical trials)and/or consultant for Procter & Gamble Co., Dial Corporation, and WarnerLambert/Pfizer.
Dr. David Hudson, Dr. Jean Gaare Eby, Sandra Burks, Dr. Karen Schwenzer, Sarah Blackman and Karen Parks have disclosed that they do not have a financialrelationship or interest with any proprietary entity producinghealthcare goods or services.