Presenter: Lawrence Tierney, MD
Professor of Medicine, UCSF
Lawrence Tierney, MD is an internist in San Francisco, California and is affiliated with multiple hospitals in the area, including San Francisco VA Medical Center and UCSF Medical Center. He received his medical degree from University of Maryland School of Medicine and has been in practice for more than 20 years. He is one of 196 doctors at San Francisco VA Medical Center and one of 616 at UCSF Medical Center who specialize in Internal Medicine.
Course Fee: $65
Course Eligible for BRN Credit
(Clinical Research Operations Program elective)
The mission of the Stanford Center for Clinical Research (SCCR) includes offering educational resources, training, and support for investigators and research staff. We have invited Savita Sinha, MS, clinical research consultant and instructor in the UCSC Extension Certificate Program in Clinical Trials Design and Management, to provide you with a solid foundation in successful clinical trial monitoring. This lecture will present the essential elements of monitoring a clinical trial as well as the interactions between a sponsor and one or more sites during a clinical investigation. Expectations of the FDA, sponsor and site will also be presented.
At the conclusion of this class, you will be able to:
- Understand tasks to be completed before, during and after a monitoring visit
- Examine compliance audits and fraud and misconduct
- Evaluate the importance of accurate data entry and product accountability
- Interpret expectations of the FDA, sponsor and clinical site
Attendance is open to all research staff but seating is limited to 30.
Registration for this course is through STARS (activity code SCCR-5062) and you may use your STAP funds. If you have any questions, please contact Kiera Larsen at klarsen5@stanford.edu.
About the Instructor:
Savita Sinha, MS, obtained her Master of Science degree in microbiology from the University of Bombay, India. She also completed a graduate study in management from St. Thomas University in Miami, FL. She has immense experience in all aspects of clinical operations, trial management and monitoring. She has worked as a clinical research consultant for the past 20 years, managing multi-center, global phase II, phase III and post-marking studies. She has also presented and conducted multiple training sessions at investigator meetings and served as a mentor for CRAs. She has also worked as a Clinical Research Associate II, monitoring phase I-IV trials, including multi-center trials. Currently, she is an instructor in the UCSC Extension Certificate Program in Clinical Trials Design and Management, specializing in clinical trial monitoring.
BRN OPTIONAL
Spectrum Stanford Center for Clinical and Translational Education is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 4.0 contact hour(s).
To receive your certificate with BRN credit, you are required to complete an evaluation at the conclusion of this class.
BRN Cancellation Policy: If you wish to cancel your registration, please DROP this class in STARS within 7 days of the course date or notify Kiera Larsen at klarsen5@stanford.edu to receive a refund.
Presenter: Wes Brown, MD; Professor of Medicine (Blood and Marrow Transplantation) at the Stanford University Medical Center. Zoom Meeting ID: 858 696 854
Digestive Disease Clinical Conference (DDCC) is an educational series produced by Stanford University School of Medicine, Department of Gastroenterology & Hepatology. Subspecialties and topics include GI Motility, Esophageal, IBD, Colorectal Cancer, HBV, Liver Disease, Journal/Article Review and Discussion, Internal/external research, and many more.
TARGET AUDIENCE
DDCC is reccomended for residents, fellows, physicians, nurses, pharmacists, nurse practitioners and physician assistants, allied health professionals, interns, residents, fellows and community partners specializing in Gastroenterology and Hepatology, Family Practice, Internal Medicine, Primary Care, General and Colorectal Surgery and Basic scientists.
AGENDA
February 6th, 2018
Main: LK-208. | RWC- Emmet Keeffe C-320. | Dial-in Link: 929709574@stanford.webex.com
4-4:30pm – Board review: Rob Lerrigo, MD | Chief Fellow
4:30-5:30pm – Subspecialty Group Talk: Pancreas
Walter Park, MD | Assistant Professor of Medicine, Stanford University
5:30-6:00pm – Clinical Case Review: Hepatology |Nimy John, MD | Hepatology Fellow
To subscribe to our mailing list contact Shannon Judd – judds@stanford.edu
Presenter: Rachel Hess, MD, MS
Chief, Division of Health System Innovation and Research
University of Utah
As a General Internist, Rachel Hess, MD, MS, provides primary care for adults. She has a special interest in women’s health, particularly mid-life women’s health. She is board certified in Internal Medicine. Her research focuses on understanding and improving patient-centered outcomes, such as health-related quality of life. She directs the University of Utah’s Health System Innovation and Research Program.
Arthur L. Bloomfield Professor of Medicine
Cardiovascular Institute
Stanford University Medical Center
Dr. Robert A. Harrington is an interventional cardiologist and the Arthur L. Bloomfield Professor of Medicine and Chairman of the Department of Medicine at Stanford University. Dr. Harrington was previously the Richard Sean Stack, MD Distinguished Professor and the Director of the Duke Clinical Research Institute (DCRI) at Duke University. His research interests include evaluating antithrombotic therapies to treat acute ischemic heart disease and to minimize the acute complications of percutaneous coronary procedures, studying the mechanism of disease of the acute coronary syndromes, understanding the issue of risk stratification in the care of patients with acute ischemic coronary syndromes, building local, national and international collaborations for the efficient conduct of innovative clinical research and trying to better understand and improve upon the methodology of clinical research. His research has been extensively funded through NIH, NIA, other peer reviewed agencies and private industry. Committed to training and mentorship, Harrington has served as the principal mentor for more than 20 post-doctoral clinical research fellows focused on cardiovascular research.
He has authored more than 640 peer-reviewed manuscripts, reviews, book chapters, and editorials. Thomson Reuters lists him as one of the most cited investigators in clinical medicine from 2002-2014. He is a deputy editor of JAMA Cardiology and an editorial board member for the Journal of the American College of Cardiology. He has served as editor of five textbooks and is a senior editor of the 13th and 14th editions of Hurst’s The Heart, one of the leading textbooks of cardiovascular medicine. He has been a member of the NHLBI’s Clinical Trials Study Section and the IOM’s Working Group on Data Sharing. He served as a member of the NIH NCATS Advisory Council Working Group on the IOM CTSA Program. He recently served a second term as a member and the chair of the US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee.
Harrington was recently a member of the American College of Cardiology (ACC) Board of Trustees and is currently a member of the American Heart Association’s (AHA) Board of Directors, its Science Advisory and Coordinating Committee, and its President-elect. He will serve as the AHA President beginning in July 2019. He served as the Chair for the AHA’s Scientific Sessions in 2013 and 2014. Harrington is a Fellow of the American College of Cardiology, the American Heart Association, the Society for Cardiac Angiography and Intervention, the European Society of Cardiology, the American College of Chest Physicians and the American College of Physicians. He is an elected member of the Association of American Physicians and the Association of University Cardiologists. In 2015, he was elected to membership in the National Academy of Medicine/Institute of Medicine. In 2016, he was named a Master of the American College of Cardiology. He was awarded the AHA’s Clinical Research Prize in 2017.
Harrington received his BA in English at the College of the Holy Cross, Worcester, MA. He attended Dartmouth Medical School and received his MD from Tufts University School of Medicine, Boston MA. He did his internship, residency and served as the chief resident in internal medicine at the University of Massachusetts Medical Center, Worcester MA. He trained in cardiology, interventional cardiology and clinical research (Duke Databank for Cardiovascular Disease) at Duke University Medical Center, Durham NC where he was a faculty member from 1993-2012 before joining the Stanford University faculty in 2012. Interested in innovative learning tools, including novel methods of communicating scientific information, Harrington hosts a regular podcast on theheart.org, The Bob Harrington Show, and can be followed on Twitter @HeartBobH.
Presenter: Quinn Capers, IV, MD, FACC, FSCAI
Dean of Admissions and Professor of Medicine, Ohio State University College of Medicine
Program Director of Interventional Cardiology at the Wexner Medical Center
Quinn Capers, IV, MD, FACC, FSCAI, Dean of Admissions and Professor of Medicine, Ohio State University College of Medicine and Program Director of Interventional Cardiology at the Wexner Medical Center will present “The Lack of Diversity in Medicine is a National Emergency: The Way Forward” August 12, 2019, 12:00-1:00pm in LKSC 120. No registration required. CME Credit will be offered.
Presenters: Andre Kumar, MD, MEd and Jeffrey Chi, MD
Kumar: Clinical Assistant Professor of Medicine, Stanford University
Chi: Clinical Associate Professor of Medicine, Stanford University
From Intern to Chief: A Tale of Partnerships and Persistence with a Vision for the Future
Dr. Heather Wakelee is a Professor of Medicine in the Division of Oncology at Stanford University and is the faculty director of the Stanford Cancer Clinical Trials Office. Dr. Wakelee has authored or co-authored over 200 medical articles on lung cancer and other thoracic malignancies and is involved in dozens of clinical trials related to lung cancer therapy and diagnostics. Her research focuses on many specific lung cancer subtypes defined by specific mutations in EGFR, ALK, ROS1, RET, BRAF and others. She is also involved in trials of adjuvant therapy, immunotherapy and anti-angiogenesis agents in addition to collaborations with colleagues focused in biomarkers and others focused in population science research.
Dr. Wakelee is active in multiple national and international lung cancer research organizations including serving as a member of the Board of Directors of the International Association for the Study of Lung Cancer (IASLC), co-chair of the thoracic committee and Stanford Principal Investigator for the Eastern Cooperative Oncology Group (ECOG-ACRIN), and as a Fellow of the American Society of Clinical Oncology (FASCO).
Join us on Zoom: http://bit.ly/FIOWakelee Password: 383676