Presenter: Eric Holmboe, MD
Professor of Medicine and Vice President for Evaluation Research
American Board of Internal Medicine (ABIM)
Dr. Holmboe is a board-certified internist, with over 20 years of experience in education assessment and quality improvement sciences.
Prior to joining the ABIM, he was the associate program director of the Yale Primary Care Internal Medicine Residency Program, and director of student clinical assessment for the Yale School of Medicine, prior to which he served as division chief of general internal medicine at the National Naval Medical Center.
Dr. Holmboe is a graduate of Franklin and Marshall College and the University of Rochester School of Medicine. He completed his residency and chief residency in internal medicine at Yale-New Haven Hospital, was a Robert Wood Johnson Clinical Scholar at Yale University School of Medicine, and completed his internship in categorical medicine at the Naval Hospital in Bethesda, Maryland.
Dr. Holmboe is a member of the National Board of Medical Examiners and Medbiquitous, and serves on the Committee on Research and Evaluation of Programs at the American Board of Medical Specialties. He also serves on several technical expert panels for the Agency for Healthcare Research and Quality and the Centers for Medicare and Medicaid. Professional memberships include the American College of Physicians, where he is a Fellow, Society of General Internal Medicine and Association of Medical Education in Europe and is an honorary Fellow of the Royal College of Physicians in London.
Presenter: Thomas Krummel, MD
Chair, Department of Surgery
Stanford University
Thomas M. Krummel, M.D. is the Emile Holman Professor and Chair, Department of Surgery at Stanford University and the Susan B. Ford Surgeon-in-Chief at Lucile Packard Children’s Hospital. Dr. Krummel has served in leadership positions in the American College of Surgeons, the American Surgical Association, the American Board of Surgery, the American Board of Pediatric Surgery and is currently President of the American Pediatric Surgical Association. He has served the ACS Committee on the Emerging Surgical Technology and Education for 20 years and was recently appointed Chair. He played a fundamental role in the collaboration between SAGES and the ACS leading to the wildly successful Fundamentals of Laparoscopic Surgery (FLS) assessment tool. He has mentored over 200 students, residents and post docs.
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Please note: Department of Medicine Teaching Awards will be awarded at this Grand Rounds.
Presenter: Kelley Skeff, MD, PhD
George DeForest Barnett Professor in Medicine
Stanford University
Dr. Skeff is co-director and founder of the Stanford Faculty Development Center for Medical Teachers that has trained more than 350 faculty from over 150 institutions to train their own faculty and housestaff. Kelley was a residency program director for two decades, overseeing the education of Stanford internal medicine residents from 1989 to 2009. He has recently served on the Board of Regents of the American College of Physicians (ACP), the nation’s largest medical specialty organization. He has also received Stanford and national teaching awards, including Stanford’s Walter J. Gores Faculty Achievement Award, the APDIM Distinguished Medical Educator Award, and the Abraham Flexner Award from the AAMC. His research is focused on the process of clinical teaching, including the development of methods to assist clinical and basic science teachers in improving their performance.
Presenters: Kelley Skeff, MD, PhD
George DeForest Barnett Professor in Medicine
Stanford University
Dr. Skeff is the George DeForest Barnett Professor in the Department of Internal Medicine at Stanford University, and Co-Director of the Stanford Faculty Development Center (SFDC). Dr. Skeff was the internal medicine residency program director at Stanford for 2 decades. He received his MD from the University of Colorado and his PhD from the Stanford School of Education.
Dr. Skeff’s academic career has focused on methods to assist faculty and residents internationally to improve their teaching effectiveness, resulting in the development of the Stanford Faculty Development Center (SFDC). The SFDC uses a dissemination approach that trains faculty from institutions internationally to train their own faculty colleagues and housestaff to become more effective teachers.
Since 1986, the SFDC has trained 361 faculty trainers from 149 institutions in 16 countries to become local, regional, and national resources for the improvement of medical education. These faculty have, in turn, assisted over 15,000 faculty and residents to improve their teaching effectiveness. He has received several awards including the Association of Program Directors in Internal Medicine’s Distinguished Medical Educator Award and the AAMC Flexner Award for Distinguished Service to Medical Education. He is a Regent and Master of the American College of Physicians.
Ursula M. Staudinger, PhD
Professor of Psychology
Columbia University
Event and Registration Information
“Plasticity of Aging: Lifespan Perspectives”
Aging is neither biologically nor contextually determined. Instead it is probabilistic in nature, as it is the result of continuous interactions between biological and sociocultural forces. This is why a given individual’s aging trajectory can take many different shapes within biological limits. This intraindividual variability has been labeled ‘plasticity of human development’. Examples from demography, epidemiology, cognitive and personality psychology are introduced to illustrate the plasticity of aging and its limits. Limits of plasticity have been identified for very old age and in highly developed nations. Given the findings accumulating from the field of epigenetics, the question arises whether these age-related limits are biological constants that outlast even sociocultural change or whether these limits also underlie historical change. Recently, evidence has become available that highlights the fact that plasticity is personalized. Given this plasticity of aging, it is worthwhile compiling more and more scientific knowledge about how to optimize aging. It is pivotal to systematically collect cohort- and country-comparative longitudinal data on biological and behavioral parameters to being able to better capture such influences.
Francesco Vallania,
Postdoctoral Scholar,
ITI, Stanford University
ABSTRACT:
Post-translational modifications of histone proteins and exchanges of histone variants at chromatin are central to the regulation of nearly all DNA-based biological processes. However, the degree and variability of chromatin modifications in specific human immune cells remain largely unknown. Here, we present a highly multiplexed mass cytometry analysis to profile the global levels of a broad array of chromatin modifications in primary human immune cells at the single-cell level. Our data reveal markedly different cell type- and hematopoietic lineage-specific chromatin modification patterns. Differential analysis between younger and older adults shows that aging is associated with increased heterogeneity between individuals and elevated cell-to-cell variability in chromatin modifications. Analysis of a twin cohort unveils heritability of chromatin modifications and demonstrates that aging-related chromatin alterations are predominantly driven by non-heritable influences. We present a powerful platform for chromatin and immunology research. Our discoveries highlight the profound impacts of aging on chromatin modifications.
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 a highly-experienced educator in clinical research training, Patty Kasper, MS, to provide you with an advanced training on preparing for an FDA audit.
Click HERE to Register!
At the conclusion of this class, you will be able to:
- List key areas checked by an FDA inspector
- Describe how to prepare documentation prior to a regulatory inspection
- State important ways to be inspection-ready
Registration for this course is through STARS, activity code SCCR-5069 and is STAP eligible. The cost of the training is $100. Please note that class size is limited to 25. If you have any questions, please contact Kiera (Larsen) Davis at klarsen5@stanford.edu.
About the Instructor:
Patty Kasper, MS, received her Masters of Science degree in Bacteriology and Public Health from Washington State University. She is a recognized expert in clinical research training and operations with more than 20 years of industry experience. For the last two decades, Patty and her team have provided training to more than 1,800 research professionals in the biopharmaceutical and medical device industries. Patty also served on the faculty of the UCSC Extension Program as part of the Clinical Trials Design and Management Certificate Program. She is active in the Northern California Chapter of ACRP and is currently serving as the Vice President.
Board of Registered Nursing (BRN) OPTIONAL
- Kasper & Associates will provide 2 BRN contact hours to each attendee who completes the class. A certificate of completion will be provided to each participant at the conclusion of the class. Please also complete an evaluation of the course. An evaluation link will be emailed to you at the conclusion of the class.
ATTENDANCE POLICY
In order to receive credit for attending this workshop, you are required to attend the full 2-hour session. In an effort to respect others and our guest instructor, please make prior arrangements if you need to arrive late or leave early by contacting Kiera (Larsen) Davis.
CANCELLATION POLICY
If you can no longer attend and wish to drop the course, you must drop the course in STARS. You must drop the course at least 4 BUSINESS DAYS prior to the course to avoid being charged.
WHO CAN ATTEND THIS TRAINING?
This workshop is designed to provide training to any member of the research staff. Space is limited to 25 attendees per class.
Click HERE to Register!
Presenter: Bhanu Sharma, PhD
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 highly experienced Clinical Quality and Compliance leader, Bhanu Sharma, PhD, to present on 21CFR Part 11 (aka Part 11) and its applicability in Clinical Research for Drugs and Devices when performing research electronically. The course will provide an overview of Part 11 and discuss in detail important areas that must be addressed to maintain compliance. At the end of the course, you will gain the knowledge to implement in your research to meet compliance.
At the conclusion of this class, you will be able to:
- Describe what Part 11 is – Electronic Records and Electronic Signature
- Determine how to know where it is applicable
- Identify the Electronic Systems such as Software as a Medical Device (SAMD), Electronic Data Capture, Database, Cloud Storage, Paperless Clinical Trials
- Explain how to make a software system Part 11- compliant
- Learn FDA current thinking on Part 11
Attendance is open to all research staff
About the Instructor:
Bhanu Sharma, PhD holds a PhD degree in Biochemistry from University of Mysore. He obtained his postdoc at The Ohio State University and Michigan State University, then went on to start his career in industry developing commercial diagnostic tests for toxins, bacteria, viruses, stem cells and large molecules. He has published 5 books in the areas of diagnostics, immunology and targeted therapeutic systems. He holds 1 patent and has published over 20 papers in peer-reviewed journals. He was a key opinion leader on 21CFR Part 11 when this regulation was in its infancy. He was invited to speak on this topic around the world. His love for academia and compliance brought him back to SCCR 3 years ago as a Quality & Compliance Leader.
BRN OPTIONAL
Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 2 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 contact Susan Saba at ssaba@stanford.edu.
Click HERE to Register!
Presenter: Kiera Davis, RN, BSN
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 highly experienced Clinical research Education Program Manager, Kiera Davis, RN, BSN, to present on the important topic of Protocol adherence, Noncompliance and protocol deviations.
At the conclusion of this class, you will be able to:
• Identify Investigator Responsibilities
• Understand Protocol Deviations and Proper Deviation Process
• Recognize Types of Deviations
• Demonstrate Understanding of Common Deviations Related to AE/SAE Reporting
• Review Examples and Case Studies
Attendance is open to all research staff
About the Instructor:
Kiera Davis, RN, BSN joined Stanford University in 2015 and is the Education Program Manager in the Stanford Center for Clinical Research. She has worked in clinical research for 10 years at Stanford University and at the Duke Clinical Research Institute. Kiera obtained a BA in History from Boston University in 2006 followed by a BS in Nursing from Duke University. She worked as a Clinical Nurse II in the pediatric cardiac intensive care unit at Duke Hospital followed by two years as a travel nurse, working at Children’s Hospital of Los Angeles, Colorado Children’s in Denver, CO, Stanford Children’s Hospital, and Seattle Children’s Hospital. She is currently working towards a Master’s of Science in Clinical Research from Campbell University with projected graduation in Spring 2022.
BRN OPTIONAL
Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 2 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 contact Susan Saba at ssaba@stanford.edu.
Click HERE to Register!
Presenter: Kiera Davis, RN, BSN
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 the Clinical Associate Director of Education and Training, Kiera Davis, RN, BSN, to present you with the history of human subjects research protection.
At the conclusion of this class, you will be able to:
- Understand the definition of human subjects research and exemptions
- Differentiate between human subjects and non-human subjects research
- Review the NIH decision tree for clinical trial
- Review the historical background of HSR and the corresponding principles, regulations and GCP
- Describe the most common forms on noncompliance/violations
Attendance is open to all research staff
About the Instructor:
Kiera Davis, RN, BSN joined Stanford University in 2015 and is the Clinical Associate Director of Education and Training in the Stanford Center for Clinical Research. She has worked in clinical research for 10 years at Stanford University and at the Duke Clinical Research Institute. Kiera obtained a BA in History from Boston University in 2006 followed by a BS in Nursing from Duke University. She worked as a Clinical Nurse II in the pediatric cardiac intensive care unit at Duke Hospital followed by two years as a travel nurse, working at Children’s Hospital of Los Angeles, Colorado Children’s in Denver, CO, Stanford Children’s Hospital, and Seattle Children’s Hospital. She is currently working towards a Master’s of Science in Clinical Research from Campbell University with projected graduation in Spring 2022.
BRN OPTIONAL
Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 1.5 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 contact Susan Saba at ssaba@stanford.edu.