Click HERE to register!
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 Clinical Assistant Professor of Orthopedic Surgery, Emily Kraus, MD, to present on the basics of Sports Medicine and sports related injuries. Injuries in sports are common and can lead to the premature end of a season or even an athletic career. This talk will review the role of the sports medicine physician in the athlete’s care providing, followed by a discussion of the epidemiology, risk factors, types of sports injuries, and management approach.
At the conclusion of this class, you will be able to:
- Understand the role of the sports medicine physician in the care of the athlete
- Define acute and chronic sports injury
- Define a concussion (mild traumatic brain injury)
- Understand the epidemiology and risk factors of sports injuries
- Explore new research and concepts related to sports injuries
- Understand the most common types of sports injuries and approach to management
Attendance is open to all research staff
About the Instructor:
Emily Kraus, MD, is a Clinical Assistant Professor at Stanford Children’s Orthopedic and Sports Medicine Center. She specializes in Physical Medicine and Rehabilitation (PM&R) sports medicine and takes a unique approach to the diagnosis, treatment, and prevention of sports injuries in athletes of all ages. She is involved in multiple Stanford IRB-approved research projects, including The Healthy Runner Project, a multicenter prospective interventional study focused on bone stress injury prevention in collegiate middle and long distance runners. Dr. Kraus also spends time performing gait analysis at the Stanford Run Safe Injury Prevention Program and serves as a medical advisors for the Adaptive Sports Injury Prevention Program at the Palo Alto VA. She has research and clinical interests in endurance sports medicine, injury prevention, running biomechanics, the prevention of bone stress injuries in collegiate athletes and the promotion of health and wellness at any age of life. She has completed seven marathons including Boston Marathon twice and one 50k ultramarathon. With running and staying physically active as one of her personal passions, she recognizes the importance of fitness for overall wellbeing and the prevention of chronic medical conditions.
Presenter: Joann Wu, PhD
Click HERE to Register!
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 monitor, Joann Wu, PhD, to provide you with a training on Thinking like a Monitor, and its importance to identify and correct mistakes and deficiencies for Protection of human subjects, trial and data integrity.
At the conclusion of this class, you will be able to:
- Anticipate potential quality and compliance issues in your day-to-day work
- Better understand commonly seen issues from monitoring visits
- Concentrate on issues that matter in being your own monitor
- Identify time points during study development (besides monitor visits), where special attention to quality and compliance is advantageous.
- Understand the approach of risk-based quality management
Attendance is open to all research staff
About the Instructor:
Joann Wu, PhD, came from a multi-disciplinary engineering background with a B.S. from Massachusetts institute of Technology and a PhD in Integrated science and engineering (Biochemistry and Electrical engineering) from National University of Singapore. Often found daydreaming about efficiency and compliance, she is almost obsessed with bringing medical advances to people at low-cost and faster. She first became interested in clinical research because of the fulfilling patient interactions she had as a clinical research coordinator at Kaiser Permanente where she worked on various therapeutic areas in infectious disease, cardiology, surgery, orthopedics, gynecology, and gastroenterology. After joining SCCR as Quality and Compliance Associate, and learning more about regulations and quality management with the SCCR Q&C team, she is now enthusiastically helping colleagues engineer clinical study processes that are both compliant and humanly possible.
We are Not offering BRN/CEU credit for this workshop. If you have any question please contact the course coordinators, Susan Saba, ssaba@stanford.edu or Kiera Davis, klarsen5@stanford.edu.
Presenter: Maya Berdichesky, DMD
Click HERE to Register!
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 manager, Maya Berdichesky, DMD, to present on the important topic of adverse events (AEs) in clinical research, how it must be documented and tracked, and, under certain conditions reported to Sponsors, regulatory agencies, and IRBs. In this talk you will learn about prompt and proper management of adverse events (AEs) and serious AEs (SAEs) that are encountered in human subject research with drugs. You will also get to put this learning to practice with case studies.
At the conclusion of this class, you will be able to:
• Identify adverse events and adverse events classification
• Explain the Stakeholder responsibilities
• Recognize the Information flow
• Understand the Reporting timelines
• Discuss Case studies
Attendance is open to all research staff
About the Instructor:
Until recently, Maya Berdichesky, DMD, has been the Quality and Compliance Manager at the Stanford Center for Clinical Research (SCCR), where she has been crafting and leading the center’s quality and compliance program for the past 5 years. Maya has been involved in clinical research for over 10 years, after making a career change from dentistry. Her research career at Stanford began six years ago when she accepted a Regulatory position with the Stanford Pain Division. Maya has recently taken on a new role with the Stanford Research Office, as the CTSA Hub Liaison Manager.
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: 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.
Click HERE to Register!
Presenter: Kristin Anderberg, 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 SCCR’s Quality and Compliance Manager, Kristin Anderberg, RN, BSN, to present you with quality incident reporting, and how it does differ from CAPA.
At the conclusion of this class, you will be able to:
- Understand Quality Incidents
- Recognize why quality incident reporting is important
- Identify how quality incident differ from CAPA
- Apply your learning to research
Attendance is open to all research staff
About the Instructor:
Kristin Anderberg, RN, BSN received her BSN from Emory University in Atlanta. Following graduation she worked in the pediatric cardiac ICU. She has over 30 years of research experience working for AROs and industry. Her knowledge extends to clinical trial management for global studies, GCP, compliance audits, regulatory agency inspections, clinical events classification, quality management of clinical trials, policy and procedure development. She currently works at SCCR as Quality and Compliance Manager, and her passion in research is quality, clinical events classification, and endpoint adjudication.
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.
Click HERE to Register!
Presenters: Kristin Anderberg, RN, BSN & Doran Triggs, BS
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 SCCR’s Quality and Compliance Manager, Kristin Anderberg, RN, BSN, and her team member Doran Triggs, BS, to provide you an overview of the TMF and importance of maintaining a TMF.
At the conclusion of this class, you will be able to:
- Understand the definition of TMF and ISF
- Recognize the requirements
- Learn how to manage the TMF
- Identify recommended contents for TMF
- Understand Inspection Readiness
- Outline common errors
Attendance is open to all research staff
About the Instructors:
Kristin Anderberg, RN, BSN received her BSN from Emory University in Atlanta. Following graduation she worked in the pediatric cardiac ICU. She has over 30 years of research experience working for AROs and industry. Her knowledge extends to clinical trial management for global studies, GCP, compliance audits, regulatory agency inspections, clinical events classification, quality management of clinical trials, policy and procedure development. She currently works at SCCR as Quality and Compliance Manager, and her passion in research is quality, clinical events classification, and endpoint adjudication.
Doran Triggs, BS, is a Clinical Research Coordinator II, within SCCR’s Quality and Compliance team. Doran has been in the clinical research field for over 4 years. She first joined SCCR in 2018 as a CRC working on Vascular Surgery and Women’s Heart Health trials. Within her 4 years Doran focused her training on regulatory compliance and study data monitoring. Since 2021 she has transitioned to a role on SCCR’s Quality and Compliance team where she provides support to study teams within SCCR. Most recently she helped develop and manage SCCR’s monitoring program as well as monitor multiple trials within SCCR and other departments across the SOM.
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.
Click HERE to Register!
Presenters: Leonard Basobas, MS, and Kiera Davis, MS, 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 Research Director of Emergency Medicine, Leonard Basobas, partnering with SCCR’s Clinical Associate Director of Education and Training, Kiera Davis, MS, RN, BSN, to jointly present you with the clinical research responsibilities of the Principal Investigator and clinical research coordinator. Good Clinical Practice, FDA and HHS regulations will be presented, along with practical, real-world case studies for content application.
At the conclusion of this class, you will be able to:
- Describe the role of CRC and PI according to regulations and GCP Guidelines
- Understand the concepts of delegation of authority (DOA) and scope of practice
- Outline the clinical research ecosystem
- Define study roles and responsibilities
- Understand the incorrect DOA
- Learn DOA best practices
Attendance is open to all research staff
About the Instructors:
Kiera Davis, MS, RN, BSN, is the Associate Director for Education and Training at SCCR, working to improve clinical research education and training across the School of Medicine. Kiera also functions as the Program Management Office (PMO) Lead, providing oversight and guidance to SHC Tri-Valley as they expand the research enterprise in the East Bay. Kiera has over 10 years of research experience and has worked at Stanford for the last 7 years, previously working as a pediatric cardiac intensive care nurse.
Leonard Basobas, MS, is currently the Director of Growth & Development for the Emergency Medicine-Clinical Research Unit (EM-CRU) at Stanford University. He has over 20 years of experience in the field of Clinical Research, he was a Sr. Research Manager at Stanford Center for Clinical Research (SCCR), and a Study Lead, Sr. Project Manager at various academic institutions, Contract Research Organizations (CROs), large health care systems, and in the private sector. Leonard has extensive experience successfully building and managing cross-functional teams, and training and developing staff in accordance with Good Clinical Practice and federal regulations.
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.
Click HERE to Register!
Presenters: Kristin Anderberg, 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 SCCR’s Senior Quality and Compliance Manager, Kristin Anderberg, RN, BSN, to provide you with the common findings from FDA inspections and site audits.
At the conclusion of this class, you will be able to:
- Define FDA Inspection/BIMO
- Understand most common BIMO findings
- Outline FDA references
- Define audit
- Identify most common findings
- Recognize pitfalls and how to avoid them
Attendance is open to all research staff
About the Instructors:
Kristin Anderberg, RN, BSN received her BSN from Emory University in Atlanta. Following graduation she worked in the pediatric cardiac ICU. She has over 30 years of research experience working for AROs and industry. Her knowledge extends to clinical trial management for global studies, GCP, compliance audits, regulatory agency inspections, clinical events classification, quality management of clinical trials, policy and procedure development. She currently works at SCCR as Quality and Compliance Manager, and her passion in research is quality, clinical events classification, and endpoint adjudication.
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.