Department of Medicine OnCore Hack-a-Thon!

Do you need to register your protocols?

Do you have protocols that are registered but you haven’t completed the entry?

Do you have participants you haven’t yet entered?

Do you have any questions at all about OnCore?

Join SCCR at the OnCore Hack-a-thon – OnCore specialists and experienced users from the Spectrum team and SCCR will be available to help you start the registration process, complete the entry, or enter participants. Drop in anytime with questions.

**You must have already completed OnCore Basic (Non-cancer) training before attending –

See the training schedule & sign up through STARS.

Enjoy a cup of coffee and snack on us and help move the Department of Medicine forward to meeting the September deadline for OnCore compliance!

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.

Register here!

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.

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 Associate Professor of Psychiatry and Behavioral Sciences, Anna Lembke, MD, to present on the important topic of prescription drug misuse. In this course, you will learn about the opioid epidemic and what health care professionals need to know to help with recovering from this crisis.

At the conclusion of this class, you will be able to: 

• Recognize how and why opioid prescribing has changed from 1980 to 2016
• Identify the neurobiological, sociocultural, and psychodynamic factors driving over-prescribing and over-consumption of prescription opioids
• List ideas for what health care providers can do to target and reduce this public health crisis going forward 

Attendance is open to all research staff

About the Instructor:

Anna Lembke, MD, Associate Professor of Psychiatry and Behavioral Sciences, Medical Director of Addiction Medicine, and Chief of Addiction Medicine Dual Diagnosis Clinic, was one of the first in the medical community to sound the alarm regarding opioid overprescribing and the opioid epidemic. In 2016, she published her best-selling book on the prescription drug epidemic, Drug Dealer, MD – How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop, which combines case studies with public policy, cultural anthropology, and neuroscience, to explore the complex relationship between doctors and patients around prescribing controlled drugs, the science of addiction, and the barriers to successfully addressing prescription drug misuse and addiction. Using her teaching/academic position and her public platform, Dr. Lembke continues to advocate for people with addiction, and educate health care professionals, policymakers, and the public on a wide variety of addiction-related topics.

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 the course coordinator, Kiera Larsen, klarsen5@stanford.edu.

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:

1. List key areas checked by an FDA inspector
2. Describe how to prepare documentation prior to a regulatory inspection
3. 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

1. 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.

Department of Medicine Managers and Coordinators,

Please join us for the first SCCR Coordinator Brown Bag for 2019 on Wednesday, March 13^th, 2019 from 9:00-10:00 am in LKSC Room 209.

Meet your fellow coordinators, receive updates and announcements, share best practices – and enjoy breakfast among colleagues! SCCR will be hosting quarterly Brown Bag meetings in 2019. Future dates will be provided in the near future.

Please RSVP HERE by end of day Monday, March 11, 2019

Breakfast will be provided

Date: Wednesday, March 13, 2019

Time: 9:00-10:00 am

Location: LKSC 209

Topic: “Work Purpose and Career Paths”

Fulfillment, Satisfaction, Engagement, name it; why does it matter to have clarity around our work purpose? Let’s gather at this Brown Bag workshop to discuss and share our thoughts and our experiences on what makes our work worthwhile, and how that defines the career paths we’re on!

Moderator: Susan Saba, MPH

Visit SCCR Events HERE

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 Connor O’Brien, MD, research fellow in Cardiovascular Medicine and a highly experienced cardiology educator, to provide you with a solid foundation in the basics of ECG interpretation. Additionally, Kiera Davis, RN, BSN, will be conducting a tutorial on proper 12-lead ECG electrode placement.

Click HERE to register!

At the conclusion of this class, you will be able to:  

• Identify heart structures
• Describe the conduction system of the heart
• Identify ECG morphology
• Interpret basic ECGs
• Perform proper ECG electrode placement
• Describe the rationales for ECG use

Attendance is open to all research staff 

About the Instructors: 

Connor O’Brien, MD, is currently completing a research fellowship, after completing his fellowship in Cardiovascular Medicine at Stanford University. He obtained his medical degree from Columbia University and his BA in Biology and Biological Basis of Behavior from the University of Pennsylvania. Connor has received multiple teaching awards including the Timothy F. Becket Jr. Award for Best Clinical Teaching by a Medicine fellow in 2016 and Best Clinical Fellow in the Division of Cardiovascular Medicine in 2017.

Kiera Davis, RN, BSN, began her career at Duke University as a clinical research coordinator in the Department of Pulmonary and Critical Care Medicine. She then attended Duke University School of Nursing, obtaining her Bachelor of Science in Nursing from the Accelerated BSN program. From 2011-2015, she worked as a pediatric cardiac ICU nurse, caring for pre- and post-surgical cardiac patients. She was a member of the education committee at Duke University in the pediatric cardiac ICU, training nursing students and new nursing graduates. She joined the Stanford Center for Clinical Research is 2015 and is the Education Program Manager, facilitating and developing training for clinical research staff across the Department of Medicine and Stanford affiliated sites.

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 the course coordinator, Kiera Davis at klarsen5@stanford.edu.

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 educator in data integrity and risk-based monitoring training, Andrew Lawton, to provide you with an advanced training on the inspection findings after ICH E6 R2 implementation and a basic understanding of CRO oversight.

At the conclusion of this class, you will be able to:

1. Identify the differences in approach to inspections by the FDA, EMA, PMDA (Japan) and MRHA(UK)
2. Understand the expectations and drivers for each of the FDA, EMA, PMDA, and MRHA
3. Outline the implementation of ICH E6 R2 by examining the inspection case studies
4. Describe the inspection methods, sponsor preparation methods, and overall findings
5. Define CRO oversight
6. Recognize the use of the oversight in regulatory documents since 2011 (FDA, EMA, ICH, WHO) with examples of good oversight
7. Explain the overall methodology of oversight
8. Examine what has been done by sponsors and classed as oversight
9. State what has been used in other industries

Registration for this course is through STARS, activity code SCCR-9000. The cost of the training is $100, and the course is STAP eligible. If you have any questions, please contact Kiera (Larsen) Davis at klarsen5@stanford.edu or Susan Saba at ssaba@stanford.edu.

About the Instructor:

Andrew Lawton has extensive experience in computing, statistics, data management, RDE/RDC, system design, Risk Based Approach in both CSV and clinical trials.

He is currently a consultant and director of Risk Based Approach Ltd and has worked with a variety of companies and institutions on the implementation of ICH E6 R2 and Risk Based Monitoring.

Previously, Andy held the position of Global Head of Clinical Data Management at Boehringer Ingelheim where he also held positions of increasing responsibility during his 32 years with BI.  Andy was a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream, and a Member of EFPIA WG on Data Transparency. His most notable publication is with Dr. Alistair Ross on GP Audit – throughout the 80’s and 90’s this was the most quoted paper in the BMJ, and he won “best author of the year 2015 and 2016” from the DIA, for the TransCelerate papers on SDV and Central Monitoring in the TIRS Journal.

Board of Registered Nursing (BRN) OPTIONAL

Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 2 contact hour(s).

ATTENDANCE POLICY

In order to receive CEC credit for attending this workshop, you are required to attend the full 2.5-hour workshop. 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 can 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.

Stanford is phasing in an enhanced Coverage Analysis (CA) process for NEW studies with clinical services rendered at Stanford Health Care (SHC) or the Clinical and Translational Research Unit (CTRU). The CA process will ensure that clinical services rendered in a clinical trial are accurately billed to patient insurer(s) or charged to the study account. Stanford Healthcare has hired an external firm, Ankura Consulting, to conduct the Coverage Analyses.

Join us for an informational session to learn more about this new process and how it will benefit  study teams. We’ll cover:

• What is Coverage Analysis (“CA”)?
• What is changing about CA at Stanford
• What are the investigator and study team member’s responsibilities in the Coverage Analysis process once the draft CA has been prepared by Ankura?

Clinical research staff involved in budgeting of clinical trials are encouraged to attend. CLICK HERE TO SIGN UP.