Wednesday
2018 Introduction to Clinical Research Boot Camp
Wednesday, June 6, 2018
8:30 am – 9:20 am
All Attendees
Keynote: Inspiration, Motivation, and Innovation to Improve the Health of our Communities
8:30 am – 9:20 am
From the perspective of a patient, clinician, and researcher, this session showcases a personal odyssey within our local academic health research environment. Be inspired by reflections on the cutting edge contributions of academic researchers in improving the health of our communities.
Speaker
Keith Eaton, MD, PhD
Associate Professor, School of Medicine, University of Washington
Associate Member, Fred Hutchinson Cancer Research Center
Wednesday
9:30 am – 10:30 am
Faculty
Physician vs. the Physician-Investigator: Is there a Difference?
9:30 am – 10:30 am
This session will explore the similarities and differences between the role of the physician and the role of the physician investigator, comparing responsibilities in the areas of patient care decisions, treatment interventions, legal accountability, documentation, and collaborators.
Speaker
Paul Martin, MD
Co-PI of the Institute of Translational Health Sciences
Member, Fred Hutchinson Cancer Research Center
Staff
The Protocol Review: How to Read for both the Big Picture and Your Responsibilities in Implementing a Study
9:30 am – 10:30 am
It is essential for research staff to understand fundamental concepts and terminology common to clinical trial protocols. This session will go over sample protocols and describe strategies for reading protocols to maximize study success.
Speaker
Amy Good, PhD
Manager, Research Coordination Center, ITHS
University of Washington
Wednesday
10:40 am – 11:40 pm
Faculty
The Study Start-Up Process: Navigating the Sequence and Timing of Reviews, Approvals, and Resources before Your Study Starts
10:40 am – 11:40 pm
This session will illustrate how to steer a new research project through the financial, timeline, institutional oversight, and research support resources necessary to complete the study start-up process.
Speaker
Bojana Askovich, MD
Research Administrator
Seattle Cancer Care Alliance
Staff
The Clinical Research Billing Cycle: Staff Role in Research Budget
10:40 am – 11:40 pm
The clinical research billing cycle is a complex process that involves multiple offices billing both clinical and study tests to the patient and the study budget. This session will provide an overview of a typical clinical research billing cycle, and highlight hand-offs between billing offices and members of the research team to prevent errors.
Speaker
Kurt Schaeffer
Associate Director, Clinical Research Billing Office
Seattle Cancer Care Alliance
Wednesday
11:40 pm – 12:40 pm
All Attendees
Lunch Break
11:40 pm – 12:40 pm
Wednesday
12:45 pm – 1:45 pm
Faculty
Research Budget Oversight: Tips for Responsible Financial Management
12:45 pm – 1:45 pm
Understanding the costs and financial commitments is essential to securing financial support commensurate with the research plan. This session will guide you through the development of a financial plan to keep your studies on target.
Speakers
Nora Disis, MD
Associate Dean for Translational Health Sciences, School of Medicine
University of Washington
Lauren Corulli
Lab Manager, Cancer Vaccine Institute
University of Washington
Staff
Clinical Trial Management Systems: A One Stop Solution
12:45 pm – 1:45 pm
Clinical Trials Management Systems (CTMS) integrate the multiple components of clinical research, such as billing, implementation timelines, and reporting guidelines. This session will describe the role of a CTMS and give a demonstration of the CTMS that will be rolled out at UW, SCCA, and Fred Hutch.
Speaker
Jason Morrison, MBA, PMP
Director of Research Information Technology
University of Washington
Wednesday
2:00 pm – 3:00 pm
Faculty
An Ethical Framework for Clinical Research: Rethinking and Going Beyond Informed Consent
2:00 pm – 3:00 pm
In this session you will learn about eight ethical benchmarks for clinical research and apply them to cases to understand the trade-offs involved in ethical analysis.
Speakers
Seema Shah, JD
Faculty, Treuman Katz Center for Pediatric Bioethics
Seattle Children’s
Stephanie Kraft, JD
Acting Instructor, Treuman Katz Center for Pediatric Bioethics
Seattle Children’s
Ben Wilfond, MD
Director, Treuman Katz Center for Pediatric Bioethics
Seattle Children’s
Kathryn Porter, JD, MPH
Research Associate
Seattle Children’s
Staff
Accelerating Study Initiation: Institutional Resources to Catalyze Study Design
2:00 pm – 3:00 pm
Learn sound methods to determine how best to approach implementing a new study, and apply elements of project management to organize the financial, timeline, institutional oversight, and research support resources to move your study through the start-up process.
Speaker
Ashley Waldie, MA, CCRP
Operations Manager
Fred Hutchinson Cancer Research Center
Wednesday
3:10 pm – 4:10 pm
Faculty
Adverse Event Vigilance: The Intersection of Patient Safety, Treatment Risks & Compliant Reporting
3:10 pm – 4:10 pm
This session will give you insights into the importance of comprehensive identification, tracking, and reporting of events experienced by research participants in your studies, and provide best practices for mitigating common issues around adverse event documentation.
Speaker
Reina Hibbert, CCRC
Regulatory Affairs Coordinator/Manager
Seattle Cancer Care Alliance
Staff
An Ethical Framework for Clinical Research: Rethinking and Going Beyond Informed Consent
3:10 pm – 4:10 pm
In this session you will learn about eight ethical benchmarks for clinical research and apply them to cases to understand the trade-offs involved in ethical analysis.
Speakers
Seema Shah, JD
Faculty, Treuman Katz Center for Pediatric Bioethics
Seattle Children’s
Stephanie Kraft, JD
Acting Instructor, Treuman Katz Center for Pediatric Bioethics
Seattle Children’s
Ben Wilfond, MD
Director, Treuman Katz Center for Pediatric Bioethics
Seattle Children’s
Kathryn Porter, JD, MPH
Research Associate
Seattle Children’s