Thursday
2018 Introduction to Clinical Research Boot Camp
Thursday, June 7, 2018
8:30 am – 9:30 am
Faculty
Responsibilities and Oversight Obligations: The Critical Role of the Principal Investigator
8:30 am – 9:30 am
This is a deep dive into the critical leadership role of the Principal Investigator for a clinical trial. You will work through case studies that highlight important compliance responsibilities, quality assurance, and methods to manage the clinical research team.
Speaker
Ann Melvin, MD, MPH
Associate Professor, Pediatrics
Seattle Children’s
Staff
Leveraging the EMR: Tools & Rules for EMR Research Data Acquisition
8:30 am – 9:30 am
Electronic medical records (EMR) are a common source of clinical research data. In this session, you will learn about the tools and resources available to optimize the EMR to identify potential research participants and run custom reports to quickly create a data set, as well as how to comply with EMR privacy rules when using protected health information.
Speaker
Beth Britt, PhD
Director of Analytics, School of Medicine
University of Washington
Thursday
9:40 am – 10:40 am
Faculty
Protocol Design: Balancing Scientific Validity with Ethical Approaches and Pragmatic Operations
9:40 am – 10:40 am
Poorly designed protocols can result in recruitment problems, inadequate or unreliable data, protocol deviations, and safety issues. This session will guide you through the process of planning and writing a clinical research protocol from the perspective of the Good Clinical Practice (GCP) protocol guidelines to ensure successful implementation of your research study.
Speaker
Thomas Fleming, PhD
Professor, Biostatistics
University of Washington
Staff
Clinical Trial Documentation: Essential Recordkeeping for Compliance
9:40 am – 10:40 am
This session provides an overview of essential clinical trial documentation for investigative sites involved in FDA regulated drug trials. Attendees will be able to describe why documentation is integral to conducting compliant and ethical clinical research, understand the various types of documentation required throughout a study life cycle, review samples of pertinent data tools and strategies for proper management, and engage in a hands on activity to further the learning.
Speakers
Kersten Brinkworth, CCRC
Training Program Manager
Fred Hutchinson Cancer Research Center
Claudia Moore, MSc
Regulatory Program Operations Manager
Fred Hutchinson Cancer Research Center
Thursday
10:50 am – 11:50 am
Faculty
Return of Research Results: From Design to Delivery
10:50 am – 11:50 am
This session will discuss best practices for study designs that will support efficient reporting in publications, ClinicalTrials.gov, and other reporting requirements.
Pre-read materials: Information for the Researcher about ClinicalTrials.gov
Speaker
Ted Gooley, PhD
Director, Clinical Biostatistics Program
Fred Hutchinson Cancer Research Center
Ted Gooley, PhDStaff
The Human Research Protection Program: Cultivating a Partnership with your IRB
10:50 am – 11:50 am
Institutional Review Boards (IRBs) have a federal mandate to facilitate research that protects the rights, safety, and well-being of research participants. By establishing a collaborative relationship with your IRB office, you can minimize misunderstandings, efficiently move your studies through the work flow, and together promote safe, ethical, high quality research.
Speaker
Adrienne Meyer, MPA, CIP
Assistant Director for Research Support, Human Subjects Division
University of Washington
Thursday
11:50 pm – 12:40 pm
All Attendees
Lunch Break
11:50 pm – 12:40 pm
Thursday
12:45 pm – 1:45 pm
Faculty
Noncompliance, Unanticipated Problems & Complaints: Learn to Prevent, Correct and Report
12:45 pm – 1:45 pm
Problems happen in every research study. This session will provide several compliance case studies to work through in order to highlight some common issues, what you can do to avoid serious problems, and what resources are available when things do go wrong.
Speaker
Jason Malone, MPH
Assistant Director for Regulatory Affairs, Human Subjects Division
University of Washington
Staff
ClinicalTrials.gov: Your Role in Providing Public Access to Trials & the FDA/NIH Rules
12:45 pm – 1:45 pm
This session will provide an overview of the federal requirements for registering and maintaining study information on ClinicalTrials.gov, and give tricks and tips to help you hasten the process.
Speaker
Tania Bardyn, MLIS, AHIP
Associate Dean of University Libraries
University of Washington
Thursday
2:00 pm – 3:00 pm
Faculty
Closing Panel: Engaging Your Team: Fostering an Integrated Team Toward Study Success
2:00 pm – 3:00 pm
What does a successful research team look like? How do these teams foster the implementation of high quality research in a productive team environment? We will hear from faculty-staff teams about how they successfully navigate the research process and maintain team engagement. Audience members will have a chance to ask questions of these teams.
Panel
Amy Good, PhD
Manager, Research Coordination Center, ITHS
University of Washington
Chessa Goss, MSc
Research Coordinator, ITHS
University of Washington
Kevin Conley, PhD
Professor, Radiology
University of Washington
Jeanne Hoffman, PhD
Professor, Rehabilitation Medicine
University of Washington
Kevin Gertz
Research Manager
University of Washington
Kevin Gertz