Registration & Breakfast
Keynote: Working Toward a Cure in Hemophilia
Description to come
Barbara Konkle, MD
The Human Research Protection Program: Cultivating a Partnership with your IRB
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.
Adrienne Meyer, MPA, CIP
The Clinical Research Billing Cycle: Staff Role in Research Budget
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.
Clinical Trial Management Systems: A One Stop Solution
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.
Accelerating Study Initiation: Institutional Resources to Catalyze Study Design
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.
Ashley Waldie, MA, CCRP
An Ethical Framework for Clinical Research: Rethinking and Going Beyond Informed Consent
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.
Ben Wilfond, MD
The Protocol Review: How to Read for both the Big Picture and Your Responsibilities in Implementing a Study
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.
Amy Good, PhD
Increase Study Success Through Integration of Team Science Competencies
Innovation success depends not on the combining of the best people but on creating the most psychologically safe environment. A creative team environment can be intentionally created and anyone can contribute to that creation. Collaborative problem solvers are made—not born. Nearly two-thirds of recent graduates believe they can effectively work on teams, but only one third of manages agreed. In fact, the less competent you are, the less accurate your self-assessment of your own competence. This session will provide insights and resources focused on starting your team off on the right path. You will walk away with both tools and resources to increase your team’s effectiveness and efficiency.
Nicole Summerside, MHA
Leveraging the EMR: Tools & Rules for EMR Research Data Acquisition
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.
Bas de Veer
ClinicalTrials.gov: Increasing the Transparency of Clinical Research
This session will introduce attendees to ClinicalTrials.gov and its importance in the clinical research process. We’ll discuss the contents of ClinicalTrials.gov; legal, NIH, and publisher requirements for submitting data; and how this resource benefits researchers and the public. In illustrating the benefits of ClinicalTrials.gov, we’ll focus on its role in increasing the transparency of clinical research and how that contributes to sound scientific practices, public accountability, and opportunities for patients.
Diana Nelson Louden, MLIBR
Networking Activity TBD
Description to come.