Registration & Breakfast
Keynote: Working Toward a Cure in Hemophilia
Description to come
Barbara Konkle, MD
Physician vs. the Physician-Investigator: Is There a Difference
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.
Paul Martin, MD
Research Budget Oversight: Tips for Responsible Financial Management
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.
Nora Disis, MD
Return of Research Results: From Design to Delivery
This session will discuss best practices for study designs that will support efficient reporting in publications, ClinicalTrials.gov, and other reporting requirements.
Ted Gooley, PhD
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
Noncompliance, Unanticipated Problems & Complaints: Learn to Prevent, Correct and Report
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.
Jason Malone, MPA, CIP
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
Protocol Design: Balancing Scientific Validity with Ethical Approaches and Pragmatic Operations
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.
Andrei Shustov, MD
The Study Start-Up Process: Navigating the Sequence and Timing of Reviews, Approvals, and Resources Before Your Study Starts
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.
Emily Cox, PhD
Responsibilities and Oversight Obligations: The Critical Role of the Principal Investigator
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.
Ann Melvin, MD, MPH
Networking Activity TBD
Description to come