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Faculty Sessions

Agenda

8:00-8:30am

Registration & Breakfast

8:30-9:20am

Keynote: Working Toward a Cure in Hemophilia

Description to come

Speaker

Barbara Konkle, MD

9:30-10:30am

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.

Speaker

Paul Martin, MD

10:40-11:40am

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.

Speakers

Nora Disis, MD

Lauren Corulli

11:40am-1:00pm

Lunch Break

1:00-2:00pm

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.

Speaker

Ted Gooley, PhD

2:00-2:15pm

Break

2:15-3:15pm

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.

Speaker

Ben Wilfond, MD

3:25-4:25pm

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.

Speaker

Jason Malone, MPA, CIP

8:00-8:30am

Continental Breakfast

8:30-9:30am

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.

Speakers

Jennifer Sprecher

Nicole Summerside, MHA

9:40-10:40am

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.

Speaker

Andrei Shustov, MD

10:50-11:50am

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.

Speaker

Emily Cox, PhD

11:50am-12:45pm

Lunch Break

12:45-1:45pm

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.

Speaker

Ann Melvin, MD, MPH

1:45-2:00pm

Break

2:00-3:00pm

Networking Activity TBD

Description to come