8:00 - 8:15 Registration and Continental Breakfast
8:15 - 8:30 Welcome and Introduction
8:30 – 9:45 Clinical Research Professionals’ Responsible Oversight of Artificial Intelligence
David Vulcano, MBA, VP Clinical Research Compliance & Integrity, HCA Healthcare
Mr. Vulcano will provide a high-level overview of key considerations that clinical research professionals and those with research compliance and/or human subject protection oversight should be knowledgeable of given the emergence of Artificial Intelligence (AI) technology. He shall review existing and emerging regulations that govern this new technology, trends in voluntary organizational oversight programs, regulatory details on performing research on AI as a clinical product, successes and lessons learned when deploying AI-enhancements to activities across the research lifecycle and finally a projection of the impact on the profession. He will also reference additional privacy risk and risk mitigation when developing AI on personal information for research purposes.
9:45 - 10:45 The Use of Artificial Intelligence in the Development of Informed Consent Documents for Research Participants
Cheryl Jacobs, BS
The use of Artificial Intelligence (AI) is expanding in all areas, including clinical research. This technology can be used to assist in writing informed consent documents and to facilitate the informed consent process. Use of AI assistants in informed consent form (ICF) development will be demonstrated. AI is not perfect and, therefore, the need for human review of output and interaction with the technology is a must. Discussion will include legitimate concerns about and the current regulatory environment regarding their use.
10:45 – 11:00 Break
11:00 - 12:00 The Times and the FDA are Changing, Are you?
Catherine Gregor MBA, CCRP, Chief Clinical Trial Officer, Florence Healthcare
The landscape of clinical trials continues to shift thanks to the rapid infusion of technology and an increased emphasis on inclusion and access. As a result, the FDA and Congress are reevaluating their stance. Attendees will understand the tenets of specified guidance documents and how they apply to them, gain insights into operational best practices for running trials in 2025 and understand how government policy decisions impact FDA guidance and operational realities in clinical trials areas in order to further speed the path to innovation. However, these changes in policy can present operational challenges for sites and sponsors in the day-to-day management of trials and patient care. This session will run through the latest guidance changes and what they mean for sites and sponsors in 2025.
12:00 – 1:00 Lunch
1:00 - 2:00 Innovative Strategies for Evaluating and Managing Study Coordinator Workload
Jeanette Graf, BS, CCRP, Research Program Manager, Medical College of Wisconsin
Amy Blair, BA, Clinical Research Coordinator III, Medical College of Wisconsin
To effectively manage study coordinator workload, it's essential to use assessment tools that evaluate tasks based on study complexity and protocol requirements. Regularly monitoring and adjusting workloads can prevent burnout and ensure high-quality research. Additionally, providing ongoing training and support helps coordinators manage their responsibilities efficiently. This approach not only improves job satisfaction but also justifies the need for additional resources when necessary.
2:00 - 3:00 CRA Experiences, What’s Your Story?
Michelle Brignac, MPA, CIP, CCRP, Senior Manager of Clinical Research Operations, St. Jude Children’s Research Hospital
Many institutions have research requirements beyond the regulatory requirements required by laws. This talk will discuss institutional nuances, institutional policies and guidance’s and successfully navigating the research landscape at an institutional level.
3:00 - 3:15 Break
3:15 - 4:15 Decentralized Clinical Trials: What are they, and why should I care?
Daniel Redline, BA, CCRP, Senior Director, Global Clinical Affairs, Align Technology
Decentralized clinical trials (DCTs) have been around for years, but they gained lots of visibility and support during the COVID-19 pandemic. Given their continued importance and popularity, the FDA in 2024 released a guidance on DCTs to help ensure compliance and proper oversight. Dan will describe DCTs and discuss best practices relative to the guidance to help ensure human subject protection.
4:15 – 4:45 Day One Discussion/ Q&A
Wendy Lloyd, BA, CCRP, LPN, Senior Clinical Research Quality Analyst-Education, Vanderbilt University Medical Center
Join conference speakers and fellow attendees for this opportunity to engage with the speakers and delve deeper into the topics of the day.
8:00 - 8:30 Registration and Continental Breakfast
8:30 - 9:45 Enhancing Quality Research Through Internal Audits and Competency Development at an Academic Center
Michelle Dewey, BS, Senior Clinical Research Quality Analyst, Vanderbilt Coordinating Center
Wendy Lloyd, BA, CCRP, Senior Clinical Research Quality Analyst - Education, Vanderbilt University Medical Center
This presentation highlights the exceptional services provided by our Coordinating Center department in coordinating multi-center studies and supporting investigators in conducting research at our academic institution. We achieve this through our integrated approach to Auditing, Compliance, and Education (ACE). Through thorough internal audits, we continually reassess the quality of our work and strive for excellence in research. These audits not only highlight areas for improvement but also directly influence the development of our educational programs.
9:45 - 10:45 A Self-paced Virtual Research Boot Camp: A Unique Use of REDCap to Train Research Staff
Natalie Dilts, MPH, Principal Research Strategy & Program Specialist, Vanderbilt University Medical Center
This presentation will educate attendees on how to use REDCap to develop a free online, self-paced training course to meet all of their staff education needs, including Good Clinical Practice, human subjects protection, and protocol-specific training. The use-case scenario will show attendees how REDCap was utilized to share pre-recorded training videos, enable features to ensure viewership and prevent skipping ahead, deliver interactive quizzes to test for understanding and knowledge, and provide a certificate of completion at the end. Upon conclusion, attendees can consider tailoring this resource for their own unique staff training needs.
10:45 – 11:00 Break
11:00 - 12:00 Clinical Research Site Challenges and Opportunities for Improvement
Wendy Lloyd, BA, CCRP, Senior Clinical Research Quality Analyst - Education, Vanderbilt University Medical Center
Ms Lloyd will present a portion of the results from a WCG™, 2024 Clinical Research Site Challenges Report. She will discuss the top challenges facing clinical research sites, the cause for increased complexity of clinical trials, staff turn over trends and study start up challenges. Following the survey results she will facilitate break out sessions for the small groups to network and discuss their challenges and come up with possible solutions and/or discuss possible solutions for those revealed in the survey.
12:00 – 1:00 Lunch
1:00 - 2:15 Break Out Session - Discuss Challenges and Suggest Improvements
Course Faculty
Attendees will collaborate to identify research site challenges based on survey results or team members' institutions. They will also have the opportunity to brainstorm potential solutions and improvements.
2:15 – 2:30 Break
2:30 – 3:15 Present improvement suggestions
Course Faculty
Attendees will have the opportunity to share their identified challenge and suggestions for improvements.
3:15 – 3:45 Day Two Discussion/Q&A
Wendy Lloyd, BA, CCRP, LPN, Senior Clinical Research Quality Analyst-Education, Vanderbilt University Medical Center
Join conference speakers and fellow attendees for this opportunity to engage with the speakers and delve deeper into the topics of the day.