When you arrive in Orlando, make your way to the registration desk (Convention Level) to receive your conference badge and essential materials, ensuring you're fully equipped for ACRP 2026.
If you have questions or need assistance throughout the conference, the registration desk is where you’ll find the answers you seek.
Start your day with a delicious breakfast and engaging conversations in the Plaza/Regency Foyer on the final day of ACRP 2026.
The challenge we all face in clinical research is how we balance home life and work life. This session, led by experienced monitors in the medical device industry, will explore practical tools and strategies for achieving work-life integration and a healthy balance. From managing traveling, achieving critical trial deadlines, managing a high site load, resolving queries, writing monitoring visit reports, navigating challenging site discussions, and working in a high-pressure environment, this question becomes critical: Where do we draw the line for work?
Speakers will share real-world experiences as well as tips on self-reflection, prioritization, boundary-setting, and difficult conversations. This session will also touch on the positive impact remote monitoring and risk-based monitoring strategies have had on improving monitor workload and balance.
To be productive in fast-paced clinical trials, we must prioritize our work-life balance just as we prioritize our work deliverables. This session can help ignite that mindset change.
CEU: 1.00 ACRP
Speakers:
Minoritized populations have historically been underrepresented in clinical trials. Speakers for this panel from a research center located in an underserved California community that is 80% Latino have found that observational trials—when strategically implemented—can build trust and engagement. Panelists will share their experiences with an Alzheimer’s disease observational study that became a catalyst for broader community involvement. The site achieved top-three national enrollment, increased Latino participation, and fostered partnerships with local community centers and adult day programs. The effort significantly improved health literacy and facilitated acceptance of interventional Alzheimer’s trials. The center's site director, manager, study coordinator, pre-screener/recruiter, and community engagement representatives will highlight key strategies across all stages of the trial, demonstrating how observational studies can enhance community engagement, reduce stigmas related to trial participation, and lay the foundation for future research.
CEU: 1.00 ACRP
Speakers:
Alessandra Castañeda, Regulatory Specialist (Research Assistant), Sun Valley Research Center
Leslie Michelle Dowling, Site Manager, Sun Valley Research Center
Judy Galindo, CCRC, Executive Director & Site Co-Owner, Sun Valley Research Center
Vanessa Nuño, Community Engagement Representative, Sun Valley Research Center
Rosalia Tanory, Pre-Screener/Recruiter, Sun Valley Research Center
In the clinical research industry, the importance of cultivating strong, trusted relationships between sponsors, sites, and patients is widely acknowledged as a key factor for clinical trial success. However, building and nurturing these relationships can be more challenging than it may appear. Upon closer examination of the underlying issues reveals that communication barriers and a lack of mutual understanding between stakeholders often hinder trial efficiency. This session will explore how professionals with experience on both the site and sponsor side of clinical research are uniquely positioned to bridge the gap. By providing sponsors with valuable insights into site challenges and patient needs while simultaneously empowering sites to better understand the sponsor’s objectives, we aim to foster the right relationships necessary for effective collaboration. When executed correctly, this approach can improve recruitment and retention, ensure higher data quality, and ultimately lead to more successful trials.
CEU: 1.00 ACRP
Speakers:
Summer Borsack, Associate Clinical Research Associate, Merck
Doris Chang, Associate Clinical Research Associate, Merck
Protocol deviations, if not properly identified and addressed, can jeopardize participant safety, data integrity, and trial credibility. The FDA’s December 2024 draft guidance on "Protocol Deviations for Clinical Investigations" introduces clearer expectations around assessing, categorizing, and reporting deviations, especially those deemed “important.” This session will provide attendees with a practical framework to align their practices with the evolving regulatory landscape. Through real-world case scenarios and an interactive exercise, participants will learn how to evaluate deviations using a risk-based approach and strengthen communication with institutional review boards and sponsors. We will also analyze emerging tools, including automation and artificial intelligence, that support proactive deviation detection and inspection readiness. Designed for clinical operations teams, site staff, and quality assurance professionals, this session combines compliance essentials with forward-looking strategies.
CEU: 1.00 ACRP
Speakers:
Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, President, Assured of Quality Consulting & Training
Meghana Rao, Sr. Manager, Clinical Trial Lead, Olema Oncology
Kaushal Shah, PhD, Director & Clinical Associate Professor, Clinical Research Management & Regulatory Science Programs, Arizona State University
As the ICH E6(R3) guideline reshapes expectations for Good Clinical Practice, organizations must go beyond compliance to embed risk-based thinking and critical-to-quality practices across functions. This panel brings together senior leaders to share firsthand experiences of putting the new guideline into practice—from big-picture strategy to everyday decision-making. Panelists will discuss how critical thinking supports better choices, where risk-based approaches add the most value, and lessons learned in leading the cultural mindset shift needed for sustainable quality practices. Attendees will walk away with practical strategies to lead change, collaborate across functions, and build systems that last.
CEU: 1.00 ACRP
Speaker:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Join us for an inside look at how the Center for Clinical Research Management (CCRM) transformed its onboarding approach to meet the evolving needs of today’s clinical research environment. This session explores the creation of a scalable, flexible, and role-specific training program that balances standardization with individualization. Discover how platforms like Microsoft Teams, REDCap, and OnCore CTMS were integrated to enhance training, compliance, and collaboration. We’ll share key lessons, data insights, and practical tips to help you build or refine your own onboarding systems.
CEU: 1.00 ACRP
Speakers:
Amber Anaya, MS, CCRP, Clinical Research Manager, The Ohio State University
Kelly Dunsky, MS, CCRC, Associate Director of Clinical Research Operations, The Ohio State University
This fast-paced, highly interactive lecture helps clinical research and quality professionals move beyond terminology and into real-life application. Participants will examine practical strategies and thinking to implement oversight, Quality by Design (QbD), and risk-based thinking in day-to-day trial decisions. Drawing on ICH E6(R3) expectations and real-world examples from both site and sponsor perspectives, the session includes guided activities and tools that help translate regulatory concepts into operational action. Attendees will also gain bonus takeaways that demystify two additional ICH E6(R3) expectations—data governance and fit-for-purpose thinking—showing how these newer terms apply to documentation, system design and oversight, and proportional quality approaches. Interactive elements such as Buzzword Bingo and a closing Jeopardy-style quiz reinforce key concepts and encourage critical thinking. This session is ideal for site and sponsor professionals seeking clarity, confidence, and practical insight into applying ICH E6(R3) in the real world.
CEU: 1.00 ACRP
Speaker:
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Clinical research coordinators (CRCs) are the backbone of trial execution, yet many sites lack a structured, competency-based approach to support their development beyond onboarding. This session introduces a tiered CRC Competency Checklist designed to guide coordinators from beginner through advanced levels of practice. Originally developed for an independent research site, the checklist integrates the Joint Task Force Core Competency Framework and ACRP’s CRC Competency Development and Assessment Roadmap with practical, observable skill demonstrations—promoting role clarity, professional growth, and high-quality performance. Attendees will explore how this adaptable tool fosters ongoing workforce training, simplifies evaluations, and builds a culture of excellence. This session is designed for mid-level professionals seeking to improve training programs and enhance team performance. This session aligns with ACRP’s Workforce Development and Training focus by offering a sustainable method to invest in the growth and retention of CRCs across the industry.
CEU: 1.00 ACRP
Speakers:
Jesse Fuhriman, Clinical Research Coordinator, Rocky Mountain Clinical Research
Brittani Holden, Certified Senior Clinical Research Coordinator, Rocky Mountain Clinical Research
Kelsie Wetzel, Certified Senior Clinical Research Coordinator, Rocky Mountain Clinical Research
This session will explore the goals of, and lessons learned from, migrating clinical trial data between two different electronic data capture (EDC) systems. Attendees will gain insight into preparing for and executing data migration, including data mapping and validation strategies. We will highlight challenges such as mapping issues, EDC differences, data integrity, and disruptions to study sites. We will discuss investigator site support, new tool training, and data collection during EDC downtime. Real study examples will highlight planned processes versus actual tasks completed. This session will outline best practices for enhancing study-team communication, managing timelines, and maintaining data quality. By the end of this session, attendees will understand the steps needed for planning a data migration, supporting sites during the migration, and applying lessons learned to maintain data integrity and prepare for future EDC transitions. This session is ideal for data managers, clinical operation staff, site staff, and investigative teams.
CEU: 1.00 ACRP
Speakers:
Diana Cunningham, MEd, Senior Director of Data Solutions, TRiNDS LLC.
Abby Loden, MPH, Lead Data Manager, TRiNDS LLC.
Clinical studies rely on seamless collaboration between sponsors, contract research organizations (CROs), and site teams. However, misalignment, communication breakdowns, and unclear expectations can slow progress and lead to frustration across all teams. This session will explore how to strengthen these essential relationships to accelerate study timelines, improve data quality, and reduce burnout. Drawing on real-world case studies and audience input, we’ll examine the most common pitfalls in sponsor-CRO-site dynamics and offer practical strategies to drive collaboration and trust.
CEU: 1.00 ACRP
Speakers:
Anna Rillo, BSN, RN, Associate Study Director, Bright Research
Claire Swan, Clinical Research Associate, Bright Research
Manual data entry drains site resources and delays trial timelines, especially as studies grow in complexity, volume, and number of sources. However automated electronic health record-to-electronic data capture (EHR-to-EDC) integration can dramatically reduce site burden when it’s designed with usability in mind. This session explores what it really takes to make eSource and EHR-to-EDC work for sites: no new systems, no additional logins, no information technology support—just streamlined, intuitive workflows that fit naturally into how research coordinators already work, drawing on experiences from dozens of oncology trials across academic and commercial research settings. Attendees will gain actionable insights on how EHR-connected workflows can save time, reduce errors, and improve monitoring through traceable data capture, plus practical best practices for improving execution, supporting smarter source data verification, and scaling eSource without added complexity.
CEU: 1.00 ACRP
Speaker:
Samir Jain, VP, Product Management, Healthcare Data Interoperability and EHR Solutions, Medidata, Dassault Systemes
Participant payments, reimbursements, and compensation policies vary widely across sponsors, sites, and geographies—leading to confusion, inequity, and potential barriers to enrollment. This session will explore the current landscape of participant benefits in clinical trials and propose a framework for standardization that balances ethical, operational, and regulatory considerations. Drawing on real-world case studies, stakeholder feedback, and emerging policy trends, we will present actionable strategies to modernize and harmonize how we support trial participants—especially those from underrepresented communities.
CEU: 1.00 ACRP
Speaker:
Jessica Propps, ACRP-CP, Clinical Operations Manager - Regulatory, Merck
Clean data don't just fall from the sky. They are the result of smart systems, agile teamwork, and strong protocol design. We’ll walk through real-world cases involving National Institutes of Health-funded clinical trials launched during the pandemic and adapted for decentralized and hybrid delivery models. Attendees will learn how to navigate complex databases even when study teams lack experience with Good Clinical Practice, design usable workflows from complicated protocols, and handle unexpected data management hurdles. We’ll share wins, near-misses, and lessons learned from integrating mobile apps, multiple electronic data capture platforms, Veterans Affairs systems, and real-time secure file transfer protocols. We’ll tie it all together using coordination science principles to show how better communication, shared understanding, and team alignment can lead to cleaner data and fewer deviations. Come for the strategy, stay for the stories, and leave with tools to clean up your own data chaos.
CEU: 1.00 ACRP
Speakers:
Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Program Director, University of Utah
Jamie Dwyer, MD, Assistant Vice President for Clinical Research, University of Utah
John VanBuren, PhD, Senior Faculty Biostatistician, University of Utah
Sponsors are revolutionizing the site experience by leveraging artificial intelligence (AI) to develop a survey automation tool, significantly simplifying the site feasibility survey process. This tool aims to reduce administrative burdens, enhance data accuracy, and provide real-time support, making it easier for sites to participate in clinical trials. Beyond current metrics, AI is also employed to identify the best-fit sites by creating an optimal potential site list based on extensive priorities. This includes tiering sites according to past performance, quality, and proximity to diverse catchment areas. By integrating these advanced AI-driven techniques, sponsors ensure that the site selection process is efficient, inclusive, and of the highest quality. These efforts not only streamline operations but also foster stronger collaborations with sites, ultimately advancing clinical research and improving patient outcomes.
CEU: 1.00 ACRP
Speaker:
Bonnie Lam, Feasibility, Strategy and Analytics Lead, Pfizer Inc.
Patient recruitment and retention can be enhanced by understanding patients, building strong relationships, and fostering a connected, engaged community. This session explores the paradigm shift from enrolling participants on a trial-by-trial basis to encouraging lifelong recruitment. Patients who feel part of a community and have strong relationships with sites are more likely to stay in studies and participate in future trials. The presenter will share strategies and tactics for turning the non-qualified leads--the hidden treasure for recruitment--into members of the patient community. Recruiting from this community is both efficient and cost effective. Through interactive polling and real-world case scenarios, this session demonstrates how a retention-first approach improves outcomes, reduces recruitment burden, and lowers costs. Attendees will leave with practical tools that they can apply immediately at their sites.
CEU: 1.00 ACRP
Speaker:
Anuj Bhargava, MD, MBA, CDCES, FACP, FACE, Founder, CEO & Medical Director, Iowa Diabetes
A site’s greatest asset isn’t its technology—it’s its people. As clinical trials grow in complexity, building confident, capable teams is essential for quality execution and staff retention. This session introduces a practical, mentorship-based approach to empower site staff at all levels, drawn from real-world experience leading clinical teams through change and growth. Attendees will learn how structured onboarding, peer mentorship, and ongoing development improve protocol compliance, morale, and team stability. Whether you're training new coordinators, addressing burnout, or fostering internal leadership, this session offers actionable tools to strengthen site performance by investing in your people.
CEU: 1.00 ACRP
Speaker:
Dean Jang, Site Director, IMA Clinical Research
To engage the future clinical research workforce earlier, our team created a collaborative summer camp for high school students. This session explores the facilitators and barriers to designing and implementing a curriculum across multiple academic institutions. Attendees will learn strategies to address challenges such as inter-institutional coordination, resource allocation, and maintaining consistent quality and engagement. We will share insights on effectively reaching high school students and fostering their interest in clinical research. Key findings include identifying success factors and obstacles in multi-institutional collaboration, applying a team science framework, and integrating Bandura’s Four Elements of Social Learning Theory into lesson planning. We will also present our evaluation methods, including pre- and post-tests, self-efficacy measures, and participant feedback. Finally, we will introduce a comprehensive toolkit for replicating the camp model, featuring lesson plans, evaluation tools, and best practices.
CEU: 1.00 ACRP
Speaker:
Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor & Director, Master of Clinical Research and Certificate Programs, The Ohio State University
Fuel up with a tasty lunch and make the most of your final day at ACRP 2026—connect with colleagues, reflect on insights, and keep the momentum going.
This presentation explores how engaging communities at every stage of clinical research builds trust, promotes informed participation, and enhances recruitment efforts. The presentation will discuss various strategies for involving communities during the design, implementation, and dissemination of research findings, highlighting their benefits and challenges related to cost, feasibility, and timing; as well as sharing examples of successful community engagement initiatives. Attendees will learn how to identify the most effective engagement approaches for their studies and the importance of early community involvement in ensuring ethical and impactful research.
CEU: 1.00 ACRP
Speaker:
Bashar Shihabuddin, MD, MS, Assistant Professor, Nationwide Children’s Hospital
As clinical research evolves, sites are challenged to streamline workflows while upholding rigorous regulatory standards. This presentation outlines an evidence-informed approach to modernizing research conduct through informatics and digital tools. The session will deliver actionable strategies for integrating computerized systems into clinical research infrastructure—including electronic source documentation, e-regulatory platforms, and billing compliance automation. The session will explore key performance indicators to assess site health, lessons learned from multisite consultations, and practical guidance for regulatory alignment across varied geographic regions. Emphasis will be placed on optimizing research operations in academic settings, promoting digital transformation, and fostering global collaboration. Attendees will gain tools to assess and enhance site-level research operations; implement informatics systems that support regulatory integrity; and align compliance strategies with evolving state and federal guidelines. This session is ideal for clinical research professionals, site directors, and compliance specialists seeking to advance digital integration and sustain high-functioning research programs.
CEU: 1.00 ACRP
Speaker:
Candida Barlow, PhD, MSN, CRN-BC, RN, Director Clinical Research, Oklahoma State University Center for Health Sciences
As clinical research embraces digital transformation, traditional roles in data management and adjacent functions are rapidly evolving. The integration of artificial intelligence, automation, and advanced analytics is reshaping how we collect, clean, and interpret data, impacting not only data managers but also medical monitors, safety reviewers, and clinical monitors. This session will explore practical strategies for upskilling and reskilling existing talent to meet the demands of tomorrow's trials. Attendees will gain insights into identifying skill gaps, fostering a learning culture, and aligning workforce development with emerging technologies. We'll also discuss cross-functional implications and opportunities for collaboration as clinical operations and data oversight become increasingly interconnected. Whether you're leading teams or navigating change yourself, this session will provide a roadmap for talent transformation that keeps people at the center of innovation.
CEU: 1.00 ACRP
Speaker:
Tracy Parker, Vice President, Biometrics, Advanced Clinical
It's easy to recognize that a study is regulated by the U.S. Food and Drug Administration (FDA) when working on an industry-sponsored protocol under Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Even then, however, clinical research professionals face challenges with documentation, sponsor communications, and institutional review board (IRB) requirements, especially when investigator-initiated or multisite studies complicate regulatory matters. We will walk through key indicators of IND/IDE applicability, common misconceptions, and decision points that affect regulatory classification and IRB review. We’ll also explore emerging trends in regulation of artificial intelligence/machine learning-based products, companion diagnostics, radiation-emitting devices, and digital health technologies, so that participants will leave with practical decision tools, case-based examples, and communication tips to support confident and compliant conduct of FDA-regulated research.
CEU: 1.00 ACRP
Speaker:
Purna Garimella, MS, CIP, RAC, Director, Human Research Protection Program, Indiana University
The advancement and rapid utilization of artificial intelligence (AI) scribes and other AI assistant tools in the clinical space raise new questions about what constitutes "source" for data in healthcare settings. During this discussion, we will look at AI scribe programs that are currently being used at major hospitals and clinics accross the U.S. in order to identify concerns, discuss mitigations, and better understand what should be considered when conducting site qualification visits from a quality management perpective. For example: What is source when the orignial records/transcripts are not maintained? What is the role of investigators in ensuring accurate, artifically created notes and care plans? Does the institution have plans in place to ensure data integity in the age of AI-generated notes?
CEU: 1.00 ACRP
Speaker:
Michele La Badie, ACRP-CP, ACRP-MDP, ACRP-PM, Clinical Trial Manager, Shoulder Innovations
Training is an integral piece of the onboarding process for new staff in clinical research, but is often not approached systematically with evidence-based methodology. This session offers a framework for building efficacious and engaging orientation and training programs that emphasize problem-solving and critical thinking. Attendees will gain skills in identifying common areas of improvement in their own institution's programs and learn how to apply teaching theories and skills to improve their curriculum and align with Joint Task Force competencies. The presentation will culminate in reviewing methods of data collection to assess the impact of changes made to a training program.
CEU: 1.00 ACRP
Speaker:
Aja Macias, Clinical Research Educator, Stanford Cancer Institute
This session will describe the current state of clinical evidence planning for medical devices with respect to regulatory submissions (with emphasis on the expectations of the U.S. Food and Drug Administration and the European Union Commission) and broader business needs (e.g., reimbursement, support of claims). A description with specific examples of implementation of an integrated clinical evidence strategy and deliverables within medical device research and development (R&D) will be shared. Benefits and challenges encountered with clinical evidence planning and regulatory submissions for medical devices used in oncology settings will also be shared. Specific action points for organizations looking to build an integrated evidence strategy will be described and discussed.
CEU: 1.00 ACRP
Speaker:
Lisa Colton, Clinical Regulatory Lead, BSI
Regina Fulkerson, PhD, Director, Clinical Evidence Planning & Evaluations, Varian Medical Systems
Jamie Mangold, PhD, Clinical Evidence Planning & Evaluations Manager, Varian Medical Systems
Eric Sugalski, Founder & CTO, Archimedic
Maintaining optimal staffing levels to meet the dynamic nature of the clinical research environment effectively and efficiently has significant operational, financial, and compliance implications. Managing appropriate staffing levels across centralized offices requires communication, access to data, defined metrics, and an understanding of institutional processes. There are multiple mechanisms, tools, and resources to determine appropriate staffing levels for business roles to manage your clinical research portfolio. During this panel discussion, we will address various institutional methodologies for calculating full-time equivalent (FTE) needs and the data required to make informed decisions. This will help attendees identify opportunities for improving their infrastructure by exploring optimum staffing levels by task/function to promote quality research, meet sponsor expectations, and enhance workplace satisfaction levels in every role. We will also explore approaches to plan for growth and project future FTE needs.
CEU: 1.00 ACRP
Speakers:
Mindy Muenich, Senior Director, Huron Consulting Group
Shannen Nelson, Executive Director, Clinical Research Operations, Children’s Hospital Los Angeles
Stephanie Pabst, Assistant Vice President, Sponsored Research Services, Cincinnati Children’s Hospital Medical Center
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Study & Site Management Journey Sponsor
In the world of research and development, we often think about new and emerging technologies, cutting-edge ideas, and innovative approaches. What if we could also strengthen the foundations by developing core competencies? The goal of this presentation is to highlight the importance of establishing and maintaining a healthy relationship between sponsors and research sites. This relationship highly relies on the competencies of the clinical research associate (CRA) to create and nurture this connection whatever the situation is (database lock, recurring issues/deviations, late sponsor payments, etc.). The presentation will focus on key strategies for maintaining effective communication and addressing common challenges. By promoting mutual respect and understanding, the CRA can ensure that both sponsors and sites work harmoniously toward common objectives. Emphasis will be placed on practical tips and real-world examples, exploring the Dos and Don’ts, important soft skills, and management of difficult conversations--ultimately aiming to enhance the effectiveness of clinical trials through strong and cooperative relationships.
CEU: 1.00 ACRP
Speakers:
Amine Sehboub, BSc, PgD, Pharm, Clinical Research Associate, Syneos Health
Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
Related Blog Content:
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Study & Site Management Journey Sponsor
In this session, we will explore the often-overlooked financial and operational costs associated with implementing diversity and inclusion (D&I) practices in clinical research, and practical strategies to mitigate these costs. While the benefits of D&I are widely recognized, understanding and addressing the hidden costs can help organizations create more effective and sustainable strategies. By enhancing their competencies and skills in this area, attendees will be better equipped to implement effective and sustainable D&I practices in their organizations.
CEU: 1.00 ACRP
Speakers:
MaryAnn Bowman, Founder / CEO, ClinGRO Solutions
Mitchell Hilbe, CEO / Co-Founder, DiversiTrials
Related Blog Content
Study & Site Management Journey Sponsor
Clinical research professional shortages, high turnover rates, and an increasingly competitive job market contribute to negatively impact the conduct and success of clinical research studies. Employing individual retention conversations to improve and foster retention is one strategy in addressing this issue. These conversations empower managers/leaders in addressing areas of concern impacting an organization’s workforce while building transparency and trust. Attendees will learn the benefits and gain practical skills in preparing for, participating in, and conducting individual retention conversations, focusing on creating a positive atmosphere, asking probing questions, actively listening, and developing action plans based on conversation outcomes. Participants will leave with strategies for continuous follow-up and ongoing professional development, ensuring a sustained positive impact on employee satisfaction and retention. Results from pilot study will be discussed.
CEU: 1.00 ACRP
Speaker:
Stephanie Freel, PhD, PMP, Director, Clinical Research Operations, Education & Outreach, Duke University
Lindsay Hanes, BS, CCRC, Clinical Research Manager, The Ohio State University Medical Center
Shirley Helm, MS, CCRP, Senior Administrator for Network Capacity and Workforce Strategies, Virginia Commonwealth University
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Research sites often grapple with the complexities of disbursing participant stipends and reimbursements. These challenges stem from unclear stakeholder roles, diverse payment methods (e.g., reloadable cards, cash, checks), federal tax rules, guardianship issues, and ethical considerations for providing payments for clinical trial participation. To address these hurdles, this session will explore creative approaches in this arena, including diverse methods for handling reimbursements, sponsor budget negotiation tactics, and technology systems for efficient and compliant management. The session will emphasize the importance of adhering to federal regulations while considering institutional organizational structures such as centralized or decentralized management of payments and reimbursements. The session will also give attendees the tools and strategies to determine the best solution for their organization.
CEU: 1.00 ACRP
Speakers:
Samantha Herbst, Manager, Huron Consulting Group
Shreya Singh, Senior Associate, Huron Consulting Group
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Study & Site Management Journey Sponsor
This session explores the current state of available clinical research workload tools and compares several similar adaptations of a specific tool for tracking productivity at various types of research programs. The focal model presented offers great flexibility in both oncology and non-oncology settings, as it allows for continuity of care amongst study coordinators for their study participants. The metrics presented can be used to justify new and existing employees for research programs running clinical trials predominately on the high end of the acuity continuum. Further, the metrics can be used to increase funding for additional coordinator and support staffing while improving study coordinator job satisfaction and retention at sites. This allows sites to achieve their enrollment goals and promote progress in their clinical research practice. In the wake of such improvements, research programs can expect more funding opportunities and greater success.
CEU: 1.00 ACRP
Speaker:
Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital
Related Blog Content:
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Study & Site Management Journey Sponsor
Is the crowded daily work routine at your study site reaching overwhelming proportions? Does it feel as if you have too many things to do and not enough hours in the day? You're not alone. We will discuss how to find support in one another in the workplace when our caseloads can seem overwhelming, share some valuable tools we have used to help us stay organized when we are responsible for multiple studies, and offer some tips and tricks to make onboarding new coordinators a breeze, especially when you feel like you don’t have the time! Teamwork makes the dream work. Join us for a great look at how an academic medical center handles a variety of studies and what we have found helps make us successful.
CEU: 1.00 ACRP
Speakers:
Hannah Culpepper, CCRC, Clinical Research Coordinator, Medical University of South Carolina
Stephanie Schorr, CCRC, Clinical Research Coordinator, Medical University of South Carolina
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Whether you’re new to negotiating budgets or have been doing it for years, budgets can be daunting—each budget is different, challenging, and full of ever-changing details. What shouldn’t change is how you handle budgets from one time to the next, so it’s time to standardize your budget review process. During this session, you’ll learn how to determine costs at your site and then maintain, track, and update those costs while implementing a plan to use what you’ve developed. We’ll also discuss how to review a protocol to uncover hidden costs that can then be factored into your budgets.
CEU: 1.00 ACRP
Speaker:
Matt Lowery, ACRP-CP, CCRC, CEO / Principal Consultant, The Pathways Grp, LLC
Study & Site Management Journey Sponsor
Over the last two decades, the landscape of clinical research has transformed dramatically with increased staffing needs, largely due to the dynamic nature of the field and escalating regulatory demands. Many clinical research stakeholders have developed workforce programs to address challenges in hiring, recruitment, education, and maintenance of a skilled research team, ultimately enhancing the caliber of clinical research. Opportunities to attract top-tier clinical research personnel are abundant in unconventional environments. Members of this panel will recount the unique paths they traveled along from atypical professions to their current roles in clinical research. Utilizing their adaptable skills, they have successfully transitioned to this sector, contributing their extensive relevant experience. As we tackle the issues of hiring and keeping a dedicated workforce, it is advantageous to consider candidates from non-standard clinical research backgrounds.
CEU: 1.00 ACRP
Speakers:
Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University School of Medicine
Sherry Huber, Clinical Research Nurse Coordinator, Senior, Duke University School of Medicine
Leadership & Professionalism Journey Sponsor
Using lessons learned from the implementation of the National Institutes of Health single institutional review board (IRB) mandate in 2018 and the Common Rule cooperative research provisions enacted in 2020, participants will explore how changes in the U.S. Food and Drug Administration (FDA) regulations requiring single IRB review, as proposed in 2022, would impact how clinical researchers get IRB approval for their studies. Building on the processes already in place nationally to have IRB review conducted by a single IRB, this session will discuss how the narrower scope of the FDA’s proposed single IRB requirements will necessitate that clinical research teams work more closely with their local IRBs and possibly the FDA prior to proposal submission. Participants will also learn more about the specific decision points required when considering whether the proposed FDA single IRB requirement applies to proposals.
CEU: 1.00 ACRP
Speaker:
Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
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The overall focus and goal of the session is to support attendees’ knowledge and skills on the key elements for building a successful investigator-initiated clinical trial protocol, with a specific focus on developing clinical trials in oncology. Participants will gain an understanding of how to effectively move research ideas from the bench to the bedside, beginning with the design of a feasibility assessment and feasibility review. The development of early protocol documents that are used to secure study drugs/devices and funding will be discussed, along with the planning strategies necessary for making the protocol as comprehensive and inclusive as possible (e.g., choosing entry criteria to enhance diversity and inclusiveness will be discussed).
CEU: 1.00 ACRP
Speaker:
Kimberly Bullock, PhD, CCRP, Director, Protocol Development Team and Associate Professor of Research, University of Virginia
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With a 30-year legacy, ACRP Certification is the most reputable credentialing program in clinical research, earned by more than 42,000 professionals around the world.
You may have considered ACRP Certification for your professional development but felt you didn't have the time, or it would be too expensive. Or perhaps you don't know where to start. Fear not, this 45-minute informal session can help!
ACRP certified professionals and staff will guide you through ACRP's flagship certification and specialty credential programs. They'll cover eligibility requirements, exam content, the application process, ACRP-developed resources to prepare for the exam, testing options, and what to expect after the exam. You will hear firsthand insights on the professional and personal benefits of ACRP Certification and have the opportunity to get your questions answered. Whether you're just curious about the certification process or ready to become certified, this session will equip you with the information needed to make your next move.
This session does not provide ACRP Contact Hours.
Speakers:
Steven Gonzalez, ICE-CCP, Director, Certification, Association of Clinical Research Professionals (ACRP)
Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health
This session will focus on helping attendees understand what undue inducement of human research subjects is and how to reconcile this with fair compensation for participating in clinical trials. Guidance documents regarding subject payment will be examined, as will the topics of how undue inducement might occur indirectly, and the delicate ethical balance between compensation as a tool for diversification and exploitation of vulnerable subject populations.
CEU: 1.00 ACRP
Speaker:
Steffi Leung Newell, MS, RN, OCN, CCRC, Clinical Research Nurse, Rush Medical Center
Related Blog Content:
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Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Clinical research is one of many industries being disrupted by rapid technological advancements, and while the number of vendors today is overwhelming, most agree that the overall tech experience remains poor (especially at the site level). With a need for tech transformation in mind, the audience will be challenged to consider what we can learn from disruptive technology that we’ve experienced as consumers ourselves; how real estate, marketing, eCommerce, and other arenas have evolved with the goal of an improved consumer experience as their driving force; and how we should be optimizing based on where other industries have found success. This interactive session will challenge all attendees, from novice to expert, to intentionally evolve our own industry based on what others have already learned.
CEU: 1.00 ACRP
Speaker:
Bree Burks, RN, MSN, Vice President of Strategy, Veeva Systems
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Effective data governance is crucial for organizations involved in clinical research for drug and medical device development. However, the implications of evolving European Union (EU) laws, such as the General Data Protection Regulation (GDPR), Clinical Trials Regulation (CTR), Medical Device Regulation (MDR), Artificial Intelligence (Ai) Act, and Data Act, bring many new challenges. This session will explore some of the key data privacy compliance challenges for contract research organizations and sponsors, sharing real-world business examples and insights. The implications of the CTR, MDR, AI Act, and other jurisdictional regulations will be explored, focusing on the complexities of processing EU/United Kingdom trial participants’ data. Guidance on when to appoint a data privacy officer and representative will also be provided. Attendees will gain a deeper understanding of how to identify the challenges posed by privacy laws, particularly the EU’s GDPR, and recognize what is required for effective data governance under the CTR and MDR.
CEU: 1.00 ACRP
Speaker:
Rob Masson, CEO, The DPO Centre
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How can sites decrease the most common non-compliance issues cited in regulatory inspections? The types and frequency of these findings have not changed significantly in the past decade. With increasing complexity in research protocols, quality remains a concern to regulatory authorities. While monitors play a significant role in ensuring site performance and compliance, U.S. Food and Drug Administration notices place the onus on site personnel. In this presentation, we will highlight areas of deficiencies seen over many years at investigator sites. We will also discuss common inspection findings and how to spot the pitfalls that sites need to address in order to ensure compliance in conduct, performance, and overall execution of clinical trials.
CEU: 1.00 ACRP
Speakers:
Suheila Abdul-Karrim, CCRA, FACRP, ACRP-MDP, MICR CSci, RQAP-GCP, Independent Clinical Research Consultant
Jerry Stein, PhD, FACRP, ACRP-MDP, ACRP-CP, President, Summer Creek Consulting, LLC , Independent Clinical Research Professional, Medical Writer, Consultant
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Study & Site Management Journey Sponsor
Clinical research represents a robust profession with many enticing factors: advancement opportunities, diverse skill application, good pay, and the potential to play a significant role in improving healthcare. However, development of a sustainable, diverse, and talented workforce has several known barriers. Among these are limited awareness of clinical research career and training opportunities compounded by a persistent catch-22 requiring prior work experience for entry-level positions. Here we explore a few of the innovative new models that are tackling these critical issues. From clinical research competency training in high schools, equity-focused internships, employer-based apprenticeship programs, and city-site partnerships to support economic development through CRP training and placement, employers and educators are using creativity and collaboration to reduce roadblocks and forge new pathways into the clinical research workforce.
CEU: 1.00 ACRP
Speakers:
Stephanie Freel, PhD, PMP, Director, Clinical Research Operations, Education & Outreach, Duke University
Olga Kishchenko, CCRP, Education Program Manager, UC Davis Health
Leshon Matthews, AAS Clinical Trial Research Associate, Clinical Research Specialist Senior, Duke University
Sharleen Traynor, PhD, MPH, Director, Clinical Trials Research Associate Program, Durham Technical Community College
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National strategic policy in England is to expand the diversity of clinical trial participants, bringing research opportunities to communities most in need. Our hospital has worked to commission wide-ranging dataset visualizations, to pinpoint which specific areas of the country have the greatest disease burden, and so may be prime candidates for clinical trial site selection. We have integrated assessment of cancer incidence, prevalence, and mortality--in addition to demographic data--to create a data-driven approach to site identification and selection, rather than using more traditional performance metrics or simply prior experience and relationships. We aim for an England where no cancer patient is left behind without access to research, and where our clinical trials recruit rapidly to time and target whilst bringing immediate patient benefit to those most in need.
CEU: 1.00 ACRP
Speaker:
Mark Brandon-Grove, Head of Clinical Research Performance & Quality, The Royal Marsden NHS Foundation Trust
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This interactive session is intended for experienced professionals who deal with complex clinical trials issues focused on during U.S. Food and Drug Administration (FDA) audits and inspections, need to understand the latest developments, and can contribute their own experiences. Presenters will cover important Good Clinical Practice topics to prepare for audits and regulatory inspections and for addressing any resulting observations. The presentation will be followed with hands-on activities to create corrective and preventive action (CAPA) plans, utilizing root cause analysis procedures to address FDA citations in Warning Letters, Notices of Initiation of Disqualification Proceedings and Opportunity to Explain, and Form 483s (Notice of Inspectional Observations). Tools will be provided and participants will work in groups. The session provides an opportunity to collaboratively hone skills in problem solving and root cause analysis, resulting in effective CAPA plans.
CEU: 2.00 ACRP
Speakers:
Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, ACRP-MDP, FACRP, Independent Consultant, Assured of Quality Consulting & Training
Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer
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Study & Site Management Journey Sponsor
Are the ICH E6(R3) guideline changes keeping you up at night? If there are burning questions and specific scenarios you need answered—or you want to hear how your industry colleagues will handle the transition from E6(R2) to E6(R3) this 60-minute live discussion is for you!
Leslie Sam and Beth Bieze will lead this interactive Q&A session where you'll have the opportunity to ask questions in an informal setting and benefit from knowledge-sharing with your ACRP peers. There will not be a prepared lecture and presentation slides, so please come with questions!
This session will continue the conversation from ACRP's live webinar, Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3). The webinar content was designed to help clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance.
Some of the questions posed by the webinar attendees which may be addressed at ACRP 2025 include:
When will the ICH E6(R3) guideline become effective?
How long does the industry have to update their SOPs to include E6(R3) principles and guideline updates?
Will clinical research professionals need to retake their GCP training?
Is there a reason why Annex 2 was not included in the ICH E6 R3 before it was adopted?
Does ICH E6(R3) allow the flexibility of an advanced practitioner to be the Principal Investigator?
When will the ACRP Certification exams change to include ICH E6(R3) instead of E6(R2)?
CEU: 1.00 ACRP
Speakers:
Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials Research Inc.
Katherine Mary Marangio, Learning Program Consultant, Parexel Academy
Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Watch the Webinar Replay Ahead of the Q&A Session (Free Without Contact Hours):
Related Resource:
ACRP's Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Over the next four years, the U.S. Food and Drug Administration (FDA) will phase out enforcement discretion for laboratory developed tests. These tests will be regulated as in vitro diagnostic (IVD) medical devices subject to FDA risk classification and premarket requirements for clearance/approval. Likely, there will be an increase in IVD pivotal clinical investigations. This session will look at the various IVD study designs as they relate to test users and use environments, and will highlight site considerations for readiness to support these kinds of clinical studies.
CEU: 1.00 ACRP
Speaker:
Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
Data form the cornerstone of efforts to address health disparities and advance health equity across the globe. In the United States, Medicare and Medicaid collect and publicly disclose race, ethnicity, and socio-economic characteristics to address health disparities and identify underserved communities. In Europe, healthcare systems and policies vary significantly across countries. While some European countries collect similar data as in the U.S., other countries collect and share no or only limited data due to concerns about discrimination, individual privacy, or historical sensitivities. Despite the limitations, there is still a broad range of high-quality data which can be consolidated, standardized, and visualized to support streamlined diversity and site identification strategies. We’ll take a deep dive into the hurdles and complexities of diversity data collection and the efforts needed for standardization of data, explore the potential barriers and factors that explain the gaps in current data strategies, and discuss data-driven approaches for more diverse clinical research.
CEU: 1.00 ACRP
Speaker:
Elke Ydens, Associate Director of Business Solutions, Anju Software
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Conducting clinical trials on a global scale presents unique challenges, including navigating dynamic regulatory requirements and diverse landscapes. This session will examine The U.S. Food and Drug Administration's 21 CFR Part 11 from the Code of Federal Regulations and its European Union counterpart, EudraLex Annex 11, to uncover the foundational requirements for utilizing electronic records and electronic signatures in clinical trials conducted within these regions.
CEU: 1.00 ACRP
Speaker:
Sara Saunders, MHA, CCRP, Sr. Manager, Regulatory Affairs, Florence Healthcare
Related Resource:
The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.
We will examine the evolution of the clinical research coordinator (CRC) role, focusing on the impacts of traditional job descriptions and requirements assigned to the role. We will also look at how the mindset resulting in a “gatekeeping” approach for hiring impacts potential new CRCs' interest in and recruitment/retention for the role. Comparing the traditional requirements of 2-3+ years experience in the field for CRC roles puts many qualified candidates out of the running when they have transferable skills. This panel will provide a collaborative platform for discussions and dialogue regarding past, present, and future practices, and responsibilities of the next generation of CRCs. A primary focus for this session will be examining the changing research landscape and encouraging reflection on the impacts of recent trends on sites/studies. Through panel members sharing experiences and attendees engaging throughout the session, participants will gain insights into the value of more inclusive hiring practices and strategies to promote diversity in the field.
CEU: 1.00 ACRP
Speakers:
Micki Le, Director or CRCs and PMs, SiteBridge Research
Lauren Stockwell, Content & Engagement Manager, Society for Clinical Research Sites
Related Blog Content:
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Signature Series Session
Artificial Intelligence (AI) is on the loose, but don't panic – instead, join us for a panel discussion that offers a scenic tour of the work of AI. We will start the journey with an introduction to the basics of what AI is and how it is being implemented into clinical research. Our panelists will then steer us toward critical talking points regarding the responsible use of AI and how we can navigate this journey together as we move to embrace its many applications in clinical research.
Objectives:
Describe the components of AI
Explain the current role of AI in clinical research
Discuss responsible use of AI
Discuss how the clinical research industry (including patients) can benefit from AI now and in the future.
CEU: 1.00 ACRP
Speakers:
Noelle Gaskill, MBA, ACRP-CP, VP, GM of Time Network, Tempus
Lisa Moneymaker, Head of Strategic Customer Engagement, Medidata Solutions
Pamela Tenaerts, MD, Chief Scientific Officer, Medable
David Vulcano, LCSW, MBA, CIP, RAC, FACRP, VP Clinical Research Compliance & Integrity, HCA Healthcare
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When you arrive in New Orleans, make your way to the registration area to receive your conference badge and essential materials, ensuring you're fully equipped for four days of engaging education sessions and valuable networking experiences.
Join us for breakfast while connecting with 100+ leading-edge organizations and suppliers helping you get better results in clinical research.
