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

Grab a quick pick-me-up in the Plaza Foyer—caffeine and conversation await to keep your final day at ACRP 2026 buzzing.

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

Watch a Sneak Peek into the Session Content:

This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings.

Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidance, International Council for Harmonization guidelines, and ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for all stakeholders across the entire clinical research enterprise.

CEU: 1.00 ACRP

Speaker:

• David Vulcano, LCSW, MBA, CIP, RAC, FACRP, Vice President, Clinical Research Compliance & Integrity, HCA Healthcare

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

Related Blog Content:

• Following the Rhythm of Effective Mentorship Leads to Many Rewards for Sites

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

Signature Series Session

Clinical research is undergoing a dynamic transformation—propelled by breakthrough developments, evolving regulations, and fresh approaches to collaboration. In this fast-moving landscape, adaptability and strategic foresight are no longer optional—they’re essential for navigating what’s next.

David Burrow will offer strategic insights on elevating trial quality and minimizing regulatory uncertainty—sharing forward-thinking approaches and practical tools designed to help research professionals thrive in today’s complex and rapidly shifting environment.

Key topics:

• Emerging trends shaping the future of clinical research

• Foundational principles of Quality by Design

• Leveraging the FDA’s CDER Center for Clinical Trial Innovation (C3TI)

• The growing impact of artificial intelligence on trial design and execution

• Actionable strategies for navigating periods of rapid change

Whether you're rethinking trial design, exploring new technologies, or seeking clarity in a changing regulatory landscape, you’ll leave this session equipped to lead with purpose and drive meaningful progress in a field that’s redefining what’s possible.

CEU: 1.00 ACRP

Speaker:

• David Burrow, PharmD, JD, Director, Office of Scientific Investigations, U.S. Food and Drug Administration