Friday Registration Hours
Apr
24
7:00 AM07:00

Friday Registration Hours

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.

View Event →
Workshop—Your Blueprint for Inspection Readiness
Apr
24
9:00 AM09:00

Workshop—Your Blueprint for Inspection Readiness

Workshops are NOT included with Full Conference registration and require a separate fee.

Are you fully prepared for a U.S. Food and Drug Administration (FDA) inspection? Inspections can be high-stakes events that bring stress, potential delays, and reputational risk if not managed effectively. This comprehensive full-day workshop is designed to help quality, regulatory, and research professionals approach inspections with confidence, clarity, and a concrete plan.

Moving beyond generic advice, the session delivers a structured, actionable framework—your blueprint for achieving and sustaining inspection readiness. Participants will learn how to build a proactive inspection strategy, master pre-inspection preparation, assemble and train an effective readiness team, and navigate inspection day with assurance.

The workshop emphasizes practical, real-world tactics supported by examples and interactive discussions. Attendees will leave equipped with proven tools and a step-by-step approach to strengthen their organization’s inspection readiness, reduce risk, and maintain compliance—transforming a daunting process into a manageable, even strategic, opportunity for operational excellence.

CEUs: 4.50 ACRP

Trainer:

View Event →
Workshop—Mastering Patient Recruitment in Today’s Clinical Research Landscape
Apr
24
9:00 AM09:00

Workshop—Mastering Patient Recruitment in Today’s Clinical Research Landscape

Workshops are NOT included with Full Conference registration and require a separate fee.

Patient recruitment remains one of the toughest challenges in clinical research, despite years of innovation and investment. While sponsors and CROs often provide recruitment solutions, the real work of identifying, engaging, and supporting patients happens at the site and community level.

This interactive workshop takes a practical, real-world look at today’s recruitment landscape. Attendees will first gain an overview of sponsor and CRO expectations, the resources they provide, and how sites can align with them. The focus then shifts to actionable strategies sites can implement immediately—emphasizing the human touch required to build trust, particularly with diverse populations.

The session also highlights emerging methods that leverage technology and data, including artificial intelligence, to strengthen traditional approaches. Participants will leave with insights into the vendor landscape, practical tools for community-level engagement, and a clearer understanding of how to integrate both human-centered and data-driven strategies for better recruitment outcomes.

CEUs: 5.50 ACRP

Trainer:

View Event →
Workshop—Clinical Trials Project Management from Fundamentals to Real-World Application
Apr
24
9:00 AM09:00

Workshop—Clinical Trials Project Management from Fundamentals to Real-World Application

Workshops are NOT included with Full Conference registration and require a separate fee.

Whether you’re leading your first project or stepping up as a solo project manager, this workshop equips you with the skills and tools to succeed. In this interactive session, participants explore essential project management competencies for clinical research—communication, conflict resolution, critical thinking, negotiation, emotional intelligence, time management, and budgeting.

Working through a Phase II trial scenario, attendees examine the project manager’s role from both the site and sponsor/CRO perspectives. The session covers how to create and manage core project tools—project plans, timelines, budgets, RACI charts (responsible, accountable, consulted, informed), risk management plans, communication plans, and resourcing plans.

Participants collaborate in site- and sponsor/CRO-based teams, practicing how to adapt, problem-solve, and revise plans when challenges arise. They will leave with practical, hands-on experience and a toolkit to lead projects confidently—driving efficiency, fostering collaboration, and making a measurable impact in clinical research project delivery.

CEUs: 4.50 ACRP

Trainers:

View Event →
Workshop—Top 10 Lessons from ICH E6(R3) Implementation: Insights, Pitfalls, and Change Strategies
Apr
24
9:00 AM09:00

Workshop—Top 10 Lessons from ICH E6(R3) Implementation: Insights, Pitfalls, and Change Strategies

Workshops are NOT included with Full Conference registration and require a separate fee.

Since ICH E6(R3) was finalized, the industry has recognized that implementation goes beyond updating SOPs. It requires new ways of working, proportionate risk-based approaches, and a culture that prioritizes quality and critical thinking. This interactive workshop builds on the momentum of ACRP’s “Crack the Code” webinar, diving into the realities of R3 implementation.

Through the “Top 10 Lessons,” we’ll examine challenges and successes—embedding Quality by Design in protocol development and site operations, overseeing service providers, making data governance actionable, and defining what qualifies as an “important” protocol deviation.

Lessons will be brought to life with concise teaching segments, case studies, and interactive activities. Participants will practice applying these lessons to realistic scenarios, discuss solutions with peers, and leave with tools ready for use.

At the core of the workshop is change management, engaging stakeholders, equipping teams with the right tools, and empowering people to embrace new ways of working.

CEUs: 4.50 ACRP

Trainer:

Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates

View Event →
Saturday Registration Hours
Apr
25
7:00 AM07:00

Saturday Registration Hours

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.

View Event →
Signature Series—Embrace the Now, Ignite What’s Next
Apr
25
9:00 AM09:00

Signature Series—Embrace the Now, Ignite What’s Next

Signature Series Session

Clinical research is a dynamic field involving complex policies and processes whose planning, conduct, and oversight are shaped by people at every stage of their professional journey. This panel brings together diverse voices—from early-career professionals to seasoned leaders—to share their unique career paths, the leadership skills that helped them grow, and the pivotal moments that shaped their trajectories. Panelists will offer insights into entering and evolving within the clinical research space; the leadership competencies that make a tangible difference; lessons learned for those forging their own path; and what keeps them motivated in this ever-changing field. Whether you're navigating your first role or mentoring the next generation, this conversation will impart valuable perspectives into the leadership, resilience, and passion that drive success in clinical research. You’ll leave with a renewed motivation to shape your own path, contribute with purpose, and stay inspired in a field that’s always evolving.

CEU: 1.00 ACRP

Speakers coming soon!

View Event →
Protecting Vulnerable Patients in Oncology Trials Through Optimized Informed Consent
Apr
25
10:30 AM10:30

Protecting Vulnerable Patients in Oncology Trials Through Optimized Informed Consent

This session explores a real-world case study from an interventional oncology trial to demonstrate how informed consent can be ethically and systematically optimized for vulnerable participants with impaired decision-making capacity. Attendees will examine how regulatory requirements and institutional safeguards can be integrated into a practical framework that ensures participant protection while supporting trial enrollment. Through a step-by-step analysis, we will cover patient eligibility verification, capacity assessment, legally authorized representatives, and documentation practices. The session offers a reproducible and proactive framework for how early planning, use of validated tools, and adherence to institutional review board guidance can support ethical trial conduct involving vulnerable populations.

CEU: 1.00 ACRP

Speaker:

  • Elena Alferova, Clinical Research Regulatory Coordinator II, UCSD Moores Cancer Center

View Event →
Implementing Generative AI for Improved Clinical Research Workflows
Apr
25
10:30 AM10:30

Implementing Generative AI for Improved Clinical Research Workflows

As clinical research embraces digital transformation, generative artificial intelligence (AI) stands out as both a powerful and often misunderstood tool. This session—led by a clinical operations consultant with more than 17 years of contract research organization and pharmaceutical firm experience—offers a grounded look at how AI is reshaping operational workflows. Drawing from real-world examples, the session outlines a phased, risk-aware approach to AI implementation. Attendees will gain practical strategies for applying AI in feasibility, site communications, document authoring, risk-based monitoring, testing scripts, and data cleaning—while safeguarding data integrity and compliance. Designed for clinical trial professionals seeking actionable guidance—not hype—this session's emphasis is on starting small, building trust, and ensuring AI supports science and patients alike.

CEU: 1.00 ACRP

Speaker:

  • Michael Thomas, Clinical Operations Consultant, MT Clinical Consulting

View Event →
Risk-Averse or Recklessly Traditional?: Considering the Cognitive Dissonance of Clinical Research
Apr
25
10:30 AM10:30

Risk-Averse or Recklessly Traditional?: Considering the Cognitive Dissonance of Clinical Research

Clinical research is often seen as a risk-averse industry, but is that perception accurate? This interactive session challenges the assumption that traditional choices are inherently safe. Through real-world case studies and a behavioral risk framework, we’ll explore how decisions around protocol design, site selection, technology adoption, and feasibility often mask high operational risk under the guise of caution. Attendees will examine how “playing it safe” can lead to protocol amendments, recruitment failures, and delays, and learn how to use Quality by Design (QbD) and ICH E8(R1) principles to anticipate and mitigate these outcomes. The session includes audience polling, risk-mapping exercises, and practical tools to identify where organizations may be unintentionally risk-seeking. Whether you’re in study startup, clinical operations, or site management, you’ll walk away with actionable strategies to reframe risk, support better decision-making, and challenge the illusion of safety that drives costly inefficiencies in clinical trials.

CEU: 1.00 ACRP

Speakers:

View Event →
Exploring Federally Qualified Health Centers as Decentralized Clinical Trial Sites
Apr
25
10:30 AM10:30

Exploring Federally Qualified Health Centers as Decentralized Clinical Trial Sites

Federally Qualified Health Centers (FQHCs) are nonprofit organizations governed by patients that provide high-quality, comprehensive healthcare to medically underserved populations across the United States, regardless of income or insurance coverage. In 2023, FQHCs served 32.5 million patients, with 63% identifying as people of color. In North Carolina specifically, FQHCs serve more than 750,000 patients annually, with more than 60% of them being people of color. Despite this broad reach and impact, FQHCs remain an underutilized resource in clinical research. This session will explore how FQHCs can serve as decentralized clinical trial sites to expand access and address long-standing disparities in trial participation. The session will highlight insights from surveys and questionnaires completed by patients and FQHC care teams, share best practices for integrating clinical trials, and discuss the necessary infrastructure to support research within FQHCs.

CEU: 1.00 ACRP

Speaker:

View Event →
Communicating Your Value: From Elevator Pitch to Career Plan
Apr
25
10:30 AM10:30

Communicating Your Value: From Elevator Pitch to Career Plan

Whether you're early in your career or a seasoned professional, it’s easy to confuse “doing good work” with “communicating your value.” This session offers practical tools to help you tell your professional story with clarity and purpose—on paper, online, or in conversation. Through guided reflection, real-world examples, and structured templates, you will learn to draft an authentic elevator pitch, apply the STAR (Situation, Task, Action, Result) method to describe outcomes, translate daily work into impactful résumé content, and outline a personal career communication plan with specific actions to build visibility over the next 30 days. Beyond the job-seeking context, the focus is on ongoing visibility and confidence—whether you are looking to grow, pivot, or lead from where you are. Advancement isn’t just about upward mobility—it’s about alignment with your goals. This session delivers usable tools to help you own your narrative and support career development in any direction.

CEU: 1.00 ACRP

Speaker:

View Event →
Designed for Resiliency: Building Holistic Risk Management into the Trial Lifecycle
Apr
25
10:30 AM10:30

Designed for Resiliency: Building Holistic Risk Management into the Trial Lifecycle

As clinical research grow more complex and data-driven, patient-centered risk management is essential to designing resilient trials. This panel explores a holistic, ICH E6(R3)-aligned approach that embeds risk mitigation across the trial lifecycle while prioritizing patient needs, safety, and experience. Panelists will share real-world examples of how inclusive protocol design and patient advisory input during early planning reduce risk by improving accessibility, engagement, and retention. In startup, automated site selection and harmonized regulatory workflows minimize delays and variability, accelerating patient access. Artificial intelligence-based image sharing and interpretation require validated, explainable models and human oversight as key risk mitigation strategies to safeguard outcomes. Predictive analytics, risk-based monitoring, and centralized oversight tools help identify early warning signals and enable timely intervention. By embedding holistic risk mitigation with patient-centered operational strategies, innovation, and oversight, this session highlights how to build trials that are not only compliant and efficient, but also resilient and responsive.

CEU: 1.00 ACRP

Speakers:

  • Lourdes Carhuapoma, PhD, CRNP, Director, Participant-Centered Research Integrity and Risk, Johns Hopkins University, BIOS Clinical Trials Coordinating Center

  • Lindsay Eyzaguirre, MS, Assistant Professor, Johns Hopkins University School of Medicine; Clinical Coordinating Center Director, BIOS CTCC; Project Lead, Johns Hopkins University Trial Innovation Center (JHU TIC), Johns Hopkins University, BIOS Clinical Trials Coordinating Center

  • Shannon Hillery, Manager, Accelerated Start-Up Unit, Johns Hopkins University, BIOS Clinical Trials Coordinating Center

  • Andrew Mould, MPH, Assistant Professor, Department of Neurology; Data Coordinating Center Director, BIOS CTCC; HEAL Director, JHU SSRC HEAL Pain ERN; Assistant Director, Johns Hopkins University Trial Innovation Center, Johns Hopkins University, BIOS Clinical Trials Coordinating Center

View Event →
ALIGN and Thrive: Building an Engaged Workplace Culture “ to “How to Thrive by Building an Engaged Workplace Culture
Apr
25
11:30 AM11:30

ALIGN and Thrive: Building an Engaged Workplace Culture “ to “How to Thrive by Building an Engaged Workplace Culture

Transform your workplace culture through proven strategies that build genuine employee engagement, trust, and accountability. This session focuses on creating a thriving organizational environment where employees feel valued, connected, and motivated to contribute their best work. Participants will learn to establish trust as the foundation of engagement through transparency and consistent leadership behaviors. The session features the innovative ALIGN method for collaborative goal setting, enabling teams to create shared objectives that drive organizational success. Discover how to shift from traditional performance reviews to growth-focused evaluation conversations that inspire development rather than judgment. Learn to implement positive accountability systems that support employees while building trust. Key topics include positive workplace habits, open communication channels, transparent progress tracking, and sustainable cultural change through continuous feedback and recognition. Attendees will leave with practical frameworks and actionable strategies to immediately transform their workplace culture.

CEU: 1.00 ACRP

Speaker:

View Event →
Clinical Research in Primary Care: From Disconnection to Integration
Apr
25
11:30 AM11:30

Clinical Research in Primary Care: From Disconnection to Integration

Too few research organizations (e.g., sponsors and sites) have access to the large and diverse populations that primary care organizations (PCOs) and their healthcare professionals serve. This session will bring forth the results and easy-to-use, action-oriented tactics from the first-of-its-kind “Research in Primary Care Action Roundtable,” which included participants from PCOs, study sponsors, and study sites. PCOs are a healthcare entity focused on delivering first-contact, comprehensive, and continuous care to individuals and families across all ages, genders, and health conditions. They care for more than 100 million people in the United States, yet clinical trial access and participation through them continue to be seen at minimal levels. A shared vision is to build a movement to make clinical trials mainstream in support of healthcare’s pivot toward value-based care, and to provide research organizations with access to large and diverse populations leading to more efficient, representative, and accelerated study enrollment.

CEU: 1.00 ACRP

Speakers:

View Event →
Engaging Vulnerable Populations in Research in Trying Times
Apr
25
11:30 AM11:30

Engaging Vulnerable Populations in Research in Trying Times

Engaging vulnerable populations in research requires careful consideration of ethical and practical challenges. Researchers must prioritize participants' safety, privacy, and well-being while ensuring the research is meaningful and impactful for the community. This presentation will highlight real-world experiences, challenges, and practical solutions for involving vulnerable populations in research during trying times such as those we face now. It's important to emphasize that additional protections should not deter researchers from involving these groups. Instead, such safeguards enable ethical inclusion, ensuring that individuals who may benefit most from research are not systematically excluded due to perceived risks or complexities.

CEU: 1.00 ACRP

Speaker:

View Event →
The ABCs of IDEs: Making Sense of Regulatory Expectations for Investigational Device Exemptions
Apr
25
11:30 AM11:30

The ABCs of IDEs: Making Sense of Regulatory Expectations for Investigational Device Exemptions

How does a site know that a sponsor's medical device and study design will generate appropriate scientific evidence to justify or require a clinical trial? Sites may already be familiar with the sponsor and investigator responsibilities for Investigational Device Exemption (IDE) studies outlined in 21 CFR 812 of the Code of Federal Regulations, but this session will provide a tutorial on the regulatory expectations for IDE application submission or a non-significant risk (NSR) determination before initiating device clinical trials. The content will cover IDE applications and the documents that will be reviewed by the U.S. Food and Drug Administration before approving an IDE and how an NSR determination translates to abbreviated 21 CFR 812 requirements. Also discussed will be design controls to ensure a medical device is clinically ready for a clinical trial and how they still apply to NSR device studies including in vitro diagnostic products.

CEU: 1.00 ACRP

Speaker:

View Event →
Scaling Smart: Using AI Budget Tools to Determine Trial Costs
Apr
25
11:30 AM11:30

Scaling Smart: Using AI Budget Tools to Determine Trial Costs

As the University of Alabama at Birmingham's Clinical Research Support Enterprise (CReSt) expanded, traditional systems proved insufficient for managing the growing complexity of clinical trial operations. Determining trial costs became a focus, with a goal of implementing no-cost, scalable solutions that improved visibility across the trial lifecycle, empowered staff, and could be replicated by other institutions. The CReSt unit adopted a suite of open-source tools to develop platforms for managing such core trial functions as study startup, enrollment tracking, subject reimbursements, and automated reporting. These tools were created entirely by clinical research administrators without the support of an information technology team or professional developers. Crucially, generative artificial intelligence (AI) tools were used to build, debug, and refine these systems. These tools accelerated development and lowered the technical barrier for non-programmers to build impactful solutions.

CEU: 1.00 ACRP

Speakers:

  • Meredith Fitz-Gerald, RN, MSN, Clinical Research Support Enterprise Director - Education and Clinical Outreach, The University of Alabama at Birmingham'

  • Patrick Frazier, RN, Clinical Research Support Enterprise Director of Systems and Compliance, The University of Alabama at Birmingham

View Event →
How to Advance a Medical Device to Human Trials with No Industry Sponsor in Sight
Apr
25
11:30 AM11:30

How to Advance a Medical Device to Human Trials with No Industry Sponsor in Sight

Bringing a novel implantable device from concept to human trials is daunting—doing it entirely within an academic setting, without commercial sponsorship, is almost unheard of. Our team successfully navigated the full translational pipeline: developing the device and treatment protocol, conducting rigorous preclinical testing, securing U.S. Food and Drug Administration (FDA) Investigational Device Exemption approval, and executing an early feasibility study, ultimately culminating in a Nature publication. This session provides a practical framework for managing operational complexity in sponsor-investigator trials. We will share actionable strategies for communication, regulatory preparedness, role delineation, and risk mitigation—focusing on the tools and practices that allowed our team to proceed with confidence. For academic institutions, startups, or research teams operating at the edge of innovation, this session offers grounded, replicable strategies for moving from concept to clinic—and highlights the operational systems we would never do without.

CEU: 1.00 ACRP

Speaker:

  • Amy Porter, PE, MBA, Director, Texas Biomedical Device Center at the University of Texas at Dallas

View Event →
Starting Quality Assurance and Improvement Programs from the Ground Up
Apr
25
1:30 PM13:30

Starting Quality Assurance and Improvement Programs from the Ground Up

This presentation will discuss the experience and process of building a quality assurance/quality improvement (QA/QI) program from the ground up following the merger of two large health systems across geographical distances. It will discuss where to begin, considerations when designing services, operationalization, the importance of including stakeholders, and lessons and pitfalls learned through real-world experiences.

CEU: 1.00 ACRP

Speakers:

View Event →
Sponsor Perspectives on Developing Innovative Participant Recruitment Strategies for Trials
Apr
25
1:30 PM13:30

Sponsor Perspectives on Developing Innovative Participant Recruitment Strategies for Trials

This session will delve into how sponsors develop effective recruitment strategies for clinical trials, emphasizing the practical impact of these tactics. Attendees will gain insights into how feedback from clinical sites is utilized by sponsors to craft creative and adaptive recruitment approaches. The session will highlight real-world examples and case studies to illustrate the success of these strategies in enhancing participant engagement and trial efficiency.

CEU: 1.00 ACRP

Speakers:

View Event →
The Future is Coordinated: Developing the Research Nurse Workforce
Apr
25
1:30 PM13:30

The Future is Coordinated: Developing the Research Nurse Workforce

The clinical research workforce is facing growing challenges, especially in the recruitment and retention of research nurse coordinators. This session will highlight an innovative collaboration between a clinical research team and a bachelor of science in nursing program aimed at introducing nursing students to clinical research as a meaningful and dynamic career option. By engaging future nurses early in their education, this partnership helps bridge the gap between clinical care and research, building awareness, interest, and preparedness among new graduates. Attendees will hear how this model not only expands the pipeline of qualified professionals but also enhances the visibility and value of the research nurse coordinator role within healthcare. The presenters will share insights, lessons learned, and steps for developing similar collaborations with nursing schools. This forward-thinking approach has the potential to significantly strengthen the clinical research workforce and ensure a more sustainable, informed, and engaged generation of research-ready nurses.

CEU: 1.00 ACRP

Speakers:

  • Lauren Hasty, Clinical Research Nurse, St Jude Children's Research Hospital

  • Jamie Russell, Manager- Clinical Research Management, St Jude Children's Research Hospital

View Event →
Clinical Research Across Borders: Navigating the Global Landscape
Apr
25
1:30 PM13:30

Clinical Research Across Borders: Navigating the Global Landscape

This dynamic session explores the complexities and opportunities of conducting clinical research outside the United States. Through real-time polling, interactive Q&A, and scenario-based reflection, attendees will gain practical insights into regulatory, cultural, and operational differences across global regions. The session will equip clinical research professionals with tools and strategies to confidently engage in multinational trials, while promoting inclusion, equity, and global collaboration.

CEU: 1.00 ACRP

Speaker:

View Event →
Innovating Engagement: Reimagining Approaches to Equitable Clinical Trials Participation
Apr
25
1:30 PM13:30

Innovating Engagement: Reimagining Approaches to Equitable Clinical Trials Participation

This highly interactive session will introduce participants to an innovative, multiculturally aware approach for advancing equitable and inclusive representation in clinical trials. We will share our journey in developing and piloting a novel engagement model, highlighting both the community-engaged design process and early findings from our pilot implementation. Participants will then engage in a hands-on activity that maps key inclusivity-driven strategies and frameworks from our model to their own work. By the end of the session, attendees will leave with practical, actionable tools to advance equity and racial justice in their clinical trial recruitment efforts.

CEU: 1.00 ACRP

Speakers:

View Event →
AI in Clinical Research: Real-World Impacts on Protocols, Participants, and Trial Conduct
Apr
25
3:00 PM15:00

AI in Clinical Research: Real-World Impacts on Protocols, Participants, and Trial Conduct

Artificial intelligence (AI) is revolutionizing clinical research by enhancing protocol generation, operational efficiency, and participant recruitment/engagement. Through predictive analytics and digital twins, AI streamlines protocols, optimizes inclusion criteria, and minimizes risk. AI also strengthens safety monitoring by identifying early adverse event patterns across diverse datasets, enabling proactive responses. For sponsors and sites, AI supports ongoing access to training and streamlines standard operating procedure development by analyzing past performance and recommending standardized practices. It automates data collection, reducing manual errors and accelerating timelines. In recruitment, machine learning matches ideal candidates using electronic health records and real-world data, while adaptive algorithms personalize recruiting messaging to improve enrollment rates. Together, these innovations reshape the trial landscape, making studies faster, safer, and more inclusive without compromising data integrity or participant protection. Examples reviewed include seen and unseen real-world AI impacts.

CEU: 1.00 ACRP

Speakers:

View Event →
The "Four Cs" of Clinical Research Leadership
Apr
25
3:00 PM15:00

The "Four Cs" of Clinical Research Leadership

In a rapidly evolving clinical research landscape, effective leadership is more crucial than ever for driving collaboration, innovation, and trust among academic centers, site management organizations, and technology partners. This dynamic session will introduce the “Four Cs” leadership framework—character, competence, caring, and communication—adapted for today’s complex research environment. Three seasoned leaders with varied backgrounds will share insights on how leadership philosophies must adapt to varying organizational cultures, regulatory demands, and operational realities. Attendees will explore practical strategies to cultivate leadership capacity, manage resource constraints, and prevent burnout while promoting ethical and patient-centered research. Real-world stories will illuminate challenges and solutions in building and sustaining successful collaborations among sites, sponsors, contract research organizations, and academia. The session encourages interactive discussion, equipping attendees with actionable tools to strengthen their own leadership impact and foster high-performing, resilient research partnerships.

CEU: 1.00 ACRP

Speakers:

View Event →
Trials in Transition: Navigating HHS Policy Shifts in 2025
Apr
25
3:00 PM15:00

Trials in Transition: Navigating HHS Policy Shifts in 2025

In 2025, the U.S. Department of Health and Human Services (HHS) initiated several significant policy changes impacting how clinical trials are conducted in the U.S. This session will explore five major developments: updated informed consent standards prioritizing plain language and accessibility; new HHS-led interoperability efforts to streamline trial data exchange; clarified Internal Revenue Service guidance on taxing participant stipends; a shift from mandated diversity action plans to a voluntary reporting framework; and cross-agency modernization efforts through the HHS Clinical Trials Modernization Working Group. These changes—while intended to promote transparency and innovation—have introduced ambiguity for sites, sponsors, and contract research organizations. Attendees will gain clarity on how to operationalize these updates, navigate compliance challenges, and align processes with the evolving federal landscape in 2026 and beyond.

CEU: 1.00 ACRP

Speakers:

View Event →
Stronger Together: Leveraging Site-CRO Synergy for Better Research Outcomes
Apr
25
3:00 PM15:00

Stronger Together: Leveraging Site-CRO Synergy for Better Research Outcomes

Strong collaboration between contract research organizations (CROs) and study sites is essential for reducing trial delays, improving data quality, and accelerating patient access to new therapies. This panel, designed for clinical research professionals in operations, monitoring, study startup, and site roles, explores how intentional collaboration between CROs and study sites can drive measurable improvements in operational efficiency and data quality. Panelists will share real-life case studies and practical examples that highlight strategies for streamlining study startup, reducing rework, and building trust. Attendees will gain forward-thinking insights and walk away with actionable tips, tools, and processes to strengthen site-CRO relationships and enhance trial success. Join us to explore how shifting from reactive problem-solving to proactive partnership can transform site-CRO relationships into high-impact alliances that advance research and patient care.

CEU: 1.00 ACRP

Speakers:

View Event →
AI at the Helm: Shaping the Future of Oncology Clinical Research
Apr
25
4:00 PM16:00

AI at the Helm: Shaping the Future of Oncology Clinical Research

Artificial intelligence (AI) is transforming clinical research by streamlining patient identification, automating data capture, and enhancing imaging analysis. This session explores practical applications of AI in oncology trials, focusing on three high-impact areas: 1) patient matching and identification using advanced algorithms to accelerate enrollment and improve diversity; 2) seamless data collection through integration from electronic medical records to electronic data capture, reducing manual errors and increasing efficiency; and 3) automated imaging analysis, such as AI-driven RECIST measurements, to improve consistency and speed in response assessments. Attendees will take away actionable insights and learn from real-world examples for implementing AI solutions while addressing challenges in adoption, data quality, and regulatory considerations.

CEU: 1.00 ACRP

Speaker:

View Event →
Behind Closed Doors: The Inner Workings of Institutional Review Boards
Apr
25
4:00 PM16:00

Behind Closed Doors: The Inner Workings of Institutional Review Boards

The session is designed to open the door to a live reinactment of an institutional review board (IRB) meeting that includes samples of the the most sensitive and controverted decisions facing IRBs today. The purpose is to inform researchers of the inner workings and, more importantly, the often intense deliberations arising from today's clinical trial proposals and reports as the panel reconciles regulatory mandates and ethical principles with modern research conundrums. The 30-minute, mock IRB meeting will include a protocol, amendment, report of noncompliance, and continuing review followed by a 15-minute Q&A opportunity.

CEU: 1.00 ACRP

Speaker:

View Event →
Promoting Training and Curiosity to Advance Professionalism Across Clinical Research Roles
Apr
25
4:00 PM16:00

Promoting Training and Curiosity to Advance Professionalism Across Clinical Research Roles

Clinical expertise has a clearly defined role and purpose in clinical research from randomizing treatments to managing adverse events to monitoring the overall health of participants. However, scientific expertise seems to be expected only from those who design studies, analyze final datasets, and manage the investigational products in question. This increases a sense of separation between sponsors and sites that results in clinical trial operations being considered mostly in terms of financial transactions. At the site level, a similar divide in research staff often occurs as the study coordinators understand the study mechanics and the medical clinicians understand the disease, often causing friction in operations and staff turnover. By developing a novel clinical research model, our team has addressed these gaps and witnessed improvements in staff recruitment and retention as well as decreases in detrimental protocol deviations. This model includes a clear career development pathway for clinical research professionals.

CEU: 1.00 ACRP

Speaker:

  • Lacey Andrews, MS, CCRC, CCRA, Lead Clinical Research Coordinator, Marshall University's Joan C. Edwards School of Medicine, Department of Family and Community Health

  • Todd Davies, PhD, Associate Director of Research, Marshall Health

View Event →
Switching Roles from Site to Sponsor: Skills to Build for a Leap of Faith
Apr
25
4:00 PM16:00

Switching Roles from Site to Sponsor: Skills to Build for a Leap of Faith

The clinical research industry offers a variety of career pathways, yet many site-based professionals struggle to transition to roles within contract research organizations or sponsor settings. This session will outline the skills, experiences, and strategic positioning needed to make that leap successfully. Drawing from real-world examples, panel insights, and current hiring trends, we’ll explore how site-based coordinators, managers, and research staff can translate their operational expertise into qualifications for project management, clinical research associate, medical affairs, regulatory affairs, and other sponsor-side roles. Attendees will leave with a roadmap, tools for self-assessment, and strategies to proactively align their current responsibilities with future goals.

CEU: 1.00 ACRP

Speaker:

View Event →
Time Flies: Project Management from Strategic Initiatives to Daily Tasks
Apr
25
4:00 PM16:00

Time Flies: Project Management from Strategic Initiatives to Daily Tasks

This interactive presentation guides participants through applying proven project management principles across all scales of work, from organizational initiatives to everyday task management. Attendees will learn to leverage essential project management tools including strategic planning frameworks, effective scheduling techniques, Gantt chart creation and interpretation, and dependency mapping to optimize workflow and productivity. Through practical examples and hands-on exercises, participants will discover how to break down complex projects into manageable components, identify critical path dependencies, and create realistic timelines that account for resource constraints and competing priorities. The session will demonstrate how the same methodologies that drive successful large-scale initiatives can transform daily task management, reducing stress and increasing efficiency.

CEU: 1.00 ACRP

Speaker:

View Event →
Sunday Registration Hours
Apr
26
7:00 AM07:00

Sunday Registration Hours

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.

View Event →
Signature Series—Next is You: Leadership as a Clinical Trial Competency
Apr
26
9:00 AM09:00

Signature Series—Next is You: Leadership as a Clinical Trial Competency

Signature Series Session

Clinical research is a dynamic field shaped by the people who plan, conduct, and oversee it at every career stage. This engaging panel brings together diverse voices—from early-career professionals to seasoned leaders—to share their career journeys, the leadership skills that fueled their growth, and the pivotal moments that defined their paths.

Panelists will offer insights on:

  • How they entered and advanced within clinical research

  • The leadership competencies that made the greatest impact

  • Lessons learned and practical advice for others shaping their careers

  • What keeps them motivated and passionate in an evolving field

Whether you’re just starting out or guiding the next generation, this conversation will highlight the resilience, leadership, and sense of purpose that drive long-term success. Attendees will leave with fresh perspectives, actionable guidance, and renewed inspiration to chart their own path, make meaningful contributions, and thrive in a field that is constantly evolving.

CEU: 1.00 ACRP

Speakers coming soon!

View Event →
Lighting the Path to Clinical Research Careers with C-CLEAR
Apr
26
10:30 AM10:30

Lighting the Path to Clinical Research Careers with C-CLEAR

The Careers in Clinical Research (C-CLEAR) Program is an eight-week immersive summer experience designed to introduce undergraduate students to careers in oncology clinical trials. Hosted by the University of Kansas Cancer Center's Clinical Trials Office, the program provides hands-on exposure to core research functions including informed consent, protocol navigation, adverse event reporting, regulatory documentation, and data entry. Students complete Good Clinical Practice (GCP) training and gain real-world experience through shadowing across multiple departments, including time with oncologists in the Phase One Clinic. The program also emphasizes professional development through mentorship, résumé building, and final presentations to research staff. This session will present a practical and replicable model for building early-career pathways into clinical research. Attendees will receive tools, strategies, and lessons learned to support workforce training and sustainable pipeline development in academic research settings.

CEU: 1.00 ACRP

Speaker:

  • Joseph Hines II, MPH, Executive Director, Research Operations-Clinical Trial Office, University of Kansas Cancer Center


View Event →
Creating Sustainable and Efficient Clinical Research Compliance Programs
Apr
26
10:30 AM10:30

Creating Sustainable and Efficient Clinical Research Compliance Programs

In response to growing pressures from federal sponsors to demonstrate efficient research oversight, the Penn State College of Medicine undertook a strategic reorganization of clinical research monitoring and auditing services. This effort involved centralizing monitors from multiple units and realigning an auditor into our human research quality assurance office. A scalable chargeback model was developed to support this new structure, financial stewardship, and risk-based workload allocation. Attendees will learn how institutions can transition from siloed, grant-dependent quality functions to a centralized model that is both cost-recoverable and operationally sustainable. They will learn how to evaluate capacity, align oversight with risk profiles, and design a flexible fee structure based on study complexity and enrollment. The session explores how the reorganization positions the institution to adapt to the evolving expectations around indirect costs. This presentation provides a practical roadmap for modernizing research oversight by enhancing sustainability, or maximizing value from existing resources.

CEU: 1.00 ACRP

Speaker:

View Event →
 How I Got Certified: Real Stories from ACRP Professionals
Apr
26
10:30 AM10:30

How I Got Certified: Real Stories from ACRP Professionals

Are you preparing for ACRP Certification? Join this engaging panel session led by ACRP’s Certification Director and facilitated by ACRP’s Certification Manager. You’ll hear firsthand from three clinical research professionals—including an ACRP Board Member, a dedicated ACRP volunteer, and an active ACRP Member—who have successfully earned their ACRP Certification. Panelists will share their unique certification journeys, offering insights into how they navigated the application process—from submission to eligibility approval. They’ll discuss the timeline, what to expect during the review, and how they prepared for the exam. Attendees will also learn about different testing modalities and hear practical advice, study strategies, and tips for success directly from those who’ve been through it. Note: This session will not cover exam content.

This session does not provide ACRP Contact Hours.

Speakers coming soon!

View Event →
Equipping Your Decentralized Clinical Trials Toolbox
Apr
26
10:30 AM10:30

Equipping Your Decentralized Clinical Trials Toolbox

The emergence of decentralized clinical trials (DCTs) has reshaped the way we approach execution of clinical trials requiring few or no face-to-face touchpoints with patients. A successful DCT requires a different operational infrastructure, different technology, and different personnel from a traditional clinical trial. This session offers a practical, end-to-end toolbox for designing and operationalizing DCTs. Attendees will learn actionable strategies for protocol design that allow remote workflows and patient-centric recruitment. We will discuss common pain points that contribute to attrition in DCTs and strategies for prevention. The session will review approaches for building and leading remote teams and for leveraging technology to improve efficiency of remote work. Finally, we will discuss the role of the principal investigator, research coordinator, and data manager as they are deployed in a decentralized fashion. This talk is for those interested in launching DCTs and for those running DCTs who want to expand their capabilities.

CEU: 1.00 ACRP

Speaker:

  • Megan Lamberti, Vice President of Clinical and Regulatory Affairs, Nilo Medical Consulting Group

View Event →
Innovative Approaches to Oncology Trials: Site Perspectives
Apr
26
10:30 AM10:30

Innovative Approaches to Oncology Trials: Site Perspectives

The field of oncology clinical trials is dynamic and intricate, with continuous evolution introducing new challenges for research sites. This panel discussion features seasoned representatives from highly active research sites sharing their innovative strategies for navigating this evolving landscape. While universal solutions are elusive, each site employs a unique blend of technology and human expertise to achieve its research objectives.

CEU: 1.00 ACRP

Speakers:

View Event →
Psychological Safety for Clinical Trial Monitors: What You Need to Know
Apr
26
10:30 AM10:30

Psychological Safety for Clinical Trial Monitors: What You Need to Know

The clinical research enterprise often attracts the kind of perfectionists who feel crushed when they make mistakes. They take failure personally, and, in an industry where every "i" and "t" are quality checked, their shortcomings are always noticed. But, what if we could build a clinical research team that promotes inclusion, learning, expression, and contribution--a team whose members no longer wake up in the night wondering if they forgot a signature during the monitoring visit? This session will promote the values of psychological safety in the workplace, and empower listeners to identify psychological safety principles and the impact on teams that lack them. Participants will be guided through real-life monitoring scenarios, learn what went right or wrong, and practice applying the four stages of psychological safety.

CEU: 1.00 ACRP

Speakers:

View Event →
Reducing Turnover in Clinical Research: The Untapped Power of Psychological Safety
Apr
26
11:30 AM11:30

Reducing Turnover in Clinical Research: The Untapped Power of Psychological Safety

Turnover among clinical research professionals increases trial costs, delays timelines, and compromises data quality. Across sponsors, contract research organizations, health systems, and academic sites, workforce instability puts studies—and outcomes—at risk. This session shares a case study from the healthcare sector, where investing in psychological safety through expert-led group coaching led to a 20-point drop in annual turnover and $32 million in annual savings—while improving team performance and engagement. Psychological safety—the belief that team members can speak up and take risks without fear—is a proven driver of retention, operational efficiency, and proactive problem-solving. Group coaching embeds this mindset into team culture, enabling trust, reducing errors, and supporting sustainable performance. Attendees will leave with practical strategies to apply this low-lift, high-impact approach to onboarding, leadership development, and daily operations.

CEU: 1.00 ACRP

Speakers:

View Event →
The Perils and Pitfalls of Managing Unfunded and Underfunded Studies
Apr
26
11:30 AM11:30

The Perils and Pitfalls of Managing Unfunded and Underfunded Studies

Research teams are being asked to do more with less—especially when it comes to unfunded or underfunded studies. Whether it’s supporting investigator-initiated trials with no startup budget or absorbing hidden costs from sponsor studies, the financial strain is real. This session offers practical strategies for identifying and managing financial risk at the site level. We’ll walk through tools for feasibility screening, cost recovery, and portfolio-level decision-making. Attendees will leave with insights they can use to engage investigators and institutional leaders in honest conversations about what it really costs to “just get it done.”

CEU: 1.00 ACRP

Speaker:

View Event →
 ACRP Game Show: The Ultimate Clinical Research Showdown
Apr
26
11:30 AM11:30

ACRP Game Show: The Ultimate Clinical Research Showdown

Back by popular demand and reimagined for 2026, the ACRP Game Show returns with more energy, more surprises, and more chances to test your knowledge in this high-energy session. Teams of clinical research professionals will go head-to-head in a fast-paced trivia battle covering everything from ICH-GCP principles to eClinical technology, informed consent essentials, and more!

Audience members won’t just watch—they’ll play along, cheer on their peers, and maybe even walk away with bragging rights. Whether you're a seasoned expert or a curious newcomer, this session is your chance to learn, laugh, and celebrate the clinical research enterprise in a whole new way.

CEU: 1.00 ACRP

Speaker:

View Event →
Leading eClincial Transitions: The Future-Ready Site
Apr
26
11:30 AM11:30

Leading eClincial Transitions: The Future-Ready Site

Technology rollouts in clinical research struggle when change isn’t managed effectively. This session explores how to lead successful transitions to site-based eClinical solutions like electronic investigator site files, electronic source, and participant engagement platforms. The session will highlight common pitfalls in site-level implementations and how to avoid them through proactive communication, pilot workflows, and leadership alignment. Designed for site leaders and operations professionals, the session focuses on practical, real-world strategies for overcoming resistance, fostering cross-functional buy-in, and building adoption plans that last beyond go-live. Attendees will walk away with a clear framework on how to engage stakeholders early, design training that sticks, and track meaningful adoption metrics.

CEU: 1.00 ACRP

Speakers:

  • Alicia Gearhart, Director of Professional Services, RealTime eClinical Solutions

  • Kristen Schoch, Marketing & Events Manager, RealTime eClinical Solutions

View Event →
Aligned for Impact: Collaboration for FDA Inspection Readiness in Site Networks
Apr
26
11:30 AM11:30

Aligned for Impact: Collaboration for FDA Inspection Readiness in Site Networks

U.S. Food and Drug Administration (FDA) inspections can be high-stakes events for clinical research sites, especially within large site networks. Yet, many sites and quality assurance (QA) teams only engage reactively, leading to inconsistent readiness and potential regulatory exposure. This session presents a proactive, collaborative model for ongoing alignment between site operations and the network’s QA function. Through real-world examples and practical tools, we’ll demonstrate how early QA involvement, open communication, and joint preparation foster a culture of continuous inspection readiness. Attendees will leave equipped with actionable strategies for collaborative mock audits, risk-based Corrective and Preventive Action (CAPA) plan implementation, and quality-focused training that empowers staff and mitigates FDA risk.

CEU: 1.00 ACRP

Speakers:

View Event →
Bridging the Gap Between Health Literacy and Informed Consent in Clinical Research
Apr
26
11:30 AM11:30

Bridging the Gap Between Health Literacy and Informed Consent in Clinical Research

Informed consent is a cornerstone of ethical research, but without accounting for health literacy, it often fails to ensure true participant understanding. This session will explore how research professionals can bridge the gap between regulatory compliance and meaningful comprehension, particularly in sensitive fields like reproductive health. Drawing from real-world experience in Phase III trials, biorepository studies, and community health research, I will share practical strategies for improving the consent process using plain language, teach-back methods, and visual aids. We’ll also examine relevant ICH-GCP guidelines, including the requirement that consent information be presented “in a language understandable to the subject,” and discuss how these principles apply in daily research practice. Attendees will leave with actionable tools to support participant-centered communication and to elevate the informed consent process beyond a signature to a personal, nuanced, and regulatory-compliant conversation that leaves patients feeling empowered in their decision.

CEU: 1.00 ACRP

Speaker:

  • Gianna Gemignani, BS, ACRP-CP, Clinical Research Project Coordinator, University of Wisconsin-Madison School of Medicine and Public Health (Department of OB/GYN)

View Event →
Getting to Yes: How Sites Can Use Their Preferred Technology in Trials
Apr
26
1:30 PM13:30

Getting to Yes: How Sites Can Use Their Preferred Technology in Trials

Sites are overwhelmed by the increasing number and complexity of technology solutions required to execute clinical trials. This is exacerbated by the increasing number of solution providers selected. Currently, research sites are typically required to use sponsor-provided technology systems. The Decentralized Trials and Research Alliance's (DTRA's) "Bring Your Own Technology" initiative aims to enable clinical research sites to use their own validated technology systems in industry-sponsored clinical trials while maintaining regulatory compliance and sponsor oversight. The objective is to reduce operational inefficiencies, improve data quality, and enhance site and patient experiences. This session will share the work done by DTRA to date to define a process to enable adoption of site-preferred technology in registrational trials. Using eConsent as a model, key considerations and impact assessments conducted to identify opportunities and challenges from a multi-stakeholder perspective will be shared. The work continues in 2025-26, focusing on site-preferred eSource adoption by sponsors.

CEU: 1.00 ACRP

Speakers:

  • Joe Dustin, Founder and Principal, Dauntless eClinical Strategies

  • Rick Greenfield, BBA-IS, Founder & Chief Strategy Officer, RealTime eClinical Solutions

  • Brandon Maggio, Global Head of Digital Operations & Process Optimization, Glaxo Smith Kline

  • Jane Myles, Program Director, Decentralized Trials and Research Alliance

View Event →
Streamlining Confidentiality Disclosure Agreements to Accelerate Clinical Research
Apr
26
1:30 PM13:30

Streamlining Confidentiality Disclosure Agreements to Accelerate Clinical Research

Study startup delays represent a critical barrier impairing efficiency in clinical research timelines and our ability to ultimately serve patients. Tackling each contributing factor in this issue should be an effort we all engage in. The Site-Sponsor Consortium—a unique collaboration of sponsors, contract research organizations, institutional sites, and commercial sites—will unveil its inaugural whitepaper, which details actionable strategies to simplify and harmonize Confidentiality Disclosure Agreement processes across the industry. Consortium members will discuss the operational and ethical imperatives for reform, the value of master and bilateral agreements, and the collaborative journey that led to consensus-driven solutions. Attendees will gain insight into the practical steps needed to reduce study startup timelines and foster a culture of shared responsibility, transparency, and innovation in clinical research.

CEU: 1.00 ACRP

Speaker:

View Event →
Building Trust in Clinical Research Through Literacy-First Community Engagement
Apr
26
1:30 PM13:30

Building Trust in Clinical Research Through Literacy-First Community Engagement

Clinical research can be made more trustworthy and accessible by engaging communities through unconditional, literacy-driven outreach. This session shares a model for engaging people where they are, not as future participants or workforce members, but as community members deserving of clarity, inclusion, and respect. Presenters will share examples of how they deliver plain-language education about clinical research, facilitate conversations around research mistrust, and equip communities with the tools to navigate research information and options. These efforts aren’t tied to active studies or enrollment; rather, they’re grounded in the belief that long-term public trust is built through repeated, agenda-free education. Attendees will walk away with replicable strategies for building community-facing literacy initiatives centered on equity, transparency, and relationship-building.

CEU: 1.00 ACRP

Speakers:

View Event →
Transforming Coordinator-Monitor Tensions into Clinical Trials Teamwork
Apr
26
1:30 PM13:30

Transforming Coordinator-Monitor Tensions into Clinical Trials Teamwork

The relationship between clinical research coordinators and monitors is at the heart of every trial. Too often, it is defined by miscommunication, mistrust, and turf wars, but clinical trials move too quickly and are too important to allow these avoidable barriers to persist. This interactive session, led by monitors who were once coordinators, flips the script. With a unique dual perspective of site and sponsor, the speakers explore how empathy, communication, and perspective-taking can transform this critical relationship from adversarial to collaborative. Attendees will gain heightened self-awareness and actionable strategies for their unique situations. When coordinators and monitors work in sync, clinical trials run smoothly. Let's rethink the status quo and co-create a culture of mutual respect and shared goals--because better relationships mean better research.

CEU: 1.00 ACRP

Speakers:

View Event →
Communicating Effectively with IRBs for Faster and More Robust Approvals
Apr
26
1:30 PM13:30

Communicating Effectively with IRBs for Faster and More Robust Approvals

Does working with your IRB feel like a roadblock? With the right strategies, you can develop a powerful partnership to ensure ethical, efficient, and compliant research.

In this session, participants will learn how to communicate with the IRB in ways that reduce delays, improve protocol clarity, and support ethical decision-making. Grounded in real-world IRB review practices, federal regulations (45 CFR 46), and institutional experience, we’ll explore what the IRB actually prioritizes in a protocol submission and how to deliver a clear and concise submission for review.

We’ll cover how to describe study activities in a way that aligns with regulatory criteria, write protocols with clarity around data handling, participant interactions, and multi-site coordination, and navigate pushback or differing IRB interpretations. Whether you’re managing a straightforward survey study or a complex, multi-site data integration project, this session will equip you with strategies to make your IRB submissions more efficient and effective.

CEU: 1.00 ACRP

Speakers:

  • Marianna Azar, Director, Human Research Protection Program, Research Foundation for Mental Hygiene (New York State Psychiatric Institute)

  • Challace Pahlevan-Ibrekic, Director, Clinical Research, Northwell Health

View Event →
The People Puzzle: How Communication Styles Shape Recruitment and Retention
Apr
26
3:00 PM15:00

The People Puzzle: How Communication Styles Shape Recruitment and Retention

What if the real obstacle to better recruitment isn’t your budget or your systems... but how you communicate? Too often, clinical teams overlook the role personality plays in how messages are delivered, received, and acted on in both internal departments and patient communications.  And believe or not, they coorelate more than you think.

This session explores how internal misalignment in communication can spill over into patient-facing interactions, impacting trust and clarity (and ultimately recruitment & retention). Using personality test frameworks like DISC, MBTI, and others, we’ll explore our own communication preferences, categorize communication styles of others, and how to adjust your approach to build stronger connections. When applied to patient recruitment, strong communication builds greater trust with patients by showing an understanding of who they are, their priorities, and how they communicate. When patients feel understood, you earn their trust.

When communication flows, recruitment follows.

CEU: 1.00 ACRP

Speaker:

View Event →
Rethinking Soft Skills for Excellence in the Clinical Workforce
Apr
26
3:00 PM15:00

Rethinking Soft Skills for Excellence in the Clinical Workforce

Discover how prioritizing soft or aligned skills in hiring and training entry-level clinical research professionals can open sustainable pathways to success—and learn how to put skills-based hiring into action at your institution. We’ll briefly examine industry trends and the importance of a sustainable talent pipeline with the right skills. We will share our real-life experiences building a workforce development program, and provide tools for screening, hiring, and developing the desired soft skills. Participants will reflect on their own institutional needs and practices, and come away with actionable strategies to create inclusive, skills-based paths into the profession. By revisiting the Joint Task Force for Clinical Trial Competency model through the lens of your institution’s prioritized soft skills, you’ll assess alignment, identify gaps, and explore ways to refine expectations—ensuring your training goals and performance benchmarks are appropriate and personalized.

CEU: 1.00 ACRP

Speaker:

View Event →
From Silos to Synergy: Fixing Budget Friction Through Cross-Stakeholder Understanding
Apr
26
3:00 PM15:00

From Silos to Synergy: Fixing Budget Friction Through Cross-Stakeholder Understanding

Delays in clinical trial budgeting often result not from lack of effort, but from a lack of shared understanding across stakeholders. Sites, sponsors, and contract research organizations each have different processes and constraints that create friction in this critical startup process. This session presents findings from a cross-industry working group that explored the root causes of budgeting misalignment and developed practical, stakeholder-informed strategies to close the gap. The group’s work centers on three key domains—study startup operations, budget estimation, and budget justification—and shares insights from real-world experiences across the research ecosystem. The goal is to accelerate study startup by building mutual understanding, streamlining communication, and promoting efficient negotiation. Attendees will walk away with actionable tools that can be used to upskill staff, improve cross-functional collaboration, and support an improved approach to budgeting in clinical research.

CEU: 1.00 ACRP

Speakers:

View Event →
Optimizing Site Resources and Data Quality Through Focused Enrollment Blocks
Apr
26
3:00 PM15:00

Optimizing Site Resources and Data Quality Through Focused Enrollment Blocks

Clinical trial recruitment faces persistent challenges, including prolonged enrollment periods, high screen failure rates, and inconsistent data quality. This session introduces the innovative block enrollment strategy, which accelerates trial recruitment by concentrating all site resources on a single protocol during a focused enrollment period. By aligning the entire research team and optimizing patient engagement, the block enrollment approach improves enrollment efficiency, reduces screen failures, and enhances participant retention. Drawing on real-world data from ophthalmic trials, attendees will explore how this model streamlines workflows while maintaining rigorous quality standards. The session will engage participants in discussing scalability and adaptation of block enrollment across various therapeutic areas. Key roles of principal investigators, study coordinators, and support staff in this focused recruitment method will be highlighted. Attendees will have the opportunity to learn about a transformative, practical approach that reshapes clinical trial enrollment and optimizes site performance.

CEU: 1.00 ACRP

Speaker:

View Event →
Rewriting the Rules: Transformative Approaches to Decentralized Research
Apr
26
3:00 PM15:00

Rewriting the Rules: Transformative Approaches to Decentralized Research

Decentralized clinical trials are reshaping how research is conducted, offering new opportunities to expand access, improve participant accrual, and reduce the burden on limited organizational resources. This session will explore transformative approaches institutions can take to implement and manage decentralized trials effectively. Attendees will learn how to adopt flexible models that support research growth without requiring extensive staffing or infrastructure. The session will highlight practical strategies for integrating decentralized elements into existing workflows, including virtual visits, digital tools, and participant-centered processes. Real-world examples will show how organizations have successfully used decentralized models to reach underserved populations and streamline operations. Whether the organization is beginning to explore decentralized research or looking to scale existing efforts, this session will provide actionable insights to help align trial design with institutional goals. Attendees will discover how decentralized research can be a powerful tool for increasing efficiency, expanding reach, and supporting sustainable research operations.

CEU: 1.00 ACRP

Speaker:

  • Shreya Singh, Consulting Sr. Associate, Huron Consulting Group

View Event →
Empowering Clinical Research Through New Operational Roles at the Site Level
Apr
26
3:00 PM15:00

Empowering Clinical Research Through New Operational Roles at the Site Level

This session proposes a new operational paradigm focused on redesigning the internal structure of clinical trial sites through the incorporation of specialized roles--with active support from the industry--to ensure quality, efficiency, and long-term sustainability. The presenter will analyze the structural limitations of the traditional site model and their implications for quality, compliance, and efficiency; demonstrate the strategic value of new key roles such as clinical trial managers, quality control specialists, quality assurance specialists, clinical trial educators, and clinical research coordinator assistants; present a scalable framework based on quality management systems (QMS) that integrates these roles; and offer an action plan to transform site structures and strengthen the workforce.

CEU: 1.00 ACRP

Speaker:

View Event →
From Chaos to Control: Project Management Fundamentals for Early-Career Clinical Research Professionals
Apr
26
4:00 PM16:00

From Chaos to Control: Project Management Fundamentals for Early-Career Clinical Research Professionals

Many early-career clinical research professionals are thrust into complex, fast-paced project environments with limited exposure to formal project management training. This session provides a practical introduction to core project management principles tailored to clinical research settings—specifically at the study and site level. Attendees will explore key tools and strategies for managing timelines, tracking milestones, handling communications, and identifying potential risks before they become problems. Real-world case examples will highlight how applying simple project management frameworks can reduce study delays, improve team coordination, and support operational success. This session will be especially valuable for site coordinators, study managers, and new team leads looking to enhance their organizational skills and confidence in managing day-to-day research operations.

CEU: 1.00 ACRP

Speaker:

View Event →
Bridging the Gaps to Succeed as a Multigenerational Team
Apr
26
4:00 PM16:00

Bridging the Gaps to Succeed as a Multigenerational Team

This session explores how to celebrate Gen Z colleagues, collaborate effectively with Millennial bosses, and embrace the strengths of a multigenerational workforce. Today’s organizations face new challenges as employees bring diverse values, attitudes, and expectations. Baby Boomers represent 15% of the workforce, Gen X 31%, Millennials 36%, and Gen Z 18%.

Participants will learn to identify and compare generational core values and cultural influences to enhance communication and build high-performing, inclusive teams. The session highlights recognizing personal biases and avoiding snap judgments about other generations.

A key focus is the paradigm shift from a traditional “boss” mentality to a “coach” approach, fostering trust and engagement across age groups.

In the clinical research community, where collaboration is critical, each generation contributes unique strengths and perspectives. This session equips attendees to support intentional cross-generational communication, encourage mutual understanding, and leverage diversity to strengthen teamwork and improve outcomes in this dynamic environment.

CEU: 1.00 ACRP

Speakers:

View Event →
Transforming Workflows for Protocol Activation and Study Lifecycle Management
Apr
26
4:00 PM16:00

Transforming Workflows for Protocol Activation and Study Lifecycle Management

This session will highlight the transformation of protocol activation and lifecycle management that results in improved research billing compliance, streamlined workflows, aligned financial policies, and enhanced training curriculum. Despite the complexity of study activation, we found that mastering the basics—clear policies and procedures along with practical tools—was key to success. Attendees will leave with strategies and tools to confidently support clinical trial workflow transformation projects.

CEU: 1.00 ACRP

Speakers:

View Event →
How Much is Too Much?: Taking a Closer Look at the Ethics of Subject Compensation
Apr
26
4:00 PM16:00

How Much is Too Much?: Taking a Closer Look at the Ethics of Subject Compensation

The question of how—and how much—to compensate research participants is far from settled. While undue influence remains a central concern, too little compensation can be equally problematic—failing to respect participants’ time, reinforcing inequities, and limiting recruitment from underrepresented groups. What truly constitutes "undue influence"?  Should compensation only reflect time and inconvenience, or also acknowledge risk?  Do higher payments undermine voluntariness, or do they simply acknowledge the realities of participation? This session will examine current debates alongside emerging trends, including reimbursement versus compensation, digital wallet payments, gamification, and punitive terms of payment. Drawing on ethical frameworks, regulatory guidance, and real-world case examples, we will provide attendees with practical tools to evaluate and justify compensation strategies that withstand scrutiny while supporting participant trust and engagement.

CEU: 1.00 ACRP

Speaker:

View Event →
Monday Registration Hours
Apr
27
7:00 AM07:00

Monday Registration Hours

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.

View Event →
Work Life Balance As A Monitor - Is It Possible?
Apr
27
9:00 AM09:00

Work Life Balance As A Monitor - Is It Possible?

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:

View Event →
Community Engagement in Observational Studies for Rural and Small Sites
Apr
27
9:00 AM09:00

Community Engagement in Observational Studies for Rural and Small Sites

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:

View Event →
Cultivating Key Relationships for Optimized Collaboration Between Sponsors, Sites, and Participants
Apr
27
9:00 AM09:00

Cultivating Key Relationships for Optimized Collaboration Between Sponsors, Sites, and Participants

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:

View Event →
Oops in the Ops: Catching, Categorizing, and Reporting Protocol Deviations
Apr
27
9:00 AM09:00

Oops in the Ops: Catching, Categorizing, and Reporting Protocol Deviations

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:

View Event →
The Ripple Effect: Making ICH E6(R3) Real Across Clinical Research
Apr
27
9:00 AM09:00

The Ripple Effect: Making ICH E6(R3) Real Across Clinical Research

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:

View Event →
Building a Stronger Foundation in Clinical Research Through Reimagined Onboardings
Apr
27
9:00 AM09:00

Building a Stronger Foundation in Clinical Research Through Reimagined Onboardings

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:

View Event →
Beyond the Buzzwords: Oversight, Quality by Design, and Risk-Based Thinking
Apr
27
10:00 AM10:00

Beyond the Buzzwords: Oversight, Quality by Design, and Risk-Based Thinking

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:

View Event →
Strategic CRC Development Using Competency-Based Checklists
Apr
27
10:00 AM10:00

Strategic CRC Development Using Competency-Based Checklists

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

View Event →
Getting to Database Lock Challenges, Solutions, and Lessons Learned
Apr
27
10:00 AM10:00

Getting to Database Lock Challenges, Solutions, and Lessons Learned

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:

View Event →
Three’s Company: Strengthening Sponsor-CRO-Site Relationships
Apr
27
10:00 AM10:00

Three’s Company: Strengthening Sponsor-CRO-Site Relationships

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:

View Event →
Site-First eSource: Practical Strategies for EHR-to-EDC Adoption
Apr
27
10:00 AM10:00

Site-First eSource: Practical Strategies for EHR-to-EDC Adoption

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

View Event →
Standardizing Participant Benefits to Improve Equity, Retention, and Trust in Clinical Trials
Apr
27
11:00 AM11:00

Standardizing Participant Benefits to Improve Equity, Retention, and Trust in Clinical Trials

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:

View Event →
Clean Data: Signed, Sealed, and Delivered
Apr
27
11:00 AM11:00

Clean Data: Signed, Sealed, and Delivered

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:

View Event →
Applying Artificial Intelligence to Site Selection and Feasibility
Apr
27
11:00 AM11:00

Applying Artificial Intelligence to Site Selection and Feasibility

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.

View Event →
How Patient Relationships and Community Connections Fuel Study Recruitment and Retention
Apr
27
11:00 AM11:00

How Patient Relationships and Community Connections Fuel Study Recruitment and Retention

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:

View Event →
Elevating Clinical Trial Performance Through Mentorship and Staff Empowerment
Apr
27
11:00 AM11:00

Elevating Clinical Trial Performance Through Mentorship and Staff Empowerment

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

View Event →
Designing and Evaluating a High School Clinical Research Camp for Inspiring Future Professionals
Apr
27
11:00 AM11:00

Designing and Evaluating a High School Clinical Research Camp for Inspiring Future Professionals

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:

View Event →
Strategic Approaches for Achieving Robust Community Engagement in Clinical Research
Apr
27
1:00 PM13:00

Strategic Approaches for Achieving Robust Community Engagement in Clinical Research

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:

View Event →
Digitally Driven Compliance: Transforming Clinical Research Operations Through Informatics Integration
Apr
27
1:00 PM13:00

Digitally Driven Compliance: Transforming Clinical Research Operations Through Informatics Integration

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:

View Event →
Reimagining Roles and Upskilling Talent for Tomorrow's Trials
Apr
27
1:00 PM13:00

Reimagining Roles and Upskilling Talent for Tomorrow's Trials

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:

View Event →
Better (Not) Call FDA: When and How to Flag Regulatory Oversight in Your Study
Apr
27
1:00 PM13:00

Better (Not) Call FDA: When and How to Flag Regulatory Oversight in Your Study

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:

View Event →
Source Data Verification in the Age of AI
Apr
27
1:00 PM13:00

Source Data Verification in the Age of AI

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:

View Event →
There's a Better Way to Approach Training for New Clinical Trials Team Members
Apr
27
1:00 PM13:00

There's a Better Way to Approach Training for New Clinical Trials Team Members

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

View Event →
Establishing Partnerships for Fixing the Training Disconnect at Sites
Apr
28
1:30 PM13:30

Establishing Partnerships for Fixing the Training Disconnect at Sites

Training challenges persist throughout the clinical research enterprise. This session presents benchmark data and discusses practical solutions for partnerships between sponsors, contract research organizations, and sites to address site-based training shortcomings for the betterment of clinical trial conduct.

CEU: 1.00 ACRP

Speaker:

View Event →

Building an Integrated Clinical Evidence Strategy for Medical Device R&D
Apr
27
2:00 PM14:00

Building an Integrated Clinical Evidence Strategy for Medical Device R&D

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:

View Event →
Perfecting the Science and Art of Staffing for Clinical Trials
Apr
27
2:00 PM14:00

Perfecting the Science and Art of Staffing for Clinical Trials

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

Watch a Sneak Peek into the Session Content:


Study & Site Management Journey Sponsor

 
View Event →
Unlocking Professional Engagement at Sites Through Individual Retention Conversations
Apr
27
2:00 PM14:00

Unlocking Professional Engagement at Sites Through Individual Retention Conversations

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:

Watch a Sneak Peek into the Session Content:

View Event →
Defining the Role of the Clinical Research Associate in Site-Sponsor Relationships
Apr
27
2:00 PM14:00

Defining the Role of the Clinical Research Associate in Site-Sponsor Relationships

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:

Related Blog Content:

Watch a Sneak Peek into the Session Content:


Study & Site Management Journey Sponsor

 
View Event →
The Hidden Costs of Diversity and Inclusion in Clinical Research
Apr
27
2:00 PM14:00

The Hidden Costs of Diversity and Inclusion in Clinical Research

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:

Related Blog Content


Study & Site Management Journey Sponsor

 
View Event →
Transforming Stipend and Reimbursement Practices for Trial Participants
Apr
27
2:00 PM14:00

Transforming Stipend and Reimbursement Practices for Trial Participants

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:

Watch a Sneak Peek into the Session Content:


Study & Site Management Journey Sponsor

 
View Event →
Assessing and Managing Study Coordinator Workload
Apr
27
12:45 PM12:45

Assessing and Managing Study Coordinator Workload

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:

Related Blog Content:

Watch a Sneak Peek into the Session Content:


Study & Site Management Journey Sponsor

 
View Event →
Escaping the Grind: Time Management in the Real World
Apr
27
12:45 PM12:45

Escaping the Grind: Time Management in the Real World

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:

Watch a Sneak Peek into the Session Content:

View Event →
Back to Clinical Trial Budgeting Basics: Are Your Costs Covered?
Apr
27
12:45 PM12:45

Back to Clinical Trial Budgeting Basics: Are Your Costs Covered?

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:


Study & Site Management Journey Sponsor

 
View Event →
How the New Single IRB Requirements Will Change Clinical Research
Apr
27
12:45 PM12:45

How the New Single IRB Requirements Will Change Clinical Research

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:

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.

Watch a Sneak Peek into the Session Content:

View Event →
Career Shift: Enriching the Clinical Research Workforce Talent Pool
Apr
27
12:45 PM12:45

Career Shift: Enriching the Clinical Research Workforce Talent Pool

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

 
View Event →
From Inspiration to Execution of a Successful Investigator-Initiated Trial Protocol
Apr
27
12:45 PM12:45

From Inspiration to Execution of a Successful Investigator-Initiated Trial Protocol

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:

Watch a Sneak Peek into the Session Content:

View Event →
ACRP Certification: What You Need to Know
Apr
27
10:30 AM10:30

ACRP Certification: What You Need to Know

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:

View Event →
Compensating Research Subjects: The Fine Line Between Fairness and Inducement
Apr
27
10:30 AM10:30

Compensating Research Subjects: The Fine Line Between Fairness and Inducement

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:

Related Blog Content:

Watch a Sneak Peek into the Session Content:

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.

View Event →
The Clinical Research Technology Reboot: Are We Getting it Right?
Apr
27
10:30 AM10:30

The Clinical Research Technology Reboot: Are We Getting it Right?

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:

Related Blog Content:

View Event →
European Data Privacy Roadmap: Balancing Research, Innovation, and Compliance
Apr
27
10:30 AM10:30

European Data Privacy Roadmap: Balancing Research, Innovation, and Compliance

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:

Related Blog Content:

Watch a Sneak Peek into the Session Content:

View Event →
Detecting and Addressing the Quality Pitfalls at Study Sites
Apr
27
10:30 AM10:30

Detecting and Addressing the Quality Pitfalls at Study Sites

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:

Related Blog Content:

Watch a Sneak Peek into the Session Content:


Study & Site Management Journey Sponsor

 
View Event →
Innovative Models to Promote Pathways into the Clinical Research Workforce
Apr
27
10:30 AM10:30

Innovative Models to Promote Pathways into the Clinical Research Workforce

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:

Watch a Sneak Peek into the Session Content:

View Event →
A Data-Driven Approach to Site Selection for Oncology Trials
Apr
27
9:15 AM09:15

A Data-Driven Approach to Site Selection for Oncology Trials

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

Watch a Sneak Peek into the Session Content:

View Event →
Managing the Consequences of Audits and FDA Inspections
Apr
27
9:15 AM09:15

Managing the Consequences of Audits and FDA Inspections

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:

Related Blog Content


Study & Site Management Journey Sponsor

 
View Event →
ICH E6(R3): Real-World Questions & Answers
Apr
27
9:15 AM09:15

ICH E6(R3): Real-World Questions & Answers

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:

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.

View Event →
Data Strategies for Health Equity and Inclusion: Key European Trends
Apr
27
9:15 AM09:15

Data Strategies for Health Equity and Inclusion: Key European Trends

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

Watch a Sneak Peek into the Session Content:

View Event →
Comparing and Contrasting Approaches to In Vitro Diagnostics Research vs. Other Medical Devices
Apr
27
9:15 AM09:15

Comparing and Contrasting Approaches to In Vitro Diagnostics Research vs. Other Medical Devices

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:

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.

View Event →
Your Guide to 21 CFR Part 11 and Annex 11 Compliance
Apr
27
9:15 AM09:15

Your Guide to 21 CFR Part 11 and Annex 11 Compliance

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:

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.

View Event →
Gatekeeping Practices and the Evolving Clinical Research Coordinator Role
Apr
27
9:15 AM09:15

Gatekeeping Practices and the Evolving Clinical Research Coordinator Role

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:

Watch a Sneak Peek into the Session Content:

View Event →
AI in Clinical Research
Apr
27
8:00 AM08:00

AI in Clinical Research

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:

Related Blog Content:

View Event →
Closing Remarks at the Networking Reception
Apr
26
5:00 PM17:00

Closing Remarks at the Networking Reception

Join us for the closing remarks as ACRP Leadership shares final announcements, including the reveal of the three winners of the Clinical Research Poster Presentations.

Take this final opportunity to connect with colleagues and explore innovative solutions from 100+ leading-edge organizations and suppliers driving better results in clinical research.

Relax and celebrate a successful conference with a beverage and light hors d'oeuvres in the Expo Hall.

View Event →