This package is a replay of 14 on-demand session recordings and presentation slides from the Regulatory & Quality Track at the ACRP 2026 Conference, April 24 – 27, Orlando, Florida. Offers clinical research leaders and teams the insights and best practices needed to support compliance and quality in clinical trials.
Member: $99 | Nonmember: $149
Participants can earn up to 14 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Learning Portal.
This session will provide a high-level overview of the emerging regulatory environment governing clinical research. There are many trends to keep track of as actions by the current administration in the White House affect available funding, workforce readiness, and research priorities in governmental, academic, industry, and private practice settings. Further, recent and forthcoming updates to various U.S. Food and Drug Administration guidance, International Council for Harmonization guidelines, and ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials will make this a valuable session for all stakeholders across the entire clinical research enterprise. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, FACRP, Vice President, Clinical Research Compliance & Integrity, HCA Healthcare
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. Speakers: Margaret (Meg) Rood, VP, Operational Excellence, IMA Clinical Research; Andreja Vlajankov-Salaj, Sr. Director, Quality Assurance, IMA Clinical Research
The session is designed to open the door to a live reenactment of an institutional review board (IRB) meeting that includes samples of 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. Speakers: Claudia G. Christy, MSN, RN, CCRC, ACRP-CP, FACRP, IRB Board Member, Univo IRB; Melissa Gottke, BA, CIP, IRB Chairperson, Advarra; Amanda Higley, MS, PhD, CIP, IRB Chair Director, Advarra IRB; Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB; Deborah L. Rosenbaum, FACRP, CCRC, CCRA, ACRP-CP, ACRP-PM, Consultant, Sarrison Clinical Research, LLC
It is often straightforward to recognize FDA regulatory oversight when working on industry-sponsored studies conducted under Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. However, clinical research professionals frequently encounter uncertainty when determining whether FDA oversight applies in less obvious scenarios, including investigator-initiated, multisite, or early-phase studies. This session will present a practical framework to help participants identify and flag FDA regulatory oversight by walking through key indicators of IND/IDE applicability, common misconceptions, and critical decision points that influence regulatory classification and IRB review. The session will also explore emerging regulatory considerations related to artificial intelligence and machine learning–based products, companion diagnostics, radiation-emitting devices, and digital health technologies. Participants will leave with practical decision tools, case-based examples, and communication strategies to support confident, compliant conduct of FDA-regulated research. Speaker: Purna Garimella, MS, CIP, RAC, Director, Human Research Protection Program, Indiana University
This fast-paced, highly interactive lecture helps clinical research and quality professionals move beyond terminology and into real-life application. Participants will examine practical strategies and thinking to implement oversight, Quality by Design (QbD), and risk-based thinking in day-to-day trial decisions. Drawing on ICH E6(R3) expectations and real-world examples from both site and sponsor perspectives, the session includes guided activities and tools that help translate regulatory concepts into operational action. Attendees will also gain practical insight into two additional ICH E6(R3) expectations—data governance and fit-for-purpose thinking—showing how these concepts apply to system design, oversight, and proportional quality approaches. Interactive elements such as Buzzword Bingo, live polling, and decision-based scenarios 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. Speaker: Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
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. Speakers: Rachel Lally, MPH, CIP, Assistant Vice President for Research, Penn State University; Challace Pahlevan-Ibrekic, Director, Clinical Research, Northwell Health
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. Speaker: Kevin Gardner, Jr., MS, BSN, RN, CCRC, Director, Clinical Trials Office, Penn State College of Medicine
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. Speaker: Robert Romanchuk, CIP, BSHS, Chairperson, Regulatory Director, Univo IRB
This session will discuss the implementation a novel tool for Identifying IRB Review Level for Studies involving Secondary Use of Data/Specimens. Speaker: Leslie Bell, Regulatory Specialist, Medical University of South Carolina-South Carolina Clinical and Translational Research Institute (SCTR)
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. Speaker: Elena Alferova, Clinical Research Regulatory Coordinator II, UCSD Moores Cancer Center
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. Speakers: Sarandeep Kaur, MS, CCRC, Research Accountability Specialist, Corewell Health; Karen Sherer, Director, Research QA/QI, Corewell Health; Laura Stuecher, RN, BSN, CCRP, QA/QI Research Specialist, Corewell Health
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. Speaker: Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
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. Speakers: Lisa Ince, BS, CCRC, CCRA, FACRP, Project Manager, Syneos Health; Katherine Mary Marangio, MSc, Learning Program Consultant, Parexel Academy; Emma Pinto, BA, MBA, Manager, Clinical Trial Education & Communications, Kaiser Permanente Northern California Clinical Trials Program; Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC; Jennifer Tugwell, MSN, RN, ACRP-CP, Sr. Manager Clinical Trials Education, Training & Policies, City of Hope
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. Speakers: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare; Sophia McLeod, Director, Government Relations, Association of Clinical Research Organizations (ACRO)