This package is a replay of 17 on-demand session recordings and presentation slides from the Regulatory & Compliance Journey at the ACRP 2025 Conference, April 24 – 27, New Orleans, Louisiana. Hear tips and strategies to mitigate risk and keep your studies in compliance.
Member: $99 | Nonmember: $149
Participants can earn up to 17 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Courses Dashboard. Replay sessions expire on May 23, 2028.
This session will provide a high-level overview of the emerging regulatory environment governing clinical research. With a new administration in the White House and recent and forthcoming updates to various U.S. Food and Drug Administration guidances, International Council for Harmonization guidelines, and more targeting ethical, safety, and efficacy concerns in the design and conduct of drug and device clinical trials, this is a session providing value for stakeholders across the entire clinical research enterprise. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, FACRP, VP Clinical Research Compliance & Integrity, HCA Healthcare
Artificial intelligence (AI) and machine learning (ML) technologies are transforming healthcare delivery. Understanding the regulatory framework for study AI/ML utility, accuracy, efficacy, and reproducibility is key to the research process prior to its use in patient diagnosis and care. This is a cutting-edge topic upon which many new federal guidance documents have focused. It is often misunderstood by sponsors, sites, and investigators that if AI/ML is used for diagnosis, the technology it is FDA regulated. Operationally, the inclusion or exclusion of AI/ML findings into the electronic health record is poorly understood, although it is analogous to the 21 CFR 812 Investigational Device Exemption or 510 K pathway used for new laboratory testing procedures. Speakers: Betty Donoval, Director, Research & Regulatory Affairs, Cook County Health; Pamela Gonzalez, Manager Research Consultant, Huron LLC
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. Speakers: Lisa Colton, Clinical Regulatory Lead, BSI; Regina Fulkerson, PhD, Director, Clinical Evidence Planning & Evaluations, Varian Medical Systems; Jamie Mangold, PhD, Clinical Evidence Planning & Evaluations Manager, Varian Medical Systems; Eric Sugalski, Founder & CTO, Archimedic
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. Speaker: Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA
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. Speaker: Steffi Leung Newell, MS, RN, OCN, CCRC, Clinical Research Nurse, Rush Medical Center
Applying for institutional review board (IRB) review can be a daunting process when you don’t understand how these boards function or why their decisions are so important. What application do I use for my study? What’s the big deal about consent forms? How long will review take? Why do similar-sounding studies earn different decisions? The IRB review process can seem quite opaque initially; however, most IRBs use similar processes and a lot happens behind the scenes to bring order out of potential chaos. In this session, you will learn the base rules and regulations IRBs follow when reviewing applications, the possible outcomes following review, and the general flow most IRBs use when reviewing applications. Speaker: Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
This presentation will consider the regulatory, operational, and ethical facets of collecting genetic information for clinical research. Topics covered will include regulations surrounding genetic testing and return of results; optimizing protocol design to facilitate specific genetic testing while reducing unnecessary collection; and considerations for biobanking, de-identification, and future research. Participants will leave this session with a robust view of research regulations, innovative ideas to incorporate into protocol design, and a deeper appreciation for patient privacy concerns. Speaker: Lauren Blizzard, MCR, Emerging Talent Rotational Associate, Merck
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. Speaker: Rob Masson, CEO, The DPO Centre
Join a seasoned U.S. Food and Drug Administration (FDA) Investigator for an overview of how to “stress test” your electronic source (eSource) documents to ensure that they are compliant with FDA regulations and current guidance. This session offers a brief overview of regulatory requirements governing the creation, maintenance, and storage of electronic data at clinical sites and reviews some examples of shortcomings observed in FDA inspections that resulted in FDA Form 483s (Notice of Inspectional Observations) and even Warning Letters. We will also review different types and sources of eSource documentation, including digital health technology, registries used to source real-world data, and electronic medical records, and review common pitfalls associated with them. After the presentation, there will be a live Q&A opportunity. Speaker: Barbara Wright, JD, Senior Advisor, Office of Bioresearch Monitoring Inspectorate, Office of Inspections & Investigations, U.S. Food and Drug Administration
The U.S. Food and Drug Administration’s (FDA’s) recent guidance for institutional review boards on informed consent was the first update to the old “information sheets” on the topic in nearly 20 years. The Office for Human Research Protections beat FDA to the punch with new consent form requirements, but does the latest guidance mean there is a new “reasonable person” in the room? In this session, we will break down the new FDA guidance and what it means for accredited Human Research Protection Programs. Some organizations may not need to make any extensive changes, but there are differences between the FDA guidance and the expectations of the Common Rule concerning informed consent that must be considered. Speaker: James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra
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. Speaker: Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego
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. 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. Speakers: Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials Research Inc.; Katherine Mary Marangio, Learning Program Consultant, Parexel Academy; Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC
Leveraging electronic tools is essential for maintaining inspection readiness in today’s regulatory landscape. Paper-based methods are cumbersome and time-consuming, and they create logistical challenges in record keeping. In contrast, technology offers centralized record keeping, and electronic file storage is now both cost-effective and user-friendly. This shift is underscored by updated guidelines such as ICH E6(R3), which promotes media neutrality, flexibility, innovation, proactive quality, and robust data governance. Additionally, remote regulatory assessments, which were proven effective during the pandemic, enhance efficiency, flexibility, and global reach while reducing travel and disruption. Despite these advancements, recent feedback from regulators indicates a regression in the adoption of these technological tools. It is time for sponsors to embrace risk proportionality, which is supported by regulatory authorities, to maintain inspection readiness. Speakers: Marc Wartenberger, CQA, CTFL, Senior Director, Security, Corporate QA & Compliance, CRIO
ICH E6 changes are upon us. Are you ready to implement new expectations for Good Clinical Practice (GCP) and a flexible framework for clinical trial design and conduct? Please join us for a panel discussion on the principles described within ICH E6(R3), the changes from ICH E6(R2), the implications for GCP, considerations for implementation, and insights on how we as an industry can think through flexible design in a quality-minded environment. Speakers: Katherine Mary Marangio, Learning Program Consultant, Parexel Academy; Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC; Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University (Moderator)
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. Speaker: Bree Burks, RN, MSN, Vice President of Strategy, Veeva Systems
The assurance of study subjects’ privacy and confidentiality is fundamental to the enrollment of participants in clinical research. At the same time, the number of datapoints collected and commodified by the commercial world on each individual has increased exponentially. The potential overlap or convergence of these datastreams, whether intentional or inadvertent, threatens the promise of privacy. This session will explore the range and means of data collected in the pursuit of human research and the limits of protections possible in today’s digital world. Speaker: Robert Romanchuk, CIP, Chairperson, Univo IRB
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. Speaker: Sara Saunders, MHA, CCRP, Sr. Manager, Regulatory Affairs, Florence Healthcare