The Association of Clinical Research Professionals

ACRP 2024 Regulatory & Compliance – Replay

This package is a replay of 13 on-demand session recordings and presentation slides from the Regulatory & Compliance Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Hear tips and strategies to mitigate risk and keep your studies in compliance.

Note: These 13 sessions will appear on your course dashboard individually as the titles seen below.


Member: $99 | Nonmember: $149


Participants can earn up to 14 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Courses Dashboard. Replay sessions expire on May 31, 2027. 

  • A Primer on the CMS Criteria for Approving Investigational Device Exemption Studies

When the Centers for Medicare and Medicaid Services (CMS) considers billing issues tied to Investigational Device Exemption (IDE) studies, it’s usually not the facts about such details as the National Clinical Trial number or an institutional review board’s decisions that come into question. More often, CMS is challenging the principal purpose of the study along with its methodology and applicability to Medicare beneficiaries and health outcomes. This session focuses on troubleshooting the “justifications” for the 10 approval criteria that matter most to CMS and learning more about what kinds of IDEs become winners. Speaker: Wendy Schroeder, Principal Strategy Consultant, Clinical. NAMSA

  • Oversight of Decentralized Components of a Clinical Trial

We will discuss regulatory oversight of clinical trials that use decentralized components. Through this presentation, the audience will hear about regulatory requirements and expectations of the coordination of these trials while using the unique aspects of ‘hybrid’ components. Speaker: Eric Pittman, MBA, Director, Bioresearch Monitoring Division (West), U.S. Food and Drug Administration

  • Strategies for Ensuring Part 11 Compliance for “eSystems” at Research Sites

With the U.S. Food and Drug Administration making it clear in recent guidance that electronic regulatory records in site-owned systems are definitely subject to CFR 21 Part 11 in the Code of Federal Regulations, this session focuses on how sites need to understand the requirements and develop strategies for compliance. Speaker: Stuart Cotter, VP, Product Strategy, Advarra

  • Are Your Electronic Records Ready for FDA Inspection?

This session dives into the U.S. Food and Drug Administration (FDA) policies, guidance, and expectations regarding the collection, creation, and storage of electronic source documentation at study sites. An experienced FDA Investigator will share examples of modern electronic record creation tools, programs, and devices alongside real-world examples of deficiencies observed on inspections and how the deficiencies could be prevented at a clinical site. Speaker: Richard Berning, Foreign Cadre Investigator / Specialist, U.S. Food and Drug Administration

  • Early Feasibility Studies: What You Need to Know to Make Them Succeed

This panel session delivers an interactive discussion on key concepts related to contracting for early feasibility studies, implementing such studies in academic settings, launching enrollment for them after activation, and utilizing them for novel devices. Speakers: Kate Dalton, Director, Cardiology Research, Columbia University; Lynne Goodreau, Administrative Director, Northwestern University; Eileen Mihas, Program Director – Early Feasibility Studies, Medical Device Innovation Consortium

  • European Clinical Trials: Roadmap for EU Data Protection Compliance

This session will provide valuable insights into European data privacy laws and their effect on EU and UK clinical trials, including an overview of the implications for life sciences organizations globally. With the challenges of jurisdictional specifics and the ever-complex international data-sharing environment, this session will provide guidance on good data protection practices and the processes required to mitigate the risks and build participant trust, therefore leading to improved trial engagement. Speaker: Rob Masson, CEO, The DPO Centre

  • Maintaining Data Integrity from Collection to Reporting and Everything in Between

This session offers a U.S. Food and Drug Administration Investigator’s insights from sponsor inspections that will help you to identify and prevent the problems that may arise for your data and/or application during the collection of tens to hundreds of thousands of documents during a single trial. Speaker: Lakecha Lewis, International Inspection Cadre, U.S. Food and Drug Administration

  • Two Steps Forward, One Step Back: Getting Ahead of Tech-Related Data Integrity Challenges

U.S. Food and Drug Administration (FDA) Investigators have uncovered data integrity issues related to electronic data in clinical trials, resulting in regulatory actions and/or FDA withholding of approval. This presentation will provide insight into electronic data on efficacy and safety and some real-world examples of questionable validity that the FDA has seen recently. Speaker: Craig Garmendia, PhD, MS, Investigator, International Inspection Cadre, U.S. Food and Drug Administration

  • Defining Roles and Responsibilities at the Study Site When Non-Compliance is Detected

This session highlights the importance of a successful partnership between research operations and compliance, and will walk through lessons learned from cases of billing and research noncompliance that could only be resolved through effective collaboration and mutual support. Speakers: Kate Cohen, JD, CHC, CHRC, Chief Compliance Officer, Southern Illinois University School of Medicine; Amber Fifer, PharmD, ACRP-CP, Director of Operations, Center for Clinical Research, Southern Illinois University School of Medicine

  • Ethics in Action: Handling Cases of Exemption from Informed Consent

This panel discussion reviews the ethical, regulatory, and operational challenges of conducting Exemption from Informed Consent (EFIC) trials in cases involving life-saving, emergency treatments when obtaining consent is impossible. Speakers: Kammy Jacobsen, PECARN Program Director, University of Utah, Data Coordinating Center; Ann Johnson, MPH, IRB & HRPP Director, University of Utah, Institutional Review Board; John VanBuren, PhD, Associate Professor, University of Utah

  • Key Clinical Research Regulatory Updates for Thriving in 2024

Clinical research regulations, guidances, and advisories that come in an unending stream from the U.S. Food and Drug Administration are a fact of life that no one in the professional can afford to ignore. This session provides a high-level overview of recent and emerging regulatory issues in the conduct of clinical trials and other kinds of research in the United States. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare

  • Navigating the Single IRB Process

Most federally funded, multisite studies already require oversight by a single institutional review board (sIRB), and soon that likely will be true for U.S. Food and Drug Administration-regulated studies. It’s no secret that sIRB review presents challenges for study teams, especially those managing investigator-initiated studies. This session will help you understand your responsibilities related to sIRB review and point you to resources you can take advantage of. Speakers: Polly Goodman, Associate Director of Regulatory Affairs Operations, SMART IRB, Harvard Catalyst | The Harvard Clinical and Translational Science Center; Michael Linke, PhD, Adjunct Professor/Director of Education, University of Cincinnati/SMART IRB

  • Subject Injury: Creating a Process from Pre-Award through Participant Enrollment

Concerned about capturing subject injury charges? Worried items and services have slipped out the door when Sponsor has agreed to pay? Unsure if all stakeholders have been alerted to a subject injury? Join us and hear about our journey in building a process to train all stakeholders and ensure billing compliance. This presentation is geared to research billing compliance professionals, study coordinators, and site staff involved in operations and administration. Speakers: Kevin Gardner, Jr., Director, Clinical Trials Office, Penn State College of Medicine; Kimberly Perkins, Assistant Director, Clinical Trials Office, Penn State College of Medicine