Signature Series Session

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. This is a session you will not want to miss. 

CEU: 1.00 ACRP

Speaker:

• Kassa Ayalew, MD, MPH, Director, Division of Clinical Compliance Evaluation, Office of Scientific Investigation, Center for Drug Evaluation and Research (CDER), U.S. Food & Drug Administration (FDA)

• Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University

• Katherine Mary Marangio, Learning Program Consultant, Parexel

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

Watch the Webinar Replay Ahead of the Live Session (Free Without Contact Hours):

• Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)

Related Blog Content:

• The Impact of ICH E6(R3) on GCP: Implementing New Expectations in a Culture of Quality

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.

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.

CEU: 1.00 ACRP

Speaker:

• Robert Romanchuk, CIP, Chairperson, Univo IRB, Univo IRB

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.

Your patient recruitment engine is the machine that fuels your site's success. Regardless of your wins or losses, every site wants to improve and add efficiency to its recruiting process. Chances are, a lot of what you're already doing is right, but there seems to be something new every day that clinicians can't resist seeking--the next "silver bullet" for marketing and recruiting. It's easy to feel you're behind in the space. It's easy to think you're over- or under-invested. It's easy to ponder that others are finding patients you're not. This session is designed to ease those fears. Find out about the things you think you might be missing. We'll discuss the media options sites are using, spend some time on the new things you keep hearing about, and give you the tactics to evaluate your recruiting operation. Then you can decide where best to allocate resources and grow.

CEU: 1.00 ACRP

Speaker:

• Mark Metzner, Senior Manager, Patient Recruiting & Feasibility, CTI Clinical Trial Services, Inc.

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.

CEU: 1.00 ACRP

Speaker:

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

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.

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.

CEU: 1.00 ACRP

Speaker:

• Barbara Wright, JD, Senior Advisor, Office of Bioresearch Monitoring Inspectorate, Office of Inspections & Investigations, U.S. Food and Drug Administration

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.

CEU: 1.00 ACRP

Speakers:

• Betty Donoval, Director, Research & Regulatory Affairs, Cook County Health

• Pamela Gonzalez, Manager Research Consultant, Huron LLC

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.

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.

CEU: 1.00 ACRP

Speaker:

• Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

• Lauren Blizzard, MCR, Emerging Talent Rotational Associate, Merck

Watch a Sneak Peek into the Session Content:

Signature Series Session

Join Dr. David Burrow from FDA's Center for Drug Evaluation and Research as he explores operational strategies for implementing Quality by Design and the integration of Risk Based Quality Management Systems into routine trial design and conduct. Dr. Burrow will build on the key themes discussed in his 2024 Signature Series presentation titled, “Reimagining Clinical Research: The Transformation of Trial Design & Conduct” and bring his own unique perspectives to the next stage of reimagining clinical research and removing barriers to innovation. Take away practical approaches to mitigating obstacles, advancing the shared interests of human subject protection, generating high quality evidence of safety and effectiveness, and enabling action through strategies to manage fear - both as an organization and as an individual. 

Objectives: 

1. Discuss key themes of Quality by Design, Critical to Quality factors, and Risk Based Quality Management Systems. 

2. Advance shared understanding of the CDER Center for Clinical Trial Innovation (C3TI) and other FDA drug development programs.  

3. Provide strategies to advance innovation and enhance quality while also minimizing fear of regulatory oversight. 

CEU: 1.00 ACRP

Speaker:

• David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Related Blog Content:

• Mitigating FEAR in Clinical Research Innovation: ‘Face Everything And Rise’ Together!

In a post-pandemic landscape, learning, conducting, and implementing clinical trials significantly changed with the adoption of globally accepted decentralized methods. Variability across educational offerings may not assess learner competency to perform clinical research operational activities. In this panel, clinical investigators, a U.S. Food and Drug Administration representative, and educators will explore varied modalities for training investigators and consider avenues for comprehension in terms of learning on the job, through structured courses, by attending sponsor/contract research organization-conducted trainings, or by completing online modules--none of which may be sufficient in isolation. Fundamentals of online teaching and learning, coupled with adult learning methods and the industry's continued reliance on a "decentralized method of training," are pivotal to assess learner capability. In the absence of documented analysis and evaluation of the effectiveness of micro-credentials, presenters will discuss strengths/weaknesses, gaps, and challenges of the biopharmaceutical industry's reliance on the current modes of training and education of clinical research professionals.

CEU: 1.00 ACRP

Speakers:

• David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

• Nadina Jose, MD, Assistant Professor, School of Health Profession, Rutgers, The State University of New Jersey

• Anita Kablinger, MD, CPI, FAAP, FAPA, FACRP, FASCP, Professor, Academic Vice Chair and Director of Clinical Research, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, Virginia Tech Faculty of Health Sciences

• Erika Stevens, MA, FACRP, Director, Research Experience, Rutgers

Watch a Sneak Peek into the Session Content:

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.

CEU: 1.00 ACRP

Speaker:

• James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra

Related Blog Content:

• New Informed Consent Expectations Should Aid Participants’ Understanding, May Catch Professionals Off Guard

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.

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.

CEU: 1.00 ACRP

Speaker:

• Marc Wartenberger, CQA, CTFL, Senior Director, Security, Corporate QA & Compliance, CRIO

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.

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:

• Sara Saunders, MHA, CCRP, Sr. Manager, Regulatory Affairs, Florence Healthcare

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.

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:

• Wendy Schroeder, Principal Strategy Consultant, Clinical, NAMSA

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.

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 your 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)?

This live discussion will be held twice on the schedule (or however you want to say this, but will be good to mention both days and times)

CEU: 1.00 ACRP

Speakers:

• Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director, ProTrials Research Inc.

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

Watch the Webinar Replay Ahead of the Q&A Session (Free Without Contact Hours):

• Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)

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.

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:

• Rob Masson, CEO, The DPO Centre

Related Blog Content:

• Research, Innovation, and Compliance in the EU and UK: A Data Privacy Roadmap

Watch a Sneak Peek into the Session Content:

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:

• Bree Burks, RN, MSN, Vice President of Strategy, Veeva Systems

Related Blog Content:

• Can a Technology Reboot Help Sites, Sponsors, Patients, and Others Talk Seamlessly?

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:

• Steffi Leung Newell, MS, RN, OCN, CCRC, Clinical Research Nurse, Rush Medical Center

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.

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:

• Ben Mooso, MS, CCRP, Director, Office of IRB Administration, UC San Diego

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:

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:

• Lisa Colton, Clinical Regulatory Lead, BSI

• Regina Fulkerson, PhD, Director, Clinical Evidence Planning & Evaluations, Varian Medical Systems

• Jamie Marigold, PhD, Clinical Evidence Planning & Evaluations Manager, Varian Medical Systems

• Eric Sugalski, Founder & CTO, Archimedic