This package contains the most popular recordings from ACRP 2022. It includes the following sessions:
Do not allow research compliance risk to be nail biting at your site. Take the steps to analyze your risk, know your portfolio, and always be audit ready. Thwart suspicion and create trustworthiness to ensure compliance and ethics is first and foremost. Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager, Kelly Willenberg & Associates
Opportunities for robust data collection in decentralized clinical trials have increased as the landscape has become more digitized. Studies collecting endpoints in the home via electronic Clinical Outcome Assessments (eCOA) have evolved beyond self-reported Patient Reported Outcome (PRO) assessments, to include an expanding list of Performance Outcome (PerfO) assessments and connected device technologies. In addition to offering a more convenient patient experience, these developments may yield more comprehensive and representative data because it represents a broader window of data capture than endpoints collected during a traditional clinical visit (e.g., 1 week of experience vs. 1 hour of a clinic visit). Our experience operationalizing decentralized trials with multiple clinical outcome endpoints has provided important lessons that will benefit clinical research professionals across disciplines and roles. A unified experience for patients and clinical staff is vital to a trial’s success, and all scientific and regulatory priorities must be balanced with time demands associated with study conduct and site and patient burden. This presentation will start with case examples of hybrid/decentralized trial visit schedules and move to a discussion of what will be required by sites and patients to operationalize the study during start-up and for on-going study support (e.g., device registration, training, helpdesk). Finally, the session will discuss the future of clinical trials, including the path to regulatory approval of digital endpoints, overall, and potentially in support of patient-focused drug development. Dr. Lindsay Hughes, PhD, MS, Principal Scientific Advisor, Clario; Matthew Johnson, MSE, Vice President, Wearables/Digital Biomarkers, Clario
Despite decades of experience, regulatory supervision, and ethical analysis, the informed consent process for research is still not highly effective for ensuring informed decision-making. Consent forms are typically long, dense, and complex. Multi-center trials can collectively require hundreds of consent documents, each with site-specific language. The degree to which investigators spend time explaining and discussing the protocol with potential participants is variable and poorly documented. Whether individuals are actually making an informed decision about participation is rarely assessed. To advance translational science and maintain public trust, the ethical pillars of consent must be strengthened by investing in innovative approaches for informed decision-making about research participation, and for documentation of informed consent. This panel will discuss innovative eSolutions for research consent. Consent Builder (CB) is a consent document building tool that can benefit IRBs and study teams dealing with preparation and review of consent documents. An innovative two-part template provides consistent description of the study while accommodating site-specific local verbiage. Interactive Consent (iConsent) is a web-based platform to improve informed decision-making leveraging multimedia and adult learning principles to communicate the concise consent summary. A clinical trial of iConsent demonstrated significant improvements in knowledge, satisfaction and clarity of information. Electronic consent (eConsent) platforms allow participants to digitally sign consent documents on-site or remotely using a computer or tablet; while maintaining compliance with FDA, HHS, and related regulations. These eSolutions can be used together or individually to improve informed decision-making and support a high-quality consent process. Jeri Burr, MS, RN, PED-BC, CCRC, FACRP, Executive Director, Utah Trial Innovation Center, University of Utah; Dr. Ann Johnson, PhD, MPH, Director, IRB and Human Research Protection Program, University of Utah; Kathy Sward, PhD, RN, FAAN, Professor in Nursing and Biomedical Informatics, University of Utah
Regardless of the size of the research site or whether you are leading a multi-site study or a participating site within a study, you may often feel you are swimming against a current of issues including communication barriers, an ever-changing research environment, and frequent coordinator turnover. Much like Ariel in the Little Mermaid, many research coordinators dream of their own “legs” to help them achieve their personal version of “treasure” whether that may be better pay, higher job titles, or advanced education We plan to present strategies to; lessen the impact of coordinator turnover and to build robust research teams that are both adaptable in this ever-changing research environment and effective at using their voices to communicate across land and sea. Mary Dreher, MPH, CCRP, Clinical Research Program Coordinator, Nationwide Children’s Hospital; Corinna Bowers, BSBA, CCRC, Team Lead – Clinical Research Program Manager, Nationwide Children’s Hospital; Samantha Sharpe, MD, Clinical Research Program Coordinator, Nationwide Children’s Hospital
How do you measure success? This session will help you identify what data elements are needed from an operational and administrative perspective. Then discuss how you develop and implement a process to capture these data points so you can showcase your department and sites success for performance. This presentation will help attendees focus in on what metrics they need to track to facilitate annual reports as well as justify resource needs. Grace Wentzel, CCRP, CHRC, Director, Clinical Research Services, Nationwide Children’s Hospital; Jessica Fritter, MACPR, ACRP-CP, Clinical Research Administration Manager, Nationwide Children’s Hospital
Have you ever considered that “informed consent” is both a form and a discussion? In this session, attendees will learn about both the required elements of informed consent and how to conduct a more effective informed consent discussion. Attendees will also walk through tricky informed consent scenarios and discuss. Research personnel of all experience levels are welcome. Catherine Barnes, Personnel Development and Training Specialist, UNC Chapel Hill
How do you assess if a study is feasible? Do you have criteria that align with your institutional values and strategic plan? This session will give you the tools on how to implement and manage an institutional feasibility process and how to effectively assess a study to ensure it meets institutional values. It will provide key information on how centralizing budget contacts/negotiations allows you more negotiating power and evaluate the importance of establishing a cost worksheet to ensure your institution is following NIH policy. Jessica Fritter, MACPR, ACRP-CP, Clinical Research Administration Manager, Nationwide Children’s Hospital; Grace Wentzel, CCRP, CHRC, Director, Clinical Research Services, Nationwide Children’s Hospital; Amy Dutcher, MCR, Team Lead of Clinical Research Business Operations, Nationwide Children’s Hospital
Clinical trial monitoring procedures has evolved significantly over the last twenty five years and each year processes and procedures change, tools to increase efficiency and reliability are put into practice. What does the future look like for the site monitor, what skills will be needed? How will we attract, retain and develop the clinical monitor of the future now? Pamela Nelson, PhD, MSN, CCRA, Founder/CEO, Bracane Company
Explore strategies for efficient IRB submission of materials used in the conduct of virtual research. Unlike traditional research settings (in-clinic study visits), virtual research involving humans involves continuous – and often dynamic – contact and communication with participants to facilitate implementation of the protocol, presenting an opportunity to assess what study-related documents, or changes to such, require review and approval by the IRB. Using the SOP template created to support our center’s virtual research service line, you’ll get tips on how to collaborate with clinical research team’s local IRB for efficient and effective review of research. Challace Pahlevan-Ibrekic, Director, Clinical Research, Northwell Health/Feinstein Institutes for Medical Research
Please join Dr. Suzanne Rose as she shares her insight and knowledge on how to create a broad range of research positions on any size clinical research team. In this session, you will learn about best utilizing each team member to their fullest capacity and how to be creative in job sharing and maximizing performance from each team member. In addition, job descriptions and justifications for hiring will be included as key take away items for you to build a strong and successful team. Dr. Suzanne Rose, MS, PhD, CCRC, FACRP, Director, Office of Research, Stamford Hospital
Core challenge: With the onslaught of the pandemic in 2021 – many CRPs have had to deliver their site training, team training, staff training and organizational training via the internet. And, many CRPs have identified ‘they don’t know, what they don’t know’ to develop and deliver engaging and efficient ‘virtual classroom training’..that is not a ‘one way lecture’ with a few knowledge checks and chat box/Q&As. Liz and Barb are going to share the 6 TIPS for success – called the 6 Ps – that are the foundation for successful virtual classroom training- emulating an in-person training class! Our speakers’ have expertise with virtual classroom training, and curating numerous references, and technology solutions and will equip the participants – that will WOW the attendee to say ‘I can do this’…’I now have the roadmap’..and I don’t have to spend thousands of dollars, hours reading and attending ‘free webinars’ that don’t give a ‘deep dive’. Liz and Barb are teaching the 6 Ps Presence Presentation Preparation Planning Platform Producer This is a critical skill/ability/behavior for CRPs to master because remote work and decentralized clinical trials are in the forefront right now – and CRPs need and want to know ‘am I engaging the participant to learn, using their critical thinking’ via course design, visual presentation and delivering the course in a manner that fosters building an online learning community. Participants will develop and deliver impactful, performance-based virtual classroom trainings with a WOW factor! Liz Wool, RN, BSN, CCRA, CMT, President, Wool Consulting Group; Barbara Potter, Senior Director, Learning Strategy, Wool Consulting Group
Collaboration is key to good execution for any clinical trial. The pandemic helped us go more electronic, but in many ways, it simply layered on more systems required to get the work done. So often this collection of disconnected technology is prohibiting good collaboration and communication between sites and sponsors. The reality is, until stakeholders can operate on connected technology, they are each limited by how much operating efficiency they can truly gain. Join this session and learn from sites and sponsors how operating on connected technology not only decreased their system fatigue, but enabled better collaboration through digital insights, connected workflows and seamless information sharing – and ultimately, allows all parties to focus their time and efforts on the most important aspect of trials – the patient. Bree Burks, RN, MSN, VP of Strategy, Site Solutions, Veeva Systems
It’s never too early or too late to hone communication skills to set yourself up for success in research. In this session, we will discuss methods for improving communication skills—including how to get the most out of meetings, how to have difficult conversations, and how to effectively engage in meaningful conversations. Jennifer McLeland, MSW, MA, ACRP-PM, CCRC, Clinical Research Specialist, Washington University School of Medicine
Join this exciting overview on how the pandemic forced many into decentralization of the site and the effects of site cash flow, workforce safety and increased flexibility. How can we all (Sponsor/CRO/Site) help each other through these challenges and how we as a workforce can maintain compliance while working in a remote environment. David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare
Please join David Burrow from FDA’s Center for Drug Evaluation and Research as he discusses key opportunities for the clinical research industry to make their FDA inspection experience a positive one. Dr. Burrow will outline the impact inspections have on marketing applications, and will identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. In this session, you will be able to take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. Dr. David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Center for Drug Evaluation and Research, FDA
What does the FDA say about the future of inspections and how you can prepare? Join us for a session on how you may want to prepare for your next inspection and/or maintain the audit inspection readiness. Eric Pittman, MBA, Director, Bioresearch Monitoring Division (West) at the US Food and Drug Administration
This session describes communication methods, explores leading solutions for miscommunication, identifies steps for messaging alignment with competing directives and analyzes effective modalities to share information across multiple stakeholders in the clinical research enterprise. Organizational communication requires an understanding of urgency, impact, and cadence of the intended messaging. Understanding the context of the targeted recipients, the business communication needs and the channels for information, impacts communication effectiveness. Clinical research programs are frequently impacted by inaccurate and ineffective communication. Critical to the success or failure of communication is timeliness and mode of execution. Leveraging proven steps for effective communication include conducting a communication needs assessment, implementing communication laddering, applying the rule of nine and establishing communication plans. Analyzing lessons learned, leading practices and implementation methods via case study will be addressed in this session. Erika Stevens, MA, Principal, Recherche Transformation Rapide; Mary Veazie, MBA, CPA, CHC, CHRC, Manager/Principal, Clinical Research Consulting & Education Services LLC
In today’s society, information on virtually every aspect of our existence is being challenged. Clinical research continues to take multiple forms and requires diverse skills. As a result, clinical research professionals are in high demand. Career pathways in the clinical research industry do not need to be scripted. This session describes the non-traditional path of two clinical research leaders and provides insights for professional development and career opportunities. Dr. Quincy Byrdsong, EdD, CIP, CCRP, Vice Provost for Health Sciences, Lipscomb University; Erika Stevens, MA, Principal, Recherche Transformation Rapide
Leadership and professionalism avenues can be difficult for coordinators to navigate. There are many different challenges in finding pathways to advance your career as a clinical research professional. This session will provide an overview of educational opportunities as well networking and development strategies. The speakers offer a wide variety of degrees among themselves as well as different clinical, research and professional experiences. Each of the speakers is from a different site and with diverse work backgrounds, offering the audience a wide variety of information. They will show evidence of their collaborative work to advance the profession and how training and networking has been effective within their research roles. This session will include a panel discussion where audience members can become active participants in asking questions and dialoguing with each other. Teri Crumb, MSN, RN, CCRC, Pediatric Clinical Research Nurse II, Spectrum Health/Helen DeVos Children’s Hospital; Theresa Kump, BA, CCRP, Division Administrator and Clinical Research Manager, Medical College of Wisconsin; Dr. Margret Kamel, PhD, CHES, CCRC, Associate Director of Research Projects, Emory University; Corinna Bowers, BSBA, CCRC, Team Lead – Clinical Research Program Manager, Nationwide Children’s Hospital
Have you ever received an email that made you very frustrated, or even upset? Have you ever had tense conversations that didn’t go well, though you felt like you were being reasonable? Communication is an area where everyone can improve. Research professionals of all levels are invited to join this educational session where you will learn about verbal and written communication, as well as tips to help make those tricky conversations more manageable. Catherine Barnes, Personnel Development and Training Specialist, UNC Chapel Hill
With site evaluation visits, the adage, “presentation is everything” rings resoundingly true and applies to far more than mere facilities and equipment. It extends far beyond investigational staff interest and experience. Site evaluation includes the fundamental first impression/ first contact element, a cornerstone from which the sponsors/cro/site relationship is formed. How a site presents capabilities means everything; how enthusiasm is demonstrated, how information is communicated and how abilities/logistics are translated will most definitely influence site selection decisions. Considering that the key to a successful site evaluation is how the site is showcased to demonstrate experience, equipment, and patient access, it is paramount that an appropriate site representative facilitates this process. The investigational site representatives present during the site evaluation visit must be knowledgeable, with an essential balance of the clinical and personable. Anyone with sufficient understanding of the investigational site can answer the essential questions regarding site infrastructure, site research policy and process, site personnel and experience, and site equipment, facilities and access to ancillary departments required to fulfill study expectations. The savvy researcher charged with execution of site evaluation visits must possess the innate ability to do more than merely answer questions, but bridge the communication gap with enthusiasm, knowledge, and finesse to make a positive impression on the sponsor and strengthen site selection. This presentation will define the traits that investigational site staff need to effectively conduct the site evaluation visit. Elizabeth Weeks-Rowe, LVN, CCRA, Clinical Research Trainer/Writer
Please join us in an empowering session with Sue Friedman, DVM on her story and how she decided to empower others. Sue will provide her story and where it has taken her to be a FORCE in the awareness and promotion of clinical research. Moderator: Amanda Wright Co-Founder and Chief Development Officer, Javara; Sue Friedman, DVM, Executive Director, Facing Our Risk of Cancer Empowered (FORCE); Grace Wentzel, CCRP, CHRC, Director, Clinical Research Services, Nationwide Children’s Hospital
Developing diversity in clinical trials in both the workforce and the patient participants has been a topic of interest for some time. Join our panel as they discuss interesting study results and current initiatives to help put action into increasing diversity in clinical research. Bringing different perspectives and sharing stories of their own perspectives of how we can move forward in developing a more diverse workforce and patient demographic within clinical trials is what they are excited to share with you. Moderator: R’Kes Starling, RPh, MBA, Chief Executive Officer/President, Reveles Clinical Services; Rick Fisher, Senior Director of Operations, Velocity Clinical Research; Maria Florez, Research Consultant, Tufts Center for the Study of Drug Development; Nadege T. Gunn, MD, CPI, Medical Director, Impact Research Institute; Carlette Heath-Brogden, RDH, Clinical Trial Diversity Lead, Merck & Co.; Julia Medina, Clinical Operations Lead, Genentech; Samson Tom, Vice President, Kelly Science and Clinical
What will the future of clinical research hold? What PROCESSES will we keep and what PEOPLE AND TECHNOLOGIES will we need to have moving forward? Join our panel as they provide their insight into what the future may hold and how they suggest you should prepare. Moderator: Jeanne Taylor Hecht, CEO, JTH Consulting & Associates; Elisa Cascade, Chief Product Officer, Science 37; Dawn Furey, Chief Clinical Operations Officer, Circuit Clinical LinkedIn; Elisa Hurley, PhD, Executive Director, Public Responsibility in Medicine and Research (PRIM&R); Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, Senior Vice President, Scientific and Clinical Affairs, Drug Development Services, Head, Strategy Center for Decentralized Clinical Trials and Digital Medicine, ICON; Leslie Wolfe, BS, MHA, Leslie Wolfe, Director, Clinical Research- Early Talent Development & Clinical Trial Coordinator Organization, Global Clinical Trial Operations, Merck
This session welcomes our ACRP Research Community to our Annual Conference, with overarching themes of gratitude and ideas for the future. Join us as we thank our members and everyone throughout the clinical research community for their commitment to excellence in clinical research and their dedication and contribution to improving health outcomes for all. ACRP’s Executive Director will present an update of the key advancements across ACRP, the Association’s evolution of educational offerings, and ACRP’s vision for the future. Special guests will share thanks and hope for the future. Susan P. Landis, Executive Director, Association of Clinical Research Professionals (ACRP). NOTE: This session does NOT offer ACRP Contact Hours.
In this session, Stuart Cotter, Director of Product Management at Advarra, will outline challenges faced by sites who are overburdened with sponsor-driven technology, resulting in duplicative efforts, longer timelines, and reduced patient focus. He will share progress made by a new consortium of sites, sponsors, and CROs to address this problem, working together to connect existing site technology to sponsor systems seamlessly. Stuart will also provide actionable insight for attendees to take advantage of this connected ecosystem, empowering site stakeholders to drive efficiencies across their clinical trial lifecycle. Stuart Cotter, Director of Product Management, Advarra NOTE: This session does NOT offer ACRP Contact Hours.
Adding value for study participants will lead to improved retention, regulatory compliance and higher quality data. Rick Greenfield, RealTime Clinical Trial Management Systems NOTE: This session does NOT offer ACRP Contact Hours.
Sites across the industry have historically been tasked with tracking and reporting on the status of clinical trial candidates over long and complicated trials with suboptimal, manual, and often duplicative tools. It’s a dynamic that can lead to lengthy trial delays, especially in oncology where protocols are complex and the demands on sites is heavy. Join Samatha Birtel from Merck’s Global Trial Optimization (GTO) team and Ralph Passarella from Reify Health as they discuss how their recruitment and retention strategies have helped reduce site burden related to oncology trial enrollment. Ralph Passarella, CEO, Reify Health; Samantha Birtel, BSN, RN, Senior Scientist, Global Trial Optimization, Merck NOTE: This session does NOT offer ACRP Contact Hours.
Amy Abernethy MD PhD is the President of Verily’s Clinical Studies Platforms, where she oversees the company’s clinical evidence generation platform product vision and related clinical research portfolio. In this session, Dr. Abernethy will draw upon her prior experiences as the Principal Deputy Commissioner at the FDA, the agency’s acting Chief Information Officer, the former Chief Medical and Chief Scientific Officers of Flatiron Health, and as a research leader at Duke University, to discuss how clinical research needs are evolving and how Verily is building towards a superior evidence generation platform. She will discuss Verily’s recent acquisition of SignalPath, how SignalPath’s state-of-the-art clinical trial management system (CTMS) can improve the ease, quality and efficiency of conducting clinical research at study sites, and how Verily’s growing Clinical Studies Platforms plans to set a new standard for clinical studies and evidence generation. Amy Abernethy, MD, PhD, President, Clinical Studies Platforms, Verily NOTE: This session does NOT offer ACRP Contact Hours.
Providing patient-centric care while managing complexity at a frenetic pace can take a toll on site coordinators. Learn practical strategies for daily self-care, best practices for self-organization, and standard operating procedures for managing lab kit and supply inventory to make your days as a site coordinator less stressful and more enjoyable. Alex Yant, Solutions Coordinator, Slope NOTE: This session does NOT offer ACRP Contact Hours.
Discover how clinical trials as a treatment option has moved beyond vision with the integration of legacy medical systems and content, and new practices such as biomarker parsing and decentralized trials. Hear how this evolution puts data at the forefront of the Healthcare Organization while supporting best practices for clinical trial process improvements impacting efficiency, revenue cycle management, and transforming the patient enrollment journey. Jeanie Magdalena Gatewood, Managing Director, Cancer Center Support Services, Inteliquet, an IQVIA Company NOTE: This session does NOT offer ACRP Contact Hours.
The future of clinical trials is unified technology that connects sites, sponsors, and patients. This can only be achieved through technology that meets the unique needs of sites, can be adopted at their pace, and connects to sponsors without complex integrations. Join us to see how sites can work more effectively with sponsors and patients on the industry’s only unified and connected digital trials platform. Hear about our progress, see the latest developments, and explore our plans for the future. Bree Burks, RN, MSN, VP of Strategy, Site Solutions, Veeva Systems NOTE: This session does NOT offer ACRP Contact Hours.