This package is a replay of 17 on-demand session recordings and presentation slides from the Study Management & Conduct Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Learn practical, proven ways to maximize study and site performance.
Member: $99 | Nonmember: $149
Participants can earn up to 18 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Courses Dashboard. Replay sessions expire on May 31, 2026.
According to the Code of Federal Regulations, research should be designed to develop or contribute to generalizable knowledge. It should be undertaken with a goal of learning something. However, a large portion or research does not profess to that goal. Instead, many projects state an aim of performing the research, not that of increasing knowledge. They use process-oriented “objective’ statements instead of goal-oriented ones. A recent look at 100 consecutive objective statements in ClinicalTrials.gov submissions found only 34% of the “objectives” expressing a goal. The majority just convey a goal of performing a study. An objective of “to investigate…” or “to evaluate…” does not convey a quest to increase knowledge like “to determine…” or “to identify…” While this may seem punctilious, we feel the proper use of objectives can increase confidence in the research team. As the research objectives often provide the first impression of the project, accurately presenting them seems to be desirable. If we want to find whether an investigational drug is safe and effective, we would want to “determine” that, not just “assess” it. We should not be satisfied asking the question, we should want to answer it. This session will help the audience recognize objective statements that do not adequately express the goals of the project, and help attendees assist in constructing statements that are accurate in presenting the desired goals. Speaker: Richard Ogletree, PharmD, Research Coordinator, AIS HealthCare
Site technology is expanding. This session will use market trend data to guide sites and sponsors on who should pay for, own, and control technology that connects research teams. It will help managers at both sites and sponsors understand what tools are available to improve site connectivity and will share best practices on adopting technologies that help sites work with sponsors and vice versa. Speaker: Catherine Gregor, MBA, CCRP, CCRC, Chief Clinical Trial Officer, Florence Healthcare
This session is intended for Sponsor and Site personnel interested in learning more about the importance of Chain of Custody of Investigational Products. Learners will take away a better understanding of the rationale behind why the chain should not be broken. Speaker: Dawn Partridge, Country Clinical Quality Manager, Merck
In recent years, the need for increasing racial and ethnic diversity of participants in clinical research has important goal for study sponsors and regulatory authorities. A diverse study population is essential for quality clinical research results that can be generalized to the population. Clinical research site personnel and investigators may have insights on ways to improve diversity in clinical trial enrollment and may be using new techniques for improving the participant experience. This program will discuss the results of a mixed methods survey study describing current clinical research site practices and perspectives on racial and ethnic diversity in clinical research. This information will empower sponsors, CROs, vendors, and sites alike to understand gaps in facilitators and barriers to recruiting diverse participant populations, leading to insights that may influence practice change. Speakers: Carolynn Jones, DNP, MSPH, RN, FAAN, Associate Professor-Clinical, The Ohio State University; Demi MacLennan, MS, CCRA, ACRP-PM, Clinical Trial Project Manager, Labcorp Drug Development; Jennifer Plahovinsak, MS, DABT, Director, Master of Science Translational Pharmacology Program, The Ohio State University
Participants will gain key insights, best practices, and simple tactics for advancing the medical and scientific knowledge base of their clinical research professionals. By increasing therapy area knowledge, CRAs will be able to more effectively monitor complex clinical trials, speak the language of the clinician, and deliver high-quality support of site personnel. Speakers: Jennifer Berdovich, PharmD, BCOP, Senior Director, US Medical Affairs, Merck Research Labs, Merck & Co., Inc.; Kelly Clark, BScN, MSHS, Head of US Partnerships and Global Site Development, Merck; Maximiliano Elizari, MSc, Senior Clinical Research Director, Merck
It is easy to become lost and burdened with regulations which were originally designed to protect us from repeating research abuses of the past. We can easily forget that history and why the system of research protections in place today exists in the form that it does. In this session we will take a tour through the history of research, the foundations of the Belmont Report, and explore the ethical underpinning of our research ethics review systems. We will also explore contemporary research ethics issues. Speaker: James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra
The recently adopted ICH E8 (R1) encourages sponsors to “create a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to quality for a particular study or development program”. Although unspoken, with this remit comes the responsibility to not only create a culture, but organizations must periodically monitor the progress or status of the culture that has been created. In this session, case studies will illustrate how existing quality metrics can be used to monitor an organization’s culture of quality and its impact. The case study will include: an analysis of established quality metrics over time and an action plan linked to quality culture enablers (e.g., critical thinking and open, proactive dialogue) designed to achieve the quality outputs that uphold patient safety, data integrity. Speaker: Leslie Sam, BA, LSS BB, CIQ, President, Leslie Sam & Associates
Have you ever wondered how many trials a clinical research coordinator can or should be able to handle? If you are basing your decisions on management instinct, please come to this session prepared to take the guesswork out of assigning trials. In this talk, we learn about a practical tool that can help you assign trials based on clinical research coordinator workload. In addition, relevant revenue information collected as part of the tool utilization can also highlight what studies may be more beneficial or lucrative for your site to conduct. Speaker: Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of Research, Stamford Hospital
DID YOU KNOW… …in today’s clinical research world it’s hard to keep up, let alone answer all the questions we receive from our staff, sites, and others we work with. It is difficult to keep track of all the information we need to remember to do our jobs, but YOU can make a BIG difference and bring ENORMOUS value by becoming a knowledgeable resource and information “library.” Even if you don’t have all the answers, learn how to become an invaluable resource to your colleagues AND a huge motivator and leader. Knowing where to look will not only make you an MVP but can propel your team to the next level. Examples of information communications, knowledge libraries, and leadership tools will be shared. Speaker: Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Operations Strategy and Training Director, ProTrials Research, Inc.
This session focuses on a systematic approach to resource allocation that results in adequate, trained, and flexible staff to support study operations. Those involved in resource allocation, operationalizing studies or supporting study operations will gain insight into an approach that they may consider implementing in programs that they support. Speakers: Adrianna Byrnes, PhD, Protocol Navigator Manager, Frederick National Laboratory for Cancer Research/Leidos Biomedical; Jennifer Jo Kyte, DNP, APRN, ACNS-BC, CCRN, Supervisory Research Nurse Specialist, National Institutes of Health
The interdependent, inverse relationship between risk management and knowledge management will be explored. In practice, the evidence of this understanding in clinical development is not obvious. With better integration of the complimentary quality management system enablers, there is an opportunity to better manage risk and thus increase patient protection. In this session, attendees will examine the details of the infinity cycle framework and its application to clinical development lifecycle phases. A strategic approach to knowledge management will also be explored. Speaker: Leslie Sam, BA, LSS BB, CIQ, Principal Consultant, Risk Management and Issue Management Practice Lead, Wool Consulting Group
Successful research depends on the teamwork of several key individuals, representing differing project priorities and institutional requirements. In this session, we aim to present strategies for navigating the research administration process at your institution so that projects can more quickly obtain approval for site initiation. Drawing from our experience with galvanizing teams to conduct longitudinal, virtual research at a large academic medical center, we will provide tips on preparing for and executing the research process. We will focus on communication with stakeholders and discuss best practices for across-aisle collaboration with sponsors, researchers, and administration. Speakers: Stefani D’Angelo, MS, CCRC, CHES, Senior Clinical Research Manager, Northwell Health/Feinstein Institutes for Medical Research; Challace Pahlevan-Ibrekic, MBE, CIP, Director, Clinical Research, Northwell Health/Feinstein Institutes for Medical Research
The Renown Health-University of Nevada, Reno School of Medicine signed an affiliation agreement in June of 2021 creating Nevada’s first integrated health system, with expansion of clinical research opportunities for patients as a core pillar of the affiliation’s mission and indicator of success. This presentation focuses on the importance of a strategic communication and marketing plan in the context of ambitious development goals in clinical research. The discussion will also address the leadership and teamwork skills necessary to bring visions for clinical research to life in communities with minimal understanding of the purpose and benefit associated with clinical trials. Speakers: Danielle Eaton, Director of Clinical Research, Renown Health and University of Nevada, Reno School of Medicine; Kristen Gurnea, MPH, CCRC, ACRP-PM, Manager of Clinical Research, Renown Health
Who is responsible for community engagement? The answer is, unequivocally, all of us. This session will discuss the necessary and unique role of each stakeholder (sponsors, CROs and sites) in community engagement work and how we hold each other accountable. We must accept that the strategies we have embraced in the past must change to engage minority communities and that we all must be committed, and we must hold each other accountable for community building. For there to be real change in the way that underrepresented communities are included in clinical research, the nonprofit and community organizations serving communities must play an active role in the outreach/engagement to these communities. Learn how to involve those grassroots leaders who hold the answers to the question, how do we engage minority communities? Speaker: Ashley C. Moultrie, CCRP, Director of DEI & Community Engagement, Javara
Our industry has struggled to create streamlined workflows that meet regulatory requirements, align with SOPs, work within protocol restraints, and meet the needs of sponsors/CROs in an efficient manner. The push for decentralized trials adds another layer of complexity to trial operations. Sponsors and CROs have a desire and a responsibility to secure high-quality data while minimizing delays to study timelines. This session will discuss opportunities for sponsors and CROs to leverage industry technology as a platform to help sites streamline workflows while increasing sponsor/CRO visibility into study progress. Benefits of increased project oversight to areas such as risk management, data quality, study timelines, audit readiness, and budgets will be explored. Speaker: Kristin Surdam, MS, PMP, CCRC, Senior Director, KOL & Strategy, Florence Healthcare
Community Engagement is not the same as patient recruitment/engagement, yet many professionals use the terms interchangeably and don’t create actionable plans that delineate them. In this session, you will hear why there is a need to think about community engagement differently and how you can begin to create balanced strategies and tactics that can lead to better awareness and trust within the community that leads to greater diversity and inclusion. Speaker: Chris Komelasky, CEO, SiteBridge Research Inc.
Over the past ten years, over four million dollars have been invested internally to support the growth of clinical research at Nationwide Children’s Hospital. As a result, numerous clinical fellow and faculty have secured external grant funding related to their intramural project—including NIH funding. In 2021, 16 scientific publications can be attributed to this investment and 28 fellows, residents, and faculty have presented their results at more than 35 conferences and seminars. The academic and scientific return on investment remains high and continues to grow year over year. Attend this session to learn how to build a program that builds better researchers and kickstarts research careers! Speaker: Samantha Sharpe, CCRP, Senior Program Administrator, Nationwide Children’s Hospital