Connect with your colleagues and 100+ leading-edge organizations and suppliers helping you get better results in clinical research.
Relax and unwind with a beverage and light hors d'oeuvres in the Expo Hall.
For more than a decade, multiple sources of regulatory guidance have increased their focus on risk management in clinical studies, paving the way for industry to adopt more risk-based monitoring strategies internationally. With the issuance of ICH E6(R3), an even more focused risk-based approach is expected. While Industry initially struggled to implement risk-based monitoring, moving review into central/remote scenarios as opposed to traditional onsite monitoring, we can now apply lessons learned to various indications and phases of research. We’ve come very far in tailoring systems and approaches to fit the needs of studies while still building in quality by design. Sites are important partners, but have been left out of the conversation about risk-based monitoring. Industry has fallen short in making risk-based monitoring something tangible to sites. Our goal is to bring sites a greater understanding of what sponsors/contract research organizations (CROs) are looking for, how they develop their key risk indicators, and how their ongoing monitoring and mitigation strategies impact their studies.
CEU: 1.00 ACRP
Speaker:
Sara Croteau, Associate Director, Clinical Operations - Quality Management, Innovaderm
Valerie Paolella, Associate Director, Clinical Trial Management, Innovaderm
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.
This session will review the ways in which critical representatives, including patient and caregiver advocates, from across the research landscape can be meaningfully engaged by sponsors and sites to co-develop effective, patient-facing processes or resources. Through the lens of an ongoing community-engaged project, steps and strategies to recruit, engage with, and retain key informants will be presented and discussed. Participants will come away with an appreciation of the opportunities that sustained relationship-building affords a project, as well as tips and techniques for including patients and community members from initiation through dissemination, and beyond. Topics to be covered include health literacy concepts, clear communication strategies, and workgroup facilitation techniques.
CEU: 1.00 ACRP
Speaker:
Sylvia Baedorf Kassis, MPH, Program Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
One of the predominate challenges we face in our field is not having enough "hands on deck" to tackle all the work in front of us. This principal issue is accompanied by a litany of subsequent challenges that impact managers, coordinators, sponsors, stakeholders, and most importantly, study patients. We will discuss how to keep a team of research professionals seaworthy across entire studies by diminishing the strain on its members through provision of "floating coordinators" giving temporary coverage for projects and departments on an as-needed basis. We will break the ice on this topic, which we believe will become increasingly relevant, and we'll share our top tips for instituting and managing such programs wherever they are needed in the research enterprise.
CEU: 1.00 ACRP
Speakers:
Michelle Bright, MA, CCRP, Director of Clinical Research Operations, Center for Clinical Research Management, Ohio State University College of Medicine
Diana Burke, MA, CCRC, Lead Clinical Research Coordinator, Center for Clinical Research Management, Ohio State University College of Medicine
Patrick Rowan, MS, CCRP, Senior Clinical Research Coordinator, Center for Clinical Research Management, Ohio State University College of Medicine
Watch a Sneak Peek into the Session Content:
Join us for an engaging, fun-filled session where staff from a large healthcare and research organization will share practical strategies for creating a workshop course series that elevates informed consent training from adequate to superior heights. Identify tactics to address gaps in your informed consent education and to navigate unique informed consent scenarios. Learn how to utilize gameplay applications and simulation activities, and how to share the knowledge of experienced clinical research staff to improve the practices of your novice clinical research workforce. Discover how to enhance your clinical research operations through empowerment of your teams to offer research opportunities to diverse clinical trial participant populations in non-ideal conditions--all while keeping your training exciting and interesting.
CEU: 1.00 ACRP
Speaker:
Cathe Hanson, Education Coordinator - Research, Mayo Clinic
Pam Draayer, CCRP, Education Coordinator - Research, Mayo Clinic
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.
Join us for the closing remarks as ACRP Leadership shares final announcements, including the reveal of the three winners of the Clinical Research Poster Presentations.
Take this final opportunity to connect with colleagues and explore innovative solutions from 100+ leading-edge organizations and suppliers driving better results in clinical research.
Relax and celebrate a successful conference with a beverage and light hors d'oeuvres in the Expo Hall.
