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This talk will translate the founding ethical principles of clinical research into practical considerations for researchers and sites in the execution of research protocols. Using the presentation of typical scenarios encountered in the daily operations of research sites, Ms. Holtz will analyze the intersection of the ethical principles and site operations, understand the impacts on decision making, and discuss tools and checklists to reinforce ethical decision making in daily research operations. 517
Presenter: Laura Holtz, MS, PMP, CCRP, Clinical Research Associate, Yale School of Medicine
How does the transformation work? How long does it take? What can you do to make it most effective as a tool? What are the positives and pitfalls? In the end, is it really worth the cost and effort? 519
Presenter: Mark Sulik, PharmD, CCRP, Director of Clinical Research, Rocky Mountain Diabetes Center
Ms. Wentzel has been leading a multi-dimensional clinical research team for over 25 years. She will share lessons learned as well as strategies and tactics for interviewing, team-cohesiveness and, most importantly, retention. 521
Presenter: Grace Wentzel, BA, CCRP, CHRC, Executive Director, Site Operations, Javara
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to the design, conduct, and reporting of clinical trials.
Electronic-Based records systems are being increasingly used in the conduct of clinical research. They enable the capability to streamline data transfer, remote enrollment capabilities, greater transparency of the trial conduct, improved research documentation, clearer audit trails and to solve the challenges of physical document storage constraints at trial sites.
From a monitoring perspective, Ms. Wright will discuss the basics of GCP in an electronic-based records system, highlight the importance of a culture of total quality, how to identify challenges, as well as offer solutions for good recordkeeping practices. Examples will be provided. 523
Presenter: Alicia Wright, MS, CCRP, Clinical Research Associate III, Vanderbilt University Medical Center
Learning the role of the coordinator is difficult. Learning effective communication strategies in working with your site clinical investigators and research team is not typically offered in training. This session provides guidance and useful strategies for effective communication as well as the importance of documenting that communication. 529
Presenter: Margret Kamel, PhD, CCRC, Associate Director of Research Projects, Emory University
Presenter: Teri Crumb, MSN, RN, CCRC, Project Manager, Pediatric Nephrology Research Consortium
The supply of clinical research personnel is not keeping up with the growing demand, across the industry, but especially at academic health centers. Ms. O’Malley will briefly discuss the factors and barriers that have contributed to the critical shortage of experienced research personnel and describe an innovative model to address the need. The presentation will describe the difficult but surmountable journey to create a sustainable program to train and retain entry level clinical research personnel and create a diverse workforce. 531
Presenter: Kathleen O'Malley, BSN, RN, CCRP, Director of Education and Training, Jefferson Clinical Research Institute, Thomas Jefferson University