Download Breakout Session Overviews | Download Schedule of Breakout Sessions | View Conference Schedule
Ms. Artman will define good documentation practices (GDP) and ALCOACCEA. She will also illustrate how GDP affects all roles of clinical research at the site, in monitoring, in auditing, and in the CRO/sponsor role. Provide examples of various documentation and engage audience in discussion of whether they meet GCP (and if not, why). 317
Presenter: Tammy Artman, BS, CCRP, Senior Clinical Research Associate, IQVIA
The frustrations experienced by sponsors, CROs, and sites underscore the need to innovate our approaches to data collection and site selection. 319
Presenter: Andrea Bastek, PhD, MSE, Vice President of Innovation, Florence Healthcare
Dr. Fraser will discuss the hurdles and difficulties of human subject research with astronauts in space and present how we have successfully overcome them. 321
Presenter: M. Amoy Fraser, PhD, MA, MS, BS, CCRP, PMP, Director, Clinical Research, University of Central Florida College of Medicine
Ms. Jackson will discuss some of the principles of GCP that need heightened attention and priority in research given the rapid introduction of ever-changing and emerging technology. 323
Presenter: Casey Jackson, MS, CCRP, Director, Research Quality Improvement & Compliance, University of Maryland, Baltimore
Ms. Propps will provide best practices that allow for decreased start-up times. 325
Presenter: Jessica Propps, BS, Clinical Operations Manager - Regulatory, Merck
Ms. Sands will consider pre-screening activities that assess critical thinking skills, attention to detail, and time management skills, personality, interests, and ethics of a potential candidate. 327
Presenter: Kylie Sands, MBA, BS, CCRP, Operations Manager, St. Lawrence Health System
Health systems struggle to use their data for research. In this talk we will discuss the importance of observational studies and opportunities for health systems to unlock value from their data and support observational studies more effectively, filling important gaps in the research landscape. 329
Presenter: Kate Sheeran, MSN, AGPCNP-BC, Director, Clinical Research, Q-Centrix
Ms. Hodsdon will explore the hidden burdens of research and the impacts delivering advanced therapy trials has on research delivery staff as well as the patients and their families. 331
Presenter: Lorraine Hodsdon, BSc, MSc, RN, Head of Nursing Research and Innovation; Co-Director, NIHR GOSH Clinical Research Facility