Advanced Management


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2024 Agenda

Sat., Sept 28 8:30 to 9:15                                     Track: Advanced Management
Good Documentation Practices and ALCOACCEA

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

Sat., Sept 28 9:20 to 10:05                                   Track: Advanced Management
Collaborative Approaches to Redefine and Improve Site Selection

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

Sat., Sept 28 10:50 to 11:35                                 Track: Advanced Management
An Astronomical Task: Support Human Subject Research in Space

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

Sat., Sept 28 11:40 to 12:25                                 Track: Advanced Management
GCP Principles of Priority in an Age of Rapidly Emerging Technology

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

Sat., Sept 28 1:40 to 2:25                                     Track: Advanced Management
Grand Opening, Grand Closing: Best Practices for Accelerating Study Startup Timelines

Ms. Propps will provide best practices that allow for decreased start-up times. 325

Presenter: Jessica Propps, BS, Clinical Operations Manager - Regulatory, Merck

Sat., Sept 28 2:30 to 3:15                                     Track: Advanced Management
Assessment of "Soft Skills" in the Search for New Clinical Research Personnel

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

Sat., Sept 28 3:45 to 4:30                                     Track: Advanced Management
Data Alchemy: Transforming Registry Data Into Observational Study Gold

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

Sat., Sept 28 4:35 to 5:20                                     Track: Advanced Management
The Hidden Burdens of Clinical Research

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