Advanced Management

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2022 Agenda

Thursday, September 15, 2022 at 11:00 am to 11:45 am ET                                                                            Track: Advanced Management
Challenges with Conducting Multicenter Trials at Satellite Sites

Many challenges are faced when conducting multicenter trials at satellite sites. Dr. Elrod will focus on how to mitigate common issues such as PI oversight (and what language should be included in Standard Operating Procedures), operationalization of the study at multiple sites, and financial concerns. This discussion will help sites prepare for successful implementation of the study. 109
Presenter: Jo Ann Elrod, PhD, CCRP, Clinical Research Director, Fred Hutchinson Cancer Center

Thursday, September 15, 2022 at 11:50 am to 12:35 pm ET                                                                            Track: Advanced Management
Patient-Oriented Research and Improving Health

The goal of clinical research is simple, to improve the health of people. Therefore, patient-oriented research can offer opportunity for a more focused approach to clinical research and improved patient health. From an operational perspective adopting patient-oriented approach to clinical research may not be immediately cost effective and even feasible to begin with. Ms. Arsovska will aim to provide historical context and hands-on methods and tips for implementing patient-oriented approach to existing and new clinical research projects as well as adopting patient-oriented approaches as part of organizational management practices. 111
Presenter: Olga Arsovska, MA, BSc, CCRP, CPM, Research Manager, University of British Columbia

Thursday, September 15, 2022 at 1:15 pm  to 2:00 pm ET                                                                               Track: Advanced Management
Understanding System Regulatory Requirements: FDAAA 801 and Final Rule (42 CFR Part 11)

This lecture will cover the important legal requirements of the system, such as FDAAA section 801 and Final Rule (42 CFR Part 11). A brief history of will be provided, along with an overview of trial registration and reporting processes. Attendees will understand the challenges that clinical trial organizations face in determining whether a study is qualified and required to be registered, which also includes determining the time interval for updates and results to be posted. This event is aimed at principal investigators and clinical research coordinators seeking to understand these challenges and stay compliant with system regulatory requirements. 113
Presenter: Susan Hmwe, PhD, MS, MBBS, CCRP, Manager, Clinical Research Data Quality & Reporting, City of Hope

Thursday, September 15, 2022 at 2:05 pm to 2:50 pm ET                                                                               Track: Advanced Management
Beyond the Academic Medical Centers: The role of rural-based healthcare systems in clinical research

Research conducted in a rural healthcare setting presents unique challenges as well as novel opportunities for patient and physician engagement, growth, and improving the health and well-being of populations typically underrepresented. Ms. Rowe and Ms. Lovelett will share their experiences from two clinical research programs located in the rural Northeast. Both programs serve rural populations where resources are limited, health disparities are ever present, and clinical research is relatively unknown to the community. This presentation will look at a healthcare system in south central Pennsylvania with an established research program that is being reimagined because the acquisition of smaller, rural hospitals has changed the dynamic of its patient and provider base. A healthcare system in northern New York provides a look into building a research program to engage a rural population. The presenters will discuss establishment and growth of a research program in a rural healthcare system including challenges faced, lessons learned, and opportunities for growth. 115
Presenter: Carly Lovelett, MS, MBA, CCRP, Director of Clinical and Rural Health Research, St. Lawrence Health System

Presenter: Jessica Rowe, MA, MS, CCRP, Associate Director, HRPP/YCCI, RCQ, Yale School of Medicine

Thursday, September 15, 2022 at 2:55 pm to 3:40 pm ET                                                                                 Track: Advanced Management
Workforce Development Transformation and Implementation: Critical Role of the Leader for Success

The role of the leader for successful implementation of a workforce development program is often overlooked. Notably, the critical role of understanding change management and the leader's fluency in implementing change is necessary for many industries. This session will discuss the critical leader attributes for managing and implementing workforce development for their organization that is based on transformation and change management principles and practices. 117

Presenter: Erika Stevens, MA, Principal, Recherche Transformation Rapide

Presenter: Liz Wool, BSN, RN, CCRA, CMT, President, Wool Consulting Group Inc

Friday, September 16, 2022 at 11:00 am to 11:45 am ET                                                                                  Track: Advanced Management
Research Integrity and the Publishing Process

This session will discuss issues related to research integrity and the publication of journal articles. Topics will include authorship issues such as guest and ghost authors, complete and transparent reporting of trials, conflicts of interest including any role the sponsor played in deciding what to publish, and predatory publishing. Dr. Selfe will look at some cases of misconduct and the repercussions, such as retractions, loss of funding, and damage to public trust in the research enterprise. The focus will be on resources that can inform ethical practices, such as ICMJE authorship criteria, reporting guidelines, and tools to help identify credible journals. 119

Presenter: Terry Selfe, PhD, DC, CCRP, Translational Research & Impact Librarian, University of Florida