Quality Management
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2023 Agenda
Saturday, September 30, 2023 at 8:30 to 9:15 Track: Quality Management
The Winding Road of Building a Competency Program
Ms. Lloyd will describe the winding road traveled to build a competency program for a large department. The requirement for buy in and involvement from leadership is essential for success as well as the willingness to take sharp turns during the journey for continued process improvement. This session outlines lessons learned from the development of the program. The session will be interactive allowing the audience to discuss their successes and struggles they may have experienced. 417
Presenter: Wendy Lloyd, BA, CCRP, LPN, Senior Clinical Research Quality Analyst-Educatio, Vanderbilt University Medical Center
Saturday, September 30, 2023 at 9:20 to 10:05 Track: Quality Management
The Road from Compliance to Quality in Clinical Trials
The transformation of a clinical trials compliance program to a quality assurance program presents substantial challenges. From reorienting the stakeholders to practical issues such as title and role changes and developing new worksheets, there are many things to consider in the effort to improve oversight of studies. A successful quality assurance program offers a much more satisfying experience for the entire clinical trials team. 419
Presenter: Eileen Healy, MS, CCRP, Clinical Research Quality Assurance Coordinator, Roswell Park Comprehensive Cancer Center
Saturday, September 30, 2023 at 10:50 to 11:35 Track: Quality Management
Notes to File: Compliant Practices and Ensuring Data Integrity
This Note to File (NTF) presentation will review what an NTF is, current practices, and current problems as well as Quality System oversight. Lessons learned from audits and the use of NTFs will also be presented. 421
Presenter: Heather Pham, MS, CCRP, CHRC, Clinical Research Educator, Providence St. Joseph Health
Saturday, September 30, 2023 at 11:40 to 12:25 Track: Quality Management
Managing Upward: Strategies for Working as a Team
As researchers, we work with a broad variety of individuals and personalities. One of the more difficult challenges faced by research Coordinators and Managers alike is a colleague who does not respond well to feedback from the study team. The good news is that there are a number of things that can be done to help get the study team functioning smoothly again. This talk will focus on some of these strategies from the perspectives of a Research Coordinator, a Compliance Manager, and a Research Administrator. 423
Presenter: Kevin Smith, MS, MBA, CCRP, Research Administrator, Cleveland Clinic
Saturday, September 30, 2023 at 1:40 to 3:15 Track: Quality Management
A Quality Improvement Program in Human Subject Research
As research monitoring and compliance paradigms evolve, human subject research teams are challenged to ensure that quality in research maintains or exceeds expectations and standards. 425/427
Presenter: Jennifer Dolan, MS, LMT, CCRC, Specialist, Research Quality Improvement, University of Rochester
Presenter: Kathleen Wessman, MPA, RN, RQAP-GCP, CCRC, Director, Research Quality Improvement, University of Rochester
Presenter: Elizabeth Lyda, BS, RRT, Research Quality Improvement Specialist, University of Rochester
Saturday, September 30, 2023 at 3:45 to 4:30 Track: Quality Management
Analysis of Quality Challenges in Phase I and II in Cellular and Gene Therapies
Dr. Soans will compare quality challenges seen in FDA approved cellular and gene therapies in the market to early phase development products at St. Jude. We will look at how we have responded to FDA Information requests on quality and time taken from pre-IND stages to IND submissions and what have been the limitations. 429
Presenter: Eroica Soans, PhD, CCRA, Senior Medical Writer, St Jude Children's Research Hospital