Quality Management
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2024 Agenda
Sat., Sept 28 10:50 to 11:35 Track: Quality Management
The Application of Lean in Clinical Research Operations
Ms. Breeden will provide an overview of Lean principles and process improvement and how to improve working relationships, reduce barriers, improve processes and systems, and increase team morale. 621
Presenter: Amanda Breeden, MA, CRA, AOR, Director, Sponsored Programs and Research Office (SPARO), Denver Health
Sat., Sept 28 11:40 to 12:25 Track: Quality Management
Deviations, Root Causes, and CAPAs...Oh My!
Ms. Gateman will examine practical root-cause analysis strategies for assessing, documenting, and reporting research deviations and violations. Steps for corrective and preventive action plans will be described in order to provide a clear path to confidently address and learn from past deviations. 623
Presenter: Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office, Yale Cancer Center
Sat., Sept 28 1:40 to 2:25 Track: Quality Management
Quality Assurance in Clinical Trials
Dr. Prasad will discuss clinical trial related procedures that ensure protection of human subjects from research risk, assure reliability of the data collected, and thereby assure internal consistency in trial management. 625
Presenter: Seema Prasad, MD, MPH, CCRP, Supervisor, Clinical Studies, MD Anderson Cancer Center
Sat., Sept 28 2:30 to 3:15 Track: Quality Management
How To Effectively Use Project Management Software to Run Successful Clinical Trials and Get Buy-In From Your Team
Project management software can be a great tool for managers and coordinators, IF you know how to use it effectively, and IF the rest of your team is using it fully. Learn common pitfalls in using project management software across a research support team, and, perhaps most importantly, learn how to get buy-in from your team. The end result is smoother, lower-stress management of clinical trials. 627
Presenter: Kelly Ryberg, MA, CCRP, Associate Director, MnDRIVE Deep Brain Stimulation Core, University of Minnesota
Sat., Sept 28 3:45 to 4:30 Track: Quality Management
Quality Assurance and associated Challenges at the Resource Limited, Rural Research Site
Ms. Wandile will consider the issues related to managing clinical trials at a rural site. 629
Presenter: Pranali Wandile, MS, CCRP, Clinical Research Manager, Low Country Pain Center LLC
Sat., Sept 28 4:35 to 5:20 Track: Quality Management
Creating A Clinical Research Quality Assurance Program From Scratch
Each medical test site must establish and follow policies and procedures for a comprehensive quality assurance (QA) program. Where to start? What is needed? 631
Presenter: Karima Yataghene, MD, Senior Director, Clinical Research Quality Assurance, Memorial Sloan Kettering Cancer Center