The COVID-19 pandemic has placed additional strain on the conduct of clinical research in global, national, and local settings. The pandemic has changed the way we physically review research, prioritize research reviews, write consent forms, obtain consent, recruit subjects, conduct subject visits, collect data, and analyze and interpret data. It is unknown how these changes will impact study outcomes and the generation of new ideas to translate into medical practice. It is well known that translation of research into clinical practice is already slow and inefficient despite continuous administrative and management strategies to alleviate regulatory burdens. However, it might be that all is not lost in these unusual times, as novel changes have also occurred that improve facilitation of participant visits through telemedicine, simplify consent procedures, and speed up regulatory review processes as necessary. This Coffee Talk will allow attendees to think of creative ways to leverage these changes. Learning Objectives:
- Understand the changing environment in the pandemic era and how this is impacting regulatory management
- Prioritization guidelines for reviewing protocols related to COVID-19 which minimizes barriers for quicker turnaround times for approval
- Impact of COVID-19 on participant visits and the use of telemedicine in clinical research
- Opportunities for process improvement and innovation to address the challenges caused by the pandemic
Philip A. Cola, PhD
Associate Professor of Management and Medicine
Director, Regulatory Knowledge and Support Component
Case Western Reserve University, CTSA
Vicki McHugh, MS-CRM
Administrative Director, Medical Research
Gundersen Medical Foundation
Kevin Titus, MBA
Cincinnati Children's Hospital Medical Center
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