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Description

Decentralized clinical trials (DCTs) use processes and technologies that differ from traditional clinical trials. DCTs use telemedicine and mobile and local healthcare providers, conduct visits virtually, obtain consent remotely, and vary from being completely site-less to incorporating virtual elements.

This webinar introduces DCTs (also called virtual trials) and explores the evolution from traditional trials to decentralized models. It discusses the potential benefits to sites and subjects, and barriers to adaptation. It explains terminology and components of DCTs and reviews regulatory considerations when conducting them. It concludes with a discussion of the types of research protocols that may best include virtual aspects and “web-side” practices when conducting virtual study visits.

 

Learning Objectives

  • Identify differences between traditional trials and decentralized clinical trials.
  • Review brief history of development of DCTs.
  • Learn about the terminology, regulations, and best practices of DCTs.
  • Learn appropriate preparation for, interactions during, and overall conduct for virtual visits.

 

Audience

Graduate Students, Clinical Investigators, IRB Administrators, IRB Members, Clinical Research Coordinators, IRB Chairs, Students

 

Meet the Presenter

Amanda Rangel, MS, CCRC – VirTrial, a Signant Health Company
Amanda has spent 17 years in the clinical research industry serving a variety of functions including CRC, patient recruitment specialist, BD, and head of operations for a US Site Network. Amanda is now able to leverage her site background to lead VirTrial’s integration of telehealth into the research industry.