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Evaluation On-Demand Video

2024 PRIM&R Annual Conference

FDA Regulated Research

HRPP/IRB Management and Administration

IRB Review

H01 - PLENARY: Regulatory and IRB Challenges in Reviewing Decentralized Clinical Trials (DCTs)

Wednesday, November 20, 2024
10:30 AM – 11:45 AM PT
Location: Room 323-324
Human Subject Research - HSR Live Streamed Session Live Session Recorded Thought Leader Series CIP Accredited
CLICK HERE to view captioning for this session! 

Among other Task forces in the White House Cancer Moonshot is a Work Group promoting the implementation of decentralization (including decentralized methods) in federal government and private sector clinical trials. This session will review important regulatory, educational, and operational hurdles to implementing DCTs/DCT methods along with current resources and solutions for Human Research Protection Plans (HRPP) reviewing and implementing them. Case examples from the Department of Veterans Affairs (VA) will be discussed along with the regulatory issue of engagement and FDA requirements related to Investigational New Drug clinical investigations and its draft guidance on DCTs.

Learning Objectives:

  • Articulate the basic framework of a DCT
  • Describe some of the benefits and potential complications of implementing a DCT or DCT methods
  • Recognize DCTs/DCT methods when they are submitted and have resources for considering the regulatory and operational issues that need to be considered prior to approval and in post-approval monitoring