Unlocking FDA DCT Guidelines: What do They Mean for You and Your Team?
Date & Time
Tuesday, April 16, 2024, 9:00 AM - 11:00 AM

In the ever-evolving landscape of clinical research, understanding the FDA's guidelines for Decentralized Clinical Trials (DCTs) is crucial to navigating the future of trial conduct. In this session we will break down the intricacies of FDA guidelines and discuss what they mean for you and your center. Panelists will discuss the changes they have made in response to the guidance and the impact those changes have had on their study teams.

Learning Objectives:

  1. Decoding FDA Guidelines: Gain a comprehensive understanding of the FDA’s guidelines for DCTs. We'll break down complex regulatory language into digestible, actionable information.
  2. Adapting to a Decentralized Approach: Learn how to modify your existing protocols and procedures to align with the FDA's guidelines on DCTs to unlock your site's potential to conduct robust, efficient, and compliant trials. 
  3. Conducting Technology Enabled Trials: Discover how to incorporate technologies and processes that can facilitate remote patient participation.
  4. Ensuring Data Integrity and Patient Safety: Understand how to ensure data integrity and patient safety in a decentralized setting, as emphasized by the FDA.
Sandy Smith Melissa Bomben Catherine Catherine Amanda Santimaw Lovie Negrin