Program Description

Decentralized Clinical Trials

Goal: The Society of Clinical Research Associates (SOCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution.
SOCRA is excited to offer this comprehensive two day in-person workshop on Decentralized Clinical Trials (DCTs). In this workshop, you'll gain a solid understanding of the fundamental considerations for DCTs and learn practical approaches to designing, administration, and implementation.

Objective: Led by top industry experts, this course offers a unique opportunity to discuss the various roles of clinical research professionals and gain valuable insights into the FDA's perspective on DCTs. Through a mix of informative instructional sessions and hands-on interactive exercises, you'll be able to apply what you learn and gain the confidence you need to succeed in the field.

Learning Objectives

• Review the regulatory, ethical, and operational challenges in the planning and execution of decentralized clinical trials. 
• Review the FDA’s current regulations and guidance in regard to decentralized clinical trials. 
• Discuss designing, developing, and implementing Risk-Based Quality Management (RBQM) in decentralized clinical trials.
• Identify and prepare for the unique challenges raised when supporting a study that includes decentralized trial components.
• Highlight key operational considerations of implementing decentralized clinical trials at the institutional level.
• Discuss the role of the human research protection program to assist in the assessment of decentralized clinical trials.
• Discuss the ethics review of conducting decentralized clinical trials.
• Discuss the significance of post-approval monitoring within a human subject protection program.
• Engage with the speakers and delve deeper into the topics through panel discussions.