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Moving Forward with Decentralized Clinical Trials (DCTs)

Learn the important considerations for implementing decentralized clinical trials and get the key take-aways from the recently issued FDA Draft Guidance on Decentralized Clinical Trials.

Overview

Decentralized Clinical Trials (DCTs) are part of a new era in drug development. In this comprehensive three-part on-demand course, participants will learn the fundamental considerations for DCTs and practical approaches to their design and implementation.

This course includes a mixture of informative instructional sessions and interactive exercises where learners can apply what they learn.

Featured topics

  • What a DCT is
  • Common terminology and definitions
  • Value of DCTs
  • Considerations for trial design
  • Recruitment and retention strategies
  • Application of end user insights
  • Technology and service providers that enable remote activities in DCTs
  • Data privacy and security considerations
  • Data collection and monitoring considerations
  • Best practices for successful implementation
  • Risk mitigation in DCT

Who should attend?

This course is designed for professionals working in the development and/or implementation of decentralized clinical trials, including:

  • Clinical Development
  • Clinical Operations Project Management
  • Clinical Research (Site Directors, Coordinators)
  • Data Management
  • Statistics
  • Regulatory Affairs

This course may also benefit company decision makers, as well as other stakeholders involved in DCT strategy and implementation.

Learning objectives

At the conclusion of this course, participants should be able to:

  • Define decentralized clinical trials
  • Recognize decentralized clinical trial elements
  • Evaluate decentralized clinical trial designs, including benefits, limitations, and challenges
  • Analyze key considerations when designing and implementing decentralized clinical trials
  • Identify key considerations when developing DCT protocols
  • Determine the patient journey in a DCT through mapping
  • Identify areas and strategies for risk mitigation with DCTs

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