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considerations for implementing decentralized clinical trials and get the key take-aways from the recently issued FDA Draft Guidance on Decentralized Clinical Trials.

概览

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.

精选主题

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

谁应该参加？

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.

学习目标

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

Moving Forward with Decentralized Clinical Trials (DCTs)

概览

精选主题

谁应该参加？

学习目标

获得信息并保持参与