This is the REd Online (ASYNCHRONOUS) Class.

Class Description: This class provides a high level overview of general research compliance expectations when engaging in human subject research with a particular emphasis on interventional clinical trials. This includes the requirements for study activation, study management, as well as monitoring and data and safety monitoring oversight. Engaging in clinical research activities takes a village of people including the medical care team, coordination, regulatory, finance, investigational pharmacy, specimen processing, etc. Ensuring that clinical research activities are carried out compliantly with the highest ethical and regulatory standards and regulations protects our patients and our communities.

Class Objectives: At the conclusion of this class, you should be able to:

• Understand the ethical and regulatory expectations for opening a new clinical trial
• Identify who is ultimately responsible for ensuring protocol compliance at a site level
• Describe the informed consent process
• Produce examples of types of reportable events
• Explain how we ensure data integrity and source documentation in clinical trials                
• Summarize why data and safety monitoring oversight is important and the difference between quality and compliance

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Instructors:

 Priscilla Rosen 
 Clinical Research Manager
 Priscilla.Rosen@hsc.utah.edu
 Pediatrics, Clinical Trials Office

 Kelli Thorne
 Director, Research and Science
 Kelli.Thorne@hci.utah.edu
 Huntsman Cancer Institute Research Compliance Office

 Erin Vanderhoof
 Clinical Research Manager
 Erin.Vanderhoof@hsc.utah.edu
 Pediatrics, Clinical Trials Office 

REd Asynchronous Classes feature lessons and exercises designed to build competency and increase efficiency. Modules are accessible 24/7 and are all self-paced. All members of the University research community are invited to complete any online classes of interest.