Working with Investigational Assay Results

Course Description

Kaitlin Morrison, PhD takes you through when a correlative assay is considered an FDA regulated device and what types of devices require different levels of IRB and FDA approval.

Learning Objectives

  • Understand what a device is.
  • Understand that the greater the risk the more device rules that are associated with the device.
  • Understand what needs to be communicated to the study team about an investigational device.

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Course summary
Available credit: 
  • 1.00 Participation
Course opens: 
Course expires: 
Photo of Kaitlin Morrison, PhD 

Kaitlin Morrison, PhD

Director of UNC Lineberger Sponsored Clinical Research
Assistant Professor of Medicine, Division of Hematology

UNC Lineberger Sponsored Clinical Research
UNC Lineberger Comprehensive Cancer Center
UNC School of Medicine
University of North Carolina at Chapel Hill


Presenter Disclosure Information

The presenter has no relevant financial relationships with ineligible companies as defined by the ACCME.



The following accrediting agencies have approved this course for continuing education credits. Participants should understand that their individual participation and claiming credit must abide by the regulations set forth by their respective accrediting agency.

1.00 General Participation Credit
UNC Lineberger Cancer Network certificate of participation.


Available Credit

  • 1.00 Participation
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