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.


Taking the Course

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Course summary
Available credit: 
  • 1.00 AMA PRA Category 1 Credit
    The UNC School of Medicine of The University of North Carolina at Chapel Hill is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The School of Medicine of The University of North Carolina at Chapel Hill designates this activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
    The UNC School of Medicine of The University of North Carolina at Chapel Hill is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The School of Medicine of The University of North Carolina at Chapel Hill designates this activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 Participation

    UNC Lineberger Cancer Network certificate of participation.

    Tim Poe, Director of Telehealth

Course opens: 
04/29/2022
Course expires: 
04/28/2023
Rating: 
0
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.

This activity has been planned and implemented under the sole supervision of the Course Director, William A Wood, MD, MPH, in association with the UNC Office of Continuing Professional Development (CPD). The course director and CPD staff have no relevant financial relationships with ineligible companies as defined by the ACCME.

 

 

The UNC School of Medicine of The University of North Carolina at Chapel Hill is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.  

The School of Medicine of The University of North Carolina at Chapel Hill designates this activity for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Available Credit

  • 1.00 AMA PRA Category 1 Credit
    The UNC School of Medicine of The University of North Carolina at Chapel Hill is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The School of Medicine of The University of North Carolina at Chapel Hill designates this activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
    The UNC School of Medicine of The University of North Carolina at Chapel Hill is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The School of Medicine of The University of North Carolina at Chapel Hill designates this activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 Participation

    UNC Lineberger Cancer Network certificate of participation.

    Tim Poe, Director of Telehealth

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