Working with Investigational Assay Results
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.
- 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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Kaitlin Morrison, PhD
Director of UNC Lineberger Sponsored Clinical Research
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 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.
**CME credits available for UNC personnel only**
1.00 AMA PRA Category 1 Credit™
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.
1.00 AMA PRA Category 1 Credit™ - Non-physician
Non-physicians will receive credit for time spent in an activity designated for AMA PRA Category 1 Credit™. Most health care professionals can use this credit, but UNC CPD cannot guarantee that licensing boards and other organizations will accept it. If you are not sure, please check with your organization to make sure that AMA PRA Category 1 Credits are accepted.
1.00 General Participation Credit
UNC Lineberger Cancer Network certificate of participation.
- 1.00 AMA PRA Category 1 Credit™
- 1.00 AMA PRA Category 1 Credit™ - Non-physician
- 1.00 Participation