IND Safety Reporting- LCCC IITs

Course Description

In this talk, Kaitlin Morrison, PhD covers how to fill out a MedWatch report form and how/when/why to notify FDA of an SAE.

Learning Objectives

  • Understand what SAE qualify for IND safety reporting
  • Understand what is required for completion of a MedWatch Form
  • Learn the process for submission of an IND safety report to FDA.


Taking the Course

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Course summary
Available credit: 
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 Participation
Course opens: 
04/29/2022
Course expires: 
04/27/2024
Rating: 
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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 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 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 internet enduring material 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 General Participation Credit
UNC Lineberger Cancer Network certificate of participation.

Available Credit

  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 Participation
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