Hot and Cold Topics for Investigators

Course Description

Kaitlin Morrison, PhD takes you through the top topics investigators are asking about and the other questions that they should be asking too.

These topics include:  

  •     I want to grant a single subject exception. What should I consider? Is it allowed?  
  •     What is a single patient IND vs. what is an expanded access program? What resources are there to help me?  
  •     I have an idea for a letter of intent (LOI) or an approved concept, now what? Who is there to help me?
  •     What happens if my concept is for a multicenter study? When can I open my sites?
  •     When do I need to send an IND safety report to FDA for my study?
  •     What is Part 11 Compliance and why should I care about it?
  •     What is the electronic common technical document (eCTD) and why should I care about it?
  •     What is institutional conflict of interest? What could happen if we have it?


Learning Objectives

  • Understand when a single subject exception is not appropriate.
  • Understand the general process for developing an idea into a clinical protocol open at UNC and multicenter sites.
  • Understand the importance of Part 11 Compliance.

Taking the Course

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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.

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 Participation
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