IIT- Protocol Amendments

Course Description

Nasrin Babadi, PhD takes you through LCCC’s processes for amending protocols and submitting them to FDA talking about key tips on how to best edit your protocol and applicable FDA regulations for submitting your protocol.

Learning Objectives

  • Understand what type of protocol changes require an amendment
  • Learn how to write a protocol amendment, including QA
  • Learn what type of external (funding sources), internal (PRC/Biosafety/etc.) reviews, and regulatory approvals are required for an amendment 

Taking the Course

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Course summary
Available credit: 
  • 1.00 Participation
Course opens: 
Course expires: 
Photo of Nasrin H. Babadi, PhD, RAC

Nasrin Babadi, PhD, RAC

IND Specialist
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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