Everything a PI Needs to Know about Holding an IND

Course Information

Allison Camp, PhD provides an overview of INDs: what they are, when they are needed, what is required for their preparation and submission, and how they are maintained with the FDA. This topic is discussed with the help of past LCCC examples.

Learning Objectives

  • Recognize when an investigator-initiated trial (IIT) may need an IND, and who to contact to initiate the process.
  • Describe the general steps and required information for an initial IND application.
  • List the types of maintenance FDA submissions that are required throughout the life cycle of an IND.

 

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Please contact us with any questions at [email protected] or (919) 445–1000.

Disclaimer

The views expressed herein are those of the presenter, they do not necessarily reflect the views of the contracted organization, department, School of Medicine, nor the University of North Carolina at Chapel Hill.

 

Course summary
Available credit: 
  • 1.00 Participation
Course opens: 
06/08/2026
Course expires: 
06/07/2028
Logo for course series, Oncology Clinical Trials: a UNC Lineberger CRTEC course series 

Oncology Clinical Trials Series
Developed by Claire Dees, MD, ScM

The Oncology Clinical Trials series, developed by Claire Dees, MD, ScM, provides an introduction to clinical research in oncology, with a focus on the design and conduct of clinical trials. Topics include trial design, implementation, regulatory and ethical considerations, data management, and common challenges in oncology research.

The series also introduces complementary areas such as biomarkers, correlative studies, and other approaches that support therapeutic trials, along with considerations for career development in clinical research.

This series is designed for fellows, faculty, and oncology advanced practice providers (APPs) across cancer-related disciplines, including medical, hematologic, gynecologic, urologic, head and neck, pediatric, surgical, and radiation oncology.

Photo of Allison Camp 

Allison Camp, PhD

Assistant Director, Clinical Development
UNC School of Medicine
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

Available Credit

  • 1.00 Participation
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