OpenRegSource

This web portal is an up-to-date repository of links from government, academic, and scientific institutions. Its goal is to provide an overview of regulatory information along with resources to help orient clinical research professionals in their approach to plan and conduct clinical trials in the United States, ultimately bringing bench discoveries to the patient’s bedside. This self-help tool is not meant to replace professional consultation.

Not sure where to begin? Watch the OpenRegSource tour video, or start with this page.

Interested in studying Regulatory Science? 
Visit the USC Mann Department of Regulatory and Quality Sciences or enroll in our free Clinical Trial Quality Training Series courses.  Learn more about the self-paced series HERE.

Created and maintained by the Southern California Clinical and Translational Institute (SC CTSI) Regulatory and Knowledge and Support (RKS) core, this work is supported by grants UL1TR001855 from the National Center for Advancing Translational Science (NCATS) of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

The contents of this Regulatory Repository ©2024 USC Mann School of Pharmacy and Pharmaceutical Sciences Department of Regulatory and Quality Sciences.