Changes in Institutional Regulatory Support

On November 1, 2019, ORAQ implemented several changes to regulatory support at Duke University.  These changes, which were implemented at the request of the School of Medicine, aim to improve the quality of regulatory submissions, increase efficiency and reduce delays with regulatory approvals, and decrease risk by ensuring compliance with federal regulations:

  1. Regulatory Review Requirements: All regulatory submissions associated with a clinical trial must be reviewed by ORAQ prior to submission to the U.S. Food and Drug Administration (FDA).
  2. Costs for ORAQ Support: In order to sustain and expand resources, ORAQ will charge for regulatory support. ORAQ effort that is not supported by a grant or contract will be charged back to academic research departments.
  3. New Submission Processes: Any drug or biologic submissions sent to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) for research INDs will be submitted electronically through FDA’s Electronic Submissions Gateway (ESG) in non-eCTD format.

Have questions? Please review the presentation below or visit our frequently asked questions on regulatory review requirements, ORAQ costs, and submission processes. If you can’t find the answers to your questions here, please reach out to us at ORAQ@duke.edu.

 

Presentation: Updates from the Office of Regulatory Affairs and Quality 

Video  Slides