The Office of Regulatory Affairs and Quality (ORAQ) supports the clinical research community at Duke University. We offer regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. Our goal is to provide the Duke community with the tools, training and support needed to navigate the complex regulatory pathways that accompany translational research. We aim to do this by providing support in the following areas:
- Early Regulatory Strategy Development: We encourage early interaction as a means to develop a regulatory strategy that is appropriate for the complexity of your research project.
- Preclinical Testing and GMP Manufacturing: We provide guidance and support to research teams developing and executing preclinical studies or manufacturing investigational products.
- Regulatory Submissions and Maintenance: We provide full preparation, submission, and maintenance of regulatory applications to the FDA. See template documents.
- FDA Meetings and Inspections: We can prepare, schedule, and facilitate meetings with the FDA. We also support FDA audits/inspections and can assist with the preparation and implementation of responses to audit observations.
- Educational Opportunities: We provide a variety of education and training, including the Regulatory Affairs Training Program and Sponsor and Investigator Training.
- Outreach and Collaboration: We are a contributing member of ReGARDD, a regional regulatory forum that offers guidance to academic researchers through curation of resources at ReGARDD.org.
Questions? Contact our “help desk” at ORAQ@duke.edu.
Want to know more about FDA regulation of medical products? Click on the image below to take a short course.
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.
Individual Patient IND Support
Physicians interested in using an investigational drug (i.e., not FDA approved) to treat a patient with a serious or immediately life-threatening condition can now receive full support in obtaining regulatory authorizations and throughout the entire process. Use of an investigational drug outside of a clinical trial requires a physician to obtain informed consent and seek authorization from the drug company, the Food and Drug Administration (FDA), and the Institutional Review Board (IRB). To utilize the Individual Patient IND Support resource, please complete the survey of required information and key staff will be notified of your request. If you would like additional information, please visit Individual Patient IND Support or contact ORAQ@duke.edu.
The Office of Regulatory Affairs and Quality (ORAQ) is supported in part by Duke’s Clinical and Translational Science Award (CTSA) from the National Center for Advancing Translational Sciences (NCATS). Please cite the CTSA grant (UL1TR002553) in publications utilizing ORAQ resources and register your publication with PubMed Central.