The Office of Regulatory Affairs and Quality serves as a no-cost resource to the clinical research community at Duke Health. 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-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.
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 approvals. Use of an investigational drug outside of a clinical trial requires a physician to obtain informed consent and seek approval from the drug company, the Food and Drug Administration (FDA), and the Institutional Review Board (IRB). For assistance with regulatory approvals, 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 (UL1TR001117) in publications utilizing ORAQ resources and register your publication with PubMed Central.