About Regulatory

We provide clinical regulatory assistance, guidance and education to investigators and study coordinators. We help ensure adherence with national regulatory and institutional requirements.

We support clinical and translational research through the following programs:

  • Scientific and tactical advice to navigate the drug and device development process
  • Preclinical consultation, IND gap analysis, guidance for CMC activities
  • Assistance in regulatory writing and consulting
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  • Investigational New Drug and Device Exemption application support
  • Clinicaltrials.gov registration support
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  • TraCS Data and safety monitoring board (DSMB) oversight
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  • Protocol and IRB guidance and support
  • Clinical trial implementation services
  • Consent form and consent process guidance
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  • Review grants for adequacy of human subject protection
  • Development of monitoring plans
  • Clinical trial monitoring and audit preparation
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  • Guidance on completion of the human subjects and clinical trial information forms required for NIH grant submissions
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  • Regulatory training programs for faculty and the research workforce
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  • Affiliates at UNC, Duke, Wake Forest, and RTI share current best practices for preparing IND and IDE submissions to the FDA
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The integration of the UNC and RTI regulatory services leverages extensive expertise across the drug and device development pathways to meet the difficult challenges of clinical research.