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
    learn more »
  • Investigational New Drug and Device Exemption application support
  • Clinicaltrials.gov registration support
    learn more »
  • TraCS Data and safety monitoring board (DSMB) oversight
    learn more »
  • Clinical trial implementation and study start-up services
  • Regulatory and IRB guidance and support
  • Consent form and consent process guidance
    learn more »
  • Review grants for adequacy of human subject protection
  • Development of monitoring plans
  • Clinical trial monitoring and audit preparation
    learn more »
  • Regulatory training programs for faculty and the research workforce
    learn more »

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.