We provide expertise and guidance on completion of a variety of research forms and regulatory documents required when implementing a clinical study.

Regulatory consultations are available to guide and support you as you design protocols, navigate through the approval process, and conduct your research.

Study Implementation

We provide expertise and guidance on completion of a variety of research forms and regulatory documents required when implementing a clinical study.

Regulatory consultations are available to guide and support you as you design protocols, navigate through the approval process, and conduct your research.

Services include:

  • Guidance with protocol development
  • IRB application guidance and review
  • Guidance responding to IRB contingencies
  • Consent form development
  • Consent process guidance
  • Regulatory document guidance
  • Guidance with study implementation
  • Guidance with ClinicalTrials.gov registration and results posting requirements

Remote Consent

Due to the presence of COVID-19, many researchers have been hard at work to pivot studies from in-person to remote activities. NC TraCS, in collaboration with the Office for Human Research Ethics, School of Medicine Clinical Research Support Office, and UNC ITS has developed a document outlining best practices and options on conducting the informed consent process remotely.


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Contact Us


Brinkhous-Bullitt, 2nd floor
160 N. Medical Drive
Chapel Hill, NC 27599

919.966.6022
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Cite Us


CitE and SUBMit CTSA Grant number - UL1TR002489

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