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.

Protocol Development

We provide expertise, guidance and education on development of a clinical or master protocol for investigator-initiated research.

Regulatory consultations are available to guide and support you as you design protocols and navigate through the scientific review process.

Services include:

  • Education on protocol development
  • Review and feedback on clinical or master protocols
  • Guidance with Scientific Review Committee (SRC) review process
  • Recommendation of suitable protocol template
  • Facilitate referrals for statistical assistance

Links and guidance documents to help in developing a research protocol

Resources

Clinical Protocol Development Series

This two-day series provides researchers with knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. Recorded sessions for day one and day two (Spring 2022) are available below.

View slides: Day One (pdf)

View slides: Day Two (pdf)

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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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