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You are here: Home / Research / Investigator-Initiated Trials

Investigator-Initiated Trials

Most Investigator-Initiated Trials do not have an industry sponsor. With limited resources and less oversight, investigators face challenges in ensuring compliance with regulations and good clinical practices. Below are guidelines and templates on the responsibilities of investigator initiated/ sponsor-investigator research.

  • FDA Guidance for Investigational Drugs (IND)
  • FDA Guidance for Investigational Devices (IDE)

USC Resources

  • USC Sponsor-Investigator Agreement
  • Regulatory Science Consulting Services
  • Organizing a Clinical Trial Binder

Protocol Templates

  • Cancer Center Protocol (Please go to the CISO website for Cancer studies) 
  • NIH Clinical Trial Template (Phase 2, 3)
  • Norris Protocol Template
  • Protocol Writing Tips (Kinetiq)
  • Phase I Trial Design Tips

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HRPP
3720 S. Flower Street, Suite 325
Los Angeles, CA 90089
oprs@usc.edu
irb@usc.edu
(323) 442-0114

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