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.

USC Resources

Protocol Templates

Guidance from Other Institutions

Resources for Holders of IND or IDE — Virgina Commonwealth University 
UCSF Investigational New Drug (IND) Submissions for Sponsor-Investigators
UCSF Investigational Device Exemption (IDE) Development Process


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