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)
- Best Practices in Clinical Research Protocol Writing
USC Resources
Protocol Templates
- NIH Clinical Trial Template (Phase 2, 3)
- Norris Protocol Template
- Protocol Template (Cooperative Health System)
- Protocol Writing Tips (Kinetiq)
- Organizing a Clinical Trial Binder
- Phase I Trial Design Tips