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 Sponsor-Investigator Agreement
- Regulatory Science Consulting Services
- Organizing a Clinical Trial Binder
- NIH Clinical Trial Template (Phase 2, 3)
- Norris Protocol Template
- Protocol Writing Tips (Kinetiq)
- Phase I Trial Design Tips