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
- Are you the Holder of an IDE?
- Are you the Holders of IND?
- USC Template for Investigator Initiated Research
- 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
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
To recommend additional resources email firstname.lastname@example.org