Forms
Investigator-Initiated Forms
- CRI Protocol Format
- Data Sheet Template
- Helpful Data Collection Hints
- Frequently Asked Questions
- Financial Disclosure Form
- Application Form for Industry-Sponsored Studies
- The National Institutes of Health (NIH) has released two important related items.
- The first is the Final NIH-FDA Clinical Trial Template for Phase 2 and 3 IND/IDE Studies. The template aims to assist NIH-funded investigators in preparing clinical trial documents efficiently so that both IRBs and the FDA can perform speedy reviews.
- NIH has also released a web-based platform where investigators can utilize the protocol template in an interactive fashion. The allows for a collaborative approach to writing and reviewing protocols. Investigators will be able to use the tool to form a "protocol writing team" and assign different individuals with writing and reviewing roles. All of the above resources can be found on the NIH Office of Science Policy website: