- CRI On Line Work Order
- CRI Protocol Format
- Excel Data Sheet Template
- Frequently Asked Questions
- Financial Disclosure Form
- Student Volunteer Form
- Application Form for Industry-Sponsored Studies
- FDA Guidance on Investigator Responsibilities
- 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 Electronic Protocol Writing Toolallows 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: http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials