NIH Releases e-Protocol Writing Tool and Final NIH-FDA Clinical Trial Template for Phase 2 and 3 IND/IDE Studies

Today, the National Institutes of Health (NIH) 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 Tool 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 OSP website.

To learn more about the importance of these new resources, please read the latest Under the Poliscope blog by NIH Associate Director for Science Policy, Dr. Carrie D. Wolinetz. For an additional perspective please also see the statement released today by NIH Director Dr. Francis Collins.

If you have any questions or require further information about these resources, please contact the NIH Office of Science Policy at SciencePolicy@od.nih.gov