NIH and FDA collaborated with the research community to develop a common Phase 2 and Phase 3 IND/IDE clinical trial protocol template. The goal is to support investigators and speed up FDA review of NIH clinical trials. The document is consistent with International Council for Harmonisation E6 (R2) Good Clinical Practice Guidance.
At the same time, NIH released an electronic protocol writing tool that allows investigators to work together in a common platform to develop their protocol. NIH anticipates future releases of the e-Protocol Writing Tool will include templates for Phase 1 and behavioral studies.
Please note that the use of these tools is optional. Individual Schools/Centers/Departments may already have protocol template requirements in place.
NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
Notice Number: NOT-OD-17-064
Release Date: May 2, 2017
National Institutes of Health (NIH)
The National Institutes of Health (NIH) and Food and Drug Administration (FDA) developed a clinical trial protocol template with instructional and example text for NIH-funded investigators to use when writing protocols for phase 2 and 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications. In March 2016 a draft template was released for public comment generating nearly 200 comments from 60 respondents. All comments were carefully considered and many were incorporated into the final template. The agencies’ goal is to encourage and make it easier for investigators to prepare clinical trial protocols that are organized consistently and that contain all of the information necessary for the review of the protocol. The template follows the International Conference on Harmonisation (ICH) E6 (R2) Good Clinical Practice and is available as a Word document
The NIH also released a secure web-based e-Protocol Writing Tool that allows investigators to generate a new protocol using the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template. The e-Protocol Writing Tool fosters protocol writing collaboration by allowing multiple writers and reviewers to participate in the protocol development process. The e-Protocol Writing Tool allows the author to assign writers and collaborators and the tool assists the author with tracking progress and document version control.
The NIH expects to expand the development of the e-Protocol Writing Tool by adding instructional text and sample text for other types of studies, such as a behavioral and phase 1 trials. Future releases of this e-Protocol Writing Tool will have improvements and enhanced tool functionality.
Please direct all inquiries to:
NIH Office of Science Policy