The National Institutes of Health (NIH) and Food and Drug Administration (FDA) announced on March 17, 2016, their co-development of a draft clinical trial protocol template for use by NIH-funded investigators. The template is meant for use in writing phase 2 or 3 clinical trial protocols where Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications are required.
The template provides instructions and sample text that are intended to facilitate the preparation of consistent, organized, and complete protocols, so that clinical trials can be properly and more efficiently reviewed by the agencies. The template protocol follows the International Conference on Harmonisation E6 Good Clinical Practice guidance.
NIH and FDA request public comment on the draft template from investigators, investigator-sponsors, institutional review board members, and any other stakeholders involved in protocol development and review. The agencies are particularly interested in the utility of the template and the readability and clarity of the instructional and sample text. Comments will be accepted through April 17, 2016, but the announcement notes that comments will be used at the agencies’ discretion and responses to comments will not be provided. Draft template documents can be found here, and responses may be made here.