The clinical trials electronic protocol writing template/tool provides a useful format for NIH-funded Phase II and III clinical trials that are being conducted under an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. The goal of the template is to help investigators think through the scientific basis of their assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data. A common protocol structure and organization will also facilitate review by oversight entities. The template is modifiable to any type of clinical trial, including clinical trials with behavioral interventions, and is available as an online collaborative tool or as a Word template.
Effective for due dates on/after May 25, 2020: Since the new Human Subjects and Clinical Trial Information Form (FORMS-F) collects key elements from the protocol, the optional protocol submission will be removed from the Appendix Policy. (NIH Notices NOT-OD-17-098 and NOT-OD-20-026).
Protocols and other materials are allowed only when specified/required in the funding opportunity announcement (FOA).
For NIDCD U01 Applications
A clinical trial protocol is not required or allowed as an attachment for the NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) PAR-21-064 application package; however, a full clinical trial protocol and informed consent will be required and subject to review and acceptance by the NIDCD at the time of funding. Although the use of the protocol template and tool is optional for most FOAs, it is expected that funded U01 clinical trials will use the Clinical Trial Protocol Template for Phase II and III IND/IDE studies as developed by the FDA and NIH. See Section VI.2: Award Administration Information - Cooperative Agreement Terms and Conditions of Award of the FOA for details.