Applicants conducting phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications can use a NIH-FDA template with instructional and sample text to help write protocols. A separate template is available for applicants conducting behavioral and social sciences clinical trials. Use of these templates is optional.
To facilitate the development of clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application, the NIH and FDA collaboratively developed a Phase 2/3 Clinical Trial Protocol Template and an electronic protocol-writing tool to help investigators think through the scientific basis of their assumptions, minimize uncertainty in the interpretation of outcomes, and prevent loss of data.
Policy Guidelines & Implementation
The tool provides a suggested format for phase 2 and 3 clinical trials funded by NIH that are being conducted under an FDA IND or IDE Application.
A common protocol structure and organization facilitates protocol review by oversight entities.
Note that the use of the tool is voluntary and is not required for NIH applications or contract proposals.