Clinical Trials Protocol Template for Phase II and III Clinical Trials Conducted Under an IND or IDE

Investigators 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.

Download the Word Version of Final Template.

Investigators are also encouraged to use an electronic protocol-writing tool, developed by the NIH and the Food and Drug Administration, to facilitate the development of phase 2 and 3 clinical trial protocols.

See e-protocol.od.nih.gov for more information.