Clinical Research Policy

Clinical Trials

The electronic protocol writing tool aims to facilitate the development of phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. The development of the Phase 2 and 3 clinical trial protocol template was an initiative supported by the NIH-FDA Joint Leadership Council and the NIH Clinical Trial Stewardship Reform Task Force, and meets the standards outlined in the International Conference on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6). Questions about the tool can be sent to SciencePolicy@od.nih.gov.

Take me to the e-Protocol Writing Tool.


Final Template Documents