Download the template(s) of your choice. The template documents open as Word files; save as a Word file to begin drafting your protocol. All instructions in the template are highlighted in blue.

For clinical application of your trial results ... You will already have argued in your trial protocol and sample size paragraph what minimum theoretical difference between groups you consider ...

The Draft Guidance highlights that FDA does not consider all potential violations of good clinical practice guidelines or requirements (“GCPs”) to be protocol deviations even where the study ...

Examples of important protocol deviations provided in the guidance include the following: In general, the guidance emphasizes thoughtful clinical trial protocol design as a means to minimize ...