All Investigator-initiated protocols submitted to the IRB must be on the template HRP-503-Template Protocol. All sponsored protocols, when submitted to the IRB, must include both the sponsor protocol ...

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 ...

Likewise, sponsors can use sample questions and guides ... underscore opportunities to reduce their protocol burdens and simplify their clinical trial experience. All these elements could ...