A good protocol begins with team consensus on what you want to claim about your device when the study is over. Writing a clear statement about efficacy or performance takes thought and debate. The difficulty is that you must commit today to what you will call a success tomorrow.
In this workshop, we'll look at common objectives for conducting a study, and review other sections that address the rationale, justification for the study, a contention of non-significant risk (if appropriate), and other elements of the protocol.
