Study Analysis Plan

Lead Author(s): Jeff Martin, MD

When Written

Written before the data are analyzed

Study Analysis Plan Content

For example, it will outline whether you will use a forward or backward selection process.


Required for clinical trial registration Such a pre-specificed plan is required for registration of clinical trials with the FDA. I have to wonder if observational studies are far behind?


A plan helps to keep the analysis: There are many advantages to having such a plan.