Closeout

Abstract

The closeout phase starts with the final follow-up visit of the first participant enrolled and lasts until all analyses have been completed. It is evident that well before the scheduled end of the trial, there needs to be a detailed plan for this phase if the study is to be completed in an orderly manner. Importantly, one must be prepared to implement or modify this plan prior to the scheduled termination since unexpected trial results, either beneficial or harmful, may require the trial to be stopped early.