Trial Closeout

The closeout phase of a clinical trial starts with the final follow-up visit of the last enrolled participants and ends once all study activities are appropriately reconciled, recorded, and reported. The detailed requirements of closeout are easy to underestimate, and early detailed planning is necessary to ensure that it is accomplished in an orderly, complete, and effective fashion. It is important that contingencies are made, to implement or modify this plan should stop criteria be met. In this chapter, we define the trial closeout period, highlighting the benefit of comprehensive planning. We outline critical aspects of the closeout as they relate to individual recruiting sites and central coordinating centers. This includes cleanup and verification of data, management of study related materials, reporting results, and archiving of data. We also consider aspects of results dissemination, as well as issues relating to post study transition and follow-up of patients.