End of Trial and Close Out of Data Collection

Abstract

Trial closure refers to the activities that take place in preparation for the cessation of trial recruitment through to archiving of the trial. Trial closure can be notionally divided into five stages: End of Recruitment; End of Trial Intervention; End of Trial; Trial Reporting and Publishing; and Archiving. The length and scheduling of each stage of trial closure is determined by the trial design and operating model. As trial closure approaches there is an increased emphasis on monitoring and controls to ensure the correct number of participants is recruited and data collection and cleaning in preparation for final database lock and analysis is complete. The End of Trial is a key ethical and regulatory milestone defined in the approved trial protocol and has associated time-dependent notification and reporting requirements to the independent ethics committee and, for regulated trials, the regulator(s). Key steps of trial closure, reporting, publishing, and data sharing are important mechanisms to support transparency in clinical trials. A Trial Closure Plan can be used to support the activities that ensure appropriate control over the final stages of the trial.