Finishing the Study

Abstract

Like study start-up, the time of closure of the study involves additional procedures for the team. Subjects must be brought in for final visit early in their visit windows, collecting all study-related materials and updating all contact information. Effort must be expended to complete all study queries, and financial conflict of interest reporting must be repeated. All financial billing must be completed and received before the study can be formally closed. While subject charts can be stored off-site, a list of documents to be kept on-site indefinitely includes the sponsor closure letter, the IRB closure letter, sponsor contact list, contents of the boxes to be sent to storage, CDs of subject data, unblinding notifications, and study publications.