ABSTRACT
After the last patient’s data has been collected from the sites, the race is on to close and “lock” the study. Once a study has been locked, the final analysis can be made and conclusions drawn. Because there is usually high pressure to make those analyses (and related decisions) as soon as possible, companies frequently keep track of “time to database lock” and work constantly to minimize that time. The pressure to quickly lock a database for analysis comes up against a long list of time-consuming tasks that need to be performed first. The list involves many individual steps, including: collecting the final data, resolving outstanding queries, reconciling against other databases, and performing final quality control (QC).
