Automated identification of task items that must be completed before a clinical trial database can be locked

Abstract

An automated method is provided for generating summary data regarding task items that must occur to achieve a database lock for a clinical trial study that is performed based on a previously defined clinical trial protocol. The clinical trial study is managed using a processor and a database in communication with the processor. The database includes clinical trial data and the status of the data for a plurality of patients participating in the clinical trial study. At least one clinical database lock criterion is defined for the study from at least a plurality of user-selected subsets of the clinical trial data. The processor receives the at least one clinical database lock criterion for the study, and the clinical trial data and the status of the data, as retrieved from the database, for the plurality of patients participating in the clinical trial study as defined by the clinical database lock criteria. The processor then automatically and programmatically generates summary data regarding task items that must occur to achieve the database lock as defined by the at least one clinical database lock criterion, using the clinical trial data and the status of the data. Different summary data will be generated for different clinical database lock criteria.