Patent ID: 7657446

Claim:
An automated method of 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 being managed using (i) a processor, and (ii) a database in communication with the processor, the database including clinical trial data and the status of the data for a plurality of patients participating in the clinical trial study, the method comprising: (a) electronically selecting at least one of the following criteria for a database lock: (i) one or more subsets of clinical trial data from a plurality of subsets of clinical trial data, (ii) one or more time frames or a time point in the study, (iii) one or more patient types, and (iv) a predefined number of patients; (b) receiving in a processor the electronically selected criteria; (c) defining in the processor clinical database lock criteria for the study from the electronically selected criteria; (d) inputting into the processor: (i) the clinical database lock criteria for the study, and (ii) 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; and (e) automatically and programmatically generating via the processor summary data regarding task items that must occur to achieve the database lock as defined by the clinical database lock criteria for the study, wherein different summary data will be generated for different clinical database lock criteria.