Patent ID: 7885825
Filing Date: 2011-02-08
Classification: G16H,H04L

Abstract:
1. A clinical trial data management system comprising: a document management system and operator workstations, programmed to control the steps of receiving and indexing clinical trial response data in electronic form via the Internet and in hard copy form with scanning and indexing case record forms of clinical response data; a cluster of clinical data management application servers linked by a network to the document management system and the client workstations, the clinical data management application servers being programmed to: a cluster of work flow servers linked in a network with a second storage area network and with said clinical data management application servers, said work flow servers maintaining a work flow database in a second storage area network; means in the clinical data management application servers for automatically updating the work flow servers with updates as clinical response data is written to the clinical data database, the work flow servers in response writing item history data to the work flow database in synchronism with the clinical response data updates to the clinical data database; database servers for both of the storage area networks, at least some of said servers comprising means for automatically replicating the clinical data database and the work flow database to mirrored databases at separate sites; and means in said work flow and database servers for automatically archiving the work flow data independently of the clinical trial response data database; wherein the clinical data management application servers and the work flow servers operate in synchronism to generate a simultaneous display of an image of a case record form, a display of associated work flow data, and a display of a data entry window for entry of clinical response data both automatically by the clinical data management application servers and manually by an operator; wherein said clinical data management application servers recognize completion of the data entry window as an event for simultaneous updates to the clinical data database and to the work flow database; and wherein said clinical data management application servers and said work flow servers iteratively perform data entry and cleaning with query management operations, in which the query management operations comprise generating a query form for an investigator and monitoring responses from the investigator.