Patent ID: 8041581
Filing Date: 2011-10-18
Classification: G06F,G16H

Abstract:
1. An integrated clinical trial data capture system comprising: a collecting means for electronically gathering clinical trial data at a clinical trial site; a clinical trial data server for capturing and instantly preserving all of the clinical trial data and clinical trial data related events as an electronic source document for the clinical trial immediately upon receipt by said clinical trial data server, wherein all of said electronic source documents are defined as a human readable computer file that cannot be edited or modified; a secure source data storage server in communication with said capturing means for archiving the clinical trial data in a trusted data server maintained by an independent third-party, by sending the source document from said capturing means to said secure source data storage server; said secure source data storage server transmitting an acknowledgement back to said clinical trial data server upon successful transmission of said secure document thereto, and said clinical trial data server being in communication with a clinical trial database for transmitting said source document to the clinical trial database only after successful transmission of said secure document to said secure source data storage server; an electronic health record database in communication with said source data storage server for receiving the clinical trial data exported from said source data storage server to update at least one individual's health records; an electronic interface for remotely accessing and viewing the archived clinical trial data for monitoring quality and integrity of the clinical trial data; and an audit trail that logs all clinical trial data-related events.