Method for collecting, processing, and storing discrete data records based upon a single data input

A method of maintaining discrete data records based upon a single clinical data input consisting of the steps of:

• a system user logging into a system for capturing clinical trial data with a unique user ID;
• electronically transmitting clinical trial data and data-related events from a workstation at a clinical location to a central data server;
• instantly capturing the collected clinical trial data and data-related events including existing data and modifications to existing data as an electronic source document in a human-readable file-format in the central data server;
• transmitting, by the central data server, the source document to a source data storage server that is independent of control by the central data server, wherein the central data server is not controlled by the source data storage server;
• securely archiving the source document including existing data and modifications to existing data in the source data storage server on computer readable media;
• transmitting only an acknowledgement from the source data storage server back to the central data server upon successful independent archiving of the source document in the source data storage server;
• transmitting the source document from the central data server to a clinical trial database and preventing deletion of the source document from the source data storage server at any time;
• storing the source document in the clinical trial database;
• remotely accessing the clinical trial data through a remote access interface with the source data storage server;
• and
• tracking data-related events in the clinical trial database by logging and storing on computer readable media all clinical trial data and clinical trial data-related events in an audit trail by maintaining a comprehensive audit trail log and history of all data-related activity and communications, and providing a reason for any modification of data and storing the modification with the clinical trial data.