CLINICAL TRIAL ADVERSE EVENT DATA CHANGE REPORTING SYSTEM

摘要

A system is provided that sends data changes to a safety compliance management system. The system defines at least one data field as a significant data field. The system further monitors data, and identifies a change to the data. The system further determines whether the change to the data includes a change to at least one significant data field. The system further sends the data to the safety compliance management system when the change to the data includes a change to at least one significant data field.

主权项

1. A computer-readable medium having instructions stored thereon that, when executed by a processor, cause the processor to send data changes to a safety compliance management system, the sending comprising:
defining at least one data field as a significant data field; monitoring data, wherein the data comprises one or more data fields and one or more data values, and wherein the data is stored within an electronic data capture system; identifying a change to the data; determining whether the change to the data comprises a change to at least one data value associated with at least one significant data field; and sending the data to the safety compliance management system when the change to the data comprises a change to at least one data value associated with at least one significant data field.