Wellcome Group Computer-Based System for Worldwide Adverse Drug Reaction Report Management

Wellcome Group Clinical Safety Surveillance Service uses a mainframe database management system to store summarized case data. A PC-integrated software package is used for logging/tracking, regulatory authority reporting, and distribution of adverse drug reaction reports worldwide to operating companies. Both systems are menu-driven and considerable efforts have been made to automate routine data handling in a user-friendly manner. The system has been designed to try to avoid loss or undue delay of reports and to carry out extensive validation of input data.