Armor: ICI's Automated Tracking System for Adverse Events from Clinical Trials

An important responsibility of a pharmaceutical company is proper and effective management of reports of adverse events for patients receiving their drugs. In this regard, there are ethical as well as regulatory considerations. Because of the time frame in which certain adverse event reports from clinical trials must be filed with the Food and Drug Administration, ICI Pharmaceuticals Group has developed a computerized data base system with monitoring and reporting capabilities. The system described is menu-driven for user-friendly data input, and automated for efficient production and distribution of reports. Under optimal conditions, the appropriate data can be entered and reviewed in 1 day and the report distributed the next day.