New Methodologies in Computer-Based Training for Adverse Event Reporting

Abstract

The United States Food and Drug Administration requires pharmaceutical companies to report adverse events that occur in association with the use of their products. Astra Pharmaceuticals' Product Safety Department has developed a computer-based training module to assist in training employees about reporting adverse event information. Computer-based training is a valuable tool because it can be made available wherever there is a computer, always presents the same material, allows the user to learn at his or her own pace, can be easily customized for many different end users, and can document training activities and employee understanding of relevant materials. The Astra Pharmaceuticals' Product Safety Department computer-based training module consists of a course overview followed by six chapters that introduce the employee to the concepts of identifying, classifying, communicating, and reporting adverse events. There is a quiz at the end of each chapter. The results of these quizzes are reported to the training supervisor via e-mail to document completion of the module. Employees have shown incremental improvement in their testing scores with the use of computer-based training, and this type of training has been shown to be effective for training multiple types of employees.