The project calls for the maintenance of the following CTEP Information Systems: the Main Administrative System, the Phase II System, and the Drug Distribution and Protocol Monitoring System (DDPMS) with further development of linkages between these systems and with outside data bases. This project is a recompetition of the Cancer Therapy Evaluation Program Information System (CTEP-IS) contract that assists in the management of large amounts of clinical information, protocol administration data and drug information. The system will be expanded to include detailed scientific data on all protocols and drugs undergoing Phase I-III evaluation, and will be able to meet additional current and future needs of the CTEP such as maintenance of Investigational New Drug Exceptions and Adverse Drug Reaction files and automated support for the site visit monitoring function within the Investigational Drug Branch.
