The purpose of this project is to modify and enhance Information Analysis Corporation's MEDLOG clinical data management system for use as a remote data entry system in multi-center clinical trials, particularly in the area of cancer research. Remote data entry is a new technology which holds much promise for improving the quality and timeliness of multi-center clinical trial data and for lowering the cost of conducting trials. In remote data entry systems, clinic staff enter patient data into a microcomputer, and the data are transmitted at frequent intervals to the coordinating center. The proposed work is the development of computer software to support a remote data entry system for clinical trials, including: 1) Improved data entry, error checking, and reporting capabilities. 2) Procedures for sharing data between clinic and coordinating center. 3) Clinical trial administrative facilities such as treatment randomization and appointment scheduling. 4) Large computer versions of the MEDLOG system. There is great interest in remote data entry among non-profit institutions and pharmaceutical companies, and a strong demand for the proposed product is expected. In Phase I a set of specifications for a MEDLOG-based remote data entry system will be prepared. The work will include identifying requirements, reviewing alternatives, and drawing up a detailed plan for the necessary software development work. Phase II of the project will carry out the software production planned in Phase I.
