A REMOTE DATA ENTRY SYSTEM FOR CANCER CLINICAL TRIALS

THE GOAL OF THIS PROJECT IS TO MODIFY AND ENHANCE THE MEDLOG CLINICAL DATA MANAGEMENT SYSTEM FOR USE AS A REMOTE DATA ENTRY SYSTEM IN MULTICENTER CLINICAL TRIALS, PARTICULARLY IN THE AREA OF CANCER RESEARCH. REMOTE DATA ENTRY IS A NEW TECHNOLOGY AIMED AT IMPROVING THE QUALITY ANDTIMELINESS OF MULTICENTER CLINICAL TRIAL DATA AND LOWERING THE COST OF CONDUCTING TRIALS. IN REMOTE DATA ENTRY SYSTEMS, CLINIC STAFF ENTER PATIENT DATA INTO A MICRO- COMPUTER AND THE DATA ARE TRANSMITTED AT FREQUENT INTERVALS TO THE COORDINATING CENTER. THIS PROJECT WILL DEVELOP 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; AND (4) LARGE COMPUTER VERSIONS OF THE MEDLOG SYSTEM. IN THIS PHASE I PROJECT, 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 PLANS TO CARRY OUT THE SOFTWARE PRODUCTION DESIGNED IN PHASE I.