A Comprehensive On-Line Collection System

Abstract

In the normal conduct of a clinical drug trial, a considerable time lag exists between the point when drug response data are collected, usually by means of a standard written case report form completed at the time of an individual patient visit, and the time when it is entered into the computer system (and thereafter available for assessment) in the sponsor's facility. This lag period may range from a matter of days to one or several months. Previous efforts to reduce this time span by providing electronic data entry capability within the clinical investigator's office have generally proven unsatisfactory for reasons of complexity and relative inaccuracy. A recently-developed potential solution to this entire problem will be described. It involves the provision of a microcomputer equipped with sophisticated customized data entry software that offers a means to substantially reduce this long-standing source of delays in the completion of clinical drug trials.