Abstract

There has been intense activity during the past 2 years in exploring the applications of personal or microcomputers (PCs) as a means of capturing data emanating from clinical investigations. A number of pharmaceutical companies, including Ives Laboratories, have explored this method. Conceptually, this idea is very appealing. Properly posed to management or the medical monitor, the presenter can argue that this method of capturing data is the most effective (both in cost and time) and superior to other currently available procedures. However, detailed examination of this technology reveals that before this method of data collection can be accepted as viable and effective, especially on a large scale, a number of issues must be resolved. The purpose of this paper is to examine these issues, especially in the context of clinical research as sponsored by the pharmaceutical industry. An alternative approach to remote data entry, utilizing the currently available facsimile transceiver technology, is discussed.

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