This Phase I application proposes to assess the feasibility of a handheld personal digital assistant (PDA) system (""""""""CliniPadTM"""""""") designed to support multi-site clinical trials in the recording, transmission, and storage of subject assessment and rating data. Clinical subject assessment and rating data collection using handheld PDA electronic source documents (ESDs) will improve both the efficiency and quality of clinical trials. Both of these improvements will in turn increase the quality of public health, and both hold potential for commercial value in the pharmaceutical sector where clinical trials are a necessary and on-going procedure. CliniPad will present interview and rating forms to the rater on their PDA, including forms the user has created. From there the user will select subject ratings and other notations from an on-screen visual display, and the data will be stored on the PDA. Data will be transferred from the PDA to a desktop computer, and then from the desktop computer to a central Internet web server, where data from multiple trial sites will be maintained, managed, and accessible from multiple sites. On the PDA, desktop computer, and web server, the data will be encrypted, password-protected, and stored in a database. There are four basic components to the CliniPad system's end-to-end data gathering and management infrastructure: (1) a form creation application; (2) the PDA data gathering applet; (3) server-based management and communication software; and (4) a back-end database. The form creation application allows users to design their own subject rating forms. The handheld data gathering applet allows users to use these forms on their PDA to collect subject ratings. The server software will handle all form and rating data transfers between the central server and the desktop computer (and the PDA in Phase II). The back-end database will provide a central management for data from all sites, and allow role-based secure access to data.
The health industry relies on clinical trials for the marketing of its products, and a system that facilitates and improves these trials will be useful to companies dependent upon clinical trial results for income.
