Electronic data collection for clinical trials using tablet and handheld PCs

摘要

This paper describes a system that uses electronic forms to collect patient and procedure data for clinical trials. During clinical trials, patients are typically required to provide background information such as demographics and medical history, as well as review and complete any consent forms. Physicians or their assistants then usually have additional forms for recording technical data from the procedure and for gathering follow-up information from patients after completion of the procedure. This approach can lead to substantial amounts of paperwork to collect and manage over the course of a clinical trial with a large patient base. By using e-forms instead, data can be transmitted to a single, centralized database, reducing the problem of managing paper forms. Additionally, the system can provide a means for relaying information from the database to the physician on his/her portable wireless device, such as to alert the physician when a patient has completed the pre-procedure forms and is ready to begin the procedure. This feature could improve the workflow in busy clinical practices. In the future, the system could be expanded so physicians could use their portable wireless device to pull up entire hospital records and view other pre-procedure data and patient images.