DIGITAL CRF FILE, DIGITAL CRF PROGRAM, AND DIGITAL CRF CREATION SUPPORT DEVICE

摘要

PPROBLEM TO BE SOLVED: To provide a digital CRF (case report form) creation support device making it possible to reduce the labor required to create case report forms for clinical trial during the process of developing a new medicine and manage contents written on the case report forms. PSOLUTION: The digital CRF creation support device has a digital CRF file and a digital CRF program. The digital CRF file comprises a form data structure which makes a case report form when displayed in a display device or printed, and an information data structure for retaining information defining the attributes of values to be input to the input boxes of the form data structure, information indicating the input boxes to be filled, information for checking input errors, and information for medically checking the input values. In accordance with the information held in the information data structure, the digital CRF program sequentially manages the values input to the input boxes of the form data structure displayed. PCOPYRIGHT: (C)2003,JPO