Electronic clinical examination information gathering system, electronic clinical examination information gathering method, electronic clinical examination information gathering program and computer readable recording medium having the same

摘要

PROBLEM TO BE SOLVED: To provide an EDC system that can freely add, modify, search, and collect a record relating to a data input field in an eCRF form while running a database management system, and can quite easily convert an electric case report form into a prescribed form such as a CDISC format and the like, and output the electric case report form in the prescribed form.SOLUTION: The eCRF form to be prepared and stored by an EDC server 100A is configured so as to be described by an associative array composed of a set of an item name (key) relating to one data input field (record) and a data input value (value) corresponding to the item name. Further, in a case where a data input value to the data input field is output by the CDISC SDTM formats, information on a domain, a variable, a repeating number of the item and the like in this case is configured to be described as meta data on the data input field.