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. |