Clinical trial data management apparatus and method for generating EDC form thereof

摘要

A clinical trial data management device and a method of generating an EDC form thereof are disclosed. The EDC form creation method is a step of receiving a test protocol according to a test protocol for a clinical trial, applying the input test protocol to a basic template in a pre-made csv file format to create a CSV template, and using the generated CSV template. By converting to json file format and creating a JSON template, creating a final JSON template by applying the mapping data of the variable definition table to the generated JSON template, and creating a project using the generated final JSON template. , Creating an EDC form.