INTEGRATED CLINICAL TRIAL APPARATUS BASED ON CDISC

摘要

In the clinical trial apparatus of the present invention, a test protocol analysis module 100 for generating and storing one or more of a test information table, an adverse reaction table, a risk prediction table, or a test plan statement result by analyzing a test plan input from a sponsor or researcher And an EDC form generation module 200 for generating electronic data capture (EDC) forms by integrating screen configuration priority information inputted from a test operator and test information of a test information table, and information of the test information table or a risk prediction table. The test module 300 for calculating one or more of a clinical trial plan, a test report, a user acceptance test report, a production report, or a risk prediction report, and the electronic clinical test data. For example, EHR) or data input / lower to store the clinical investigator input data or query list in the clinical trial DB unit 900. Chapter 400, test progress control / monitoring module 500 for generating control or monitoring information on the test progress, report generation module 600 and test plan for generating statistical processing result list and statistical report Clinical trial data including one or more of analytical information, EDC screen information, test (DMP) plan, test report, risk prediction report, query result list log, DB access list, risk prediction result list, statistical processing result list or statistical report It includes a clinical trial DB unit 900 to store the.