Clinical trial system for clinical application, clinical trial management server, and clinical trial management program

摘要

The trial management server 300 randomly assigns the subject to either the treatment group or the control group based on the subject assignment factor information input together with the subject identification information from the doctor terminal 200, and the assignment information indicating the assignment result Is registered in the allocation database, and the allocation information is transmitted to the subject terminal 100. Then, when registering the subject identification information or the like in the allocation database, the lock of the access to the allocation database is released, and when the allocation information read from the allocation database is transmitted to the subject terminal 100, the lock is set. This allows both the subject and physician to conduct a clinical trial applying a placebo-controlled trial to a treatment app so that it does not know whether the subject is assigned to a treatment group or a control group. , Enabling randomization and double-blinding of allocation systematically.