Therapeutic application clinical trial system, 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 assignment factor information of the subject input together with the subject identification information from the doctor terminal 200, and the assignment information indicating the assignment result. Is registered in the assignment database, and the assignment information is transmitted to the subject terminal 100. Then, at the time of registering the subject identification information and the like in the allocation database, the lock on access to the allocation database is released, and the lock is set when the allocation information read from the allocation database is transmitted to the subject terminal 100. This ensures that both the subject and the physician do not know whether the subject is assigned to the treatment group or the control group, and to conduct a trial using a placebo-controlled trial for the therapeutic app. , So that randomization and double-blinding of the allocation can be realized systematically.