Encyclopedia

The process of randomly assigning study participants to different treatment arms in a clinical trial is called randomization. In order to avoid a potential bias, the allocation is not performed by an investigator or a sponsor’s representative. An investigator who is convinced of the investigational drug’s effectiveness might (possibly unintentionally) assign certain patients to the…

The goal of a registry is to enroll the highest possible number of patients in order to collect data. Patients who have a common attribute – e.g. are suffering from the same disease or receiving the same certain treatment – can become part of the registry. If the patients agree to participate, they give their…

Regulatory Affairs include all activities that predominantly deal with the regulations in the area of research, approval or marketing authorization. In pharmaceutical research, the Regulatory Affairs sector includes the application for approval / a positive opinion regarding the conduct of a clinical trial, the subsequent steps such as the reply to deficiency letters, notification of…