Data Handling

The unwanted events are recorded in a database. All plain text information is coded according to MedDRA (Medical Dictionary for Regulatory Activities Terminology). MedDRA is a validated medical directory and coding instrument recommended by international drug regulatory authorities.

The reporting of an adverse event to RABBIT does not release the participating physician from his obligation to report to the Medicines Commission of the German Medical Profession (AkdÄ) or to the manufacturer.