Pharmacovigilance and medical device safety system

摘要

The invention relates to the automatic warning, in particular early warning, in the occurrence of safety-relevant situations, in particular of complications, in the context of clinical studies. In this case, medical monitoring data in a first data format and reference data containing one or more safety-related test criteria for checking the observation data are received at a safety system (1) via one or more data interfaces (7 to 10). The received observation data is checked on the basis of at least one of the test criteria as to whether they meet the at least one test criteria, and if this is the case, the test result signaling first warning data generated (S4a) and automatic to one, in particular in the reference data, predetermined receiver circuit means sent an electronic notification and / or output to a data output device. In a second predetermined data format, case data are generated (S5) and output (S8), wherein the case data at least partially contain the observation data and optionally the first warning data.