Adverse event reporting
MDD, death
ADVERSE EVENTS, EVENTS
The current study is associated with a moderate risk as patients with moderate to severe MDD and CT can be seen as a vulnerable patient group. Solicited and spontaneously reported adverse events (AEs) are assessed in a structured manner during the study measurements. All SAEs that are associated with mental health excesses or death are reported to the accredited MREC according to its requirements after obtaining knowledge of the events. All (S)AEs are followed up until they have abated or until a stable situation has been reached.