Adverse event reporting and harms
cognitive difficulties, anxio-depressive
ADVERSE EVENTS, ADVERSE EVENT
The project does involve interventions, but they are considered ‘low risk’ with no anticipated serious adverse events. Here, we should observe only mild adverse events related to the interventions, such as increased anxio-depressive affects in some patients when faced with cognitive difficulties. Such adverse events will be discussed with clinician and a trial safety group (composed of one principal investigator of the center, chief investigator, Trial Project Manager, one representative of patients) to determine the most appropriate response (e.g. mail to the general practitioner, psychological counselling outside of the intervention protocol). The date, description of the related adverse event, solution proposed will be recorded in the eCRF and in the source documentation (patient medical record). This information will be also transmitted to TSC.