Aware of its obligations as a health player and partner alongside the Pharmaceutical Industry, VICTA Conseil is committed to pharmacovigilance.
Any undesirable effect, any situation to be notified or any complaint, associated with a laboratory product collected within the framework of the study, will be reported immediately or at the latest within 24 hours of becoming aware, regardless of the severity of the 'event.
To meet its obligations in terms of pharmacovigilance VICTA Conseil undertakes to train and enforce the same obligations for all of its employees, throughout the duration of the study.
The laboratory must make available to ViCTA Conseil a summary document setting out the specificities and principles to which it is attached in the area of pharmacovigilance. This document will be used to train ViCTA Conseil employees in charge of the service.
As part of its interventions, ViCTA Conseil will transmit:
Systematically at the end of the field, a reconciliation form summarizing all the cases brought up during the study.
On request a quality control form for source data.