EMPOWER is a Health Canada regulated trial investigating the use of Domperidone in an off-label indication. As such, it is our responsibility as the Sponsor to ensure the safety and well-being of each patient enrolled into the EMPOWER trial and to adhere to the regulations put in place to verify our compliance. In so doing, compliance and quality assurance will be closely monitored by the Coordinating Centre. These measures may require additional processes, but have been designed to limit excess work for each site.
If you have any questions or concerns regarding Health Canada regulations, please feel free to contact the EMPOWER Research Coordinator at email@example.com.