The study is preliminarily planned to start in Autumn 2021 after receiving permission from the Ethics Committee in all countries.
The proposed study is an observational study with no interference with the patient’s routine care, which is in accordance with the good clinical practice and no research-related interventions. Therefore, no ethical concerns are expected, and ethical approval may not be required in some centres. However, where ethical approval is required, this approval must be obtained before the start of inclusion.
A template that can be used for your application to the Ethics Committee:
ENCORE Ethics Committee Submission Accompanying letter Template
Each participating centre must report to ESAIC all the steps of Ethical submission and approval or notification, using the completed Approval Documentation Coversheet, to be signed sent to ESAIC with proof of approval/notification (local language is OK), by scan to firstname.lastname@example.org