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As the study has been deemed non-interventional by the ethics committee, legally no formal monitoring is requested. Nonetheless, the study will be monitored for quality and regulatory compliance. The monitoring will be supervised by the promoter (Dijon-Bourgogne University Hospital) in all of the participating centres. The frequency depends on inclusion rates, questions and pending issues from earlier audits: once or twice a year.
Copyright and License information: ©2017 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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