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Trial management

AZ Alexander Zarbock
JG Joachim Gerß
HA Hugo Van Aken
AB Andreea Boanta
JK John A. Kellum
MM Melanie Meersch
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Initiation and close-out visits will be performed. The trial site will be regularly visited during recruitment and follow-up. The scope of these visits is to check compliance of the trial site with the study protocol and ‘good clinical practice’ rules. For all patients, the informed consent documents will be checked. In addition, source data verification of the key data (eligibility criteria, intervention, outcome measures) will be performed routinely in a random sample of 50 % of the patients. Monitoring will follow the standard operating procedure (SOP) based on the Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V. (TMF)-SOPs.

Copyright and License information: Zarbock et al. ©2016
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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