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Adverse experiences are reported as required by the IRB at each site. There are no additional US Food and Drug Administration regulations because we are not studying a biological agent. The Manual of Operations includes detailed definitions of adverse experiences, a table for grading their severity, and details of how clinical sites are to report them.
Copyright and License information: The Author(s). ©2017
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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