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Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting

BMC Medical Research MethodologyBMC series – open, inclusive and trusted201616:159

Received: 22 July 2016

Accepted: 7 November 2016

Published: 22 November 2016

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Open Peer Review reports

Pre-publication versions of this article are available by contacting

Original Submission
22 Jul 2016 Submitted Original manuscript
Author responded Author comments
Reviewed Reviewer Report
Resubmission - Version 2
Submitted Manuscript version 2
Author responded Author comments
Resubmission - Version 3
Submitted Manuscript version 3
7 Nov 2016 Editorially accepted
22 Nov 2016 Article published 10.1186/s12874-016-0259-3

How does Open Peer Review work?

Open peer review is a system where authors know who the reviewers are, and the reviewers know who the authors are. If the manuscript is accepted, the named reviewer reports are published alongside the article. Pre-publication versions of the article are available by contacting

You can find further information about the peer review system here.

Authors’ Affiliations

Institute of Medical Informatics, University of Münster, Münster, Germany
University of Dundee, Dundee, UK
Département d’Informatique Hospitalière, AP-HP, Hôpital Européen Georges Pompidou, Paris, France
CHIME, Institute of Health Informatics, University College London, London, UK
Previously Bayer Healthcare, Leverkusen, Germany
Novartis Pharma AG, Basel, Switzerland
Chair of Medical Informatics, University of Erlangen/Nuremberg, Erlangen, Germany