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Resource implications of preparing individual participant data from a clinical trial to share with external researchers

  • Catrin Tudur Smith1Email author,
  • Sarah Nevitt1,
  • Duncan Appelbe1,
  • Richard Appleton2,
  • Pete Dixon3,
  • Janet Harrison1,
  • Anthony Marson3,
  • Paula Williamson1 and
  • Elizabeth Tremain4

Received: 30 January 2017

Accepted: 15 June 2017

Published: 17 July 2017

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Open Peer Review reports

Pre-publication versions of this article and author comments to reviewers are available by contacting

Original Submission
30 Jan 2017 Submitted Original manuscript
17 Apr 2017 Reviewed Reviewer Report - Marc Buyse
1 May 2017 Reviewed Reviewer Report - Frank Rockhold
30 May 2017 Author responded Author comments - Catrin Tudur Smith
Resubmission - Version 2
30 May 2017 Submitted Manuscript version 2
15 Jun 2017 Editorially accepted
17 Jul 2017 Article published 10.1186/s13063-017-2067-4

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 and author comments to reviewers are available by contacting All previous versions of the manuscript and all author responses to the reviewers are also available.

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

Authors’ Affiliations

Department of Biostatistics, University of Liverpool, Liverpool, UK
Alder Hey Children’s NHS Foundation Trust, Liverpool, UK
Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK
National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, University of Southampton, Southampton, UK