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Data sharing in clinical trials - practical guidance on anonymising trial datasets

There is an increasing demand by non-commercial funders that trialists should provide access to trial data once the primary analysis is completed [1]. This has to take into account concerns about identifying individual trial participants, and the legal and regulatory requirements.

Using the good practice guidelines on data sharing laid out by the work funded by the MRC Network of Hubs for Trials Methodology Research [2], a collaborative effort between the University of Edinburgh and Queen Mary University of London, as part of the Asthma UK Centre for Applied Research, is devising processes and mechanisms for user access control, anonymisation and sharing of clinical trial data.

As part of this, we have anonymised a dataset from a recently completed trial [3]. Using this example, we will present practical guidance on how to anonymise a dataset, and describe rules that could be used on other trial datasets. We will describe how these might differ if the trial was to be made freely available to all, or if the data could only be accessed with specific permission and data usage agreements in place.


  1. []

  2. Tudur Smith C, Hopkins C, Sydes M, Woolfall K, Clarke M, Murray G, Williamson P: Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials. 2015

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  3. Bronchiolitis of Infancy Discharge Study (BIDS). []

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.

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Tuck, C., Lewis, S., Milne, G. et al. Data sharing in clinical trials - practical guidance on anonymising trial datasets. Trials 16 (Suppl 2), O66 (2015).

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