Publicly funded Clinical Trials Units (CTUs) provide infrastructure and multi-disciplinary teams of researchers that design, conduct, analyse and report clinical trials. Sharing Individual Participant Data (IPD) from clinical trials offers numerous well recognised advantages that can advance clinical research and benefit patients. The clinical trial community, including publicly funded CTUs, have a duty to facilitate this process. This document summarises good practice principles for publicly funded CTUs to follow when sharing IPD and associated documentation from a clinical trial. Whilst there are several different approaches that could be taken to sharing IPD from clinical trials, this document focusses on a controlled access approach. This facilitates the responsible sharing of ‘richer data’ for research purposes within the confines of a system that aims to protect patient privacy. The UK Clinical Research Collaboration (UK CRC) registered CTUs unanimously supported the use of a controlled access approach to sharing IPD in a survey which informed the development of this guidance(1).The content of this guidance has been further informed by literature, the internet and expert opinion as part of a research project funded by the Medical Research Council (MRC) Hubs for Trials Methodology Research (MR/L004933/1-R39) led from the North West Hub at the University of Liverpool. The good practice principles proposed are the result of a consultative process and take into account several other current initiatives in the field of data sharing. This guidance has been endorsed by Cancer Research UK, MRC Methodology Research Programme Advisory Group, Wellcome Trust and the Executive Group of the UK CRC Registered CTUs Network. The National Institute for Health Research (NIHR) has confirmed it is supportive of the application of this guidance

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