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4.4.4 Storing Trial IPD Securely

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Once transferred, IPD need to be stored securely by the central research team, with access limited to those members responsible for data management, checking and analysis, or overall conduct. They should have appropriate expertise in the handling of participant data, as well as training in data protection, and also should be prohibited from copying data to any mobile devices, laptops, memory sticks or cloud servers that have not been set up for the secure storage of confidential data.

It is recommended that the central research team retain the original version of each trial data file exactly as supplied. This can be used for cross checking, and provides a back‐up should any errors arise, for example, if the data file that the meta‐analysis team are working on becomes corrupted. A copy of the file should be made prior to any changes, such as re‐formatting, re‐coding or re‐defining variables (Section 4.5), being carried out. Firstly, the copy should be converted to the preferred software format (such as Stata, R or SAS) for the IPD meta‐analysis project, which nowadays is a fairly straightforward process, because statistical packages can recognise or import data from multiple other sources, and if they do not, a specialist transfer package such as StatTransfer can be utilised. It is useful to add a numeric trial identifier and label to the trial data file, so that when IPD are being checked, harmonised, merged and analysed subsequently, each trial can be easily identified in the outputs, analyses and forest plots.

Individual Participant Data Meta-Analysis

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