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An important preparatory step is developing or selecting an appropriate data‐sharing agreement, as funders may require this to be included as part of a funding application, or require that it be agreed with them before funding is released (as these agreements often set out issues around intellectual property rights, amongst other things). The central research team for the IPD meta‐analysis project will almost certainly need to have the data‐sharing agreements approved by their institutional legal team, which can be time‐consuming, making it wise to start discussions early. In our experience, data‐sharing agreements can be unhelpfully obscure, written in legal language with terms worded in a way that may not best serve collaboration or persuade data providers to partner in the IPD project.

In an attempt to make agreements as clear as possible and more readily understood by those who are agreeing to work together (the IPD meta‐analysis team and the trial investigators), we have developed a data‐sharing agreement written in language as plain as possible. This has been used successfully in several projects. Researchers are free to use and adapt this under a creative commons licence. The agreement can be found in a forthcoming publication by Stewart et al., and will be available at www.ipdma.co.uk.

One aspect of sharing agreements that requires careful consideration is commitment from trial investigators not to withdraw their IPD once provided. Although the ability of either party to withdraw is often a standard component of contractual arrangements (and may be an option recommended by institutional legal teams), this would be problematic for IPD meta‐analysis projects. For example, in more than one of our previous IPD projects, certain trial investigators did not like the IPD meta‐analysis results produced, and then wanted to withdraw their IPD on that basis. Aside from the practical and resourcing difficulties arising from having to redo the IPD meta‐analysis, the subsequently reduced IPD meta‐analysis dataset could very well be biased (Chapter 9). For this reason, our model data‐sharing agreement restricts the right to withdraw data to instances where there is a breach of the agreement that cannot be resolved. For similar reasons, it is important that the agreement makes full reference to the IPD meta‐analysis protocol, including details of the planned analyses, in order that all partners have committed to these in advance (so that, after viewing the IPD meta‐analysis results, the way IPD were analysed could not be cited as grounds for withdrawing data).