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Sharing and reuse of individual participant data from clinical trials: principles and recommendations
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  • Published on:
    Follow-up paper to the data sharing initiative, intended as a first step towards a generic but practical framework
    • Christian Ohmann, Consultant European Clinical Research Infrastructure Network (ECRIN)

    In the original publication a consensus document on providing access to individual participant data (IPD) from clinical trials was developed, using a broad interdisciplinary approach within the H2020 funded project CORBEL. The taskforce reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. What was still missing was a generic framework or architecture for data sharing that could be used for modelling, describing, and designing operations, data requirements, IT-systems and technological solutions. As a first step in developing an inventory of existing tools/services, and examining their quality and applicability for data sharing, a systematic analysis of processes and actors involved in data sharing was performed, based on the consensus document and summarized in a follow-up paper (1). The work done resulted in a systematic and comprehensive list of the processes and subprocesses that need to be supported to make data sharing a reality in the future. It is foundational work against which existing tools/services can be mapped, and gaps, where new tools/services are needed, can be identified. This follow-up work will facilitate the extension of the ideas in the original paper to create a generic but practical framework for the sharing of IPD from clinical trials. That framework is currently under development.

    Reference

    1. Ohmann C, Canham S, Banzi R e...

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    Conflict of Interest:
    None declared.