Biomedical research projects involving multiple partners from public and private sectors require coherent internal governance mechanisms to engender good working relationships. The DIRECT project is an example of such a venture, funded by the Innovative Medicines Initiative Joint Undertaking (IMI JU). This paper describes the data access policy that was developed within DIRECT to support data access and sharing, via the establishment of a 3-tiered Data Access Committee. The process was intended to allow quick access to data, whilst enabling strong oversight of how data were being accessed and by whom, and any subsequent analyses, to contribute to the overall objectives of the consortium.

中文翻译：

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DIRECT 联盟中数据访问的治理结构：创新药物倡议 (IMI) 项目

涉及公共和私营部门多个合作伙伴的生物医学研究项目需要一致的内部治理机制，以建立良好的工作关系。DIRECT 项目就是此类企业的一个例子，由创新药物倡议联合组织 (IMI JU) 资助。本文描述了 DIRECT 中开发的数据访问策略，通过建立 3 级数据访问委员会来支持数据访问和共享。该流程旨在允许快速访问数据，同时能够对数据的访问方式、访问者以及任何后续分析进行强有力的监督，以促进联盟的总体目标。