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Table 2 The legal agreements required to facilitate proposed safeguarded data sharing through CRIB

From: Developing a topic-based repository of clinical trial individual patient data: experiences and lessons learned from a pilot project

Stakeholder Document to sign
Trial data owners • Data sharing agreement to create the IPD dataset
• Data release form to permit transfer of cleaned, derived dataset to the repository
• Depositor agreement with the Institution hosting the repository
Institution hosting the IPD data set (e.g. University) Data transfer agreement
Institution hosting the repository (e.g. Cochrane) Data transfer agreement
Approved data users Research data access agreement with the Institution hosting the repository