Fig. 4.

Models rated “Most suitable” by responding CTUs. ^aData storage and transfer. Direct transfer: data transferred to external users for secondary analyses. Restricted interface: data remain with the data custodian, but access is granted for external users to analyze data through a specific interface. Central repository: data are uploaded to, and downloaded from, a central independent repository. ^bApproval process. Learned intermediary: an Independent Review Board reviews requests and judges them based on criteria such as science, benefit-risk analysis, and competence of the requestor to perform the specified analyses. Internal review: specific detailed requests are placed with the custodian who assesses the request based on science, benefit-risk analysis, and competence of the requestor to perform the specified analyses. Open access: no approval required, data available for any user to access. CTUs, Clinical Trial Units.