Fig. 3

Sudo ER diagram of complex relationships between users and data sources. Users are granted access to subject records based on protocols. Each protocol groups a list of subjects that only authorized users can manage and are part are assigned to. Within the walls of a protocol, there are groups of subjects that allow for users to differentiate between institutional or site-based cohorts (i.e., organizations). Each unique subject enrollment creates a new record for that subject in the eHB. Within a protocol there are specific data entry points set up as protocol data sources (e.g., a REDCap case report form project or LIMS specimen project), and each user has credentials to each data source. Data sources are set up as clients to each external system represented in the BRP. In our case, we have created data sources for two systems, REDCap and ThermoFisher Nautilus LIMS