The system implements a flexible Role-Based Access Control through the User, User_roles, and User_has_Clinical_study entities, ensuring precise permission management for administrators, supervisors, and data entry staff across different studies.
By utilizing a Dynamic EAV (Entity-Attribute-Value) Architecture with data_variables and Clinical_data, the model supports non-static clinical labels and accommodates diverse data types such as numeric results and external file paths for genomics or imaging.
The database is designed for Longitudinal Data Tracking, using a dedicated visits entity to capture and organize time-series clinical observations throughout the duration of the hospital appointments for each participant.
To ensure Legal Compliance and Privacy, the model decouples sensitive personal information in identity_participants from the study-specific records, allowing the linking table to be stored in a physically separate and secure database.