Translate requirements into relationships
Model cases, reporters, patients, products, events and submissions. Use cardinality and bridge tables to preserve many-to-many relationships and the context of a safety case.
Make integrity explicit
Normalization, primary and foreign keys, controlled values and Oracle SQL constraints express what a valid record should look like. Roles and security-point relationships model access concepts.
Evidence and scope
Conceptual and logical ERDs document an academic relational design for a fictional pharmacovigilance office.