EDC System Requirements and Architecture
What you must know
An electronic data capture (EDC) system must support protocol-driven data collection, audit trails, role-based access, and export capability. Architecture questions test understanding of tiers: presentation (browser), application (business logic), and database (persistence). Understand the difference between an EDC and an electronic source (eSource), and how integration with ePRO, CTMS, and lab systems works via APIs or file transfers.
Concepts to master
Know that 21 CFR Part 11 requires validated systems, accurate and complete records, audit trails, and controlled access. Understand metadata-driven design: forms, fields, edit checks, and rules defined at build time. Know that the audit trail must capture who, what, when, and why, and must be immutable. Recognize the role of a data transfer specification (DTS) and the importance of unique subject identifiers.
Traps
Questions confuse the application tier with the database tier, or imply that a vendor's SOC 2 report alone validates the system. Watch for wording that treats ePRO as a replacement for EDC when it is a data source feeding it. Another trap: assuming audit trails can be edited by administrators.
Rule of thumb
If a system creates, modifies, maintains, archives, retrieves, or transmits records in place of paper, assume Part 11 applies until proven otherwise, and verify the audit trail is tamper-evident.