Data Management Systems, Technology, and Data Integrity
Modern CDM runs on electronic systems: EDC (electronic data capture), ePRO, eSource, CTMS, and safety databases. Candidates must understand system validation (per GAMP/CSV principles), user access controls (unique IDs, role-based permissions), audit trails, and electronic signatures (21 CFR Part 11). Data integrity relies on ALCOA+ and on controls that prevent unauthorized changes while preserving a complete history.
Key concepts: computerized system validation (IQ/OQ/PQ or risk-based equivalents), change control, business continuity and disaster recovery, and data migration integrity. Understand the difference between source and transcribed data in eSource models, and how ePRO data flows into EDC with timestamps. Understand that audit trails must capture who, what, when, and why (reason for change) and must be reviewable.
Traps: assuming a validated system never needs revalidation after changes (change control triggers impact assessment); sharing login credentials (violates attributability); treating an electronic signature as equivalent to a scanned signature image (Part 11 signatures require identity verification and are legally binding); and ignoring time-zone handling in timestamps. Another trap: assuming audit trail review is optional - it is a required data integrity control.
Rule of thumb: every electronic record must be attributable to a unique person and every change must be traceable. Worked example: a coordinator uses a shared account to enter data. This breaks attributability and Part 11 compliance; the fix is unique credentials per user, role-based access, and audit trail review - not merely a password reset.