Enrolling subjects before the Electronic Data Capture (EDC) system is ready poses major data integrity and compliance risks. The primary issue is that data cannot be accurately captured, validated, or monitored without the system in place.
Per the GCDMP (Chapter: Data Management Planning and Study Start-up), data collection systems must be fully validated, tested, and released before enrollment begins to ensure:
Real-time data entry and quality control
Proper tracking of adverse events (AEs/SAEs)
Audit trails and traceability for regulatory compliance
Option A highlights the most critical consequence - without an operational EDC, data collection and verification processes cannot occur, compromising data quality and study oversight.
While options B, C, and D may be partially true, they are secondary effects. The fundamental consideration is data capture capability and monitoring control, making option A correct.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Management Planning and Study Start-up, Section 4.2 - EDC Readiness and System Validation ICH E6(R2) GCP, Section 5.5.3 - Computerized Systems Validation Before Use FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.1 - System Qualification Prior to Data Entry