Which is the MOST appropriate flow for EDC set-up and implementation?
Correct Answer: B
The correct and compliant sequence for EDC system setup and implementation begins only after the study protocol is finalized, as all case report form (CRF) designs, database structures, and validation rules derive directly from the finalized protocol. According to GCDMP (Chapter: EDC Systems Implementation), the proper order is: Protocol finalized - defines endpoints and data requirements. Database created - built according to the protocol and CRFs. Edit checks created - programmed to validate data entry accuracy. Database tested (UAT) - ensures functionality, integrity, and compliance. Sites trained and system released - only then can data entry begin. Option B follows this logical and regulatory-compliant sequence. Other options (A, C, D) are either paper-based workflows or violate GCP-compliant timelines (e.g., enrolling subjects before database validation). Reference (CCDM-Verified Sources): SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 - System Setup and Implementation Flow ICH E6(R2) GCP, Section 5.5.3 - Computerized Systems Validation and User Training Before Use FDA 21 CFR Part 11 - Validation and System Release Requirements
