The most common mode of data entry in Electronic Data Capture (EDC) systems is single data entry.
According to the GCDMP (Chapter: Electronic Data Capture Systems), EDC systems have built-in edit checks, validation rules, and audit trails that ensure data accuracy and integrity at the point of entry. These real-time validation capabilities make double data entry (a legacy practice from paper studies) unnecessary.
EDC systems automatically verify data as they are entered by site staff, generating queries for inconsistencies or out-of-range values immediately. Blind verification (option B) and third-party comparisons (option D) are not standard data entry modes but may be used for specialized reconciliation or external data imports.
Thus, single data entry (Option C) is the industry standard approach, ensuring both efficiency and compliance with FDA 21 CFR Part 11 and ICH E6 (R2) data integrity requirements.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture (EDC) Systems, Section 5.4 - Data Entry and Verification Processes ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Computerized Systems and Data Validation FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures: Validation and Data Entry Requirements