When a company transitions from paper-based data capture to Electronic Data Capture (EDC) systems, one of the most critical areas requiring procedural updates is the Data Review and Validation SOP. The introduction of EDC systems fundamentally changes how data is collected, reviewed, validated, and queried.
According to the Good Clinical Data Management Practices (GCDMP), the implementation of EDC introduces real-time data entry and review, automated edit checks, and electronic query management. These functionalities necessitate revised procedures to define how data validation, discrepancy management, and monitoring are conducted electronically. The SOP must specify roles, responsibilities, system access controls, and processes for electronic source verification (eSource), ensuring compliance with 21 CFR Part 11 and ICH E6 (R2) requirements.
Other SOPs such as Handling External Data or Data Backup may require minor updates, but the Data Review and Validation SOP undergoes the most extensive change because EDC technology shifts validation responsibilities from post-data entry review to real-time oversight within the system.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture (EDC) Systems, Section 6.3 - SOP Adaptation for EDC Implementation FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures ICH E6 (R2) Good Clinical Practice, Section 5.5.3 - Data Handling and Validation