Pre-Trial Testing of Case Report Forms in EDC Systems

This report outlines a comprehensive framework for the pre-trial testing of Case Report Forms (CRFs) within Electronic Data Capture (EDC) systems to ensure high-quality, reliable data collection in clinical trials. Pre-deployment validation of CRFs mitigates risks of data entry errors, logic failures, and workflow disruptions by identifying and correcting issues before trial launch. The testing process encompasses field-level validation (e.g., numeric ranges, date logic, required fields), input type appropriateness, and system behavior through simulated user workflows. It also includes verification of import/export processes, external tool integrations, report/dashboard accuracy, and user acceptance feedback. Tools such as REDCap, SPSS, and APIs facilitate this multi-layered assessment. The report presents detailed procedures for quality assurance using mock data, audit logs, and double data entry checks. A structured issue tracking and resolution system ensures that all problems are documented and addressed efficiently. Final validation is confirmed through standardized documentation and formal sign-off processes. This guide serves clinical data managers, EDC administrators, developers, QA professionals, and trial coordinators by promoting robust testing strategies that enhance protocol adherence, regulatory compliance, and overall trial readiness.