Manage clinical trial data integrity through structured query resolution, source data verification, and rigorous audit trail standards.
This skill provides a comprehensive operational framework for clinical data management following FDA 21 CFR Part 11 and ICH-GCP E6(R2) standards. It guides users through the entire clinical data lifecycle, from designing CDASH-compliant Case Report Forms (CRFs) and implementing programmatic edit checks to managing the query lifecycle and executing secure database locks. It is essential for ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, and Accurate) are maintained, reducing regulatory risk and ensuring the reliability of clinical trial evidence.
주요 기능
012 GitHub stars
02CDASH-compliant CRF design and SDTM mapping guidance
03Comprehensive pre-database lock checklists and SAE reconciliation
04Risk-based Source Data Verification (SDV) and ALCOA+ assessment
05Programmatic edit-check specifications for real-time data validation
06Systematic query-resolution workflows with performance benchmarking
사용 사례
01Preparing for a clinical database lock by resolving queries and reconciling external data
02Ensuring GCP compliance and data integrity during routine clinical trial monitoring
03Designing validation rules and edit checks for a new Electronic Data Capture (EDC) system
