Download Clinical Trial Dashboard

Audit Trail, Table Export, Safety-Critical Field Gate, AESI Tracking, Forest Plot RR Toggle, Exposure-Adjusted Rate Table, Vendor File Documentation

• Audit trail – append-only session logging of all user actions (data loads, exports, workspace saves, filter changes) to ~/CTDashboard/audit/
• Table export – every data table now has an Export button; supports Excel (.xlsx) with automatic CSV fallback, all exports logged to audit trail
• Safety-critical field gate – AE and LB domains require AESER, AESEV, AEDECOD, and LBNRIND to be mapped before analysis proceeds; unmapped fields require explicit acknowledgement
• AESI group tracking – AE groups of interest defined in study config now appear as purple KPI cards on the Safety Overview with subject counts
• Forest plot RR toggle – switch between Risk Difference (Wald CI) and Relative Risk (log-based CI with continuity correction) via dropdown; log-scaled axis for RR
• Exposure-adjusted rate table – PT × Arm table showing events, patient-years, and rate per 100 PY nested alongside the existing exposure charts
• Validation Summary PDF – formal GAMP 5 vendor-file document (system description, risk assessment, functional verification reference, known limitations) for sponsor qualification files