Audit Trail, Table Export, Safety-Critical Field Gate, AESI Tracking, Forest Plot Analytics, Exposure-Adjusted Rates, Vendor File Documentation
- Audit trail – append-only session logging of all user actions (data loads, exports, workspace saves, filter changes) to ~/CTDashboard/audit/ with cross-platform log viewer
- Table export – every data table now has an Export button; supports Excel (.xlsx) with automatic CSV fallback if openpyxl is unavailable; all exports logged to the audit trail
- Safety-critical field gate – AE and LB domains require AESER, AESEV, AEDECOD, and LBNRIND to be mapped before analysis proceeds; unmapped safety-critical fields require explicit user acknowledgement, logged to audit
- AESI group tracking KPIs – AE groups of interest defined in study config now appear as purple KPI cards on the Safety Overview showing unique subject counts
- Forest plot RR toggle – switch between Risk Difference (Wald CI) and Relative Risk (log-based CI with 0.5 continuity correction) via dropdown; log-scaled x-axis for RR with appropriate reference line
- Exposure-adjusted rate table – PT × Arm table showing events, patient-years, and rate per 100 PY; nested alongside the existing exposure-adjusted charts in a sub-tab
- Validation Summary PDF – formal GAMP 5 Category 4 vendor-file document covering system description, risk assessment, functional verification reference (161 checks + 115 tests), known limitations, and recommended qualification activities; downloadable from the docs page
ODM-XML Connector, XPT & Excel Support, Clinical Confirmation Flow
- ODM-XML connector – drop CDISC ODM-XML files directly into the platform; supports Medidata Rave, Oracle Clinical One, and any CDISC-compliant EDC export. Codelist decoding, field labels, and visit ordering extracted automatically from the file metadata
- XPT and Excel file support – SAS Transport (.xpt) and Excel (.xlsx / .xls) files now load alongside CSV
- Redesigned clinical confirmation flow – platform-field-centric mapping review replaces the previous column-centric dialog; rows represent fields the platform uses, yellow highlights fields missing from the source, per-domain tabs with match counts
- Improved connector experience – File → Connect Data now shows format-specific options (CSV, SAS XPT, Excel, ODM-XML) for a clearer import path
- Detection engine improvements – structural SDTM columns (DOMAIN, xxSEQ) now auto-recognised at HIGH confidence; DOMAIN_FIELDS trimmed to only fields the platform actually consumes
Validation Report, Methodology Footers & Bug Fixes
- Automated validation report – independently recalculates every displayed KPI from raw data and compares against the application’s output, with computation evidence and app screenshots
- Methodology & Assumptions footers – each tab now includes a collapsible footer disclosing the calculation methodology and clinical assumptions used
- Validation PDF in docs – downloadable validation report linked from the documentation site for sponsor review
- Fix: SAE counts per arm – serious adverse event tallies now correctly use the AE_SERIOUS column instead of the legacy AESER field
- Fix: Survival SAE crash – resolved a crash when the AESTDTC column was missing from SAE-filtered data
- Fix: Disposition KPIs – disposition section now shows the actual displayed KPI values instead of raw record counts
Auto-Update, Installer Improvements & UI Polish
- In-app auto-update – the app checks for new versions on startup and shows a subtle notification banner; download and silent install with one click
- Version display – current version shown in window title and status bar
- Installer improvements – directory selection page, silent update mode for seamless upgrades
- Improved app icon – multi-resolution icon (16px to 256px) for crisp display in taskbar, desktop, and Start Menu
DSUR Export, MedDRA Drill-Down, Comparison Tab, Field Mapping & More
- DSUR draft report export – generate ICH E2F-aligned Development Safety Update Reports as Word documents with auto-filled exposure, AE summary, SAE narrative, lab, and signal evaluation sections
- MedDRA drill-down – click body system bars in the AE dashboard to drill down to individual preferred terms; back button returns to SOC view
- Chart subtitles – every chart across the platform now shows small subtitles explaining active filter logic (e.g., relatedness criteria, flagging thresholds)
- Dedicated Comparison tab – self-contained incremental review page with Load Baseline, Clear, summary KPIs, and per-domain tables of new/modified records
- File-level data selection – Connect Data and Load Baseline now use a file picker instead of folder selection, letting you choose exactly which CSV files to load
- Field mapping dialog – visual column mapper shows “Your Column” mapped to “Maps To” CDASH fields with confidence scoring and manual override
- Session-based notes – reviewer notes are drafted per session and persisted in workspace files; unsaved notes prompt on close
- Dynamic chart scrolling – charts with many categories now expand dynamically with scroll containers instead of being clamped to a fixed height
- Comparison highlighting removed from other tabs to avoid conflicts with clinical safety colors (red/amber/green)
- Workspace files now store individual file paths instead of folder paths, and include reviewer notes
- All comparison processing remains in-memory – zero clinical data stored